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BridgeBio Pharma, Inc. develops and commercializes medicines for genetic conditions through a decentralized biopharmaceutical model. News for BBIO centers on Attruby/acoramidis, its oral transthyretin stabilizer for transthyretin amyloid cardiomyopathy (ATTR-CM), including clinical data from ATTRibute-CM, commercial updates, Brazil marketing authorization under the BEYONTTRA name, and licensing or commercialization arrangements.
Company updates also cover late-stage genetic-disease programs such as encaleret for autosomal dominant hypocalcemia type 1, BBP-418 for limb-girdle muscular dystrophy type 2I/R9, and oral infigratinib for achondroplasia. Recurring financial and corporate items include quarterly results, product revenue trends, capital actions, employee equity inducement grants, investor conference participation, and pipeline regulatory disclosures.
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.
BridgeBio Pharma announced the first patient dosed in its Phase 1 clinical trial of BBP-671, targeting coenzyme A deficiencies, including propionic acidemia (PA) and methylmalonic acidemia (MMA). Interim data showed BBP-671 was detected at therapeutic levels in plasma and cerebrospinal fluid. The company plans to release initial data for patients with PA and MMA in the first half of 2023 and is in talks for a pivotal Phase 2/3 trial for PKAN. If successful, BBP-671 could become a leading treatment for these rare disorders.
NULIBRY is the first approved therapy for MoCD Type A, a rare genetic disorder affecting fewer than 150 patients globally, resulting in a median survival of four years. Recently, it received approval from the State of Israel's Ministry of Health, enhancing access for patients. In July 2022, NULIBRY also garnered a positive opinion from the European Medicines Agency's CHMP, paving the way for potential EU approval. Clinical trials showed that NULIBRY reduced mortality risk by 82% after three years. The drug's commercialization rights are held by Sentynl in various regions.