Gilead Sciences (GILD - Free Report) closed the most recent trading day at $129.31, moving -1.18% from the previous trading session. The stock fell short of the S&P 500, which registered a gain of 0.05% for the day. Elsewhere, the Dow gained 0.46%, while the tech-heavy Nasdaq lost 0.64%.
The HIV and hepatitis C drugmaker's stock has climbed by 5.67% in the past month, exceeding the Medical sector's gain of 3.64% and the S&P 500's gain of 0.61%.
Analysts and investors alike will be keeping a close eye on the performance of Gilead Sciences in its upcoming earnings disclosure. The company's earnings report is set to go public on August 4, 2026. The company is expected to report EPS of -$7.09, down 452.74% from the prior-year quarter. Our most recent consensus estimate is calling for quarterly revenue of $7.37 billion, up 4.02% from the year-ago period.
In terms of the entire fiscal year, the Zacks Consensus Estimates predict earnings of -$0.77 per share and a revenue of $30.38 billion, indicating changes of -109.45% and +3.18%, respectively, from the former year.
It is also important to note the recent changes to analyst estimates for Gilead Sciences. These revisions help to show the ever-changing nature of near-term business trends. Hence, positive alterations in estimates signify analyst optimism regarding the business and profitability.
Research indicates that these estimate revisions are directly correlated with near-term share price momentum. To benefit from this, we have developed the Zacks Rank, a proprietary model which takes these estimate changes into account and provides an actionable rating system.
The Zacks Rank system, spanning from #1 (Strong Buy) to #5 (Strong Sell), boasts an impressive track record of outperformance, audited externally, with #1 ranked stocks yielding an average annual return of +25% since 1988. Over the last 30 days, the Zacks Consensus EPS estimate has moved 2.87% higher. At present, Gilead Sciences boasts a Zacks Rank of #3 (Hold).
The Medical - Biomedical and Genetics industry is part of the Medical sector. This group has a Zacks Industry Rank of 91, putting it in the top 37% of all 250+ industries.
The Zacks Industry Rank assesses the strength of our separate industry groups by calculating the average Zacks Rank of the individual stocks contained within the groups. Our research shows that the top 50% rated industries outperform the bottom half by a factor of 2 to 1.
Don't forget to use Zacks.com to keep track of all these stock-moving metrics, and others, in the upcoming trading sessions.
Bank of Nova Scotia trimmed its holdings in Gilead Sciences, Inc. (NASDAQ:GILD – Free Report) by 41.1% during the first quarter, according to the company in its most recent filing with the Securities and Exchange Commission. The fund owned 723,376 shares of the biopharmaceutical company’s stock after selling 503,903 shares during the period. Bank of Nova Scotia owned 0.06% of Gilead Sciences worth $100,817,000 as of its most recent filing with the Securities and Exchange Commission.
Several other hedge funds have also recently added to or reduced their stakes in GILD. Strategic Investment Solutions Inc. IL acquired a new stake in shares of Gilead Sciences in the fourth quarter valued at approximately $25,000. Vermillion & White Wealth Management Group LLC increased its stake in shares of Gilead Sciences by 71.4% during the 4th quarter. Vermillion & White Wealth Management Group LLC now owns 204 shares of the biopharmaceutical company’s stock worth $25,000 after purchasing an additional 85 shares in the last quarter. Quattro Advisors LLC acquired a new position in shares of Gilead Sciences during the 4th quarter worth approximately $26,000. Wealth Preservation Advisors LLC raised its position in shares of Gilead Sciences by 60.0% during the 4th quarter. Wealth Preservation Advisors LLC now owns 216 shares of the biopharmaceutical company’s stock worth $27,000 after purchasing an additional 81 shares during the last quarter. Finally, Ares Financial Consulting LLC purchased a new stake in Gilead Sciences in the 4th quarter valued at approximately $28,000. 83.67% of the stock is currently owned by hedge funds and other institutional investors.
Gilead Sciences Trading Up 0.4% Shares of GILD opened at $130.86 on Friday. Gilead Sciences, Inc. has a twelve month low of $108.46 and a twelve month high of $157.29. The firm has a market capitalization of $162.47 billion, a P/E ratio of 17.83 and a beta of 0.32. The company has a current ratio of 1.97, a quick ratio of 1.77 and a debt-to-equity ratio of 0.89. The stock’s fifty day simple moving average is $129.55 and its 200 day simple moving average is $135.54.
Gilead Sciences (NASDAQ:GILD – Get Free Report) last posted its quarterly earnings results on Thursday, May 7th. The biopharmaceutical company reported $2.03 earnings per share (EPS) for the quarter, beating analysts’ consensus estimates of $1.91 by $0.12. The firm had revenue of $6.96 billion during the quarter, compared to the consensus estimate of $6.91 billion. Gilead Sciences had a return on equity of 48.19% and a net margin of 30.99%.The firm’s quarterly revenue was up 4.4% compared to the same quarter last year. During the same quarter in the previous year, the business earned $1.81 earnings per share. Gilead Sciences has set its FY 2026 guidance at -1.050–0.650 EPS. On average, equities research analysts forecast that Gilead Sciences, Inc. will post -0.77 earnings per share for the current year.
Gilead Sciences Announces Dividend The company also recently announced a quarterly dividend, which was paid on Monday, June 29th. Stockholders of record on Monday, June 15th were issued a dividend of $0.82 per share. The ex-dividend date was Monday, June 15th. This represents a $3.28 dividend on an annualized basis and a dividend yield of 2.5%. Gilead Sciences’s payout ratio is presently 44.69%.
Analysts Set New Price Targets Several equities analysts have weighed in on the company. Wall Street Zen raised Gilead Sciences from a “hold” rating to a “buy” rating in a research report on Sunday, July 12th. Weiss Ratings downgraded Gilead Sciences from a “buy (b)” rating to a “buy (b-)” rating in a research report on Thursday, May 28th. HSBC upgraded Gilead Sciences from a “hold” rating to a “buy” rating and upped their price objective for the company from $133.00 to $155.00 in a research report on Monday, July 6th. Leerink Partners cut Gilead Sciences from an “outperform” rating to a “market perform” rating and dropped their price objective for the stock from $146.00 to $127.00 in a research report on Tuesday. Finally, The Goldman Sachs Group boosted their target price on shares of Gilead Sciences from $125.00 to $130.00 and gave the company a “neutral” rating in a research note on Friday, April 17th. Twenty-five equities research analysts have rated the stock with a Buy rating and four have assigned a Hold rating to the stock. According to MarketBeat.com, the stock presently has a consensus rating of “Moderate Buy” and an average target price of $158.33.
Get Our Latest Analysis on GILD
Insider Transactions at Gilead Sciences In other Gilead Sciences news, CEO Daniel Patrick O’day sold 15,000 shares of Gilead Sciences stock in a transaction that occurred on Wednesday, July 1st. The shares were sold at an average price of $126.29, for a total transaction of $1,894,350.00. Following the transaction, the chief executive officer directly owned 607,133 shares of the company’s stock, valued at $76,674,826.57. The trade was a 2.41% decrease in their ownership of the stock. The sale was disclosed in a filing with the SEC, which is accessible through this hyperlink. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan. Also, CFO Andrew D. Dickinson sold 3,000 shares of the business’s stock in a transaction that occurred on Monday, June 15th. The stock was sold at an average price of $125.40, for a total transaction of $376,200.00. Following the sale, the chief financial officer owned 171,646 shares of the company’s stock, valued at approximately $21,524,408.40. This represents a 1.72% decrease in their ownership of the stock. Additional details regarding this sale are available in the official SEC disclosure. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan. In the last quarter, insiders sold 77,000 shares of company stock worth $9,978,740. 0.30% of the stock is currently owned by company insiders.
Gilead Sciences Company Profile (Free Report)
Gilead Sciences, Inc, founded in 1987 and headquartered in Foster City, California, is a biopharmaceutical company focused on the discovery, development and commercialization of medicines in areas of high unmet medical need. The company initially built its reputation in antiviral therapies and has since expanded into oncology, cell therapy and inflammatory diseases. Gilead operates a global research and commercial organization, conducting clinical development and selling medicines in markets around the world.
Gilead’s product portfolio is anchored by antiviral therapies for HIV and viral hepatitis.
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FOSTER CITY, Calif.--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending the marketing authorization of Trodelvy® (sacituzumab govitecan-hziy) in combination with Keytruda® (pembrolizumab), for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received.
Key Takeaways Gilead raised 2026 HIV sales growth guidance to about 8% on strong HIV performance and Yeztugo guidance.GILD and Merck reported positive phase III data for a once-weekly oral HIV regimen supporting filings.Gilead expects no major HIV exclusivity losses until 2036 and sees up to seven new HIV therapies by 2033. Gilead Sciences, Inc. (GILD - Free Report) has a market-leading HIV franchise, led by flagship HIV therapies — Biktarvy for treatment and Descovy for prevention.
The company’s HIV business continues to maintain momentum, driven by solid performances of Biktarvy and Descovy, and incremental contributions from Yeztugo.
Biktarvy continues to be a dominant player in the HIV treatment market, holding more than 52% market share and retaining its position as the most prescribed therapy for both treatment-naïve and switch patients across major markets.
Gilead’s HIV pre-exposure prophylaxis (PrEP) portfolio comprises daily oral Descovy and the first and only twice-yearly injectable Yeztugo.
Descovy’s performance continues to be strong, primarily driven by higher demand and average realized price.
The approval of injectable lenacapavir, a first-in-class capsid inhibitor (under the brand name Yeztugo), has solidified GILD’s HIV portfolio. With a twice-yearly dosing schedule, the therapy offers meaningful adherence advantages over daily oral regimens and targets a broad patient population.
Driven by increased Yeztugo sales expectations and strong first-quarter HIV performance, Gilead now projects total 2026 HIV sales growth of approximately 8% year over year, up from its prior guidance of 6% issued in February.
Gilead continues to make efforts to strengthen its HIV portfolio further. The company has also collaborated with Merck (MRK - Free Report) to advance its HIV pipeline.
Gilead and Merck recently announced positive phase III results from the ISLEND-1 and ISLEND-2 studies evaluating their investigational once-weekly oral HIV regimen, islatravir plus lenacapavir. At week 48, the regimen was non-inferior to daily standard-of-care treatments, including Biktarvy, in maintaining virologic suppression and demonstrated a comparable safety profile with no new safety concerns. Patients receiving the once-weekly therapy also reported higher treatment satisfaction and lower treatment burden.
The data will support regulatory submissions for what could become the first once-weekly oral HIV treatment.
The FDA had earlier accepted Gilead’s new drug application for bictegravir/lenacapavir (BIC/LEN) for virologically suppressed people living with HIV under priority review, setting a target action date of Aug. 27, 2026. A potential approval of BIC/LEN will further bolster its HIV portfolio.
With no significant loss-of-exclusivity (LOE) events expected until 2036, Gilead’s HIV franchise is well positioned for sustained long-term growth, supported by the potential launch of up to seven new HIV therapies by 2033.
Approval of additional treatments should strengthen its dominant HIV franchise.
Competition for GILD’s HIV BusinessThe HIV treatment landscape is dominated by many bigwigs, such as GSK plc (GSK - Free Report) and Merck, apart from GILD.
HIV sales account for a major chunk of GSK’s Specialty Medicines portfolio. GSK continues to grow its HIV business, driven by strong patient demand for long-acting injectable medicines (Cabenuva and Apretude) and Dovato. The solid growth from these drugs has helped GSK combat the decline in Triumeq sales.
MRK markets doravirine for treating adults with HIV-1 in the United States, either as a monotherapy under the brand name Pifeltro or as part of the single-tablet combination regimen under the brand name Delstrigo (doravirine/lamivudine/tenofovir disoproxil fumarate).
MRK recently won FDA approval of Idvynso, a once-daily, two-drug single-tablet regimen containing doravirine (100 mg) and islatravir (0.25 mg), for adults living with HIV-1 who are virologically suppressed on a stable antiretroviral regimen. The approval covers patients with no history of treatment failure and no known resistance-associated mutations to doravirine, allowing them to switch from their current HIV therapy.
Merck is also evaluating a once-daily, oral, two-drug, single-tablet regimen of doravirine/islatravir [DOR/ISL (100 mg/0.25 mg)] in treatment-naïve adults with HIV-1 infection.
GILD’s Price Performance, Valuation and EstimatesShares of GILD have gained 6.2% year to date compared with the industry’s growth of 1.4%.
Image Source: Zacks Investment Research
Going by the price/earnings ratio, GILD’s shares currently trade at 25.56X forward earnings, higher than its mean of 14.92X and the large-cap pharma industry’s 17.29X.
Image Source: Zacks Investment Research
The bottom-line estimate for 2026 has deteriorated sharply over the past 60 days, shifting to a loss of 77 cents per share from projected earnings of 8 cents per share. The estimate for 2027 has moved north to $9.73 per share from $9.58 during the same period.
Image Source: Zacks Investment Research
While Gilead’s recent aggressive dealmaking strategy strengthens its long-term pipeline and growth potential, the sizable upfront payments and integration-related costs are pressuring near-term profitability.
Acumen Wealth Advisors LLC increased its stake in Gilead Sciences, Inc. (NASDAQ:GILD – Free Report) by 1,582.0% in the 1st quarter, according to the company in its most recent 13F filing with the Securities and Exchange Commission. The fund owned 6,358 shares of the biopharmaceutical company’s stock after buying an additional 5,980 shares during the quarter. Acumen Wealth Advisors LLC’s holdings in Gilead Sciences were worth $886,000 as of its most recent SEC filing.
Other institutional investors and hedge funds have also recently added to or reduced their stakes in the company. Vanguard Group Inc. lifted its holdings in Gilead Sciences by 1.8% during the 4th quarter. Vanguard Group Inc. now owns 121,097,336 shares of the biopharmaceutical company’s stock valued at $14,863,487,000 after purchasing an additional 2,113,692 shares during the last quarter. State Street Corp raised its holdings in Gilead Sciences by 1.9% in the 4th quarter. State Street Corp now owns 60,240,518 shares of the biopharmaceutical company’s stock valued at $7,393,921,000 after acquiring an additional 1,151,213 shares during the period. Price T Rowe Associates Inc. MD raised its holdings in Gilead Sciences by 4.5% in the 4th quarter. Price T Rowe Associates Inc. MD now owns 27,698,660 shares of the biopharmaceutical company’s stock valued at $3,399,734,000 after acquiring an additional 1,195,269 shares during the period. Bank of America Corp DE lifted its position in Gilead Sciences by 15.2% during the fourth quarter. Bank of America Corp DE now owns 23,121,620 shares of the biopharmaceutical company’s stock worth $2,837,948,000 after acquiring an additional 3,046,688 shares during the last quarter. Finally, Norges Bank acquired a new stake in Gilead Sciences during the fourth quarter worth approximately $2,617,152,000. 83.67% of the stock is owned by institutional investors.
Gilead Sciences Stock Down 2.2% NASDAQ GILD opened at $130.28 on Wednesday. The company has a current ratio of 1.97, a quick ratio of 1.77 and a debt-to-equity ratio of 0.89. Gilead Sciences, Inc. has a 1-year low of $108.06 and a 1-year high of $157.29. The company has a 50 day moving average of $129.63 and a 200-day moving average of $135.42. The company has a market cap of $161.75 billion, a price-to-earnings ratio of 17.75 and a beta of 0.32.
Gilead Sciences (NASDAQ:GILD – Get Free Report) last issued its quarterly earnings results on Thursday, May 7th. The biopharmaceutical company reported $2.03 earnings per share (EPS) for the quarter, beating the consensus estimate of $1.91 by $0.12. The business had revenue of $6.96 billion during the quarter, compared to analysts’ expectations of $6.91 billion. Gilead Sciences had a return on equity of 48.19% and a net margin of 30.99%.The firm’s revenue for the quarter was up 4.4% compared to the same quarter last year. During the same period in the previous year, the company posted $1.81 earnings per share. Gilead Sciences has set its FY 2026 guidance at -1.050–0.650 EPS. On average, equities research analysts expect that Gilead Sciences, Inc. will post -0.77 earnings per share for the current fiscal year.
Gilead Sciences Dividend Announcement The business also recently announced a quarterly dividend, which was paid on Monday, June 29th. Stockholders of record on Monday, June 15th were given a dividend of $0.82 per share. This represents a $3.28 dividend on an annualized basis and a dividend yield of 2.5%. The ex-dividend date was Monday, June 15th. Gilead Sciences’s dividend payout ratio is presently 44.69%.
Insider Activity In other news, insider Johanna Mercier sold 3,000 shares of the stock in a transaction on Monday, June 15th. The stock was sold at an average price of $123.92, for a total transaction of $371,760.00. Following the sale, the insider directly owned 124,234 shares of the company’s stock, valued at approximately $15,395,077.28. This represents a 2.36% decrease in their position. The transaction was disclosed in a document filed with the SEC, which can be accessed through this hyperlink. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan. Also, CFO Andrew D. Dickinson sold 3,000 shares of the firm’s stock in a transaction on Monday, June 15th. The stock was sold at an average price of $125.40, for a total value of $376,200.00. Following the completion of the transaction, the chief financial officer owned 171,646 shares in the company, valued at $21,524,408.40. The trade was a 1.72% decrease in their position. The disclosure for this sale is available in the SEC filing. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan. In the last three months, insiders sold 77,000 shares of company stock worth $9,978,740. 0.30% of the stock is currently owned by company insiders.
Wall Street Analyst Weigh In Several equities analysts have recently commented on GILD shares. Morgan Stanley decreased their target price on Gilead Sciences from $168.00 to $166.00 and set an “overweight” rating on the stock in a research report on Wednesday, July 8th. Rothschild & Co Redburn dropped their price target on Gilead Sciences from $170.00 to $167.00 in a report on Monday, May 11th. Daiwa Securities Group reduced their price target on Gilead Sciences from $161.00 to $150.00 and set an “outperform” rating for the company in a research note on Tuesday, May 19th. Truist Financial decreased their price objective on Gilead Sciences from $157.00 to $156.00 and set a “buy” rating on the stock in a report on Tuesday, July 7th. Finally, Wall Street Zen upgraded Gilead Sciences from a “hold” rating to a “buy” rating in a research report on Sunday, July 12th. Twenty-five research analysts have rated the stock with a Buy rating and four have assigned a Hold rating to the company. According to MarketBeat, Gilead Sciences currently has a consensus rating of “Moderate Buy” and an average target price of $158.33.
View Our Latest Research Report on GILD
Gilead Sciences Company Profile (Free Report)
Gilead Sciences, Inc, founded in 1987 and headquartered in Foster City, California, is a biopharmaceutical company focused on the discovery, development and commercialization of medicines in areas of high unmet medical need. The company initially built its reputation in antiviral therapies and has since expanded into oncology, cell therapy and inflammatory diseases. Gilead operates a global research and commercial organization, conducting clinical development and selling medicines in markets around the world.
Gilead’s product portfolio is anchored by antiviral therapies for HIV and viral hepatitis.
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FOSTER CITY, Calif. & RAHWAY, N.J.--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq: GILD) and Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the detailed outcomes from the Phase 3 ISLEND-1 and ISLEND-2 trials will be presented for the first time at the 26th International AIDS Conference (AIDS 2026). The primary endpoint results at Week 48 showed that the investigational once-weekly oral single-tablet HIV treatment regimen of islatravir 2 mg/lenacap.
FOSTER CITY, Calif.--(BUSINESS WIRE)-- #Earnings--Gilead Sciences, Inc. (Nasdaq: GILD) announced today that its second quarter 2026 financial results and guidance will be released on Tuesday, August 4, 2026 after the market closes. At 4:30 p.m. Eastern Time that day, Gilead's management will host a webcast to discuss the company's second quarter 2026 financial results and provide a business update.A live webcast will be available in the Investors section of www.gilead.com and will be archived there for one.
The Merck logo is seen at a gate to the Merck & Co campus in Rahway, New Jersey, U.S., July 12, 2018. REUTERS/Brendan McDermid/File Photo Purchase Licensing Rights, opens new tab
CompaniesJuly 21 (Reuters) - Gilead Sciences (GILD.O), opens new tab and Merck (MRK.N), opens new tab said on Tuesday their experimental once-weekly HIV pill kept the virus suppressed in two late-stage trials, supporting regulatory filings for what could become the first regimen of its kind for the disease.
Here are some details:
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The combination of Merck's islatravir and Gilead's lenacapavir was tested as a single-tablet regimen in adults whose HIV was already controlled with daily antiretroviral therapy.
HIV attacks the body's immune system and, if left untreated, can progress to acquired immunodeficiency syndrome (AIDS), the most advanced stage of infection.
In one trial, none of the patients who switched to the weekly pill had detectable viral levels at 48 weeks, compared with 0.3% of those who remained on Gilead's daily Biktarvy.
In a second trial, 0.3% of patients taking the weekly pill had detectable HIV levels or higher at 48 weeks, compared with 1.3% of those who remained on standard daily HIV regimens.
Investors are closely watching the rollout of lenacapavir, branded as Yeztugo, which was approved last year, as Gilead seeks to strengthen its HIV franchise alongside blockbuster treatment Biktarvy.
The companies said the weekly treatment was non-inferior to Biktarvy and other daily HIV regimens in the two studies, meaning it performed at least as well by the studies' main measure.
Side effects were generally similar to the daily treatments studied, and no new safety concerns were identified. The most common treatment-related side effects included headache, nausea and diarrhea.
Merck's once-daily HIV pill combo Idvynso was approved by the U.S. Food and Drug Administration in April, bringing another treatment option for patients suffering from the condition.
Reporting by Padmanabhan Ananthan in Bengaluru; Editing by Vijay Kishore
Our Standards: The Thomson Reuters Trust Principles., opens new tab
Andra AP fonden decreased its position in Gilead Sciences, Inc. (NASDAQ:GILD – Free Report) by 53.9% during the 1st quarter, according to its most recent filing with the SEC. The institutional investor owned 222,601 shares of the biopharmaceutical company’s stock after selling 260,199 shares during the period. Andra AP fonden’s holdings in Gilead Sciences were worth $31,024,000 as of its most recent filing with the SEC.
Other large investors have also recently bought and sold shares of the company. Strategic Investment Solutions Inc. IL acquired a new position in shares of Gilead Sciences during the 4th quarter worth about $25,000. Vermillion & White Wealth Management Group LLC increased its position in shares of Gilead Sciences by 71.4% in the fourth quarter. Vermillion & White Wealth Management Group LLC now owns 204 shares of the biopharmaceutical company’s stock valued at $25,000 after acquiring an additional 85 shares during the last quarter. Quattro Advisors LLC bought a new stake in Gilead Sciences during the fourth quarter worth about $26,000. Wealth Preservation Advisors LLC raised its holdings in Gilead Sciences by 60.0% during the fourth quarter. Wealth Preservation Advisors LLC now owns 216 shares of the biopharmaceutical company’s stock worth $27,000 after acquiring an additional 81 shares in the last quarter. Finally, Ares Financial Consulting LLC acquired a new position in Gilead Sciences during the fourth quarter valued at approximately $28,000. Institutional investors and hedge funds own 83.67% of the company’s stock.
Analysts Set New Price Targets Several research analysts have weighed in on GILD shares. Wall Street Zen raised Gilead Sciences from a “hold” rating to a “buy” rating in a research report on Sunday, July 12th. Maxim Group raised Gilead Sciences from a “hold” rating to a “buy” rating and set a $165.00 price objective for the company in a report on Wednesday, May 20th. Rothschild & Co Redburn decreased their target price on shares of Gilead Sciences from $170.00 to $167.00 in a research note on Monday, May 11th. Citigroup boosted their target price on shares of Gilead Sciences from $156.00 to $165.00 and gave the stock a “buy” rating in a report on Monday, April 13th. Finally, Morgan Stanley dropped their price target on shares of Gilead Sciences from $168.00 to $166.00 and set an “overweight” rating on the stock in a research report on Wednesday, July 8th. Twenty-six equities research analysts have rated the stock with a Buy rating and three have issued a Hold rating to the stock. Based on data from MarketBeat, the stock presently has a consensus rating of “Moderate Buy” and an average target price of $159.04.
Check Out Our Latest Report on GILD
Insider Activity In other news, insider Johanna Mercier sold 28,000 shares of the company’s stock in a transaction that occurred on Friday, May 15th. The stock was sold at an average price of $131.29, for a total value of $3,676,120.00. Following the transaction, the insider owned 125,779 shares of the company’s stock, valued at approximately $16,513,524.91. This represents a 18.21% decrease in their ownership of the stock. The transaction was disclosed in a document filed with the Securities & Exchange Commission, which can be accessed through this link. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan. Also, CFO Andrew D. Dickinson sold 3,000 shares of Gilead Sciences stock in a transaction that occurred on Monday, June 15th. The stock was sold at an average price of $125.40, for a total value of $376,200.00. Following the sale, the chief financial officer directly owned 171,646 shares of the company’s stock, valued at approximately $21,524,408.40. The trade was a 1.72% decrease in their ownership of the stock. The disclosure for this sale is available in the SEC filing. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan. Over the last quarter, insiders have sold 77,000 shares of company stock valued at $9,978,740. 0.30% of the stock is owned by insiders.
Gilead Sciences Price Performance NASDAQ:GILD opened at $133.21 on Tuesday. The company has a market cap of $165.39 billion, a P/E ratio of 18.15 and a beta of 0.32. The firm’s fifty day moving average price is $129.72 and its two-hundred day moving average price is $135.37. Gilead Sciences, Inc. has a one year low of $107.75 and a one year high of $157.29. The company has a debt-to-equity ratio of 0.89, a current ratio of 1.97 and a quick ratio of 1.77.
