Track market-moving stories before they get noisy

Viking Therapeutics, Inc. (VKTX - Free Report) closed the most recent trading day at $32.18, moving +1.64% from the previous trading session. The stock outpaced the S&P 500's daily gain of 0.58%. Meanwhile, the Dow experienced a rise of 0.05%, and the technology-dominated Nasdaq saw an increase of 0.91%.

The stock of company has risen by 1.05% in the past month, lagging the Medical sector's gain of 2.82% and the S&P 500's gain of 4.96%.

Market participants will be closely following the financial results of Viking Therapeutics, Inc. in its upcoming release. On that day, Viking Therapeutics, Inc. is projected to report earnings of -$1.21 per share, which would represent a year-over-year decline of 108.62%.

For the entire fiscal year, the Zacks Consensus Estimates are projecting earnings of -$4.67 per share and a revenue of $0 million, representing changes of -46.39% and 0%, respectively, from the prior year.

Investors might also notice recent changes to analyst estimates for Viking Therapeutics, Inc. These revisions typically reflect the latest short-term business trends, which can change frequently. As a result, we can interpret positive estimate revisions as a good sign for the business outlook.

Based on our research, we believe these estimate revisions are directly related to near-term stock moves. Investors can capitalize on this by using the Zacks Rank. This model considers these estimate changes and provides a simple, actionable rating system.

Ranging from #1 (Strong Buy) to #5 (Strong Sell), the Zacks Rank system has a proven, outside-audited track record of outperformance, with #1 stocks returning an average of +25% annually since 1988. Over the past month, the Zacks Consensus EPS estimate has shifted 23.57% downward. Viking Therapeutics, Inc. presently features a Zacks Rank of #3 (Hold).

The Medical - Biomedical and Genetics industry is part of the Medical sector. With its current Zacks Industry Rank of 107, this industry ranks in the top 44% of all industries, numbering over 250.

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.

Ensure to harness Zacks.com to stay updated with all these stock-shifting metrics, among others, in the next trading sessions.

An upcoming trial result could change how investors think about the weight-loss drug market.

Viking Therapeutics, Inc. (VKTX) Presents at Jefferies Global Healthcare Conference 2026 Transcript

GLP-1 drugs are reshaping healthcare and consumer markets. These ETFs offer targeted exposure to the booming obesity-drug trend.

Viking Therapeutics, Inc. (VKTX - Free Report) closed the most recent trading day at $27.73, moving -5.13% from the previous trading session. The stock's performance was behind the S&P 500's daily loss of 1.62%. Elsewhere, the Dow lost 1.87%, while the tech-heavy Nasdaq lost 1.98%.

Shares of the company have depreciated by 6.67% over the course of the past month, underperforming the Medical sector's gain of 5.04%, and the S&P 500's loss of 0.03%.

The upcoming earnings release of Viking Therapeutics, Inc. will be of great interest to investors. The company's earnings per share (EPS) are projected to be -$1.21, reflecting a 108.62% decrease from the same quarter last year.

For the entire fiscal year, the Zacks Consensus Estimates are projecting earnings of -$4.7 per share and a revenue of $0 million, representing changes of -47.34% and 0%, respectively, from the prior year.

It's also important for investors to be aware of any recent modifications to analyst estimates for Viking Therapeutics, Inc. Such recent modifications usually signify the changing landscape of near-term business trends. With this in mind, we can consider positive estimate revisions a sign of optimism about the business outlook.

Based on our research, we believe these estimate revisions are directly related to near-term stock moves. We developed the Zacks Rank to capitalize on this phenomenon. Our system takes these estimate changes into account and delivers a clear, actionable rating model.

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 0.72% downward. Currently, Viking Therapeutics, Inc. is carrying 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 155, putting it in the bottom 37% of all 250+ industries.

The Zacks Industry Rank assesses the vigor of our specific industry groups by computing the average Zacks Rank of the individual stocks incorporated in the groups. Our research shows that the top 50% rated industries outperform the bottom half by a factor of 2 to 1.

Ensure to harness Zacks.com to stay updated with all these stock-shifting metrics, among others, in the next trading sessions.

Viking Therapeutics (VKTX +3.10%) has seen its stock stumble in recent times -- for example, it's slipped over the past year. But over five years, shares of the biotech company have climbed more than 300%. This is amid excitement about the company's potential in a market that's on track to reach nearly $100 billion in just a few years. I'm talking about the weight loss drug market.

Viking hasn't yet commercialized a drug, but it has a promising candidate in late-stage trials, so it may be very close to the finish line in this valuable market. All of this means the biotech, which specializes in developing candidates for metabolic and endocrine disease, might generate revenue -- and at significant levels -- in just a few years.

Though investors haven't rushed into the stock in recent months, this could soon change. Viking has catalysts just ahead: The company expects to report data from a maintenance dosing study of its weight loss drug candidate in the third quarter, and it aims to launch a phase 3 trial for the oral version of its candidate in the fourth quarter.

Considering this, is Viking stock going to $100? Let's find out.

Image source: Getty Images.

Blockbuster weight loss drugs We'll start with some details about Viking's lead candidate, VK2735. This is an investigational dual GLP-1/GIP receptor agonist, much like the popular drugs sold by market leaders Eli Lilly and Novo Nordisk. These drugs act on hormonal pathways involved in digestion, and as a result, they help control appetite and blood sugar levels. The Lilly and Novo drugs have become blockbusters, and demand has been consistently high for these products -- this is thanks to their efficacy, safety, and ease of use.

Though these pharma giants dominate the space, as mentioned, it is a high-growth market, so there is room for others to enter. And even if a company such as Viking doesn't take leadership -- and I wouldn't expect it to unseat a massive pharma company like Lilly or Novo -- it still could bring in blockbuster revenue. That could be quite a huge step for a young biotech.

And Viking does offer its own twist, differentiating itself from current GLP-1 drugs. At the moment, Lilly offers a dual GLP-1/GIP drug in injectable format and a GLP-1 drug in oral format. Novo's obesity drugs are GLP-1s. (Dual GLP-1/GIP drugs interact with two hormonal pathways, while GLP-1s interact with only one hormonal pathway.)

Injectable and oral formulations Viking is developing VK2735 in both injectable and oral formats. So, if approved, it would be the first dual GLP-1/GIP drug available in oral format -- and the first dual available in both injectable and oral formats. One big advantage of this is that patients can shift from one formulation to the other -- for example, starting with the oral treatment and then using the injectable for maintenance once they've reached their desired weight.

