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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 (BBIO) reported its Q4 2021 financial results, revealing a net loss of $147.2 million, which translates to a loss per share of $1.01. The company ended the quarter with $787.5 million in cash and equivalents, an increase from $607.1 million a year prior. Key developments included securing up to $750 million in non-dilutive debt financing, dosing its first patient in a Phase 1/2 trial for congenital adrenal hyperplasia (CAH), and initiating collaborations with Amgen and Helsinn Group to advance several oncology treatments.
BridgeBio Pharma announced the initiation of the Phase 1/2 trial for BBP-631, a gene therapy for congenital adrenal hyperplasia (CAH), marking a significant milestone in treatment options for this prevalent genetic disorder affecting over 75,000 individuals in the U.S. and EU. The trial aims to assess the safety and pharmacodynamic activity of BBP-631, potentially allowing patients to produce their own cortisol and aldosterone. Initial data is expected in the latter half of 2022, as BridgeBio advances its commitment to genetic therapies.
Atomwise, a leader in AI-driven small molecule drug discovery, has appointed David Thomson, Ph.D., as Chief Scientific Officer, alongside Jonathan Barr as Chief Financial Officer and Jeffrey Cerio, Pharm.D., J.D., as General Counsel. Dr. Thomson will spearhead the company's drug development strategy, focusing on enhancing their small molecule pipeline. His extensive experience includes leadership roles at Precision BioSciences and Shire. Barr brings expertise from Bridge Bio, where he managed significant capital raises. Cerio has a strong legal background from Moderna. The team aims to advance Atomwise's innovative drug discovery capabilities.
BridgeBio Pharma has announced a non-exclusive clinical collaboration with Amgen to study the combination of BBP-398, a SHP2 inhibitor, with LUMAKRAS (sotorasib), targeting advanced solid tumors with the KRAS G12C mutation. The Phase 1/2 trial will assess safety, pharmacokinetics, and preliminary efficacy. BBP-398 aims to inhibit oncogenic processes driven by KRAS mutations, which occur in approximately 17% of solid tumors. The collaboration builds on existing partnerships with other companies, signaling BridgeBio's commitment to advancing its precision oncology pipeline.
BridgeBio Pharma (BBIO) announced mixed results from the Month 12 analysis of its Phase 3 study, ATTRibute-CM, evaluating acoramidis for treating symptomatic TTR amyloid cardiomyopathy. The primary endpoint—six-minute walk distance—did not show improvement (9m acoramidis, 7m placebo). However, notable improvements were recorded in quality of life, NT-proBNP levels, and serum TTR concentrations. Acoramidis demonstrated good tolerability with fewer adverse events leading to death. The independent monitoring committee has recommended continuing the study into the Month 30 endpoint, focusing on all-cause mortality and cardiovascular hospitalizations.
On December 6, 2021, BridgeBio Pharma (Nasdaq: BBIO) granted restricted stock units totaling 12,073 shares to nine new employees under its 2019 Inducement Equity Plan. This grant complies with Nasdaq Listing Rule 5635(c)(4) and was designed to incentivize employees joining the company. Founded in 2015, BridgeBio focuses on developing transformative medicines for genetic diseases and cancers, with a pipeline of over 30 programs and a goal of delivering its first two approved therapies.
BridgeBio Pharma and Helsinn have announced a strategic collaboration to co-develop a first-in-class GPX4 inhibitor aimed at aiding approximately 500,000 cancer patients with unmet therapeutic needs. This non-exclusive framework agreement builds on their previous $2.45 billion collaboration for the FGFR inhibitor infigratinib. The partnership will leverage BridgeBio's drug discovery expertise and Helsinn's clinical development and commercialization capabilities to enhance the oncology pipeline. The GPX4 inhibitor aims to induce ferroptosis, a process beneficial for treating difficult tumors.
BridgeBio Pharma has secured a credit facility worth up to $750 million, combined with an existing cash balance, granting access to over $1.2 billion to support its genetic disease and cancer pipeline programs through 2024. This strategic financial move, alongside a recent $150 million stock repurchase, aims to strengthen its financial position ahead of critical clinical data readouts. The financing features a 9% fixed interest rate and offers flexibility for future business opportunities.
BridgeBio Pharma (Nasdaq: BBIO) reported its third quarter 2021 financial results, revealing a net loss of $155.9 million, compared to a net loss of $115.9 million in Q3 2020. Revenue decreased to $2.3 million from $8.1 million year-over-year. Operating costs rose to $151.8 million, driven by increased R&D expenses. The company holds $599.6 million in cash and equivalents, down from $607.1 million at year-end 2020. BridgeBio continues to advance its pipeline, with 30 programs and 20 clinical trials. Notably, it received FDA approvals for two drugs earlier this year.
BridgeBio Pharma, Inc. (Nasdaq: BBIO) announced the dosing of the first patient in the CANaspire Phase 1/2 trial for BBP-812, a gene therapy for Canavan disease, which affects approximately 1,000 children in the U.S. and EU. This investigational therapy aims to restore survival and motor function in pediatric patients. Currently, no approved therapies exist for this fatal disease. The trial evaluates safety, tolerability, and pharmacodynamic activity, with results expected in 2022. BBP-812 has received multiple designations from the FDA and EMA, highlighting its potential.
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