BOSTON (TheStreet) -- The December calendar of biotech and drug stock events.
Food and Drug Administration approval decision to expand use of Incyte's (INCY) Jakafi as a treatment for patients with polycythemia vera.
The American Society of Hematology annual meeting. This is the largest medical meeting focused on blood-related cancers like lymphoma and leukemia. As you'd expect, investors pay close attention to what goes on at the ASH annual meeting, as the stocks of biotech and drug companies will move on the clinical data presented there. Which stocks? Here's a partial list of the most important data presenters: Bluebird (BLUE) , Merck (MRK) , Bristol-Myers Squibb (BMY) , Agios Pharma (AGIO) , Epizyme (EPZM) , Acceleron Pharma (XLRN) , Pharmacyclics (PCYC) , Celgene (CELG) and Seattle Genetics (SGEN) .
Dicerna (DRNA) investor meeting.
The European Medical Agency gathers for its monthly meeting to review and vote on recommendations for new drug approvals. Orexigen Therapeutics' (OREX) weight-loss pill Contrave is on the December meeting agenda. If Contrave receives a positive recommendation, it will be the only become the only weight-loss drug approved in Europe. Vivus (VVUS) and Arena Pharmaceuticals (ARNA) have so far failed to convince Europe to allow their competing weight-loss pills to be sold there.
FDA approval decision on AbbVie's (ABBV) all-oral hepatitis C regimen -- Exviera and Viekirax. If approved, AbbVie will compete immediately against Gilead Sciences' (GILD) Harvoni for the diseased livers of hepatitis C patients. The competition is expected to boil down to price, with investors waiting to see if AbbVie will price its therapy at a discount to Gilead in order to win favor with insurance companies. Enanta Pharmaceuticals (ENTA) contributed a drug to the AbbVie regimen and will receive royalties on sales.
FDA approval decision on Biocryst Pharma's (BCRX) intravenous flu drug peramivir, to be sold under the brand name Rapivab. The drug's clinical development path has been notable for studies posting mixed results in flu patients. However, Rapivab appears to have the support of the U.S. government, which may stockpile some inventory just in case of a flu epidemic. Many investors don't project Rapivab to generate meaningful revenue for Biocryst and the company, itself, focuses more attention on other drug candidates, including BCX4161 for hereditary angioedema.
FDA approval decision on expanded use of Vertex Pharma's (VRTX) Kalydeco into cystic fibrosis patients with the R117H genetic mutation. An FDA advisory panel voted to recommended Kalydeco for these patients, so the FDA is widely expected to follow through with an approval.
On the same day, FDA is also expected to issue an approval decision on PA8140/PA325, a combination of aspirin and omeprazole (the active ingredient in the heartburn medicine Prilosec) developed by Pozen (POZN) . The drug is intended for use by patients who take daily aspirin to reduce cardiovascular disease but who are also at risk for aspirin-induced ulcers. The FDA rejected PA8140/PA325 in April, but Pozen resubmitted for a second shot at approval.
Other important stock-moving events which should happen in December:
Everyone is still waiting for Achillion Pharmaceuticals (ACHN) to release proof-of-concept results from the early-stage study of its hepatitis C "nuc" ACH-3422. This is an extremely important drug for Achillion, so expect the stock to move significantly in one direction or the other depending on the '3422 data. I wrote a primer on expectations in October.
Anthera Pharma (ANTH) will announce results from an interim analysis of the ongoing phase III "CHABLIS-SC1" study of blisibimod in lupus.