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The phase 3 trial for Viking's injectable is ongoing, and as mentioned, the phase 3 study for the oral formulation is set to begin later this year. We also should see data from its maintenance dosing trial in the months to come. These events could represent catalysts for the stock, which has been known to react to news. When Viking initially announced phase 2 data for VK2735 a couple of years ago, the stock soared more than 100% in one trading session.

So now, let's return to our question: Is Viking heading to $100? It reached a high of more than $94 when it announced phase 2 data in February of 2024. The stock has since given back much of that gain, and it trades today for about $27. But the average Wall Street estimate calls for it to reach more than $92 within the coming 12 months, recovering much of that territory.

The path to $100 represents a jump of more than 200%. I don't see that happening overnight like Viking's massive gain in February of 2024. But a few updates or general good news in the obesity drug market could help it along the way -- so Viking could indeed be heading to $100 in the quarters to come.

SAN CARLOS, Calif., April 27, 2026 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, will host a conference call and live audio webcast on Thursday, May 7, 2026 at 8:30 a.m. ET to report its first quarter 2026 financial results and corporate updates.

Iovance Biotherapeutics (IOVA - Free Report) is expected to deliver a year-over-year increase in earnings on higher revenues when it reports results for the quarter ended March 2026. This widely-known consensus outlook gives a good sense of the company's earnings picture, but how the actual results compare to these estimates is a powerful factor that could impact its near-term stock price.

The earnings report, which is expected to be released on May 7, might help the stock move higher if these key numbers are better than expectations. On the other hand, if they miss, the stock may move lower.

While management's discussion of business conditions on the earnings call will mostly determine the sustainability of the immediate price change and future earnings expectations, it's worth having a handicapping insight into the odds of a positive EPS surprise.

Zacks Consensus EstimateThis biotechnology company is expected to post quarterly loss of $0.19 per share in its upcoming report, which represents a year-over-year change of +47.2%.

Revenues are expected to be $77.11 million, up 56.4% from the year-ago quarter.

Estimate Revisions TrendThe consensus EPS estimate for the quarter has been revised 18.18% lower over the last 30 days to the current level. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period.

Investors should keep in mind that the direction of estimate revisions by each of the covering analysts may not always get reflected in the aggregate change.

Price, Consensus and EPS Surprise

Earnings WhisperEstimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. This insight is at the core of our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction).

The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier.

Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's predictive power is significant for positive ESP readings only.

A positive Earnings ESP is a strong predictor of an earnings beat, particularly when combined with a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold). Our research shows that stocks with this combination produce a positive surprise nearly 70% of the time, and a solid Zacks Rank actually increases the predictive power of Earnings ESP.

Please note that a negative Earnings ESP reading is not indicative of an earnings miss. Our research shows that it is difficult to predict an earnings beat with any degree of confidence for stocks with negative Earnings ESP readings and/or Zacks Rank of 4 (Sell) or 5 (Strong Sell).

How Have the Numbers Shaped Up for Iovance Biotherapeutics?For Iovance Biotherapeutics, the Most Accurate Estimate is lower than the Zacks Consensus Estimate, suggesting that analysts have recently become bearish on the company's earnings prospects. This has resulted in an Earnings ESP of -10.53%.

On the other hand, the stock currently carries a Zacks Rank of #3.

So, this combination makes it difficult to conclusively predict that Iovance Biotherapeutics will beat the consensus EPS estimate.

Does Earnings Surprise History Hold Any Clue?Analysts often consider to what extent a company has been able to match consensus estimates in the past while calculating their estimates for its future earnings. So, it's worth taking a look at the surprise history for gauging its influence on the upcoming number.

For the last reported quarter, it was expected that Iovance Biotherapeutics would post a loss of$0.22 per share when it actually produced a loss of -$0.18, delivering a surprise of +18.18%.

Over the last four quarters, the company has beaten consensus EPS estimates two times.

Bottom LineAn earnings beat or miss may not be the sole basis for a stock moving higher or lower. Many stocks end up losing ground despite an earnings beat due to other factors that disappoint investors. Similarly, unforeseen catalysts help a number of stocks gain despite an earnings miss.

That said, betting on stocks that are expected to beat earnings expectations does increase the odds of success. This is why it's worth checking a company's Earnings ESP and Zacks Rank ahead of its quarterly release. Make sure to utilize our Earnings ESP Filter to uncover the best stocks to buy or sell before they've reported.

Iovance Biotherapeutics doesn't appear a compelling earnings-beat candidate. However, investors should pay attention to other factors too for betting on this stock or staying away from it ahead of its earnings release.

An Industry Player's Expected ResultsAcadia Pharmaceuticals (ACAD - Free Report) , another stock in the Zacks Medical - Biomedical and Genetics industry, is expected to report earnings per share of $0.04 for the quarter ended March 2026. This estimate points to a year-over-year change of -63.6%. Revenues for the quarter are expected to be $281.75 million, up 15.3% from the year-ago quarter.

Over the last 30 days, the consensus EPS estimate for Acadia has been revised 7.9% down to the current level. Nevertheless, the company now has an Earnings ESP of +100.00%, reflecting a higher Most Accurate Estimate.

This Earnings ESP, combined with its Zacks Rank #3 (Hold), suggests that Acadia will most likely beat the consensus EPS estimate. The company beat consensus EPS estimates in each of the trailing four quarters.

Stay on top of upcoming earnings announcements with the Zacks Earnings Calendar.

1Q26 Total Revenue of ~$71M Delivers ~ 45% Year-over-Year Growth 2Q26 Revenue Guidance of $86M to $88M and FY26 of $350M to $370M 40% Confirmed Objective Response Rate in Metastatic Serous Endometrial Cancer SAN CARLOS, Calif., May 07, 2026 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a commercial biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, today reported first quarter 2026 financial results, business achievements, and corporate updates.

Iovance Biotherapeutics, Inc. (IOVA) Q1 2026 Earnings Call Transcript

Key Takeaways IOVA posted Q1 revenue growth of 45%, but sales missed estimates and shares fell 13%.Amtagvi generated about $60M in Q1 sales as referrals and earlier treatment use improved.Iovance expects 2026 product revenues of $350M-$370M, led primarily by Amtagvi. Iovance Biotherapeutics (IOVA - Free Report) incurred a first-quarter 2026 loss of 19 cents per share, in line with the Zacks Consensus Estimate. In the year-ago quarter, the company reported a loss of 36 cents.

Total revenues for the quarter rose 45% year over year to $71.4 million, generated entirely from the sales of the company’s two marketed drugs. The top line missed the Zacks Consensus Estimate of $77.1 million.

IOVA's Earnings in DetailIovance currently has two marketed drugs in its portfolio — the IL-2 product Proleukin and the TIL therapy Amtagvi. While Proleukin is approved to treat metastatic renal cell carcinoma and metastatic melanoma in adults, Amtagvi is approved for the advanced melanoma indication.

