Novavax Inc. backed off its guidance of submitting an EUA for its COVID-19 vaccine in June, pushing the anticipated date to this fall. “We expect to complete regulatory filings in the third quarter,” Stan Erck, Novavax’s president and CEO, told investors on a May 10 conference call. “We hope to have market authorizations in multiple countries in the third quarter, as early in the quarter as possible.”
Despite two recent clinical trial failures, Orphazyme A/S’s arimoclomol is still on track for its June 17 PDUFA date in treating Niemann-Pick disease type C. The newest stumble is in the pivotal study of arimoclomol for treating amyotrophic lateral sclerosis (ALS) as it failed to hit its primary and secondary endpoints.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Astrazeneca, Corcept, Enanta, Medicenna, Orphazyme, Palisade, Tarsus, Vaxart.
Amid what Moderna Inc. called "overwhelming" demand from global governments for mRNA vaccines and boosters with efficacy against SARS-CoV-2 variants of concern, the company said both its authorized vaccine, mRNA-1273, and a strain-matched candidate, mRNA-1273.351, increased neutralizing titers against the variants.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Adagio, Ascletis, Catalyst, Cerecor, Genascence, Genprex, Neoleukin, Oncopeptides, Tilt, Vivace.
HONG KONG – Lutris Pharma Ltd., a company taking on the dermal toxicity common to cancer therapy with EGFR inhibitors, has begun testing its lead product, the B-Raf inhibitor LUT-014, in a phase II trial targeting reduction of acne-like lesions associated with the class. Partial results are expected by the end of 2021.
Shares of Biolinerx Ltd. (NASDAQ:BLRX) shot up 53% to $4.88 May 4 on news that adding its lead candidate, motixafortide, to standard of care G-CSF for hematopoietic stem cell mobilization helped achieve significantly better mobilization than G-CSF alone in a phase III trial. The company said it's working "aggressively" to gain regulatory approval to market the drug for use in autologous bone marrow transplants for multiple myeloma (MM) patients, with plans to make an NDA submission in the first half of 2022.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Arch, Biolinerx, Checkmate, Cytokinetics, Cyxone, Genprex, HDT Bio, Ichnos, Immunitybio, Kiniksa, Merus, Obseva, Revolo, Rezolute, Tarsus, Vaxart, Verona.
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