Gilead Sciences (NASDAQ:GILD – Get Free Report) last posted its earnings results on Thursday, May 7th. The biopharmaceutical company reported $2.03 earnings per share (EPS) for the quarter, topping analysts’ consensus estimates of $1.91 by $0.12. Gilead Sciences had a net margin of 30.99% and a return on equity of 48.19%. The company had revenue of $6.96 billion during the quarter, compared to analysts’ expectations of $6.91 billion. During the same quarter last year, the company posted $1.81 EPS. Gilead Sciences’s quarterly revenue was up 4.4% compared to the same quarter last year. Gilead Sciences has set its FY 2026 guidance at -1.050–0.650 EPS. Equities analysts expect that Gilead Sciences, Inc. will post -0.77 earnings per share for the current year.
Gilead Sciences Announces Dividend The company also recently disclosed a quarterly dividend, which was paid on Monday, June 29th. Stockholders of record on Monday, June 15th were issued a dividend of $0.82 per share. This represents a $3.28 dividend on an annualized basis and a dividend yield of 2.5%. The ex-dividend date was Monday, June 15th. Gilead Sciences’s payout ratio is currently 44.69%.
Gilead Sciences Company Profile (Free Report)
Gilead Sciences, Inc, founded in 1987 and headquartered in Foster City, California, is a biopharmaceutical company focused on the discovery, development and commercialization of medicines in areas of high unmet medical need. The company initially built its reputation in antiviral therapies and has since expanded into oncology, cell therapy and inflammatory diseases. Gilead operates a global research and commercial organization, conducting clinical development and selling medicines in markets around the world.
Gilead’s product portfolio is anchored by antiviral therapies for HIV and viral hepatitis.
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Dimensional Fund Advisors LP reduced its position in Gilead Sciences, Inc. (NASDAQ:GILD – Free Report) by 12.7% in the 1st quarter, according to the company in its most recent 13F filing with the Securities and Exchange Commission (SEC). The institutional investor owned 7,722,929 shares of the biopharmaceutical company’s stock after selling 1,123,384 shares during the quarter. Dimensional Fund Advisors LP owned approximately 0.62% of Gilead Sciences worth $1,076,079,000 as of its most recent SEC filing.
Other hedge funds have also made changes to their positions in the company. Paulson Wealth Management Inc. boosted its stake in shares of Gilead Sciences by 1.8% in the fourth quarter. Paulson Wealth Management Inc. now owns 3,887 shares of the biopharmaceutical company’s stock valued at $477,000 after purchasing an additional 67 shares during the period. Essex Financial Services Inc. increased its stake in Gilead Sciences by 0.9% during the 4th quarter. Essex Financial Services Inc. now owns 7,724 shares of the biopharmaceutical company’s stock worth $948,000 after buying an additional 71 shares during the period. Davidson Trust Co. lifted its holdings in Gilead Sciences by 4.1% during the 1st quarter. Davidson Trust Co. now owns 1,879 shares of the biopharmaceutical company’s stock worth $262,000 after buying an additional 74 shares in the last quarter. Alpha Cubed Investments LLC lifted its holdings in Gilead Sciences by 1.1% during the 4th quarter. Alpha Cubed Investments LLC now owns 6,619 shares of the biopharmaceutical company’s stock worth $812,000 after buying an additional 75 shares in the last quarter. Finally, Personal CFO Solutions LLC boosted its position in Gilead Sciences by 1.7% in the 4th quarter. Personal CFO Solutions LLC now owns 4,572 shares of the biopharmaceutical company’s stock valued at $561,000 after buying an additional 76 shares during the period. Institutional investors and hedge funds own 83.67% of the company’s stock.
Wall Street Analysts Forecast Growth Several equities analysts have commented on the stock. Leerink Partners dropped their price target on shares of Gilead Sciences from $148.00 to $146.00 in a research note on Friday, May 8th. Morgan Stanley reduced their price objective on Gilead Sciences from $168.00 to $166.00 and set an “overweight” rating on the stock in a research note on Wednesday, July 8th. Weiss Ratings lowered Gilead Sciences from a “buy (b)” rating to a “buy (b-)” rating in a research report on Thursday, May 28th. Rothschild & Co Redburn decreased their price objective on Gilead Sciences from $170.00 to $167.00 in a research note on Monday, May 11th. Finally, Maxim Group raised Gilead Sciences from a “hold” rating to a “buy” rating and set a $165.00 price objective for the company in a research report on Wednesday, May 20th. Twenty-six research analysts have rated the stock with a Buy rating and three have assigned a Hold rating to the company. According to MarketBeat.com, the stock has a consensus rating of “Moderate Buy” and an average price target of $159.04.
View Our Latest Stock Report on GILD
Gilead Sciences Price Performance Gilead Sciences stock opened at $134.28 on Monday. The company has a current ratio of 1.97, a quick ratio of 1.77 and a debt-to-equity ratio of 0.89. The company has a fifty day simple moving average of $129.73 and a 200-day simple moving average of $135.30. The stock has a market cap of $166.72 billion, a P/E ratio of 18.29 and a beta of 0.32. Gilead Sciences, Inc. has a 12-month low of $107.75 and a 12-month high of $157.29.
Gilead Sciences (NASDAQ:GILD – Get Free Report) last posted its earnings results on Thursday, May 7th. The biopharmaceutical company reported $2.03 EPS for the quarter, beating the consensus estimate of $1.91 by $0.12. Gilead Sciences had a return on equity of 48.19% and a net margin of 30.99%.The firm had revenue of $6.96 billion for the quarter, compared to analyst estimates of $6.91 billion. During the same quarter in the prior year, the company posted $1.81 earnings per share. Gilead Sciences’s revenue for the quarter was up 4.4% compared to the same quarter last year. Gilead Sciences has set its FY 2026 guidance at -1.050–0.650 EPS. Equities analysts expect that Gilead Sciences, Inc. will post -0.77 EPS for the current fiscal year.
Gilead Sciences Announces Dividend The firm also recently disclosed a quarterly dividend, which was paid on Monday, June 29th. Stockholders of record on Monday, June 15th were given a dividend of $0.82 per share. This represents a $3.28 annualized dividend and a dividend yield of 2.4%. The ex-dividend date of this dividend was Monday, June 15th. Gilead Sciences’s dividend payout ratio is currently 44.69%.
Insider Activity In related news, CEO Daniel Patrick O’day sold 15,000 shares of the business’s stock in a transaction that occurred on Wednesday, July 1st. The stock was sold at an average price of $126.29, for a total transaction of $1,894,350.00. Following the completion of the sale, the chief executive officer owned 607,133 shares in the company, valued at $76,674,826.57. The trade was a 2.41% decrease in their ownership of the stock. The transaction was disclosed in a document filed with the Securities & Exchange Commission, which is available through the SEC website. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan. Also, insider Johanna Mercier sold 28,000 shares of the company’s stock in a transaction that occurred on Friday, May 15th. The shares were sold at an average price of $131.29, for a total value of $3,676,120.00. Following the completion of the transaction, the insider directly owned 125,779 shares of the company’s stock, valued at $16,513,524.91. This trade represents a 18.21% decrease in their ownership of the stock. Additional details regarding this sale are available in the official SEC disclosure. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan. In the last 90 days, insiders have sold 77,000 shares of company stock worth $9,978,740. 0.30% of the stock is currently owned by insiders.
Gilead Sciences Profile (Free Report)
Gilead Sciences, Inc, founded in 1987 and headquartered in Foster City, California, is a biopharmaceutical company focused on the discovery, development and commercialization of medicines in areas of high unmet medical need. The company initially built its reputation in antiviral therapies and has since expanded into oncology, cell therapy and inflammatory diseases. Gilead operates a global research and commercial organization, conducting clinical development and selling medicines in markets around the world.
Gilead’s product portfolio is anchored by antiviral therapies for HIV and viral hepatitis.
Further Reading Five stocks we like better than Gilead Sciences Strait of Hormuz Tensions Spike Tanker Trade: These 2 Stocks Are Set to Benefit Shopify’s Quiet AI Strategy Could Be Its Biggest Advantage Yet Why These 3 Nuclear ETFs Are Getting a Fresh Look as AI Power Demand Rises 3 Aerospace Suppliers That Could Benefit as Aircraft Makers Face Bottlenecks
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Boston Common Asset Management LLC lessened its holdings in shares of Gilead Sciences, Inc. (NASDAQ:GILD – Free Report) by 8.6% in the first quarter, according to its most recent 13F filing with the Securities and Exchange Commission. The institutional investor owned 77,243 shares of the biopharmaceutical company’s stock after selling 7,238 shares during the quarter. Boston Common Asset Management LLC’s holdings in Gilead Sciences were worth $10,765,000 as of its most recent SEC filing.
Several other institutional investors have also recently bought and sold shares of the business. Planning Alternatives Ltd. ADV acquired a new stake in shares of Gilead Sciences in the 1st quarter worth about $216,000. Broderick Brian C bought a new position in Gilead Sciences in the 1st quarter valued at about $461,000. Nelson Capital Management LLC acquired a new position in Gilead Sciences during the 1st quarter valued at about $408,000. Decker Wealth Management LLC acquired a new position in Gilead Sciences during the 1st quarter valued at about $394,000. Finally, SEB Asset Management AB bought a new stake in Gilead Sciences during the 1st quarter worth approximately $171,843,000. Institutional investors and hedge funds own 83.67% of the company’s stock.
Analyst Upgrades and Downgrades Several brokerages have recently commented on GILD. Maxim Group raised Gilead Sciences from a “hold” rating to a “buy” rating and set a $165.00 price objective for the company in a research note on Wednesday, May 20th. Rothschild & Co Redburn cut their target price on Gilead Sciences from $170.00 to $167.00 in a research report on Monday, May 11th. HSBC upgraded Gilead Sciences from a “hold” rating to a “buy” rating and upped their price target for the stock from $133.00 to $155.00 in a report on Monday, July 6th. Daiwa Securities Group lowered their price target on Gilead Sciences from $161.00 to $150.00 and set an “outperform” rating for the company in a research report on Tuesday, May 19th. Finally, The Goldman Sachs Group raised their price objective on Gilead Sciences from $125.00 to $130.00 and gave the company a “neutral” rating in a research note on Friday, April 17th. Twenty-six research analysts have rated the stock with a Buy rating and three have assigned a Hold rating to the company’s stock. According to MarketBeat.com, the company has a consensus rating of “Moderate Buy” and an average target price of $159.04.
View Our Latest Report on Gilead Sciences
Gilead Sciences Stock Performance NASDAQ:GILD opened at $134.28 on Monday. The company has a debt-to-equity ratio of 0.89, a quick ratio of 1.77 and a current ratio of 1.97. The firm has a market cap of $166.72 billion, a price-to-earnings ratio of 18.29 and a beta of 0.32. Gilead Sciences, Inc. has a 52 week low of $107.75 and a 52 week high of $157.29. The firm has a 50-day moving average price of $129.73 and a two-hundred day moving average price of $135.30.
Gilead Sciences (NASDAQ:GILD – Get Free Report) last posted its earnings results on Thursday, May 7th. The biopharmaceutical company reported $2.03 EPS for the quarter, topping the consensus estimate of $1.91 by $0.12. Gilead Sciences had a net margin of 30.99% and a return on equity of 48.19%. The firm had revenue of $6.96 billion for the quarter, compared to analysts’ expectations of $6.91 billion. During the same quarter last year, the firm earned $1.81 EPS. The company’s quarterly revenue was up 4.4% compared to the same quarter last year. Gilead Sciences has set its FY 2026 guidance at -1.050–0.650 EPS. On average, equities analysts expect that Gilead Sciences, Inc. will post -0.77 earnings per share for the current fiscal year.
Gilead Sciences Announces Dividend The firm also recently declared a quarterly dividend, which was paid on Monday, June 29th. Investors of record on Monday, June 15th were issued a dividend of $0.82 per share. This represents a $3.28 dividend on an annualized basis and a yield of 2.4%. The ex-dividend date was Monday, June 15th. Gilead Sciences’s dividend payout ratio (DPR) is 44.69%.
Insider Buying and Selling In other news, CEO Daniel Patrick O’day sold 15,000 shares of the firm’s stock in a transaction on Wednesday, July 1st. The stock was sold at an average price of $126.29, for a total transaction of $1,894,350.00. Following the completion of the sale, the chief executive officer directly owned 607,133 shares of the company’s stock, valued at $76,674,826.57. This trade represents a 2.41% decrease in their position. The sale was disclosed in a document filed with the SEC, which is available through the SEC website. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan. Also, insider Johanna Mercier sold 3,000 shares of the firm’s stock in a transaction on Monday, June 15th. The shares were sold at an average price of $123.92, for a total value of $371,760.00. Following the sale, the insider directly owned 124,234 shares of the company’s stock, valued at approximately $15,395,077.28. This represents a 2.36% decrease in their ownership of the stock. Additional details regarding this sale are available in the official SEC disclosure. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan. Over the last three months, insiders have sold 77,000 shares of company stock worth $9,978,740. 0.30% of the stock is owned by company insiders.
Gilead Sciences Profile (Free Report)
Gilead Sciences, Inc, founded in 1987 and headquartered in Foster City, California, is a biopharmaceutical company focused on the discovery, development and commercialization of medicines in areas of high unmet medical need. The company initially built its reputation in antiviral therapies and has since expanded into oncology, cell therapy and inflammatory diseases. Gilead operates a global research and commercial organization, conducting clinical development and selling medicines in markets around the world.
Gilead’s product portfolio is anchored by antiviral therapies for HIV and viral hepatitis.
Featured Articles Five stocks we like better than Gilead Sciences Strait of Hormuz Tensions Spike Tanker Trade: These 2 Stocks Are Set to Benefit Shopify’s Quiet AI Strategy Could Be Its Biggest Advantage Yet Why These 3 Nuclear ETFs Are Getting a Fresh Look as AI Power Demand Rises 3 Aerospace Suppliers That Could Benefit as Aircraft Makers Face Bottlenecks
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Allspring Global Investments Holdings LLC decreased its holdings in Gilead Sciences, Inc. (NASDAQ:GILD – Free Report) by 1.6% in the 1st quarter, according to the company in its most recent 13F filing with the Securities and Exchange Commission (SEC). The fund owned 357,901 shares of the biopharmaceutical company’s stock after selling 5,662 shares during the quarter. Allspring Global Investments Holdings LLC’s holdings in Gilead Sciences were worth $50,214,000 at the end of the most recent quarter.
A number of other large investors have also recently bought and sold shares of GILD. Norges Bank purchased a new position in Gilead Sciences during the 4th quarter worth $2,617,152,000. Boston Partners purchased a new stake in Gilead Sciences during the 4th quarter valued at approximately $517,808,000. Massachusetts Financial Services Co. MA raised its stake in shares of Gilead Sciences by 3,763.8% during the fourth quarter. Massachusetts Financial Services Co. MA now owns 4,223,304 shares of the biopharmaceutical company’s stock worth $518,368,000 after purchasing an additional 4,113,999 shares during the last quarter. Bank of America Corp DE lifted its holdings in shares of Gilead Sciences by 15.2% during the fourth quarter. Bank of America Corp DE now owns 23,121,620 shares of the biopharmaceutical company’s stock worth $2,837,948,000 after purchasing an additional 3,046,688 shares during the period. Finally, Vanguard Group Inc. grew its position in Gilead Sciences by 1.8% in the 4th quarter. Vanguard Group Inc. now owns 121,097,336 shares of the biopharmaceutical company’s stock valued at $14,863,487,000 after buying an additional 2,113,692 shares during the last quarter. Institutional investors and hedge funds own 83.67% of the company’s stock.
Insider Buying and Selling at Gilead Sciences In other news, CFO Andrew D. Dickinson sold 3,000 shares of the firm’s stock in a transaction that occurred on Monday, June 15th. The shares were sold at an average price of $125.40, for a total transaction of $376,200.00. Following the completion of the transaction, the chief financial officer directly owned 171,646 shares of the company’s stock, valued at $21,524,408.40. This trade represents a 1.72% decrease in their position. The sale was disclosed in a document filed with the SEC, which is available at this hyperlink. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan. Also, CEO Daniel Patrick O’day sold 15,000 shares of Gilead Sciences stock in a transaction that occurred on Wednesday, July 1st. The stock was sold at an average price of $126.29, for a total value of $1,894,350.00. Following the transaction, the chief executive officer owned 607,133 shares of the company’s stock, valued at $76,674,826.57. This represents a 2.41% decrease in their ownership of the stock. The disclosure for this sale is available in the SEC filing. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan. Insiders have sold 77,000 shares of company stock valued at $9,978,740 over the last quarter. Corporate insiders own 0.30% of the company’s stock.
Analyst Upgrades and Downgrades A number of brokerages have recently issued reports on GILD. Cantor Fitzgerald reiterated an “overweight” rating and set a $155.00 price target on shares of Gilead Sciences in a research note on Monday, July 6th. Truist Financial lowered their price objective on Gilead Sciences from $157.00 to $156.00 and set a “buy” rating on the stock in a report on Tuesday, July 7th. Leerink Partners dropped their target price on Gilead Sciences from $148.00 to $146.00 in a research report on Friday, May 8th. Maxim Group raised Gilead Sciences from a “hold” rating to a “buy” rating and set a $165.00 target price for the company in a research note on Wednesday, May 20th. Finally, Royal Bank Of Canada reduced their price target on Gilead Sciences from $122.00 to $120.00 and set a “sector perform” rating for the company in a report on Tuesday, July 7th. Twenty-six research analysts have rated the stock with a Buy rating and three have issued a Hold rating to the stock. According to MarketBeat, the company currently has a consensus rating of “Moderate Buy” and a consensus price target of $159.04.
View Our Latest Research Report on GILD
Gilead Sciences Price Performance GILD stock opened at $134.28 on Friday. The firm has a 50 day moving average of $129.73 and a 200-day moving average of $135.22. The company has a market cap of $166.72 billion, a price-to-earnings ratio of 18.29 and a beta of 0.32. The company has a current ratio of 1.97, a quick ratio of 1.77 and a debt-to-equity ratio of 0.89. Gilead Sciences, Inc. has a 12-month low of $107.75 and a 12-month high of $157.29.
Gilead Sciences (NASDAQ:GILD – Get Free Report) last released its quarterly earnings results on Thursday, May 7th. The biopharmaceutical company reported $2.03 earnings per share for the quarter, topping analysts’ consensus estimates of $1.91 by $0.12. The business had revenue of $6.96 billion for the quarter, compared to analysts’ expectations of $6.91 billion. Gilead Sciences had a return on equity of 48.19% and a net margin of 30.99%.The company’s revenue was up 4.4% compared to the same quarter last year. During the same quarter in the prior year, the firm posted $1.81 EPS. Gilead Sciences has set its FY 2026 guidance at -1.050–0.650 EPS. As a group, equities analysts expect that Gilead Sciences, Inc. will post -0.77 EPS for the current fiscal year.
Gilead Sciences Announces Dividend The firm also recently announced a quarterly dividend, which was paid on Monday, June 29th. Shareholders of record on Monday, June 15th were given a dividend of $0.82 per share. The ex-dividend date was Monday, June 15th. This represents a $3.28 dividend on an annualized basis and a yield of 2.4%. Gilead Sciences’s payout ratio is presently 44.69%.
Gilead Sciences Company Profile (Free Report)
Gilead Sciences, Inc, founded in 1987 and headquartered in Foster City, California, is a biopharmaceutical company focused on the discovery, development and commercialization of medicines in areas of high unmet medical need. The company initially built its reputation in antiviral therapies and has since expanded into oncology, cell therapy and inflammatory diseases. Gilead operates a global research and commercial organization, conducting clinical development and selling medicines in markets around the world.
Gilead’s product portfolio is anchored by antiviral therapies for HIV and viral hepatitis.
Featured Articles Five stocks we like better than Gilead Sciences Netflix May Be Cheap Enough to Tempt Buyers After Earnings Drop Delta vs. United: Which Airline Is Better Built for Higher Fuel Costs? The Market Sold Alcoa After Earnings—But It May Be Missing the Real Story Why Intuitive Surgical’s Strong Quarter Still Spooked Investors Want to see what other hedge funds are holding GILD? Visit HoldingsChannel.com to get the latest 13F filings and insider trades for Gilead Sciences, Inc. (NASDAQ:GILD – Free Report).
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In the latest close session, Gilead Sciences (GILD - Free Report) was down 1.48% at $134.28. This change lagged the S&P 500's daily loss of 1.01%. Meanwhile, the Dow lost 0.77%, and the Nasdaq, a tech-heavy index, lost 1.4%.
Shares of the HIV and hepatitis C drugmaker have appreciated by 10.13% over the course of the past month, outperforming the Medical sector's gain of 5.37%, and the S&P 500's gain of 0.32%.
The investment community will be paying close attention to the earnings performance of Gilead Sciences in its upcoming release. The company is expected to report EPS of -$7.09, down 452.74% from the prior-year quarter. Meanwhile, our latest consensus estimate is calling for revenue of $7.37 billion, up 4.02% from the prior-year quarter.
For the entire fiscal year, the Zacks Consensus Estimates are projecting earnings of -$0.77 per share and a revenue of $30.38 billion, representing changes of -109.45% and +3.18%, respectively, from the prior year.
Investors should also take note of any recent adjustments to analyst estimates for Gilead Sciences. These recent revisions tend to reflect the evolving nature of short-term business trends. Consequently, upward revisions in estimates express analysts' positivity towards the business operations and its ability to generate profits.
Empirical research indicates that these revisions in estimates have a direct correlation with impending stock price performance. To utilize this, we have created the Zacks Rank, a proprietary model that integrates these estimate changes and provides a functional rating system.
The Zacks Rank system, spanning from #1 (Strong Buy) to #5 (Strong Sell), boasts an impressive track record of outperformance, audited externally, with #1 ranked stocks yielding an average annual return of +25% since 1988. The Zacks Consensus EPS estimate has moved 2.73% higher within the past month. Gilead Sciences currently has a Zacks Rank of #3 (Hold).
The Medical - Biomedical and Genetics industry is part of the Medical sector. At present, this industry carries a Zacks Industry Rank of 93, placing it within the top 38% of over 250 industries.
The Zacks Industry Rank is ordered from best to worst in terms of the average Zacks Rank of the individual companies within each of these sectors. Our research shows that the top 50% rated industries outperform the bottom half by a factor of 2 to 1.
To follow GILD in the coming trading sessions, be sure to utilize Zacks.com.
Gilead Sciences (GILD - Free Report) has recently been on Zacks.com's list of the most searched stocks. Therefore, you might want to consider some of the key factors that could influence the stock's performance in the near future.
Over the past month, shares of this HIV and hepatitis C drugmaker have returned +5%, compared to the Zacks S&P 500 composite's +0.5% change. During this period, the Zacks Medical - Biomedical and Genetics industry, which Gilead falls in, has gained 3.2%. The key question now is: What could be the stock's future direction?
Although media reports or rumors about a significant change in a company's business prospects usually cause its stock to trend and lead to an immediate price change, there are always certain fundamental factors that ultimately drive the buy-and-hold decision.
Revisions to Earnings EstimatesHere at Zacks, we prioritize appraising the change in the projection of a company's future earnings over anything else. That's because we believe the present value of its future stream of earnings is what determines the fair value for its stock.
Our analysis is essentially based on how sell-side analysts covering the stock are revising their earnings estimates to take the latest business trends into account. When earnings estimates for a company go up, the fair value for its stock goes up as well. And when a stock's fair value is higher than its current market price, investors tend to buy the stock, resulting in its price moving upward. Because of this, empirical studies indicate a strong correlation between trends in earnings estimate revisions and short-term stock price movements.
For the current quarter, Gilead is expected to post a loss of $7.09 per share, indicating a change of -452.7% from the year-ago quarter. The Zacks Consensus Estimate has changed -0.7% over the last 30 days.
For the current fiscal year, the consensus earnings estimate of -$0.77 points to a change of -109.5% from the prior year. Over the last 30 days, this estimate has changed +2.7%.
For the next fiscal year, the consensus earnings estimate of $9.72 indicates a change of +0% from what Gilead is expected to report a year ago. Over the past month, the estimate has changed +0.1%.
Having a strong externally audited track record, our proprietary stock rating tool, the Zacks Rank, offers a more conclusive picture of a stock's price direction in the near term, since it effectively harnesses the power of earnings estimate revisions. Due to the size of the recent change in the consensus estimate, along with three other factors related to earnings estimates, Gilead is rated Zacks Rank #3 (Hold).
The chart below shows the evolution of the company's forward 12-month consensus EPS estimate:
12 Month EPS
Projected Revenue GrowthEven though a company's earnings growth is arguably the best indicator of its financial health, nothing much happens if it cannot raise its revenues. It's almost impossible for a company to grow its earnings without growing its revenue for long periods. Therefore, knowing a company's potential revenue growth is crucial.
For Gilead, the consensus sales estimate for the current quarter of $7.37 billion indicates a year-over-year change of +4%. For the current and next fiscal years, $30.38 billion and $32.18 billion estimates indicate +3.2% and +5.9% changes, respectively.
Last Reported Results and Surprise HistoryGilead reported revenues of $6.96 billion in the last reported quarter, representing a year-over-year change of +4.4%. EPS of $2.03 for the same period compares with $1.81 a year ago.
Compared to the Zacks Consensus Estimate of $6.89 billion, the reported revenues represent a surprise of +0.95%. The EPS surprise was +7.41%.
The company beat consensus EPS estimates in each of the trailing four quarters. The company topped consensus revenue estimates each time over this period.
ValuationNo investment decision can be efficient without considering a stock's valuation. Whether a stock's current price rightly reflects the intrinsic value of the underlying business and the company's growth prospects is an essential determinant of its future price performance.
Comparing the current value of a company's valuation multiples, such as its price-to-earnings (P/E), price-to-sales (P/S), and price-to-cash flow (P/CF), to its own historical values helps ascertain whether its stock is fairly valued, overvalued, or undervalued, whereas comparing the company relative to its peers on these parameters gives a good sense of how reasonable its stock price is.
As part of the Zacks Style Scores system, the Zacks Value Style Score (which evaluates both traditional and unconventional valuation metrics) organizes stocks into five groups ranging from A to F (A is better than B; B is better than C; and so on), making it helpful in identifying whether a stock is overvalued, rightly valued, or temporarily undervalued.
