FDA extends action date for Roche’s risdiplam for spinal muscular atrophy

Citing the submission of additional data that it considered a major amendment, the FDA has extended the action date for its review of Roche (OTCQX:RHHBY) unit Genentech’s marketing application seeking approval for resdiplam for the treatment of spinal muscular atrophy.

The new action date is August 24 (from May 24).

Roche in-licensed global rights to the survival motor neuron-2 (SMN2) splicing modifier from PTC Therapeutics (NASDAQ:PTCT) in November 2011.

SMA-related tickers: Biogen (NASDAQ:BIIB), Ionis Pharmaceuticals (NASDAQ:IONS), Scholar Rock Holding (NASDAQ:SRRK), Novartis (NYSE:NVS)

https://seekingalpha.com/news/3559126-fda-extends-action-date-for-roches-risdiplam-for-spinal-muscular-atrophy