BioSpace News Archive

Amydis Inc. today announced the successful completion of a pre-IND (Investigational New Drug) meeting with the U.S. Food and Drug Administration (FDA) regarding the development plans for a small-molecule tracer to detect TDP43 in the retina of amyotrophic lateral sclerosis (ALS) patients.

Catalyst Pharmaceuticals, Inc. (Catalyst) (Nasdaq: CPRX), a commercial-stage, patient-centric biopharmaceutical company focused on in-licensing, developing, and commercializing novel high-quality medicines for patients living with rare diseases, today announced that its collaboration partner DyDo Pharma (“DyDo”) has initiated a Phase 3 registrational study in Japan to evaluate the efficacy and safety of Catalyst’s FIRDAPSE®.

Helius Medical Technologies, Inc. today announced that Chief Medical Officer Antonella Favit-Van Pelt, M.D., Ph.D. will be presenting at the 4th International Brain Stimulation Conference, taking place December 6 - 9 in Charleston, S.C.

Fulcrum Therapeutics, Inc. (Nasdaq: FULC), a clinical-stage biopharmaceutical company focused on improving the lives of patients with genetically defined rare diseases, today announced positive results from the 20mg and 30mg dose cohorts in healthy adult volunteers in its Phase 1 clinical trial of FTX-6058.

Aziyo Biologics, Inc. (the “Company”) today announced that it has entered into a definitive agreement to sell securities in a private placement that is expected to result in gross proceeds to the Company of approximately $14.0 million, before deducting offering expenses.

Autolus Therapeutics plc today announced it will hold a conference call to discuss the data being presented at the 63rd American Society of Hematology (ASH) Annual Meeting & Exposition, being held between December 11-14, 2021.

ASLAN Pharmaceuticals today announced the appointment of IQVIA Biotech, a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry, as its preferred clinical research organization for logistics related to decentralized clinical trials.

GH Research PLC today reported the successful outcome of the Phase 2 part of a Phase 1/2 clinical trial of GH001, an inhalable 5-MeO-DMT product candidate, in patients with treatment-resistant depression (TRD) (GH001-TRD-102).

GRAIL, LLC announced today a partnership with Alignment Health Plan, a national Medicare Advantage health plan from Alignment Healthcare (NASDAQ: ALHC), to provide its Medicare Advantage members access to Galleri®, GRAIL’s groundbreaking multi-cancer early detection blood test.

Ocular Therapeutix, Inc. today announced positive topline results from its Phase 2 clinical trial of OTX-DED (dexamethasone intracanalicular ophthalmic insert) for the short-term treatment of dry eye disease.