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BridgeBio Pharma, Inc. develops and commercializes medicines for genetic conditions through a decentralized biopharmaceutical model. News for BBIO centers on Attruby/acoramidis, its oral transthyretin stabilizer for transthyretin amyloid cardiomyopathy (ATTR-CM), including clinical data from ATTRibute-CM, commercial updates, Brazil marketing authorization under the BEYONTTRA name, and licensing or commercialization arrangements.
Company updates also cover late-stage genetic-disease programs such as encaleret for autosomal dominant hypocalcemia type 1, BBP-418 for limb-girdle muscular dystrophy type 2I/R9, and oral infigratinib for achondroplasia. Recurring financial and corporate items include quarterly results, product revenue trends, capital actions, employee equity inducement grants, investor conference participation, and pipeline regulatory disclosures.
BridgeBio Pharma has exceeded its targeted enrollment for the interim analysis in its Phase 3 FORTIFY study of BBP-418, aimed at treating LGMD2I/R9. The company expects top-line results in 2025. The study is randomized, double-blind, and placebo-controlled, evaluating the safety and efficacy of BBP-418. The study includes an interim analysis at 12 months, focusing on glycosylated αDG levels, which may be used as a surrogate endpoint for accelerated approval.
Recent FDA interactions affirm the potential for accelerated approval based on these surrogate endpoints. Additionally, the FDA has granted Rare Pediatric Disease Designation for BBP-418, which could qualify BridgeBio for a Priority Review Voucher if BBP-418 is approved. This designation highlights the seriousness of LGMD2I/R9, a disease primarily affecting children. The study continues to enroll participants in the U.S., UK, Europe, and Australia.
On June 6, 2024, BridgeBio Pharma announced that its board's compensation committee approved equity grants to 18 new employees. These grants consist of restricted stock units totaling 90,591 shares of common stock. Under the vesting schedule, one-fourth of the shares will vest on May 16, 2025, with the remaining shares vesting quarterly over the subsequent three years, contingent on continued employment. The grants were made under BridgeBio’s Amended and Restated 2019 Inducement Equity Plan as part of an inducement to join the company, following Nasdaq Listing Rule 5635(c)(4).
BridgeBio Pharma (Nasdaq: BBIO), a commercial-stage biopharmaceutical company, will participate in the 45th Annual Goldman Sachs Global Healthcare Conference. Founder and CEO Neil Kumar, Ph.D., is scheduled to present on June 12 at 3:20 pm EDT in Miami, FL. The presentation will be available via live webcast on the Investor section of BridgeBio's website, with a replay accessible for 90 days thereafter.
BridgeBio announced promising results from the Phase 2 PROPEL 2 trial of infigratinib for achondroplasia. At 12 and 18 months, Cohort 5 participants showed a statistically significant and sustained increase in annualized height velocity (AHV) of +2.51 cm/year and +2.50 cm/year, respectively (p=0.0015). Additionally, there was a significant improvement in body proportionality, with the mean upper to lower body segment ratio improving from 2.02 at baseline to 1.88 at Month 18 (p=0.001). Infigratinib was well-tolerated with no treatment-related adverse events reported. BridgeBio also initiated the ACCEL study for infigratinib in hypochondroplasia, starting with the first participant's consent in May 2024. The company intends to continue enrolling for the global Phase 3 PROPEL 3 study, expecting completion by end of 2024.
BridgeBio Pharma (Nasdaq: BBIO) will host a call on June 4, 2024, at 8:00 am ET to present results from Month 12 and Month 18 of Cohort 5 in the Phase 2 PROPEL 2 trial. This trial evaluates the efficacy of the investigational oral therapy infigratinib in children with achondroplasia. Dr. Ravi Savarirayan from Murdoch Children’s Research Institute in Melbourne will join the call. The live webcast can be accessed via the 'Events' page in the Investors section of BridgeBio's website, with a replay available for 90 days post-event.
BridgeBio Pharma announced positive results from its Phase 3 ATTRibute-CM study regarding acoramidis treatment for ATTR-CM. The study noted significant increases in serum transthyretin (TTR) levels by Day 28, sustained through Month 30. These increases correlated with reduced all-cause mortality (ACM), cardiovascular mortality (CVM), and cardiovascular-related hospitalization (CVH). Notable improvements were also observed in the composite endpoint of CVM and CVH, with benefits evident as early as Month 3. The company shared plans for the ACT-EARLY trial to prevent ATTR amyloidosis and announced an upcoming investor call on May 29, 2024, to discuss these results.
BridgeBio Pharma will present additional analyses from its Phase 3 ATTRibute-CM study on Acoramidis at the 2024 International Symposium on Amyloidosis (ISA) in Rochester, Minnesota from May 26-30, 2024. The company will host an investor call on May 29, 2024, at 5:30 pm ET to discuss the data, featuring presentations from noted medical experts.
The presentations will highlight Acoramidis' impact on clinical outcomes, including improved survival rates and reduced cardiovascular mortality and hospitalizations in transthyretin amyloid cardiomyopathy (ATTR-CM) patients. Key insights from the trial will also be shared, focusing on quality of life improvements, reduced disease progression, and enhanced biomarkers.
For more details, visit BridgeBio's investor website where all presentations will be accessible.
BridgeBio Pharma, a biopharmaceutical company focusing on genetic diseases and cancers, announced the approval of equity grants to 24 new employees. These grants, totaling 97,557 shares of the Company's common stock, were approved by the compensation committee on May 9, 2024. The vesting schedule for these restricted stock units starts on May 16, 2025, with one-fourth of the shares vesting initially, followed by quarterly vesting of the remaining shares. These inducements, granted under the Amended and Restated 2019 Inducement Equity Plan, comply with Nasdaq Listing Rule 5635(c)(4).
BridgeBio Pharma, a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, will present at the Bank of America Merrill Lynch Global Healthcare Conference 2024.
The event is scheduled for May 15 at 3:00 pm PT in Las Vegas, NV. The presentation will be accessible via a live webcast on the company's investor relations website, with a replay available for 90 days.
BridgeBio Pharma presented positive results from its Phase 3 ATTRibute-CM study at the ESC Heart Failure Congress 2024. Acoramidis significantly reduced all-cause mortality in the entire study population, with no safety concerns. The treatment also showed benefits in health-related quality of life and NT-proBNP indices. Acoramidis has been submitted for regulatory approval in the US and Europe.