BioSpace News Archive

Harbour BioMed (the “Company"; HKEX: 02142) announces that it has resubmitted the Biologics License Application (BLA) of batoclimab (HBM9161) to the National Medical Products Administration (NMPA) of China for the treatment of generalized myasthenia gravis (gMG).

Genmab A/S (Nasdaq: GMAB) today announced that the U.S. Food and Drug Administration (FDA) has approved EPKINLY® (epcoritamab-bysp) for the treatment of adults with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy.

The U.S. Food and Drug Administration has issued a Complete Response Letter for the Biologics License Application seeking accelerated approval of Daiichi Sankyo and Merck’s patritumab deruxtecan for the treatment of adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer previously treated with two or more systemic therapies.

CalciMedica Inc. (“CalciMedica”) (Nasdaq: CALC) today announced that it will host a conference call on Thursday, June 27, 2024 at 8:30 a.m. ET/ 5:30 a.m. PT to discuss topline data from the Company’s Phase 2b CARPO trial of Auxora™ in acute pancreatitis (AP) with accompanying systemic inflammatory response syndrome (SIRS).

Medpace Holdings, Inc. announced that it will report its second quarter 2024 financial results after the market close on Monday, July 22, 2024.

CASI Pharmaceuticals, Inc. announced that it has entered into securities purchase agreements with certain investors for a private investment in public equity financing that is expected to result in aggregate gross proceeds of approximately $15.0 million, before deducting placement agent fees and other private placement expenses.

McKesson Corporation (NYSE: MCK) will release its first quarter fiscal 2025 financial results after market close on Wednesday, August 7, 2024.

2seventy bio, Inc., announced the completion of an asset purchase agreement by Novo Nordisk. Under the terms of the APA, Novo Nordisk has acquired the Hemophilia A program and rights to 2seventy’s in vivo gene editing technology outside of oncology and gene editing for autologous or allogeneic cell therapies of immune cells for the treatment of autoimmune disease.

Tonix Pharmaceuticals Holding Corp., a fully-integrated biopharmaceutical company, announced that it intends to offer and sell shares of its common stock.

AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) has approved EPKINLY® (epcoritamab-bysp) as the first and only T-cell engaging bispecific antibody administered subcutaneously for the treatment of adults with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of prior therapy.