Affinity Asset Advisors LLC cut its stake in shares of BridgeBio Pharma, Inc. (NASDAQ:BBIO – Free Report) by 53.1% during the 1st quarter, according to the company in its most recent disclosure with the Securities & Exchange Commission. The institutional investor owned 150,000 shares of the company’s stock after selling 170,000 shares during the quarter. Affinity Asset Advisors LLC owned approximately 0.08% of BridgeBio Pharma worth $11,139,000 at the end of the most recent quarter.
A number of other large investors have also bought and sold shares of BBIO. Global Retirement Partners LLC increased its position in shares of BridgeBio Pharma by 271.5% during the fourth quarter. Global Retirement Partners LLC now owns 509 shares of the company’s stock worth $39,000 after acquiring an additional 372 shares in the last quarter. Farther Finance Advisors LLC boosted its stake in shares of BridgeBio Pharma by 91.4% in the 4th quarter. Farther Finance Advisors LLC now owns 513 shares of the company’s stock worth $39,000 after buying an additional 245 shares during the last quarter. Kemnay Advisory Services Inc. purchased a new position in shares of BridgeBio Pharma in the 4th quarter worth approximately $41,000. Cary Street Partners Investment Advisory LLC grew its holdings in shares of BridgeBio Pharma by 861.0% in the fourth quarter. Cary Street Partners Investment Advisory LLC now owns 567 shares of the company’s stock valued at $43,000 after acquiring an additional 508 shares in the last quarter. Finally, Eurizon Capital SGR S.p.A. bought a new position in shares of BridgeBio Pharma in the fourth quarter valued at approximately $44,000. 99.85% of the stock is currently owned by institutional investors and hedge funds.
Analyst Upgrades and Downgrades BBIO has been the topic of a number of research reports. Weiss Ratings restated a “sell (d)” rating on shares of BridgeBio Pharma in a research note on Friday, May 15th. Citigroup raised their price objective on shares of BridgeBio Pharma from $82.00 to $93.00 and gave the stock a “neutral” rating in a report on Thursday, July 16th. Canaccord Genuity Group initiated coverage on shares of BridgeBio Pharma in a research note on Wednesday, June 3rd. They issued a “buy” rating and a $104.00 price objective for the company. Mizuho lowered their target price on shares of BridgeBio Pharma from $106.00 to $96.00 and set an “outperform” rating on the stock in a report on Tuesday, June 16th. Finally, Royal Bank Of Canada started coverage on BridgeBio Pharma in a research report on Thursday, April 9th. They set an “outperform” rating and a $100.00 target price on the stock. Twenty equities research analysts have rated the stock with a Buy rating, two have assigned a Hold rating and one has issued a Sell rating to the stock. According to data from MarketBeat.com, BridgeBio Pharma has an average rating of “Moderate Buy” and a consensus price target of $95.21.
Read Our Latest Stock Analysis on BridgeBio Pharma
BridgeBio Pharma Stock Up 1.3% Shares of NASDAQ:BBIO opened at $84.02 on Friday. The company’s 50-day moving average price is $72.69 and its 200 day moving average price is $72.53. The company has a market cap of $16.46 billion, a PE ratio of -22.47 and a beta of 0.95. BridgeBio Pharma, Inc. has a fifty-two week low of $42.09 and a fifty-two week high of $93.42.
BridgeBio Pharma (NASDAQ:BBIO – Get Free Report) last announced its quarterly earnings results on Thursday, May 7th. The company reported ($0.84) EPS for the quarter, missing the consensus estimate of ($0.70) by ($0.14). The business had revenue of $194.51 million for the quarter, compared to the consensus estimate of $178.07 million. The company’s revenue for the quarter was up 66.8% compared to the same quarter last year. During the same quarter in the prior year, the firm earned ($0.88) EPS. As a group, equities analysts anticipate that BridgeBio Pharma, Inc. will post -2.27 EPS for the current year.
Insider Buying and Selling In other news, Director Jennifer E. Cook sold 148,589 shares of the company’s stock in a transaction dated Thursday, July 9th. The stock was sold at an average price of $88.54, for a total transaction of $13,156,070.06. Following the completion of the sale, the director owned 8,383 shares in the company, valued at approximately $742,230.82. This represents a 94.66% decrease in their position. The transaction was disclosed in a legal filing with the SEC, which can be accessed through this hyperlink. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan. Also, Director Andrea Ellis sold 17,167 shares of BridgeBio Pharma stock in a transaction dated Thursday, July 9th. The stock was sold at an average price of $84.00, for a total value of $1,442,028.00. Following the completion of the transaction, the director owned 22,579 shares in the company, valued at $1,896,636. The trade was a 43.19% 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 sold 432,117 shares of company stock valued at $32,633,740. 14.23% of the stock is owned by company insiders.
BridgeBio Pharma Company Profile (Free Report)
BridgeBio Pharma, Inc is a clinical-stage biopharmaceutical company headquartered in Palo Alto, California. Founded in 2015 by Neil Kumar, the company is dedicated to discovering, developing and delivering transformative medicines for patients with genetic diseases and cancers. BridgeBio operates an integrated model that spans target identification, preclinical research, clinical development and commercialization, aiming to streamline the process from bench to bedside.
BridgeBio’s pipeline comprises multiple therapeutic modalities, including small molecules, biologics and genetic therapies.
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California Public Employees Retirement System raised its holdings in BridgeBio Pharma, Inc. (NASDAQ:BBIO – Free Report) by 21.9% in the 1st quarter, according to its most recent 13F filing with the SEC. The fund owned 253,479 shares of the company’s stock after acquiring an additional 45,596 shares during the period. California Public Employees Retirement System owned 0.13% of BridgeBio Pharma worth $18,823,000 at the end of the most recent reporting period.
Other large investors also recently made changes to their positions in the company. Global Retirement Partners LLC grew its position in shares of BridgeBio Pharma by 271.5% in the fourth quarter. Global Retirement Partners LLC now owns 509 shares of the company’s stock valued at $39,000 after purchasing an additional 372 shares during the period. Farther Finance Advisors LLC lifted its position in BridgeBio Pharma by 91.4% during the fourth quarter. Farther Finance Advisors LLC now owns 513 shares of the company’s stock worth $39,000 after buying an additional 245 shares during the period. Kemnay Advisory Services Inc. purchased a new position in BridgeBio Pharma during the fourth quarter worth about $41,000. Cary Street Partners Investment Advisory LLC boosted its stake in BridgeBio Pharma by 861.0% in the 4th quarter. Cary Street Partners Investment Advisory LLC now owns 567 shares of the company’s stock worth $43,000 after buying an additional 508 shares during the last quarter. Finally, Eurizon Capital SGR S.p.A. acquired a new stake in BridgeBio Pharma in the 4th quarter worth about $44,000. Hedge funds and other institutional investors own 99.85% of the company’s stock.
Insider Activity In related news, CEO Neil Kumar sold 40,000 shares of BridgeBio Pharma stock in a transaction on Thursday, June 4th. The shares were sold at an average price of $67.46, for a total transaction of $2,698,400.00. Following the transaction, the chief executive officer owned 535,686 shares in the company, valued at approximately $36,137,377.56. The trade was a 6.95% decrease in their position. The transaction was disclosed in a legal filing with the SEC, which can be accessed through this link. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan. Also, CFO Thomas Trimarchi sold 13,651 shares of the company’s stock in a transaction dated Monday, May 18th. The stock was sold at an average price of $65.08, for a total value of $888,407.08. Following the completion of the sale, the chief financial officer directly owned 359,194 shares of the company’s stock, valued at $23,376,345.52. The trade was a 3.66% 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. Insiders sold a total of 432,117 shares of company stock valued at $32,633,740 over the last quarter. 14.23% of the stock is owned by insiders.
BridgeBio Pharma Price Performance Shares of NASDAQ:BBIO opened at $82.93 on Friday. The business has a 50-day moving average of $72.33 and a two-hundred day moving average of $72.45. The firm has a market capitalization of $16.24 billion, a PE ratio of -22.17 and a beta of 0.95. BridgeBio Pharma, Inc. has a 12 month low of $42.09 and a 12 month high of $93.42.
BridgeBio Pharma (NASDAQ:BBIO – Get Free Report) last released its quarterly earnings data on Thursday, May 7th. The company reported ($0.84) earnings per share for the quarter, missing the consensus estimate of ($0.70) by ($0.14). The firm had revenue of $194.51 million during the quarter, compared to analyst estimates of $178.07 million. BridgeBio Pharma’s quarterly revenue was up 66.8% on a year-over-year basis. During the same quarter in the prior year, the company earned ($0.88) earnings per share. As a group, research analysts anticipate that BridgeBio Pharma, Inc. will post -2.29 earnings per share for the current year.
Analyst Ratings Changes Several analysts have commented on BBIO shares. HC Wainwright lifted their price target on BridgeBio Pharma from $110.00 to $120.00 and gave the company a “buy” rating in a report on Monday, July 13th. Weiss Ratings reissued a “sell (d)” rating on shares of BridgeBio Pharma in a research report on Friday, May 15th. Royal Bank Of Canada assumed coverage on shares of BridgeBio Pharma in a research report on Thursday, April 9th. They issued an “outperform” rating and a $100.00 target price on the stock. Canaccord Genuity Group assumed coverage on shares of BridgeBio Pharma in a report on Wednesday, June 3rd. They issued a “buy” rating and a $104.00 target price for the company. Finally, Truist Financial upped their price target on shares of BridgeBio Pharma from $95.00 to $102.00 and gave the stock a “buy” rating in a research report on Wednesday, April 29th. Twenty analysts have rated the stock with a Buy rating, two have assigned a Hold rating and one has assigned a Sell rating to the stock. According to data from MarketBeat.com, the stock currently has a consensus rating of “Moderate Buy” and an average price target of $95.21.
View Our Latest Report on BridgeBio Pharma
BridgeBio Pharma Profile (Free Report)
BridgeBio Pharma, Inc is a clinical-stage biopharmaceutical company headquartered in Palo Alto, California. Founded in 2015 by Neil Kumar, the company is dedicated to discovering, developing and delivering transformative medicines for patients with genetic diseases and cancers. BridgeBio operates an integrated model that spans target identification, preclinical research, clinical development and commercialization, aiming to streamline the process from bench to bedside.
BridgeBio’s pipeline comprises multiple therapeutic modalities, including small molecules, biologics and genetic therapies.
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Key Takeaways BridgeBio's filing for encaleret in ADH1 was accepted by the FDA, with a decision due by May 8, 2027.BBIO's filing is backed by phase III data showing restored blood and urine calcium and PTH production.BridgeBio says encaleret could expand its portfolio beyond Attruby alongside BBP-418 and infigratinib. BridgeBio Pharma (BBIO - Free Report) announced that the FDA has accepted its regulatory filing seeking approval for the investigational oral candidate encaleret to treat individuals living with a rare genetic endocrine disorder called autosomal dominant hypocalcemia type 1 (ADH1).
A final decision is expected by May 8, 2027. If approved, encaleret would become the first FDA-approved therapy specifically indicated for ADH1, offering a disease-targeted treatment for a condition that is currently managed with calcium and active vitamin D supplementation rather than therapies that address its underlying cause.
The FDA also notified BridgeBio that it is not currently planning to hold an advisory committee meeting, suggesting that the agency does not presently see the need for external expert review of the application. While this is generally viewed as a positive procedural development, it should not be interpreted as an indication of the FDA's ultimate approval decision.
The filing is supported by results from the phase III CALIBRATE study, which showed that encaleret led to the simultaneous restoration of blood and urine calcium, as well as the restoration of physiologic parathyroid hormone (PTH) production. Per BridgeBio, the findings support the drug’s potential as a disease-modifying therapy by targeting the underlying genetic cause of ADH1.
BBIO Stock’s Price PerformanceYear to date, the company’s shares have gained 8% against the industry’s 5% fall.
Image Source: Zacks Investment Research
BridgeBio Takes a Step Closer to Becoming a Multi-Product CompanyThe FDA's acceptance of encaleret marks another regulatory milestone for BridgeBio as it continues to expand its product portfolio beyond Attruby, which is currently its only marketed product. The drug is approved for the treatment of adults with transthyretin amyloid cardiomyopathy (ATTR-CM).
However, the company has several late-stage candidates that could significantly diversify its revenue base over the next 12 months. Encaleret is one of three near-term commercialization opportunities, alongside BBP-418 and infigratinib.
A filing for BBP-418 is already under FDA review for limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9), with a final decision expected by Nov. 27, 2026. On the other hand, BridgeBio is on track to submit a filing to the agency for infigratinib as a potential treatment for achondroplasia in the third quarter of 2026.
Together with encaleret, BBP-418 and infigratinib could significantly diversify BridgeBio's revenue base. If approved, these candidates would transform the company from a single-product business into a diversified rare disease commercial player, reducing its dependence on Attruby as its primary growth driver.
BBIO’s Zacks RankBridgeBio currently carries a Zacks Rank #3 (Hold).
Our Key Picks Among Biotech StocksSome better-ranked stocks from the sector are Liquidia Corporation (LQDA - Free Report) and Harmony Biosciences (HRMY - Free Report) , sporting a Zacks Rank #1 (Strong Buy) each at present. 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 (EPS) have increased from $2.97 to $3.02. Over the same period, EPS estimates for 2027 have also increased from $4.81 to $4.92. LQDA shares have skyrocketed more than 150% year to date.
