Market News
Global Acute Ischemic Stroke (AIS) Market: Key Developments
- On April 27, 2023, Otsuka America Pharmaceutical, Inc. (Otsuka), a healthcare company, and H. Lundbeck A/S (Lundbeck), a pharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) had approved the New Drug Application (NDA) for ABILIFY ASIMTUFII (aripiprazole) extended-release injectable suspension for intramuscular use, a once-every-two-months injection for the treatment of schizophrenia in adults or for maintenance monotherapy treatment of bipolar I disorder in adults.
- On January 13, 2023, TMS Co., Ltd., a Japan-based biopharmaceutical company, announced the positive results of TMS-007 Phase I Clinical trial, conducted at P1 Unit, Clinical Research Support Center of the University of Tokyo Hospital. The study supported the acceptability and safety of TMS-007 when administered intravenously in doses up to 360 mg per adult in male patients. The accomplishment provided the company the opportunity to begin and complete Phase IIa clinical trial with patients suffering from symptomatic ischemic stroke. On January 13, 2023, the results of the TMS-007 Phase I Clinical Trial was published in the British Journal of Clinical Pharmacology.
- On September 12, 2022, Algernon Pharmaceuticals Inc., a clinical stage pharmaceutical development company, announced that it had received approval to conduct a Phase 1 clinical study of an intravenous formulation ("IVF") of AP-188 (“N,N-dimethyl tryptamine” or “DMT”) for the treatment of stroke in the Netherlands from the Stichting Beoordeling Ethiek Biomedisch Onderzoek (“BEBO”), an independent Medical Research Ethics Committee (“MREC”). The trial will be conducted at the Centre for Human Drug Research (“CHDR”) in Leiden, Netherlands. DMT is a known psychedelic compound that is part of the tryptamine family.
- In June 2021, Pinteon Therapeutics, a biotechnology company, and Lonza Group AG, a biotechnology company, announced that both companies had expanded their manufacturing agreement to enable future clinical production of Pinteon\'s lead candidate named PNT001 that showed promising results in a Phase I clinical study. The extended manufacturing agreement between Pinteon and Lonza enables future clinical production of PNT001, a novel Tau antibody therapeutic that targets Alzheimer\'s disease and traumatic brain injury.