The company recorded approximately $60 million from Amtagvi sales during the quarter, up 38% from the year-ago period. Demand trends improved through the quarter, with management pointing to accelerating referrals and earlier use in the treatment pathway as awareness builds across treatment centers. Yet, the drug’s sales missed the Zacks Consensus Estimate and our model estimate, each pegged at $70 million.

Proleukin sales rose 91% to about $11 million during the quarter, benefiting from its use alongside Amtagvi. The figure also missed the Zacks Consensus Estimate and our model estimate, both pegged at $23 million.

Shares of Iovance plunged 13% yesterday, likely due to the soft sales performance of both therapies.

Still, the stock has rallied 30% so far this year against the industry’s 2% decline.

Image Source: Zacks Investment Research

IOVA Reduces Operating Costs While Extending Cash RunwayResearch & development expenses totaled $62.5 million in the quarter, down 12% from the year-ago period, reflecting ongoing operational efficiencies alongside pipeline expansion efforts.

Selling, general and administrative expenses declined 11% to about $39 million. Management positioned the cost structure as improving alongside manufacturing centralization and internal efficiency initiatives, aimed at supporting a clearer path to profitability as revenues scale.

As of March 31, 2026, Iovance had cash, cash equivalents and investments of $319 million compared with $303 million in the previous quarter. Management now expects its existing cash balance to fund operations into 2028 (previously: third-quarter 2027), driven by ongoing cost discipline alongside revenue growth and improving manufacturing leverage.

Iovance discussed its approach to financing on the call, describing its use of the at-the-market facility as opportunistic and aimed at limiting the overall cost of capital while it drives toward breakeven. The company said it continues to evaluate non-dilutive options as it scales commercial execution and advances multiple trials.

IOVA Issues 2026 OutlookIovance expects product revenues for 2026 to be between $350 million and $370 million, with the range described as predominantly fueled by Amtagvi. The company anticipates product revenues for second-quarter 2026 in the range of $86-$88 million, which includes Amtagvi sales between $79 million and $81 million.

On the earnings call, management attributed the tighter quarterly outlook to greater operational visibility, citing improved forecasting around treatment-center activity and manufacturing execution. Leadership also said the commercial organization is focused on expanding capacity and onboarding additional centers over time to support growth through the year.

Updates on IOVA’s Pipeline & Other NewsRegulatory applications for Amtagvi in the melanoma indication are under review, with potential approvals in Australia and Switzerland later this year. Last year, IOVA voluntarily withdrew its regulatory filing in the European Union due to a lack of alignment with the EMA on the clinical data supporting the submission. The company is in discussions with the agency to resubmit a regulatory filing in 2026.

Iovance continues to advance its development programs for Amtagvi. It is evaluating the drug in combination with Merck’s Keytruda in the phase III TILVANCE-301 study as a potential treatment for frontline advanced melanoma. This study will serve as a confirmatory study seeking full approval for Amtagvi in the melanoma indication.

Beyond melanoma, Iovance is developing Amtagvi for other cancer indications. Alongside earnings results, the company reported initial data from the mid-stage IOV-END-201 study evaluating the therapy in previously treated metastatic serous endometrial cancer. Data from the study showed that Amtagvi-treated patients achieved a confirmed objective response rate of 40% and a 100% disease control rate in the first five evaluable patients. Management characterized the setting as an area of high unmet need and said it plans to engage the FDA on an expedited approval pathway.

Amtagvi is being evaluated in separate mid-stage studies for cervical cancer and non-small cell lung cancer indications.

IOVA’s Zacks RankIovance currently carries a Zacks Rank #3 (Hold).

Our Key Picks Among Biotech StocksSome better-ranked stocks from the sector are Amarin Corporation (AMRN - Free Report) and Indivior Pharmaceuticals (INDV - 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 60 days, estimates for Amarin’s 2026 loss per share have narrowed from $7.01 to $6.36. Over the same period, loss per share estimates for 2027 have improved from $5.50 to $4.64. AMRN shares have risen 6% year to date.

Amarin’s earnings beat estimates in three of the trailing four quarters but missed the mark on one occasion, delivering an average surprise of 50.02%.

Over the past 60 days, estimates for Indivior Pharmaceuticals’ 2026 EPS have increased from $3.03 to $3.35. Over the same period, EPS estimates for 2027 have risen to $3.69 from $3.46. INDV shares have risen 10% year to date.

Indivior Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 65.44%.

May 22, 2026 17:15 ET  | Source: Iovance Biotherapeutics, Inc.

SAN CARLOS, Calif., May 22, 2026 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA) ("Iovance" or the “Company”), a biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (“TIL”) therapies for patients with cancer, today announced that on May 21, 2026 (the “Date of Grant”), the Company approved the grant of inducement stock options covering an aggregate of 93,340 shares of Iovance’s common stock to thirteen new, non-executive employees.

The awards were granted under Iovance’s Amended and Restated 2021 Inducement Plan, which provides for the granting of equity awards to new employees of Iovance by the Company’s compensation committee in accordance with Nasdaq Listing Rule 5635(c)(4). Each of the stock options granted as referenced in this press release has an exercise price of $3.70, the closing price of Iovance’s common stock on the Date of Grant. Each stock option vests over a three-year period, with one-third of the shares vesting on the first anniversary of the employee’s start date (the “First Vesting Date”) and the remaining shares vesting in eight quarterly installments over the next two years, commencing with the first quarter following the First Vesting Date, subject to continued employment with the Company through the applicable vesting dates.

About Iovance Biotherapeutics, Inc.

Iovance Biotherapeutics, Inc. aims to be the global leader in innovating, developing, and delivering tumor infiltrating lymphocyte (“TIL”) therapies for patients with cancer. We are pioneering a transformational approach to cure cancer by harnessing the human immune system’s ability to recognize and destroy diverse cancer cells in each patient. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. Iovance’s Amtagvi® is the first FDA-approved T cell therapy for a solid tumor indication. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, that may extend and improve life for patients with cancer. For more information, please visit www.iovance.com.

Amtagvi® and its accompanying design marks, Proleukin®, Iovance®, and IovanceCares™ are trademarks and registered trademarks of Iovance Biotherapeutics, Inc. or its subsidiaries. All other trademarks and registered trademarks are the property of their respective owners.

