Welcome to our dedicated page for Bridgebio Pharma news (Ticker: BBIO), a resource for investors and traders seeking the latest updates and insights on Bridgebio Pharma stock.
BridgeBio Pharma (BBIO) is a biopharmaceutical innovator developing genetic disease therapies through its unique portfolio-based approach. This page serves as the definitive source for official company announcements, clinical trial updates, and strategic developments.
Investors and stakeholders gain centralized access to critical updates including clinical milestones, regulatory filings, financial disclosures, and research partnerships. Our curated feed ensures timely tracking of therapeutic advancements across BridgeBio's diversified pipeline.
Key focus areas include progress in Mendelian disorder treatments, oncology targets, and gene therapy innovations. All content undergoes strict verification to maintain compliance with financial disclosure standards and medical accuracy guidelines.
Bookmark this page for efficient monitoring of BBIO's scientific advancements and corporate developments. Combine this resource with SEC filings and earnings transcripts for comprehensive investment analysis.
The European Commission has granted marketing authorization for NULIBRY® (fosdenopterin), the first treatment for molybdenum cofactor deficiency (MoCD) Type A, an ultra-rare genetic disorder affecting fewer than 150 patients globally. This therapy, developed by BridgeBio Pharma and Sentynl Therapeutics, was already approved by the FDA in 2021. Clinical data shows that NULIBRY-treated patients have a 7.1 times lower risk of death compared to untreated controls. Sentynl plans to ensure NULIBRY's availability in the EU and is optimizing access through an Early Access Program.
BridgeBio Pharma, Inc. (Nasdaq: BBIO) will participate in several investor conferences, showcasing its commitment to genetic diseases and cancers. Key events include Citi’s 17th Annual BioPharma Conference on September 7 at 8:50 am ET, Morgan Stanley Global Healthcare Conference on September 13 at 7:20 am ET, and Baird Global Healthcare Conference on September 14 at 12:50 pm ET. Live webcasts will be available on BridgeBio’s website, with replays accessible for 90 days post-event. The company focuses on delivering transformative medicines through extensive R&D efforts.
BridgeBio Pharma announced the first patient dosed in its Phase 1 clinical trial of BBP-671, targeting coenzyme A deficiencies, including propionic acidemia (PA) and methylmalonic acidemia (MMA). Interim data showed BBP-671 was detected at therapeutic levels in plasma and cerebrospinal fluid. The company plans to release initial data for patients with PA and MMA in the first half of 2023 and is in talks for a pivotal Phase 2/3 trial for PKAN. If successful, BBP-671 could become a leading treatment for these rare disorders.
NULIBRY is the first approved therapy for MoCD Type A, a rare genetic disorder affecting fewer than 150 patients globally, resulting in a median survival of four years. Recently, it received approval from the State of Israel's Ministry of Health, enhancing access for patients. In July 2022, NULIBRY also garnered a positive opinion from the European Medicines Agency's CHMP, paving the way for potential EU approval. Clinical trials showed that NULIBRY reduced mortality risk by 82% after three years. The drug's commercialization rights are held by Sentynl in various regions.
BridgeBio Pharma (NASDAQ: BBIO) reported positive interim Phase 2 data for infigratinib, showing a mean increase in annualized height velocity (AHV) of 1.52 cm/year in Cohort 4 children aged 5 and older. The company announced a Phase 3 trial for encaleret in autosomal dominant hypocalcemia type 1 (ADH1) and selected a next-generation KRAS G12C dual inhibitor. Financial results revealed a net loss of $9.9 million for Q2 2022, down from $96.3 million a year prior, with $688.6 million in cash and equivalents. The company continues to show robust pipeline momentum.
BridgeBio Pharma announced positive interim results from its Phase 2 trial, PROPEL 2, for infigratinib in children with achondroplasia. At the highest dose (0.128 mg/kg), the mean annualized height velocity (AHV) increased by 1.52 cm/yr (p=0.02, n=11), with a 64% responder rate among participants aged 5 and older. Infigratinib demonstrated a favorable safety profile, with no serious adverse events reported. The company has initiated dosing in Cohort 5 (0.25 mg/kg) after discussions with regulators and aims to present full results by mid-2023.
The CHMP has recommended the approval of NULIBRY for treating molybdenum cofactor deficiency (MoCD) Type A in the EU. This decision is based on robust efficacy and safety data. If approved by the European Commission later this year, NULIBRY will be the first and only therapy for this ultra-rare genetic disorder, which affects fewer than 150 patients globally, with a median survival age of four years. NULIBRY was previously approved by the FDA in 2021 and has shown an 86% reduction in mortality risk in clinical trials compared to historical controls.
BridgeBio Pharma (Nasdaq: BBIO) has partnered with UC Berkeley's Bakar Labs to foster innovation in genetic disease and cancer treatments. This collaboration will support up to 50 startups, leveraging world-class facilities and expertise. CEO Neil Kumar sees the partnership as a way to strengthen the Bay Area biotech ecosystem and expedite the clinical development of new therapies. Bakar Labs aims to facilitate groundbreaking research and shared resources for entrepreneurs, enhancing progress in potential therapies for genetically-driven conditions.
BridgeBio Pharma (Nasdaq: BBIO) announced a collaboration with Baylor College of Medicine on July 21, 2022, to develop therapies for genetic diseases. This partnership aims to leverage Baylor's research capabilities and BridgeBio's drug development expertise to translate innovative findings into practical treatments for patients with unmet medical needs. The collaboration underscores BridgeBio's commitment to fostering meaningful academic partnerships in the biopharmaceutical industry.
BridgeBio Pharma (BBIO) announced positive Phase 1 data for BBP-711, a novel oral therapy aimed at treating primary hyperoxaluria type 1 (PH1) and recurrent kidney stone formation. Results indicated near complete inhibition of glycolate oxidase, significantly increasing plasma glycolate levels. Following its promising tolerability and efficacy, BridgeBio plans to initiate a pivotal Phase 2/3 study by the end of 2022, as well as a Phase 2 study targeting adult recurrent kidney stone formers, which impacts 1.5 million individuals in the U.S. and EU.
