Biotech and pharmaceutical companies are generally involved in the lengthy process of getting their drug candidates to market through clinical trials. There is a fair amount to a great amount of risk involved, should a study come back negative or should a candidate not be approved. Conversely, if a drug is approved or passes a clinical trial, there can be massive upside.
The long and short of the matter is that updates within this industry, as well as U.S. Food and Drug Administration (FDA) rulings, can make or break these companies.
24/7 Wall St. has collected a few catalysts that are coming up on the calendar in November and December, added some color, along with the trading range and price target. We previously highlighted some other catalysts to keep an eye on. Note that, due to many outside and internal factors, there are no assurances that the dates will remain static. Some date changes are positive developments, and some can be disasters if a company is not deeply financed.
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As a side note about the Prescription Drug User Fee Act (PDUFA): a Priority Review designation is granted to medicines that the FDA determines have the potential to provide significant improvements in the treatment, prevention or diagnosis of a disease.
There are a couple of major annual meetings coming up in the next two months. The Society for Immunotherapy of Cancer (SITC) Annual Meeting is taking place in National Harbor, Maryland in mid-November and the American Society of Hematology (ASH) Annual Meeting is coming in mid-December.
Collegium Pharmaceutical Inc. (NASDAQ: COLL) originally had its PDUFA date for Xtampza ER (oxycodone) set for August 4, 2017, but there was a three-month extension. The PDUFA date is now expected on or around November 4, 2017. Xtampza is used in the treatment of severe pain.
Kerx Biopharmaceuticals Inc. (NASDAQ: KERX) has a PDUFA date scheduled for November 6, which will be a review of the firm’s supplemental New Drug Application (sNDA) for Auryxia (ferric citrate). Auryxia is currently approved for use in the United States for the control of serum phosphorus levels in patients with end-stage renal disease requiring dialysis.
Pfizer Inc. (NYSE: PFE) has an advisory meeting with the FDA’s Vaccines and Related Biological Products Advisory Committee on November 7. The purpose of this meeting is to discuss and make recommendations on the clinical development plan for Pfizer’s investigational Staphylococcus aureus vaccine intended for presurgical prophylaxis in elective orthopedic surgical populations.
Infinity Pharmaceuticals Inc. (NASDAQ: INFI) will be presenting data for its IPI-549 at SITC annual meeting on November 10 to 12. IPI-549 is an orally administered immuno-oncology development candidate that selectively inhibits phosphoinositide 3-kinase gamma. In simpler terms, the drug promotes an anti-tumor immune response that leads to tumor growth inhibition.
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Iovance Biotherapeutics Inc. (NASDAQ: IOVA) also will be presenting at the SITC annual meeting the data from its Phase 2 trials of LN-145 and LN-144, for the treatments of head and neck cancer and refractory metastatic melanoma, respectively.
Five Prime Therapeutics Inc. (NASDAQ: FPRX) is presenting data from its Phase 1a/1b clinical trial evaluating the immunotherapy combination of its CSF-1R antibody, cabiralizumab (FPA008), with Opdivo (nivolumab) and Bristol-Myers Squibb Co.’s (NYSE: BMY) PD-1 immune checkpoint inhibitor. This data will be presented on November 11 at the SITC.
Akari Therapeutics PLC (NASDAQ: AKTX) will be presenting interim data from its Phase 2 clinical trial of Coversin at the ASH annual meeting on December 9 to 12. Coversin works to treat paroxysmal nocturnal haemoglobinuria and atypical hemolytic uremic syndrome.
Argenx S.E. (NASDAQ: ARGX) is also presenting mid-stage interim data for ARGX-110 in the treatment of relapsed/refractory cutaneous T-cell lymphoma (Phase 2) and acute myeloid leukemia (Phase 1/2).
Valeant Pharmaceuticals International Inc. (NYSE: VRX) has a PDUFA date of December 27 for its New Drug Application (NDA) for brimonidine tartrate ophthalmic solution (Luminesse). Luminesse is an over-the-counter eye drop used to relieve redness of the eye due to minor eye irritations.
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