Phase III results from Sanofi SA’s study of amlitelimab in treating atopic dermatitis met the primary and key secondary endpoints, but investors took a step back.

Onco3r Therapeutics BV has obtained clinical trial application (CTA) approval by the Belgian regulatory authorities for its SIK3 inhibitor O3R-5671. A first-in-human trial will be conducted in Belgium and is expected to open enrollment in the coming weeks. Final data are expected in the first half of next year and will inform subsequent patient trials across a range of autoimmune diseases, which are planned to commence next year.

Bio-Thera Solutions Inc. announced Aug. 26 that the European Commission cleared Usymro (BAT-2206) as a biosimilar to Janssen Pharmaceuticals Inc.’s Stelara (ustekinumab). The EMA issued marketing authorization for Usymro on Aug. 14, following the EMA’s Committee for Medicinal Products for Human Use adopting a positive opinion on June 19.

The addition of photoisomerizable moieties in drugs opens the possibility of rapid and reversible light-dependent switching between an active and inactive form. Researchers from the National Institutes of Health and the University of Barcelona have developed MRS-7787, a photoswitchable adenosine A3 receptor (A3R) agonist that controls A3R through topical skin irradiation.

Already in the headlines plenty for their apparently broad set of benefits for patients, glucagon-like peptide 1 receptor agonists notched worth in yet another indication: hidradenitis suppurativa, the skin disease of interest to plenty of biopharma drug developers.

Bio-Thera Solutions Inc. announced Aug. 26 that the European Commission cleared Usymro (BAT-2206) as a biosimilar to Janssen Pharmaceuticals Inc.’s Stelara (ustekinumab). The EMA issued marketing authorization for Usymro on Aug. 14, following the EMA’s Committee for Medicinal Products for Human Use adopting a positive opinion on June 19.

Akeso Pharmaceuticals Inc.’s gumokimab (AK-111) and manfidokimab met all primary efficacy endpoints in its phase III trials in active ankylosing spondylitis and in moderate to severe atopic dermatitis, respectively.

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.