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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.
On November 1, 2020, BridgeBio Pharma (Nasdaq: BBIO) granted restricted stock units totaling 9,566 shares to three new employees. This initiative is intended to incentivize the employees as they join the company, in compliance with Nasdaq Listing Rule 5635(c)(4). The stock awards are part of BridgeBio's 2019 Inducement Equity Plan, established to reward individuals who contribute to the company's goals. Founded in 2015, BridgeBio focuses on developing treatments for genetic diseases and has over 20 programs in its pipeline.
BridgeBio Pharma (Nasdaq: BBIO) announced the initiation of a Phase 2 study for BBP-589, an investigational recombinant collagen 7 (rC7) therapy, in patients with recessive dystrophic epidermolysis bullosa (RDEB), a severe genetic disorder. The trial is set to enroll six patients, assessing efficacy on wound healing and safety over 30 weeks. Previous Phase 1 results instill confidence in this potential therapy. BBP-589 has Orphan Drug Designation from the FDA and EMA, indicating promise for addressing unmet medical needs in rare diseases.
BridgeBio Pharma and the University of Colorado Anschutz Medical Campus announced a collaboration to advance research on genetically driven diseases into therapeutic applications. This expanded partnership follows an eight-month pilot collaboration, aiming to accelerate early-discovery research and commercialize promising therapies. The collaboration emphasizes a close partnership model between academia and the pharmaceutical industry, focusing on delivering breakthrough medicines for unmet patient needs. BridgeBio's pipeline includes over 20 development programs targeting Mendelian diseases and cancers with clear genetic drivers.
BridgeBio Pharma (Nasdaq: BBIO) has forged a three-year collaboration with the Salk Institute to advance research in genetically driven diseases, particularly in oncology. This partnership aims to translate innovative academic discoveries into therapeutic applications. Salk's cancer research will receive funding, facilitating the development of targeted therapies. Both organizations emphasize the importance of collaboration in accelerating scientific advancements and improving patient outcomes. This alliance marks a significant step in bridging academia and industry for impactful medical innovations.
BridgeBio Pharma (Nasdaq: BBIO) has announced plans to acquire all outstanding shares of Eidos Therapeutics (Nasdaq: EIDX) that it does not already own, equating to approximately 36.3% of Eidos’ shares. Eidos shareholders may choose either 1.85 shares of BridgeBio stock or $73.26 cash per share, with a cash limit of $175 million. This acquisition aims to streamline operations and utilize BridgeBio's development infrastructure to advance Eidos’ acoramidis, a treatment for ATTR, enhancing value for both patients and investors. The transaction is expected to close in Q1 2021, pending shareholder approval.
BridgeBio Pharma announced the FDA's acceptance of its New Drug Application (NDA) for fosdenopterin (previously BBP-870/ORGN001), targeting molybdenum cofactor deficiency (MoCD) Type A. This therapy is the first of its kind, addressing a condition with no approved treatments that often leads to severe neurological injury in children. The NDA has been granted Priority Review, with prior designations including Breakthrough Therapy and Rare Pediatric Disease. This marks BridgeBio's first NDA acceptance, indicating progress in developing vital treatments for rare genetic diseases.
BridgeBio Pharma has announced that the FDA has accepted its New Drug Application (NDA) for fosdenopterin for treating molybdenum cofactor deficiency (MoCD) Type A, a condition with no approved therapies. The NDA is designated for Priority Review and has previously received Breakthrough Therapy and Rare Pediatric Disease Designations. Fosdenopterin is aimed at addressing severe neurological injuries in infants, with median survival of less than four years. This marks BridgeBio's first NDA acceptance, highlighting its commitment to developing treatments for genetic diseases.
BridgeBio Pharma, a clinical-stage biopharmaceutical company focused on genetic diseases and cancers, will host its first R&D Day on September 29 at 8:30 am E.T. The virtual event will showcase presentations from BridgeBio's leadership and external experts. Key focus areas include the company’s drug engineering platform and targeted oncology portfolio, with four highlighted programs expected to present clinical data in the next 12-24 months: acoramidis for transthyretin amyloidosis, low-dose infigratinib for achondroplasia, AAV5 gene therapy for congenital adrenal hyperplasia, and encaleret for autosomal dominant hypocalcemia type 1.
BridgeBio Pharma's affiliate, Calcilytix Therapeutics, has initiated a Phase 2 study for encaleret (CLTX-305), targeting ADH1, a rare genetic condition causing low serum calcium levels. The study, conducted at the NIH, aims to enroll 16 participants to assess the drug’s safety and efficacy. Currently, there are no approved treatments for ADH1, with conventional therapies often exacerbating symptoms. Topline proof-of-concept results are anticipated in 2021, aiming to address significant unmet medical needs for patients suffering from this debilitating disorder.
BridgeBio Pharma (Nasdaq: BBIO) announced on September 1, 2020, the granting of options to purchase 18,231 shares and restricted stock units for 19,915 shares under its 2019 Inducement Equity Plan. The compensation committee made these grants to 10 new employees as an inducement for their employment, adhering to Nasdaq Listing Rule 5635(c)(4). These awards are part of BridgeBio's effort to attract talent as it advances its pipeline of over 20 programs targeting genetic diseases and cancers with genetic drivers.
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