Gilead is graded C on this front, indicating that it is trading at par with its peers. Click here to see the values of some of the valuation metrics that have driven this grade.
ConclusionThe facts discussed here and much other information on Zacks.com might help determine whether or not it's worthwhile paying attention to the market buzz about Gilead. However, its Zacks Rank #3 does suggest that it may perform in line with the broader market in the near term.
Pfizer (NYSE:PFE | PFE Price Prediction) trades at $24.25, against a Wall Street consensus price target of $28.79, which represents implied upside of almost 19%. Gilead Sciences (NASDAQ:GILD) trades at $130.04 and has a $158.30 consensus target. Both stocks sit below sell-side fair value while flashing the same bearish technical warning.
Pfizer and Gilead Sciences are widely held large-cap pharma names, popular for yield, defensive characteristics, and late-stage pipelines. Investors are paying attention because both have seen a so-called death cross, the pattern where a stock’s 50-day moving average slips beneath the 200-day average. Pfizer’s 50-day is at 25.35, versus a 200-day of 25.87. Gilead’s 50-day is 129.85 against a 200-day of 130.44.
A death cross is a lagging indicator that says nothing on its own about valuation. Still, both names trade below analyst fair value with momentum rolling over. That puts the contrarian question squarely on the table.
What Broke the Bid Under Each Stock Pfizer’s weakness is the COVID hangover colliding with a policy overhang. Recent results still show growth, with quarterly revenue up 5.4% year over year. Yet the market is fixated on Most-Favored-Nation drug pricing, potential Section 232 pharma tariffs, the IRA Medicare Part D redesign, and international Eliquis generic entry. Management has also signaled no share buybacks in 2026, removing a support pillar.
Gilead’s story is more complex. First-quarter revenue topped expectations, but the company slashed non-GAAP EPS guidance from a profit of $8.45 to $8.85 down to a loss of $0.65 to $1.05, driven by roughly $11.5 billion in IPR&D charges tied to the Arcellx, Ouro Medicines, and Tubulis acquisitions. Those are non-cash accounting items, but Wall Street hated the optics. Add in Trodelvy’s ASCENT-07 primary endpoint miss and Veklury revenue dropping 52% year over year, and momentum turned quickly.
Both selloffs have been measured. Pfizer is down 7.5% over the past month, and Gilead is off 4.6% over the past week. The bearish signal reflects drift rather than capitulation.
Why Analysts Remain Constructive on Pfizer Wall Street analysts have mixed but generally positive views on Pfizer. The consensus target of $28.79 sits just above the 52-week high of $28.75. Ratings skew cautiously bullish.
The bull case rests on oncology (Padcev, Nurtec), the Metsera obesity acquisition, and the Vyndamax patent settlement extending U.S. exclusivity to 2031. At a forward P/E of just 8x and a 7.1% dividend yield, investors are effectively being paid to wait.
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Gilead’s bull case leans on the Yeztugo launch as the first twice-yearly HIV PrEP, Biktarvy patents extended to 2036, and two major PDUFA decisions before year-end. Analysts largely framed the guidance cut as accounting noise rather than a change in underlying earnings power. HIV franchise sales grew 10% in Q1 and product gross margin expanded 200 basis points.
Readers who want the broader framework on yield-plus-growth pharma names should check out our research team’s 10 Dividend Kings to Buy Now and Hold Forever report.
How the Numbers Actually Stack Up Pfizer is down 2.6% year to date, and Gilead is 6.0% higher, while the S&P 500 has returned 10.3% over the same stretch. Both are lagging the broader market, though Gilead’s gap is modest. On a one-year basis, Gilead is up 16.0% while Pfizer is 4.3% lower.
Pfizer’s nearly 19% implied upside is backed by a beta of 0.31 and a trailing P/E of 18x. Analyst targets are one data point, and the Hold-heavy skew makes clear that conviction is thin.
One Contrarian Buy, One Show-Me Story The contrarian case for Pfizer rests on the COVID revenue base being fully washed through and the oncology and obesity pipeline offsetting biosimilar losses in 2027 and beyond. The forward P/E of 8x and 7% yield offer defensive cover while the pipeline matures. The bear case is that Most-Favored-Nation pricing and tariff risk structurally compress margins, in which case the dividend gets scrutinized fast if free cash flow softens.
The bull case for Gilead requires looking through the IPR&D charges and trusting that Yeztugo, Biktarvy’s 2036 patent runway, and the anito-cel and BIC/LEN PDUFAs land on schedule. The bear case is that the ASCENT-07 miss signals broader oncology execution risk, given that Gilead paid a premium for those assets.
So, Pfizer is the more compelling contrarian setup given valuation and yield support. Gilead has already recovered materially off its lows, so the easy money may already be behind it.
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The logo of Gilead Sciences Inc is pictured during a news conference in New Delhi September 15, 2014. Picture taken September 15, 2014. REUTERS/Anindito Mukherjee Purchase Licensing Rights, opens new tab
CompaniesJuly 14 (Reuters) - Researchers in the Democratic Republic of Congo said on Tuesday they have started enrolling participants in a trial testing Gilead Sciences' (GILD.O), opens new tab experimental antiviral obeldesivir as a post-exposure treatment for the ongoing Bundibugyo Ebola outbreak in Congo and Uganda.
Congo's National Institute for Biomedical Research and France's ANRS Emerging Infectious Diseases — with support from humanitarian aid groups, Alliance for International Medical Action (ALIMA) and Medecins Sans Frontieres — are leading the trial in Ituri province, the epicentre of the outbreak, the agencies said in a joint statement.
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Here are some details:
The trial is designed to assess whether post-exposure treatment can reduce the risk of developing Ebola infection after contact with the virus.
The study aims to enroll about 1,000 people aged 12 years and older, who had high-risk exposure to a confirmed Ebola case within the previous five days but have not developed symptoms.
Participants will be monitored daily for 21 days, with a final follow-up at 42 days.
Obeldesivir has shown activity against filoviruses, including the Bundibugyo Ebola virus, in pre-clinical studies.
The project has received initial funding of 3.4 million euros ($3.87 million) from the Global Health EDCTP3 partnership supported by the European Commission, and $1 million from the Africa Centres for Disease Control and Prevention.
Africa CDC also helped secure an additional $5 million in funding commitments from South Africa and the Democratic Republic of Congo.
The study also includes a separate compassionate-use protocol under which Gilead's injectable antiviral remdesivir would be given to children under 12 years and pregnant or breastfeeding women exposed to the virus.
The outbreak has led to 1,963 confirmed cases in Congo, including 719 deaths, according to government data.
($1 = 0.8777 euros)
Reporting by Siddhi Mahatole in Bengaluru; Editing by Shilpi Majumdar
Our Standards: The Thomson Reuters Trust Principles., opens new tab
Shares of Gilead Sciences (GILD 3.72%) have lagged the S&P 500 average this year, rising only 9% despite strong financials and a pipeline that promises to elevate the pharmaceutical company's base beyond its core of HIV therapies.
Gilead has spent heavily on its acquisitions of Arcellx, Ouro Medicines, and Tubulis, and while it will take time to integrate them, the upside is that they add to the company's pipeline, particularly in oncology and inflammation therapies.
In its first-quarter presentation, the company said it has four potential launches this year. Instead of focusing on the cost of its purchases, investors would do well to look beyond that and see how these new launches and acquisitions will diversify Gilead's platform, reducing its reliance on its HIV franchise.
Three reasons to buy Gilead right now:
Image source: Getty Images.
The company's continued financial strength In Q1, Gilead reported revenue of $7 billion, up 4% year over year, mainly from higher sales of its HIV products. Earnings per share (EPS) were $1.61, up 54.8% over the same period last year. It's not as if the company's HIV therapies are slowing down. Biktarvy and Descovy continue to dominate market share, driving a 10% year-over-year increase in HIV product sales to $5 billion.
The company is also seeing significant growth in its breast cancer drug, Trodelvy, with sales up 37% year over year. This dependable revenue gives it product gross margins of roughly 79%. The company said it sees no major loss-of-exclusivity patent cliffs for its top drugs until 2036. This means at least another decade of secure cash flows to fund research and development and dividend growth.
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High-impact 2026 commercial launches The primary reason to look at Gilead right now is its massive, immediate product-launch calendar.
Bulevirtide was given accelerated approval on May 22 by the Food and Drug Administration (FDA) as the first treatment for adults with chronic hepatitis delta virus (HDV) infection who do not have cirrhosis (severe liver scarring) or who have compensated cirrhosis. The FDA on April 29 granted Priority Review for a once-daily, single-tablet combo regimen of bictegravir + lenacapavir (BIC/LEN) for adults with suppressed HIV, with a critical Prescription Drug User Fee Act (PDUFA) action date set for Aug. 27, and launch expected shortly thereafter.
With its purchase of Arcellx, the company gains multiple myeloma therapy anito-cel, a BCMA CAR-T therapy with a PDUFA date scheduled for December. Trodelvy also continues to gain ground, with FDA approval on June 24 that allows it to move into crucial first-line metastatic triple-negative breast cancer (mTNBC) indication.
In addition, Gilead's twice-yearly injectable HIV prevention drug, Yeztugo, has entered its multimarket launch curve following a strong clinical performance, and the company said it expects $1 billion in 2026 sales from the drug.
The price is right, and so is its dividend Despite a strong five-year run and solid operational execution, Gilead's valuation remains highly attractive, trading at around 15 times forward earnings, well below its five-year average.
For income-oriented investors, Gilead pairs this growth inflection with a reliable 2.39% dividend yield at its current share price. The company has increased its dividend for 11 consecutive years, including a 3.7% bump this year.
In the latest close session, Gilead Sciences (GILD - Free Report) was down 3.72% at $129.83. The stock's performance was behind the S&P 500's daily gain of 0.42%. Meanwhile, the Dow gained 0.29%, and the Nasdaq, a tech-heavy index, added 0.29%.
The HIV and hepatitis C drugmaker's stock has climbed by 7.13% in the past month, exceeding the Medical sector's gain of 5.6% and the S&P 500's gain of 2.2%.
The investment community will be paying close attention to the earnings performance of Gilead Sciences in its upcoming release. The company's upcoming EPS is projected at -$7.13, signifying a 454.73% drop compared to the same quarter of the previous year. At the same time, our most recent consensus estimate is projecting a revenue of $7.36 billion, reflecting a 3.98% rise from the equivalent quarter last year.
For the full year, the Zacks Consensus Estimates are projecting earnings of -$0.8 per share and revenue of $30.43 billion, which would represent changes of -109.82% and +3.34%, respectively, from the prior year.
Investors should also pay attention to any latest changes in analyst estimates for Gilead Sciences. Such recent modifications usually signify the changing landscape of near-term business trends. As a result, we can interpret positive estimate revisions as a good sign for the business outlook.
Our research shows that these estimate changes are directly correlated with near-term stock prices. To benefit from this, we have developed the Zacks Rank, a proprietary model which takes these estimate changes into account and provides an actionable rating system.
The Zacks Rank system, which ranges from #1 (Strong Buy) to #5 (Strong Sell), has an impressive outside-audited track record of outperformance, with #1 stocks generating an average annual return of +25% since 1988. Over the last 30 days, the Zacks Consensus EPS estimate has witnessed a 0.15% decrease. Gilead Sciences is currently a Zacks Rank #3 (Hold).
The Medical - Biomedical and Genetics industry is part of the Medical sector. This industry currently has a Zacks Industry Rank of 106, which puts it in the top 44% of all 250+ industries.
The Zacks Industry Rank evaluates the power of our distinct industry groups by determining the average Zacks Rank of the individual stocks forming the groups. Our research shows that the top 50% rated industries outperform the bottom half by a factor of 2 to 1.
You can find more information on all of these metrics, and much more, on Zacks.com.
A Look at Gilead Sciences Inc (GILD) After 5.2% Gain -- GF Value $96.06 vs Price $136.36
On July 07, 2026, Gilead Sciences Inc GILD shares rose 5.2% today, with the current price at $136.36. Over the past year, the stock has seen a 25.2% increase. The 52-week range for GILD is between $107.75 and $157.29.
GF Value™ verdict: GILD is currently priced at $136.36, which is 42.0% above the GF Value™ estimate of $96.06.GF Score™ of 69/100 indicates an above-average rating, suggesting potential for solid long-term returns.Notable signal: Insiders have sold $10.8 million worth of stock in the last three months, showing a lack of buying interest. Is GILD Overvalued or Undervalued? Gilead Sciences Inc is currently trading significantly above its GF Value™ of $96.06, indicating that the stock is 42.0% overvalued. This disparity suggests that GILD may be subject to a price correction, representing a potential risk for investors. The GF Valuation label categorizes GILD as “Significantly Overvalued,” which reinforces the concerns regarding its current market price compared to its intrinsic value. GF Value™ is GuruFocus' proprietary measure of intrinsic value, calculated from historical trading multiples, past business growth, and future performance estimates.
The margin of safety is critical for potential investors to consider, as a stock trading well above its intrinsic value often presents higher risks. If GILD's price were to adjust downward to align more closely with its GF Value™, substantial losses could occur for those entering at the current price. Therefore, it is essential to approach GILD with caution, given the overvaluation warning signs.
How Does GILD's Valuation Compare to Its History? Metric Current Historical P/E (TTM) 18.6x 19.0x Forward P/E 43.2x N/A Gilead's current P/E (TTM) of 18.6x is slightly below its 5-year median of 19.0x, suggesting that the stock is trading within a historically reasonable range. However, the forward P/E of 43.2x indicates that future earnings expectations may be excessively high. This analysis generally aligns with the GF Value™ verdict, reinforcing the notion that GILD is overvalued, particularly when considering potential future earnings growth might not justify the current price level.
What Does GILD's GF Score™ Tell Us? Metric Rating GF Score™ 69 Financial Strength 6/10 Profitability 8/10 Growth 6/10 Valuation 5/10 Momentum 1/10 The GF Score™ of 69/100 suggests that Gilead Sciences Inc has a solid potential for long-term returns, particularly driven by its strong profitability rank of 8/10. However, the valuation rank of 5/10 and momentum rank of 1/10 indicate weakness in price trends and valuation metrics. The mixed scores illustrate that while GILD has robust profit-generating capabilities, the stock's current valuation raises concerns moving forward.
What Are Insiders Doing with GILD Stock? In the last three months, insiders have sold approximately $10.8 million worth of GILD shares, showing a clear trend of selling without any accompanying buying activity. This pattern suggests a lack of confidence from insiders regarding the stock's future performance. Such selling can be interpreted as a negative signal, as insiders typically have more information about the company's prospects than the average investor. Their decision to sell may indicate they believe the stock is adequately valued or overvalued at current levels.
What This Means for Investors Based on the GF Value™ assessment, Gilead Sciences Inc is currently overvalued. With a significant discrepancy between the market price and the intrinsic value, investors may face heightened risks if entering at current levels. Caution is advised as the stock could experience downward pressure in the near future.
For the complete analysis, visit the Gilead Sciences Inc GILD stock page. You can also explore the GF Value™ page for detailed valuation methodology, or use the GuruFocus Stock Screener to find similar opportunities.
Frequently Asked Questions What is GILD's GF Score™?
The GF Score™ for Gilead Sciences Inc is 69/100, indicating an above-average rating with potential for solid long-term returns.
Is GILD overvalued or undervalued?
Gilead is currently overvalued, with a market price of $136.36 significantly above its GF Value™ estimate of $96.06.
What is GILD's P/E ratio?
Gilead's P/E (TTM) is 18.6x, which is slightly below its 5-year median of 19.0x, indicating it is trading near its historical valuation range, but the forward P/E suggests future expectations may be too optimistic.
This stock alert was generated using automated technology and GuruFocus financial data to provide readers with timely and accurate market reporting. This content was reviewed by GuruFocus editorial team prior to publication. Please send any questions or comments about this story to [email protected].
Disclosures I/We may personally own shares in some of the companies mentioned above. However, those positions are not material to either the company or to my/our portfolios.
Key Takeaways Gilead won FDA approval to expand Trodelvy into first-line treatment for metastatic TNBC.Trodelvy generated $402 million in Q1 2026 sales, rising 37% on higher demand.GILD aims to grow oncology and diversify beyond HIV as Trodelvy expands its market reach. Gilead Sciences, Inc. (GILD - Free Report) recently won FDA approval for the label expansion of breast cancer drug Trodelvy (sacituzumab govitecan-hziy) for the first-line treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC).
Trodelvy, a first-in-class Trop-2-directed antibody-drug conjugate (ADC), is already approved in several countries for second-line or later metastatic TNBC and in more than 50 countries for certain patients with pre-treated HR+/HER2- metastatic breast cancer (mBC).
With the latest FDA approval, Trodelvy is now approved in first-line mTNBC, either as a single agent for patients who are not candidates for PD-(L)1 inhibitor-based therapy or in combination with Merck’s (MRK - Free Report) Keytruda (pembrolizumab) or Keytruda Qlex (subcutaneous injection of Keytruda) for patients whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-authorized test.
The latest FDA approval came shortly after the European Commission expanded Trodelvy’s label for the same indication.
The approval broadens Trodelvy's addressable market by moving the therapy into the first-line mTNBC setting, where treatment options have historically been limited. The approval is significant particularly because many mTNBC patients do not progress to later lines of therapy, making access to effective first-line treatments increasingly important.
According to Gilead's management, the approval has the potential to establish Trodelvy as a new standard of care in first-line mTNBC, expanding its use beyond the second-line setting.
Trodelvy sales amounted to $402 million in the first quarter of 2026, up 37%, primarily driven by higher demand.
The recent label expansion is expected to strengthen Trodelvy's commercial opportunity and reinforce its position as a key growth driver within Gilead's oncology portfolio.
GILD is looking to strengthen its oncology franchise and diversify its revenue base, which is highly concentrated on HIV business.
Competition for GILD’s Oncology Business Datroway (datopotamab deruxtecan), developed by AstraZeneca (AZN - Free Report) and Daiichi Sankyo, is also a TROP2-directed ADC.
It is approved in several countries worldwide for the treatment of adult patients with unresectable or metastatic HR-positive, HER2-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease based on results from the TROPION-Breast01 trial.
In May 2026, AstraZeneca and Daiichi Sankyo announced that the Datroway has been approved in the United States for the treatment of adult patients with unresectable or mTNBC who are not candidates for PD-1/PD-L1 inhibitor therapy.
AstraZeneca and Daiichi Sankyo entered into a global collaboration agreement in March 2019 to jointly develop and commercialize Enhertu (trastuzumab deruxtecan), followed by a similar agreement for Datroway in July 2020. Daiichi Sankyo retains exclusive rights to both ADCs in Japan.
Merck is evaluating sacituzumab tirumotecan (sac-TMT), an investigational TROP2-directed ADC, in collaboration with Kelun-Biotech.
Merck is evaluating sac-TMT in 17 ongoing global phase III studies across multiple tumor types through the TroFuse clinical development program.
The program is evaluating sac-TMT across a diverse range of tumor types, including endometrial, bladder, breast, cervical, gastric, non-small cell lung and ovarian cancers, and it spans early-to-late-stage disease as both monotherapy and in combination with immunotherapies.
In May 2026, MRK announced that the phase III TroFuse-005 study evaluating sac-TMT met its primary endpoints of overall survival and progression-free survival in certain patients with advanced or recurrent endometrial cancer.
GILD’s Price Performance, Valuation and EstimatesShares of GILD have gained 7% year to date, in line with the industry’s growth rate.
Image Source: Zacks Investment Research
Going by the price/earnings ratio, GILD’s shares currently trade at 28.73X forward earnings, higher than its mean of 11.98X and the large-cap pharma industry’s 19.11X.
Image Source: Zacks Investment Research
The consensus estimate for 2026 has deteriorated sharply over the past 30 days, shifting to a loss of 80 cents per share from earnings of $0.01 per share. The estimate for 2027 has edged up to $9.68 per share from $9.58 over the same period.
Image Source: Zacks Investment Research
While Gilead’s recent aggressive dealmaking strategy strengthens its long-term pipeline and growth potential, the sizable upfront payments and integration-related costs are pressuring near-term profitability.
HSBC upgraded Gilead Sciences Inc. (NASDAQ:GILD) on Monday, citing that the consensus is ‘too pessimistic’ in its assumptions of continued decline once dolutegravir faces generics.
Analysts Rajesh Kumar and Dylan Whitfield upgraded the stock to Buy from Hold, and raised the price forecast to $155 from $133, citing the potential of long-acting HIV therapies, growth in HIV prevention, and multiple oncology catalysts to support.
HSBC wrote that consensus estimates assume a steeper decline in Gilead’s HIV franchise than is likely once dolutegravir loses exclusivity. Instead, long-acting HIV therapies could help improve patient adherence and offset much of the anticipated pressure on sales.
Long-Acting HIV Therapies Could Improve AdherenceAccording to the analyst, HIV treatment remains a unique market where better compliance can translate into stronger long-term demand.
Around 60% of patients are estimated to have suboptimal adherence, while more than 40% take fewer than 80% of their prescribed doses.
Long-acting treatment options already on the market, along with candidates in development, are expected to improve adherence. While the exact combinations and launch timelines remain uncertain, the analyst believes these therapies could support stronger-than-expected HIV revenue over time.
Oncology Pipeline And PrEP Business Add UpsideBeyond HIV, the analyst highlighted Gilead’s exposure to the fast-growing pre-exposure prophylaxis (PrEP) market through Yeztugo, which is expected to become a market leader.
The report also pointed to anitocabtagene autoleucel (anito-cel), a CAR T-cell therapy for relapsed or refractory multiple myeloma being co-developed by Arcellx Inc and Kite, a Gilead company.
Gilead acquired Arcellx for $115 per share in cash, along with a contingent value right of $5 per share, totaling an implied equity value of $7.8 billion.
The therapy is currently under FDA review, with a decision expected by December 2026. Although the initial launch is expected in fourth-line treatment, Gilead is pursuing a second-line indication.
The analyst added that expectations for anito-cel remain modest despite its favorable efficacy and safety profile, largely because of limited long-term data compared with competing therapies.
Attractive Valuation Supports UpgradeThe analyst expects Gilead to deliver 5.8% revenue growth through the end of the decade, with additional upside possible as long-acting HIV therapies become less risky and gain broader adoption.
Trading at roughly 13 times next year’s expected earnings following its recent share-price decline, the analyst views the valuation as attractive, supporting the upgrade.
Stock Performance And Technical AnalysisGilead stock is trading lower on Monday as the stock underperforms a soft Healthcare tape and drifts against a risk-on backdrop. The Nasdaq is up 1.21% while the S&P 500 has gained 0.71%.
Gilead is attempting to stabilize after recent weakness, but key technical hurdles remain.
The stock is trading 2.4% above its 20-day simple moving average, suggesting short-term support. However, it remains 0.3% below its 50-day SMA, 5.4% below its 100-day SMA and 0.7% below its 200-day SMA, indicating the longer-term trend is still under pressure.
A bearish death cross formed in July, with the 50-day SMA falling below the 200-day SMA. That pattern often signals continued intermediate-term weakness unless the stock reclaims those longer-term averages.
Momentum also remains mixed. The relative strength index stands at 53.15, indicating neither overbought nor oversold conditions.
The next resistance level sits near $137.50, while initial support is around $128.00, close to the 200-day exponential moving average.
Earnings And Analyst OutlookThe company’s next earnings report is expected on Aug. 6, 2026.
Wall Street expects a loss of $7.14 per share, compared with earnings of $2.01 per share a year earlier, while revenue is projected to increase to $7.40 billion from $7.08 billion.
Gilead trades at about 17.9 times earnings.
Analysts maintain a Buy consensus rating with an average price forecast of $161.23, according to data from 23 analysts. Recent rating actions include:
Cantor Fitzgerald: Reiterated Overweight, maintained a $155 price forecast on July 6. HSBC: Upgraded the stock to Buy and raised its price forecast to $155 on July 6. Cantor Fitzgerald: Reiterated Overweight with a $155 price forecast on June 16. GILD Stock Price Activity: Gilead Sciences shares were down 1.55% at $129.23 at the time of publication on Monday, according to Benzinga Pro data.
Photo by Sundry Photography via Shutterstock
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Gilead Sciences (GILD - Free Report) is one of the stocks most watched by Zacks.com visitors lately. So, it might be a good idea to review some of the factors that might affect the near-term performance of the stock.
Over the past month, shares of this HIV and hepatitis C drugmaker have returned -2.3%, compared to the Zacks S&P 500 composite's -1.4% change. During this period, the Zacks Medical - Biomedical and Genetics industry, which Gilead falls in, has gained 7.9%. The key question now is: What could be the stock's future direction?
While media releases or rumors about a substantial change in a company's business prospects usually make its stock 'trending' and lead to an immediate price change, there are always some fundamental facts that eventually dominate the buy-and-hold decision-making.
Earnings Estimate RevisionsRather than focusing on anything else, we at Zacks prioritize evaluating the change in a company's earnings projection. This is because we believe the fair value for its stock is determined by the present value of its future stream of earnings.
We essentially look at how sell-side analysts covering the stock are revising their earnings estimates to reflect the impact of the latest business trends. And if earnings estimates go up for a company, the fair value for its stock goes up. A higher fair value than the current market price drives investors' interest in buying the stock, leading to its price moving higher. This is why empirical research shows a strong correlation between trends in earnings estimate revisions and near-term stock price movements.
Gilead is expected to post a loss of $7.14 per share for the current quarter, representing a year-over-year change of -455.2%. Over the last 30 days, the Zacks Consensus Estimate has changed +23.6%.
For the current fiscal year, the consensus earnings estimate of -$0.8 points to a change of -109.8% from the prior year. Over the last 30 days, this estimate has changed -1.2%.
For the next fiscal year, the consensus earnings estimate of $9.68 indicates a change of +0% from what Gilead is expected to report a year ago. Over the past month, the estimate has changed +1%.