Liquidia’s earnings beat estimates in three of the trailing four quarters and missed once, with the average surprise being 54.40%.
Over the past 60 days, estimates for Harmony Biosciences’ 2026 EPS have increased from $3.20 to $3.30. Over the same period, EPS estimates for 2027 have risen from $3.64 to $3.87. HRMY shares have lost nearly 7% year to date.
Harmony Biosciences’ earnings missed estimates in each of the trailing four quarters, with the average negative surprise being 25.16%.
July 22, 2026 07:30 ET | Source: BridgeBio Pharma, Inc.
- PDUFA target action date of May 8, 2027
- If approved, encaleret will be the first and only approved therapy specifically indicated for individuals living with ADH1, representing a potential blockbuster opportunity for BridgeBio
- Encaleret demonstrated consistent efficacy across all pre-specified primary and key secondary efficacy endpoints normalizing key markers of CaSR-driven disease biology without the need for calcium and vitamin D supplements, with a favorable safety and tolerability profile
- BridgeBio is also currently enrolling CALIBRATE-PEDS, a registrational Phase 2/3 trial to study encaleret in pediatric ADH1 and intends to initiate the RECLAIM-HP Phase 3 registrational study of encaleret in chronic hypoparathyroidism later this summer; successful development could extend encaleret’s utility to a broader patient population
PALO ALTO, Calif., July 22, 2026 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage, multi-product biopharmaceutical company focused on developing medicines for genetic conditions, today announced the FDA has accepted for filing its New Drug Application (NDA) for encaleret for the treatment of individuals living with autosomal dominant hypocalcemia type 1 (ADH1). The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of May 8, 2027, and BridgeBio is prepared to launch encaleret upon approval, representing a potential blockbuster opportunity for the Company. The FDA also notified the Company that it is not currently planning to hold an advisory committee meeting to discuss the application.
"The FDA's acceptance of our NDA is a powerful validation of encaleret’s differentiated clinical profile and enables a major step forward for the ADH1 community. We believe encaleret has the potential to transform care for patients who currently have no indicated treatment options, and we're moving with urgency to bring it to them,” said Ananth Sridhar, Chief Executive Officer of BridgeBio Endocrinology.
CALIBRATE, the Phase 3 clinical trial of encaleret in ADH1, successfully achieved all pre-specified primary and key secondary efficacy endpoints, supporting encaleret’s potential as a disease-modifying therapy by targeting the underlying genetic cause of ADH1. The topline results can be found here. Additional results were presented at the European Congress of Endocrinology (ECE) 2026 and the Endocrine Society 2026 annual meeting (ENDO) in oral presentations, with data showing simultaneous restoration of blood and urine calcium, as well as restoration of physiologic parathyroid hormone (PTH) production.
"For too long, ADH1 has been an invisible condition, that disrupts several systems in the body, from the kidneys to the nervous system to the muscles and often goes unrecognized for years. The path to diagnosis is frequently a long and exhausting one, especially for patients with a genetic disorder. Patients often cycle through specialists before anyone connects the dots to their diagnosis. The FDA's acceptance of this NDA is a moment of real hope for ADH1 patients and a signal that the medical and regulatory community understand the seriousness of this condition and that an orally administered option may finally be on the horizon for those in need," said Patty Keating, Executive Director of the HypoPARAthyroidism Association.
As of April 2026, over 2,100 individuals have been diagnosed in the U.S. with autosomal dominant hypocalcemia since October 2023 based on claims data, suggestive of a growing marketplace and elevated diagnostic suspicion. The Company also intends to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for the use of encaleret in ADH1 in the second half of 2026.
BridgeBio is currently enrolling CALIBRATE-PEDS (NCT07080385), a global registrational Phase 2/3 study of encaleret in pediatric ADH1. The Company also plans to initiate RECLAIM-HP, a global Phase 3 study of encaleret in chronic hypoparathyroidism later this summer, building on the positive Phase 2 proof-of-concept findings of PTH-independent effects of encaleret on renal calcium handling and expanding the potential applications of encaleret beyond ADH1. Successful development could extend encaleret’s utility to a broader patient population.
About Autosomal Dominant Hypocalcemia Type 1 (ADH1)
ADH1 is a common form of genetic hypoparathyroidism caused by gain-of-function variants in the calcium-sensing receptor gene (CASR). The calcium-sensing receptor (CaSR) constantly monitors and balances blood calcium levels by regulating parathyroid hormone secretion and calcium reabsorption in the kidneys. Individuals with ADH1 typically experience hypocalcemia, hypercalciuria, and inappropriately low levels of PTH. Symptoms of hypocalcemia may include severe muscle cramps, muscle spasms (tetany), a burning or prickling sensation in the hands or feet (paresthesia), brain fog, fatigue, and seizures. Hypercalciuria may result in kidney calcification (nephrocalcinosis), kidney stones (nephrolithiasis), and kidney failure.
About Encaleret
Encaleret is an investigational, orally administered small molecule under investigation to treat ADH1 and chronic hypoparathyroidism, that is designed to selectively negatively modulate the calcium sensing receptor. Encaleret has been granted Fast Track Designation by the U.S. FDA and Orphan Drug Designation in the U.S., European Union, and Japan.
About BridgeBio
BridgeBio exists to develop transformative medicines for genetic conditions. Millions of people worldwide living with genetic conditions lack treatment options, often because drug development for small patient populations can be commercially challenging. We aim to bridge the gap between advancements in genetic science and meaningful medicines for underserved patient populations. Our decentralized, hub-and-spoke model is designed for speed, precision, and scalability. Autonomous and empowered teams focus on individual conditions, while a central hub provides the clinical, regulatory, and commercial capabilities needed to bring innovation to market. For more information, visit bridgebio.com and follow us on LinkedIn, X, Facebook, Instagram, YouTube, and TikTok.
BridgeBio Forward-Looking Statements
This press release contains forward-looking statements. Statements in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the Securities Act), and Section 21E of the Securities Exchange Act of 1934, as amended (the Exchange Act), which are usually identified by the use of words such as “anticipates,” “believes,” “continues,” “estimates,” “expects,” “hopes,” “intends,” “may,” “plans,” “projects,” “remains,” “seeks,” “should,” “will,” and variations of such words or similar expressions. BridgeBio intends these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act. These forward-looking statements include express and implied statements relating to the Company’s expectations regarding the regulatory review process for encaleret in ADH1, including the FDA’s review of the NDA and the potential for approval; the Company’s preparedness to launch encaleret upon approval; the potential for encaleret to become the first and only approved therapy specifically indicated for individuals living with ADH1 and to transform care for patients with ADH1; the potential for encaleret to be a disease-modifying therapy by targeting the underlying genetic cause of ADH1; the potential commercial opportunity for encaleret in ADH1, including as a potential blockbuster opportunity for the Company; the timing of a potential Marketing Authorization Application submission to the European Medicines Agency for encaleret in ADH1; the Company’s plans to initiate RECLAIM-HP, a global Phase 3 study of encaleret in chronic hypoparathyroidism, and the potential expansion of encaleret beyond ADH1, including the potential for encaleret to become a multi-billion-dollar opportunity for the Company. Such statements reflect the Company’s current views about the Company’s plans, intentions, expectations and strategies, which are based on the information currently available to it and on assumptions the Company has made. Although the Company believes that its plans, intentions, expectations and strategies as reflected in or suggested by those forward-looking statements are reasonable, the Company can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to, initial and ongoing data from the Company’s clinical trials not being indicative of final data, the design and success of ongoing and planned clinical trials, future regulatory filings, approvals and/or sales, despite having ongoing and future interactions with the FDA or other regulatory agencies to discuss potential paths to registration for the Company’s product candidates, the FDA or such other regulatory agencies not agreeing with the Company’s regulatory approval strategies, components of the Company’s filings, such as clinical trial designs, conduct and methodologies, or the sufficiency of data submitted, regulatory submissions not being accepted or approved on anticipated timelines or at all, encaleret not becoming the first and only approved therapy specifically indicated for individuals living with ADH1, the Company not being successful in launching encaleret on anticipated timing or at all, the potential commercial opportunity for encaleret not being realized, the Company’s plans for RECLAIM-HP not proceeding as expected, the impacts of current macroeconomic and geopolitical events, including changing conditions from hostilities in Ukraine and in Israel and the Middle East, increasing rates of inflation and changing interest rates, on business operations and expectations, as well as those risks set forth in the Risk Factors section of the Company’s most recent Annual Report on Form 10-K and the Company’s other filings with the U.S. Securities and Exchange Commission. Moreover, the Company operates in a very competitive and rapidly changing environment in which new risks emerge from time to time. These forward-looking statements are based upon the current expectations and beliefs of the Company’s management as of the date of this press release, and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as required by applicable law, BridgeBio assumes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.
BridgeBio Media Contact:
Bubba Murarka, Executive Vice President [email protected]
(650)-789-8220
Allspring Global Investments Holdings LLC cut its holdings in BridgeBio Pharma, Inc. (NASDAQ:BBIO – Free Report) by 10.5% during the 1st quarter, according to its most recent disclosure with the Securities & Exchange Commission. The institutional investor owned 889,356 shares of the company’s stock after selling 104,864 shares during the quarter. Allspring Global Investments Holdings LLC owned approximately 0.45% of BridgeBio Pharma worth $66,213,000 at the end of the most recent reporting period.
A number of other hedge funds and other institutional investors have also recently bought and sold shares of BBIO. Harvest Fund Management Co. Ltd bought a new position in BridgeBio Pharma in the 3rd quarter valued at approximately $34,000. Jones Financial Companies Lllp acquired a new position in BridgeBio Pharma during the 1st quarter worth about $35,000. Farther Finance Advisors LLC grew its position in shares of BridgeBio Pharma by 91.4% in the 4th quarter. Farther Finance Advisors LLC now owns 513 shares of the company’s stock valued at $39,000 after buying an additional 245 shares during the last quarter. Global Retirement Partners LLC grew its position in shares of BridgeBio Pharma by 271.5% in the 4th quarter. Global Retirement Partners LLC now owns 509 shares of the company’s stock valued at $39,000 after buying an additional 372 shares during the last quarter. Finally, Kemnay Advisory Services Inc. acquired a new stake in shares of BridgeBio Pharma in the fourth quarter valued at about $41,000. Institutional investors own 99.85% of the company’s stock.
Analysts Set New Price Targets A number of equities analysts have recently issued reports on the company. Weiss Ratings restated a “sell (d)” rating on shares of BridgeBio Pharma in a research report on Friday, May 15th. HC Wainwright increased their target price on shares of BridgeBio Pharma from $110.00 to $120.00 and gave the company a “buy” rating in a research report on Monday, July 13th. Mizuho decreased their target price on shares of BridgeBio Pharma from $106.00 to $96.00 and set an “outperform” rating for the company in a research report on Tuesday, June 16th. Morgan Stanley raised their price target on shares of BridgeBio Pharma from $94.00 to $98.00 and gave the stock an “overweight” rating in a report on Thursday, May 28th. Finally, Truist Financial boosted their price target on shares of BridgeBio Pharma from $95.00 to $102.00 and gave the stock a “buy” rating in a research report on Wednesday, April 29th. Twenty analysts have rated the stock with a Buy rating, two have given a Hold rating and one has assigned a Sell rating to the stock. Based on data from MarketBeat, the company has an average rating of “Moderate Buy” and a consensus target price of $95.21.
View Our Latest Research Report on BBIO
BridgeBio Pharma Price Performance NASDAQ:BBIO opened at $81.38 on Friday. BridgeBio Pharma, Inc. has a one year low of $42.09 and a one year high of $93.42. The company has a market cap of $15.94 billion, a PE ratio of -21.76 and a beta of 0.95. The firm has a 50-day moving average of $71.13 and a 200-day moving average of $72.32.
BridgeBio Pharma (NASDAQ:BBIO – Get Free Report) last announced its quarterly earnings results on Thursday, May 7th. The company reported ($0.84) earnings per share for the quarter, missing the consensus estimate of ($0.70) by ($0.14). The company had revenue of $194.51 million for the quarter, compared to analyst estimates of $178.07 million. The business’s quarterly revenue was up 66.8% compared to the same quarter last year. During the same quarter last year, the firm posted ($0.88) earnings per share. On average, equities research analysts expect that BridgeBio Pharma, Inc. will post -2.29 earnings per share for the current fiscal year.
Insider Activity In other news, CEO Neil Kumar sold 40,000 shares of the company’s stock in a transaction on Thursday, June 4th. The shares were sold at an average price of $67.46, for a total value of $2,698,400.00. Following the completion of the sale, the chief executive officer owned 535,686 shares in the company, valued at $36,137,377.56. This represents a 6.95% decrease in their position. The transaction was disclosed in a legal filing with the SEC, which is available through this hyperlink. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan. Also, Director Andrea Ellis sold 17,167 shares of the firm’s stock in a transaction dated Thursday, July 9th. The shares were sold at an average price of $84.00, for a total transaction of $1,442,028.00. Following the transaction, the director directly owned 22,579 shares in the company, valued at $1,896,636. The trade was a 43.19% 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 ninety days, insiders sold 432,117 shares of company stock worth $32,633,740. Company insiders own 14.23% of the company’s stock.
