Bridgebio Pharma - BBIO STOCK NEWS

BridgeBio Pharma (BBIO) has announced it will release its Q4 and full-year 2024 financial results on February 20, 2025. The announcement will include updates on Attruby's commercialization progress and the company's late-stage clinical pipeline. Starting with Q1 results, expected in late April or early May, the company will begin hosting earnings calls, as previously outlined in its JPM presentation.

BridgeBio Pharma (BBIO) has received European Commission approval for BEYONTTRA™ (acoramidis), the first near-complete TTR stabilizer (≥90%) to treat ATTR-CM, a fatal heart condition. The approval is based on the Phase 3 ATTRibute-CM study results, which showed:

- 42% reduction in composite all-cause mortality and recurrent cardiovascular-related hospitalization events at Month 30
- 50% reduction in cumulative frequency of cardiovascular-related hospitalization events at Month 30
- Benefits observed in as few as 3 months

Following the approval, BridgeBio will receive a $75 million milestone payment from Bayer, who will handle EU commercialization. BridgeBio will also receive tiered royalties starting in the low-thirties percent on EU sales. Bayer plans to launch the drug in the first half of 2025. The drug was previously approved in the U.S. as Attruby™ in November 2024, with 430 patient prescriptions written by 248 physicians since approval.

BridgeBio Pharma (NASDAQ: BBIO) reported significant commercial progress for its recently FDA-approved drug Attruby, with 430 prescriptions written by 248 unique physicians for ATTR-CM treatment. The company announced the completion of enrollment in three major Phase 3 clinical trials: FORTIFY (112 patients for LGMD2I/R9), CALIBRATE (70 patients for ADH1), and PROPEL 3 (114 participants for achondroplasia).

The company's financial position is strong with $406 million in cash as of last quarter, plus $500 million received upon Attruby's FDA approval from a royalty facility. BridgeBio anticipates an additional $105 million in regulatory milestones in the first half of 2025 from expected European and Japanese approvals of acoramidis. All three Phase 3 trials are expected to reach significant milestones in the second half of 2025.

BridgeBio Pharma (Nasdaq: BBIO), a biopharmaceutical company specializing in genetic diseases, has announced its participation in the 43rd Annual J.P. Morgan Healthcare Conference in San Francisco. Co-founder and CEO Neil Kumar, Ph.D., will deliver a presentation on Monday, January 13 at 7:30 am PT.

Investors and interested parties can access the live webcast through the 'Events & Presentations' section of BridgeBio's investor website. The presentation recording will remain available for 30 days following the event on the company's website.

BridgeBio Pharma (BBIO) announced that the Committee for Medicinal Products for Human Use (CHMP) has recommended approval of acoramidis in the EU for treating transthyretin amyloid cardiomyopathy (ATTR-CM). The recommendation follows positive Phase 3 ATTRibute-CM study results, showing a 42% reduction in composite all-cause mortality and recurrent cardiovascular-related hospitalization events, and a 50% reduction in cumulative frequency of cardiovascular-related hospitalization events at Month 30.

The drug was already approved by the FDA on November 22, 2024, as Attruby™, becoming the first ATTR-CM treatment achieving near-complete stabilization in the US. Through a collaboration with Bayer, BridgeBio holds US marketing rights while Bayer manages European distribution. Following expected European Commission approval, Bayer plans to launch acoramidis in Europe in first half 2025.

BridgeBio Pharma announced FDA approval of Attruby™ (acoramidis) for treating adults with ATTR-CM to reduce cardiovascular death and hospitalization. The approval is based on the ATTRibute-CM Phase 3 study results, showing a 42% reduction in composite all-cause mortality and recurrent cardiovascular-related hospitalizations at Month 30. Attruby demonstrated rapid benefits within 3 months and achieved a 50% reduction in cardiovascular-related hospitalization events. As the first approved product with near-complete TTR stabilization (≥90%), Attruby preserves native TTR function. BridgeBio will receive a $500 million payment under their royalty funding agreement and has submitted for European approval, expected in 2025.

BridgeBio Pharma (BBIO) presented positive initial outcomes from the ATTRibute-CM open-label extension study of acoramidis in ATTR-CM. Key results show that acoramidis achieved a 36% reduction in All-Cause Mortality at Month 36 and demonstrated the earliest known time to separation in cardiovascular outcomes (3 months). The study showed a 46% reduction in the composite endpoint of mortality and cardiovascular-related hospitalizations at Month 36, increasing to 48% at Month 42. The drug continues to be well-tolerated with no new safety concerns. A New Drug Application is under FDA review with a PDUFA date of November 29, 2024.

BridgeBio Pharma (BBIO) has published positive 18-month results from its Phase 2 PROPEL 2 trial of infigratinib for children with achondroplasia in the New England Journal of Medicine. The study showed statistically significant results with a +2.50cm/year increase in annualized height velocity at Month 18 using a 0.25mg/kg daily oral dose. The treatment demonstrated improved body proportionality and was well-tolerated with no serious adverse events. The drug has received multiple FDA designations, including Breakthrough Therapy Designation. The company's Phase 3 PROPEL 3 study continues enrollment, expected to complete by end of 2024.

BridgeBio Pharma (BBIO) reported Q3 2024 financial results with revenue of $2.7M and a net loss of $162.0M. Cash position ended at $405.7M. The company's lead drug acoramidis showed positive Phase 3 results in ATTR-CM with FDA PDUFA date set for November 29, 2024. Upon approval, BBIO anticipates receiving a $500M milestone payment and $105M in additional regulatory milestones for European and Japanese territories.

Three Phase 3 readouts are expected in 2025. Notable pipeline progress includes completed screening for CALIBRATE Phase 3 trial of encaleret, completed enrollment for FORTIFY Phase 3 trial, and Breakthrough Therapy Designation for infigratinib in achondroplasia.