Premarket Biotech Digest 2016-03-29: ACAD Nuplazid Review, APRI Tumbles, PBYI Delays NDA Filing

Top Pick of the Day: ALDR

Alder Biopharmaceuticals (ALDR) shares surged almost 50% on Monday after the company announced positive top-line results from a Phase 2b clinical trial evaluating its ALD403 for the treatment of prevention of migraines. Despite Monday’s huge rally, ALDR is still down more than 24% for the year. In fact, the stock is still more than 50% below its 52-week high of $54.90. Given the positive data and current valuation, ALDR is worth a look.

Focus Ticker: ACAD

Acadia Pharmaceuticals (ACAD) shares surged on Monday ahead of the crucial Ad Comm review of its Nuplazid New Drug Application. The rally was most likely due to short sellers closing their position before the review. According to latest available short interest data (March 15, 2016), short interest in ACAD stood at 15.2%. Given the high short interest and days to cover (8), short sellers were likely compelled to exit their positions, especially as the briefing document released late on Thursday suggest that Nuplazid might just get a nod from the FDA despite serious safety issues. I discussed the briefing document in an article here. Many more deaths and serious adverse events (SAEs) were observed in drug arm than in control arm. However, two well-known common drug-related SAEs, rhabdomyelosis and prolonged QT interval (cardiac) were insignificantly low for the first one and not observed for the second one. Considering this, Nuplazid might just get a positive recommendation from the Ad Comm later today. However, an eventual approval could come with a conditional warning of increased mortality/morbidity.

Sector News

Eagle Pharmaceuticals’ Request for Orphan Drug Status for BENDEKA Rejected- Eagle Pharmaceuticals (EGRX) shares edged lower after the FDA rejected the company’s request for Orphan Drug designation for its BENDEKA for the treatment of chronic lymphocytic leukemia and indolent B-cell non-Hodgkin lymphoma that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.The drug has already been approved by the FDA late last year.

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