Companies in the health care sector face great risk and great reward every time they make an announcement. Drug candidates passing clinical trials, gaining regulatory approval or being canceled can have an incredible impact on the stock.
The U.S. Food and Drug Administration (FDA) acts as a major catalyst for many of these companies, as well as clinical trials and licensing agreements.
Here, 24/7 Wall St. takes a look at what is coming up in the FDA calendar regarding biotech and pharmaceutical companies expecting updates to their drug pipeline or other major events for the rest of 2018.
It’s worth mentioning that these dates may be subject to change due to various outside and internal factors, or some of these dates may have changed already. Some of these date changes are positive developments, while some can be disasters if a company is deeply financed.
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.
Merck & Co. (NYSE: MRK) previously filed a new supplemental Biologics License Application (sBLA) seeking accelerated approval for Keytruda for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma. The FDA has set a PDUFA target action date for December 28.
Bristol-Myers Squibb Co. (NYSE: BMY) has a PDUFA date scheduled for December 29 for its sBLA of Sprycel (dasatinib) in combination with chemotherapy for the treatment of pediatric patients with newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia.
Supernus Pharmaceuticals Inc. (NASDAQ: SUPN) had its Oxtellar XR accepted for review by the FDA back in April of this year. This is for the treatment of partial seizures of epilepsy for adults and for children between the ages of 6 to 17. The FDA is expected to release its decision by the end of December.
Jazz Pharmaceuticals PLC (NASDAQ: JAZZ) has a PDUFA date scheduled for December 20 for solriamfetol, an investigational medicine for the treatment of excessive sleepiness in adult patients with narcolepsy or obstructive sleep apnea. The FDA had previously accepted the NDA for review back in March.
Idera Pharmaceuticals Inc. (NASDAQ: IDRA) will be providing an update from its Illuminate 204 trial in the first half of December, as well as laying out its expansion plans for the program in the beginning of 2019. For some background: Illuminate 204 is a Phase 1/2 trial of intratumoral tilsotolimod in combination with either ipilimumab or pembrolizumab in patients with PD-1 refractory/relapsed metastatic melanoma.
Ampio Pharmaceuticals Inc. (NASDAQ: AMPE) will receive final guidance from the FDA’s Office of Tissue Advanced Therapies by mid-December. This will determine whether the clinical trial portion of the Ampion Biologics License Applications (BLA) process is complete or will require an additional trial, which would be carried out under a Special Protocol Assessment.