) -- Biotech stocks continued to march higher at a torrid pace in the first quarter, with the Nasdaq Biotechnology Index (NBI) up 15% compared to a 10% rise in the S&P 500. In fact, the NBI is now comfortably at an all-time high, even higher today that it was during the crazy dot-com and genomics bubble of 1999-2000.
The best way for investors to profit from biotech trading is by staying on top of the most important stock-moving events. To make this job easier, I compiled a list of the most significant biotech trading catalysts for the second quarter. Happy trading!
: Decision on the accelerated approval filing for eteplirsen to treat patients with Duchenne Muscular Dystrophy (exon 51.) Sarepta met with FDA late last month to discuss the eteplirsen filing, so expect a public announcement towards the end of April.
: FDA approval decision for Zohydro, an extended-release formulation of the chronic pain drug hydrocodone without acetaminophen. A decision could come at any time following a delay of the original March 1 PDUFA date.
: The U.S. commercial launch of the weight-loss pill Belviq in April plus a possible approval decision by European regulators.
: FDA advisory panel reviewing Melblez on May 2. The FDA approval decision is expected on June 14.
: FDA advisory panel reviewing Tivozanib also on May 2.
: FDA decision expected in April on loosening marketing restrictions on the weight-loss pill Qsymia, including allowing the drug to be sold in retail pharmacies.
: FDA approval decision for Probuphine on April 30. Don't be surprised if the decision is delayed three months because Titan and FDA are still working on a final risk management plan.
Hepatitis C drug stocks
: The European Association for the Study of Liver Disease (EASL) will release research abstracts for its closely spring meeting on April 8.
The actual EASL meeting is held April 24-28. Investor focus will be on new and updated data from
: FDA acceptance (or rejection) of the Vascepa supplemental New Drug Application (sNDA) covering the larger "ANCHOR" trial population covering patients with mixed dyslipidemia in late April or early May. Acceptance is widely expected so this is an important (negative) catalyst for Amarin if FDA chooses to reject the sNDA or require pre-approval cardiovascular outcomes data. Amarin will also announce first quarter financial results (including the first reporting of Vascepa sales) in May.
: FDA approval decision for Procysbi in cystinosis on April 30.
: Interim results from phase II studies of SB-728 in HIV will be presented at the American Society of Gene and Cell Therapy annual meeting, May 15-19.
: Data from the phase II study of next-generation cystic fibrosis "corrector" VX-661 in combination with Kalydeco.
: Interim analysis of "IMPRESS" phase III trial of algenpantucel-L in resected pancreatic cancer.
: Top-line results from phase III studies of fostamatinib in rheumatoid arthritis.
: FDA approval decision for Sefelsa in menopause on May 31. An FDA advisory panel in March voted against the drug's approval.
: The commercial launch of the multiple sclerosis pill Tecfidera.
: FDA approval decision date for Amitiza in opioid-induced constipation on April 26.
: European approval decision on Provenge possible before end of the second quarter.
: FDA approval decision for efinaconazole to treat toenail fungus infection on May 24.
: FDA approval decision for dabrafenib and trametinib in melanoma on June 3.
: Potential European approval decision for Juxtapid in the second quarter.
Cancer drug stocks
: Research abstracts for the American Society of Clinical Oncology (ASCO) annual meeting will be released on May 16, ahead of the actual meeting taking place May 31 through June 4. Relevant "ASCO" stocks include
-- Reported by Adam Feuerstein in Boston.
Adam Feuerstein writes regularly for TheStreet. In keeping with company editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback;
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