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.

Aerie’s Mercury 2 Study Underway- Aerie Pharmaceuticals (AERI) announced that on March 24 it dosed the first patient in its Mercury 2 Study. The Phase III Mercury 2 study is evaluating RoclatanTM (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005% is being evaluated for its ability to lower intraocular pressure (IOP) in patients with glaucoma or ocular hypertension. The first Phase III trial called Mercury 1 commenced in September. Top-line data from the trial are expected to be announced in the second quarter of 2017.

Apricus Biosciences Tumbles as Fispemifene Fails in Mid-Stage Study- Apricus Biosciences (APRI) shares closed more than 47% lower on Monday after the company announced that itsfispemifene for the treatment of men with secondary hypogonadism failed in a Phase IIb study. The drug failed to meet its primary endpoint of improving sexual function in men with low testosterone. While participants administered with 450 mg dose did show a statistically valid increase n total, percent free and percent bioavailable testosterone versus placebo, the increase was not statistically significant.

Axsome Therapeutics Commences COAST-1 Study- Axsome Therapeutics (AXSM) announced that it has commenced enrollment in its Phase III study COAST-1. The study is assessing AXS-02 for the treatment of osteoarthritis-related knee pain associated with bone marrow lesions.

Puma Drops on Delay in Neratinib NDA Filing- Puma Biotechnology (PBYI) shares fell sharply on Monday after the company announced that based on feedback from the FDA, it is delaying the filing of New Drug Application (NDA) for its lead product candidate neratinib for the treatment of extended adjuvant breast cancer out until mid-2016. The delay will enable Puma to accommodate changes requested by the FDA. The agency specifically wants Puma to amend the statistical analysis plan for the Phase 3 ExteNET study to update the rules for censoring data for recurrent disease events or death.

Secondary Offerings

BioPharmX (BPMX) shares tumbled in after-hours trading on Monday after the company initiated a public offering of stocks and warrants. BPMX did not disclose the price, volume and terms of the offering. Shares were down almost 20% in after-hours trading.

IPOs

Aeglea BioTherapeutics announced the terms of its $60 million IPO. The company plans to offer 3.5 million shares at a price range of $16 to $18 per share. Based in Austin, Texas, Aeglea BioTherapeutics is focusing on the development of rare genetic metabolic diseases and tumors. The company plans to list its shares on the NASDAQ under the ticker symbol AGLE.

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