BridgeBio Pharma Profile (Free Report)
BridgeBio Pharma, Inc is a clinical-stage biopharmaceutical company headquartered in Palo Alto, California. Founded in 2015 by Neil Kumar, the company is dedicated to discovering, developing and delivering transformative medicines for patients with genetic diseases and cancers. BridgeBio operates an integrated model that spans target identification, preclinical research, clinical development and commercialization, aiming to streamline the process from bench to bedside.
BridgeBio’s pipeline comprises multiple therapeutic modalities, including small molecules, biologics and genetic therapies.
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When a late-stage clinical trial misses a primary endpoint, the market reaction rarely distributes evenly across the board. The fallout often reveals undeniable fundamental truths about single-asset exposure, pipeline diversification, and the competitive moats protecting established treatments. The July 9 announcement from AstraZeneca NYSE: AZN and Ionis Pharmaceuticals NASDAQ: IONS regarding the CARDIO-TTRansform Phase 3 trial provides a real-time masterclass in these market dynamics.
The investigational use of Wainua, also known as eplontersen, failed to achieve statistical significance on its primary composite endpoint of cardiovascular mortality and recurrent cardiovascular events at 140 weeks. The treatment targets transthyretin-mediated amyloid cardiomyopathy. This fatal disease causes misfolded proteins to build up in the heart muscle.
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The clinical failure removes an anticipated competitor from a highly lucrative market and triggers an immediate capital rotation across the broader biotech sector.
Unmasking the Trial: Stabilizers Block the PathTo truly understand why the market repriced these assets so aggressively, investors must look beneath the headline failure and evaluate the underlying subgroup data. The treatment landscape relies heavily on stabilizer medications like Vyndamax, manufactured by Pfizer NYSE: PFE. In the CARDIO-TTRansform trial, patients already taking these baseline stabilizers accounted for 57% of the study population at the start of the program, and that proportion rose to roughly 80% by the conclusion of the study.
Wainua failed to demonstrate an additive treatment effect in this specific stabilizer subgroup. The drug did not improve outcomes for patients who were already receiving standard-of-care treatments.
In the monotherapy subgroup, which includes patients not taking any stabilizers, Wainua demonstrated a hazard ratio of 0.71, translating to a 29% risk reduction. While that figure aligns closely with competitor benchmarks, it offers very little commercial utility. A pharmaceutical product cannot successfully capture meaningful market share if it only works for the rapidly shrinking fraction of patients who are completely naive to standard-of-care treatments.
This data exposes a fundamental disparity between antisense oligonucleotides like Wainua and RNA interference therapies developed by competitors. Alnylam Pharmaceuticals NASDAQ: ALNY previously validated its competing RNA interference therapy, Amvuttra, across both monotherapy and combination with a stabilizer subgroup in its HELIOS-B trial. By failing to show that essential additive benefit, Wainua is effectively locked out of the most lucrative and pre-treated segment of the total addressable market.
Asymmetric Damage: Single Asset SqueezeThe financial damage stemming from this clinical miss was distributed quite unevenly, highlighting the stark contrast between concentrated pipeline risk and structural business diversification.
Ionis Pharmaceuticals Today
IONS
Ionis Pharmaceuticals
$56.31 -1.94 (-3.33%)
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52-Week Range$40.03▼
$86.74Price Target$96.05
Ionis Pharmaceuticals absorbed the brunt of the impact. Shares fell by more than 9% in a single day, pushing the stock down more than 26% since the start of the year and compressing its total market capitalization to $9.63 billion.
Ionis Pharmaceuticals faces acute vulnerability due to its reliance on expanding the addressable market for Wainua. The current regulatory approval for ATTR-polyneuropathy covers fewer than 50,000 patients globally.
The cardiomyopathy indication would have unlocked a total addressable market of 300,000 to 500,000 patients.
Without that expansion, Ionis Pharmaceuticals faces a difficult fundamental reality. The developer currently generates negative earnings, with an earnings-per-share loss of 56 cents. First-quarter 2026 revenue surged to $246 million, an 87% increase year-over-year, but rapid commercial infrastructure expansion kept profit margins compressed, resulting in a net loss of $93 million.
While the company's trailing return on equity remained deeply negative at -58.65%, its balance sheet risk softened substantially after Ionis eliminated $633 million in convertible debt using restricted escrow cash on April 1, 2026.
Astrazeneca Today
$168.76 -2.85 (-1.66%)
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52-Week Range$137.23▼
$212.71Dividend Yield2.57%
P/E Ratio25.35
Price Target$211.00
AstraZeneca tells a completely different fundamental story. AstraZeneca's stock price fell briefly intraday before institutional buyers stepped in to support it. A $266.54 billion pharmaceutical sector giant does not live or die by a single indication expansion.
AstraZeneca generates $60.44 billion in annual sales, supported by blockbuster oncology franchises such as Tagrisso and Imfinzi. The company operates with a healthy 17.19% net margin, a robust 30.86% return on equity, and a conservative debt-to-equity ratio of 0.52.
Pre-trial models projected Wainua could reach peak sales of up to $6.5 billion with the ATTR-CM approval.
Analysts have since revised those estimates down to approximately $4 billion. Erasing a $2.5 billion premium certainly adjusts near-term valuation models, but it barely registers against AstraZeneca's stated $80 billion top-line revenue target for 2030. The institutional market accurately perceived the drop as a temporary mispricing rather than a structural downgrade.
The Vultures Circle: Rivals Catch the TailwindsMarkets dislike a vacuum. When Wainua was removed as an imminent competitive threat, capital immediately rotated into the rival drugmakers positioned to capture that unaddressed market share. The trial failure preserves the current duopoly and triopoly pricing power within the disease space.
BridgeBio NASDAQ: BBIO emerged as the most direct beneficiary, with shares up 16% to touch new 52-week highs following the initial announcement. BridgeBio is actively launching its newly approved therapy, Attruby.
Without Wainua entering the market to compress margins and force aggressive discounting, BridgeBio enjoys a heavily cleared commercial runway. BridgeBio recently secured a $1 billion Series A convertible preferred equity raise led by Sixth Street and KKR. This infusion provides a substantial capital buffer to execute an aggressive, unopposed commercial launch, funding sales force deployment without immediate dilution concerns.
Pfizer and Alnylam Pharmaceuticals also experienced immediate bid support. Pfizer maintains its multi-billion-dollar stronghold with Vyndamax, resting easy knowing that physicians will not have to weigh the transition of stable patients to a competing therapy. Alnylam Pharmaceuticals sustains its clinical momentum, as its RNA interference mechanism remains the only proven combination therapy that effectively stacks on top of existing stabilizers.
Discharging the Risk: Portfolio Lessons LearnedThe failure of the CARDIO-TTRansform trial fundamentally rewrites the competitive map for amyloidosis treatments. It draws a hard line between therapies that can improve the standard of care and those that merely match it in isolation.
For the entities involved, the data reinforces the protective power of a diversified revenue base. AstraZeneca easily absorbs the setback through its oncology and metabolic divisions, while Ionis Pharmaceuticals faces prolonged fundamental pressure as it navigates elevated debt levels and stalled growth drivers. Investors evaluating biotech allocations might consider prioritizing developers with validated combination therapies or deeply diversified pipelines to mitigate these specific clinical risks.
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BridgeBio Pharma (BBIO) remains a "Strong Buy," driven by regulatory approvals, robust pipeline progress, and significant commercial momentum for Attruby in ATTR-CM. Company has achieved U.S. and international approvals for acoramidis, with Q1 2026 U.S. net product revenue reaching $180.6 million, and is pursuing further pipeline expansion. Positive phase 3 PROPEL 3 data for oral infigratinib in achondroplasia supports an NDA submission in Q3 2026, targeting a $2.9B global market.
July 10, 2026 16:01 ET | Source: BridgeBio Pharma, Inc.
PALO ALTO, Calif., July 10, 2026 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a biopharmaceutical company focused on developing medicines for genetic conditions, today announced that on July 7, 2026, the compensation committee of BridgeBio’s board of directors approved equity grants to 37 new employees in restricted stock units for an aggregate of 83,283 shares of the Company’s common stock. One-fourth of the shares underlying each employee’s restricted stock units will vest on August 16, 2027, with one-twelfth of the remaining shares underlying each such employee’s restricted stock units vesting on a quarterly basis thereafter, in each case, subject to each such employee’s continued employment with the Company or one of its subsidiaries on such vesting dates.
The above-described awards were each granted as an inducement material to the employees entering into employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4) and were granted pursuant to the terms of the Plan. The Plan was adopted by BridgeBio’s board of directors in November 2019, and amended and restated on February 10, 2023 and on December 13, 2023.
About BridgeBio Pharma, Inc.
BridgeBio exists to develop transformative medicines for genetic conditions. Millions of people worldwide living with genetic conditions lack treatment options, often because drug development for small patient populations can be commercially challenging. We aim to bridge the gap between advancements in genetic science and meaningful medicines for underserved patient populations. Our decentralized, hub-and-spoke model is designed for speed, precision, and scalability. Autonomous and empowered teams focus on individual conditions, while a central hub provides the clinical, regulatory, and commercial capabilities needed to bring innovation to market. For more information, visit bridgebio.com and follow us on LinkedIn, X, Facebook, Instagram, YouTube, and TikTok.
BridgeBio Media Contact:
Bubba Murarka, Executive Vice President, Corporate Development [email protected]
(650)-789-8220
Key Takeaways BridgeBio Pharma surged after a rival's phase III ATTR-CM trial failed its primary endpoint.BBIO's Attruby is its only marketed drug and posted strong U.S. sales after its FDA approval.BridgeBio sees a large ATTR-CM opportunity as diagnoses rise and the market remains underdiagnosed. Shares of BridgeBio Pharma (BBIO - Free Report) climbed to a 52-week high of $93.42 on Thursday after rival AstraZeneca's (AZN - Free Report) late-stage clinical setback boosted investor confidence in the company's sole marketed drug, Attruby. Although the stock did not hold on to its intraday high, it still ended the session 15% higher, adding roughly $2.3 billion to its market value.
The rally followed AstraZeneca’s announcement that the phase III CARDIO-TTRansform study evaluating Wainua in patients with transthyretin amyloid cardiomyopathy (ATTR-CM) failed to meet its primary endpoint. Investors viewed the setback as a favorable development for BridgeBio's Attruby because it could strengthen the drug’s competitive position in the ATTR-CM space.
Attruby is currently BridgeBio's only marketed product and the primary driver of the company's revenues. Approved by the FDA in November 2024 for adults with ATTR-CM, the drug has enjoyed a strong commercial launch. BridgeBio generated $362.4 million in U.S. Attruby sales in 2025, its first full year on the market, followed by nearly $181 million in the first quarter of 2026 alone.
Attruby's long-term opportunity remains substantial because the target market continues to be significantly underdiagnosed. BridgeBio estimates that the number of diagnosed ATTR-CM patients in the United States grew from fewer than 5,000 in 2019 to more than 50,000 in 2025, while the global market opportunity for ATTR therapies could ultimately exceed $20 billion.
Another company that benefited from AstraZeneca’s clinical setback is Pfizer (PFE - Free Report) , whose shares also rose 1% yesterday. The U.S.-based pharma giant currently dominates the ATTR-CM market with its Vyndaqel family, comprising Vyndaqel, Vyndamax and Vynmac. The franchise generated approximately $1.6 billion in global sales in first-quarter 2026, up 8% year over year, underscoring its leadership in the space. In April, Pfizer entered into a settlement with generic drug manufacturers that extends the effective U.S. patent protection for Vyndamax until June 1, 2031, delaying generic competition and supporting the drug's long-term commercial outlook.
BBIO’s Price Performance, Valuation & EstimatesShares of BridgeBio have risen 18% year to date, outperforming the industry’s 3% growth.
Image Source: Zacks Investment Research
From a valuation standpoint, the company is currently trading at a premium to the industry. Based on the price-to-sales (P/S) ratio, the stock trades at 13.46 times forward 12-month sales, higher than the industry average of 1.95 times.
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Estimates for BridgeBio’s 2026 and 2027 bottom line have declined over the past 30 days.
Image Source: Zacks Investment Research
BBIO currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
BridgeBio Pharma (BBIO) witnessed a jump in share price last session on above-average trading volume. The latest trend in earnings estimate revisions for the stock doesn't suggest further strength down the road.
BridgeBio Pharma (BBIO - Free Report) is building its investment case around rare diseases where diagnosis, targeted treatment and commercial access are changing quickly.
Attruby's launch in transthyretin amyloid cardiomyopathy gives the company a commercial base, while late-stage programs could widen its reach in genetic diseases with limited approved options.
Attruby Shows BridgeBio Demand ExpansionAttruby is already BridgeBio's main revenue driver. The drug generated $362.4 million in U.S. sales in 2025, its first full year on the market, and nearly $181 million in first-quarter 2026 sales.
The demand backdrop matters as much as the product launch. BridgeBio estimates diagnosed ATTR-CM patients in the United States increased from fewer than 5,000 in 2019 to more than 50,000 in 2025 as awareness improved and non-invasive diagnostic tools gained wider use.
This makes Attruby part of a broader market-expansion story. A larger identified patient pool can support continued adoption if BridgeBio converts diagnosis growth into prescriptions and maintains access against entrenched alternatives.
