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.

Clinical updates, including trial initiations, enrollment status and data readouts and publications: 4D Pharma, Cardiol, Cerecor, Dermavant, Mycovia, Novartis, Oncolytics, Oncology Venture, Outlook, Silverback.

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.

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Astrazeneca, Bavarian Nordic, Bristol Myers Squibb, Byondis, Immunovant, Ipsen, Krystal, Mereo, Ovid, Takeda, Union.

A phase III study evaluating a combination of a Novartis AG anti-PD-1 candidate with the well-established BRAF/MEK inhibitor combo in first-line unresectable or metastatic BRAF V600 mutant melanoma missed its primary endpoint of progression-free survival.

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.

Adverse events (AEs) took the shine off Odonate Therapeutics Inc.’s long-awaited top-line data from the phase III trial called Contessa testing the oral taxane chemotherapy tesetaxel in metastatic breast cancer (MBC), and shares of the San Diego-based firm (NASDAQ:ODT) closed at $18.33, down $15.21, or 45%.

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Adrenomed, Aslan, Celldex, Cohbar, Cynata, Geovax, Mitsubishi Tanabe, Novartis, Novavax, Odonate, Onconova, Protalix, PTC, Reithera, Trevena.

A third child with X-linked myotubular myopathy (XLMTM) has died after receiving the higher of two doses of an experimental gene therapy for the rare disease under development at Audentes Therapeutics Inc. Preliminary findings indicate that the immediate cause of death was gastrointestinal bleeding, Audentes said. The trial, testing AT-132 (resamirigene bilparvovec), was already on an FDA clinical hold.