Forward-Looking Statements

Certain matters discussed in this press release are “forward-looking statements” of Iovance Biotherapeutics, Inc. (hereinafter referred to as the “Company,” “we,” “us,” or “our”) within the meaning of the Private Securities Litigation Reform Act of 1995 (the “PSLRA”). Without limiting the foregoing, we may, in some cases, use terms such as “predicts,” “believes,” “potential,” “achievable,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “forecast,” “guidance,” “outlook,” “may,” “can,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes and are intended to identify forward-looking statements. Forward-looking statements are based on assumptions and assessments made in light of management’s experience and perception of historical trends, current conditions, expected future developments, and other factors believed to be appropriate. Forward-looking statements in this press release are made as of the date of this press release, and we undertake no duty to update or revise any such statements, whether as a result of new information, future events or otherwise. Forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties, and other factors, many of which are outside of our control, that may cause actual results, levels of activity, performance, achievements, and developments to be materially different from those expressed in or implied by these forward-looking statements. Important factors that could cause actual results, developments, and business decisions to differ materially from forward-looking statements are described in the sections titled "Risk Factors" in our filings with the U.S. Securities and Exchange Commission, including our most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q.

CONTACTS

Investors
[email protected]
650-260-7120 ext. 150

Media
[email protected]
650-260-7120 ext. 150

Next-Generation Platform Expands into Solid Tumors 
Representing 100,000+ U.S. Deaths Annually

SAN CARLOS, Calif., June 01, 2026 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a commercial biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, today announced allowance to proceed from the U.S. Food and Drug Administration (FDA) for the investigational new drug (IND) application for a Phase 1/2 basket trial of IOV-5001, a next-generation interleukin-12 (IL-12) tethered TIL therapy.

The Phase 1/2 trial will begin enrolling in the second half of 2026 to investigate the safety and efficacy of a one-time IOV-5001 treatment regimen without the use of IL-2. Cohorts include advanced colorectal, triple-negative, and estrogen receptor-low breast cancers, as well as other highly prevalent solid tumors representing more than 100,000 U.S. deaths annually.1

IOV-5001 is engineered to express IL-12 only within the tumor to enhance efficacy, particularly in cancers caused by immunologically cold tumors, and to tether IL-12 to the cell surface to prevent release into the bloodstream to optimize safety. IOV-5001 is designed to safely deliver significantly higher cell doses and improve upon an earlier secreted IL-12 TIL therapy that showed a 63% confirmed objective response rate.2

“Proceeding into the clinical trial of IOV-5001 is a defining moment as we extend our TIL platform across additional prevalent solid tumors,” said Frederick Vogt, Ph.D., J.D., Interim Chief Executive Officer and President of Iovance. “By tethering IL-12 to the TIL cell surface and targeting its activity inside the tumor, IOV-5001 is designed to activate cold tumors and open an entirely new frontier of massive opportunities for TIL cell therapy. We look forward to beginning patient enrollment in the second half of 2026.”

1. Surveillance, Epidemiology, and End Results Program Cancer Stat Facts (accessed May 2026).
2. Zhang L, Rosenberg SA, et al, Clin Cancer Res 2015;21(10):2278–2288.

About IOV-5001
IOV-5001 is an investigational second-generation TIL therapy engineered to express IL-12 only inside the tumor, where it is anchored to the TIL cell surface rather than released into the bloodstream. This design is intended to deliver the antitumor benefit seen with earlier IL-12 TIL therapies while avoiding systemic toxicity. In preclinical studies, IOV-5001 showed stronger antitumor activity and a healthier, more durable T cell profile than unmodified TIL therapies.

About Iovance Biotherapeutics, Inc. 
Iovance Biotherapeutics, Inc. aims to be the global leader in innovating, developing, and delivering TIL therapies for patients with cancer. We are pioneering a transformational approach to cure cancer by harnessing the human immune system’s ability to recognize and destroy diverse cancer cells in each patient. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. Iovance’s Amtagvi® is the first FDA-approved T cell therapy for a solid tumor indication. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, that may extend and improve life for patients with cancer. For more information, please visit www.iovance.com.

Amtagvi® and its accompanying design marks, Proleukin®, Iovance®, and IovanceCares™ are trademarks and registered trademarks of Iovance Biotherapeutics, Inc. or its subsidiaries. All other trademarks and registered trademarks are the property of their respective owners.

Forward-Looking Statements

Certain matters discussed in this press release are “forward-looking statements” of Iovance Biotherapeutics, Inc. (hereinafter referred to as the “Company,” “we,” “us,” or “our”) within the meaning of the Private Securities Litigation Reform Act of 1995 (the “PSLRA”). Without limiting the foregoing, we may, in some cases, use terms such as “predicts,” “believes,” “potential,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “forecast,” “guidance,” “outlook,” “may,” “can,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes and are intended to identify forward-looking statements. Forward-looking statements are based on assumptions and assessments made in light of management’s experience and perception of historical trends, current conditions, expected future developments, and other factors believed to be appropriate. Forward-looking statements in this press release are made as of the date of this press release, and we undertake no duty to update or revise any such statements, whether as a result of new information, future events or otherwise. Forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties, and other factors, many of which are outside of our control, that may cause actual results, levels of activity, performance, achievements, and developments to be materially different from those expressed in or implied by these forward-looking statements. Important factors that could cause actual results, developments, and business decisions to differ materially from forward-looking statements are described in the sections titled "Risk Factors" in our filings with the U.S. Securities and Exchange Commission, including our most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, and include, but are not limited to, the following substantial known and unknown risks and uncertainties inherent in our business: the risks related to our ability to successfully commercialize our products; the acceptance by the market of our products and product candidates, if approved, and their potential pricing and/or reimbursement by payors, and whether such acceptance is sufficient to support continued commercialization or development of our products or product candidates; the risk regarding our ability to manufacture our therapies at our Iovance Cell Therapy Center facility, including the risk that our ability to increase manufacturing capacity at our facility may adversely affect our commercial launch; the risk that the successful development or commercialization of our products may not generate sufficient revenue from product sales, and we may not become profitable in the near term, or at all; the risks related to the timing of and our ability to successfully develop, submit, obtain, or maintain regulatory authority approval of our product candidates; whether clinical trial results from our pivotal studies and cohorts, and meetings with regulatory authorities may support registrational studies and subsequent approvals by regulatory authorities, including the risk that the planned registrational trial in advanced sarcomas may not support approval; preliminary and interim clinical results, which may include efficacy and safety results, from ongoing clinical trials or cohorts may not be reflected in the final analyses of our ongoing clinical trials or subgroups within these trials or in other prior trials or cohorts; the risk that we may be required to conduct additional clinical trials or modify ongoing or future clinical trials based on feedback from regulatory authorities; the risk that our interpretation of the results of our clinical trials or communications with regulatory authorities may differ from the interpretation of such results or communications by such regulatory authorities; the risk that clinical data from ongoing clinical trials of Amtagvi will not continue or be repeated in ongoing or planned clinical trials or may not support regulatory approval or renewal of authorization; the risk that unanticipated expenses may decrease our estimated cash balances and forecasts and increase our estimated capital requirements; the risk that we may not be able to recognize revenue for our products; the risk that Proleukin revenues, and other factors such as the number of authorized treatment centers, may not serve as a leading indicator for Amtagvi revenues; the risks regarding our anticipated operating and financial performance, including our financial guidance and projections; the effects of global and domestic geopolitical factors or public health events; and other factors, including general economic conditions and regulatory developments, not within our control. Any financial guidance provided in this press release assumes the following: no material change in our ability to manufacture our products; no material change in payor coverage; no material change in revenue recognition policies; no new business development transactions not completed as of the period covered by this press release; and no material fluctuation in exchange rates.

