After the last two weeks, everyone’s ready for a 3-day break.
August closed out with the S&P 500 down 6%, and the NASDAQ Biotech Index down 11%. Thankfully, Labor Day marks the end of Wall Street’s annual August hiatus. With more investors back at their desks, the hope is that sentiment begins to shift.
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It was another slow week for biotech news as many companies prepare for a slew of healthcare investor conferences: the annual Rodman & Renshaw, Baird, and Newsmakers in the Biotech Industry investor conferences all take place this coming week, and the World Conference on Lung Cancer is this weekend as well.
Last week ended with the rumor that Ariad Pharmaceuticals (ARIA) had been approached by Baxalta (BXLT), setting this past Monday up for some potential M&A news. The Ariad buyout never materialized, but Amicus Therapeutics (FOLD) made a tuck-in acquisition in the orphan drug space. Long implicated as an acquisition target itself, Amicus instead picked up Scioderm, Inc., a privately-held company developing a topical treatment for the rare skin disorder Epidermolysis Bullosa. The deal was back-end weighted, meaning Amicus isn’t forced to fork over a great deal of its own cash at the outset.
Amicus develops enzyme chaperone Galafold (migalastat) for the treatment of Fabry disease, and plans to submit a New Drug Application before the end of 2015. The product is an obvious fit for similar enzyme replacement developers (like Shire (SHPG)), which is why Amicus investors have long maintained that it’s a high-probability acquisition target. A near-term acquisition is likely off the table consider Amicus’ move this week, but FOLD ended the week modestly higher. You can catch up on the Scioderm deal here.
Acadia Pharmaceuticals (ACAD) investors can finally breath a sigh of relief. The company on Thursday confirmed that it has submitted its New Drug Application for NUPLAZID (pimavanserin) in Parkinson’s disease psychosis. It was six months ago that Acadia announced it would delay the NDA filing, citing CMC issues. The company’s CEO moved on shortly after, and it is under interim CEO Steve Davis that the NDA has been complete and now handed off to the FDA: Davis was appointed as permanent CEO in conjunction with the NDA filing.
ACADIA requested Priority Review for the NDA, which would accelerate the FDA’s review from the normal 10 months, to six months, following the conclusion of a 60-day review period that began when the FDA received the NDA. With that timeline in mind and considering the prior issues, investors will be paying close attention during the first week of November for word that the FDA has accepted the NDA for filing – potentially with a 6-month review period.
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One or more of PropThink’s contributors are long FOLD.
