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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, Inc. (Nasdaq: BBIO) announced the granting of 21,414 restricted stock units to 17 new employees on August 3, 2021. This issuance is part of the company's 2019 Inducement Equity Plan, ensuring compliance with Nasdaq Listing Rule 5635(c)(4). Founded in 2015, BridgeBio focuses on developing innovative treatments for genetic diseases and cancers. The company has over 30 programs in its pipeline, aiming to expedite the delivery of its first approved therapy.
BridgeBio Pharma has announced a non-exclusive collaboration with Bristol Myers Squibb to evaluate BBP-398, a promising SHP2 inhibitor, in combination with OPDIVO® for treating advanced solid tumors with KRAS mutations. The collaboration includes a Phase 1/2 trial assessing the safety and efficacy of BBP-398 alongside OPDIVO as doublet therapy and with a KRASG12C inhibitor as triplet therapy in non-small cell lung cancer. Both companies will co-fund the clinical development activities. BRIDGE Bio aims to provide new treatment options for patients with difficult-to-treat cancers.
BridgeBio Pharma (Nasdaq: BBIO) announced on July 1, 2021, that its compensation committee granted 20 new employees restricted stock units totaling 26,761 shares. This was done as an inducement for new hires, in compliance with Nasdaq Listing Rule 5635(c)(4). These awards were made under BridgeBio's 2019 Inducement Equity Plan, which aims to attract talent in the biopharmaceutical sector to develop treatments for genetic diseases and cancers. The company has over 30 ongoing development programs focused on advancing its first approved therapy.
BridgeBio Pharma (Nasdaq: BBIO) announced collaborations with three academic institutions: MUSC Foundation for Research Development, Stanford University, and the University of Pittsburgh. These partnerships aim to translate innovative research into therapies for genetic diseases and cancers. BridgeBio's CEO, Neil Kumar, emphasized the significance of these collaborations in accelerating the development of life-changing medicines. The company has previously partnered with 23 institutions, showcasing its commitment to advancing patient treatment options.
On June 1, 2021, BridgeBio Pharma (Nasdaq: BBIO) granted restricted stock units totaling 47,963 shares to 21 new employees under the 2019 Inducement Equity Plan. This action is compliant with Nasdaq Listing Rule 5635(c)(4) and aims to incentivize new hires. BridgeBio is dedicated to developing medicines for genetic diseases and cancers, with over 30 programs in its pipeline. Founded in 2015, the company focuses on rapid advancements in genetic medicine to benefit patients.
BridgeBio Pharma (Nasdaq: BBIO) announced that the FDA granted Fast Track designation to encaleret for treating autosomal dominant hypocalcemia (ADH1). This rare genetic condition affects approximately 12,000 people in the U.S., causing severe calcium regulation issues. Current treatments are insufficient. Promising early results from a Phase 2b study show 100% normalization of blood and urine calcium in participants. This designation may expedite development and approval of encaleret, potentially the first therapy specifically for ADH1.
BridgeBio Pharma and Helsinn announced the FDA's approval of TRUSELTIQ (infigratinib) for previously-treated patients with locally advanced or metastatic cholangiocarcinoma (CCA) harboring an FGFR2 fusion. This marked BridgeBio's first oncology product approved by the FDA and the second overall this year. In clinical trials, TRUSELTIQ demonstrated a objective response rate of 23% and a median duration of response of 5 months. The companies will co-commercialize TRUSELTIQ in the U.S., sharing profits and losses equally.
On May 4, 2021, BridgeBio Pharma, Inc. (Nasdaq: BBIO) announced the granting of restricted stock units for 70,949 shares to 27 new employees. This decision was made by the compensation committee under the company's 2019 Inducement Equity Plan, in compliance with Nasdaq Listing Rule 5635(c)(4). The Plan aims to incentivize new hires effectively. Founded in 2015, BridgeBio focuses on developing medicines for genetic diseases and cancers, with over 30 programs in various clinical stages.
BridgeBio Pharma (Nasdaq: BBIO) announced FDA Fast Track designation for BBP-631, a gene therapy for congenital adrenal hyperplasia (CAH). This designation aims to expedite the development of treatments addressing significant unmet medical needs. CAH affects over 75,000 cases in the U.S. and Europe. The company also presented preclinical data supporting the safety and efficacy of BBP-631 at the ASGCT Annual Meeting. Initial clinical trials are anticipated to begin soon, with data expected in late 2021 or early 2022.
BridgeBio Pharma has achieved significant milestones, including FDA approval for NULIBRY™ (fosdenopterin) as the first treatment for molybdenum cofactor deficiency Type A. The company reported proof-of-concept data for encaleret in Autosomal Dominant Hypocalcemia Type 1. A collaboration with Helsinn Group aims to co-develop infigratinib in oncology, with potential earnings of up to $2.45 billion. The completion of Eidos Therapeutics acquisition and the issuance of $750 million in Convertible Senior Notes bolster financial stability, ending Q1 2021 with $1 billion in cash and securities.
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