BBIO Targets First-in-Class OpportunitiesBridgeBio's late-stage pipeline is aimed at rare diseases where established therapies remain limited. BBP-418 is under FDA review for limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9), with a decision expected by Nov. 27, 2026.
If approved, BBP-418 would become the first therapy for that patient group and potentially the first approved treatment for any form of limb-girdle muscular dystrophy. Encaleret offers a similar first-in-class angle in autosomal dominant hypocalcemia type 1 (ADH1), with a possible U.S. launch in early 2027.
The strategy fits BridgeBio's broader focus on genetically defined diseases. It also gives investors multiple regulatory catalysts beyond Attruby, although approval timing and label breadth remain key variables.
How Oral Drugs Shape BridgeBio's PositioningProduct format is part of BBIO's competitive pitch. Infigratinib is an orally administered therapy being developed for achondroplasia, with a U.S. filing planned for the third quarter of 2026.
That oral profile could matter in a market that already includes injectable options. BioMarin Pharmaceutical (BMRN - Free Report) markets Voxzogo in achondroplasia, while Ascendis Pharma (ASND - Free Report) adds another competitive reference point through Yuviwel.
Attruby also operates in a competitive field. Pfizer (PFE - Free Report) remains the established player in ATTR-CM through its Vyndaqel family, which means BridgeBio must compete on clinical relevance, access and physician adoption rather than diagnosis growth alone.
BridgeBio Builds Beyond a One-Product StoryBridgeBio is still highly dependent on Attruby, but its portfolio points beyond a single commercial win. The company is preparing for three potential U.S. launches over the next 12 months, supported by a $1 billion preferred equity financing.
Earlier-stage assets add a longer runway. BBP-812 is being developed for Canavan disease, while a next-generation ATTR-CM depleter program could extend BridgeBio's presence in the same cardiac amyloidosis market over time.
Minority interests in GondolaBio and BridgeBio Oncology Therapeutics add rare disease and oncology optionality. These assets are not central to the near-term thesis, but they reinforce the company's effort to build a broader genetic-disease platform.
How BBIO Signals Trend Strength to InvestorsThe bottom line is that BridgeBio gives investors credible exposure to rare disease diagnosis growth, targeted therapy development and underpenetrated patient populations. Attruby validates the commercial side, while BBP-418, encaleret and infigratinib could determine whether BBIO becomes a broader launch story.
BBIO currently carries a Zacks Rank #3 (Hold). That rank is consistent with a balanced view in which launch execution and market expansion are offset by competition, regulatory risk and valuation pressure. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
For now, the investment debate rests less on the attractiveness of rare disease trends and more on execution. Attruby must keep gaining share, and the pipeline needs approvals that can diversify revenues without adding avoidable launch risk.
BridgeBio Pharma BBIO has become a harder stock to judge after its sharp rare-disease run. Attruby is ramping quickly, yet the valuation already assumes a good deal of future success.
Key Takeaways BridgeBio's Attruby became its main revenue driver after strong early sales following FDA approval.BBIO targets three potential U.S. launches over 12 months, led by BBP-418 under priority review.BBIO boosted liquidity with $1B financing, but debt, competition and pipeline risks remain. BridgeBio Pharma (BBIO - Free Report) is moving from a launch-driven story toward a broader commercial execution test. Attruby has quickly become the company’s financial backbone, while late-stage pipeline assets could add new revenue streams.
The stock’s outlook now depends on whether BridgeBio can scale Attruby, convert upcoming regulatory catalysts into launches and manage risks tied to a leveraged rare disease growth model.
Why Attruby Drives BBIO GrowthAttruby is BridgeBio’s key marketed product and main revenue driver. The drug was approved by the FDA in November 2024 for adults with transthyretin amyloid cardiomyopathy (ATTR-CM), a progressive heart disease caused by transthyretin amyloid buildup.
U.S. Attruby sales were $362.4 million in 2025, its first full year on the market, and nearly $181 million in the first quarter of 2026. That performance made the therapy BBIO’s financial backbone.
Growth is tied to rising diagnosis rates, physician adoption and patient uptake. BridgeBio estimates that diagnosed U.S. ATTR-CM patients rose from fewer than 5,000 in 2019 to more than 50,000 in 2025, helped by greater awareness and wider use of non-invasive diagnostic tools.
How BridgeBio Can Broaden RevenueBridgeBio’s next challenge is reducing its dependence on Attruby. The company is preparing for three potential U.S. product launches over the next 12 months, led by BBP-418, encaleret and infigratinib.
BBP-418 is the closest catalyst. The FDA accepted the filing for priority review in limb-girdle muscular dystrophy type 2I/R9, with a decision expected by Nov. 27, 2026. Approval would make it the first therapy for this patient population.
Encaleret adds another possible first-in-class launch. BridgeBio submitted the filing in May 2026 for autosomal dominant hypocalcemia type 1 (ADH1) and anticipates a U.S. launch in early 2027 if approved.
Infigratinib could follow in achondroplasia. BridgeBio intends to file in the third quarter of 2026 and is targeting a potential launch in early to mid-2027. Together, these programs could shift BBIO toward a broader rare disease platform.
BBIO Balance Sheet Supports Launch PlansBridgeBio recently raised $1 billion through preferred equity financing to support current and potential product launches. The capital gives the company more flexibility as it funds Attruby commercialization.
Liquidity looks adequate for near-term needs. BridgeBio ended the first quarter of 2026 with $940.2 million in cash, cash equivalents and marketable securities, up from $587.5 million at the end of 2025.
Debt remains part of the investment case. Long-term debt was approximately $1.93 billion as of March 31, 2026, while short-term debt was around $547 million. The cash balance covers near-term obligations, but BBIO remains a leveraged growth story.
Where BBIO Investors Should Stay CautiousThe biggest risk is concentration. Attruby is BridgeBio’s only approved product in its commercial portfolio, leaving near-term financial performance highly dependent on one therapy.
Competition is another constraint. Pfizer (PFE - Free Report) markets the established Vyndaqel family in ATTR-CM, and BridgeBio must keep proving Attruby’s clinical and access position to gain further share.
Pipeline risk is also material. An FDA delay, rejection, request for more data or narrower-than-expected label for BBP-418, encaleret or infigratinib could push out the diversification timeline.
In achondroplasia, BioMarin Pharmaceutical (BMRN - Free Report) markets Voxzogo, an injectable treatment option. That backdrop means infigratinib’s oral profile may help, but uptake would still depend on data, reimbursement and physician adoption.
How BBIO Fits a Neutral Rating SetupBBIO fits a balanced setup because the positives and risks are both clear. Attruby has delivered meaningful early revenue, the late-stage pipeline offers multiple catalysts and the balance sheet has been strengthened.
At the same time, one-product reliance, regulatory uncertainty and competition keep the risk-reward profile from being one-sided. The stock trades at 12.3X forward 12-month EV/Sales, above the Zacks sub-industry multiple of 2.7X.
A Neutral stance is consistent with a Zacks Rank #3 (Hold) style setup, where investors may prefer to watch execution rather than assume a straight-line growth path. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
July 02, 2026 07:30 ET | Source: BridgeBio Pharma, Inc.
- Acoramidis initiation was associated with rapid kidney-protective activity as exhibited in a hemodynamically mediated, reversible eGFR dip and a placebo-corrected 15.5% reduction in UACR by Day 28 (P<0.05), with no kidney-related adverse events observed in these post-hoc analyses
-Treatment with acoramidis provided a sustained, improved chronic eGFR slope (+2.47 mL/min/1.73m²/year; p<0.001) sustained UACR reduction (13.7%; p=0.026) through Month 30
- Acoramidis demonstrated a profile consistent with drugs that act directly on the kidney, such as ACE inhibitors, ARBs, and SGLT2 inhibitors, which has not previously been observed with any other approved ATTR-CM therapy and supports a direct kidney mechanism that is potentially independent of TTR-stabilization
-The magnitude of the acute eGFR dip in participants treated with acoramidis was positively associated with a reduction in early cardiovascular outcomes; the opposite was observed with placebo
- The acute, reversible eGFR dip following acoramidis initiation reflects a favorable hemodynamic renal response that may help explain the early separation in cardiovascular outcomes versus placebo. Kidney function is especially important in heart failure, where a progressive decline in kidney function compounds mortality risk
PALO ALTO, Calif., July 02, 2026 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage, multi-product biopharmaceutical company focused on developing medicines for genetic conditions, today announced the publication of new analyses in Circulation: Heart Failure, examining kidney function in individuals with transthyretin amyloid cardiomyopathy (ATTR-CM) treated with acoramidis. This publication was based on post-hoc analyses of data from randomized, double blind, placebo-controlled trials including the Phase 2 study and the Phase 3 ATTRibute-CM study. Acoramidis is the only selective small molecule, orally administered, near-complete (≥90%) transthyretin (TTR) stabilizer.
“In these data, we observed early and sustained cardiorenal benefits of acoramidis treatment with a pattern similar to what we see with drugs such as ACE inhibitors, ARBs, and SGLT2 inhibitors, suggesting acoramidis may have a direct effect on kidney function. These effects have not been reported with other ATTR-CM medications. Acoramidis appears to have a protective effect on the heart and the kidney simultaneously, with potentially meaningful implications for long-term survival and reduced cardiovascular hospitalizations. Kidney dysfunction is pervasive in this population and an independent predictor of mortality from ATTR-CM. For a patient population that is older, sicker, and increasingly surviving long enough for organ preservation to matter, these cardiorenal observations represent an important advancement in the care of patients living with ATTR-CM,” said Professor Jeffrey Testani, M.D., M.T.R. of the Yale School of Medicine, U.S., and first author on the Circulation: Heart Failure manuscript.
The post-hoc analyses shared in the publication demonstrated that acoramidis initiation was associated with direct kidney-protective effects in patients with ATTR-CM, with both early and sustained improvements in kidney function, resembling the pattern seen with drugs acting directly on the kidney. Findings included:
Acoramidis was associated with an early, reversible estimated glomerular filtration rate (eGFR) dip of 8.5±0.48 mL/min/1.73 m2 (95% CI: 7.57, 9.44), which was accompanied by a reduction in placebo-corrected urinary albumin to creatinine ratio (UACR) by 15.5% by Day 28 (P<0.05); such a reduction in UACR may suggest a direct impact on kidney healthA sustained, improved chronic eGFR slope (+2.47 mL/min/1.73m²/year; p<0.001) and sustained UACR reduction (13.7%; p=0.026) were observed through Month 30, resembling the pattern seen with drugs acting directly on the kidney, such as ACE inhibitors, ARBs, and SGLT2 inhibitorsThe acute dip in eGFR following initiation of acoramidis may represent a beneficial kidney effect that could be relevant to the previously reported, observed early separation within the first 3 months between acoramidis and placebo in adverse clinical outcomes and the cumulative cardiovascular-related mortality or recurrent cardiovascular-related hospitalizations (CVH) curves, with a numerical difference in events within 1 monthParticipants with dips larger than the overall population median experienced a 58% lower risk of death or cardiovascular hospitalization (HR: 0.42; 95% CI, 0.22–0.78; P=0.006) and 66% lower risk of hospitalization alone (HR: 0.34; 95% CI, 0.17–0.66; P=0.002) in the first year of treatment. Within the placebo arm, eGFR dips were associated with worse outcomes Acoramidis is approved as Attruby® by the U.S. FDA and is approved as BEYONTTRA® by the European Medicines Agency (EMA), Japanese Pharmaceuticals and Medical Devices Agency, Swissmedic, the Swiss Agency for Therapeutic Products, the UK Medicines and Healthcare Products Regulatory Agency, and the Brazilian Health Regulatory Agency (ANVISA) with all labels specifying near-complete stabilization of TTR.
About Attruby® (acoramidis)
INDICATION
Attruby is a transthyretin stabilizer indicated for the treatment of the cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular death and cardiovascular-related hospitalization.
IMPORTANT SAFETY INFORMATION
Adverse Reactions
Diarrhea (11.6% vs 7.6%) and upper abdominal pain (5.5% vs 1.4%) were reported in patients treated with Attruby versus placebo, respectively. The majority of these adverse reactions were mild and resolved without drug discontinuation. Discontinuation rates due to adverse events were similar between patients treated with Attruby versus placebo (9.3% and 8.5%, respectively).
About BridgeBio
BridgeBio exists to develop transformative medicines for genetic conditions. Millions of people worldwide living with genetic conditions lack treatment options, often because drug development for small patient populations can be commercially challenging. We aim to bridge the gap between advancements in genetic science and meaningful medicines for underserved patient populations. Our decentralized, hub-and-spoke model is designed for speed, precision, and scalability. Autonomous and empowered teams focus on individual conditions, while a central hub provides the clinical, regulatory, and commercial capabilities needed to bring innovation to market. For more information, visit bridgebio.com and follow us on LinkedIn, X, Facebook, Instagram, YouTube, and TikTok.
