The biotech sector's March "fluctuation" might be a temporary speed bump or the beginning of a longer downturn. Either way, investors can still count on the biotech catalyst trade for chills and thrills.
I put together a list of biotech catalysts for the second quarter. It's fairly extensive, owing much to April, May and June being the high season for medical conferences.
Take a look.
The most significant catalyst in the second quarter, perhaps the entire year, belongs to Vertex Pharmaceuticals(VRTX) - Get Report and the TRAFFIC and TRANSPORT phase III studies of Kalydeco and VX-809 in cystic fibrosis patients with the f508del mutation. Vertex has guided to top-line results mid-year, which could mean June but perhaps in May.
At the American Thoracic Society annual meeting, (May 16-21), InterMune (ITMN) and Boehringer Ingelheim will be making full data presentations of phase III studies for their competing idiopathic pulmonary fibrosis drugs Esbriet and nintedanib, respectively. Intermune announced positive top-line results from the Esbriet study in XXXX, while some of the Boehringer nintedanib data leaked.
The annual Super Bowl of cancer drug research, otherwise known as the American Society of Clinical Oncology annual meeting, runs May 31 through June 4. Like last year, the big focus will be on cancer immunotherapy, more specifically the "checkpoint inhibitors" or anti-PD1 therapies under development by Bristol-Myers Squibb(BMY) - Get Report, Merck(MRK) - Get Report and Roche RHHBY. The ASCO meeting is huge, so just about every cancer-focused biotech and drug company will have a presence. I'll throw some stocks out there to give you a taste: Incyte(INCY) - Get Report, Clovis Oncology(CLVS) - Get Report, Oncomed Pharmaceuticals(OMED) - Get Report and Pharmacyclics (PCYC) . Important to note: Research abstracts for the ASCO meeting will be released on May 14.
For the first time in a long time, there's something for investors to see UN-related to hepatitis C at a liver disease meeting. Intercept Pharmaceuticals(ICPT) - Get Report will present full data from the POISE phase III study of obeticholic acid for the treatment of primary biliary cirrhosis (PBC) at the European Association for the Study of Liver (EASL) meeting, scheduled for April 9-14. Hepatitis C won't be ignored at this year's EASL meeting, of course. Significant data presentations are expected from Merck, Gilead Sciences(GILD) - Get Report (of course) and Bristol-Myers Squibb, among others. The buzzword for this year's Hep C data presentations is "pan-genotypic" -- meaning drugs (or combinations of drugs) capable of treating all the various Hep C genotypes.
The American Association for Cancer Research annual meeting generally focuses on very early stage research, but noteworthy at this year's meeting (April 5-9) will be phase I data on Agios Pharma's(AGIO) - Get Report AG-221 in acute myeloid leukemia patients.
Pfizer(PFE) - Get Report will also be at AACR presenting the PALOMA-1 phase II breast cancer data on palbociclib. The company announced the study's success in February, leading to speculation of an early approval filing.
We'll get an update from Isis Pharma (ISIS) (partnered with Biogen Idec(BIIB) - Get Report) on the phase II study of SMN-Rx in infants with spinal muscular atrophy at the American Academy of Neurology (AAN) meeting April 26-May 3.
On March 24, Provectus Biopharmaceuticals (PVCT) announced (strangely) that a request had been filed with FDA to grant breakthrough therapy designation to the melanoma drug PV-10. FDA has 60 days to respond, so expect an announcement from Provectus on or near May 24.
Cytokinetics(CYTK) - Get Report is looking at two opportunities in the second quarter to announce results from a phase IIB study of tirasemtiv in patients with amyotrophic lateral sclerosis (ALS). The first will be at the AAN meeting (April 26-May 3) or later in the quarter at the Joint Congress of European Neurology (May 31-June 3).
Three days later, on June 10, FDA is expected to announce the approval decision for Orexigen Therapeutics' (OREX) weight-loss therapy Contrave.
When Amgen(AMGN) - Get Report bought Onyx Pharmaceuticals for $10 billion, the big prize was the multiple myeloma drug Kyprolis. Two important studies of Kyprolis are expected to read out in the second quarter. The FOCUS phase III study compares Kyprolis to best supportive care in multiple myeloma patients who no longer respond to multiple therapies. This study is intended for regulatory approval of Kyprolis in Europe and the rest of the world. The ASPIRE phase III trial compares Kyprolis, Revlimid and dexamethasone to Revlimid and dexamethasone in patients with relapsed multiple myeloma and is the confirmatory overall survival trial meant to support Kyprolis' accelerated approval in the U.S.
Ohr Pharmaceuticals (OHRP) plans an interim analysis in the second quarter of a phase II study of squalamine, an eye-drop medicine for wet age-realted macular degeneration.
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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