BridgeBio Pharma, Inc. - BBIO STOCK NEWS

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.

BridgeBio Pharma (NASDAQ: BBIO) reported positive interim Phase 2 data for infigratinib, showing a mean increase in annualized height velocity (AHV) of 1.52 cm/year in Cohort 4 children aged 5 and older. The company announced a Phase 3 trial for encaleret in autosomal dominant hypocalcemia type 1 (ADH1) and selected a next-generation KRAS G12C dual inhibitor. Financial results revealed a net loss of $9.9 million for Q2 2022, down from $96.3 million a year prior, with $688.6 million in cash and equivalents. The company continues to show robust pipeline momentum.

BridgeBio Pharma announced positive interim results from its Phase 2 trial, PROPEL 2, for infigratinib in children with achondroplasia. At the highest dose (0.128 mg/kg), the mean annualized height velocity (AHV) increased by 1.52 cm/yr (p=0.02, n=11), with a 64% responder rate among participants aged 5 and older. Infigratinib demonstrated a favorable safety profile, with no serious adverse events reported. The company has initiated dosing in Cohort 5 (0.25 mg/kg) after discussions with regulators and aims to present full results by mid-2023.

The CHMP has recommended the approval of NULIBRY for treating molybdenum cofactor deficiency (MoCD) Type A in the EU. This decision is based on robust efficacy and safety data. If approved by the European Commission later this year, NULIBRY will be the first and only therapy for this ultra-rare genetic disorder, which affects fewer than 150 patients globally, with a median survival age of four years. NULIBRY was previously approved by the FDA in 2021 and has shown an 86% reduction in mortality risk in clinical trials compared to historical controls.