BridgeBio Forward-Looking Statements
This press release contains forward-looking statements. Statements in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the Securities Act), and Section 21E of the Securities Exchange Act of 1934, as amended (the Exchange Act), which are usually identified by the use of words such as “anticipates,” “believes,” “continues,” “estimates,” “expects,” “hopes,” “intends,” “may,” “plans,” “projects,” “remains,” “seeks,” “should,” “will,” and variations of such words or similar expressions. BridgeBio intends these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act. These forward-looking statements include statements regarding the potential clinical significance of acoramidis’ observed effects on kidney function, including eGFR and UACR; the potential for acoramidis to have direct kidney-protective effects or a direct effect on kidney function that may be independent of TTR stabilization; the potential relationship between the acute, reversible eGFR dip following initiation of acoramidis and beneficial kidney effects or early separation in cardiovascular outcomes; and the potential implications of these observations for long-term survival and reduced cardiovascular hospitalizations. Although the Company believes that its plans, intentions, expectations and strategies as reflected in or suggested by those forward-looking statements are reasonable, the Company can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to, initial and ongoing data from the Company’s clinical trials not being indicative of final data, the design and success of ongoing and planned clinical trials, future regulatory filings, approvals and/or sales, the FDA or such other regulatory agencies not agreeing with the Company’s regulatory approval strategies, components of the Company’s filings, such as clinical trial designs, conduct and methodologies, or the sufficiency of data submitted, the risk that post hoc analyses may not be predictive of future clinical outcomes or treatment effect, that mechanistic interpretations of observed data may not be borne out by further analyses or additional data, and that observed effects on kidney function may not translate into improved long-term clinical outcomes, the impacts of current macroeconomic and geopolitical events, including changing conditions from hostilities in Ukraine and in Israel and the Middle East, increasing rates of inflation and changing interest rates, on business operations and expectations, as well as those risks set forth in the Risk Factors section of the Company’s most recent Quarterly Report on Form 10-Q and Annual Report on Form 10-K and the Company’s other filings with the U.S. Securities and Exchange Commission. Moreover, the Company operates in a very competitive and rapidly changing environment in which new risks emerge from time to time. These forward-looking statements are based upon the current expectations and beliefs of the Company’s management as of the date of this press release, and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as required by applicable law, BridgeBio assumes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.
BridgeBio Media Contact:
Bubba Murarka, Executive Vice President [email protected]
(650)-789-8220
- Preferred equity investment led by Sixth Street and with participation from HealthCare Royalty, a business of KKR, with an initial conversion price of approximately $138 per share (more than 100% premium to Company’s 30-day VWAP)
- The financing significantly strengthens the Company’s balance sheet, enabling it to efficiently allocate capital across its highest return opportunities
- The financing comes at a pivotal moment for the Company, as Attruby® continues to grow into a multi-billion-dollar blockbuster drug, and as BridgeBio prepares for three additional potential blockbuster U.S. product launches over the next 12 months across BBP-418 for LGMD2I/R9, encaleret for ADH1, and infigratinib for achondroplasia
PALO ALTO, Calif., July 01, 2026 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage, multi-product biopharmaceutical company focused on developing medicines for genetic conditions, today announced that it has entered into an agreement with funds managed by Sixth Street (“Sixth Street”) and funds managed by HealthCare Royalty, a business of KKR (“HCRx” and, together with Sixth Street, the “Purchasers”) under which the Purchasers have invested up to $1 billion in newly issued convertible preferred equity of the Company.
The Series A Cumulative Convertible Participating Preferred Stock has the following principal terms:
7.00% initial dividend, payable in kind or in cash at the Company’s electionInitial conversion price of $137.79 per share (more than 100% premium to BridgeBio’s 30-day volume-weighted average price), increasing to $153.10 per share (more than 125% premium) from the fifth anniversaryPermanent equity with no scheduled maturity and no redemption at the holder’s optionBridgeBio may redeem the preferred stock for cash or, in certain circumstances, convert it into common stock, in each case on the terms set forth in the definitive agreements Sixth Street funded $800M as the lead investor, and HealthCare Royalty funded $133.9M at today’s close of the preferred equity investment.
“We are privileged to be partnering with Sixth Street and HealthCare Royalty at this pivotal time in BridgeBio’s trajectory. This financing represents the best of our dual mission – 1) to put patients first and ensure that we have the resources to do so, and 2) that we execute those responsibilities in a manner that maximizes the economic value of our Firm. Access to this type and quantum of capital ensures we can deliver on the promise of our launching medicines and beyond,” said Neil Kumar, Ph.D., Co-Founder and CEO of BridgeBio.
“Sixth Street is proud to support BridgeBio’s mission of bringing meaningful medicines to patients during this exciting stage as the company is on the cusp of potential approval and launch of three important new therapies,” said Jeff Pootoolal, Partner at Sixth Street. “Providing flexible capital at scale to leading developers of transformative medicines is central to what we do, and we look forward to a long and productive partnership with the BridgeBio team."
“The BridgeBio management team has a proven track record in launching and developing life-changing therapies, and we are pleased to partner with them on this transaction,” said Clarke Futch, Chairman and CEO of HealthCare Royalty. “This capital support reaffirms our belief in the company’s growth and ability to bring to market multiple products that serve high unmet medical needs.”
Latham & Watkins LLP served as legal advisor to BridgeBio. Evercore served as financial advisor and Sullivan & Cromwell LLP and Mintz LLP served as legal advisors to Sixth Street. Gibson, Dunn & Crutcher LLP served as legal advisor to HealthCare Royalty.
Additional details about the transaction and the related definitive agreements will be included in a Current Report on Form 8-K to be filed by the Company.
About BridgeBio Pharma, Inc.
BridgeBio Pharma, Inc. (BridgeBio; Nasdaq: BBIO) exists to develop transformative medicines for genetic conditions. Millions of people worldwide living with genetic conditions lack treatment options, often because drug development for small patient populations can be commercially challenging. We aim to bridge the gap between advancements in genetic science and meaningful medicines for underserved patient populations. Our decentralized, hub-and-spoke model is designed for speed, precision, and scalability. Autonomous and empowered teams focus on individual conditions, while a central hub provides the clinical, regulatory, and commercial capabilities needed to bring innovation to market. For more information visit bridgebio.com and follow us on LinkedIn, X, Facebook, Instagram, and YouTube.
About Sixth Street
Sixth Street is a global investment firm with over $130 billion in assets under management and committed capital. Sixth Street uses its long-term flexible capital, data-enabled capabilities, and One Team culture to develop themes and offer solutions to companies across all stages of growth. Sixth Street Healthcare and Life Sciences invests thematically throughout the healthcare ecosystem, providing flexible capital solutions to companies addressing our most pressing healthcare challenges and improving patient outcomes. Investments in the sector include Apellis Pharmaceuticals, Arrowhead Pharmaceuticals, Arsenal Biosciences, Beam Therapeutics, Biohaven, Blueprint Medicines, Caris Life Sciences, Chroma Medicine, ConcertAI, Datavant, Essential Pharma, Immunogen, Ironwood, Mammoth Biosciences, Paratek Pharmaceuticals, and Velocity Clinical Research, among many others. Founded in 2009, Sixth Street has more than 750 team members including approximately 300 investment professionals around the world. For more information, visit https://www.sixthstreet.com/, or follow Sixth Street on LinkedIn.
About HealthCare Royalty
HealthCare Royalty (“HCRx”) is a leading royalty acquisition company founded in 2006 that is majority owned by KKR & Co. Inc. (NYSE: KKR). Over two decades, the HCRx team has developed a strong track record of investing in commercial-stage and near-commercial-stage biopharmaceutical assets, committing $7+ billion in over 110 biopharmaceutical products. With offices in New York, Stamford, San Francisco, Boston, London and Miami, HCRx continues to advance biopharmaceutical innovation by providing innovative capital solutions to counterparties. For more information, visit https://www.hcrx.com. HEALTHCARE ROYALTY®, HEALTHCARE ROYALTY PARTNERS® and HCRx® are registered trademarks of HealthCare Royalty Management, LLC
BridgeBio Pharma, Inc. Forward-Looking Statements
This press release contains forward-looking statements. Statements in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the Securities Act), and Section 21E of the Securities Exchange Act of 1934, as amended (the Exchange Act), which are usually identified by the use of words such as “anticipates,” “believes,” “continues,” “estimates,” “expects,” “hopes,” “intends,” “may,” “plans,” “projects,” “remains,” “seeks,” “should,” “will,” and variations of such words or similar expressions. BridgeBio intends these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act. These forward-looking statements include express and implied statements relating to the Company’s expectations regarding its anticipated growth and expected product launches and intentions for investing in indication expansions. Such statements reflect the Company’s current views about the Company’s plans, intentions, expectations and strategies, which are based on the information currently available to it and on assumptions the Company has made. Although the Company believes that its plans, intentions, expectations and strategies as reflected in or suggested by those forward-looking statements are reasonable, the Company can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to, initial and ongoing data from the Company’s clinical trials not being indicative of final data, the design and success of ongoing and planned clinical trials, future regulatory filings, approvals and/or sales, despite having ongoing and future interactions with the FDA or other regulatory agencies to discuss potential paths to registration for the Company’s product candidates, the FDA or such other regulatory agencies not agreeing with the Company’s regulatory approval strategies, components of the Company’s filings, such as clinical trial designs, conduct and methodologies, or the sufficiency of data submitted, the impacts of current macroeconomic and geopolitical events, including changing conditions from hostilities in Ukraine and in Israel and the Gaza Strip, increasing rates of inflation and changing interest rates, on business operations and expectations, as well as those risks set forth in the Risk Factors section of the Company’s most recent Annual Report on Form 10-K and the Company’s other filings with the U.S. Securities and Exchange Commission. Moreover, the Company operates in a very competitive and rapidly changing environment in which new risks emerge from time to time. These forward-looking statements are based upon the current expectations and beliefs of the Company’s management as of the date of this press release, and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as required by applicable law, BridgeBio assumes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.
- Phase 3 PROPEL 3 data published today in NEJM were simultaneously presented at ICCBH in a late-breaking oral presentation; presentation includes new arm span Z-score data showing a statistically significant improvement versus placebo (LS mean +0.37 SD; p<0.0001), the first and only statistically significant placebo-controlled arm span result reported for an achondroplasia trial at 52 weeks
- This is the first and only Phase 3 data for an achondroplasia clinical study published in The New England Journal of Medicine (NEJM), marking BridgeBio’s second NEJM publication in achondroplasia and fourth NEJM publication overall in the last three years
- The data includes the largest mean increase in AHV compared to placebo reported in any Phase 3 achondroplasia study (+2.1 cm/year observed mean improvement)
- Oral infigratinib is the only therapy to demonstrate statistically significant improvement in body proportionality in a Phase 3 achondroplasia study, with a LS mean treatment difference of –0.05 in children ages 3 to 8 years (p<0.05)
- Oral infigratinib was well tolerated, with no discontinuations or serious adverse events related to study drug
- BridgeBio intends to submit an NDA to the FDA in the third quarter of 2026 with launch anticipated in early to mid 2027, and an MAA to the EMA in the second half of 2026
PALO ALTO, Calif., June 28, 2026 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage, multi-product biopharmaceutical company focused on developing medicines for genetic conditions, today announced that positive results from PROPEL 3, the global Phase 3 pivotal study of oral infigratinib in children living with achondroplasia, were published as an original research article in the New England Journal of Medicine (NEJM). These data were also presented at the International Congress of Children’s Bone Health (ICCBH) 2026 in a late-breaking oral presentation by Ravi Savarirayan, M.D., Ph.D. of Murdoch Children’s Research Institute, Melbourne, AUS, and global lead investigator for PROPEL 3.
"The publication of our pivotal trial data (PROPEL 3) in the New England Journal of Medicine is a defining milestone for the field of skeletal dysplasia that reflects the years of rigorous clinical investigation from investigators and dedication from children and their families to make this breakthrough science possible. These remarkable data establish oral infigratinib as the first therapy to directly target FGFR3, deliver the highest treated annualized growth velocity and greatest improvement in body proportionality reported for any current therapy for children with achondroplasia. Presenting these late-breaking data at ICCBH reflects the significance of having an orally administered, mechanistically distinct treatment option that addresses achondroplasia and hypochondroplasia at their very source,” said Dr. Savarirayan. “I believe that we are on a clear path toward a best-in-class therapy for children with achondroplasia that families seeking better options are excited to have available to them.”
The positive results shared in NEJM from PROPEL 3 include:
PROPEL 3 successfully met the primary endpoint of change from baseline in annualized height velocity, with a LS mean treatment difference against placebo of +1.74 cm/yr (p<0.0001). The observed mean difference was +2.10 cm/yr (p<0.0001). Both values are the largest observed in a Phase 3 clinical study in achondroplasiaPROPEL 3 successfully met the key secondary endpoint of change from baseline in height Z-score (achondroplasia reference population) at Week 52 (p<0.0001), with an LS mean increase on the treatment arm of +0.41 SDIn a pre-specified exploratory analysis of the key secondary endpoint, oral infigratinib achieved the first statistically significant improvement in body proportionality against placebo in achondroplasia, demonstrating an LS mean treatment difference of -0.05 (p<0.05) against placebo in children younger than 8 years old (>50% of the participants)Infigratinib was well-tolerated, with: No discontinuations related to study drugNo serious adverse events related to study drug3 cases (4%) of hyperphosphatemia, all mild, transient, asymptomatic, and not requiring dose reductions or discontinuationsNo adverse events associated with inhibition of FGFR1 or FGFR2 (e.g., retinal or corneal)
Additional data presented at ICCBH showed infigratinib improved arm span vs. placebo by +0.37 SD (p<0.0001), marking the first statistically significant improvement in arm span from a placebo-controlled achondroplasia trial In addition to the late-breaking oral presentation at ICCBH 2026, one oral presentation, one poster, and three encore posters were shared. The new details shared included:
Health-Related Quality of Life in Children with Achondroplasia: Findings from the Observational PROPEL Study, presented by Marie-Eve Robinson, M.D., of Shriners Hospital for Children Canada, McGill University, Montreal, CA Results from the global observational PROPEL study demonstrated that children with achondroplasia experience reduced health-related quality of life across multiple patient-reported measures, particularly in physical functioning, reinforcing the significant day-to-day burden of the condition and providing important baseline context for future studies of oral infigratinib Qualitative Research to Evaluate the Content Validity and Relevance of Patient-Reported Outcome Measures for Children and Parents of Children with Hypochondroplasia, presented by Chandler Crews of The Chandler Project, U.S. Findings from interviews with children and parents affected by hypochondroplasia demonstrated that commonly used patient-reported outcome measures were clear, relevant, and reflective of the real-world physical, cognitive, and quality-of-life challenges experienced by children living with the condition, supporting their use in future clinical research and care BridgeBio believes oral infigratinib is positioned to become the first approved oral therapy and a potential best-in-class option for children living with achondroplasia and hypochondroplasia. The Company intends to submit an NDA for achondroplasia to the FDA in the third quarter of 2026, and an MAA for achondroplasia to the EMA in the second half of 2026. The Company anticipates a U.S. launch in early to mid 2027.