CONTACTS 

Investors
[email protected]
650-260-7120 ext. 150

Media
[email protected] 
650-260-7120 ext. 150

Iovance Biotherapeutics (NASDAQ:IOVA) said it has obtained clearance of an Investigational New Drug application for IOV-5001, extending its next-generation cell therapy platform into solid tumors the company said account for more than 100,000 US deaths a year.

The clearance allows Iovance to begin clinical work on IOV-5001 and marks the platform's move beyond its current focus and into the solid tumor setting.

The company framed the expansion around the size of the unmet need, pointing to the tens of thousands of annual US deaths in the targeted tumor types.
An IND clearance is the regulatory step that permits a company to start human testing of an experimental therapy in the United States. Carrying its next-generation platform into solid tumors widens the range of cancers Iovance's cell therapy approach could address and adds IOV-5001 to the programs the company is advancing toward the clinic.

Iovance did not detail the trial design or timing in the announcement.

Iovance Biotherapeutics is a commercial-stage biotechnology company developing cell therapies for the treatment of cancer.

First T cell therapy for a solid tumor cancer and first treatment option approved in Australia for advanced melanoma after anti-PD-1 and targeted therapy

SAN CARLOS, Calif., June 03, 2026 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a commercial biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, today announced that the Therapeutic Goods Administration (TGA) of Australia granted approval with conditions of Amtagvi® (lifileucel), a tumor-derived autologous T cell immunotherapy, for previously treated advanced (metastatic or unresectable) melanoma. Amtagvi is indicated for the treatment of adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor.

“This approval in Australia is our third marketing authorization for Amtagvi and marks a significant step forward for Iovance in the country with the highest rate of melanoma globally,” said Frederick Vogt, Ph.D., J.D., Interim Chief Executive Officer and President of Iovance. “We are in the process of authorizing our first Australian treatment center as we advance our expansion strategy for Amtagvi in additional markets with a high prevalence of advanced melanoma.”

Australia has the highest rate of melanoma globally, with an estimated 17,000 new cases diagnosed each year and more than 1,500 deaths annually.1,2 Similar to the U.S. and other global markets, there is a significant need for new therapies for patients with advanced melanoma.

TGA granted approval based on safety and efficacy results from the global, multicenter C-144-01 trial investigating Amtagvi in patients with advanced melanoma previously treated with anti-PD-1 therapy and targeted therapy, if applicable.

About the C-144-01 Clinical Trial
C-144-01 is a global, multicenter Phase 2 study in which patients received lifileucel monotherapy. The study enrolled patients with metastatic melanoma who were previously treated with at least one systemic therapy, including a PD-1 blocking antibody, and, if BRAF V600 mutation positive, a BRAF inhibitor or a BRAF inhibitor with a MEK inhibitor. Efficacy was established on the basis of objective response rate (ORR) and duration of response (DOR) by Independent Review Committee (IRC) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The detailed results of C-144-01 were published in the Journal for ImmunoTherapy of Cancer in 2022. A five-year analysis of C-144-01 was published in the Journal of Clinical Oncology in 2025.

Iovance is investigating Amtagvi in frontline advanced melanoma in the Phase 3 trial, TILVANCE-301 (NCT05727904), as well as in additional solid tumor types.

About Iovance Biotherapeutics, Inc. 

Iovance Biotherapeutics, Inc. aims to be the global leader in innovating, developing, and delivering tumor infiltrating lymphocyte (TIL) therapies for patients with cancer. We are pioneering a transformational approach to cure cancer by harnessing the human immune system’s ability to recognize and destroy diverse cancer cells in each patient. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. Iovance’s Amtagvi® is the first FDA-approved T cell therapy for a solid tumor indication. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, that may extend and improve life for patients with cancer. For more information, please visit www.iovance.com.

Amtagvi ® and its accompanying design marks, Proleukin®, Iovance®, and IovanceCares™ are trademarks and registered trademarks of Iovance Biotherapeutics, Inc. or its subsidiaries. All other trademarks and registered trademarks are the property of their respective owners.

1. Cancer Australia, Melanoma of the Skin Statistics, https://www.canceraustralia.gov.au/cancer-types/melanoma-skin/melanoma-skin-statistics (Accessed March 2026)
2. Melanoma Institute Australia, Melanoma Facts, https://melanoma.org.au/about-melanoma/melanoma-facts/ (Accessed March 2026)

