BioSpace News Archive

Myrtelle Inc., (“Myrtelle” or the “Company”) today announced that the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) Designation to the Company’s lead gene therapy product candidate, rAAV-Olig001-ASPA for the treatment of Canavan disease (CD).

Gameto announced encouraging new findings from a study evaluating how minimal controlled ovarian stimulation in combination with Fertilo, their novel investigational in vitro maturation solution containing engineered ovarian support cells to mature eggs outside of the body, affected patients’ egg retrieval experiences when compared to conventional stimulation.

Mosaic Biosciences announced two strategic leadership additions to its team: Malavi Madireddi, PhD, as Senior Vice President, Drug Discovery, and Scott Glaser, PhD, as Senior Vice President, Biologics Discovery.

Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, announced that it will release its financial results for the first quarter 2024 before the market opens on Wednesday, April 24, 2024, and will hold a conference call on the same day at 8:30 a.m. EDT.

Innovent Biologics, Inc. and HUTCHMED Limited jointly announce that the New Drug Application for the combination of sintilimab and fruquintinib for the treatment of patients with advanced endometrial cancer with pMMR[1] or non-MSI-H[2] tumors that have failed prior systemic therapy but are not candidates for curative surgery or radiation has been accepted and granted priority review by the China National Medical Products Administration.

Hansa Biopharma AB expects to report revenue of approximately SEK 54m for Q1 ending March 31, 2024, consisting of SEK 48m in product sales and SEK 6m in revenue recognition primarily related to its agreement with Sarepta Therapeutics, Inc.

Daiichi Sankyo and AstraZeneca’s Biologics License Application for datopotamab deruxtecan has been accepted in the U.S. for the treatment of adult patients with unresectable or metastatic hormone receptor positive, HER2 negative breast cancer who have received prior systemic therapy for unresectable or metastatic disease.

Merz Therapeutics, a business of Frankfurt-based Merz Group, has entered into an Asset Purchase Agreement to acquire two commercial medicines from NASDAQ-listed Acorda Therapeutics.

Rocket Pharmaceuticals, Inc. announced that the European Medicines Agency accepted the Marketing Authorization Application for RP-L102, its lentiviral vector-based investigational gene therapy for Fanconi Anemia, complementation group A, a rare genetic disorder caused by mutations in the FANCA gene affecting DNA repair and characterized by bone marrow failure, cancer predisposition, and congenital malformations.

NextCure, Inc. announced that it will present at the 23rd Annual Needham Virtual Healthcare Conference on Thursday, April 11th, at 12:45 pm ET.