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BridgeBio Pharma, Inc. (Nasdaq: BBIO) is a pioneering commercial-stage biopharmaceutical company that specializes in the discovery, creation, and delivery of transformative medicines for patients suffering from genetic diseases and cancers with clear genetic drivers. Established in 2015, the company is headquartered in Palo Alto, California. BridgeBio's mission is to address significant unmet medical needs through genetic medicine by leveraging a comprehensive pipeline of development programs that span from early-stage scientific research to late-stage clinical trials.
The company's core focus areas include Mendelian diseases, Genetic Dermatology, Oncology, and Gene Therapy. BridgeBio’s innovative approach involves systematically mapping the genetic disease landscape to identify promising therapeutic assets. Their proprietary platform and management expertise are harnessed to accelerate the development of these early-stage assets into clinically impactful treatments.
BridgeBio’s robust pipeline boasts several notable programs:
- Acoramidis (AG10): Aiming to treat transthyretin amyloid cardiomyopathy (ATTR-CM), this next-generation, orally-administered TTR stabilizer has shown positive results in the Phase 3 ATTRibute-CM trial. The New Drug Application (NDA) for acoramidis has been accepted by the FDA, with a target decision date set for November 29, 2024.
- Infigratinib: Targeting achondroplasia and hypochondroplasia, this FGFR1-3 inhibitor aims to address skeletal dysplasias. The PROPEL 2 Phase 2 trial has demonstrated significant and sustained increases in growth velocity.
- BBP-418: Designed for limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9), this glycosylation substrate is under Phase 3 trials, with the potential for accelerated approval based on recent interactions with the FDA.
BridgeBio's track record includes successful capital raises, strategic partnerships, and a series of public offerings that have strengthened its financial positioning. The company recently completed a $200 million private financing for its oncology subsidiary, BridgeBio Oncology Therapeutics, to accelerate the development of its precision oncology pipeline.
Key recent developments include:
- The initiation of a comprehensive equity grants program to attract top talent in the biopharmaceutical industry.
- Positive results from multiple clinical trials, including significant improvements in health-related quality of life measures for patients with ATTR-CM treated with acoramidis.
- Ongoing collaborations with global pharmaceutical leaders like Bayer for the commercial development and distribution of key assets in international markets.
BridgeBio remains committed to advancing genetic medicine and delivering groundbreaking therapies to improve patient lives. For more information, visit bridgebio.com and follow them on LinkedIn and Twitter.
BridgeBio Pharma, Inc. (Nasdaq: BBIO) announced participation in several investor conferences. Key events include the Citi Transthyretin Amyloid Cardiomyopathy (ATTR-CM) Panel on May 18 at 2:30 PM ET, and multiple sessions on May 24, including H. C. Wainwright Global Investment Conference at 7:00 AM ET, UBS Global Healthcare Conference at 11:30 AM ET, and J. P. Morgan West Coast Investor Day at 12:00 PM ET. For more details, visit the BridgeBio Investors page.
BridgeBio Pharma (BBIO) announced the sale of its Priority Review Voucher (PRV) for $110 million, following its acquisition in February 2021. The PRV was received after FDA approval of NULIBRY for treating molybdenum cofactor deficiency. The sale is subject to standard closing conditions. Additionally, the company secured a two-year extension on its interest-only period under its senior secured credit facility, delaying principal repayments to November 2026. These strategic moves aim to boost the development of drug programs targeting genetic diseases and cancers.
BridgeBio Pharma has secured an exclusive license with Bristol Myers Squibb for BBP-398, a SHP2 inhibitor aimed at treating challenging cancers. The deal includes an upfront payment of $90 million and potential total payments reaching $905 million from milestones and royalties. BridgeBio will continue leading ongoing clinical trials, while Bristol Myers Squibb will manage future development and commercialization. This collaboration aims to enhance treatment options for patients with advanced solid tumors, particularly those with KRAS mutations.
BridgeBio Pharma, a biopharmaceutical company focused on genetic diseases and cancers, announced its management team's participation in the Bank of America Securities Healthcare Conference on May 11, 2022, at 7:40 pm ET. Investors can access the live webcast on the 'Events & Presentations' page of BridgeBio's website, with a replay available for 90 days post-event. Founded in 2015, BridgeBio aims to develop transformative medicines for patients with genetic conditions, showcasing a commitment to genetic medicine.
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.
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