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- 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).
Allspring Global Investments Holdings LLC cut its holdings in BridgeBio Pharma, Inc. (NASDAQ: BBIO) by 10.5% during the undefined quarter, according to its most recent disclosure with the Securities and 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
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.
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.
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.
BridgeBio Pharma hit a 52-week high after a rival's phase III setback boosts confidence in Attruby's competitive position in ATTR-CM.
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.
BBIO builds on Attruby's launch as rising rare disease diagnoses and late-stage pipeline candidates set up multiple potential U.S. launches.
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