(By Mani) Biotechnology stocks have always garnered interest from investors, who are on the look out for various catalysts for making their investment decisions on this stocks. Several Biotech events, including presentations, analyst days and the PDUFA dates, are considered to be one of the key catalysts for shares as the companies would be issuing updates on the events, thereby giving a birds eye-view of its upcoming products.
Following are the list of events of various biotech companies that investors should closely watch this month:
Amgen, Inc. (NASDAQ: AMGN), the largest biotechnology company in the World, is expected to conduct an analyst day on Feb.7. The company is expected to issue updates on key pipeline programs related to cancer treatments T-Vec, AMG 386 and cholesterol drug PCSK9 and commercial outlook. It may also update developments on its own biosimilar strategy on Herceptin, Avastin, Rituxan, Erbitux.
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Investors will look at Amgen's stance on its continued long-term focus on capital allocation, and whether the company would give preference to dividends over buybacks.
Following are the key presentations to watch at Genitourinary Cancers Symposium on Feb. 14-16. Pfizer, Inc. (NYSE: PFE) is expected to present data of Axitinib in first-line on metastatic renal cell carcinoma versus Sorafenib, which is manufactured by Bayer and Onyx Pharmaceuticals, Inc. (NASDAQ: ONXX) as Nexavar.
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Aragon Pharmaceuticals Inc. is expected to present its lead drug candidate ARN-509 for treatment of castration resistant prostate cancer, which has become resistant to antihormonal therapies.
Meanwhile, several companies would present clinical data's at the WORLD Orphan Symposium, which would be held during Feb 12-15.
BioMarin Pharmaceutical, Inc.(NASDAQ:BMRN) is expected to present preliminary results from on-going BMN-701 Phase I/II trial in Pompe disease, which a progressive degenerative disease of the heart muscle, diaphragm and skeletal muscle.
In addition, Synageva BioPharma Corp. (NASDAQ: GEVA) would present updated Phase II data for sebelipase alfa (SBC-102) as an enzyme replacement therapy for LAL Deficiency. Sanofi (NYSE: SNY) would unveil first positive Phase III oral data on eliglustat in Gaucher disease. Amicus Therapeutics, Inc. (NASDAQ: FOLD) would announce Phase II data on AT2220 for Pompe.
Meanwhile, investors should keep an eye on the following PDUFA dates. A PDUFA date is the deadline by which the FDA aims to complete its review of a new drug application and announce its decision on marketing approval.
Feb.10 - FDA is expected to take an action on Celgene Corporation's (NASDAQ: CELG) Pomalyst for multiple myeloma.
Feb.24 - Dynavax Technologies Corp. (NASDAQ: DVAX) is eyeing on this date as FDA would decide the fate of its U.S. Biologics License Application (BLA) for Heplisav for immunization against infection caused by all known subtypes of hepatitis B virus in adults 18 through 70 years of age.
Feb.26 – FDA has set Feb.26 deadline for ImmunoGen, Inc.'s (Nasdaq: IMGN) Trastuzumab Emtansine (T-DM1) Marketing Application for HER2-positive, unresectable locally advanced or metastatic breast cancer who have received prior treatment with Herceptin (trastuzumab) and a taxane chemotherapy.
Feb.28 – The FDA is expected to take an action on Bayer HealthCare and Onyx Pharma's New Drug Application for Stivarga (regorafenib) tablets to treat patients with metastatic and/or unresectable gastrointestinal stromal tumors.