Having a strong externally audited track record, our proprietary stock rating tool, the Zacks Rank, offers a more conclusive picture of a stock's price direction in the near term, since it effectively harnesses the power of earnings estimate revisions. Due to the size of the recent change in the consensus estimate, along with three other factors related to earnings estimates, Gilead is rated Zacks Rank #3 (Hold).
The chart below shows the evolution of the company's forward 12-month consensus EPS estimate:
12 Month EPS
Revenue Growth ForecastEven though a company's earnings growth is arguably the best indicator of its financial health, nothing much happens if it cannot raise its revenues. It's almost impossible for a company to grow its earnings without growing its revenue for long periods. Therefore, knowing a company's potential revenue growth is crucial.
For Gilead, the consensus sales estimate for the current quarter of $7.36 billion indicates a year-over-year change of +4%. For the current and next fiscal years, $30.43 billion and $32.18 billion estimates indicate +3.3% and +5.8% changes, respectively.
Last Reported Results and Surprise HistoryGilead reported revenues of $6.96 billion in the last reported quarter, representing a year-over-year change of +4.4%. EPS of $2.03 for the same period compares with $1.81 a year ago.
Compared to the Zacks Consensus Estimate of $6.89 billion, the reported revenues represent a surprise of +0.95%. The EPS surprise was +7.41%.
The company beat consensus EPS estimates in each of the trailing four quarters. The company topped consensus revenue estimates each time over this period.
ValuationWithout considering a stock's valuation, no investment decision can be efficient. In predicting a stock's future price performance, it's crucial to determine whether its current price correctly reflects the intrinsic value of the underlying business and the company's growth prospects.
While comparing the current values of a company's valuation multiples, such as price-to-earnings (P/E), price-to-sales (P/S), and price-to-cash flow (P/CF), with its own historical values helps determine whether its stock is fairly valued, overvalued, or undervalued, comparing the company relative to its peers on these parameters gives a good sense of the reasonability of the stock's price.
As part of the Zacks Style Scores system, the Zacks Value Style Score (which evaluates both traditional and unconventional valuation metrics) organizes stocks into five groups ranging from A to F (A is better than B; B is better than C; and so on), making it helpful in identifying whether a stock is overvalued, rightly valued, or temporarily undervalued.
Gilead is graded C on this front, indicating that it is trading at par with its peers. Click here to see the values of some of the valuation metrics that have driven this grade.
ConclusionThe facts discussed here and much other information on Zacks.com might help determine whether or not it's worthwhile paying attention to the market buzz about Gilead. However, its Zacks Rank #3 does suggest that it may perform in line with the broader market in the near term.
Gilead (GILD) was a big mover last session on higher-than-average trading volume. The latest trend in earnings estimate revisions might not help the stock continue moving higher in the near term.
Gilead Sciences (GILD - Free Report) ended the recent trading session at $123.84, demonstrating a -1.05% change from the preceding day's closing price. The stock trailed the S&P 500, which registered a daily loss of 0.01%. Meanwhile, the Dow experienced a rise of 0.14%, and the technology-dominated Nasdaq saw a decrease of 0.46%.
Coming into today, shares of the HIV and hepatitis C drugmaker had lost 6.38% in the past month. In that same time, the Medical sector gained 2.92%, while the S&P 500 lost 1.4%.
The upcoming earnings release of Gilead Sciences will be of great interest to investors. The company is expected to report EPS of -$7.2, down 458.21% from the prior-year quarter. Meanwhile, the latest consensus estimate predicts the revenue to be $7.38 billion, indicating a 4.23% increase compared to the same quarter of the previous year.
For the full year, the Zacks Consensus Estimates project earnings of -$0.8 per share and a revenue of $30.43 billion, demonstrating changes of -109.82% and +3.36%, respectively, from the preceding year.
Additionally, investors should keep an eye on any recent revisions to analyst forecasts for Gilead Sciences. Recent revisions tend to reflect the latest near-term business trends. As a result, we can interpret positive estimate revisions as a good sign for the business outlook.
Our research demonstrates that these adjustments in estimates directly associate with imminent stock price performance. To benefit from this, we have developed the Zacks Rank, a proprietary model which takes these estimate changes into account and provides an actionable rating system.
The Zacks Rank system, which varies between #1 (Strong Buy) and #5 (Strong Sell), carries an impressive track record of exceeding expectations, confirmed by external audits, with stocks at #1 delivering an average annual return of +25% since 1988. Over the past month, the Zacks Consensus EPS estimate has shifted 0.34% downward. Gilead Sciences is currently a Zacks Rank #3 (Hold).
The Medical - Biomedical and Genetics industry is part of the Medical sector. With its current Zacks Industry Rank of 153, this industry ranks in the bottom 38% of all industries, numbering over 250.
The Zacks Industry Rank gauges the strength of our individual industry groups by measuring the average Zacks Rank of the individual stocks within the groups. Our research shows that the top 50% rated industries outperform the bottom half by a factor of 2 to 1.
Keep in mind to rely on Zacks.com to watch all these stock-impacting metrics, and more, in the succeeding trading sessions.
Key Takeaways Gilead secured FDA approval to expand Trodelvy into first-line metastatic TNBC treatment.Trodelvy regimens cut progression or death risk by up to 38% in ASCENT-03 and ASCENT-04.Trodelvy gains broader use as Gilead advances oncology growth beyond its HIV franchise. Gilead Sciences, Inc. (GILD - Free Report) obtained approval FDA approved for the label expansion of breast cancer drug Trodelvy (sacituzumab govitecan-hziy), a first-in-class Trop-2-directed antibody-drug conjugate (ADC).
The regulatory body approved the drug for the first-line treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC).
Consequently, Trodelvy is now approved in first-line mTNBC, either as a single agent for patients who are not candidates for PD-(L)1 inhibitor-based therapy or in combination with Merck’s (MRK - Free Report) Keytruda (pembrolizumab) or Keytruda Qlex (subcutaneous injection of Keytruda) for patients whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-authorized test.
Trodelvy is already approved in several countries for second-line or later metastatic TNBC and in more than 50 countries for certain patients with pre-treated HR+/HER2- metastatic breast cancer (mBC).
The latest FDA approval comes shortly after the European Commission expanded Trodelvy’s label for the same indication.
Gilead’s shares have gained 2% year to date compared with the industry's growth of 0.9%.
Image Source: Zacks Investment Research
More on GILD’s Trodelvy Label Expansion The FDA’s approval was based on highly statistically significant and clinically meaningful progression-free survival (PFS) results from the late-stage ASCENT-03 and ASCENT-04/KEYNOTE-D19 studies. Data from these studies showed that Trodelvy-based regimens significantly lowered the risk of disease progression or death.
In ASCENT-03, Trodelvy monotherapy reduced this risk by 38% compared with chemotherapy in patients with PD-L1–ineligible disease, while in ASCENT-04, Trodelvy combined with Keytruda cut the risk by 35% versus Keytruda plus chemotherapy in patients with PD-L1+ disease.
Trodelvy-based regimens also demonstrated substantially more durable responses across both trials. Median duration of response reached 12.2 months with Trodelvy versus 7.2 months with chemotherapy in ASCENT-03, and 16.5 months with Trodelvy plus Keytruda versus 9.2 months with Keytruda plus chemotherapy in ASCENT-04.
The National Comprehensive Cancer Network (NCCN) recommends Trodelvy with or without Keytruda as a category 1 preferred first-line treatment option for people with mTNBC across PD-L1 status in the NCCN Guidelines, based on findings from the ASCENT-03 and ASCENT-04 studies.
Trodelvy also holds Category 1 recommendations for second-line treatment of mTNBC and for patients with previously treated HR-positive/HER2-negative mBC.
Trodelvy continues to gain market share in the second-line setting. Approval in additional indications will further boost sales.
It is being studied in several ongoing phase III clinical studies across multiple tumor types characterized by high Trop-2 expression. Studies are underway in lung and gynecologic cancers, where earlier proof-of-concept trials have already demonstrated encouraging clinical activity.
However, earlier this month, Merck and Gilead Sciences announced the discontinuation of the phase III KEYNOTE-D46/EVOKE-03 study evaluating Trodelvy in combination with Keytruda as a first-line treatment for patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express high levels of PD-L1 (TPS ≥50%).
The open-label phase III study sponsored by Merck evaluated Trodelvy in combination with Keytruda versus Keytruda alone in this NSCLC patient population. The decision follows a recommendation from the external Data Monitoring Committee after reviewing the pre-specified final PFS analysis and an interim overall survival (OS) analysis.
While the combination demonstrated a numerical improvement in PFS compared with Keytruda alone, the result did not achieve statistical significance. The committee concluded that the likelihood of demonstrating a statistically significant OS benefit at the final analysis was low.
GILD’s Efforts to Diversify PortfolioGilead’s robust HIV franchise continues to maintain momentum, driven by the solid performance of Biktarvy and Descovy, and incremental contributions from Yeztugo.
Simultaneously, GILD is looking to strengthen its oncology franchise.
Gilead’s recent aggressive dealmaking strategy, including the acquisition of Arcellx and Tubulis, highlights the company’s commitment to diversifying beyond its core HIV franchise into higher-growth oncology and immunology markets.
GILD’s Zacks Rank and Stocks to ConsiderGilead currently has a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector are Liquidia Corporation (LQDA - Free Report) and Immunocore (IMCR - Free Report) , both currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Liquidia’s 2026 earnings per share have risen from $1.50 to $2.97, while those for 2027 have increased from $2.91 to $4.81. LQDA’s shares have surged 119% year to date.
Liquidia’s earnings beat estimates in three of the trailing four quarters and missed in one, with the average surprise being 54.40%.
Over the past 60 days, 2026 loss per share estimates for Immunocore have narrowed from 97 cents to 16 cents, while 2027 estimates have improved from a loss of 39 cents to earnings of 11 cents per share.
Immunocore’s earnings beat estimates in three of the trailing four quarters and missed in one, with the average surprise being 46.66%.
FOSTER CITY, Calif.--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved Trodelvy® (sacituzumab govitecan-hziy), a first-in-class Trop-2-directed antibody-drug conjugate (ADC), for the first-line treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC). Trodelvy is now approved in first-line mTNBC either as a single agent for patients who are not candidates for PD-(L)1 inhibitor-based therapy or in combination with Keytruda® (pembrolizumab) or Keytruda Qlex™ (pembrolizumab and berahyaluronidase alfa-mph) for patients whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-authorized test.
“For people living with mTNBC, the first treatment choice can be pivotal, as many patients may not have the opportunity to receive subsequent therapies,” said Sara Tolaney, MD, MPH, Chief of the Division of Breast Oncology at Dana-Farber Cancer Institute and a principal investigator of the ASCENT-03 and ASCENT-04 studies. “This approval is heartening news for patients and the clinical community, and I believe offers a practice-changing first-line treatment option for all patients across PD-L1 status.”
The FDA approval is based on highly statistically significant and clinically meaningful progression-free survival (PFS) data from the Phase 3 ASCENT-03 and ASCENT-04/KEYNOTE-D19 trials, where Trodelvy-based regimens significantly reduced the risk of disease progression or death in first-line mTNBC—by 38% as monotherapy versus chemotherapy in PD-L1 ineligible disease in ASCENT-03 and by 35% in combination with Keytruda versus Keytruda plus chemotherapy in PD-L1+ disease in ASCENT-04.
Across ASCENT-03 and ASCENT-04, Trodelvy-based regimens delivered markedly more durable responses, with median duration of response of 12.2 versus 7.2 months with chemotherapy in ASCENT-03 and 16.5 versus 9.2 months for Trodelvy plus Keytruda versus Keytruda plus chemotherapy in ASCENT-04 by blinded independent central review.
“For patients with metastatic TNBC, a new first-line treatment option offers optimism to a community with historically few choices,” said Ricki Fairley, Co-Founder and CEO of TOUCH, The Black Breast Cancer Alliance. “TNBC disproportionately affects younger women - many in the prime of their lives - and often leads to poorer outcomes. Because so many patients may never receive subsequent lines of therapy, the ability to start with a promising option like Trodelvy with or without Keytruda is critical. We have sought additional alternatives to chemotherapy-containing regimens in the first-line metastatic setting since TNBC was classified as a disease more than 20 years ago. As such, this approval represents meaningful progress for the families impacted by this disease.”
“The FDA’s approval of Trodelvy provides a new standard of care for the most aggressive form of breast cancer,” said Dietmar Berger, MD, PhD, Chief Medical Officer, Gilead Sciences. “For more than twenty years, patients with mTNBC have had limited choices in first-line treatment. Building on its impact in second-line mTNBC, Trodelvy now offers patients a powerful new backbone therapy option in the first-line setting.”
Based on the ASCENT-03 and ASCENT-04 positive study results, the National Comprehensive Cancer Network® (NCCN®) recommends Trodelvy with or without Keytruda as a category 1 preferred first-line treatment option for people with mTNBC across PD-L1 status in the NCCN Guidelines®i. Trodelvy also has a category 1 recommendation in second-line mTNBC and in pre-treated HR+/HER2-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) metastatic breast cancer (mBC).
Healthcare professionals have well-established experience with Trodelvy, with more than 75,000 breast cancer patients treated across more than 60 countries over the past six years. It remains the only Trop-2-directed ADC to demonstrate meaningful overall survival benefits in both second-line or later metastatic TNBC and pre-treated HR+/HER2- mBC. It is also the only ADC with four positive Phase 3 trials in HER2-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) mBC.
Please see below for the U.S. Indication and Important Safety Information for Trodelvy, including Boxed Warning.
KEYTRUDA® and KEYTRUDA QLEX™ are trademark(s) of Merck Sharp & Dohme LLC., a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
About Triple-Negative Breast Cancer
TNBC is the most aggressive type of breast cancer and has historically been difficult to treat, accounting for approximately 15% of all breast cancers. TNBC disproportionally impacts younger, premenopausal, and Black and Hispanic women. TNBC cells do not have estrogen and progesterone receptors and have limited HER2 expression. Due to the nature of TNBC, treatment options are extremely limited compared with other breast cancer types. TNBC has a higher chance of recurrence and metastases than other breast cancer types. The average time to metastatic recurrence for TNBC is approximately 2.6 years compared with 5 years for other breast cancers, and the relative five-year survival rate is much lower. Among women with metastatic TNBC, the five-year survival rate is 12%, compared with 28% for those with other types of mBC.
First-line metastatic TNBC has seen limited new approvals in recent years and additional options are urgently needed. Over 50% of patients do not receive treatment beyond first-line, reinforcing the urgent need for new options to help improve patient outcomes. Breast cancers expressing PD-L1 are overall more aggressive and associated with reduced survival time.
About Trodelvy
Trodelvy (sacituzumab govitecan-hziy) is a first-in-class Trop-2-directed antibody-drug conjugate. Trop-2 is a cell surface antigen highly expressed in multiple tumor types, including in more than 90% of breast and lung cancers. Trodelvy is intentionally designed with a proprietary hydrolyzable linker attached to SN-38, a topoisomerase I inhibitor payload. This unique combination delivers potent activity to both Trop-2 expressing cells and the tumor microenvironment through a bystander effect.
Trodelvy is currently approved in more than 60 countries for second-line or later metastatic triple-negative breast cancer (TNBC) and in more than 50 countries for certain patients with pre-treated HR+/HER2- metastatic breast cancer (mBC). Global regulatory submissions for the approval of Trodelvy based on ASCENT-03 and ASCENT-04 are underway.
Trodelvy is currently being evaluated in multiple ongoing Phase 3 trials across a range of tumor types with high Trop-2 expression. These studies with Trodelvy, both in monotherapy and in combination with pembrolizumab, involve earlier lines of treatment for TNBC and HR+/HER2- breast cancer—including in curative settings—as well as in lung and gynecologic cancers, where previous proof-of-concept studies have demonstrated clinical activity.
INDICATIONS
TRODELVY® (sacituzumab govitecan-hziy) is a Trop-2–directed antibody and topoisomerase inhibitor conjugate indicated in adult patients:
Locally Advanced or Metastatic Triple-Negative Breast Cancer
First Line
As a single agent for the first-line treatment of unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who are not candidates for PD-1 or PD-L1 inhibitor-based therapy In combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph for the first-line treatment of unresectable locally advanced or mTNBC whose tumors express PD-L1 [Combined Positive Score (CPS ≥10)] as determined by an FDA-authorized test Second Line or Later
For the treatment of unresectable locally advanced or mTNBC who have received two or more prior systemic therapies, at least one of them for metastatic disease. Locally Advanced or Metastatic HR-positive, HER2-negative Breast Cancer
For the treatment of unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+, or IHC 2+/ISH–) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting. IMPORTANT SAFETY INFORMATION
BOXED WARNING: NEUTROPENIA AND DIARRHEA
TRODELVY can cause severe, life-threatening, or fatal neutropenia. Withhold TRODELVY for absolute neutrophil count below 1500/mm3 or neutropenic fever. Monitor blood cell counts periodically during treatment. Primary prophylaxis with G-CSF is recommended for all patients at increased risk of febrile neutropenia. Initiate anti-infective treatment in patients with febrile neutropenia without delay. TRODELVY can cause severe diarrhea. Monitor patients with diarrhea and give fluid and electrolytes as needed. At the onset of diarrhea, evaluate for infectious causes and, if negative, promptly initiate loperamide. If severe diarrhea occurs, withhold TRODELVY until resolved to ≤Grade 1 and reduce subsequent doses. CONTRAINDICATIONS
Severe hypersensitivity reaction to TRODELVY. WARNINGS AND PRECAUTIONS
Neutropenia: Severe, life-threatening, or fatal neutropenia can occur as early as the first cycle of treatment and may require dose modification. Neutropenia occurred in 64% of patients treated with TRODELVY. Grade 3-4 neutropenia occurred in 48% of patients. Febrile neutropenia occurred in 6%. Neutropenic colitis occurred in 1.4%. Primary prophylaxis with G-CSF is recommended starting in the first cycle of treatment in all patients at increased risk of febrile neutropenia, including older patients, patients with previous neutropenia, poor performance status, organ dysfunction, or multiple comorbidities. Monitor absolute neutrophil count (ANC) during treatment. Withhold TRODELVY for ANC below 1500/mm3 on Day 1 of any cycle or below 1000/mm3 on Day 8 of any cycle. Withhold TRODELVY for neutropenic fever. Treat neutropenia with G-CSF and administer prophylaxis in subsequent cycles as clinically indicated or indicated in Table 2 of USPI.
Diarrhea: Diarrhea occurred in 62% of all patients treated with TRODELVY. Grade 3-4 diarrhea occurred in 10% of patients. One patient had intestinal perforation following diarrhea. Diarrhea that led to dehydration and subsequent acute kidney injury occurred in 0.6% of all patients. Withhold TRODELVY for Grade 3-4 diarrhea and resume when resolved to ≤Grade 1. At onset, evaluate for infectious causes and, if negative, promptly initiate loperamide, 4 mg initially followed by 2 mg with every episode of diarrhea for a maximum of 16 mg daily. Discontinue loperamide 12 hours after diarrhea resolves. Additional supportive measures (eg, fluid and electrolyte replacement) may also be employed as clinically indicated. Patients who exhibit an excessive cholinergic response to treatment can receive appropriate premedication (eg, atropine) for subsequent treatments.
Hypersensitivity and Infusion-Related Reactions: TRODELVY can cause serious hypersensitivity reactions, including life-threatening anaphylactic reactions. Severe signs and symptoms included cardiac arrest, hypotension, wheezing, angioedema, swelling, and skin reactions. Hypersensitivity reactions occurred in 28% of patients with 13% occurring within 24 hours of dosage. Grade 3-4 hypersensitivity occurred in 1.5% of patients with 0.4% of these occurring within 24 hours of dosage. The incidence of hypersensitivity reactions leading to permanent discontinuation of TRODELVY was 0.4%. The incidence of anaphylactic reaction was <0.1%. Pre-infusion medication is recommended. Have medications and emergency equipment to treat such reactions available for immediate use. Closely monitor patients for hypersensitivity and infusion-related reactions during each infusion and for at least 30 minutes after completion of each infusion. Permanently discontinue TRODELVY for Grade 4 infusion-related reactions.
Nausea and Vomiting: TRODELVY is emetogenic and can cause severe nausea and vomiting. Nausea occurred in 63% of all patients treated with TRODELVY, and Grade 3-4 nausea occurred in 3% of these patients. Vomiting occurred in 33% of patients, and Grade 3-4 vomiting occurred in 2% of these patients. Premedicate with a two- or three-drug combination regimen (eg, dexamethasone with either a 5-HT3 receptor antagonist or an NK1 receptor antagonist, as well as other drugs as indicated) for prevention of chemotherapy-induced nausea and vomiting. Withhold TRODELVY doses for Grade 3 nausea or Grade 3-4 vomiting and resume with additional supportive measures when resolved to ≤Grade 1. Additional antiemetics and other supportive measures may also be employed as clinically indicated. All patients should be given take-home medications with clear instructions for prevention and treatment of nausea and vomiting.
Increased Risk of Adverse Reactions in Patients With Reduced UGT1A1 Activity: Patients homozygous for the uridine diphosphate-glucuronosyl transferase 1A1 (UGT1A1)*28 allele are at increased risk for neutropenia, febrile neutropenia, and anemia and may be at increased risk for other adverse reactions with TRODELVY. The incidence of Grade 3-4 neutropenia was 57% in patients homozygous for the UGT1A1*28 allele, 48% in patients heterozygous for the UGT1A1*28 allele, and 41% in patients homozygous for the wild-type allele. The incidence of Grade 3-4 anemia was 17% in patients homozygous for the UGT1A1*28 allele, 9% in patients heterozygous for the UGT1A1*28 allele, and 8% in patients homozygous for the wild-type allele. Closely monitor patients with known reduced UGT1A1 activity for adverse reactions. Withhold or permanently discontinue TRODELVY based on clinical assessment of the onset, duration, and severity of the observed adverse reactions in patients with evidence of acute early-onset or unusually severe adverse reactions, which may indicate reduced UGT1A1 function.
Embryo-Fetal Toxicity: Based on its mechanism of action, TRODELVY can cause teratogenicity and/or embryo-fetal lethality when administered to a pregnant woman. TRODELVY contains a genotoxic component, SN-38, and targets rapidly dividing cells. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with TRODELVY and for 6 months after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with TRODELVY and for 3 months after the last dose.
ADVERSE REACTIONS
In the pooled safety population of TRODELVY as a single agent, the most common (≥25%) adverse reactions, including laboratory abnormalities, were decreased leukocyte count (83%), decreased neutrophil count (77%), decreased hemoglobin (71%), nausea (63%), diarrhea (62%), decreased lymphocyte count (60%), fatigue (59%), alopecia (47%), increased glucose (40%), constipation (37%), vomiting (33%), decreased albumin (32%), increased alkaline phosphatase (30%), decreased appetite (28%), abdominal pain (27%), decreased creatinine clearance (27%), decreased magnesium and potassium (26% each).
In the safety population of TRODELVY in combination with pembrolizumab, the most common (≥25%) adverse reactions, including laboratory abnormalities, were decreased neutrophil count and hemoglobin (86% each), decreased leukocyte count (84%), diarrhea (72%), nausea (68%), decreased lymphocyte count (61%), fatigue (58%), alopecia (52%), increased alkaline phosphatase and glucose (50% each), increased alanine aminotransferase (47%), constipation (41%), increased aspartate aminotransferase (40%), rash (37%), decreased potassium (35%), increased lactate dehydrogenase (34%), vomiting (29%), abdominal pain, headache, and increased eosinophils (26% each), and decreased albumin (25%).
In the ASCENT-03 study (single agent in previously untreated, unresectable locally advanced or mTNBC), the most common adverse reactions (incidence ≥25%) were nausea, diarrhea, alopecia, fatigue, constipation, and vomiting. The most frequent serious adverse reactions (SAR) (>2%) were diarrhea, febrile neutropenia, and neutropenia (3.6% each), and pneumonia (2.9%). SAR occurred in 26% of patients, and 3.6% permanently discontinued TRODELVY due to adverse reactions. Fatal adverse reactions occurred in 2.5% of patients and included sepsis (1.1%), and acute respiratory failure, neutropenic colitis, pneumonia, and septic shock (0.4% each). The most common Grade 3-4 lab abnormalities (incidence ≥25%) were decreased neutrophils and leukocytes.
In the ASCENT-04 study (in combination with pembrolizumab in previously untreated, unresectable locally advanced or mTNBC whose tumors express PD-L1), the most common adverse reactions (incidence ≥25%) were diarrhea, nausea, fatigue, alopecia, constipation, rash, vomiting, abdominal pain, and headache. The most frequent SAR (≥2%) were febrile neutropenia (7%), neutropenia (6%), diarrhea (5%), and fatigue and pneumonia (2.3% each). SAR occurred in 38% of patients, and 7% permanently discontinued TRODELVY due to adverse reactions. Fatal adverse reactions occurred in 3.2% of patients and included death (unknown cause) (0.9%) and completed suicide, neutropenic sepsis, sepsis, pneumonia, and pulmonary embolism (0.5% each). The most common Grade 3-4 lab abnormalities (incidence ≥25%) were decreased neutrophils and leukocytes.
In the ASCENT study (previously treated locally advanced or mTNBC), the most common adverse reactions (incidence ≥25%) were fatigue, diarrhea, nausea, alopecia, constipation, vomiting, abdominal pain, and decreased appetite. The most frequent SAR (>1%) were neutropenia (7%), diarrhea (4%), and pneumonia (3%). SAR occurred in 27% of patients, and 5% permanently discontinued TRODELVY due to adverse reactions. Fatal adverse reactions occurred in 1.2% of patients and included respiratory failure (0.8%) and pneumonia (0.4%). The most common Grade 3-4 lab abnormalities (incidence ≥25%) were decreased neutrophils, leukocytes, and lymphocytes.
