Celgene Corp. revealed more bad news it didn't need on Feb. 27 when the company said it received a refuse-to-file letter from the US FDA for the new drug application (NDA) for ozanimod in multiple sclerosis, which generally was seen as a sure thing based on Phase III data.
More Bad News: Celgene Reveals Refuse-To-File Letter For Ozanimod In MS
Celgene said the US FDA issued a refuse-to-file letter for ozanimod in multiple sclerosis because "the nonclinical and clinical pharmacology sections in the NDA were insufficient to permit a review." It's yet another big blow for a company whose value has been falling since October.

More from Strategy
Plus deals involving GV20/Mitsubishi Tanabe, Kaken/Alumis, AstraZeneca/Alteogen and deal terminations involving Clover/Gavi Alliance and Rhythm/RareStone.
The head of the Spanish medical dermatology specialist told Scrip that maintaining the status quo will only result in the continent’s life sciences sector slipping further behind the US and China.
Stakeholders are pleading for newly confirmed FDA Commissioner Martin Makary to stand up for the agency's high scientific standards and staff as he begins his term.
Plus deals involving Relmada/Trigone, Alvotech/Xbrane, OPKO Health/Entera, iOncologi/TargImmune and more.
More from Business
Stakeholders are pleading for newly confirmed FDA Commissioner Martin Makary to stand up for the agency's high scientific standards and staff as he begins his term.
Plus deals involving Relmada/Trigone, Alvotech/Xbrane, OPKO Health/Entera, iOncologi/TargImmune and more.
With its exon 53-skipping candidate already showing promise in 24-week data, Wave now has 48-week data showing improvements in muscle health and functional outcomes.