With the FDA approval of Cassiopea SpA’s Winlevi (clascoterone cream 1%) to treat acne in patients 12 years and older, the European company hailed it as the first acne drug in 40 years with a new mechanism of action.

Strong top-line results from Immunovant Inc.’s phase IIa clinical trial of IMVT-1401 in treating moderate to severe generalized myasthenia gravis increased the competition with Momenta Pharmaceuticals Inc. and Argenx SE in the crowded anti-FcRn space.

Privately held Alzheon Inc. picked up a $47 million grant from the NIH’s National Institute on Aging that will last over five years to support a phase III clinical trial of its oral brain-penetrant small molecule ALZ-801 to treat Alzheimer’s disease.

Now that Ovid Therapeutics Inc.’s and Takeda Pharmaceutical Co. Ltd.’s phase II study of soticlestat in children with Dravet syndrome (DS) or Lennox-Gastaut syndrome (LGS) has produced positive top-line data, Ovid is planning the drug’s phase III clinical trial while pricing a $50 million common stock offering.

Onconova Therapeutics Inc.’s lead candidate in myelodysplastic syndromes took a major hit Monday as the small molecule I.V. rigosertib failed to meet the primary endpoint of significantly improved survival vs. best supportive care in higher-risk patients.

Tricida Inc. executives were not surprised when the FDA issued a complete response letter for veverimer to treat chronic metabolic acidosis. Despite an Aug. 22 PDUFA date, the company had received an FDA notification on July 16 that there were deficiencies that would preclude discussion of labeling and postmarketing requirements and commitments.

Privately held Alzheon Inc. picked up a $47 million grant from the NIH’s National Institute on Aging that will last over five years to support a phase III clinical trial of its oral brain-penetrant small molecule ALZ-801 to treat Alzheimer’s disease.