BioSpace News Archive

Scholar Rock today announced that it has entered into a securities purchase agreement with certain institutional investors to sell, in a registered direct offering, 16,326,530 shares of common stock.

Cyclerion Therapeutics, Inc. today announced research from preclinical studies demonstrating treatment with its lead soluble guanylate cyclase (sGC) stimulator, CY6463, was associated with improved cellular energetics and reduced inflammation in preclinical models of mitochondrial disease.

Codexis, Inc. (NASDAQ: CDXS), a leading enzyme engineering company enabling the promise of synthetic biology, today announces the publication with Merck, known as MSD outside the United States and Canada, of a paper in the peer-reviewed journal Science, detailing the development of a suite of enzymes and their application for site-selective synthesis of insulin bioconjugates.

ExCellThera Inc. (ExCellThera), an advanced clinical-stage biotechnology company delivering molecules and bioengineering solutions to expand and engineer various cell lines for use in next generation cell and gene therapies, announced today that it has submitted a Type II Drug Master File (DMF) with the U.S. Food and Drug Administration (FDA) for UM171.

VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the “Company”), a biopharmaceutical company developing proprietary, innovative, and differentiated therapies for the treatment of immuno-inflammatory conditions, today announced the completion of enrollment in the Phase 2a study of FMX114 for the treatment of mild-to-moderate atopic dermatitis (“AD”).

Third approved indication for SKYRIZI (risankizumab-rzaa) is supported by safety and efficacy data from two induction and one maintenance clinical trials evaluating SKYRIZI in moderately to severely active Crohn’s disease, ADVANCE, MOTIVATE and FORTIFY 1-4.

Oral Presentation at FSHD IRC highlights preclinical data that demonstrated prevention of muscle weakness by reducing DUX4 expression.

Kazia Therapeutics Limited (NASDAQ: KZIA; ASX: KZA), an oncology-focused drug development company, is pleased to announce that the United States Food and Drug Administration (FDA) has awarded Orphan Drug Designation (ODD) to Kazia’s paxalisib for the treatment of atypical rhabdoid / teratoid tumors.

Study to support U.S. FDA approval of the novel CLAAS® implant for left atrial appendage occlusion (LAAO) and stroke prevention.

RedHill Biopharma Ltd. (Nasdaq: RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company, today announced that it will report its first quarter 2022 financial results and operational highlights on Thursday, June 23, 2022.