Forward-Looking Statements

Certain matters discussed in this press release are “forward-looking statements” of Iovance Biotherapeutics, Inc. (hereinafter referred to as the “Company,” “we,” “us,” or “our”) within the meaning of the Private Securities Litigation Reform Act of 1995 (the “PSLRA”). Without limiting the foregoing, we may, in some cases, use terms such as “predicts,” “believes,” “potential,” “achievable,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “forecast,” “guidance,” “outlook,” “may,” “can,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes and are intended to identify forward-looking statements. Forward-looking statements are based on assumptions and assessments made in light of management’s experience and perception of historical trends, current conditions, expected future developments, and other factors believed to be appropriate. Forward-looking statements in this press release are made as of the date of this press release, and we undertake no duty to update or revise any such statements, whether as a result of new information, future events or otherwise. Forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties, and other factors, many of which are outside of our control, that may cause actual results, levels of activity, performance, achievements, and developments to be materially different from those expressed in or implied by these forward-looking statements. Important factors that could cause actual results, developments, and business decisions to differ materially from forward-looking statements are described in the sections titled "Risk Factors" in our filings with the U.S. Securities and Exchange Commission, including our most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, and include, but are not limited to, the following substantial known and unknown risks and uncertainties inherent in our business: the risks related to our ability to successfully commercialize our products; the acceptance by the market of our products and product candidates, if approved, and their potential pricing and/or reimbursement by payors, and whether such acceptance is sufficient to support continued commercialization or development of our products or product candidates; the risk regarding our ability to manufacture our therapies at our Iovance Cell Therapy Center facility, including the risk that our ability to increase manufacturing capacity at our facility may adversely affect our commercial launch; the risk that the successful development or commercialization of our products may not generate sufficient revenue from product sales, and we may not become profitable in the near term, or at all; the risks related to the timing of and our ability to successfully develop, submit, obtain, or maintain regulatory authority approval of our product candidates; whether clinical trial results from our pivotal studies and cohorts, and meetings with regulatory authorities may support registrational studies and subsequent approvals by regulatory authorities, including the risk that the planned registrational trial in advanced sarcomas may not support approval; preliminary and interim clinical results, which may include efficacy and safety results, from ongoing clinical trials or cohorts may not be reflected in the final analyses of our ongoing clinical trials or subgroups within these trials or in other prior trials or cohorts; the risk that we may be required to conduct additional clinical trials or modify ongoing or future clinical trials based on feedback from regulatory authorities; the risk that our interpretation of the results of our clinical trials or communications with regulatory authorities may differ from the interpretation of such results or communications by such regulatory authorities; the risk that clinical data from ongoing clinical trials of Amtagvi will not continue or be repeated in ongoing or planned clinical trials or may not support regulatory approval or renewal of authorization; the risk that unanticipated expenses may decrease our estimated cash balances and forecasts and increase our estimated capital requirements; the risk that we may not be able to recognize revenue for our products; the risk that Proleukin revenues, and other factors such as the number of authorized treatment centers, may not serve as a leading indicator for Amtagvi revenues; the risks regarding our anticipated operating and financial performance, including our financial guidance and projections; the effects of global and domestic geopolitical factors or public health events; and other factors, including general economic conditions and regulatory developments, not within our control. Any financial guidance provided in this press release assumes the following: no material change in our ability to manufacture our products; no material change in payor coverage; no material change in revenue recognition policies; no new business development transactions not completed as of the period covered by this press release; and no material fluctuation in exchange rates.

CONTACTS 

Investors
[email protected]
650-260-7120 ext. 150

Media
[email protected] 
650-260-7120 ext. 150

Key Takeaways HIMS builds a unified virtual-care ecosystem spanning telehealth, prescriptions and wellness products.Hims & Hers leans on subscriptions and owned pharmacies, labs and manufacturing to boost speed and control.TDOC and LFMD are expanding integrated virtual-care platforms, adding AI support and prescription access. Hims & Hers Health, Inc. (HIMS - Free Report) continues to strengthen its position as a vertically integrated virtual-care platform by combining technology, provider networks, pharmacy infrastructure and recurring patient relationships into a unified healthcare ecosystem. Through its digital-first platform, the company enables consumers to access telehealth consultations, ongoing clinical support, prescription therapies and wellness products across a growing range of health categories. HIMS’ affiliated medical groups and healthcare providers deliver care through the platform, while integrated operational capabilities help support continuity of care and long-term patient engagement.

The company’s business model is increasingly centered on recurring relationships, with subscription-based offerings driving patient retention and providing ongoing access to treatments and provider support. Hims & Hers has also continued to expand its vertically integrated infrastructure, investing in wholly owned pharmacies, laboratory testing facilities and manufacturing capabilities to enhance fulfillment efficiency, quality control and speed to market.

Recent developments further highlight this strategy. In March, HIMS launched a membership program for its weight-loss offerings that provides eligible customers access to weight-loss medications and unlimited support from its provider network. The company is also pursuing international expansion, including its planned acquisition of Eucalyptus, a digital health platform operating across multiple international markets, to broaden access to personalized virtual care.

TDOC & LFMD Advancing Integrated Virtual Care PlatformsTeladoc Health, Inc. (TDOC - Free Report) operates a vertically integrated virtual-care platform that combines proprietary technology, a large provider network, chronic-care and mental-health services and long-term patient relationships to deliver coordinated healthcare at scale. Teladoc Health leverages its Prism care delivery platform and AI-powered Pulse intelligence engine to enhance care delivery, risk stratification and clinical workflows, while TDOC’s integrated model supports ongoing engagement across urgent, chronic and behavioral health needs. Recent initiatives include the enhanced 24/7 Care service launched in January and the recent expansion of Teladoc Health’s services through Walmart’s Better Care Services platform, further broadening access to virtual care and prescriptions.

LifeMD, Inc. (LFMD - Free Report) is a vertically integrated virtual-care company that combines a proprietary technology platform, a 50-state affiliated provider network, pharmacy infrastructure and AI-enabled operational systems to deliver longitudinal healthcare services and prescriptions at scale. LFMD generates the vast majority of its revenue from recurring subscriptions, supporting ongoing patient relationships across primary care, weight management, women’s health and behavioral health. It is increasingly embedding AI into clinical workflows and care delivery, while recent launches include Novo Nordisk’s Wegovy subscription program and Eli Lilly’s Foundayo oral GLP-1 offering through the LifeMD platform, further expanding access to ongoing, clinically supported treatment.

HIMS’ Price Performance, Valuation and EstimatesShares of Hims & Hers have lost 21.9% year to date compared with the industry’s decline of 20.5%.

Image Source: Zacks Investment Research

HIMS’ forward 12-month P/S of 1.8X is lower than the industry’s average of 3.4X and its five-year median of 2.6X. It has a Value Score of D.

Image Source: Zacks Investment Research

The Zacks Consensus Estimate for HIMS’ 2026 earnings per share suggests a 149.1% plunge compared with 2025.

Image Source: Zacks Investment Research

Hims & Hers currently carries a Zacks Rank #4 (Sell).

You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

SAN FRANCISCO--(BUSINESS WIRE)--Hims & Hers Health, Inc. (NYSE: HIMS) has completed its acquisition of Eucalyptus, advancing its position as the world's largest consumer health platform. Building on the earlier acquisitions of ZAVA and Livewell, Hims & Hers now has a leading presence across the US, UK, Australian, and Canadian markets, with a growing presence in France, Germany, Ireland, Spain, and Japan. Continuing to expand internationally will enable Hims & Hers to lead the next.

TOKYO--(BUSINESS WIRE)--Hims & Hers Health, Inc. has completed its acquisition of Eucalyptus, the parent company of Juniper, marking a significant milestone in the company's global growth and its formal entry into Japan. This milestone puts the full weight of Hims & Hers' technology, data, and clinical infrastructure behind a platform that supports weight management care for people in Japan, a market the company approaches with deep respect for its distinct healthcare values and the tru.