In the TROPiCS-02 study (locally advanced or metastatic HR+/HER2– breast cancer), the most common adverse reactions (incidence ≥25%) were diarrhea, fatigue, nausea, alopecia, and constipation. The most frequent SAR (>1%) were diarrhea (5%), febrile neutropenia (4.1%), neutropenia (3%), abdominal pain (2.2%), neutropenic colitis and vomiting (1.9% each), and colitis and pneumonia (1.5% each). SAR occurred in 28% of patients, and 6% permanently discontinued TRODELVY due to adverse reactions. Fatal adverse reactions occurred in 2.2% of patients and included arrhythmia, COVID-19 pneumonia, pneumonia, nervous system disorder, pulmonary embolism, and septic shock (0.4% each). The most common Grade 3-4 lab abnormalities (incidence ≥25%) were decreased neutrophils and leukocytes.
DRUG INTERACTIONS
UGT1A1 Inhibitors: Avoid administering UGT1A1 inhibitors with TRODELVY. SN-38 is a UGT1A1 substrate. Concomitant administration of TRODELVY with inhibitors of UGT1A1 may increase the incidence of adverse reactions due to potential increase in systemic exposure to SN-38.
UGT1A1 Inducers: Avoid administering UGT1A1 inducers with TRODELVY. SN-38 is a UGT1A1 substrate. Concomitant administration of TRODELVY with inducers of UGT1A1 may reduce exposure to SN-38.
Please see full Prescribing Information, including BOXED WARNING.
About Gilead and Kite Oncology
Gilead and Kite Oncology are working to transform how cancer is treated. We are innovating with next-generation therapies, combinations and technologies to deliver improved outcomes for people with cancer. We are purposefully building our oncology portfolio and pipeline to address the greatest gaps in care. From antibody-drug conjugate technologies and small molecules to cell therapy-based approaches, we are creating new possibilities for people with cancer.
About Gilead Sciences
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, cancer and inflammation. In 2025, Gilead announced a planned $32 billion investment to further strengthen its U.S. footprint to power the next era of discovery, job creation and public health preparedness – while continuing to invest globally to ensure patients everywhere benefit from its scientific innovation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, Calif.
Forward-Looking Statements
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including Gilead’s ability to initiate, progress or complete clinical trials or studies within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing and additional clinical trials or studies, including those involving sacituzumab govitecan-hziy (such as ASCENT-03 and ASCENT-04); uncertainties relating to regulatory applications and related filing and approval timelines, including potential applications for programs and/or indications currently under evaluation, and the risk that any regulatory approvals, if granted, may be subject to significant limitations on use or subject to withdrawal or other adverse actions by the applicable regulatory authority; the possibility that Gilead may make a strategic decision to discontinue development of these programs and, as a result, these programs may never be successfully commercialized for the indications currently under evaluation; the risk that physicians and patients may not see advantages of Trodelvy for first-line mTNBC and may therefore be reluctant to prescribe the products; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and factors are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements.
Trodelvy, Gilead and the Gilead logo are trademarks of Gilead Sciences, Inc., or its related companies.
U.S. Prescribing Information for Trodelvy, including BOXED WARNING, is available at www.gilead.com.
For more information about Gilead, please visit the company’s website at www.gilead.com, follow Gilead on X/Twitter (@Gilead Sciences) and LinkedIn (@Gilead-Sciences).
Key Takeaways Gilead won EC approval for Trodelvy in first-line metastatic TNBC for eligible adult patients.Trodelvy cut progression or death risk by 38% versus chemotherapy in the ASCENT-03 study.GILD is pursuing broader first-line TNBC approvals in Europe and the United States. Gilead Sciences, Inc. (GILD - Free Report) obtained approval from the European Commission (EC) for a label expansion of its breast cancer drug Trodelvy (sacituzumab govitecan-hziy).
The EC granted marketing authorization to Trodelvy as monotherapy for the treatment of adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic disease and are not candidates for PD-1 or PD-L1 inhibitor therapy.
Trodelvy is a first-in-class Trop-2-directed antibody-drug conjugate (ADC). It is already approved in several countries for second-line or later metastatic TNBC and in more than 50 countries for certain patients with pre-treated HR+/HER2- metastatic breast cancer.
The latest approval makes Trodelvy the first ADC to be approved in first-line metastatic TNBC in the European Union and the first new treatment option in 20 Years in Europe for these patients.
Gilead’s shares have gained 1.9% year to date compared with the industry's growth of 0.9%.
Image Source: Zacks Investment Research
More on Gilead’s TrodelvyThe EC’s marketing authorization is based on data from the late-stage ASCENT-03 study, which showed that Trodelvy delivered a statistically significant and clinically meaningful improvement in progression-free survival compared with standard-of-care chemotherapy when used as a first-line treatment.
Trodelvy demonstrated a 38% reduced risk of disease progression or death in patients who are not candidates for PD-1/PD-L1 inhibitors. The ASCENT-03 study utilized a patient-centered crossover design, which allowed patients in the chemotherapy arm to receive Trodelvy after their disease progressed.
Gilead has expanded its regulatory efforts for Trodelvy in the first-line metastatic TNBC setting. The company has submitted an application to the EMA seeking approval of Trodelvy in combination with Merck’s (MRK - Free Report) Keytruda (pembrolizumab) for patients with PD-L1-positive unresectable locally advanced or metastatic TNBC, supported by data from the phase III ASCENT-04 study.
This application is currently under review. If approved, Trodelvy could become a backbone first-line treatment option for metastatic TNBC across PD-L1 status in Europe.
In the United States, Gilead has also filed supplemental applications with the FDA for Trodelvy in the first-line treatment of unresectable locally advanced or metastatic TNBC. The filings seek approval of Trodelvy as a monotherapy for patients who are not eligible for PD-(L)1 inhibitor-based therapy and in combination with Keytruda or Keytruda Qlex for patients with PD-L1-expressing tumors (CPS ≥10), as determined by an FDA-authorized test.
Trodelvy continues to gain market share in the second-line setting. Approval in additional indications will further boost sales.
Trodelvy is currently being investigated in multiple ongoing phase III studies across different tumor types, including in small cell lung cancer and gynecologic cancers, where previous proof-of-concept studies have demonstrated clinical activity.
However, earlier this month, Merck and Gilead Sciences announced the discontinuation of the phase III KEYNOTE-D46/EVOKE-03 study evaluating Trodelvy in combination with Keytruda as a first-line treatment for patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express high levels of PD-L1 (TPS ≥50%).
The open-label phase III study sponsored by Merck evaluated Trodelvy in combination with Keytruda versus Keytruda alone in this NSCLC patient population. The trial enrolled approximately 620 patients.
The decision follows a recommendation from the external Data Monitoring Committee after reviewing the pre-specified final progression-free survival (PFS) analysis and an interim overall survival (OS) analysis.
While the combination demonstrated a numerical improvement in PFS compared with Keytruda alone, the result did not achieve statistical significance. The committee concluded that the likelihood of demonstrating a statistically significant OS benefit at the final analysis was low.
GILD’s Efforts to Diversify PortfolioGilead’s robust HIV franchise continues to maintain momentum, driven by the solid performance of Biktarvy and Descovy, and incremental contributions from Yeztugo.
Simultaneously, GILD is looking to strengthen its oncology franchise.
Gilead’s recent aggressive dealmaking strategy, including the acquisition of Arcellx and Tubulis, highlights the company’s commitment to diversifying beyond its core HIV franchise into higher-growth oncology and immunology markets.
However, GILD lowered its full-year earnings outlook due to expected acquired IPR&D charges of $11.5 billion and financing expenses associated with the Arcellx, Ouro Medicines, and Tubulis GmbH deals.
While these transactions strengthen Gilead’s long-term pipeline and growth potential, the sizable upfront payments and integration-related costs are pressuring near-term profitability.
This, in turn, has prompted Gilead to lower its EPS guidance, raising investor concerns about margin pressure and the timeline required for these acquisitions to generate meaningful returns.
GILD’s Zacks Rank and Stocks to ConsiderGilead currently has a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector are Liquidia Corporation (LQDA - Free Report) and Immunocore (IMCR - Free Report) , both currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Liquidia’s 2026 earnings per share have risen from $1.50 to $2.97, while those for 2027 have increased from $2.91 to $4.81. LQDA’s shares have surged 114.7% year to date.
Liquidia’s earnings beat estimates in three of the trailing four quarters and missed in one, with the average surprise being 54.40%.
Over the past 60 days, 2026 loss per share estimates for Immunocore have narrowed from 97 cents to 16 cents, while 2027 estimates have improved from a loss of 39 cents to earnings of 11 cents per share.
Immunocore’s earnings beat estimates in three of the trailing four quarters and missed in one, with the average surprise being 46.66%.
Gilead Sciences (GILD - Free Report) has been one of the most searched-for stocks on Zacks.com lately. So, you might want to look at some of the facts that could shape the stock's performance in the near term.
Over the past month, shares of this HIV and hepatitis C drugmaker have returned -4%, compared to the Zacks S&P 500 composite's +0.3% change. During this period, the Zacks Medical - Biomedical and Genetics industry, which Gilead falls in, has gained 1.5%. The key question now is: What could be the stock's future direction?
While media releases or rumors about a substantial change in a company's business prospects usually make its stock 'trending' and lead to an immediate price change, there are always some fundamental facts that eventually dominate the buy-and-hold decision-making.
Revisions to Earnings EstimatesHere at Zacks, we prioritize appraising the change in the projection of a company's future earnings over anything else. That's because we believe the present value of its future stream of earnings is what determines the fair value for its stock.
Our analysis is essentially based on how sell-side analysts covering the stock are revising their earnings estimates to take the latest business trends into account. When earnings estimates for a company go up, the fair value for its stock goes up as well. And when a stock's fair value is higher than its current market price, investors tend to buy the stock, resulting in its price moving upward. Because of this, empirical studies indicate a strong correlation between trends in earnings estimate revisions and short-term stock price movements.
For the current quarter, Gilead is expected to post a loss of $5.88 per share, indicating a change of -392.5% from the year-ago quarter. The Zacks Consensus Estimate has changed -40.5% over the last 30 days.
For the current fiscal year, the consensus earnings estimate of -$0.8 points to a change of -109.8% from the prior year. Over the last 30 days, this estimate has changed -3.7%.
For the next fiscal year, the consensus earnings estimate of $9.71 indicates a change of +0% from what Gilead is expected to report a year ago. Over the past month, the estimate has changed +0.9%.
With an impressive externally audited track record, our proprietary stock rating tool -- the Zacks Rank -- is a more conclusive indicator of a stock's near-term price performance, as it effectively harnesses the power of earnings estimate revisions. The size of the recent change in the consensus estimate, along with three other factors related to earnings estimates, has resulted in a Zacks Rank #3 (Hold) for Gilead.
The chart below shows the evolution of the company's forward 12-month consensus EPS estimate:
12 Month EPS
Revenue Growth ForecastEven though a company's earnings growth is arguably the best indicator of its financial health, nothing much happens if it cannot raise its revenues. It's almost impossible for a company to grow its earnings without growing its revenue for long periods. Therefore, knowing a company's potential revenue growth is crucial.
For Gilead, the consensus sales estimate for the current quarter of $7.38 billion indicates a year-over-year change of +4.2%. For the current and next fiscal years, $30.43 billion and $32.38 billion estimates indicate +3.4% and +6.4% changes, respectively.
Last Reported Results and Surprise HistoryGilead reported revenues of $6.96 billion in the last reported quarter, representing a year-over-year change of +4.4%. EPS of $2.03 for the same period compares with $1.81 a year ago.
Compared to the Zacks Consensus Estimate of $6.89 billion, the reported revenues represent a surprise of +0.95%. The EPS surprise was +7.41%.
The company beat consensus EPS estimates in each of the trailing four quarters. The company topped consensus revenue estimates each time over this period.
ValuationWithout considering a stock's valuation, no investment decision can be efficient. In predicting a stock's future price performance, it's crucial to determine whether its current price correctly reflects the intrinsic value of the underlying business and the company's growth prospects.
Comparing the current value of a company's valuation multiples, such as its price-to-earnings (P/E), price-to-sales (P/S), and price-to-cash flow (P/CF), to its own historical values helps ascertain whether its stock is fairly valued, overvalued, or undervalued, whereas comparing the company relative to its peers on these parameters gives a good sense of how reasonable its stock price is.
As part of the Zacks Style Scores system, the Zacks Value Style Score (which evaluates both traditional and unconventional valuation metrics) organizes stocks into five groups ranging from A to F (A is better than B; B is better than C; and so on), making it helpful in identifying whether a stock is overvalued, rightly valued, or temporarily undervalued.
Gilead is graded C on this front, indicating that it is trading at par with its peers. Click here to see the values of some of the valuation metrics that have driven this grade.
ConclusionThe facts discussed here and much other information on Zacks.com might help determine whether or not it's worthwhile paying attention to the market buzz about Gilead. However, its Zacks Rank #3 does suggest that it may perform in line with the broader market in the near term.
FOSTER CITY, Calif.--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the European Commission (EC) has granted marketing authorization for Trodelvy® (sacituzumab govitecan-hziy) as monotherapy for the treatment of adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic disease and are not candidates for PD-1 or PD-L1 inhibitor therapy. Trodelvy is the first antibody-drug conjugate (ADC) to be approved in first-line metastatic TNBC in the European Union’s 27 member states, as well as Norway, Iceland and Liechtenstein.
“This approval brings a profound sense of hope to a community that has long been waiting for progress,” said Dr. Javier Cortes, Head of the International Breast Cancer Center, Madrid and Barcelona, Spain. “For women diagnosed with metastatic TNBC, particularly those who are younger, every second counts, and having an effective treatment option that can delay the progression of their disease is invaluable. This is the kind of meaningful advance our community needs.”
For many living with metastatic TNBC, the most aggressive form of breast cancer, first-line therapy may be their only line of treatment, creating an urgent need for effective treatment options to be used as early as possible.
“This approval represents a significant step forward in how we treat people with first-line metastatic TNBC in Europe,” said Mika Kakefuda Derynck, MD, Senior Vice President, Clinical Development, Oncology at Gilead Sciences. “We have long recognized the challenges that patients and clinicians face with this aggressive cancer, and we believe this approval will provide a much-needed new option for people with metastatic TNBC.”
The EC’s marketing authorization is based on data from the Phase 3 ASCENT-03 study which demonstrated a highly statistically significant and clinically meaningful progression-free survival for Trodelvy compared to standard of care chemotherapy as a first-line treatment. In ASCENT-03, Trodelvy demonstrated a 38% reduced risk of disease progression or death in patients who are not candidates for PD-1/PD-L1 inhibitors. The ASCENT-03 study utilized a patient-centered crossover design, which allowed patients in the chemotherapy arm to receive Trodelvy after their disease progressed. The EC’s approval, based on the strength of the PFS data, confirms the study's objective to demonstrate using Trodelvy earlier provides a clinical benefit over chemotherapy for metastatic TNBC patients.
Continued Global Regulatory Filings for Trodelvy in First-Line Metastatic TNBC
Gilead has submitted a supplemental filing to the European Medicines Agency for Trodelvy in combination with Keytruda® (pembrolizumab) for patients with PD-L1 positive unresectable locally advanced or metastatic TNBC, based on data from the Phase 3 ASCENT-04 study. This application is currently under review. If approved, Trodelvy has the potential to be a backbone treatment in 1L metastatic TNBC, across PD-L1 status in Europe. In the U.S., Gilead has also submitted supplemental filings to the Food and Drug Administration (FDA) for Trodelvy for the first-line treatment of adult patients with unresectable locally advanced or metastatic TNBC as a single agent for patients who are not candidates for PD-(L)1 inhibitor-based therapy, or in combination with Keytruda or Keytruda Qlex in patients whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-authorized test.
KEYTRUDA® and KEYTRUDA QLEX™ are trademarks of Merck Sharp & Dohme LLC., a subsidiary of Merck & Co., Inc., Rahway, NJ, USA
About Triple-Negative Breast Cancer In Patients Who Are Not Candidates for PD-1/PD-L1 Inhibitors
TNBC is the most aggressive type of breast cancer and has historically been difficult to treat, accounting for approximately 15% of all breast cancers. TNBC disproportionally impacts younger, premenopausal, and Black and Hispanic women. TNBC cells do not have estrogen and progesterone receptors and have limited HER2 expression. Due to the nature of TNBC, treatment options are extremely limited compared with other breast cancer types. TNBC has a higher chance of recurrence and metastases than other breast cancer types. The average time to metastatic recurrence for TNBC is approximately 2.6 years compared with 5 years for other breast cancers, and the relative five-year survival rate is much lower. Among women with metastatic TNBC, the five-year survival rate is 12%, compared with 28% for those with other types of mBC.
About Trodelvy
Trodelvy (sacituzumab govitecan-hziy) is a Trop-2-directed antibody-drug conjugate. Trop-2 is a cell surface antigen highly expressed in multiple tumor types, including in more than 90% of breast and lung cancers. Trodelvy is intentionally designed with a proprietary hydrolyzable linker attached to SN-38, a topoisomerase I inhibitor payload. This unique combination delivers potent activity to both Trop-2 expressing cells and the tumor microenvironment through a bystander effect.
Outside of Europe, Gilead has submitted supplemental applications to the U.S. Food and Drug Administration (FDA) for approval of Trodelvy based on the ASCENT-03 and ASCENT-04 studies.
Healthcare professionals have substantial clinical experience with Trodelvy, with more than 75,000 breast cancer patients treated since 2020. In addition to its first-line indication approval, Trodelvy is currently approved in more than 60 countries for patients with second-line or later mTNBC and in over 50 countries for certain patients with pre-treated HR+/HER2- metastatic breast cancer. It is the only ADC with four positive Phase 3 trials in HER2-negative metastatic breast cancer and the only Trop-2-directed ADC to demonstrate a meaningful overall survival benefit in two distinct types of metastatic breast cancer.
Trodelvy is currently being evaluated in multiple ongoing Phase 3 trials across different tumor types, including in small cell lung cancer and gynecologic cancers, where previous proof-of-concept studies have demonstrated clinical activity.
U.S. Indications for Trodelvy
TRODELVY® (sacituzumab govitecan-hziy) is a Trop-2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with:
Unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease. Unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH–) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting. U.S. Important safety information FOR TRODELVY
BOXED WARNING: NEUTROPENIA AND DIARRHEA
TRODELVY can cause severe, life-threatening, or fatal neutropenia. Withhold TRODELVY for absolute neutrophil count below 1500/mm3 or neutropenic fever. Monitor blood cell counts periodically during treatment. Primary prophylaxis with G-CSF is recommended for all patients at increased risk of febrile neutropenia. Initiate anti-infective treatment in patients with febrile neutropenia without delay. TRODELVY can cause severe diarrhea. Monitor patients with diarrhea and give fluid and electrolytes as needed. At the onset of diarrhea, evaluate for infectious causes and, if negative, promptly initiate loperamide. If severe diarrhea occurs, withhold TRODELVY until resolved to ≤ Grade 1 and reduce subsequent doses. CONTRAINDICATIONS
Severe hypersensitivity reaction to TRODELVY. WARNINGS AND PRECAUTIONS
Neutropenia: Severe, life-threatening, or fatal neutropenia can occur as early as the first cycle of treatment and may require dose modification. Neutropenia occurred in 64% of patients treated with TRODELVY. Grade 3-4 neutropenia occurred in 49% of patients. Febrile neutropenia occurred in 6%. Neutropenic colitis occurred in 1.4%. Primary prophylaxis with G-CSF is recommended starting in the first cycle of treatment in all patients at increased risk of febrile neutropenia, including older patients, patients with previous neutropenia, poor performance status, organ dysfunction, or multiple comorbidities. Monitor absolute neutrophil count (ANC) during treatment. Withhold TRODELVY for ANC below 1500/mm3 on Day 1 of any cycle or below 1000/mm3 on Day 8 of any cycle. Withhold TRODELVY for neutropenic fever. Treat neutropenia with G-CSF and administer prophylaxis in subsequent cycles as clinically indicated or indicated in Table 2 of USPI.
Diarrhea: Diarrhea occurred in 64% of all patients treated with TRODELVY. Grade 3-4 diarrhea occurred in 11% of patients. One patient had intestinal perforation following diarrhea. Diarrhea that led to dehydration and subsequent acute kidney injury occurred in 0.7% of all patients. Withhold TRODELVY for Grade 3-4 diarrhea and resume when resolved to ≤ Grade 1. At onset, evaluate for infectious causes and if negative, promptly initiate loperamide, 4 mg initially followed by 2 mg with every episode of diarrhea for a maximum of 16 mg daily. Discontinue loperamide 12 hours after diarrhea resolves. Additional supportive measures (e.g., fluid and electrolyte substitution) may also be employed as clinically indicated. Patients who exhibit an excessive cholinergic response to treatment can receive appropriate premedication (e.g., atropine) for subsequent treatments.
Hypersensitivity and Infusion-Related Reactions: TRODELVY can cause serious hypersensitivity reactions including life-threatening anaphylactic reactions. Severe signs and symptoms included cardiac arrest, hypotension, wheezing, angioedema, swelling, pneumonitis, and skin reactions. Hypersensitivity reactions within 24 hours of dosing occurred in 35% of patients. Grade 3-4 hypersensitivity occurred in 2% of patients. The incidence of hypersensitivity reactions leading to permanent discontinuation of TRODELVY was 0.2%. The incidence of anaphylactic reactions was 0.2%. Pre-infusion medication is recommended. Have medications and emergency equipment to treat such reactions available for immediate use. Observe patients closely for hypersensitivity and infusion-related reactions during each infusion and for at least 30 minutes after completion of each infusion. Permanently discontinue TRODELVY for Grade 4 infusion-related reactions.
Nausea and Vomiting: TRODELVY is emetogenic and can cause severe nausea and vomiting. Nausea occurred in 64% of all patients treated with TRODELVY and Grade 3-4 nausea occurred in 3% of these patients. Vomiting occurred in 35% of patients and Grade 3-4 vomiting occurred in 2% of these patients. Premedicate with a two or three drug combination regimen (e.g., dexamethasone with either a 5-HT3 receptor antagonist or an NK1 receptor antagonist as well as other drugs as indicated) for prevention of chemotherapy-induced nausea and vomiting (CINV). Withhold TRODELVY doses for Grade 3 nausea or Grade 3-4 vomiting and resume with additional supportive measures when resolved to Grade ≤ 1. Additional antiemetics and other supportive measures may also be employed as clinically indicated. All patients should be given take-home medications with clear instructions for prevention and treatment of nausea and vomiting.
Increased Risk of Adverse Reactions in Patients with Reduced UGT1A1 Activity: Patients homozygous for the uridine diphosphate-glucuronosyl transferase 1A1 (UGT1A1)*28 allele are at increased risk for neutropenia, febrile neutropenia, and anemia and may be at increased risk for other adverse reactions with TRODELVY. The incidence of Grade 3-4 neutropenia was 58% in patients homozygous for the UGT1A1*28, 49% in patients heterozygous for the UGT1A1*28 allele, and 43% in patients homozygous for the wild-type allele. The incidence of Grade 3-4 anemia was 21% in patients homozygous for the UGT1A1*28 allele, 10% in patients heterozygous for the UGT1A1*28 allele, and 9% in patients homozygous for the wild-type allele. Closely monitor patients with known reduced UGT1A1 activity for adverse reactions. Withhold or permanently discontinue TRODELVY based on clinical assessment of the onset, duration and severity of the observed adverse reactions in patients with evidence of acute early-onset or unusually severe adverse reactions, which may indicate reduced UGT1A1 function.
Embryo-Fetal Toxicity: Based on its mechanism of action, TRODELVY can cause teratogenicity and/or embryo-fetal lethality when administered to a pregnant woman. TRODELVY contains a genotoxic component, SN-38, and targets rapidly dividing cells. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with TRODELVY and for 6 months after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with TRODELVY and for 3 months after the last dose.
ADVERSE REACTIONS
In the pooled safety population, the most common (≥ 25%) adverse reactions including laboratory abnormalities were decreased leukocyte count (84%), decreased neutrophil count (75%), decreased hemoglobin (69%), diarrhea (64%), nausea (64%), decreased lymphocyte count (63%), fatigue (51%), alopecia (45%), constipation (37%), increased glucose (37%), decreased albumin (35%), vomiting (35%), decreased appetite (30%), decreased creatinine clearance (28%), increased alkaline phosphatase (28%), decreased magnesium (27%), decreased potassium (26%), and decreased sodium (26%).
In the ASCENT study (locally advanced or metastatic triple-negative breast cancer), the most common adverse reactions (incidence ≥25%) were fatigue, diarrhea, nausea, alopecia, constipation, vomiting, abdominal pain, and decreased appetite. The most frequent serious adverse reactions (SAR) (>1%) were neutropenia (7%), diarrhea (4%), and pneumonia (3%). SAR were reported in 27% of patients, and 5% discontinued therapy due to adverse reactions. The most common Grade 3-4 lab abnormalities (incidence ≥25%) in the ASCENT study were reduced neutrophils, leukocytes, and lymphocytes.
In the TROPiCS-02 study (locally advanced or metastatic HR-positive, HER2-negative breast cancer), the most common adverse reactions (incidence ≥25%) were diarrhea, fatigue, nausea, alopecia, and constipation. The most frequent serious adverse reactions (SAR) (>1%) were diarrhea (5%), febrile neutropenia (4%), neutropenia (3%), abdominal pain, colitis, neutropenic colitis, pneumonia, and vomiting (each 2%). SAR were reported in 28% of patients, and 6% discontinued therapy due to adverse reactions. The most common Grade 3-4 lab abnormalities (incidence ≥25%) in the TROPiCS-02 study were reduced neutrophils and leukocytes.
DRUG INTERACTIONS
UGT1A1 Inhibitors: Concomitant administration of TRODELVY with inhibitors of UGT1A1 may increase the incidence of adverse reactions due to potential increase in systemic exposure to SN-38. Avoid administering UGT1A1 inhibitors with TRODELVY.
UGT1A1 Inducers: Exposure to SN-38 may be reduced in patients concomitantly receiving UGT1A1 enzyme inducers. Avoid administering UGT1A1 inducers with TRODELVY.
Please see full Prescribing Information, including BOXED WARNING.
