After delaying a June PDUFA date, the U.S. FDA has approved Kalvista Pharmaceuticals Inc.’s Ekterly (sebetralstat) for hereditary angioedema (HAE) in those aged 12 and older. The plasma kallikrein inhibitor now joins a market with previously approved drugs for the rare, genetic, life-threatening condition, as well as other companies with HAE drugs in development. Ekterly is the first orally-delivered on-demand treatment, as all others in the U.S. are intravenously or subcutaneously administered.

Just a month after laying off 147 employees and announcing plans to mull “strategic alternatives,” Vor Biopharma Inc. reported raising $175 million in private placement in public equity financing and inking a new $4.23 billion license deal for Yantai Rongchang Biotechnologies (Remegen) Co. Ltd.’s telitacicept, a dual-target fusion protein drug approved in China for three autoimmune indications. The news was disclosed after U.S. market hours June 25. Vor’s shares (NASDAQ:VOR) gained 34 cents, or 60.5%, to close June 26 at 89 cents. The company’s shares had risen for eight consecutive trading days since June 17.

In recognition of the fact that diversity, equity and inclusion are necessary prerequisites for precision medicine, the European Academy of Neurology announced the launch of a DEI Hub at its 11th Congress, which is being held in Helsinki through June 24.

In recognition of the fact that diversity, equity and inclusion (DEI) are necessary prerequisites for precision medicine, the European Academy of Neurology (EAN) announced the launch of a DEI Hub at its 11th Congress, which is being held in Helsinki through June 24. “We know now that when we talk about personalized medicine, we have to understand that talking about stroke, for example, in a woman is different than talking about stroke in a man,” EAN president Elena Moro told the audience at the opening session of the conference.

The U.S. FDA clearance June 16 of CSL Behring LLC’s humanized anti-factor XIIa monoclonal antibody garadacimab (CSL-312) to prevent hereditary angioedema (HAE) attacks juiced up the space in which – although other therapies are available as well – developers continue working on new prospects.

Four biotech companies from South Korea announced new or planned financings mid-June, including GC Genome Corp. Rznomics Inc., G2Gbio Inc. and Mezzion Pharma Co. Ltd. Six major mid-June deals included R&D pacts between Y-Biologics Inc. and Crosspoint Therapeutics, Daewoong Pharmaceutical Co. Ltd. and Salipro Biotech AB, Next & Bio Inc. and GC Cell Corp., Galux Inc. and Hanall Biopharma Co. Ltd., Celltrion Inc. and Onconic Therapeutics Inc., and SK Plasma Co. Ltd. and Aimedbio Inc.

Shares of Lyra Therapeutics Inc. soared more than 310% on data from its second phase III trial testing drug-device candidate LYR-210 in patients with chronic rhinosinusitis, with results from the Enlighten 2 study showing statistical significance on primary and key secondary endpoints and offering hopes of a regulatory pathway ahead.

Facing erosion of its mighty Eylea (aflibercept) franchise and near-term loss of exclusivity with Dupixent (dupilumab), Regeneron Pharmaceuticals Inc. took a blow as one of two phase III trials with IL-33-blocking monoclonal antibody itepekimab failed in chronic obstructive pulmonary disease (COPD). The Tarrytown, N.Y.-based firm’s shares (NASDAQ:REGN) closed May 30 at $490.28, down $115.11, or 19%. Partner Sanofi SA, of Paris, saw its stock (NASDAQ:SNY) dip somewhat, too, and ended at $49.37, down $2.98. Cantor analyst Carter Gould opined that the latest news “all but [ruled] out a path forward short of a new study” with the compound.