BioSpace News Archive

Shanghai Junshi Biosciences Co., Ltd announced today that the National Medical Products Administration (the “NMPA”) has conducted urgent review and approval under Special Examination and Approval of Drugs, and conditionally approved for marketing Deuremidevir Hydrobromide Tablets (project code: JT001/VV116, “VV116”), an oral nucleoside analog anti-SARS-CoV-2 drug, for the treatment of adult patients with mild to moderate coronavirus disease 2019 (“COVID-19”).

NovelMed announced today that the U.S. Food and Drug Administration (FDA) cleared the Company’s investigational drug NM8074 to initiate an efficacy trial in patients with aHUS in coming months. NovelMed is advancing its anti-Bb antibody (NM8074) to treat patients with evidence of treatment-related resistance or complement-mediated relapses in aHUS, a rare disease with unmet need.

Throughout 2022, GeneDx (Nasdaq: WGS), a leader in delivering improved health outcomes through genomic and clinical insights, contributed a significant amount – 22% – of total candidate gene submissions to GeneMatcher, a platform that facilitates new disease gene discovery and enables connections between patients, clinicians and researchers by allowing individuals to submit and search genes of interest.

Proov, a diagnostics company offering medical grade at-home tests and a support platform, is announcing that it has received patent issue notification for its fourth utility patent.

CureVac N.V. (Nasdaq:CVAC), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid (“mRNA”), today announced positive extended preliminary data from ongoing Phase 1 clinical programs in COVID-19 and seasonal flu conducted in collaboration with GSK.

C4 Therapeutics, Inc. today announced that the first patient has been dosed in its Phase 1/2 clinical trial of CFT1946, an orally bioavailable mutant-selective BiDAC™ degrader for the treatment of BRAF V600 mutant solid tumors.

Tonix Pharmaceuticals Holding Corp. announced today that it has regained compliance with the minimum bid price requirement for continued listing on The Nasdaq Capital Market.

scPharmaceuticals Inc. (Nasdaq: SCPH), today announced that the company is targeting February 20, 2023 as the date for commercial availability of FUROSCIX® (furosemide injection), a proprietary formulation of furosemide delivered via an On-Body Infusor for outpatient treatment of congestion due to fluid overload in adult patients with New York Heart Association (NYHA) Class II and Class III chronic heart failure.

Jasper Therapeutics, Inc. (Nasdaq: JSPR) (“Jasper”) announced today that it will host an investor conference call and webcast to provide a corporate update on Tuesday, January 31 from 8:30 am – 9:30 am Eastern Time.

CymaBay Therapeutics, Inc. (Nasdaq: CBAY), a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet medical need announced the closing, on January 26, 2023, of its previously announced underwritten public offering of its common stock and pre-funded warrants.