Nov. 12 Company Quick Takes: Clinical hold for Solid Bio; plus Foamix-Menlo, Chi-Med, RegeneRx and Actelion

Solid Bio shares sag on news of latest clinical hold
FDA has placed a clinical hold on the Phase I/II IGNITE DMD study of gene therapy SGT-001 from Solid Biosciences Inc. (NASDAQ:SLDB) after one of the trial's six patients experienced a serious adverse event. Solid said the patient experienced complement activation, thrombocytopenia, a dip in red blood cell count, acute kidney injury and cardio-pulmonary insufficiency. Solid lost $8.18 (74%) to $2.82 on the news. Last year, FDA placed and later lifted a separate hold on the Duchenne muscular dystrophy program (see "FDA Lifts Hold on DMD Therapy").

Dermatology companies Foamix, Menlo merge
Foamix Pharmaceuticals Ltd. (NASDAQ:FOMX) and Menlo Therapeutics Inc. (NASDAQ:MNLO) announced plans to merge, creating a dermatology company with a portfolio that includes an approved product and three late-stage candidates. Foamix's Amzeeq minocycline, which received FDA approval in October to treat inflammatory lesions of non-nodular moderate-to-severe acne vulgaris in adults and pediatric patients nine and older, is slated to launch in January. The transaction is expected to close by 2Q20, after which Foamix shareholders will own about 59% and Menlo shareholders about 41% of the combined company. ...