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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) has received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA for BBP-812, its gene therapy program for Canavan disease. This designation is based on promising clinical evidence from the CANaspire Phase 1/2 trial, which showed functional improvements in all dosed patients. RMAT status offers benefits like faster and more frequent FDA interactions, potentially accelerating the approval process.
Key points:
- BBP-812 is an intravenous AAV9 gene therapy for Canavan disease
- All patients in the trial showed improvements in key functional areas
- The therapy has been well-tolerated with a safety profile consistent with other AAV9 gene therapies
- BBP-812 also has Orphan Drug, Rare Pediatric Disease, and Fast Track Designations
If approved, BBP-812 could be the first treatment option for this fatal neurodevelopmental disorder.
BridgeBio Pharma (Nasdaq: BBIO) announced topline results from its Phase 1/2 ADventure study of BBP-631, an investigational gene therapy for congenital adrenal hyperplasia (CAH). The study showed increased endogenous cortisol production in all patients at higher doses, with a maximum change from baseline of 6.6 μg/dL. The therapy was well-tolerated with no treatment-related serious adverse events. Despite these advancements, BridgeBio decided the data do not warrant additional capital investment. The company is reducing its gene therapy budget by over $50M and seeking partnership opportunities for future development of BBP-631 or next-generation CAH gene therapies.
BridgeBio Pharma (Nasdaq: BBIO), a commercial-stage biopharmaceutical company focused on genetic diseases, has announced the approval of equity grants for 123 new employees. The grants, approved on September 4, 2024, consist of restricted stock units totaling 359,926 shares of the Company's common stock. The vesting schedule begins with one-fourth of the shares vesting on August 16, 2025, followed by quarterly vesting of one-twelfth of the remaining shares, subject to continued employment. These awards were made under BridgeBio's Amended and Restated 2019 Inducement Equity Plan, in accordance with Nasdaq Listing Rule 5635(c)(4), as inducement material for new employees joining the Company.
BridgeBio Pharma (Nasdaq: BBIO) presented additional data from its Phase 3 ATTRibute-CM and open-label extension study of acoramidis in ATTR-CM at ESC 2024. Key findings include:
1. Participants switching from tafamidis and placebo to acoramidis showed a mean increase in serum TTR of 3.0mg/dL at Month 1 and 3.4mg/dL at Month 6 of the OLE.
2. Increased serum TTR at Day 28 correlated with reduced risk of all-cause mortality, cardiovascular mortality, and cardiovascular-related hospitalization.
3. Acoramidis demonstrated a 42% reduction in composite CVH and ACM events and a 50% reduction in cumulative CVH events at Month 30.
BridgeBio has submitted regulatory applications for acoramidis, with FDA PDUFA date set for November 29, 2024, and EMA decision expected in 2025.
BridgeBio Pharma (Nasdaq: BBIO) announced that additional data from its Phase 3 ATTRibute-CM study of acoramidis in ATTR-CM will be presented at two major conferences. At the ESC Congress 2024 in London (Aug 30 - Sep 2), Dr. Mathew S. Maurer will present a moderated poster on the increase in serum TTR levels observed with acoramidis treatment. At the HFSA Annual Scientific Meeting 2024 in Atlanta (Sep 27-30), Dr. Daniel P. Judge will give an oral presentation on how acoramidis improves clinical outcomes in ATTR-CM patients, based on a post hoc recurrent event analysis. These presentations aim to provide further insights into the efficacy of acoramidis in treating transthyretin amyloid cardiomyopathy.
BridgeBio Pharma (Nasdaq: BBIO), a commercial-stage biopharmaceutical company focused on genetic diseases, has announced its participation in three major investor conferences in September 2024:
1. Morgan Stanley 22nd Annual Global Health Care Conference in New York, NY on September 4th at 10:00 am ET (Fireside Conversation)
2. Wells Fargo 19th Annual Healthcare Conference 2024 in Boston, MA on September 5th
3. Cantor Global Healthcare Conference in New York, NY on September 17th at 10:20 am ET (Presentation)
Investors can access live webcasts of BridgeBio's presentations on the company's website. Replay of the webcasts will be available for 90 days following each event.
BridgeBio Pharma (Nasdaq: BBIO) has initiated a scientific collaboration with the CarDS Lab at Yale School of Medicine to address the underdiagnosis of transthyretin amyloid cardiomyopathy (ATTR-CM). The TRACE-AI Network Study will deploy a scalable screening toolkit across diverse health system electronic health records (EHRs) to identify individuals with ATTR-CM earlier and quantify the potential prevalence of undiagnosed cases.
The CarDS Lab has developed novel deep learning tools applied to real-world data sets, including AI-electrocardiography, AI-point-of-care ultrasound, and AI-echocardiography, which may identify potentially missed ATTR-CM cases with high accuracy. This initiative aims to improve diagnosis across the U.S. and potentially enhance outcomes for patients in need.
BridgeBio Pharma (Nasdaq: BBIO) and its affiliate QED Therapeutics have launched MyAchonJourney, an online resource for families navigating achondroplasia. Developed in collaboration with skeletal dysplasia community leaders, the initiative aims to provide education and support for families affected by achondroplasia.
The initial phase of MyAchonJourney offers guidance on medical topics, psychosocial issues, and quality-of-life adaptations for children up to five years old. It covers pregnancy, birth, infancy, toddlerhood, and early childhood, with plans to expand resources for older children, teenagers, and young adults in future phases.
The platform was created with input from a task force of experts, including medical professionals and community advocates, to ensure comprehensive and reliable information for families navigating life with achondroplasia.
BridgeBio Pharma (Nasdaq: BBIO), a commercial-stage biopharmaceutical company focusing on genetic diseases, has announced the approval of equity grants for 17 new employees. The grants, approved by the compensation committee on August 6, 2024, consist of restricted stock units totaling 71,859 shares of the company's common stock. The vesting schedule includes one-fourth of the shares vesting on August 16, 2025, followed by quarterly vesting of one-twelfth of the remaining shares, subject to continued employment. These grants were made under BridgeBio's Amended and Restated 2019 Inducement Equity Plan, in accordance with Nasdaq Listing Rule 5635(c)(4), as inducements for the new employees joining the company.
BridgeBio Pharma reported its Q2 2024 financial results, focusing on significant clinical trial progress and financial updates. Acoramidis demonstrated a 42% reduction in composite CVH and ACM events by Month 30, with improvements starting by Month 3. Infigratinib showed +2.50 cm/yr annualized height velocity at Month 18 in Cohort 5 of the PROPEL 2 study. The company exceeded its enrollment target for the Phase 3 FORTIFY study of BBP-418 in LGMD2I/R9. Financially, BridgeBio ended the quarter with $587M in cash, driven by various financing activities. Revenue for the quarter was $2.2M, up from $1.6M in the same period last year, primarily due to collaborations with Bayer and Kyowa Kirin. Operating costs increased to $177.7M, leading to a net loss per share of $0.39, an improvement from $0.98 in Q2 2023.
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