BioSpace News Archive

Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to develop and launch the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, today announced recent corporate highlights and financial results for its fiscal first quarter ended December 31, 2022.

Radiopharm Theranostics, a developer of a world-class platform of radiopharmaceutical products for both diagnostic and therapeutic uses, announced the initiation of the process to obtain a secondary listing on the Nasdaq Capital Market.

Aytu BioPharma, Inc. (the Company or “Aytu”) (NASDAQ:AYTU), a commercial stage pharmaceutical and consumer health company providing pediatric-focused prescription drugs and cost-effective consumer health solutions, has announced the delayed filing of its Form 10-Q for its second quarter fiscal year 2023, ended December 31, 2022 to allow for additional assessment and management review time on an accounting matter.

Ensysce Biosciences, Inc. (“Ensysce” or the “Company”) (NASDAQ:ENSC), a clinical-stage biotech company applying transformative chemistry to improve prescription drug safety to reduce abuse and overdose, today announced a Poster Presentation will be presented by Geoff Birkett, Chief Commercial Officer of Ensysce, at the Annual NIH HEAL Meeting on February 22, 2023, in Washington, D.C.

Creative Medical Technology Holdings, Inc. (“Creative Medical Technology Holdings” or the “Company”) (NASDAQ: CELZ), a biotechnology company working to revolutionize care through the development of potentially best-in-class regenerative therapeutics, today announced positive three-year follow-up data for the Company’s StemSpine® pilot study.

Tasso, Inc. today announced that the TassoOne™ Plus, a new high-volume liquid blood collection device, has received CE Mark certification and successfully fulfilled all of the performance, safety, and relevant product requirements under the new European Union Medical Device Regulation.

Albireo Pharma, Inc. (Nasdaq: ALBO) today announced that the U.S. Food and Drug Administration (FDA) has accepted the Company’s supplemental New Drug Application (sNDA) and issued a Prescription Drug User Fee Act (PDUFA) action date of June 15, 2023 for a second Bylvay (odevixibat) indication for patients with Alagille syndrome (ALGS)

Aditxt, Inc. announces the formation of a U.S.-based wholly- owned subsidiary, Pearsanta, Inc., to accelerate the growth of Aditxt’s second program, AditxtScore™, through future strategic revenue and growth-oriented transactions.

Delcath Systems, Inc. (Nasdaq: DCTH) announced it submitted a new drug application (NDA) resubmission to the US Food and Drug Administration (FDA) for the HEPZATO™ Kit (melphalan hydrochloride for Injection/Hepatic Delivery System or Melphalan/HDS) seeking approval for the treatment of patients with unresectable hepatic-dominant metastatic ocular melanoma (mOM).

EDAP TMS SA, a global leader in robotic energy-based therapies, announced preliminary unaudited fourth quarter and full year 2022 revenue and other financial highlights.