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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 reported significant updates, including the sale of NULIBRY™ to Sentynl Therapeutics and an updated collaboration with Helsinn Group for infigratinib. Positive Phase 2 data for BBP-418 showed a 43% increase in glycosylated alpha-dystroglycan in LGMD2i patients. The ongoing study of acoramidis in ATTR-CM patients continued to demonstrate well-tolerated results. Financially, the company ended Q1 with $633.5 million in cash, while restructuring efforts are expected to reduce expenses significantly. However, a net loss of $196.4 million was recorded.
BridgeBio Pharma has provided an update on its ongoing Phase 2 open-label extension study of acoramidis for patients with symptomatic transthyretin amyloid cardiomyopathy (ATTR-CM). Results show NT-proBNP levels were stable or improved, with a median change of -437 pg/mL at Month 30. Additionally, serum TTR levels increased by 41%, from 21.55 mg/dL to 30.06 mg/dL. Acoramidis was well-tolerated with no significant safety concerns. Topline Phase 3 trial data is expected in mid-2023, raising optimism for treatment efficacy.
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.