About Gilead and Kite Oncology
Gilead and Kite Oncology are working to transform how cancer is treated. We are innovating with next-generation therapies, combinations and technologies to deliver improved outcomes for people with cancer. We are purposefully building our oncology portfolio and pipeline to address the greatest gaps in care. From antibody-drug conjugate technologies and small molecules to cell therapy-based approaches, we are creating new possibilities for people with cancer.
About Gilead Sciences
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, cancer and inflammation. In 2025, Gilead announced a planned $32 billion investment to further strengthen its U.S. footprint to power the next era of discovery, job creation and public health preparedness – while continuing to invest globally to ensure patients everywhere benefit from its scientific innovation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, Calif.
Forward-Looking Statements
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including Gilead’s ability to initiate, progress or complete clinical trials or studies within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing and additional clinical trials or studies, including those involving Trodelvy; uncertainties relating to regulatory applications and related filing and approval timelines, including such as the pending applications for Trodelvy in 1L mTNBC and potential applications for programs and/or indications currently under evaluation, and the risk that any regulatory approvals, if granted, may be subject to significant limitations on use or subject to withdrawal or other adverse actions by the applicable regulatory authority; the possibility that Gilead may make a strategic decision to discontinue development of these programs and, as a result, these programs may never be successfully commercialized for the indications currently under evaluation; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and factors are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements.
Trodelvy, Gilead and the Gilead logo are trademarks of Gilead Sciences, Inc., or its related companies.
U.S. Prescribing Information for Trodelvy, including BOXED WARNING, is available at www.gilead.com.
For more information about Gilead, please visit the company’s website at www.gilead.com, follow Gilead on X/Twitter (@Gilead Sciences) and LinkedIn (@Gilead-Sciences).
Gilead Sciences offers a compelling long-term value opportunity after a significant pullback, with a "Buy" rating reaffirmed. GILD's core HIV franchise drives 72% of sales, with robust growth from Biktarvy and rapid adoption of Yeztugo, now expected to reach $1 billion in annual sales. Management raised 2026 revenue growth guidance to 5.5% at midpoint, citing strong HIV performance and momentum in oncology with Trodelvy.
Key Takeaways FDA accepted GILD's sNDA for once-weekly oral Yeztugo for HIV prevention; decision due Feb. 2, 2027.PURPOSE studies showed strong lenacapavir efficacy for HIV prevention across diverse populations.Gilead raised its 2026 Yeztugo sales forecast to $1 billion following strong market uptake. Gilead Sciences, Inc. (GILD - Free Report) announced that the FDA has accepted its supplemental new drug application (sNDA) for Yeztugo (lenacapavir) 300-mg tablets as a potential once-weekly oral pre-exposure prophylaxis (PrEP) option for HIV prevention.
The FDA has set a target action date of Feb. 2, 2027.
We note that Yeztugo (lenacapavir) twice-yearly injection is already approved in the United States for PrEP to reduce the risk of sexually acquired HIV-1 in adults and adolescents who are at risk for HIV-1 acquisition.
Gilead’s shares have gained 1.3% year to date against the industry's decline of 1.3%.
Image Source: Zacks Investment Research
More on GILD’s Once Weekly YeztugoThe submission is supported by data from the PURPOSE 1 and PURPOSE 2 studies, which demonstrated strong efficacy of lenacapavir for HIV prevention across diverse populations, including cisgender women, cisgender men and gender-diverse individuals.
Oral lenacapavir tablets are already part of the approved Yeztugo regimen as a loading dose and as temporary bridge therapy when the twice-yearly injectable schedule is delayed.
GILD is seeking to build on lenacapavir’s established clinical profile by expanding its long-acting HIV prevention portfolio with new formulations.
The company aims to increase access to PrEP by offering prevention options tailored to diverse patient preferences and needs. If approved, once-weekly oral Yeztugo would provide an additional, convenient PrEP alternative, reflecting the view that HIV prevention requires a range of individualized approaches.
GILD’s Efforts to Diversify PortfolioGilead maintains a leading position in the HIV market, anchored by its flagship products, Biktarvy for HIV treatment and Descovy for HIV prevention. Biktarvy is a once-daily, single-tablet regimen that combines bictegravir, a potent integrase strand transfer inhibitor (INSTI), with the Descovy backbone of emtricitabine and tenofovir alafenamide.
The approval of Yeztugo in 2025 has further strengthened Gilead’s HIV portfolio. Unlike traditional daily oral PrEP medications, Yeztugo is administered just twice a year, offering a more convenient prevention option for many patients.
Driven by strong first-quarter sales and favorable market uptake, Gilead recently increased its 2026 sales forecast for Yeztugo to $1 billion, putting the drug on track to attain blockbuster status in its first full year following its launch.
The company’s HIV business also benefits from a lengthy exclusivity runway, with no major patent expirations expected before 2036. Combined with plans to introduce as many as seven new HIV therapies by 2033, Gilead appears well positioned to sustain long-term growth in its core HIV franchise.
GILD has also collaborated with Merck (MRK - Free Report) to advance its HIV pipeline further.
Gilead and Merck recently reported positive results from the phase III ISLEND-1 and ISLEND-2 studies evaluating an investigational once-weekly oral single-tablet regimen combining islatravir and lenacapavir for HIV treatment.
The regimen pairs Merck’s islatravir, a next-generation nucleoside analog that suppresses HIV replication through multiple mechanisms, including reverse transcriptase translocation inhibition, with Gilead’s long-acting capsid inhibitor lenacapavir.
Both trials achieved their primary efficacy endpoint at week 48, supporting the potential of a convenient once-weekly treatment option. Following these results, the partners plan to submit the ISLEND data to global regulatory agencies and present detailed findings at an upcoming scientific meeting.
Beyond the Merck partnership, Gilead continues to advance its wholly owned HIV pipeline. Earlier this year, the company reported promising phase I results for GS-3242, a long-acting integrase inhibitor. Additional data expected later in 2026 could pave the way for a twice-yearly injectable regimen combining GS-3242 with lenacapavir, further strengthening Gilead’s HIV portfolio.
Approval of additional better treatments should bolster GILD’s HIV franchise in the wake of increasing competition from the likes of GSK plc (GSK - Free Report) .
GSK continues to grow its HIV business, driven by strong patient demand for long-acting injectable medicines (Cabenuva and Apretude) and Dovato. The solid growth from these drugs has helped GSK combat the decline in Triumeq sales.
In the latest trading session, Gilead Sciences (GILD - Free Report) closed at $124.30, marking a -1.03% move from the previous day. The stock's performance was behind the S&P 500's daily gain of 1.65%. Meanwhile, the Dow gained 0.92%, and the Nasdaq, a tech-heavy index, added 3.07%.
Shares of the HIV and hepatitis C drugmaker witnessed a loss of 3.08% over the previous month, trailing the performance of the Medical sector with its gain of 3.59%, and the S&P 500's gain of 0.48%.
The investment community will be paying close attention to the earnings performance of Gilead Sciences in its upcoming release. The company's upcoming EPS is projected at -$5.31, signifying a 364.18% drop compared to the same quarter of the previous year. Meanwhile, the Zacks Consensus Estimate for revenue is projecting net sales of $7.36 billion, up 3.98% from the year-ago period.
For the full year, the Zacks Consensus Estimates are projecting earnings of -$0.79 per share and revenue of $30.37 billion, which would represent changes of -109.69% and +3.16%, respectively, from the prior year.
It is also important to note the recent changes to analyst estimates for Gilead Sciences. Such recent modifications usually signify the changing landscape of near-term business trends. Therefore, positive revisions in estimates convey analysts' confidence in the business performance and profit potential.
Our research shows that these estimate changes are directly correlated with near-term stock prices. To exploit this, we've formed the Zacks Rank, a quantitative model that includes these estimate changes and presents a viable rating system.
The Zacks Rank system ranges from #1 (Strong Buy) to #5 (Strong Sell). It has a remarkable, outside-audited track record of success, with #1 stocks delivering an average annual return of +25% since 1988. Over the past month, there's been a 1.73% fall in the Zacks Consensus EPS estimate. Gilead Sciences presently features a Zacks Rank of #3 (Hold).
The Medical - Biomedical and Genetics industry is part of the Medical sector. This industry, currently bearing a Zacks Industry Rank of 147, finds itself in the bottom 40% echelons of all 250+ industries.
The Zacks Industry Rank is ordered from best to worst in terms of the average Zacks Rank of the individual companies within each of these sectors. Our research shows that the top 50% rated industries outperform the bottom half by a factor of 2 to 1.
To follow GILD in the coming trading sessions, be sure to utilize Zacks.com.
FOSTER CITY, Calif.--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq: GILD) today announced the U.S. Food and Drug Administration (FDA) accepted its supplemental New Drug Application (sNDA) for Yeztugo® (lenacapavir) 300-mg tablet as a potential once-weekly (QW) oral formulation for the prevention of HIV as pre-exposure prophylaxis (PrEP). The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of February 2, 2027. “This filing reflects Gilead's continued commitment to advancin.
Key Takeaways Gilead said Livdelzi significantly improved ALP normalization versus placebo at 52 weeks in PBC.GILD's IDEAL enrolled 96 adults; safety findings were consistent with prior Livdelzi studies.Gilead said strong Livdelzi uptake and Hepcludex approval have bolstered its liver franchise. Gilead Sciences, Inc. (GILD - Free Report) announced positive results from the late-stage IDEAL study in patients with primary biliary cholangitis (PBC).
Results showed that Livdelzi (seladelpar) significantly increased the proportion of patients achieving normalization of alkaline phosphatase (ALP), an important marker of liver disease progression, compared with placebo after 52 weeks.
The positive results were seen in patients with inadequately controlled PBC, characterized by ALP levels above the upper limit of normal (ULN) but below 1.67 times the ULN, despite treatment with ursodeoxycholic acid (UDCA), or in those unable to tolerate UDCA.
Although this patient group is commonly seen in clinical practice, it has historically been underrepresented in randomized clinical trials.
Livdelzi is an orally administered peroxisome proliferator-activated receptor delta (PPAR-δ) agonist. It is indicated for the treatment of PBC in combination with UDCA in adults who have had an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA.
More on GILD’s IDEAL Study ResultsIDEAL is a phase III, randomized, double-blind, placebo-controlled trial evaluating Livdelzi in adults with PBC whose disease remains inadequately controlled despite treatment with UDCA who are unable to tolerate UDCA. Eligible participants had ALP levels above the ULN but below 1.67 times the ULN.
The study’s primary objective is to assess the efficacy of Livdelzi versus placebo at week 52 in achieving ALP normalization. The trial enrolled 96 adults aged 18 to 75 years.
The safety findings from the IDEAL study were consistent with the established safety profile of Livdelzi observed in previous clinical trials, with no new safety signals or unexpected adverse events reported.
PBC is a chronic autoimmune liver disorder characterized by damage to the bile ducts, affecting approximately 130,000 individuals in the United States. The condition occurs more frequently in women and, if left untreated, can lead to progressive liver damage, liver failure, and the eventual need for a liver transplant.
The FDA approved Livdelzi for PBC under accelerated approval based on a reduction of ALP. Improvement in survival or prevention of liver decompensation events has not been demonstrated. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
Gilead intends to present the complete IDEAL study findings at a forthcoming medical conference and will work with regulatory agencies worldwide to review and discuss the results.
GILD’s Efforts to Bolster PortfolioThe strong uptake of Livdelzi has fueled liver disease franchise sales in the first quarter.
Last month, the FDA granted accelerated approval to Hepcludex (bulevirtide-gmod) for adults with chronic hepatitis delta virus (HDV) infection.
The approval makes Hepcludex the first FDA-approved therapy for HDV in the United States.
The FDA approval of Hepcludex bolsters the GILD’s liver disease franchise, which spans treatments for HCV, chronic HBV, and chronic HDV.
Gilead’s shares have gained 4% year to date against the industry's decline of 2.2%.
Image Source: Zacks Investment Research
Gilead’s first-quarter results were good. HIV business continues to maintain momentum, driven by the solid performance of Biktarvy and Descovy, and incremental contributions from Yeztugo.
Driven by increased Yeztugo sales expectations and strong first-quarter HIV performance, Gilead now projects total 2026 HIV sales growth of approximately 8% year over year, up from its prior guidance of 6% issued in February.
Approval of better HIV treatments should strengthen the HIV franchise in the wake of increasing competition from the likes of GSK plc (GSK - Free Report) .
GSK continues to grow its HIV business, driven by strong patient demand for long-acting injectable medicines (Cabenuva and Apretude) and Dovato.
GILD lowered its full-year earnings outlook due to expected acquired IPR&D charges of $11.5 billion and financing expenses associated with the Arcellx, Ouro Medicines and Tubulis GmbH deals.
Gilead’s aggressive dealmaking strategy — including the acquisition of Arcellx and agreements with Ouro and Tubulis — highlights the company’s commitment to diversifying beyond its core HIV franchise into higher-growth oncology and immunology markets. While these transactions strengthen Gilead’s long-term pipeline and growth potential, the sizable upfront payments and integration-related costs are pressuring near-term profitability.
This, in turn, has prompted Gilead to lower its EPS guidance, raising investor concerns about margin pressure and the timeline required for these acquisitions to generate meaningful returns.
GILD’s Zacks Rank & Key PicksGILD currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector are Liquidia Corporation (LQDA - Free Report) and Immunocore (IMCR - Free Report) , each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 30 days, estimates for Liquidia’s 2026 earnings per share have increased to $2.97 from $1.50. Over the same period, EPS estimates for 2027 have risen to $4.81 from $2.91. LQDA shares have gained 60.7% year to date.
Liquidia’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 54.40%.
Over the past 30 days, bottom-line estimates for Immunocore have improved from a loss of 88 cents to earnings of 6 cents for 2026. Over the same period, earnings estimates for 2027 have increased to 87 cents per share from 24 cents. IMCR shares have lost 18.4% year to date.
– Companies will collaborate on the development of gamgertamig, a potential first-in-class and best-in-class T cell engager in autoimmune diseases –
FOSTER CITY, Calif. & MECHELEN, Belgium--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq: GILD) and Lakefront Biotherapeutics NV (Euronext & Nasdaq: LKFT) today announced the successful completion of the previously announced acquisition of Ouro Medicines to advance T cell engager therapies for autoimmune diseases.
The acquisition adds gamgertamig (OM336), a clinical-stage BCMAxCD3 T cell engager, to Gilead’s growing inflammation portfolio and will be the foundation of Lakefront’s clinical development pipeline. Gamgertamig is designed to enable rapid and deep plasma cell and B cell depletion following a limited subcutaneously administered treatment course with the potential to induce durable disease control in severe antibody-mediated orphan diseases including autoimmune hemolytic anemia (AIHA) and immune thrombocytopenia (ITP). Gamgertamig has been granted both Fast Track and Orphan Drug Designation by the U.S. FDA for the treatment of AIHA and ITP and is expected to enter registrational studies as early as 2027.
The addition of gamgertamig builds on Gilead’s long-term strategy to invest in differentiated science and accelerate the development of therapies that address significant unmet need. Combined with existing expertise in immunology and cell therapy, this approach supports the company’s ambition to shift treatment paradigms from chronic disease management toward the potential for durable immune reset.
Under the terms of the agreement, Gilead acquired all the outstanding equity of Ouro Medicines for $1,675 million and up to $500 million in contingent milestone payments. Lakefront and Gilead will equally split the upfront payment, subject to customary adjustments, and contingent milestone payments of up to $500 million.
With this transaction, Lakefront has acquired substantially all of Ouro Medicines’ team and operational assets in connection with Gilead’s acquisition of Ouro Medicines and will collaborate with Gilead on the development of gamgertamig. As part of the collaboration, Lakefront is responsible for the ongoing and future Phase 1/2 clinical studies of gamgertamig, with Gilead leading the registrational and later-stage studies. Gilead will retain sole worldwide commercialization rights, including all related costs, globally outside of Keymed’s territories. Lakefront will receive tiered royalties of 20%–23% on net sales of gamgertamig from Gilead.
Lakefront has also in-licensed a preclinical portfolio of three additional autoimmune focused programs originally from Ouro with an opt-in for Gilead for a 50/50 profit split post clinical proof-of-concept for $75 million per program.
The transaction provides relief under the Option, License and Collaboration Agreement dated July 14, 2019, between Lakefront and Gilead (the “OLCA”) to enable Lakefront to deploy at least $500 million of its available cash independently from Gilead and outside the scope of the OLCA and the Ouro transaction, including up to $150 million for share buybacks.
The Ouro portfolio will be the cornerstone of Lakefront’s R&D pipeline. Following this transaction, Lakefront will continue to have a majority of its cash remaining for additional strategic transactions and other capital allocation priorities. Lakefront’s year-end 2026 cash balance is expected to be approximately €2B.
About Gamgertamig
Gamgertamig is an investigational BCMAxCD3 bispecific T cell engager for the treatment of autoantibodies driven immune-mediated disease. Gamgertamig has been granted Orphan Drug Designation and Fast Track Designation by the U.S. FDA for certain autoimmune diseases. Gamgertamig is currently in Phase 2 studies is expected to enter registrational studies as early as 2027. Gamgertamig is in-licensed from Keymed Biosciences, which owns the rights to develop the program in Greater China.
About Gilead Sciences
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, cancer and inflammation. In 2025, Gilead announced a planned $32 billion investment to further strengthen its U.S. footprint to power the next era of discovery, job creation and public health preparedness – while continuing to invest globally to ensure patients everywhere benefit from its scientific innovation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, Calif.
About Lakefront® Biotherapeutics
Lakefront Biotherapeutics (formerly known as Galapagos) is a biotechnology company built to bring meaningful medicines to patients with serious diseases in therapeutic areas of unmet need. The Company combines world-class deal making expertise with capital to identify, acquire, and advance promising opportunities that have the potential to drive value for patients and shareholders. Applying a modality-agnostic asset selection approach and operational flexibility, Lakefront Biotherapeutics prioritizes oncology and immunology & inflammation programs with clear clinical proof-of-concept in emerging areas. For more information, visit https://www.lakefrontbio.com or follow us on LinkedIn or X.
Gilead Forward-Looking Statement
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors. All statements other than statements of historical fact are statements that could be deemed forward-looking statements, including all statements regarding the intent, belief or current expectation of Gilead and Ouro Medicines and members of their respective senior management teams. In some cases, forward-looking statements can be identified by the use of words such as “anticipate,” “believe,” “estimate,” “expect,” “intend,” “seek,” “may,” “plan,” “project,” “should,” “target,” “will,” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements include, without limitation, statements regarding the transactions and related matters, prospective performance and opportunities, post-closing operations and the outlook for the companies’ businesses; the potential of Ouro Medicines’ programs; timing of prospective clinical trials; Gilead’s long-term strategy; and any assumptions underlying any of the foregoing. Actual results may differ materially from those currently anticipated due to a number of risks and uncertainties. Risks and uncertainties that could cause the actual results to differ from expectations contemplated by forward-looking statements include: the effects of the transactions on relationships with employees, other business partners or governmental entities; the difficulty of predicting the timing or outcome of regulatory approvals or actions, if any; the risk that the businesses will not be integrated successfully and that other anticipated benefits from the transactions will not be realized; the impact of competitive products and pricing; other business effects, including the effects of industry, economic or political conditions outside of the companies’ control; transaction costs; actual or contingent liabilities; the risk that Gilead may not realize the expected benefits of the Ouro Medicines acquisition or the Lakefront license and collaboration; the ability of Gilead to advance their product pipeline and successfully commercialize product candidates following the acquisition; the ability of the parties to initiate and complete clinical trials involving such product candidates in the currently anticipated timelines or at all; the possibility of unfavorable results from one or more of such trials involving such product candidates; uncertainties relating to regulatory applications and related filing and approval timelines, including potential applications for programs and/or indications currently under evaluation, and the risk that any regulatory approvals, if granted, may be subject to significant limitations on use or subject to withdrawal or other adverse actions by the applicable regulatory authority; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and factors are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, as filed with the U.S. Securities and Exchange Commission. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, all of which involve certain risks and uncertainties. These statements are often, but are not always, made through the use of words or phrases such as “believe,” “anticipate,” “expect,” “intend,” “plan,” “seek,” “upcoming,” “future,” “estimate,” “may,” “will,” “could,” “would,” “potential,” “forward,” “goal,” “next,” “continue,” “should,” “encouraging,” “aim,” “progress,” “remain," “explore,” “further” as well as similar expressions. These statements include, but are not limited to, statements regarding Lakefront’s business development strategy and clinical development pipeline, expected benefits and potential of gamgertamig, post-closing operations and benefits of the transaction, timing of prospective clinical trials, and our expected cash balance in 2026 and expected uses of cash. Lakefront cautions the reader that forward-looking statements are based on our management’s current expectations and beliefs and are not guarantees of future performance. Forward-looking statements may involve known and unknown risks, uncertainties and other factors which might cause actual events, financial condition and liquidity, performance or achievements, or the industry in which we operate, to be materially different from any historic or future results, financial conditions, performance or achievements expressed or implied by such forward-looking statements. In addition, even if our results, performance, financial condition and liquidity, and the development of the industry in which Lakefront operates are consistent with such forward-looking statements, they may not be predictive of results or developments in future periods. Such risks include, but are not limited to, the risk that Lakefront’s financial estimates, including cash position, may be incorrect (including because one or more of its assumptions may not be realized); risks associated with the changes to our capital allocation strategies; the risk that we will not be able to execute on our currently contemplated business plan or strategy and/or will revise our business plan or strategy; risks related to our ability to successfully identify, pursue and consummate new transformational business development transactions, including our ability to identify product candidates that will have commercial success and/or be profitable; the risk that the commercial potential of gamgertamig proves to be inaccurate; the risk that the businesses will not be integrated successfully and that other anticipated benefits from the transactions will not be realized; the inherent risks and uncertainties associated with competitive developments, clinical trials, recruitment of patients, product development activities and regulatory approval requirements; risks related to our reliance on collaborations with third parties (including, but not limited to, our collaboration partner Gilead); the impact of competitive products and pricing; and the risk that our estimates regarding the commercial potential of our product candidates (if approved) or expectations regarding the costs and revenues associated with the commercialization rights may be inaccurate. A further list and description of these risks, uncertainties and other risks can be found in our filings and reports with the Securities and Exchange Commission (SEC), including in our most recent annual report on Form 20‐F filed with the SEC and our subsequent filings and reports filed with the SEC. Given these risks and uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. In addition, even if the result of our operations, financial condition and liquidity, or the industry in which we operate, are consistent with such forward-looking statements, they may not be predictive of results, performance or achievements in future periods. These forward-looking statements speak only as of the date of publication of this release. We expressly disclaim any obligation to update any such forward-looking statements in this release to reflect any change in our expectations or any change in events, conditions or circumstances, unless specifically required by law or regulation.
Gilead and the Gilead logo are trademarks of Gilead Sciences, Inc., or its related companies.
For more information about Gilead, please visit the company’s website at www.gilead.com, follow Gilead on X/Twitter (@Gilead Sciences) and LinkedIn (@Gilead-Sciences).
Companies will collaborate on the development of gamgertamig, a potential first-in-class and best-in-class T cell engager in autoimmune diseases
Foster City, Calif. and Mechelen, Belgium; June 4, 2026, 22.15 CET – Gilead Sciences, Inc. (Nasdaq: GILD) and Lakefront Biotherapeutics NV (Euronext & Nasdaq: LKFT) today announced the successful completion of the previously announced acquisition of Ouro Medicines to advance T cell engager therapies for autoimmune diseases.
The acquisition adds gamgertamig (OM336), a clinical-stage BCMAxCD3 T cell engager, to Gilead’s growing inflammation portfolio and will be the foundation of Lakefront’s clinical development pipeline. Gamgertamig is designed to enable rapid and deep plasma cell and B cell depletion following a limited subcutaneously administered treatment course with the potential to induce durable disease control in severe antibody-mediated orphan diseases including autoimmune hemolytic anemia (AIHA) and immune thrombocytopenia (ITP). Gamgertamig has been granted both Fast Track and Orphan Drug Designation by the U.S. FDA for the treatment of AIHA and ITP and is expected to enter registrational studies as early as 2027.
The addition of gamgertamig builds on Gilead’s long-term strategy to invest in differentiated science and accelerate the development of therapies that address significant unmet need. Combined with existing expertise in immunology and cell therapy, this approach supports the company’s ambition to shift treatment paradigms from chronic disease management toward the potential for durable immune reset.
Under the terms of the agreement, Gilead acquired all the outstanding equity of Ouro Medicines for $1,675 million and up to $500 million in contingent milestone payments. Lakefront and Gilead will equally split the upfront payment, subject to customary adjustments, and contingent milestone payments of up to $500 million.
With this transaction, Lakefront has acquired substantially all of Ouro Medicines’ team and operational assets in connection with Gilead’s acquisition of Ouro Medicines and will collaborate with Gilead on the development of gamgertamig. As part of the collaboration, Lakefront is responsible for the ongoing and future Phase 1/2 clinical studies of gamgertamig, with Gilead leading the registrational and later-stage studies. Gilead will retain sole worldwide commercialization rights, including all related costs, globally outside of Keymed’s territories. Lakefront will receive tiered royalties of 20%–23% on net sales of gamgertamig from Gilead.
Lakefront has also in-licensed a preclinical portfolio of three additional autoimmune focused programs originally from Ouro with an opt-in for Gilead for a 50/50 profit split post clinical proof-of-concept for $75 million per program.
The transaction provides relief under the Option, License and Collaboration Agreement dated July 14, 2019, between Lakefront and Gilead (the “OLCA”) to enable Lakefront to deploy at least $500 million of its available cash independently from Gilead and outside the scope of the OLCA and the Ouro transaction, including up to $150 million for share buybacks.
The Ouro portfolio will be the cornerstone of Lakefront’s R&D pipeline. Following this transaction, Lakefront will continue to have a majority of its cash remaining for additional strategic transactions and other capital allocation priorities. Lakefront’s year-end 2026 cash balance is expected to be approximately €2B.
