Here are the latest stories being discussed in biopharma today:
Sanofi Touts Phase 3 Sarclisa Data in Multiple Myeloma, Chasing J&J’s Darzalex
Sanofi has revealed promising Phase 3 results for Sarclisa in newly-diagnosed multiple myeloma patients, positioning it for a potential U.S. launch this year. The French pharmaceutical giant aims to differentiate Sarclisa from Johnson & Johnson’s market-leading CD38 inhibitor, Darzalex. The IMROZ trial tested Sarclisa combined with bortezomib, lenalidomide, and dexamethasone (VRd) against just VRd in 446 transplant-ineligible patients. Nearly five years on, the Sarclisa regimen has notably not yet reached the median progression-free survival threshold and showed a 40% reduced risk of disease progression or death compared to the control group.
Agios Plans Thalassemia Filing in the U.S. Following Positive Data
Agios Pharmaceuticals saw a surge in its stock price by over 19% on Monday after unveiling data that its oral candidate for thalassemia significantly cut the need for transfusions in a Phase 3 trial. Preparations are underway to seek U.S. approval by late 2024. The drug, mitapivat (already branded as Pyrukynd for pyruvate kinase deficiency), posted wins in both transfusion-dependent and non-dependent thalassemia patients. CEO Brian Goff emphasized the company’s focus on expanding its infrastructure to support a 2025 U.S. launch.
Delaware Court Moves Forward with Zantac Lawsuits, $8B+ Wiped from GSK Market Cap
GSK’s shares plummeted more than 9% early Monday after a Delaware court greenlighted over 70,000 Zantac-related lawsuits. The court ruled that the scientific methods used by the plaintiffs’ experts were reliable enough to be presented at trial. This decision enables experts to testify before a jury about the alleged connection between Zantac and cancer, although it doesn’t determine liability. A similar ruling in California last year led to settlements outside of court, avoiding jury trials. Earlier this year, a Zantac case in Chicago resulted in a win for the defendants.
Fauci Defends Pandemic Response Amid Divided House Panel Attacks
Four years post-pandemic onset, former top infectious disease official Anthony Fauci testified before lawmakers on Monday, defending his handling of the Covid-19 crisis. The heated hearing included debates on gain-of-function research definitions, vaccine efficacy in preventing virus transmission, and NIH researchers’ royalties from drug developments. Representative Brad Wenstrup criticized Fauci’s leadership, accusing him of dismissing legitimate questions about the vaccine and not sufficiently considering the lab-origin theory for the virus.
ASCO Highlights: Big Readouts and Revenue Questions amid ADC Developments
CHICAGO – A staggering turnout of over 40,000 professionals in cancer research gathered at McCormick Place for the ASCO annual meeting. Dominated by large pharmaceutical companies, the event featured pivotal data releases, including insights on antibody-drug conjugates’ successes and failures and promising lung cancer treatments. Novartis also shared updates on its third-gen chronic myeloid leukemia medication. Attendees navigated through an impressive array of posters and pharmaceutical booths, showcasing the varied scales of companies’ presence from modest setups to sprawling spaces.
Exclusive: Isotope Shortage Stalls Bristol Myers Phase 3 Radiopharmaceutical Trial
Bristol Myers Squibb faces delays in developing its lead drug from the recent $4.1 billion acquisition of RayzeBio due to a shortage of a critical radioactive isotope. The company has paused new patient enrollment in the Phase 3 RYZ101 trial targeting neuroendocrine tumors. Current patients will continue with their treatments, and the company expects to resume enrolling new patients by the third quarter. Additionally, Bristol Myers continues screening patients for a related Phase 1b trial focused on specific small cell lung cancers.