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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 announced the initiation of a Phase 1/2 clinical trial for BBP-398, an investigational SHP2 inhibitor, in combination with OPDIVO for treating patients with KRAS-mutated non-small cell lung cancer (NSCLC). The trial aims to evaluate the safety and preliminary efficacy of this combination, targeting a significant unmet medical need as KRAS mutations are present in approximately 27% of NSCLC cases. If successful, this therapy could enhance treatment options for patients with these mutations. Initial data from this trial is expected later in 2023.
BridgeBio Pharma will present preliminary data on its muscle tissue-based bioassay for LGMD2I patients at the MDA 2023 Annual Meeting from March 19-22 in Dallas, Texas. The company will discuss 15-month Phase 2 data and the design of its Phase 3 clinical trial for BBP-418, expected to start in mid-2023. An oral presentation will be held on March 20, featuring results from the ongoing Phase 2 trial. An investor call with Dr. Jeffrey Rosenfeld is scheduled for March 21 at 8:30 am ET, discussing findings and study updates.
BridgeBio Pharma, Inc. (Nasdaq: BBIO) announced an underwritten public offering of 8,823,530 shares at $17.00 per share, targeting gross proceeds of approximately $150 million. The offering includes a 30-day option for underwriters to purchase an additional 1,323,529 shares. The offering is managed by Goldman Sachs, Evercore ISI, Morgan Stanley, and KKR Capital Markets. Closing is expected around March 10, 2023. The shares are offered under an effective shelf registration statement filed with the SEC. This press release does not constitute an offer to sell or solicit any offers to buy these securities in unlawful jurisdictions.
BridgeBio Pharma, Inc. (Nasdaq: BBIO) has initiated an underwritten public offering of $150 million in common stock, with an additional $22.5 million option for underwriters. The offering is under the management of Goldman Sachs, Evercore, and Morgan Stanley and is subject to market conditions. The shares are offered under an effective shelf registration statement filed with the SEC in July 2020. A preliminary prospectus supplement detailing the offering will be filed shortly. This announcement does not serve as an offer to sell or solicit purchases in jurisdictions where it would be illegal. BridgeBio is dedicated to advancing treatments for genetic diseases and cancers.
BridgeBio Pharma announced positive results from the PROPEL2 Phase 2 trial of infigratinib in children with achondroplasia. Key findings include:
- In Cohort 5, a mean increase in annualized height velocity (AHV) of +3.03 cm/yr (p = 0.0022) was observed at the highest dose (0.25 mg/kg once daily).
- 80% of participants were responders with an average AHV increase of +3.81 cm/yr.
- Median absolute AHV reached 7.6 cm/yr.
- Infigratinib showed a clean safety profile with no treatment-related adverse events.
- BridgeBio is now enrolling for a pivotal Phase 3 trial and exploring infigratinib for hypochondroplasia.
BridgeBio Pharma (Nasdaq: BBIO) announced an investor call on March 6, 2023, at 7:30 am ET to discuss Phase 2 Cohort 5 data from the PROPEL2 clinical trial of infigratinib, targeting achondroplasia. Infigratinib is designed to inhibit fibroblast growth factor receptor 3 (FGFR3), addressing a genetic condition affecting ~55,000 in the US and EU. This genetic disorder can lead to serious health complications, emphasizing the importance of continued research and treatment innovation. For more details, visit BridgeBio's website.
BridgeBio Pharma (Nasdaq: BBIO) reported its Q4 and full-year 2022 financial results, ending the year with $466.2 million in cash and equivalents, down from $787.7 million in 2021. The company incurred a net loss of $484.7 million for the year, with revenues decreasing to $77.6 million from $69.7 million. Key clinical trials continue, including the Phase 3 ATTRibute-CM trial for acoramidis, with topline data expected mid-2023, and the PROPEL 2 trial for infigratinib, expected to report in March 2023. Operating expenses decreased due to restructuring efforts, with total operating costs at $589.9 million.
On February 13, 2023, BridgeBio Pharma (Nasdaq: BBIO) granted 11 new employees restricted stock units totaling 59,800 shares of common stock. These awards were made under the company’s 2019 Inducement Equity Plan, adhering to Nasdaq Listing Rule 5635(c)(4). BridgeBio, a biopharmaceutical firm founded in 2015, focuses on creating medicines for genetic diseases and cancers, leveraging advances in genetic medicine. The company’s pipeline ranges from early-stage research to advanced clinical trials.
BridgeBio Pharma, Inc. (Nasdaq: BBIO) announced a roundtable discussion on February 16, 2023, focusing on the medical and social implications of achondroplasia. The discussion will feature Dr. Melita Irving, a clinical geneticist at Guy's and St Thomas' NHS Foundation Trust, who is known for her expertise in genetic and rare conditions, particularly skeletal dysplasia. The event aims to shed light on the challenges faced by individuals with achondroplasia and explore new treatment options. The live webcast will be accessible on the BridgeBio website, with a replay available for 90 days.
BridgeBio Pharma (Nasdaq: BBIO), a biopharmaceutical company, announced participation in several investor conferences in February and March 2023. Key events include the SVB Securities Global Biopharma Conference on February 14 at 2:20 PM ET, the Goldman Sachs Bus Tour on March 1 at 8:00 AM PT, and the Cowen 43rd Annual Healthcare Conference on March 8 at 10:30 AM ET.
Live webcasts will be available on the company's website, with replays accessible for 90 days post-event. Founded in 2015, BridgeBio focuses on developing transformative medicines for genetic diseases and cancers.
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