About Gamgertamig
Gamgertamig is an investigational BCMAxCD3 bispecific T cell engager for the treatment of autoantibodies driven immune-mediated disease. Gamgertamig has been granted Orphan Drug Designation and Fast Track Designation by the U.S. FDA for certain autoimmune diseases. Gamgertamig is currently in Phase 2 studies is expected to enter registrational studies as early as 2027. Gamgertamig is in-licensed from Keymed Biosciences, which owns the rights to develop the program in Greater China.
About Gilead Sciences
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, cancer and inflammation. In 2025, Gilead announced a planned $32 billion investment to further strengthen its U.S. footprint to power the next era of discovery, job creation and public health preparedness – while continuing to invest globally to ensure patients everywhere benefit from its scientific innovation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, Calif.
About Lakefront® Biotherapeutics
Lakefront Biotherapeutics (formerly known as Galapagos) is a biotechnology company built to bring meaningful medicines to patients with serious diseases in therapeutic areas of unmet need. The Company combines world-class deal making expertise with capital to identify, acquire, and advance promising opportunities that have the potential to drive value for patients and shareholders. Applying a modality-agnostic asset selection approach and operational flexibility, Lakefront Biotherapeutics prioritizes oncology and immunology & inflammation programs with clear clinical proof-of-concept in emerging areas. For more information, visit lakefrontbio.com or follow us on Linkedin or X.
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors. All statements other than statements of historical fact are statements that could be deemed forward-looking statements, including all statements regarding the intent, belief or current expectation of Gilead and Ouro Medicines and members of their respective senior management teams. In some cases, forward-looking statements can be identified by the use of words such as “anticipate,” “believe,” “estimate,” “expect,” “intend,” “seek,” “may,” “plan,” “project,” “should,” “target,” “will,” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements include, without limitation, statements regarding the transactions and related matters, prospective performance and opportunities, post-closing operations and the outlook for the companies’ businesses; the potential of Ouro Medicines’ programs; timing of prospective clinical trials; Gilead’s long-term strategy; and any assumptions underlying any of the foregoing. Actual results may differ materially from those currently anticipated due to a number of risks and uncertainties. Risks and uncertainties that could cause the actual results to differ from expectations contemplated by forward-looking statements include: the effects of the transactions on relationships with employees, other business partners or governmental entities; the difficulty of predicting the timing or outcome of regulatory approvals or actions, if any; the risk that the businesses will not be integrated successfully and that other anticipated benefits from the transactions will not be realized; the impact of competitive products and pricing; other business effects, including the effects of industry, economic or political conditions outside of the companies’ control; transaction costs; actual or contingent liabilities; the risk that Gilead may not realize the expected benefits of the Ouro Medicines acquisition or the Lakefront license and collaboration; the ability of Gilead to advance their product pipeline and successfully commercialize product candidates following the acquisition; the ability of the parties to initiate and complete clinical trials involving such product candidates in the currently anticipated timelines or at all; the possibility of unfavorable results from one or more of such trials involving such product candidates; uncertainties relating to regulatory applications and related filing and approval timelines, including potential applications for programs and/or indications currently under evaluation, and the risk that any regulatory approvals, if granted, may be subject to significant limitations on use or subject to withdrawal or other adverse actions by the applicable regulatory authority; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and factors are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, as filed with the U.S. Securities and Exchange Commission. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, all of which involve certain risks and uncertainties. These statements are often, but are not always, made through the use of words or phrases such as “believe,” “anticipate,” “expect,” “intend,” “plan,” “seek,” “upcoming,” “future,” “estimate,” “may,” “will,” “could,” “would,” “potential,” “forward,” “goal,” “next,” “continue,” “should,” “encouraging,” “aim,” “progress,” “remain,’ “explore,” “further” as well as similar expressions. These statements include, but are not limited to, statements regarding Lakefront’s business development strategy and clinical development pipeline, expected benefits and potential of gamgertamig, post-closing operations and benefits of the transaction, timing of prospective clinical trials, and our expected cash balance in 2026 and expected uses of cash. Lakefront cautions the reader that forward-looking statements are based on our management’s current expectations and beliefs and are not guarantees of future performance. Forward-looking statements may involve known and unknown risks, uncertainties and other factors which might cause actual events, financial condition and liquidity, performance or achievements, or the industry in which we operate, to be materially different from any historic or future results, financial conditions, performance or achievements expressed or implied by such forward-looking statements. In addition, even if our results, performance, financial condition and liquidity, and the development of the industry in which Lakefront operates are consistent with such forward-looking statements, they may not be predictive of results or developments in future periods. Such risks include, but are not limited to, the risk that Lakefront’s financial estimates, including cash position, may be incorrect (including because one or more of its assumptions may not be realized); risks associated with the changes to our capital allocation strategies; the risk that we will not be able to execute on our currently contemplated business plan or strategy and/or will revise our business plan or strategy; risks related to our ability to successfully identify, pursue and consummate new transformational business development transactions, including our ability to identify product candidates that will have commercial success and/or be profitable; the risk that the commercial potential of gamgertamig proves to be inaccurate; the risk that the businesses will not be integrated successfully and that other anticipated benefits from the transactions will not be realized; the inherent risks and uncertainties associated with competitive developments, clinical trials, recruitment of patients, product development activities and regulatory approval requirements; risks related to our reliance on collaborations with third parties (including, but not limited to, our collaboration partner Gilead); the impact of competitive products and pricing; and the risk that our estimates regarding the commercial potential of our product candidates (if approved) or expectations regarding the costs and revenues associated with the commercialization rights may be inaccurate. A further list and description of these risks, uncertainties and other risks can be found in our filings and reports with the Securities and Exchange Commission (SEC), including in our most recent annual report on Form 20‐F filed with the SEC and our subsequent filings and reports filed with the SEC. Given these risks and uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. In addition, even if the result of our operations, financial condition and liquidity, or the industry in which we operate, are consistent with such forward-looking statements, they may not be predictive of results, performance or achievements in future periods. These forward-looking statements speak only as of the date of publication of this release. We expressly disclaim any obligation to update any such forward-looking statements in this release to reflect any change in our expectations or any change in events, conditions or circumstances, unless specifically required by law or regulation.
# # #
Lakefront and the Lakefront logo are trademarks of Lakefront Biotherapeutics NV, or its related companies.
GILEAD SCIENCES AND LAKEFRONT COMPLETE ACQUISITION OF OURO MEDICINES TO FURTHER EXPAND INFLAMMATION PIPELINE
FOSTER CITY, Calif.--(BUSINESS WIRE)--Gilead applauds the leadership of the Government of South Africa and the Global Fund for accelerating access to lenacapavir, a long-acting HIV prevention medication. This marks an important step toward expanding access to lenacapavir for communities most affected by HIV.
“South Africa is at the heart of global efforts to end HIV. With the country’s launch of lenacapavir, there is now an opportunity to rapidly accelerate progress,” said Daniel O’Day, Chairman and Chief Executive Officer of Gilead Sciences.
Share “South Africa is at the heart of global efforts to end HIV. With the country’s launch of lenacapavir, there is now an opportunity to rapidly accelerate progress,” said Daniel O’Day, Chairman and Chief Executive Officer of Gilead Sciences. “Through partnerships with country leadership, the Global Fund, and the U.S. State Department via PEPFAR, Gilead is working to bring lenacapavir to the communities most in need, ahead of the broad rollout of generic versions of the medicine.”
South Africa carries the largest HIV burden globally, with approximately 7.8 million people living with HIV and an estimated 170,000 new infections each year, including a disproportionate impact on women, according to national epidemiological data. Despite significant progress, the scope of the country’s epidemic and the incidence of new infections underscore the need for more effective HIV prevention options. The Phase 3 PURPOSE 1 and PURPOSE 2 trials included many sites in South Africa, reflecting Gilead’s commitment to developing solutions in the communities most affected by HIV.
Gilead’s efforts to accelerate access are reflected through our global access commitments, including working with partners such as the Global Fund and the U.S. State Department, through PEPFAR to support initial supply (at no profit to the company), advancing voluntary licensing agreements to enable broad geographic reach, and supporting local and regional manufacturing pathways to strengthen long-term supply resilience.
Gilead is committed to supporting broad, equitable and sustainable access to lenacapavir for HIV prevention globally. Through our royalty-free voluntary license agreements with six manufacturers, we are enabling generic supply across 120 low- and lower-middle-income countries as part of a comprehensive access strategy to support long-term, lower-cost medication supply.
As highlighted by today’s announcement and the strong, coordinated leadership demonstrated in South Africa, the continued collaboration between countries, global health partners and industry will be critical to reaching people with new innovations at scale, reducing new HIV infections and advancing our shared goal of ending HIV as a public health threat.
For more information about Gilead, please visit the company’s website at www.gilead.com, follow Gilead on X/Twitter (@Gilead Sciences) and LinkedIn (@Gilead-Sciences).
Assembly Biosciences NASDAQ: ASMB is awaiting a key development plan from partner Gilead Sciences for its herpes simplex virus programs while advancing ABI-6250 into multiple liver disease indications, Chief Executive Officer Jason Okazaki said during a Jefferies biotech event.
Okazaki said 2024 was “a pretty big year” for the company’s HSV work, with ABI-5366 and ABI-1179 both showing “high proof of concept” in Phase 1b studies. Gilead opted into both programs in December and now controls development and commercialization, he said.
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The next expected catalyst is Gilead’s clinical development plan, which Okazaki said should indicate whether one or both molecules will move into Phase 2 and Phase 3, as well as outline commercialization plans. Assembly then has the option to opt into a 40/60 U.S. cost and profit share, a decision Okazaki said the company expects to make around mid-year.
Okazaki said Assembly will evaluate the opportunity largely through a quantitative analysis comparing the potential U.S. profit share against the costs of development and commercialization, as well as the alternative of receiving milestones and royalties without sharing costs. He added that funding a 40% share of Phase 2, Phase 3 and commercial launch expenses would likely require “a significant raise down the road,” making dilution a consideration.
ABI-6250 Expands Beyond Hepatitis Delta Assembly is also preparing to advance ABI-6250, an NTCP inhibitor, in hepatitis delta and cholestatic liver diseases. Okazaki said the company reported positive Phase 1a data last year showing target engagement and bile acid elevation, and has completed chronic toxicology studies. Assembly plans to start a Phase 2 study in hepatitis delta by the end of this year, with data expected in the second half of next year.
The company recently announced plans to study ABI-6250 in primary biliary cholangitis, or PBC, and primary sclerosing cholangitis, or PSC. Okazaki said the expansion followed about 18 months of discussions with key opinion leaders and a pre-IND meeting with the FDA. He said Assembly has received funding for the program through the end of Phase 2 and expects to initiate PBC and PSC studies in the first quarter of 2027, with data expected in the first half of 2028.
Katie Kitrinos, Assembly’s senior vice president of preclinical R&D, said ABI-6250 was initially developed as a small-molecule NTCP inhibitor for chronic hepatitis delta because NTCP is the receptor the virus uses to enter cells. She said Phase 1a results showed dose-dependent increases in serum bile acids that were “consistent with or actually higher than” levels observed with 2 milligram and 8.5 milligram doses of bulevirtide.
Kitrinos said preclinical work also showed ABI-6250 had low nanomolar potency against bile acid transport, supporting its potential use in cholestatic liver disease. The company views the drug as potentially hepatoprotective because it is designed to prevent bile acids from entering hepatocytes.
PBC and PSC Study Design Kitrinos said the planned PBC and PSC basket study is intended to be operationally efficient because the same clinical sites could enroll patients with either disease. Okazaki said the study design includes testing ABI-6250 as a second-line single agent and as an add-on to PPAR therapy, reflecting how the company believes the drug could be positioned commercially if successful.
Kitrinos said the company will evaluate biochemical endpoints such as alkaline phosphatase, ALT and bilirubin, as well as non-invasive fibrosis measures including FibroScan and ELF score. The study will also assess pruritus, or itch, and quality-of-life measures.
For PBC, Kitrinos said Assembly will focus heavily on alkaline phosphatase because biochemical endpoints are considered approvable in that indication. For PSC, she said current approvable endpoints are based on clinical outcomes, but the planned 12-week Phase 2 study will instead look for directional changes across biomarkers, fibrosis measures and pruritus scores.
On safety, Kitrinos said the Phase 1a study showed a favorable profile over 10 days of dosing, with no adverse events of pruritus. She added that chronic toxicology studies showed “great safety margins” and no notable safety signals requiring follow-up.
Hepatitis Delta and Potential Oral Advantage In hepatitis delta, Kitrinos said Assembly expects to run a longer Phase 2 trial, likely 24 to 48 weeks, with multiple doses. The goal is to achieve serum bile acid elevations consistent with or greater than those observed with bulevirtide, which she said have been associated with multiple-log reductions in RNA and ALT normalization.
Kitrinos said ABI-6250 could offer an advantage as a daily oral small molecule. Because hepatitis delta patients are also infected with hepatitis B and typically take a daily oral nucleoside therapy, she said ABI-6250’s expected low dose could make it suitable for co-formulation with a nucleoside, potentially allowing treatment of both viruses in one daily pill.
HBV Program Seeking Partner Okazaki also discussed ABI-4334, Assembly’s hepatitis B program for which sole rights were returned to the company. He said Assembly has begun a formal partnering process with a bank to identify potential global partners.
Okazaki said Assembly continues to believe a core inhibitor, or CAM, could be one of the cornerstones of a hepatitis B cure regimen alongside a nucleoside backbone. However, he said the company does not have the additional immunomodulatory component needed to pursue the combination strategy on its own.
“Most important for us is making sure somebody could actually take that to the next stage,” Okazaki said, adding that Assembly is flexible on deal structure and focused on finding a partner with a scientific rationale for advancing the asset.
Cash Runway Okazaki said Assembly’s last published cash runway extended into 2028 and that the company has not updated guidance since a recent $115 million financing. He said the financing should fund the company beyond the planned PBC and PSC trials in 2028, and that it is “safe to say” the runway extends into the second half of 2028, potentially longer depending on the Gilead development plan and Assembly’s opt-in decision.
About Assembly Biosciences NASDAQ: ASMBAssembly Biosciences, Inc NASDAQ: ASMB is a clinical-stage biotechnology company dedicated to the discovery, development and commercialization of novel therapies for hepatitis B virus (HBV) and hepatitis D virus (HDV) infections. The company's core expertise lies in small-molecule modulation of viral proteins and host-targeted pathways to achieve sustained viral suppression and potential functional cure. Assembly's research model integrates medicinal chemistry, structural biology and translational virology to advance its pipeline from early discovery through clinical development.
The company's lead programs include core protein allosteric modulators (CpAMs) designed to disrupt the HBV lifecycle by interfering with capsid assembly and viral DNA replication, as well as prenylation inhibitors targeting the HDV lifecycle.
This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected].
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Assembly Biosciences NASDAQ: ASMB outlined its antiviral and liver disease development strategy during a fireside chat at the 47th Annual Goldman Sachs Healthcare Conference, highlighting upcoming decisions tied to its herpes simplex virus type 2 program, expansion of its hepatitis delta candidate into cholestatic liver diseases and expected clinical data readouts in 2027 and 2028.
Jason, an Assembly representative identified by the moderator, described the South San Francisco-based biotechnology company as focused primarily on recurrent genital herpes caused by HSV-2 and hepatitis delta, with a recent expansion into primary biliary cholangitis, or PBC, and primary sclerosing cholangitis, or PSC. He said the company historically has been virology-focused and is now broadening into liver disease, drawing on the experience of team members who previously worked in antiviral and liver disease programs, including at Gilead Sciences.
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HSV-2 Program Moves Forward Under Gilead Collaboration Assembly’s lead HSV-2 candidates, 5366 and 1179, are helicase-primase inhibitors being developed for patients with high-recurrence genital herpes. Jason said the target product profile for both compounds is once-weekly oral dosing, with the goal of superior efficacy compared with Valtrex, the current standard of care.
Jason said Assembly’s Phase 1b data showed more than 95% reduction in viral shedding, more than 90% lesion reduction and more than 98% reduction in high viral load shedding, which the company views as a potential surrogate for transmission. He said those results contributed to Gilead opting into the HSV-2 program before the Phase 1b studies were complete.
Katie Kitrinos, senior vice president of preclinical research and development at Assembly Biosciences, said the recurrent genital herpes patient population remains underserved, with no new advancements in more than 30 years. She said Valtrex reduced transmission by less than 50% from infected individuals to partners and said Assembly’s two molecules could improve both efficacy and convenience.
Jason said the next key HSV-2 catalyst is Assembly’s decision on whether to opt into a 40/60 U.S. cost and profit share with Gilead or instead participate through milestones and royalties. He said that decision will be based on Gilead’s clinical development plan, which is expected to clarify which molecule, or whether both molecules, will advance. He said Assembly would expect head-to-head data against Valtrex potentially in the second half of next year, if timelines align with the company’s assumptions.
6250 Positioned as Oral NTCP Inhibitor for Hepatitis Delta Assembly also discussed 6250, an oral small-molecule inhibitor of NTCP, a receptor on hepatocytes involved in bile acid transport and used by hepatitis delta and hepatitis B viruses to enter liver cells. Kitrinos said the program was initiated based on bulevirtide, an approved NTCP inhibitor that has demonstrated efficacy but requires daily subcutaneous injection and cold chain storage.
Kitrinos said 6250 has low nanomolar potency in inhibiting hepatitis delta entry into cells and bile acid transport. She said Phase 1a data recently presented at EASL showed “excellent” pharmacokinetics, including a three- to four-day half-life supporting daily oral dosing, along with elevations in serum bile acids that met or exceeded levels seen with approved doses of bulevirtide. She also said the company observed good safety over 10 days of dosing and no adverse events of pruritus, and that chronic toxicology studies provided safety margins for planned Phase 2 doses.
Jason said Assembly plans to initiate a Phase 2 hepatitis delta study by the end of this year, with interim data expected by the end of 2027. He said the company will look for ALT reduction and results compared with bulevirtide.
Expansion Into PBC and PSC Assembly recently announced that 6250 would also be evaluated in PBC and PSC, both cholestatic liver diseases. Jason said the decision followed discussions with key opinion leaders, development of a clinical plan and a pre-IND meeting with the U.S. Food and Drug Administration. He said Assembly believes the drug’s hepatoprotective mechanism could be additive to, or potentially replace, existing second-line therapies in PBC, though he noted that the company must prove that in clinical data.
Kitrinos said cholestatic liver disease is driven by accumulation of bile acids in hepatocytes and that 6250 directly prevents bile acids from moving from serum into hepatocytes. She said the drug could potentially reduce alkaline phosphatase more than PPAR agonists, which primarily reduce de novo bile acid production, though she emphasized that this remains to be demonstrated in studies.
On pruritus risk, Kitrinos said Assembly did not observe pruritus adverse events in Phase 1a or chronic toxicology studies. She said the company expects 6250 could reduce IL-31, a cytokine associated with itch, by preventing bile acid accumulation in hepatocytes.
Jason said the PBC clinical plan is designed to evaluate 6250 both as a standalone second-line therapy after UDCA and as an add-on to PPAR therapy. He said studies in PBC and PSC are expected to begin by the first quarter of 2027, with data expected in the first half of 2028.
Upcoming Milestones Decision on whether Assembly will opt into the 40/60 U.S. HSV-2 cost and profit share with Gilead.
Gilead’s clinical development plan for the HSV-2 program, including molecule selection and timing.
Initiation of a Phase 2 hepatitis delta study for 6250 by the end of this year.
Interim hepatitis delta data expected by the end of 2027.
PBC and PSC studies expected to start by the first quarter of 2027, with data expected in the first half of 2028.
Jason said financing completed in August 2025 and a more recent financing are expected to fund the HSV-2 program through Phase 2 proof-of-concept data against Valtrex and the PBC and PSC programs past the mid-2028 proof-of-concept readouts. He also said Assembly continues to maintain a research pipeline and expects to nominate additional programs.
About Assembly Biosciences NASDAQ: ASMBAssembly Biosciences, Inc NASDAQ: ASMB is a clinical-stage biotechnology company dedicated to the discovery, development and commercialization of novel therapies for hepatitis B virus (HBV) and hepatitis D virus (HDV) infections. The company's core expertise lies in small-molecule modulation of viral proteins and host-targeted pathways to achieve sustained viral suppression and potential functional cure. Assembly's research model integrates medicinal chemistry, structural biology and translational virology to advance its pipeline from early discovery through clinical development.
The company's lead programs include core protein allosteric modulators (CpAMs) designed to disrupt the HBV lifecycle by interfering with capsid assembly and viral DNA replication, as well as prenylation inhibitors targeting the HDV lifecycle.
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RAHWAY, N.J. & FOSTER CITY, Calif.--(BUSINESS WIRE)---- $MRK #MRK--Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and Gilead Sciences, Inc. (Nasdaq: GILD) today announced the discontinuation of the Phase 3 KEYNOTE-D46/EVOKE-03 study investigating Gilead's Trodelvy® (sacituzumab govitecan-hziy) in combination with KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, compared to KEYTRUDA monotherapy in certain patients with previously untreated metastatic non-small cell lung cancer,.
– Novel Investigational Combination Pairs Merck’s Islatravir, a Next-Generation Nucleoside Analog with Distinct Mechanisms of Action, Including Reverse Transcriptase Translocation Inhibition, with Gilead’s Lenacapavir, a First-in-Class Capsid Inhibitor that Disrupts HIV at Multiple Stages of its Lifecycle –
– Islatravir/Lenacapavir has the Potential to be the First Approved Long-Acting Oral HIV Treatment Taken Once-Weekly –
FOSTER CITY, Calif., & RAHWAY, N.J.--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq: GILD) and Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the primary efficacy endpoint at Week 48 was met in both the Phase 3 ISLEND-1 and ISLEND-2 trials with the investigational oral once-weekly single-tablet HIV treatment regimen of islatravir/lenacapavir. The ISLEND trials are evaluating the efficacy and safety of islatravir 2 mg/lenacapavir 300 mg (ISL/LEN) in people with HIV who are virologically suppressed and switched from BIKTARVY® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) (ISLEND-1) or standard of care antiretroviral regimens (ISLEND-2). The safety profile of ISL/LEN was generally comparable to the comparator regimens studied in the ISLEND trials, and no new safety concerns were identified. Gilead and Merck plan to file the Phase 3 data from the ISLEND trials with regulatory authorities globally and submit the detailed findings for presentation at a future scientific congress.
“Long-acting oral therapies represent a new wave of transformational innovation in HIV drug development, with the potential to reshape the landscape of care,” said Jared Baeten, MD, PhD, Senior Vice President, Clinical Development, Virology Therapeutic Area Head, Gilead Sciences. “Innovative oral HIV treatment options that allow for less frequent dosing may make a meaningful difference in the lives of people living with the virus, potentially offering more flexibility and discretion.”
The primary efficacy endpoint of ISLEND-1 and ISLEND-2 was the percentage of participants with HIV-1 RNA levels ≥ 50 copies/mL at Week 48, defined by the FDA snapshot algorithm. In the double-blind ISLEND-1 trial, the once-weekly, single-tablet regimen of ISL/LEN was found to be statistically non-inferior to BIKTARVY. In the open-label ISLEND-2 trial, ISL/LEN was found to be statistically non-inferior to standard of care daily oral antiretroviral therapy regimens. The safety profile of ISL/LEN was generally comparable to BIKTARVY in ISLEND-1 and to standard of care antiretroviral regimens in ISLEND-2.
“These results underscore the shared focus and commitment that we and our collaborators at Gilead have on continuing research to help people living with HIV. By advancing this investigational novel once-weekly oral regimen of islatravir and lenacapavir, we aim to bring forward a new long-acting oral option that, if approved, would represent the first of its kind with less frequent dosing and further expand options for people living with HIV,” said Dr. Eliav Barr, Senior Vice President, Head of Global Clinical Development and Chief Medical Officer, Merck Research Laboratories.
The combination of islatravir and lenacapavir targets multiple stages of HIV-1 replication, potentially offering people with HIV who are virologically suppressed a novel, long-acting oral single-tablet regimen. The potency and pharmacokinetic profiles of islatravir and lenacapavir enable long-acting dosing as a once-weekly tablet for HIV treatment, if approved.
Islatravir and lenacapavir in combination are investigational and not approved for use.
There is currently no cure for HIV or AIDS.
About ISLEND-1
ISLEND-1 (NCT06630286) is a Gilead-sponsored, multicenter Phase 3 randomized, double-blind, active-controlled trialdesigned to evaluate the safety and efficacy of switching to a once-weekly tablet of islatravir/lenacapavir (ISL/LEN) versus continuing treatment with BIKTARVY (bictegravir/emtricitabine/tenofovir alafenamide) in people with virologically suppressed HIV (HIV-1 RNA levels < 50 copies/mL) on BIKTARVY for ≥ 6 months prior to screening. Participants were randomized 1:1 to receive initial doses of ISL/LEN on Day 1 and Day 2 followed by once-weekly ISL/LEN from Day 8 to Week 96 plus placebo-to-match BIKTARVY daily, or BIKTARVY daily plus placebo-to-match initial doses of ISL/LEN on Day 1 and Day 2 and placebo-to-match once-weekly ISL/LEN from Day 8 to Week 96. The primary endpoint was the proportion of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48, as determined by the US FDA-defined snapshot algorithm. Key secondary endpoints included the proportion of participants with HIV-1 RNA ≥ 50 copies/mL at Week 96, as determined by the US FDA-defined snapshot algorithm; the proportion of participants with virologic suppression (HIV viral load < 50 copies/mL per US FDA Snapshot) at Week 48 and Week 96; change from baseline in CD4 cell count at Week 48 and Week 96; and the proportion of participants treated with ISL/LEN who discontinued treatment due to treatment-emergent adverse events.
