PALO ALTO, Calif. — BridgeBio Pharma, Inc. (Nasdaq: BBIO), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, today shared positive results from the Japan Phase III trial of acoramidis in adults with transthyretin-mediated amyloid with cardiomyopathy (ATTR-CM), conducted by Alexion, AstraZeneca Rare Disease. Results showed consistency to those...
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PALO ALTO, Calif. — BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, announced that updated data from CANaspire, its Phase 1/2 clinical trial of BBP-812, an investigational intravenous (IV) adeno-associated virus serotype 9 (AAV9) gene therapy for the treatment...
PALO ALTO, Calif. & LUGANO, Switzerland – BridgeBio Pharma, Inc. (Nasdaq: BBIO), through its affiliate QED Therapeutics, Inc., and Helsinn Group today announced that the US Food and Drug Administration (FDA) has approved TRUSELTIQ™ (infigratinib) under the accelerated approval program for the treatment of patients with previously-treated locally advanced or...
PALO ALTO, Calif. — BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a new type of biopharmaceutical company focused on genetic diseases, today announced positive topline results from CALIBRATE, its global Phase 3 study of encaleret in autosomal dominant hypocalcemia type 1 (ADH1). CALIBRATE was designed to study the...
PALO ALTO, Calif. — BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage, multi-product biopharmaceutical company focused on developing medicines for genetic conditions, today announced the submission of its New Drug Application (NDA) to the FDA for encaleret as a potential targeted treatment for autosomal dominant hypocalcemia type...
Palo Alto, California – BridgeBio Pharma is positioning its oral achondroplasia therapy as a potential alternative to injectable treatments after late-stage data showed the drug not only increased growth but also improved body proportions in children—an outcome analysts view as a key competitive advantage. The company said Sunday that it...
New York, NY – Bristol Myers Squibb (NYSE: BMY) today announced that the pivotal Phase 3 KRYSTAL-12 study, evaluating KRAZATI® (adagrasib) as a monotherapy in patients with pretreated locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring a KRASG12C mutation, met the primary endpoint of progression-free survival (PFS) and...
New York, NY – It isn’t often that a single company has an advisory committee meeting for one product and an FDA decision for another in the same week. Even more unusual is when the two drugs are of the same therapeutic class. That’s what’s happening this week for Bristol...
PRINCETON, N.J. –– Bristol Myers Squibb (NYSE: BMY) reinforces its hematology leadership through new research across multiple therapies for patients with lymphoma at the 67th American Society of Hematology (ASH) Annual Meeting. Highlights include updates from the company’s targeted protein degradation pipeline, including data on first-in-class investigational lymphoma CELMoD™ agent golcadomide and first-in-class...
PRINCETON, N.J. – Bristol Myers Squibb (NYSE: BMY) announced positive topline results from the Phase 3 CheckMate -648 trial evaluating treatment with Opdivo (nivolumab) plus chemotherapy or Opdivo plus Yervoy (ipilimumab) in patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC). In the study, Opdivo plus chemotherapy demonstrated a statistically...