BioSpace News Archive

Takeda (TSE:4502/NYSE:TAK) today announced that, following discussions with the U.S. Food and Drug Administration (FDA), it will be working with the FDA towards a voluntary withdrawal of EXKIVITY® (mobocertinib) in the U.S. for adult patients with epidermal growth factor receptor (EGFR) Exon20 insertion mutation-positive (insertion+) locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease has progressed on or after platinum-based chemotherapy.

Sonendo, Inc. announced that on September 28, 2023, it received notice from the New York Stock Exchange that the Company is not in compliance with applicable price criteria in the NYSE’s continued listing standard set forth in the NYSE Listed Company Manual because the average closing price of the Company’s common stock, par value $0.001 per share, was less than $1.00 per share over a consecutive 30 trading-day period.

Immunovant, Inc. announced the closing of its previously announced underwritten public offering of 8,475,500 shares of its common stock at a price of $38.00 per share.

Tenaya Therapeutics, Inc. (NASDAQ: TNYA), a clinical-stage biotechnology company with a mission to discover, develop and deliver potentially curative therapies that address the underlying causes of heart disease, today announced the publication of preclinical research in the October 3, 2023 issue of the American Heart Association’s (AHA) journal, Circulation.

NANO-X IMAGING LTD (NASDAQ: NNOX) (“ Nanox ” or the “ Company ”), an innovative medical imaging technology company, today announced it will host an Investor Day at the Nasdaq in New York City on Tuesday, October 17, 2023.

The Bladder Cancer Advocacy Network announced its exclusive partnership with Ferring Pharmaceuticals as the National Presenting Sponsor for its 2024 Walks to End Bladder Cancer.

Sermonix Pharmaceuticals today shared the results of EQUALS 2 (ESR1 QUAlity of Life Survey 2), a survey on the vaginal and sexual health of patients with ER+/HER2- metastatic breast cancer.

Caliway Biopharmaceuticals (Caliway) announced the topline results of the CBL-0202 stage 2 phase 2 study met all the primary and secondary efficacy endpoints compared with placebo in the ITT (Intent-to-treat) and PP (per-protocol) analysis population.

Precision Biologics, Inc. (“Precision”), a clinical-stage immunotherapy and targeted oncology company, announced today that on September 26, 2023, the USPTO granted a patent for its lead clinical asset, NEO-201, which is currently being tested in Phase 2 human Clinical Trials in the US.

Novo Nordisk announced today that the U.S. Food and Drug Administration (FDA) has approved RivflozaTM (nedosiran) injection 80 mg, 128 mg, or 160 mg, a once-monthly subcutaneous ribonucleic acid interference (RNAi) therapy, to lower urinary oxalate levels in children 9 years of age and older and adults with primary hyperoxaluria type 1 (PH1) and relatively preserved kidney function.