Acorda’s snafu-plagued attempt to get a fast FDA marketing decision on a critically important new drug has just run into a fresh setback — and it’s painful to watch.
Two days after the biotech’s shares $ACOR cratered on the loss of an appeal aimed at protecting its patents on Ampyra — its only real asset on the market — the biotech is back with news that the FDA wants more time to consider new info it asked for on CMC related to Inbrija (levodopa inhalation powder), adding a three-month delay to the process and extending the PDUFA to January 5 of next year.
Usually a delay of this nature would be seen as a speed bump to a biopharma company. But Acorda’s first attempt to file their application was met with a rare refuse-to-file notice, saying the package was incomplete. That forced the company to reset the clock on Inbrija, a Parkinson’s drug which it needs to start marketing last year, as they look to replace Ampyra with the new drug.
Evidently, though, the re-filed application was still light on required information. And at this stage that qualifies as another self-inflicted wound Acorda can’t afford. Now’s the time to execute, not explain.
Paul Matteis at Stifel was quick to weigh in Thursday morning.
We expect the stock to be under pressure on the news; one of the overarching fears (or bear cases) has been that as a drug-device combo, Inbrija, despite having relatively clean clinical data, is at greater than average risk of receiving a complete response letter. In turn, the extension, according to Acorda, is related to recent submissions made by the company regarding “CMC” (manufacturing). FDA determined these submissions constitute a major amendment – such determination is a standard rationale for extending a PDUFA date by 3 months (from October to now January). Our thesis on the stock is that Inbrija is likely to attain approval and eventually grow into an important drug for Parkinson’s OFFs, but that the initial rollout may be slow.
Ampyra, meanwhile, faces imminent generic competition for the franchise that will carve it to a fraction of its former size as the company waits impatiently to get on the field with their new drug — provided they get an OK, which is not guaranteed.
Earlier in the week the company’s stock dropped 25%. This morning it’s down 17% in pre-market trading.
“We look forward to continuing our constructive dialogue with FDA,” said Acorda CEO Ron Cohen in a statement.
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