BERLIN--(BUSINESS WIRE)--Hims & Hers Health, Inc. has completed its acquisition of Eucalyptus, the parent company of Juniper, advancing its position as the world's largest consumer health platform. In Germany, the closing strengthens Juniper's comprehensive, clinically rigorous, weight management offering with the technology, data, and infrastructure of Hims & Hers behind it. Since launching in Germany in March 2023, Juniper has grown into a trusted partner for customers seeking evidenc.

Hims & Hers Health Inc. (HIMS, Financials) completed its acquisition of Eucalyptus, giving the telehealth company a larger international footprint in Australia, Canada and Japan.

Eucalyptus owns several digital health brands, including Juniper, Pilot, Kin and Software. The deal gives Hims & Hers an established platform in those markets instead of forcing the company to build from the ground up.

The transaction calls for Hims & Hers to pay about $240 million in cash. For a company still focused on expanding its customer base, the acquisition adds both reach and local operating experience.

The move also comes as telehealth companies look for growth beyond the U.S. market. Hims & Hers has built its business around direct-to-consumer health services, and Eucalyptus gives it access to customers already using online care platforms.

For investors, the key issue is execution. International expansion can bring new revenue opportunities, but it also adds integration work, regulatory complexity and marketing costs.

Hims & Hers Health, Inc. (NYSE: HIMS), the leading health and wellness platform, today announced Dr. Anant Vinjamoori is joining as the Chief Medical Officer of the Hims brand. As the company reimagines how everyone can access proactive, comprehensive care that helps them feel great, Dr. Vinjamoori will provide the clinical guidance that shapes the next phase of the Hims brand across sexual health, hormone health, dermatology, weight loss, and mental health, as well as emerging categories like longevity medicine and peptide therapy. He joins a team of medical experts at Hims & Hers led by Global Chief Medical Officer, Dr. Pat Carroll.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260604732825/en/

An expert in longevity medicine and preventive healthcare, Vinjamoori joins Hims & Hers to help more men feel great at every stage of life

Dr. Vinjamoori has more than a decade of clinical and executive experience in internal medicine, primary care, and longevity. He has led both product and medical teams at prominent health technology companies, including Virta Health and Modern Age. He is a leading expert in preventive and longevity care, combining deep clinical experience with command of the latest diagnostic and therapeutic technologies—from advanced diagnostic testing to targeted therapies such as peptides—to support recovery, cognition, sleep, and body composition. As the founder of Next Generation Medicine, he provides best-in-class medical education and AI technology to help clinicians learn, implement, and scale evidence-based, clinically rigorous longevity medicine in their practices. Dr. Vinjamoori has also served as an advisor to consumer wellness companies like Superpower and Midi Health. He is the author of several peer-reviewed publications, and he received his MD from Harvard Medical School and his MBA from Harvard Business School.

“Men are increasingly seeking care that goes beyond reactive treatment – they want to feel their best at every age, and they are paying close attention to the science that makes that possible,” said Dr. Anant Vinjamoori. “This is the right time to increase access to high-quality, science-driven care that helps men feel like the best versions of themselves. Hims has the scale, consumer trust, and vision to do it right. I can’t wait to get started.”

“As medicine advances, we have a responsibility to bring our customers the latest innovations in treatments, services, and research,” said Dr. Pat Carroll, Global Chief Medical Officer of Hims & Hers. “Dr. Vinjamoori has been at the leading edge of helping people feel great at every stage of life, and he brings the perfect combination of clinical expertise and dedication to consumer access to Hims & Hers. I’m excited to see the deep impact he will have on our Hims customers.”

The team of medical leaders at Hims & Hers has more than 100 years of combined experience across weight loss, sexual health, hormone health, mental health, dermatology, and primary care. These physicians are the clinical backbone of the company, providing critical medical expertise that ensures the care available through Hims & Hers is rooted in the latest research and clinical guidelines.

About Hims & Hers Health, Inc.

Hims & Hers is the leading health and wellness platform on a mission to help the world feel great through the power of better health. We believe how you feel in your body and mind transforms how you show up in life. That’s why we’re building a future where nothing stands in the way of harnessing this power. Hims & Hers normalizes health & wellness challenges—and innovates on their solutions—to make feeling happy and healthy easy to achieve. No two people are the same, so the company provides access to personalized care designed for results. For more information, please visit www.hims.com and www.forhers.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260604732825/en/

Hims & Hers Health, Inc. (HIMS - 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 company have returned -7.4%, compared to the Zacks S&P 500 composite's +1.9% change. During this period, the Zacks Medical Info Systems industry, which Hims & Hers Health falls in, has lost 0.4%. 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.

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.

Hims & Hers Health is expected to post a loss of $0.02 per share for the current quarter, representing a year-over-year change of -111.8%. Over the last 30 days, the Zacks Consensus Estimate has changed -125.7%.

The consensus earnings estimate of -$0.26 for the current fiscal year indicates a year-over-year change of -149.1%. This estimate has changed -92.4% over the last 30 days.

For the next fiscal year, the consensus earnings estimate of $0.49 indicates a change of +289.5% from what Hims & Hers Health is expected to report a year ago. Over the past month, the estimate has changed -30.2%.

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 #4 (Sell) for Hims & Hers Health.

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 Hims & Hers Health, the consensus sales estimate for the current quarter of $689.29 million indicates a year-over-year change of +26.5%. For the current and next fiscal years, $2.91 billion and $3.37 billion estimates indicate +23.8% and +16% changes, respectively.

Last Reported Results and Surprise HistoryHims & Hers Health reported revenues of $608.1 million in the last reported quarter, representing a year-over-year change of +3.8%. EPS of -$0.18 for the same period compares with $0.2 a year ago.

Compared to the Zacks Consensus Estimate of $619.62 million, the reported revenues represent a surprise of -1.86%. The EPS surprise was -550%.

Over the last four quarters, the company surpassed EPS estimates just once. The company topped consensus revenue estimates just once 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.

Hims & Hers Health is graded D on this front, indicating that it is trading at a premium to its peers. Click here to see the values of some of the valuation metrics that have driven this grade.

Bottom LineThe 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 Hims & Hers Health. However, its Zacks Rank #4 does suggest that it may underperform the broader market in the near term.

A month has gone by since the last earnings report for Hims & Hers Health, Inc. (HIMS - Free Report) . Shares have added about 15.8% in that time frame, outperforming the S&P 500.

Will the recent positive trend continue leading up to its next earnings release, or is Hims & Hers Health due for a pullback? Well, first let's take a quick look at the latest earnings report in order to get a better handle on the recent catalysts for Hims & Hers Health, Inc. before we dive into how investors and analysts have reacted as of late.

