Welcome to our dedicated page for Bridgebio Pharma news (Ticker: BBIO), a resource for investors and traders seeking the latest updates and insights on Bridgebio Pharma stock.
BridgeBio Pharma (BBIO) is a biopharmaceutical innovator developing genetic disease therapies through its unique portfolio-based approach. This page serves as the definitive source for official company announcements, clinical trial updates, and strategic developments.
Investors and stakeholders gain centralized access to critical updates including clinical milestones, regulatory filings, financial disclosures, and research partnerships. Our curated feed ensures timely tracking of therapeutic advancements across BridgeBio's diversified pipeline.
Key focus areas include progress in Mendelian disorder treatments, oncology targets, and gene therapy innovations. All content undergoes strict verification to maintain compliance with financial disclosure standards and medical accuracy guidelines.
Bookmark this page for efficient monitoring of BBIO's scientific advancements and corporate developments. Combine this resource with SEC filings and earnings transcripts for comprehensive investment analysis.
BridgeBio Pharma has announced the FDA's acceptance of their New Drug Application (NDA) for infigratinib, an oral FGFR1-3 selective inhibitor aimed at treating cholangiocarcinoma, a rare bile duct cancer. The NDA has been granted a Priority Review designation and is part of the Real-Time Oncology Review (RTOR) pilot program, expediting cancer treatments. This marks BridgeBio's second NDA acceptance, with plans for concurrent reviews in Australia and Canada through Project Orbis. Cholangiocarcinoma affects around 20,000 people annually in the U.S. and EU, with a low five-year survival rate of just 9%.
BridgeBio Pharma (Nasdaq: BBIO) and Navire Pharma have initiated a Phase 1 clinical trial for the SHP2 inhibitor BBP-398, targeting solid tumors with MAPK pathway mutations. The trial, led by MD Anderson’s David S. Hong, aims to evaluate safety and preliminary anti-tumor activity. The study consists of two parts, the first focusing on dose escalation to establish the recommended Phase 2 dose. BBP-398 emerged from collaborative research with MD Anderson, highlighting the potential of SHP2 inhibitors in treating hard-to-manage cancers.
BridgeBio Pharma (Nasdaq: BBIO) has executed a merger agreement with Eidos Therapeutics, aiming to enhance clinical and commercial capabilities for Eidos' acoramidis. The FDA accepted the New Drug Application for fosdenopterin for MoCD Type A under Priority Review. Financially, BridgeBio ended Q3 2020 with $710.7 million in cash and equivalents, a rise from $577.1 million at the end of 2019. However, operating expenses surged to $128.1 million for Q3 2020, up 58% from the previous year, resulting in a net loss of $130.2 million.
On November 1, 2020, BridgeBio Pharma (Nasdaq: BBIO) granted restricted stock units totaling 9,566 shares to three new employees. This initiative is intended to incentivize the employees as they join the company, in compliance with Nasdaq Listing Rule 5635(c)(4). The stock awards are part of BridgeBio's 2019 Inducement Equity Plan, established to reward individuals who contribute to the company's goals. Founded in 2015, BridgeBio focuses on developing treatments for genetic diseases and has over 20 programs in its pipeline.
BridgeBio Pharma (Nasdaq: BBIO) announced the initiation of a Phase 2 study for BBP-589, an investigational recombinant collagen 7 (rC7) therapy, in patients with recessive dystrophic epidermolysis bullosa (RDEB), a severe genetic disorder. The trial is set to enroll six patients, assessing efficacy on wound healing and safety over 30 weeks. Previous Phase 1 results instill confidence in this potential therapy. BBP-589 has Orphan Drug Designation from the FDA and EMA, indicating promise for addressing unmet medical needs in rare diseases.
BridgeBio Pharma and the University of Colorado Anschutz Medical Campus announced a collaboration to advance research on genetically driven diseases into therapeutic applications. This expanded partnership follows an eight-month pilot collaboration, aiming to accelerate early-discovery research and commercialize promising therapies. The collaboration emphasizes a close partnership model between academia and the pharmaceutical industry, focusing on delivering breakthrough medicines for unmet patient needs. BridgeBio's pipeline includes over 20 development programs targeting Mendelian diseases and cancers with clear genetic drivers.
BridgeBio Pharma (Nasdaq: BBIO) has forged a three-year collaboration with the Salk Institute to advance research in genetically driven diseases, particularly in oncology. This partnership aims to translate innovative academic discoveries into therapeutic applications. Salk's cancer research will receive funding, facilitating the development of targeted therapies. Both organizations emphasize the importance of collaboration in accelerating scientific advancements and improving patient outcomes. This alliance marks a significant step in bridging academia and industry for impactful medical innovations.
BridgeBio Pharma (Nasdaq: BBIO) has announced plans to acquire all outstanding shares of Eidos Therapeutics (Nasdaq: EIDX) that it does not already own, equating to approximately 36.3% of Eidos’ shares. Eidos shareholders may choose either 1.85 shares of BridgeBio stock or $73.26 cash per share, with a cash limit of $175 million. This acquisition aims to streamline operations and utilize BridgeBio's development infrastructure to advance Eidos’ acoramidis, a treatment for ATTR, enhancing value for both patients and investors. The transaction is expected to close in Q1 2021, pending shareholder approval.
BridgeBio Pharma announced the FDA's acceptance of its New Drug Application (NDA) for fosdenopterin (previously BBP-870/ORGN001), targeting molybdenum cofactor deficiency (MoCD) Type A. This therapy is the first of its kind, addressing a condition with no approved treatments that often leads to severe neurological injury in children. The NDA has been granted Priority Review, with prior designations including Breakthrough Therapy and Rare Pediatric Disease. This marks BridgeBio's first NDA acceptance, indicating progress in developing vital treatments for rare genetic diseases.
BridgeBio Pharma has announced that the FDA has accepted its New Drug Application (NDA) for fosdenopterin for treating molybdenum cofactor deficiency (MoCD) Type A, a condition with no approved therapies. The NDA is designated for Priority Review and has previously received Breakthrough Therapy and Rare Pediatric Disease Designations. Fosdenopterin is aimed at addressing severe neurological injuries in infants, with median survival of less than four years. This marks BridgeBio's first NDA acceptance, highlighting its commitment to developing treatments for genetic diseases.