Bridgebio Pharma Stock Price, News & Analysis

BridgeBio Pharma (Nasdaq: BBIO) announced that updated data from its Phase 2 open-label extension study of acoramidis (AG10) for symptomatic transthyretin amyloid cardiomyopathy (ATTR-CM) will be presented at the ACC Annual Scientific Session on April 3, 2022. Additionally, the company will address unmet needs in ATTR patient care at the same event. The ongoing Phase 3 ATTRibute-CM study is expected to provide topline data by mid-2023, with a primary endpoint focusing on all-cause mortality and cardiovascular hospitalizations.

BridgeBio Pharma announced promising results from the Phase 2 trial of BBP-418 for limb-girdle muscular dystrophy type 2i (LGMD2i), presented at the MDA 2022 Annual Meeting. The trial demonstrated a 43% increase in glycosylated alpha-dystroglycan and a 70% reduction in creatine kinase after 90 days, indicating reduced muscle breakdown. Improvements were also seen in the 10-meter walk test. With plans for a Phase 3 trial in late 2022, BBP-418 could become the first approved therapy for LGMD2i, addressing a significant unmet need.

BridgeBio Pharma (Nasdaq: BBIO) announced an investor call on March 14, 2022, to discuss data from its Phase 2 study of BBP-418 for limb-girdle muscular dystrophy type 2i (LGMD2i). Results will be showcased at the MDA 2022 Annual Meeting in Nashville. LGMD2i affects around 7,000 patients in the U.S. and EU, caused by mutations in the FKRP gene. BBP-418 aims to improve glycosylation of αDG, potentially becoming the first approved treatment. The company is committed to advancing its pipeline of therapies for unmet medical needs.

BridgeBio Pharma (Nasdaq: BBIO) has entered into an asset purchase agreement with Sentynl Therapeutics for its FDA-approved drug NULIBRY™ (Fosdenopterin). This drug is critical for reducing mortality risks in patients with the ultra-rare genetic disorder MoCD Type A. Sentynl will handle the global commercialization and development of NULIBRY, with BridgeBio sharing development responsibilities. The deal includes cash payments upon regulatory milestones and potential future royalties for BridgeBio based on net sales.

BridgeBio Pharma (BBIO) reported its Q4 2021 financial results, revealing a net loss of $147.2 million, which translates to a loss per share of $1.01. The company ended the quarter with $787.5 million in cash and equivalents, an increase from $607.1 million a year prior. Key developments included securing up to $750 million in non-dilutive debt financing, dosing its first patient in a Phase 1/2 trial for congenital adrenal hyperplasia (CAH), and initiating collaborations with Amgen and Helsinn Group to advance several oncology treatments.

BridgeBio Pharma announced the initiation of the Phase 1/2 trial for BBP-631, a gene therapy for congenital adrenal hyperplasia (CAH), marking a significant milestone in treatment options for this prevalent genetic disorder affecting over 75,000 individuals in the U.S. and EU. The trial aims to assess the safety and pharmacodynamic activity of BBP-631, potentially allowing patients to produce their own cortisol and aldosterone. Initial data is expected in the latter half of 2022, as BridgeBio advances its commitment to genetic therapies.

Atomwise, a leader in AI-driven small molecule drug discovery, has appointed David Thomson, Ph.D., as Chief Scientific Officer, alongside Jonathan Barr as Chief Financial Officer and Jeffrey Cerio, Pharm.D., J.D., as General Counsel. Dr. Thomson will spearhead the company's drug development strategy, focusing on enhancing their small molecule pipeline. His extensive experience includes leadership roles at Precision BioSciences and Shire. Barr brings expertise from Bridge Bio, where he managed significant capital raises. Cerio has a strong legal background from Moderna. The team aims to advance Atomwise's innovative drug discovery capabilities.

BridgeBio Pharma has announced a non-exclusive clinical collaboration with Amgen to study the combination of BBP-398, a SHP2 inhibitor, with LUMAKRAS (sotorasib), targeting advanced solid tumors with the KRAS G12C mutation. The Phase 1/2 trial will assess safety, pharmacokinetics, and preliminary efficacy. BBP-398 aims to inhibit oncogenic processes driven by KRAS mutations, which occur in approximately 17% of solid tumors. The collaboration builds on existing partnerships with other companies, signaling BridgeBio's commitment to advancing its precision oncology pipeline.

BridgeBio Pharma (BBIO) announced mixed results from the Month 12 analysis of its Phase 3 study, ATTRibute-CM, evaluating acoramidis for treating symptomatic TTR amyloid cardiomyopathy. The primary endpoint—six-minute walk distance—did not show improvement (9m acoramidis, 7m placebo). However, notable improvements were recorded in quality of life, NT-proBNP levels, and serum TTR concentrations. Acoramidis demonstrated good tolerability with fewer adverse events leading to death. The independent monitoring committee has recommended continuing the study into the Month 30 endpoint, focusing on all-cause mortality and cardiovascular hospitalizations.