In Ionis Pharmaceuticals Inc.’s second U.S. FDA approval in under a year, the agency approved Dawnzera (donidalorsen) as a prophylactic therapy in the rare and genetic disease hereditary angioedema (HAE). The approval came as scheduled as the NDA had a PDUFA date of Aug. 21. Dawnzera 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.

Regenerative medicine company Avita Medical Inc. raised AU$23 million (US$15 million) through a private placement on the Australian Securities Exchange (ASX:AVH) to support growth of its Recell therapeutic acute wound portfolio. Funds raised will support continued growth of the company’s therapeutic acute wound portfolio and will cover operations through 2026.

Shanghai Moyom Biotechnology Co. Ltd. has launched its Aphranel Magiccrystal dermal filler, the first injectable calcium hydroxylapatite microsphere-based dermal filler developed in China, and the company is already expanding globally.

Among the strong points of Nektar Therapeutics Inc.’s atopic dermatitis (AD) prospect, rezpegaldesleukin (rezpeg), an IL-2 pathway agonist and regulatory T-cell proliferator, is the drug’s faster onset of action – a feature that experts say may help differentiate the compound from competitors in the OX40 space.

Neucore Bio Inc. announced it has been awarded a US$304,000 National Science Foundation Small Business Technology Transfer grant to evaluate scalable manufacturing of exosome-based gene delivery methods.

Becoming the first approved treatment for chronic hand eczema in the U.S., Leo Pharma A/S’s Anzupgo (delgocitinib) received FDA clearance for an indication that affects 10% of adults worldwide. The cream, dosed at 20 mg/g and applied topically, will treat moderate to severe cases in those not responsive to, or unable to take, topical corticosteroids.

Plasmacure B.V. secured €6 million (US$7 million) in series A funding for its Plasoma cold plasma system to treat complex wounds. The round was led by Venture Medical LLC, a U.S.-based provider of solutions for wound care, which also committed to spend over $10 million to support regulatory approval, reimbursement and U.S. market expansion of the Plasoma technology.

When injured, the human skin is repaired through a wound-healing process that forms fibrotic scar tissue. Scarring burdens patients at both the functional and esthetic levels, and scars in the craniofacial region in particular can be psychologically damaging for the individual. The principal limitation to developing effective scarring treatments is the limited understanding of the molecular mechanisms behind scar formation and the mechanisms that drive repair without scarring.

Eluciderm Inc. has received clearance from the U.S. FDA for its IND to conduct a phase I/IIa open-label study evaluating the safety and efficacy of ELU-42, a topical spray-on solution for open wound healing, in patients with diabetic foot ulcers (DFUs).