Hims & Hers Post Q1 Earnings Miss, Gross Margin DownHims & Hers Health reported quarterly adjusted loss per share of 18 cents in first-quarter 2026, against the year-ago period’s adjusted earnings per share (EPS) of 20 cents and the Zacks Consensus Estimate of EPS of 4 cents.

HIMS’ Revenues in DetailHims & Hers registered revenues of $608.1 million in the first quarter, up 3.8% year over year. However, the figure lagged the Zacks Consensus Estimate by 1.9%.

Solid revenues from the Rest of the World segment drove the top line.

Hims & Hers’ Geographical ResultsIn the first quarter of 2026, revenues in the United States declined 8.4% year over year to $529.9 million.

Rest of the World revenues grossed $78.2 million, up from the year-ago quarter’s $7.3 million.

During the reported quarter, subscribers were 2.6 million, up 9.2% year over year.

Monthly online revenue per average subscriber decreased 5.9% year over year to $80 in the first quarter. Per management, the decrease was primarily due to the shift to shorter shipping cadences for certain of HIMS’ offerings.

HIMS’ Margin AnalysisIn the first quarter of 2026, Hims & Hers’ gross profit decreased 7.9% year over year to $396.8 million. The gross margin contracted 825 basis points (bps) to 65.2%.

Marketing expenses decreased 3.9% year over year to $222 million, while technology and development expenses jumped 56.9% year over year to $46.9 million. General and administrative expenses surged 125.6% year over year to $109.7 million, while operations and support expenses increased 53.1% year over year to $96.5 million. Operating expenses of $475.1 million increased 27.4% year over year.

Operating loss totaled $78.3 million against the year-ago quarter’s operating profit of $57.9 million.

Hims & Hers’ Financial PositionHims & Hers exited first-quarter 2026 with cash and cash equivalents and short-term investments of $750.9 million compared with $577.5 million at the end of 2025.

Net cash provided by operating activities at the end of first-quarter 2026 was $89.4 million compared with $109.1 million a year ago.

HIMS’ OutlookHims & Hers has provided its revenue outlook for the second quarter and raised the same for 2026.

The company projects revenues for the second quarter of 2026 in the range of $680 million to $700 million, reflecting an uptick of 25%-28% year over year.

For the full year, HIMS now projects revenues in the range of $2.8 billion to $3 billion (representing growth of 19%-28% from 2025 levels), up from the prior outlook of $2.7 billion to $2.9 billion (representing growth of 15%-24% from 2025 levels).

How Have Estimates Been Moving Since Then?In the past month, investors have witnessed a downward trend in estimates review.

The consensus estimate has shifted -125.7% due to these changes.

VGM ScoresCurrently, Hims & Hers Health has a great Growth Score of A, though it is lagging a lot on the Momentum Score front with an F. Following the exact same course, the stock has a grade of F on the value side, putting it in the fifth quintile for this investment strategy.

Overall, the stock has an aggregate VGM Score of D. If you aren't focused on one strategy, this score is the one you should be interested in.

OutlookEstimates have been broadly trending downward for the stock, and the magnitude of these revisions indicates a downward shift. It's no surprise Hims & Hers Health has a Zacks Rank #5 (Strong Sell). We expect a below average return from the stock in the next few months.

Performance of an Industry PlayerHims & Hers Health belongs to the Zacks Medical Info Systems industry. Another stock from the same industry, 10x Genomics (TXG - Free Report) , has gained 46.2% over the past month. More than a month has passed since the company reported results for the quarter ended March 2026.

10x Genomics reported revenues of $150.84 million in the last reported quarter, representing a year-over-year change of -2.6%. EPS of -$0.10 for the same period compares with -$0.36 a year ago.

For the current quarter, 10x Genomics is expected to post a loss of $0.23 per share, indicating a change of -182.1% from the year-ago quarter. The Zacks Consensus Estimate has changed -6.5% over the last 30 days.

The overall direction and magnitude of estimate revisions translate into a Zacks Rank #3 (Hold) for 10x Genomics. Also, the stock has a VGM Score of B.

Hims & Hers Health, Inc. (HIMS - Free Report) closed the most recent trading day at $27.71, moving -4.38% from the previous trading session. This change lagged the S&P 500's 1.62% loss on the day. Meanwhile, the Dow experienced a drop of 1.87%, and the technology-dominated Nasdaq saw a decrease of 1.98%.

The company's stock has climbed by 15.78% in the past month, exceeding the Medical sector's gain of 5.04% and the S&P 500's loss of 0.03%.

The investment community will be closely monitoring the performance of Hims & Hers Health, Inc. in its forthcoming earnings report. It is anticipated that the company will report an EPS of -$0.02, marking a 111.76% fall compared to the same quarter of the previous year. Meanwhile, the latest consensus estimate predicts the revenue to be $689.29 million, indicating a 26.52% increase compared to the same quarter of the previous year.

Looking at the full year, the Zacks Consensus Estimates suggest analysts are expecting earnings of -$0.26 per share and revenue of $2.91 billion. These totals would mark changes of -149.06% and +23.78%, respectively, from last year.

It is also important to note the recent changes to analyst estimates for Hims & Hers Health, Inc. These latest adjustments often mirror the shifting dynamics of short-term business patterns. Hence, positive alterations in estimates signify analyst optimism regarding the business and profitability.

Our research suggests that these changes in estimates have a direct relationship with upcoming stock price performance. Investors can capitalize on this by using the Zacks Rank. This model considers these estimate changes and provides a simple, actionable rating system.

Ranging from #1 (Strong Buy) to #5 (Strong Sell), the Zacks Rank system has a proven, outside-audited track record of outperformance, with #1 stocks returning an average of +25% annually since 1988. The Zacks Consensus EPS estimate has moved 92.39% lower within the past month. Currently, Hims & Hers Health, Inc. is carrying a Zacks Rank of #5 (Strong Sell).

Digging into valuation, Hims & Hers Health, Inc. currently has a Forward P/E ratio of 724.5. This expresses a premium compared to the average Forward P/E of 25.06 of its industry.

We can additionally observe that HIMS currently boasts a PEG ratio of 54.37. Comparable to the widely accepted P/E ratio, the PEG ratio also accounts for the company's projected earnings growth. Medical Info Systems stocks are, on average, holding a PEG ratio of 1.6 based on yesterday's closing prices.

The Medical Info Systems industry is part of the Medical sector. Currently, this industry holds a Zacks Industry Rank of 159, positioning it in the bottom 35% 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.

Ensure to harness Zacks.com to stay updated with all these stock-shifting metrics, among others, in the next trading sessions.

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