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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 (Nasdaq: BBIO) announced two new collaborations with Columbia University and Mount Sinai to develop therapies for genetic diseases and cancers. This strategic partnership enhances BridgeBio's existing network of over 25 collaborations aimed at rapidly progressing therapeutic options for patients. Both institutions will focus on leveraging early-stage innovations to expedite research into potential treatments, continuing BridgeBio's commitment to driving advancements in genetic medicine.
BridgeBio Pharma (Nasdaq: BBIO) reported significant advancements in its KRAS cancer portfolio during its second annual R&D Day on October 12, 2021. The company unveiled the discovery of next-generation G12C dual inhibitors for KRAS cancers, showing over 500-fold potency compared to first-generation inhibitors. BridgeBio also introduced new gene therapy programs, including BBP-818 for classic galactosemia, and shared updates on its cardiorenal and Mendelian programs. In addition, the launch of BridgeBioX aims to enhance early-stage research and innovation in genetic diseases.
BridgeBio Pharma (Nasdaq: BBIO) announced promising preclinical data for its SHP2 inhibitor, BBP-398, targeting non-small cell lung cancer (NSCLC). The data, presented at the AACR-NCI-EORTC Conference, reveals BBP-398's potential as a combination agent with KRAS and EGFR inhibitors. The company is advancing a Phase 1 trial for patients with solid tumors with MAPK pathway mutations. The anticipated continuous once-daily dosing and strong preclinical efficacy could position BBP-398 as a leading treatment option for RAS-driven cancers. Further insights will be shared at the virtual R&D Day on October 12, 2021.
BridgeBio Pharma, Inc. (Nasdaq: BBIO) will hold its second R&D Day on October 12, 2021, at 8:30 a.m. ET, showcasing its pipeline and new programs. The event will feature key executives, including founder and CEO Neil Kumar, discussing 14 clinical programs and over 30 total pipeline programs targeting genetic diseases and cancers. A focus will be on acoramidis, an investigational therapy for transthyretin amyloidosis (ATTR), with topline results expected in late 2021 and 2023. The webcast will be accessible through BridgeBio's investor website.
BridgeBio Pharma (Nasdaq: BBIO) reported updated results from its ongoing Phase 2b study of encaleret for treating Autosomal Dominant Hypocalcemia Type 1 (ADH1). The study involved 13 participants, with encaleret normalizing mean blood calcium levels and 24-hour urine calcium excretion within five days. No serious adverse events were reported, showcasing the drug's tolerability. The company plans to engage regulatory authorities for a Phase 3 study, aiming to develop the first approved therapy for ADH1. The ongoing research highlights a significant unmet medical need in this rare condition.
BridgeBio Pharma (Nasdaq: BBIO) announced that the FDA has granted Fast Track designation for BBP-418, aimed at treating Limb-girdle Muscular Dystrophy Type 2i (LGMD2i). This designation will expedite the development and review process for the therapy, addressing a critical unmet medical need for patients with this rare genetic condition. With 7,000 patients affected by LGMD2i, BBP-418 represents a significant advancement in BridgeBio's pipeline, which includes multiple ongoing programs in genetic diseases and cancers.
BridgeBio Pharma announced on September 2, 2021, the granting of restricted stock units totaling 61,210 shares to 29 new employees. This initiative aims to incentivize new hires and is in accordance with Nasdaq Listing Rule 5635(c)(4). These awards were made under the 2019 Inducement Equity Plan, which was approved in November 2019. BridgeBio focuses on developing transformative medicines for genetic diseases and cancers, with over 30 development programs currently in progress.
LianBio and BridgeBio Pharma announced the treatment of the first patient in a Phase 2a clinical trial of infigratinib for gastric cancer with FGFR2 gene amplification in China. This study is critical due to China's high gastric cancer prevalence. Infigratinib, an FGFR inhibitor, is already approved in the U.S. for cholangiocarcinoma and is being evaluated for other cancers. The trial's primary endpoint is objective response rate, with significant implications for treatment options in Asia.
BridgeBio Pharma, Inc. (Nasdaq: BBIO) announced the addition of three independent directors to its board: Fred Hassan, a veteran of the pharmaceutical industry; Andrea Ellis, CFO of Lime; and Douglas Dachille, former CIO of AIG. These appointments aim to enhance BridgeBio's strategic direction and expand its commercial infrastructure as it advances therapies for genetic diseases. CEO Neil Kumar expressed confidence that their diverse expertise will strengthen the company's mission. BridgeBio, founded in 2015, is focused on innovative therapies for patients with genetic conditions.
BridgeBio Pharma, Inc. (Nasdaq: BBIO) reported second-quarter financial results for the period ending June 30, 2021, with total revenues of $54.0 million. The company achieved its second FDA approval for TRUSELTIQ™ (infigratinib) for cholangiocarcinoma, a significant milestone. Operating costs rose to $148.0 million due to increased personnel and stock-based compensation, leading to a net loss of $102.1 million. Cash and cash equivalents totaled $898.4 million, highlighting a strong liquidity position despite rising expenses.
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