Oral infigratinib has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) based on the shared results from the PROPEL 2 clinical trial, which meet the FDA’s requirement of potentially demonstrating substantial improvement in efficacy over available therapies on clinically significant endpoints. In addition to receipt of Breakthrough Therapy Designation, oral infigratinib has also received Orphan Drug Designation, Fast Track Designation, and Rare Pediatric Disease Designation for achondroplasia from the FDA. If infigratinib is approved, BridgeBio may qualify for a Priority Review Voucher.
Information about PROPEL Infant & Toddler trial (NCT07169279) can be found here on clinicaltrials.gov. Information about ACCEL, the Company’s observational lead-in study for oral infigratinib in hypochondroplasia’s Phase 3 study, (NCT06410976) can be found here, and information about ACCEL 2/3, BridgeBio’s Phase 2/3 clinical study of oral infigratinib in hypochondroplasia, (NCT06873035) can be found here. BridgeBio is committed to exploring the potential of oral infigratinib on wider medical and functional impacts of achondroplasia, hypochondroplasia and other skeletal dysplasia conditions, which hold significant unmet needs for families.
About Achondroplasia
Achondroplasia is the most common cause of disproportionate short stature, affecting approximately 55,000 people in the U.S. and European Union (EU), including up to 10,000 children and adolescents with open growth plates. Achondroplasia impacts overall health and quality of life, leading to medical complications such as obstructive sleep apnea, middle ear dysfunction, kyphosis, and spinal stenosis. The condition is uniformly caused by an activating variant in FGFR3.
About Oral Infigratinib
Oral infigratinib is an investigational small molecule designed to inhibit FGFR3 signaling and target skeletal dysplasias, including achondroplasia and hypochondroplasia, at their source. Overactivating FGFR3 pathogenic variants drive downstream MAPK and STAT1 signaling that aberrates growth plate development, thereby causing disproportionate short stature and the potential for serious health complications. Oral infigratinib improves bone growth by decreasing the overactivity of FGFR3.
About BridgeBio Pharma, Inc.
BridgeBio exists to develop transformative medicines for genetic conditions. Millions of people worldwide living with genetic conditions lack treatment options, often because drug development for small patient populations can be commercially challenging. We aim to bridge the gap between advancements in genetic science and meaningful medicines for underserved patient populations. Our decentralized, hub-and-spoke model is designed for speed, precision, and scalability. Autonomous and empowered teams focus on individual conditions, while a central hub provides the clinical, regulatory, and commercial capabilities needed to bring innovation to market. For more information, visit bridgebio.com and follow us on LinkedIn, X, Facebook, Instagram, YouTube, and TikTok.
BridgeBio Pharma, Inc. Forward-Looking Statements
This press release contains forward-looking statements. Statements in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the Securities Act), and Section 21E of the Securities Exchange Act of 1934, as amended (the Exchange Act), which are usually identified by the use of words such as “anticipates,” “believes,” “continues”, “estimates,” “expects,” “hopes,” “intends,” “may,” “plans,” “projects,” “remains”, “seeks,” “should,” “will,” and variations of such words or similar expressions, or the negative of these terms or other comparable terminology are intended to identify forward-looking statements, though not all forward-looking statements necessarily contain these identifying words. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act. These forward-looking statements, including express and implied statements relating to our expectations regarding the potential approval of oral infigratinib for achondroplasia; the timing of a potential NDA submission to the FDA and MAA submission to the EMA for achondroplasia and a potential launch of oral infigratinib; the potential of oral infigratinib to become the first approved oral therapy and a potential best-in-class option for children living with achondroplasia and hypochondroplasia; the potential of oral infigratinib to address achondroplasia, hypochondroplasia and other skeletal dysplasia conditions at their source and with respect to wider medical and functional impacts; the potential use of findings from our observational and qualitative research in future clinical research and care; and our potential qualification for a Priority Review Voucher if oral infigratinib is approved, reflect our current views about our plans, intentions, expectations and strategies, which are based on the information currently available to us and on assumptions we have made. Although we believe that our plans, intentions, expectations and strategies as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to, initial and ongoing data from our preclinical studies and clinical trials not being indicative of final data, the potential size of the target patient populations our product candidates are designed to treat not being as large as anticipated, the design and success of ongoing and planned clinical trials, difficulties with enrollment in our clinical trials, adverse events that may be encountered in our clinical trials, future regulatory filings, approvals and/or sales, despite having ongoing and future interactions with the FDA or other regulatory agencies to discuss potential paths to registration for our product candidates, the FDA or such other regulatory agencies not agreeing with our regulatory approval strategies, components of our filings, such as clinical trial designs, conduct and methodologies, or the sufficiency of data submitted, the continuing success of our collaborations, our ability to obtain additional funding, potential volatility in our share price, the impacts of current macroeconomic and geopolitical events, including changing conditions from the hostilities in Ukraine and the Middle East, increasing rates of inflation and changing interest rates, on our overall business operations and expectations, as well as those risks set forth in the Risk Factors section of our most recent Annual Report on Form 10-K, subsequent Quarterly Reports on Form 10-Q and our other filings with the U.S. Securities and Exchange Commission. Except as required by applicable law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.
BridgeBio Media Contact:
Bubba Murarka, Executive Vice President [email protected]
(650)-789-8220
June 22, 2026 07:30 ET | Source: BridgeBio Pharma, Inc.
PALO ALTO, Calif., June 22, 2026 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage, multi-product biopharmaceutical company focused on developing medicines for genetic conditions, announced today that additional positive data from PROPEL 3, the global Phase 3 pivotal study of oral infigratinib in children living with achondroplasia, will be shared in a late breaking oral presentation at the International Congress of Children’s Bone Health (ICCBH) 2026 taking place in Montreal, Canada on June 27-30, 2026.
BridgeBio will also share an oral presentation and four posters at the meeting highlighting quality of life, early intervention research, observational study findings, and educational resources through MyAchonJourney for individuals with achondroplasia and related skeletal dysplasias. Additionally, the Company will share an autosomal dominant hypocalcemia type 1 (ADH1) poster on findings from CLARIFY, its disease monitoring study of autosomal dominant hypocalcemia (ADH) type 1 and type 2.
Late-Breaking Oral Presentation:
A Randomized Controlled Trial of Oral Infigratinib in Children with Achondroplasia
Presenter: Ravi Savarirayan, M.D., Ph.D. of Murdoch Children’s Research Institute, Melbourne, AU, and Global Lead Investigator for PROPEL 3
Date & Time: Sunday, June 28 at 3:45 pm EDT
Oral Presentation:
Health-Related Quality of Life in Children with Achondroplasia: Findings from the Observational PROPEL Study
Presenter: Marie-Eve Robinson, M.D., M. Sc., Shriners Hospital for Children Canada, McGill University, CA
Date & Time: Monday, June 29 at 11:00 am EDT
Skeletal Dysplasia Posters:
A Phase 2/2b Study of Infigratinib in Children Under 3 Years Old with Achondroplasia: Design of PROPEL Infant and Toddler
Presenter: Julie Hoover-Fong, M.D., Ph.D., Johns Hopkins University, U.S.
Date & Time: Sunday, June 28 at 12:00 pm EDT
The ACCEL Observational Study: Diagnostic Features, Medical History, and Baseline Characteristics of Children with Hypochondroplasia
Presenter: Marie-Eve Robinson, M.D., M. Sc., Shriners Hospital for Children Canada, McGill University, CA
Date & Time: Monday, June 29 at 12:00 pm EDT
MyAchonJourney: An Online Educational Resource for Individuals with Achondroplasia and Their Families, Developed by Advocacy Leaders and Healthcare Providers
Presenter: Kirsten Kiefer, BridgeBio Skeletal Dysplasias, U.S.
Date & Time: Monday, June 29 at 12:00 pm EDT
Qualitative Research to Evaluate the Content Validity and Relevance of Patient-Reported Outcome Measures for Children and Parents of Children with Hypochondroplasia
Presenter: Chandler Crews, The Chandler Project, U.S.
Date & Time: Monday, June 29 at 12:00 pm EDT
ADH1 Poster:
Autosomal Dominant Hypocalcemia Type 1 and Type 2: Baseline Burden of Disease and Quality of Life in Pediatric Participants in the CLARIFY Disease Monitoring Study
Presenter: Raja Padidela, M.D., Royal Manchester Children's Hospital, University of Manchester, UK
Date & Time: Monday, June 29 at 12:00 pm EDT
About BridgeBio
BridgeBio exists to develop transformative medicines for genetic conditions. Millions of people worldwide living with genetic conditions lack treatment options, often because drug development for small patient populations can be commercially challenging. We aim to bridge the gap between advancements in genetic science and meaningful medicines for underserved patient populations. Our decentralized, hub-and-spoke model is designed for speed, precision, and scalability. Autonomous and empowered teams focus on individual conditions, while a central hub provides the clinical, regulatory, and commercial capabilities needed to bring innovation to market. For more information, visit bridgebio.com and follow us on LinkedIn, X, Facebook, Instagram, YouTube, and TikTok.
BridgeBio Media Contact:
Bubba Murarka, Executive Vice President [email protected]
(650)-789-8220
June 23, 2026 16:31 ET | Source: BridgeBio Pharma, Inc.
PALO ALTO, Calif., June 23, 2026 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a biopharmaceutical company focused on developing medicines for genetic conditions, today announced that on June 18, 2026, the compensation committee of BridgeBio’s board of directors approved equity grants to 30 new employees in restricted stock units for an aggregate of 66,810 shares of the Company’s common stock. One-fourth of the shares underlying each employee’s restricted stock units will vest on May 16, 2027, with one-twelfth of the remaining shares underlying each such employee’s restricted stock units vesting on a quarterly basis thereafter, in each case, subject to each such employee’s continued employment with the Company or one of its subsidiaries on such vesting dates.
The above-described awards were each granted as an inducement material to the employees entering into employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4) and were granted pursuant to the terms of the Plan. The Plan was adopted by BridgeBio’s board of directors in November 2019, and amended and restated on February 10, 2023 and on December 13, 2023.
About BridgeBio Pharma, Inc.
BridgeBio exists to develop transformative medicines for genetic conditions. Millions of people worldwide living with genetic conditions lack treatment options, often because drug development for small patient populations can be commercially challenging. We aim to bridge the gap between advancements in genetic science and meaningful medicines for underserved patient populations. Our decentralized, hub-and-spoke model is designed for speed, precision, and scalability. Autonomous and empowered teams focus on individual conditions, while a central hub provides the clinical, regulatory, and commercial capabilities needed to bring innovation to market. For more information, visit bridgebio.com and follow us on LinkedIn, X, Facebook, Instagram, YouTube, and TikTok.
BridgeBio Media Contact:
Bubba Murarka, Executive Vice President, Corporate Development [email protected]
(650)-789-8220
Amphastar Pharmaceuticals (AMPH - Free Report) is expected to deliver a year-over-year decline 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 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 specialty pharmaceutical company is expected to post quarterly earnings of $0.70 per share in its upcoming report, which represents a year-over-year change of -5.4%.
Revenues are expected to be $170.71 million, up 0.1% from the year-ago quarter.
Estimate Revisions TrendThe consensus EPS estimate for the quarter has been revised 6.15% higher 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 an aggregate change may not always reflect the direction of estimate revisions by each of the covering analysts.
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. Our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction) -- has this insight at its core.
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 Amphastar?For Amphastar, the Most Accurate Estimate is higher than the Zacks Consensus Estimate, suggesting that analysts have recently become bullish on the company's earnings prospects. This has resulted in an Earnings ESP of +2.37%.
On the other hand, the stock currently carries a Zacks Rank of #2.
So, this combination indicates that Amphastar will most likely 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 Amphastar would post earnings of $0.97 per share when it actually produced earnings of $0.73, delivering a surprise of -24.74%.
Over the last four quarters, the company has beaten consensus EPS estimates three 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.
