Late Friday, with the government shutdown looming, the biotech reported that the FDA has approved their inhaled levodopa therapy Inbrija for Parkinson’s patients, putting the company on a short path to a crucially needed market launch.
Acorda $ACOR had been looking at a PDUFA date in early January. But with the FDA racking up a record number of approvals this year — and its third on Friday — the company was given a little bit of an added edge for its 2019 rollout.
They need it.
The FDA held up their decision on Inbrija twice, first with a refuse-to-file on the application and later with an extension on the original PDUFA date. Meanwhile, Acorda lost patent protection on its only marketed product, Ampyra, making Inbrija a bridge to its ability to stay in business.
The big question for some of the analysts covering the company — after a big sigh of relief on the approval — is whether Acorda with its newly approved therapy gets marked out for a takeover.
Paul Matteis at Stifel put the 2022 sales consensus at $300 million, marking this as a possible takeout drug in a busy market — though well short of blockbuster status.
Acorda’s shares jumped 5% in pre-market trading Monday.
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