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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'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.
BridgeBio Pharma (Nasdaq: BBIO) announced the grant of stock options and restricted stock units to 22 employees on August 3, 2020. The total awards comprise options for 30,443 shares and restricted units for 61,760 shares, with an exercise price of $27.20 per share. These grants are part of the 2019 Inducement Equity Plan, established to incentivize new employees under Nasdaq Listing Rule 5635(c)(4). Founded in 2015, BridgeBio focuses on developing transformative medicines for genetic diseases, holding a diverse pipeline of over 20 programs.
BridgeBio Pharma (Nasdaq: BBIO) reported second-quarter results for 2020, achieving significant milestones in its clinical pipeline and collaborations. The company initiated four clinical trials and submitted three IND applications to the FDA, with a reported cash position of $840.9 million as of June 30, 2020. BridgeBio expanded its global presence through a partnership with LianBio, focusing on oncology, with potential payments of $26.5 million upfront and up to $505 million in future milestones. Operating expenses increased to $124.6 million, resulting in a net loss of $136.2 million for the quarter.
BridgeBio Pharma (NASDAQ: BBIO) announces a strategic partnership with LianBio to expand its presence in China, a significant pharmaceutical market. The collaboration involves initial $26.5 million in payments and potential future milestones of up to $505 million. It focuses on the development of FGFR inhibitor infigratinib and SHP2 inhibitor BBP-398 for cancers with genetic mutations. BridgeBio aims to address patient needs in Asia by leveraging LianBio's local access and expertise. CEO Neil Kumar joins LianBio's board, reinforcing their partnership.
BridgeBio Pharma announced that the first patient has been dosed in a Phase 0/2 clinical trial of infigratinib, an investigational drug targeting FGFR genetic alterations in recurrent high-grade glioma patients. This trial aims to confirm the drug’s effectiveness in crossing the blood-brain barrier and hitting molecular targets. Patients showing positive pharmacokinetic responses will continue treatment post-surgery. The primary endpoint is a six-month progression-free survival rate. FGFR alterations are present in 5-7% of glioblastoma cases, highlighting the drug's potential impact.
BridgeBio Pharma's affiliate, QED Therapeutics, has initiated the PROPEL 2 Phase 2 clinical trial, dosing the first child with achondroplasia using infigratinib, an oral medicine targeting FGFR3. This trial aims to assess safety and measure height growth impact. Preclinical data show potential for significant growth improvement. CEO Michael Henderson emphasized the trial's significance, highlighting the extensive preparatory work. Infigratinib operates as a selective tyrosine kinase inhibitor, and the trial follows previous assessments demonstrating its efficacy at lower doses.
BridgeBio Pharma's affiliate, Phoenix Tissue Repair, announced the presentation of interim safety and tolerability data from a Phase 1/2 trial for PTR-01, a recombinant collagen 7 therapy aimed at treating recessive dystrophic epidermolysis bullosa (RDEB). The results will be shared virtually during the Society for Pediatric Dermatology’s Annual Meeting from July 10-12, 2020. PTR-01 has previously shown promising preclinical results, with Orphan Drug Designation granted by the FDA and EMA. Currently, no approved therapies exist for DEB, and the standard care is limited to wound management.
BridgeBio Pharma, Inc. (Nasdaq: BBIO) announced on July 1, 2020, that it granted stock options for 7,120 shares and restricted stock units for 15,134 shares to eight employees. The exercise price for the stock options is set at $30.34. These awards are part of BridgeBio's 2019 Inducement Equity Plan and were granted to incentivize employees joining the company, complying with Nasdaq Listing Rule 5635(c)(4). Founded in 2015, BridgeBio focuses on developing medicines for genetic diseases and has over 20 programs in its pipeline.
BridgeBio Pharma (NASDAQ: BBIO) announced the appointment of three new independent directors: Brent Saunders, Randy Scott, Ph.D., and Andrew Lo, Ph.D. Saunders, former CEO of Allergan, brings expertise in scaling businesses, having driven significant product launches and revenue growth. Scott, a leader in genomics, aims to revolutionize genetic medicine application, while Lo will leverage his financial engineering background to enhance funding strategies. This leadership expansion aims to accelerate the development of innovative therapies for genetic diseases.
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