Amphastar appears 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 ResultsBridgeBio Pharma (BBIO - Free Report) , another stock in the Zacks Medical - Generic Drugs industry, is expected to report loss per share of $0.71 for the quarter ended March 2026. This estimate points to a year-over-year change of +19.3%. Revenues for the quarter are expected to be $179.6 million, up 54% from the year-ago quarter.
Over the last 30 days, the consensus EPS estimate for BridgeBio Pharma has been revised 3.9% down to the current level. Nevertheless, the company now has an Earnings ESP of -4.23%, reflecting a lower Most Accurate Estimate.
When combined with a Zacks Rank of #3 (Hold), this Earnings ESP makes it difficult to conclusively predict that BridgeBio Pharma will beat the consensus EPS estimate. Over the last four quarters, the company surpassed EPS estimates just once.
Stay on top of upcoming earnings announcements with the Zacks Earnings Calendar.
BridgeBio remains a compelling Buy, driven by Attruby's strong U.S. launch and favorable competitive dynamics following Pfizer's patent settlements. Attruby's peak annual sales are conservatively modeled at $2.2B, with sensitivity up to $4B, underpinned by a protected branded market through mid-2031. BBIO's late-stage pipeline—infigratinib, encaleret, and BBP-418—offers potential for additional blockbusters, supporting long-term value beyond Attruby.
PALO ALTO, Calif., April 30, 2026 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a biopharmaceutical company focused on developing medicines for genetic conditions, today announced that it will release its first quarter 2026 financial results and business update after the market closes on Thursday, May 7, 2026. BridgeBio will host a conference call to discuss the financial results and program updates at 4:30 pm ET the same day.
May 04, 2026 07:30 ET | Source: BridgeBio Pharma, Inc.
PALO ALTO, Calif., May 04, 2026 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a biopharmaceutical company focused on developing medicines for genetic conditions, announced today upcoming presentations, including one late-breaking oral presentation, of new data from the Phase 3 ATTRibute-CM study in individuals with transthyretin amyloid cardiomyopathy (ATTR-CM) at Heart Failure 2026, organized by the Heart Failure Association of the European Society of Cardiology (ESC-HF), taking place in Barcelona, Spain on May 9-12, 2026.
Bayer, BridgeBio’s exclusive European licensing partner of acoramidis, will be presenting a late-breaking oral presentation on data from ATTRibute-CM related to acoramidis’ impact on the outcome of outpatient worsening heart failure.
Acoramidis is approved as Attruby® by the U.S. FDA and is approved as BEYONTTRA® by the European Medicines Agency (EMA), Japanese Pharmaceuticals and Medical Devices Agency, Swissmedic, the Swiss Agency for Therapeutic Products, and the UK Medicines and Healthcare Products Regulatory Agency with all labels specifying near-complete stabilization of TTR.
Late-Breaking Oral Presentation:
Effect of Acoramidis on Temporal Variability of Serum Transthyretin and its Influence on Outcomes: Insights from the ATTRibute-CM Trial
Presenter: Senthil Selvaraj, M.D., Duke University School of Medicine, U.S.
Date: Monday, May 11 at 3:30 pm CEST
Moderated ePoster:
Anchored Matching-Adjusted Indirect Comparison of Acoramidis (ATTRibute-CM) Versus Tafamidis (ATTR-ACT) for Risk of Cardiovascular-Related Hospitalization, All-Cause Mortality and Safety in ATTR-CM
Presenter: Emer Joyce, M.D., Ph.D., The Mater Misericordiae University Hospital, IE
Date: Sunday, May 10 at 3:30 pm CEST
Acoramidis Treatment Attenuates the Rise in NT-proBNP from Baseline to Month 30 Compared to Placebo Across all Subgroups
Presenter: Marianna Fontana, M.D., University College London, UK
Date: Monday, May 10 at 3:30 pm CEST
Posters:
Consistent Benefit on Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS) with Acoramidis Treatment Compared with Placebo Across Participant Subgroups in ATTRibute-CM
Presenter: Marianna Fontana, M.D., University College London, UK
Date: Saturday, May 9 at 12:56 pm CEST
Effect of Acoramidis on Improvement or Maintenance of Heart Failure-Related Health Status as Assessed by KCCQ-OS Score in ATTRibute-CM
Presenter: Charles Sherrod, M.D., Saint Luke’s Health System, Kansas City, U.S.
Date: Saturday, May 9 at 3:36 pm CEST
About Attruby™ (acoramidis)
INDICATION
Attruby is a transthyretin stabilizer indicated for the treatment of the cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular death and cardiovascular-related hospitalization.
IMPORTANT SAFETY INFORMATION
Adverse Reactions
Diarrhea (11.6% vs 7.6%) and upper abdominal pain (5.5% vs 1.4%) were reported in patients treated with Attruby versus placebo, respectively. The majority of these adverse reactions were mild and resolved without drug discontinuation. Discontinuation rates due to adverse events were similar between patients treated with Attruby versus placebo (9.3% and 8.5%, respectively).
About BridgeBio
BridgeBio exists to develop transformative medicines for genetic conditions. Millions of people worldwide living with genetic conditions lack treatment options, often because drug development for small patient populations can be commercially challenging. We aim to bridge the gap between advancements in genetic science and meaningful medicines for underserved patient populations. Our decentralized, hub-and-spoke model is designed for speed, precision, and scalability. Autonomous and empowered teams focus on individual conditions, while a central hub provides the clinical, regulatory, and commercial capabilities needed to bring innovation to market. For more information, visit bridgebio.com and follow us on LinkedIn, X, Facebook, Instagram, YouTube, and TikTok.
BridgeBio Media Contact:
Bubba Murarka, Executive Vice President [email protected]
(650)-789-8220
PALO ALTO, Calif., May 05, 2026 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a biopharmaceutical company focused on developing medicines for genetic conditions, announced today that additional data in individuals with autosomal dominant hypocalcemia type 1 (ADH1) from CALIBRATE, its Phase 3 study of encaleret, will be shared in an oral presentation at the 2026 European Congress of Endocrinology (ECE) taking place in Prague, Czech Republic on May 9-12, 2026. The Company will also share an additional oral presentation, one poster, and one eposter at the meeting.
May 06, 2026 07:30 ET | Source: BridgeBio Pharma, Inc.
- The approval of Beyonttra in Brazil is based on positive results from the Phase 3 ATTRibute-CM study, in which acoramidis demonstrated the most rapid benefit seen in any Phase 3 study of ATTR-CM to date, including:
- By Month 1, numerically fewer cumulative cardiovascular events, including CVM or recurrent CVH, were observed with acoramidis compared to placebo
- A 42% reduction in composite ACM and recurrent CVH events relative to placebo at Month 30
- A 50% reduction in the cumulative frequency of CVH events relative to placebo at Month 30
- Acoramidis is the first and only approved ATTR-CM treatment in the U.S., EU, UK, Switzerland, Japan, and Brazil that all have a label specifying near-complete stabilization (≥90%)
PALO ALTO, Calif., May 06, 2026 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a new type of biopharmaceutical company focused on genetic diseases, today announced the Brazilian Health Regulatory Agency (ANVISA) has granted marketing authorization for acoramidis, under the brand name BEYONTTRA, for the treatment of wild-type or variant transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM). Acoramidis is a selective small molecule, orally administered near-complete (≥90%) transthyretin (TTR) stabilizer.
“The ATTRibute-CM results represent a major advance for patients with ATTR-CM, who often face an earlier and more aggressive course of disease,” said Fábio Fernandes, M.D., Ph.D., Director at the Heart Institute of the Clinical Hospital of the University of São Paulo Medical School (HCFMUSP), and investigator in the trial. “For too long, this community has lived with limited options and delayed recognition of their condition. Seeing a therapy like acoramidis deliver significant reductions in cardiovascular-related hospitalizations, improvements in survival, and preservation of functional capacity and quality of life is profoundly encouraging. These results signal a transformative shift in how we can care for patients across Brazil.”
The approval in Brazil is based on results of the pivotal ATTRibute-CM Phase 3 study of acoramidis, which showed clear benefits on cardiovascular outcomes. ATTRibute-CM evaluated the efficacy and safety of acoramidis in 632 participants with symptomatic ATTR-CM, associated with either wild-type or variant TTR who were randomized 2:1 to receive acoramidis or placebo for 30 months. The study met its primary clinical endpoints at Month 30 by significantly reducing cardiovascular-related hospitalization, improving survival, and preserving functional capacity and quality of life for patients.
“The ANVISA approval of BEYONTTRA marks an important step forward for Brazilian patients living with ATTR-CM. It is a particularly meaningful advance for patients living in Brazil who have long faced limited options for this progressive, life-threatening disease,” said Jonathan Fox, M.D., Chief Medical Officer of BridgeBio Cardiorenal. “This authorization brings new hope to communities where ATTR-CM is increasingly recognized. This also reflects our commitment to ensuring that as many patients as possible in as many countries as possible have access to transformative care. We are profoundly grateful to the patients, families, investigators, and clinical partners whose courage and partnership made this milestone possible.”
Acoramidis was approved as Attruby® by the U.S. FDA in November 2024 and was approved as BEYONTTRA by the European Commission in February 2025, the Japanese Ministry of Health, Labour, and Welfare (MHLW) Agency in March 2025, and the UK Medicines and Healthcare Products Regulatory Agency in April 2025 with all labels specifying near-complete stabilization of TTR. Acoramidis is also currently under review by other global regulatory agencies.
BridgeBio will work in partnership with Biopas, a Swixx BioPharma company with an established pharmaceutical commercialization platform in Latin America, to commercialize BEYONTTRA in Brazil. Commercialization efforts are expected to begin in the second half of 2026, ensuring that Brazilian patients with ATTR-CM gain access to acoramidis as quickly as possible.
About BEYONTTRA
BEYONTTRA is an orally administered near-complete (≥90%) stabilizer of transthyretin (TTR) indicated for the treatment of wild-type or variant transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM). Full prescribing information for Brazil will be available through ANVISA.
About Attruby® (acoramidis)
INDICATION
Attruby is a transthyretin stabilizer indicated for the treatment of the cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular death and cardiovascular-related hospitalization.
IMPORTANT SAFETY INFORMATION
Adverse Reactions
Diarrhea (11.6% vs 7.6%) and upper abdominal pain (5.5% vs 1.4%) were reported in patients treated with Attruby versus placebo, respectively. The majority of these adverse reactions were mild and resolved without drug discontinuation. Discontinuation rates due to adverse events were similar between patients treated with Attruby versus placebo (9.3% and 8.5%, respectively).
About BridgeBio
BridgeBio Pharma, Inc. (BridgeBio; Nasdaq: BBIO) is a new type of biopharmaceutical company founded to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases. BridgeBio’s pipeline of development programs ranges from early science to advanced clinical trials. BridgeBio was founded in 2015 and its team of experienced drug discoverers, developers and innovators are committed to applying advances in genetic medicine to help patients as quickly as possible. For more information visit bridgebio.com and follow us on LinkedIn, X, Facebook, Instagram, and YouTube.
BridgeBio Forward-Looking Statements
This press release contains forward-looking statements. Statements in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), which are usually identified by the use of words such as “anticipates,” “believes,” “continues,” “estimates,” “expects,” “hopes,” “intends,” “may,” “plans,” “projects,” “remains,” “seeks,” “should,” “will,” and variations of such words or similar expressions, or the negative of these terms or other comparable terminology. These words are intended to identify forward-looking statements, though not all forward-looking statements necessarily contain these identifying words. BridgeBio intends these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act.These forward-looking statements, including statements regarding the potential clinical and commercial benefits of acoramidis and the potential outcomes; expected timing of commercialization efforts; potential patient access to acoramidis; and expected timing and outcome of regulatory reviews and approvals by other global regulatory agencies, are based on the information currently available to BridgeBio and on assumptions BridgeBio has made. Although BridgeBio believes that its plans, intentions, expectations, and strategies as reflected in or suggested by these forward-looking statements are reasonable, BridgeBio can give no assurance that such plans, intentions, expectations, or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties, and assumptions, including, but not limited to, risks associated with the continued development and commercialization of acoramidis; the occurrence of adverse safety events; the ability to maintain regulatory approvals; the need for additional clinical data or analyses requested by regulatory authorities; whether future results will be consistent with prior clinical findings; BridgeBio’s reliance on third parties, including commercialization partners, and their ability to execute on commercialization and distribution activities; manufacturing, supply continuity, and quality obligations; pricing, reimbursement, market access, and adoption in Brazil and other markets; and the impacts of current macroeconomic and geopolitical events, including changing conditions from hostilities in Ukraine and in Israel and the Gaza Strip, and increasing rates of inflation and changing interest rates, on BridgeBio’s business operations and expectations. Additional risks are set forth in the “Risk Factors” section of BridgeBio’s most recent Annual Report on Form 10-K and other subsequent filings with the U.S. Securities and Exchange Commission. Except as required by applicable law, BridgeBio assumes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events, or otherwise.
BridgeBio Media Contact:
Bubba Murarka, Executive Vice President, Corporate Development [email protected]
(650)-789-8220
May 06, 2026 16:01 ET | Source: BridgeBio Pharma, Inc.
