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. Read More
Stock-price weakness that has beset Chemocentryx Inc. since early March – likely based on jitters ahead of the FDA advisory panel for avacopan slated for May 6 – became an outright tumble when Wall Street got a gander at briefing documents related to the meeting. Shares of the San Carlos, Calif-based firm (NASDAQ:CCXI) closed at $22.19, down $26.63, or 45%, as company backers sifted paperwork on the complement C5a receptor inhibitor for anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis. The compound has been assigned a PDUFA date of July 7. Read More
LONDON – A year on from delivering positive phase IIb data, Oculis SA has raised $57 million in an oversubscribed series C, to take OCS-01, a topical nanoparticle formulation of dexamethasone, through two phase III trials. Read More
DUBLIN – Danish startup Cytoki Pharma ApS raised $45 million in a series A round to take forward an engineered, long-acting version of interleukin-22 (lipidated IL-22), for development in inflammatory bowel syndrome (IBD). Read More
Nearly a week after U.S. President Joe Biden called on Congress to get prescription drug pricing reform done, a House subcommittee took up dueling bills aimed at bringing down drug prices. Read More
LONDON – Cell transdifferentiation specialist Mogrify Ltd. has raised $17 million in the second close its series A, taking the round to $33 million and enabling the company to progress three cell therapy programs to the clinic. Read More
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. Read More
Dangerous blood clots and thrombocytopenia, rare simultaneous side effects seen with two adenoviral vector vaccines from Astrazeneca plc and Johnson & Johnson, as well as a worldwide spike in COVID-19 cases and deaths, primarily in India, has set the stage for what could soon become the next big vaccine option, a protein subunit candidate from Gaithersburg, Md.-based Novavax Inc. Read More
New hires and promotions in the biopharma industry, including: Arca, Catalym, Cerevel, Codagenix, Engitix, Faze, Iteos, Kintara, Myeloid, Shionogi, Shoreline, Theseus, Ventyx, Vistagen. Read More
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. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astellas, Carmot, Clarity, Eli Lilly, Hutchmed, Immunomet, Newron, Pfizer, Quercis, R-Pharm Germany, Siga Technologies, Viiv Healthcare. Read More