BioSpace News Archive

GigaGen Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application to initiate a Phase 1 trial to evaluate the company’s oncology candidate, GIGA-564, for the treatment of solid tumors.

AEON Biopharma, Inc. announced today completion of enrollment with the last patient first visit in the Phase 2 study of ABP-450 for the preventive treatment of chronic migraine. The Company expects to announce topline data in the third quarter of 2024.

Humacyte, Inc. today announced that it has submitted a Biologics License Application (BLA) to U.S. Food and Drug Administration (FDA) seeking approval of the Human Acellular Vessel (HAV) in urgent arterial repair following extremity vascular trauma when synthetic graft is not indicated, and when autologous vein use is not feasible.

Immuneering Corporation (Nasdaq: IMRX) today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for IMM-6-415, paving the way for the company to initiate a Phase 1/2a clinical trial of this oral, twice-daily small molecule, in development for the treatment of advanced RAF or RAS mutant solid tumors.

Plus Therapeutics, Inc., a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system cancers, announced that it has partnered with K2bio to implement novel analysis for cerebrospinal fluid tumor and molecular biomarkers for CNS cancers.

Agile Therapeutics, Inc., (Nasdaq: AGRX), a women’s healthcare company, today provided an update on the actions being taken to strengthen the Affordable Care Act’s (ACA) no-cost contraceptive coverage requirement.

Candel Therapeutics, Inc. today announced that the U.S. Food and Drug Administration (FDA) granted Fast Track Designation for its lead investigational adenovirus asset CAN-2409 plus prodrug (valacyclovir).

Genetic Technologies Limited, a global leader in genomics-based tests in health, wellness and serious disease, announced its plans to effect.

GT Medical Technologies, Inc. (“GT Medical Technologies”), a medical device company with a corporate purpose of improving the lives of patients with brain tumors, today announced it has agreed to acquire substantially all of the radioactive Cesium-131 seed assets and related business infrastructure from Isoray Medical, which is a subsidiary of Perspective Therapeutics, Inc. (“Isoray”).

MAPS Public Benefit Corporation (“MAPS PBC”) announced the submission of a new drug application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) for MDMA (midomafetamine capsules) used in combination with psychological intervention, which includes psychotherapy, or talk therapy, and other supportive services provided by a qualified healthcare provider.