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 initiated the pivotal CALIBRATE Phase 3 trial of encaleret for treating autosomal dominant hypocalcemia type 1 (ADH1). This study aims to assess the efficacy of encaleret compared to standard care over 24 weeks, focusing on achieving normal blood and urinary calcium levels. Preliminary Phase 2 results showed that 69% of participants met these targets without standard care. If successful, encaleret could be the first approved therapy specifically for ADH1, impacting an estimated 25,000 patients in the US and EU.
BridgeBio Pharma, Inc. (Nasdaq: BBIO), a biopharmaceutical company focused on genetic diseases and cancers, will present at two upcoming investor conferences. The first, the Jefferies Health Care Conference, will be held in London, UK on November 15 at 9:40 am ET. The second, the Evercore ISI HealthCONx Conference, will take place virtually on November 30 at 10:05 am ET. Live webcasts of the presentations can be accessed via the company's website, with replays available for 90 days following each event.
BridgeBio Pharma reported promising developments in its drug pipeline, including positive preclinical data for BBO-8520, a KRASG12C inhibitor, and updated 12-month Phase 2 results for BBP-418 in Limb-Girdle Muscular Dystrophy Type 2i. Recent trials showed no serious adverse events for infigratinib in achondroplasia. Q3 2022 operating expenses were $129.5 million, down 26.2% from Q1 2022, with cash reserves totaling $558.3 million, ensuring operational stability into 2024. The company continues to progress key trials while actively managing costs.
BridgeBio Pharma (Nasdaq: BBIO) will host an investor call on October 17, 2022, at 1:30 pm ET, to discuss two advanced RAS precision oncology programs, including BBO-8520, a KRAS G12C GTP/GDP dual inhibitor, and a novel PI3Kα:RAS breaker mechanism. BBO-8520 has shown significant potency in KRAS models compared to first-generation inhibitors, with strong activity in vivo and the potential to overcome resistance mechanisms. The PI3Kα:RAS program aims for broad applicability in RAS-driven tumors and potentially avoids hyperglycemia, a common side effect of existing PI3Kα inhibitors.
BridgeBio Pharma announced promising results from a Phase 2 study of its investigational therapy BBP-418 for limb-girdle muscular dystrophy type 2i (LGMD2i). After 12 months, patients showed significant improvements, including a more than 75% reduction in creatine kinase levels and enhancements in functional measures like the north star assessment for dysferlinopathy. The novel assay developed to evaluate alpha-dystroglycan (αDG) glycosylation indicated potential disease modification. Plans to initiate a Phase 3 trial in 2023 are underway, aiming to fill a significant treatment gap for LGMD2i patients.
BridgeBio Pharma, Inc. (Nasdaq: BBIO) announced promising results from its Phase 1/2 clinical trial of BBP-812, a gene therapy for Canavan disease. The preliminary data from three participants show sustained reductions in N-acetylaspartate (NAA) levels, a key disease marker, with reductions of up to 89% in cerebrospinal fluid and 81% in urine. All participants tolerated the treatment well without serious adverse events. The therapy aims to be the first approved treatment for this fatal genetic condition, with further data expected in the first half of 2023.
BridgeBio Pharma announced the initiation of a Phase 1/2 clinical trial for BBP-398, a SHP2 inhibitor, in combination with Amgen's LUMAKRAS for patients with KRAS G12C-mutated non-small cell lung cancer (NSCLC). The trial aims to address the unmet medical need in a patient population with poor survival rates. With approximately 30,000 new diagnoses yearly in the US, the trial leverages promising preclinical data indicating synergistic effects of the combination therapy. Initial results are anticipated by the end of 2024, following the FDA's grant of Fast Track designation.
BridgeBio Pharma, Inc. (Nasdaq: BBIO) will showcase preclinical data for its next-generation KRAS G12C dual inhibitor and PI3Kα:RAS breaker programs at the Fourth RAS Initiative Symposium, scheduled from October 17-19, 2022, in Frederick, MD. The oral presentation will be held on October 17 at 9:50 am ET, led by Dr. Eli Wallace. Additionally, an investor call is set for October 17 at 1:30 pm ET to discuss the findings and future developments. RAS mutations drive 30% of human cancers, highlighting the significance of this research.
The European Commission has granted marketing authorization for NULIBRY® (fosdenopterin), the first treatment for molybdenum cofactor deficiency (MoCD) Type A, an ultra-rare genetic disorder affecting fewer than 150 patients globally. This therapy, developed by BridgeBio Pharma and Sentynl Therapeutics, was already approved by the FDA in 2021. Clinical data shows that NULIBRY-treated patients have a 7.1 times lower risk of death compared to untreated controls. Sentynl plans to ensure NULIBRY's availability in the EU and is optimizing access through an Early Access Program.
BridgeBio Pharma, Inc. (Nasdaq: BBIO) will participate in several investor conferences, showcasing its commitment to genetic diseases and cancers. Key events include Citi’s 17th Annual BioPharma Conference on September 7 at 8:50 am ET, Morgan Stanley Global Healthcare Conference on September 13 at 7:20 am ET, and Baird Global Healthcare Conference on September 14 at 12:50 pm ET. Live webcasts will be available on BridgeBio’s website, with replays accessible for 90 days post-event. The company focuses on delivering transformative medicines through extensive R&D efforts.