About ISLEND-2
ISLEND-2 (NCT06630299) is a Gilead-sponsored, multicenter Phase 3 randomized, open-label, active-controlled trialevaluating the safety and efficacy of switching to a once-weekly tablet of ISL/LEN versus continuation of standard of care treatment in people with virologically suppressed HIV (HIV-1 RNA levels < 50 copies/mL) on a stable standard of care antiretroviral regimen for ≥ 6 months prior to screening. A standard of care regimen included two or three antiretroviral medicines, including integrase strand transfer inhibitors (INSTI), nucleoside reverse transcriptase inhibitors (NRTIs), boosted protease inhibitors (PI) and non-nucleoside reverse transcriptase inhibitors (NNRTI). Participants either received an initial dose of ISL/LEN followed by once-weekly ISL/LEN from Day 8 to Week 96, or continued their standard of care treatment with two/three antiretroviral medicines up to Week 96. The primary endpoint is the proportion of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 by FDA-defined Snapshot Algorithm. Key secondary endpoints included the proportion of participants with HIV-1 RNA ≥ 50 copies/mL at Week 96, as determined by the US FDA-defined snapshot algorithm; the proportion of participants with virologic suppression (HIV viral load < 50 copies/mL per US FDA Snapshot) at Week 48 and Week 96; change from baseline in CD4 cell count at Week 48 and Week 96; and the proportion of participants treated with ISL/LEN who discontinued treatment due to treatment-emergent adverse events.
About Lenacapavir
The multi-stage mechanism of action of lenacapavir is distinguishable from other approved classes of antiretroviral agents. While most antiretrovirals act on one stage of viral replication, lenacapavir is designed to inhibit HIV at multiple stages of its lifecycle and has no known exhibited cross-resistance in vitro to other existing drug classes.
Lenacapavir is being evaluated as a long-acting option in multiple ongoing and planned early and late-stage clinical studies in Gilead’s HIV treatment and prevention research program. Lenacapavir is being developed as a foundation for potential future HIV therapies to offer both long-acting oral and injectable options with several dosing frequencies, in combination or as a mono-agent, that help address the individual needs and preferences of people and communities affected by HIV.
For an overview of Gilead’s HIV treatment and prevention clinical development program, please click here.
About Islatravir (MK-8591)
Islatravir (MK-8591) is Merck’s potent, next-generation nucleoside analog that blocks HIV-1 replication by multiple mechanisms including inhibition of reverse transcriptase translocation, resulting in immediate chain termination, and induction of structural changes in the viral DNA (delayed chain termination).
Islatravir is anchoring multiple ongoing early and late-stage clinical trials of two-drug regimens in combination with other Merck antiretrovirals for potential treatments for HIV-1. Islatravir is being studied in Phase 3 in combination with Merck’s doravirine (DOR/ISL) as a once-daily pill for treatment of HIV-1 infection in adults with no prior antiviral treatment history and in Phase 2b in combination with Merck’s investigational non-nucleoside reverse transcriptase inhibitor (NNRTI) ulonivirine (MK-8507) as an oral once-weekly treatment for HIV-1.
For an overview of Merck’s HIV treatment and prevention clinical development program, please click here.
About Gilead HIV
For almost 40 years, Gilead has been a leading innovator in the field of HIV, driving advances in treatment, prevention and cure research. Gilead researchers have developed 13 HIV medications, including the first single-tablet regimen to treat HIV, the first antiretroviral for pre-exposure prophylaxis (PrEP) to help reduce new HIV infections, and the first long-acting injectable HIV prevention medication administered twice-yearly. Our advances in medical research have helped to transform HIV into a treatable, preventable, chronic condition for millions of people.
Gilead is committed to continued scientific innovation to provide solutions for the evolving needs of people affected by HIV around the world. Through partnerships, collaborations and charitable giving, the company also aims to improve education, expand access and address barriers to care, with the goal of ending the HIV epidemic worldwide. Gilead has been repeatedly recognized as one of the top two leading philanthropic funders of HIV-related programs in a report released by Funders Concerned About AIDS.
Discover more about Gilead’s unique collaborations worldwide and the work to help end the HIV epidemic.
About Gilead Sciences
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, cancer and inflammation. In 2025, Gilead announced a planned $32 billion investment to further strengthen its U.S. footprint to power the next era of discovery, job creation and public health preparedness – while continuing to invest globally to ensure patients everywhere benefit from its scientific innovation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, Calif.
Merck’s Commitment to HIV
For 40 years, Merck has been committed to scientific research and discovery in HIV leading to scientific breakthroughs that have helped change HIV treatment. Our work has helped pioneer the development of new options across multiple drug classes to help those impacted by HIV. Today, we are developing a series of antiviral options designed to help people manage HIV and protect people from HIV. We are researching for real life and want to ensure people are not defined by HIV. Our work focuses on transformational innovations, collaborations with others in the global HIV community, and access initiatives aimed at helping to end the HIV epidemic for everyone.
About Merck
At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn.
Gilead Forward-Looking Statements
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including Gilead’s ability to initiate, progress or complete clinical trials or studies within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing and additional clinical trials or studies, including those involving lenacapavir (such as ISLEND-1 and ISLEND-2); uncertainties relating to regulatory applications and related filing and approval timelines, including potential applications for programs and/or indications currently under evaluation, such as oral once-weekly single-tablet HIV treatment regimen of islatravir/lenacapavir, and the risk that any regulatory approvals, if granted, may be subject to significant limitations on use or subject to withdrawal or other adverse actions by the applicable regulatory authority; the possibility that Gilead may make a strategic decision to discontinue development of these programs and, as a result, these programs may never be successfully commercialized for the indications currently under evaluation; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and factors are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements.
Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA
This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.
Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.
The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2025 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).
BIKTARVY, Gilead and the Gilead logo are trademarks of Gilead Sciences, Inc., or its related companies.
For more information about Gilead, please visit the company’s website at www.gilead.com, follow Gilead on X (@Gilead Sciences) and LinkedIn, or contact Gilead Public Affairs.
While the combo showed a numerical improvement in progression-free survival, it did not reach statistical significance, and investigators said the probability of achieving a meaningful overall survival benefit at final analysis was low. Safety remained consistent with known profiles, with no new signals identified. Full data will be presented at a future medical meeting.
Separately, the companies reported positive Phase 3 results for an investigational once-weekly oral HIV regimen combining islatravir and lenacapavir, which met its primary efficacy endpoint in two studies.
Once-Weekly HIV Regimen Meets Late-Stage Trial GoalsThe Phase 3 ISLEND-1 and ISLEND-2 trials evaluated the safety and efficacy of the oral single-tablet regimen in people living with HIV who were already virologically suppressed.
According to the companies, the primary endpoint in both studies measured the percentage of participants with HIV-1 RNA levels of at least 50 copies/mL at Week 48 under the FDA snapshot algorithm.
In the ISLEND-1 study, patients switched from Biktarvy to the once-weekly islatravir/lenacapavir regimen. The treatment was found to be statistically non-inferior to Biktarvy.
Meanwhile, in the open-label ISLEND-2 trial, the regimen demonstrated statistical non-inferiority compared with standard-of-care daily oral antiretroviral therapies.
The companies said the safety profile of the combination was generally comparable to the comparator regimens in both studies, with no new safety concerns identified.
Regulatory Filings Planned Following HIV ResultsGilead and Merck said they plan to submit the Phase 3 findings to regulatory authorities worldwide and present detailed data at a future scientific congress.
The investigational combination targets multiple stages of HIV-1 replication. If approved, the treatment could offer virologically suppressed patients a long-acting, once-weekly oral single-tablet option.
GILD and MRK Stock Price Activity: Gilead Sciences shares were down 2.28% at $125.18, and Merck shares were up 0.46% at $120.07 at the time of publication on Tuesday, according to Benzinga Pro data.
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Key Takeaways GILD and Merck's phase III ISLEND studies met primary endpoints at week 48 in HIV.The once-weekly islatravir/lenacapavir regimen showed non-inferior efficacy and comparable safety.GILD and Merck discontinued a phase III NSCLC study after missing statistical significance on PFS. Gilead Sciences, Inc. (GILD - Free Report) and partner Merck (MRK - Free Report) announced positive data from two late-stage studies, ISLEND-1 and ISLEND-2, evaluating investigational oral once-weekly single-tablet HIV treatment regimen of islatravir/lenacapavir.
The investigational regimen combines Merck's islatravir, a next-generation nucleoside analog that inhibits HIV replication through multiple mechanisms, including reverse transcriptase translocation inhibition, with Gilead's lenacapavir, a first-in-class capsid inhibitor designed to disrupt the virus at several stages of its lifecycle.
Both studies met the primary efficacy endpoint at week 48.
Gilead’s shares have gained 2.2% year to date against the industry's decline of 3.1%.
Image Source: Zacks Investment Research
More on GILD and MRK’s HIV StudiesThe ISLEND studies are evaluating the efficacy and safety of islatravir 2 mg/lenacapavir 300 mg (ISL/LEN) in people with HIV who are virologically suppressed and switched from Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) (ISLEND-1) or standard of care antiretroviral regimens (ISLEND-2).
The primary efficacy endpoint in both ISLEND-1 and ISLEND-2 was the proportion of participants with HIV-1 RNA levels ≥ 50 copies/mL at week 48, as measured by the FDA snapshot algorithm. In ISLEND-1, a double-blind study, the once-weekly oral regimen of islatravir/lenacapavir (ISL/LEN) demonstrated non-inferior efficacy compared with Biktarvy. Similarly, in the open-label ISLEND-2 trial, ISL/LEN achieved non-inferior results versus standard daily oral antiretroviral therapies.
The regimen also showed a safety profile comparable to the respective comparator treatments in both studies, with no new safety concerns identified.
Following the positive phase III results, Gilead and Merck intend to submit the ISLEND trial data to regulatory authorities worldwide and present detailed study findings at an upcoming scientific conference.
The investigational once-weekly oral combination of islatravir and lenacapavir could become the first long-acting oral HIV treatment with weekly dosing, potentially offering people living with HIV a new and more convenient treatment option if approved.
Gilead is a dominant player in the HIV market.
Gilead’s Biktarvy is a once-daily, single-tablet HIV treatment that combines three antiretroviral medicines, including bictegravir, a potent integrase strand transfer inhibitor (INSTI) with the Descovy backbone of emtricitabine and tenofovir alafenamide. The regimen offers convenient dosing with or without food, has a low potential for drug interactions, and provides a high barrier to resistance.
In 2025, the FDA approved lenacapavir for the prevention of HIV under the brand name Yeztugo for pre-exposure prophylaxis to reduce the risk of sexually acquired HIV in adults and adolescents weighing at least 35 kg.
The approval has significantly boosted Gilead’s HIV franchise, as lenacapavir needs to be taken twice yearly, unlike daily oral pills.
Following Yeztugo’s strong first-quarter performance and improving market trends, Gilead raised its 2026 sales guidance to $1 billion, positioning the drug to achieve blockbuster status in its first full year on the market.
Approval of additional better treatments should bolster GILD’s HIV franchise in the wake of increasing competition from the likes of GSK plc (GSK - Free Report) .
GSK continues to grow its HIV business, driven by strong patient demand for long-acting injectable medicines (Cabenuva and Apretude) and Dovato.
GILD, MRK Update on Lung Cancer StudyConcurrently, Merck and Gilead Sciences announced the discontinuation of the phase III KEYNOTE-D46/EVOKE-03 study evaluating Trodelvy (sacituzumab govitecan-hziy) in combination with Keytruda as a first-line treatment for patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express high levels of PD-L1 (TPS ≥50%).
The open-label phase III study sponsored by Merck evaluated Trodelvy in combination with Keytruda versus Keytruda alone in this NSCLC patient population. The trial enrolled approximately 620 patients.
The decision follows a recommendation from the external Data Monitoring Committee after reviewing the pre-specified final progression-free survival (PFS) analysis and an interim overall survival (OS) analysis. While the combination demonstrated a numerical improvement in PFS compared with Keytruda alone, the result did not achieve statistical significance. Additionally, the committee concluded that the likelihood of demonstrating a statistically significant OS benefit at the final analysis was low.
The companies plan to present the detailed study results at a future medical conference.
Gilead’s Trodelvy is a first-in-class Trop-2-directed antibody-drug conjugate.
Trodelvy is currently approved in various countries for patients with metastatic triple-negative breast cancer who have received at least one prior therapy and for certain patients with previously treated HR-positive/HER2-negative metastatic breast cancer.
Trodelvy continues to gain market share in the second-line setting. GILD has submitted two supplemental biologics license applications seeking approval of the drug for use in first-line metastatic triple-negative breast cancer patients.
MRK’s blockbuster immuno-oncology drug Keytruda is approved for several types of cancer and alone accounts for around 50% of sales.
Key Takeaways Gilead's HIV business is growing on strong Biktarvy and Descovy demand and Yeztugo contributions.Gilead raised 2026 Yeztugo sales guidance to $1 billion and now expects HIV sales growth of 8%.Gilead's BIC/LEN filing won priority review, while ISLEND studies met week-48 efficacy goals. Gilead Sciences, Inc. (GILD - Free Report) has a market-leading HIV franchise, led by flagship HIV therapies — Biktarvy for treatment and Descovy for prevention.
Last month, the company reported better-than-expected first-quarter results, driven by strong HIV breast cancer drug Trodelvy and liver disease drug Livdelzi sales.
HIV business continues to maintain momentum, driven by solid performance of Biktarvy and Descovy, and incremental contributions from Yeztugo.
Biktarvy continues to be a dominant player in the HIV treatment market, holding more than 52% market share and retaining its position as the most prescribed therapy for both treatment-naïve and switch patients across major markets.
Gilead’s HIV pre-exposure prophylaxis (PrEP) portfolio comprises daily oral Descovy and the first and only twice-yearly injectable Yeztugo.
Descovy’s performance continues to be strong, primarily driven by higher demand and average realized price.
The FDA approval of injectable lenacapavir, a first-in-class capsid inhibitor (under the brand name Yeztugo), solidifies GILD’s HIV portfolio. With a twice-yearly dosing schedule, the therapy offers meaningful adherence advantages over daily oral regimens and targets a broad patient population.
Following better-than-expected first-quarter results and improving market trends, Gilead raised its 2026 sales guidance for Yeztugo to $1 billion, signaling the product’s potential to achieve blockbuster status in its first full year on the market.
Driven by increased Yeztugo sales expectations and strong first-quarter HIV performance, Gilead now projects total 2026 HIV sales growth of approximately 8% year over year, up from its prior guidance of 6% issued in February. The updated outlook includes an estimated 2% headwind related to the U.S. government’s Medicaid drug pricing agreement and proposed Affordable Care Act changes.
The FDA accepted Gilead’s new drug application for bictegravir/lenacapavir (BIC/LEN) for virologically suppressed people living with HIV under priority review, setting a target action date of Aug. 27, 2026. A potential approval of BIC/LEN will further bolster its HIV portfolio.
Looking ahead, with no significant loss-of-exclusivity (LOE) events expected until 2036, Gilead’s HIV franchise is well positioned for sustained long-term growth, supported by the potential launch of up to seven new HIV therapies by 2033.
GILD has also collaborated with Merck (MRK - Free Report) to advance its HIV pipeline further.
Gilead and Merck recently announced positive data from two late-stage studies, ISLEND-1 and ISLEND-2, evaluating investigational oral once-weekly single-tablet HIV treatment regimen of islatravir/lenacapavir.
The investigational regimen combines Merck's islatravir, a next-generation nucleoside analog that inhibits HIV replication through multiple mechanisms, including reverse transcriptase translocation inhibition, with Gilead's lenacapavir.
Both studies met the primary efficacy endpoint at week 48. Following the positive phase III results, Gilead and Merck intend to submit the ISLEND trial data to regulatory authorities worldwide and present detailed study findings at an upcoming scientific conference.
Gilead presented encouraging phase I data for the long-acting integrase inhibitor GS-3242 in February. Additional data expected later this year could support the development of a twice-yearly injectable regimen combining GS-3242 with lenacapavir.
Approval of additional treatments should strengthen its dominant HIV franchise.
Competition for GILD’s HIV BusinessThe HIV treatment landscape is dominated by many bigwigs, such as GSK plc (GSK - Free Report) and Merck, apart from GILD.
HIV sales account for a major chunk of GSK’s Specialty Medicines portfolio. GSK continues to grow its HIV business, driven by strong patient demand for long-acting injectable medicines (Cabenuva and Apretude) and Dovato. The solid growth from these drugs has helped GSK combat the decline in Triumeq sales.
MRK markets doravirine for treating adults with HIV-1 in the United States, either as a monotherapy under the brand name Pifeltro or as part of the single-tablet combination regimen under the brand name Delstrigo (doravirine/lamivudine/tenofovir disoproxil fumarate).
MRK recently won FDA approval of Idvynso, a once-daily, two-drug single-tablet regimen containing doravirine (100 mg) and islatravir (0.25 mg), for adults living with HIV-1 who are virologically suppressed on a stable antiretroviral regimen. The approval covers patients with no history of treatment failure and no known resistance-associated mutations to doravirine, allowing them to switch from their current HIV therapy.
Merck is also evaluating a once-daily, oral, two-drug, single-tablet regimen of doravirine/islatravir [DOR/ISL (100 mg/0.25 mg)] in treatment-naïve adults with HIV-1 infection.
GILD’s Price Performance, Valuation and EstimatesShares of GILD have gained 2.3% year to date against the industry’s decline of 3.1%.
Image Source: Zacks Investment Research
Going by the price/earnings ratio, GILD’s shares currently trade at 33.39X forward earnings, higher than its mean of 11.87X and the large-cap pharma industry’s 17.59X.
Image Source: Zacks Investment Research
The consensus estimate for 2026 has deteriorated sharply over the past 30 days, shifting to a loss of 79 cents per share from projected earnings of $4.32 per share. The estimate for 2027 has also edged lower to $9.53 per share from $9.57 during the same period.
Image Source: Zacks Investment Research
While Gilead’s recent aggressive dealmaking strategy strengthens its long-term pipeline and growth potential, the sizable upfront payments and integration-related costs are pressuring near-term profitability.
- Three-year, ~$3M commitment to expand leadership development, strengthen HIV education and engagement, and preserve the HIV movement’s history for future generations -
SAN FRANCISCO & FOSTER CITY, Calif.--(BUSINESS WIRE)--The National AIDS Memorial together with the Gilead Foundation today announced a transformative three-year, ~$3 million commitment to help preserve the history of the HIV epidemic, expand public education and engagement, and inspire the next generation of leaders advancing access to care. The fight against HIV/AIDS has always depended on more than medicine. It has required scientific innovation, public education, activism, compassion, communities caring for one another through crisis and change, and a shared commitment to ensuring these stories are never lost.
National AIDS Memorial and the Gilead Foundation Launch Major Investment to Expand HIV/AIDS Education and Community Leadership
Share The initiative will help expand leadership development for emerging advocates, increase access to the stories preserved within the AIDS Memorial Quilt, elevate community voices through public engagement programs, and support stewardship of the National AIDS Memorial Grove.
“The history of the HIV movement is defined by acts of courage, activism, compassion, and community leadership. Through the Gilead Foundation’s partnership with the National AIDS Memorial, we are helping ensure those stories and experiences continue to educate future generations and inspire them to make their own contributions,” said Daniel O’Day, Chairman and Chief Executive Officer, Gilead Sciences. “As science transforms what is possible in the fight against HIV, the hard-won lessons of this movement must continue to guide how we advance innovation, expand access, and support the communities most affected.”
For the National AIDS Memorial and the Gilead Foundation, that commitment reflects a shared belief that remembrance is not simply about preserving history but helping shape what comes next.
“The work of remembrance is future work,” said John Cunningham, Chief Executive Officer of the National AIDS Memorial. “This transformative commitment allows us not only to care for the Quilt and Grove entrusted to us, but to ensure that the stories and enduring lessons of the HIV/AIDS movement remain active forces in public life. We want future generations to understand not only the history of the epidemic, but the determination that shaped the response, and to recognize their own power to carry that work forward.”
The commitment will expand the Pedro Zamora Young Leaders Scholarship and Fellowship Program, creating new opportunities for emerging leaders pursuing careers in public health, medicine, education, social justice, and HIV advocacy. It will also support a multi-year effort to preserve and re-digitize thousands of AIDS Memorial Quilt panels, making them more accessible to families, educators, students, researchers, and communities worldwide.
The initiative will expand public programs that encourage dialogue on leadership, community engagement, and the ongoing HIV response, including the National AIDS Memorial Leadership Award and Speaker Series. Funding will also support conservation efforts, volunteer programs, and future enhancements at the National AIDS Memorial Grove in San Francisco’s Golden Gate Park, a place of reflection, healing, and community connection.
The initiative builds on years of collaboration between the National AIDS Memorial and the Gilead Foundation, including support for Quilt preservation, public education initiatives, and programs reaching communities disproportionately impacted by HIV. The commitment arrives at a milestone moment for the HIV community: this year the Grove marks its 35th anniversary, and in 2027 the Quilt will reach its 40th. Together they stand as national symbols of remembrance, resilience and community action.
Funding will also support future chapters of Surviving Voices, the National AIDS Memorial’s award-winning documentary series preserving oral histories from people and communities affected by HIV. Alongside expanded Quilt access, leadership programs, and community engagement initiatives, these efforts will help ensure the experiences and contributions of those impacted by the epidemic remain visible and accessible for future generations.
Today, the AIDS Memorial Quilt remains the world’s largest community folk art project, with more than 50,000 panels honoring more than 110,000 lives. Together with the Grove, these living memorials continue to serve as places of remembrance and resources for education, connection, and engagement.
As the HIV community looks ahead, the National AIDS Memorial and the Gilead Foundation remain committed to ensuring that the history, voices, and lessons that shaped the response to HIV continue to inspire progress toward a healthier future for all.
About the National AIDS Memorial
The National AIDS Memorial stewards the National AIDS Memorial Grove and the AIDS Memorial Quilt to remember, heal, and inspire—and to ensure the ongoing story and lessons of the AIDS crisis foster a more just, healthy society.
About the Gilead Foundation
The Gilead Foundation is a nonprofit organization that works to create a thriving health ecosystem. The Gilead Foundation takes a holistic approach to mitigate the root causes of health inequities by providing resources to organizations that empower people with the skills to be their own best advocate and create systems of support that strengthen communities, classrooms and workplaces.
About Gilead Sciences
Gilead Sciences, Inc. (Nasdaq: GILD) is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, cancer and inflammation. In 2025, Gilead announced a planned $32 billion investment to further strengthen its U.S. footprint to power the next era of discovery, job creation and public health preparedness – while continuing to invest globally to ensure patients everywhere benefit from its scientific innovation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, Calif.
For more information about Gilead, please visit the company’s website at www.gilead.com, follow Gilead on X/Twitter (@Gilead Sciences) and LinkedIn (@Gilead-Sciences).
FOSTER CITY, Calif.--(BUSINESS WIRE)--Gilead Sciences today announced a donation of more than 2,000 vials of its intravenous antiviral therapy, remdesivir, to the Republic of Uganda to support response efforts to the current outbreak of Ebola Bundibugyo virus disease (BVD). This donation, along with the additional supply being readied, continues the company’s long-standing work to address emerging infectious diseases.
“At Gilead, we recognize the urgency and human toll of global health emergencies – and the responsibility to act quickly,” said Anu Osinusi, MD, Vice President of Clinical Research for Hepatitis, Respiratory and Emerging Viruses at Gilead Sciences.
Share“At Gilead, we recognize the urgency and human toll of global health emergencies – and the responsibility to act quickly,” said Anu Osinusi, MD, Vice President, Clinical Development, Virology at Gilead Sciences. “Building on decades of experience responding to serious infectious diseases, our teams are working alongside partners with focus and purpose to support the response to this outbreak.”
Remdesivir is being provided to support the Ugandan Ebola outbreak under both compassionate use and Monitored Emergency Use of Unregistered and Investigational Interventions (MEURI) frameworks for the treatment of BVD. In parallel, Gilead is preparing to support requests from the Democratic Republic of the Congo, World Health Organization (WHO) and other regional and global partners for both remdesivir and obeldesivir, an oral investigational antiviral agent, as part of the broader regional response to Ebola BVD, including the support of several planned clinical trials.
Over the past decade, Gilead has aided responses to multiple filovirus outbreaks in Sub-Saharan Africa through donation of remdesivir for emergency and compassionate use, as well as for investigational use in clinical trials – reflecting a sustained commitment to rapid response in times of urgent need.
Remdesivir has demonstrated promising preclinical activity across multiple filoviruses but has not been approved for the treatment of filovirus disease in any country. The safety and efficacy of remdesivir for the Bundibugyo strain have not yet been established; ongoing studies are working to generate this evidence.
About Remdesivir
Remdesivir is a nucleotide analog prodrug invented and developed by Gilead, building on more than a decade of the company’s antiviral research. Remdesivir has broad-spectrum antiviral activity both in vitro and in animal models against multiple viral pathogens, including Marburg, Ebola, SARS, MERS and SARS-CoV-2, the virus that causes COVID-19.
Remdesivir has been approved as a COVID-19 treatment in approximately 50 countries worldwide. To date, remdesivir has been made available to more than 14.5 million patients around the world, including more than 8.1 million people in middle- and low-income countries through Gilead’s voluntary licensing program.
The clinical efficacy of remdesivir for BVD remains to be established. Remdesivir is currently not approved in any country for the treatment of BVD. This emergency use donation is based on the preclinical data for Ebola virus together with extensive clinical safety data from the use of remdesivir for the treatment of COVID-19.
For more information about Gilead’s commitment to global health, visit Gilead.com.
About Gilead Sciences
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, cancer and inflammation. In 2025, Gilead announced a planned $32 billion investment to further strengthen its U.S. footprint to power the next era of discovery, job creation and public health preparedness – while continuing to invest globally to ensure patients everywhere benefit from its scientific innovation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, Calif.
Gilead and the Gilead logo are registered trademarks of Gilead Sciences, Inc., or its related companies.
For more information about Gilead, please visit the company’s website at www.gilead.com, follow Gilead on X/Twitter (@Gilead Sciences) and LinkedIn (@Gilead-Sciences).