PALO ALTO, Calif., May 06, 2026 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a biopharmaceutical company focused on developing medicines for genetic conditions, today announced that members of its management team will participate in fireside chats at the following healthcare investor conferences:
BofA Securities Health Care Conference 2026, Las Vegas, NV: Tuesday, May 12 at 2:20 pm PDT2026 Jefferies Global Healthcare Conference, New York, NY: Thursday, June 4 at 11:05 am EDTGoldman Sachs 47th Annual Global Healthcare Conference, Miami FL: Tuesday, June 9 at 8:00 am EDT To access the live webcast of BridgeBio’s presentations, please visit the “Events and Presentations” page within the Investors section of the BridgeBio website at https://investor.bridgebio.com. A replay of the webcasts will be available on the BridgeBio website for 90 days following the event.
About BridgeBio Pharma, Inc.
BridgeBio exists to develop transformative medicines for genetic conditions. Millions of people worldwide living with genetic conditions lack treatment options, often because drug development for small patient populations can be commercially challenging. We aim to bridge the gap between advancements in genetic science and meaningful medicines for underserved patient populations. Our decentralized, hub-and-spoke model is designed for speed, precision, and scalability. Autonomous and empowered teams focus on individual conditions, while a central hub provides the clinical, regulatory, and commercial capabilities needed to bring innovation to market. For more information, visit bridgebio.com and follow us on LinkedIn, X, Facebook, Instagram, YouTube, and TikTok.
BridgeBio Media Contact:
Bubba Murarka, Executive Vice President [email protected]
(650)-789-8220
PALO ALTO, Calif., May 07, 2026 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage, multi-product biopharmaceutical company focused on developing medicines for genetic conditions, announced today its financial results for the first quarter ended March 31, 2026, and provided an update on Attruby's commercial progress.
BridgeBio Pharma (BBIO) came out with a quarterly loss of $0.84 per share versus the Zacks Consensus Estimate of a loss of $0.7. This compares to a loss of $0.88 per share a year ago.
PALO ALTO, Calif. , May 08, 2026 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) ("BridgeBio" or the "Company"), a biopharmaceutical company focused on developing medicines for genetic conditions, today announced that on May 6, 2026, the compensation committee of BridgeBio's board of directors approved equity grants to 52 new employees in restricted stock units for an aggregate of 115,007 shares of the Company's common stock.
May 12, 2026 07:30 ET | Source: BridgeBio Pharma, Inc.
- Phase 3 CALIBRATE primary results were presented in an oral presentation at the 2026 ECE, demonstrating the rapid and durable benefit of encaleret across key clinical parameters in ADH1
- All pre-specified primary and key secondary efficacy endpoints were met in the Phase 3 CALIBRATE trial; 76% of participants administered encaleret achieved both serum and urine calcium within the respective target ranges at Week 24 compared to 4% when on conventional therapy at Week 4 (p<0.0001)
- Encaleret may be eligible for priority review; BridgeBio anticipates U.S. launch in early 2027
- If approved, encaleret could be the first approved therapy specifically indicated for individuals living with ADH1
- BridgeBio also intends to initiate the RECLAIM-HP Phase 3 clinical study of encaleret in chronic hypoparathyroidism in Summer 2026
PALO ALTO, Calif., May 12, 2026 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage, multi-product biopharmaceutical company focused on developing medicines for genetic conditions, today announced the submission of its New Drug Application (NDA) to the FDA for encaleret as a potential targeted treatment for autosomal dominant hypocalcemia type 1 (ADH1).
CALIBRATE, the Phase 3 clinical trial of encaleret in ADH1, successfully achieved all pre-specified primary and key secondary efficacy endpoints, supporting encaleret’s potential as a disease-modifying therapy by targeting the underlying genetic cause of ADH1. The topline results can be found here. Additional positive results were presented at the European Congress of Endocrinology (ECE) 2026 in an oral presentation, with data showing comprehensive normalization of mineral homeostasis.
Primary results of the study include:
76% of participants randomized to encaleret achieved both target serum calcium and urine calcium levels compared to 4.4% of those same individuals while on standard of care (p<0.0001)Rapid and sustained improvements in calcium metabolism for participants randomized to encaleret, with increases in serum calcium observed by Day 3 and reductions in urine calcium by Week 3, maintained through Week 24At Week 24, more participants randomized to encaleret achieved both target serum and urine calcium levels than participants who remained on standard of care (76% on encaleret vs. 19% on standard of care; p < 0.0001)Encaleret was observed to restore endogenous parathyroid hormone (91.1% on encaleret vs. 0% of participants on standard of care at Week 24)Favorable safety and tolerability profile, with no discontinuations in the encaleret arm and low rates of serious adverse events with frequency similar between treatment arms
“These Phase 3 findings are a landmark moment for the autosomal dominant hypocalcemia type 1 community,” said Filomena Cetani, M.D., Ph.D. of the University of Pisa, Italy. “Encaleret not only has the potential to become the first-ever approved therapy for this rare disease, but it does so by addressing the root cause, restoring normal calcium regulation and lowering the risk of renal complications that individuals on current treatment face every day. Together, these findings exemplify what a first-in-class therapy should look like.”
BridgeBio anticipates a U.S. launch in early 2027. Nearly 2,000 individuals have been diagnosed in the U.S. with autosomal dominant hypocalcemia (ADH) since October 2023 based on claims data, suggestive of a growing marketplace and elevated diagnostic suspicion. The Company also intends to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for the use of encaleret in ADH1 in the second half of 2026.
BridgeBio is currently enrolling CALIBRATE-PEDS (NCT07080385), a global registrational Phase 2/3 study of encaleret in pediatric ADH1. The Company also plans to initiate RECLAIM-HP, a global Phase 3 study of encaleret in chronic hypoparathyroidism in Summer 2026, building on the Phase 2 proof-of-concept findings of PTH-independent effects of encaleret on renal calcium handling and expanding the potential applications of encaleret beyond ADH1.
About Encaleret
Encaleret is an investigational, orally administered small molecule under investigation to treat ADH1 and chronic hypoparathyroidism, that is designed to selectively negatively modulate the calcium sensing receptor. Encaleret has been granted Fast Track Designation by the U.S. FDA and Orphan Drug Designation in the U.S., European Union, and Japan.
About BridgeBio
BridgeBio exists to develop transformative medicines for genetic conditions. Millions of people worldwide living with genetic conditions lack treatment options, often because drug development for small patient populations can be commercially challenging. We aim to bridge the gap between advancements in genetic science and meaningful medicines for underserved patient populations. Our decentralized, hub-and-spoke model is designed for speed, precision, and scalability. Autonomous and empowered teams focus on individual conditions, while a central hub provides the clinical, regulatory, and commercial capabilities needed to bring innovation to market. For more information, visit bridgebio.com and follow us on LinkedIn, X, Facebook, Instagram, YouTube, and TikTok.
BridgeBio Forward-Looking Statements
This press release contains forward-looking statements. Statements in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the Securities Act), and Section 21E of the Securities Exchange Act of 1934, as amended (the Exchange Act), which are usually identified by the use of words such as “anticipates,” “believes,” “continues,” “estimates,” “expects,” “hopes,” “intends,” “may,” “plans,” “projects,” “remains,” “seeks,” “should,” “will,” and variations of such words or similar expressions. BridgeBio intends these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act. These forward-looking statements include express and implied statements relating to the Company’s expectations regarding the regulatory review process, potential approval, timing of a potential launch for encaleret in ADH1, potential regulatory submissions outside the United States, including the timing of a potential Marketing Authorization Application submission to the European Medicines Agency for encaleret in ADH1, and the potential market opportunity for encaleret, including the size of the diagnosed patient population and future diagnostic rates; the potential for encaleret to become a disease-modifying therapy by targeting the underlying genetic cause of ADH1 and for it to be the first-ever approved therapy for ADH1; the anticipated regulatory pathway for encaleret; and the Company’s plans and expectations regarding the development of encaleret in additional populations and indications, including pediatric ADH1 and chronic hypoparathyroidism. Such statements reflect the Company’s current views about the Company’s plans, intentions, expectations and strategies, which are based on the information currently available to it and on assumptions the Company has made. Although the Company believes that its plans, intentions, expectations and strategies as reflected in or suggested by those forward-looking statements are reasonable, the Company can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to, initial and ongoing data from the Company’s clinical trials not being indicative of final data, the design and success of ongoing and planned clinical trials, future regulatory filings, approvals and/or sales, despite having ongoing and future interactions with the FDA or other regulatory agencies to discuss potential paths to registration for the Company’s product candidates, the FDA, EMA or such other regulatory agencies not agreeing with the Company’s regulatory approval strategies, components of the Company’s filings, such as clinical trial designs, conduct and methodologies, or the sufficiency of data submitted, regulatory submissions for encaleret not being accepted, reviewed or approved on anticipated timelines or at all, encaleret not becoming the first approved therapy specifically indicated for ADH1, estimates regarding the diagnosed patient population, market opportunity and diagnostic trends not proving accurate, the Company’s planned studies, including CALIBRATE-PEDS and RECLAIM-HP, being delayed or not proceeding as expected, the impacts of current macroeconomic and geopolitical events, including changing conditions from hostilities in Ukraine and in Israel and the Middle East, increasing rates of inflation and changing interest rates, on business operations and expectations, as well as those risks set forth in the Risk Factors section of the Company’s most recent Quarterly Report on Form 10-Q and Annual Report on Form 10-K and the Company’s other filings with the U.S. Securities and Exchange Commission. Moreover, the Company operates in a very competitive and rapidly changing environment in which new risks emerge from time to time. These forward-looking statements are based upon the current expectations and beliefs of the Company’s management as of the date of this press release, and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as required by applicable law, BridgeBio assumes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.
BridgeBio Media Contact:
Bubba Murarka, Executive Vice President [email protected]
(650)-789-8220
BridgeBio Pharma NASDAQ: BBIO executives used a BofA healthcare conference appearance in Las Vegas to reiterate confidence in the commercial trajectory of Attruby and outline expectations for three potential near-term product launches from the company's late-stage pipeline.
BridgeBio Pharma (NASDAQ:BBIO | BBIO Price Prediction) received a Neutral initiation from Citi Neutral on Tuesday, reflecting a measured stance on the company’s transthyretin amyloid cardiomyopathy (ATTR-CM) franchise. The call contrasts with Citi’s simultaneous Buy initiation Buy ratings on peer biotechs Alnylam, Ascendis Pharma, BioMarin, Cytokinetics, and of Ionis Pharmaceuticals (NASDAQ:IONS), making the BBIO Neutral a cautious outlier. For prudent investors, the rating frames a real tension between commercial momentum and competitive risk.
Ticker Company Firm Action Old Rating New Rating Old Target New Target BBIO BridgeBio Pharma Citi Initiation N/A Neutral N/A Not disclosed BridgeBio’s lead drug Attruby (acoramidis) is tracking a steep commercial ramp, alongside $500 million share repurchase program and three additional NDAs planned for 2026. Citi’s caution stands against broader Wall Street sentiment that includes 22 buy ratings on BBIO stock.
The Analyst’s Case Citi’s Neutral rating reflects a balanced view of BridgeBio’s cardiomyopathy story. The bull case centers on acoramidis’s differentiated mechanism of action, a large and growing ATTR-CM patient population, broader pipeline assets, and attractive risk/reward relative to other gene-targeted biotechs.
The bear case is equally concrete. BridgeBio’s Attruby competes head-to-head with Pfizer’s established tafamidis (Vyndaqel/Vyndamax) franchise, while commercial ramp execution risk, R&D burn, and pipeline assets early in development weigh on the setup. That Citi initiated Ionis Pharmaceuticals at Buy the same day sharpens the signal: the firm sees opportunity in gene-targeted biotech, yet drew a line at BridgeBio’s competitive setup.
Company Snapshot BridgeBio is a clinical-stage biopharmaceutical company focused on genetic diseases and cancers driven by Mendelian disease drivers. Lead product Attruby won U.S. approval for ATTR-CM in late 2024 and posted Q1 2026 U.S. net product revenue of $180.6 million, versus $36.74 million a year earlier. Total revenue rose year over year.
BridgeBio closed the quarter with $940.19 million in cash and a market cap near $13.03 billion. The pipeline includes upcoming NDAs for BBP-418 in LGMD2I/R9, encaleret in ADH1, and oral infigratinib in achondroplasia, each potentially eligible for priority review.
Why the Move Matters Now The Neutral call arrives against a broadly bullish analyst tape. Pfizer (NYSE:PFE) still generated $1.688 billion in Q4 2025 Vyndaqel-family revenue, up 9% year over year, underscoring how much share Attruby must capture to justify BBIO’s valuation.
BBIO stock has been under pressure recently, with shares down 15% over the past month, even as the one-year return remains up 94%. Citi’s initiation lands in a more skeptical tape than the buy-rated chorus suggests.
What It Means for Your Portfolio For prudent investors, the Citi Neutral initiation is a reminder that strong launch metrics and competitive risk coexist. BridgeBio’s commercial trajectory looks healthy, yet Pfizer’s incumbency and Ionis’s eplontersen CARDIO-TTRansform readout expected later 2026 could pressure the long-term ATTR-CM share thesis.
BBIO stock may suit investors comfortable with biotech volatility and execution risk. Moderate position sizing, rather than aggressive accumulation, fits the balanced framing Citi is signaling. Keep an eye on BridgeBio through three planned 2026 NDAs and competitive cardiomyopathy data flow.
- Accepted for Priority Review with PDUFA target action date of November 27, 2026, and poised to launch upon approval; being granted Priority Review by the FDA reiterates the serious unmet need for treatment options for the LGMD2I/R9 community