Spectrum Pharmaceutecals Inc (SPPI)

[antihama]

Sanofi and Regeneron were hit w a CRL for manufacturing. A Fierce Pharma article also mentions a bunch of other biotechs getting hit w CRLs recently.

But the partners now join a handful other drugmakers that have had drug approvals delayed this year because of manufacturing concerns.
Portola had consideration of AndexXa, its breakthrough anticoagulant reversal agent, delayed in August when it received a CRL focused primarily on manufacturing questions. Valeant Pharmaceuticals and Ocular Therapeutix both got CRLs for their eye drugs tied to manufacturing, as did AstraZeneca for its investigational treatment for hyperkalemia, a drug candidate that was the target of AstraZeneca’s $2.7 billion buyout of ZS Pharma.
Starting it all off this year was the CRL that Miami-based OPKO received because of issues the FDA had with the manufacturing plant in Florida where its drugs are being manufactured by Catalent. But in that case, the company won approval weeks later for its chronic kidney disease drug Rayaldee after Catalent worked with the FDA to quickly get the issues resolved.

I’m not happy about it but I think Spectrum and the CRL for Evomela a year ago are in good company. At least, as was the case w Catalent's drugs, Evomela was approved in a relatively short time. Now, when Evomela sales get going....