Health and Healthcare

Major Biopharma Catalysts on July's FDA Calendar

Chris Lange

Published: July 7, 2018 8:15 am

Last Updated: January 11, 2020 9:22 pm

Biotech and pharmaceutical companies are generally involved in the lengthy process of getting their drug candidates to market through clinical trials. The amount of risk involved ranges from fair to great, should a study come back negative or a candidate not be approved. Conversely, if a drug is approved or passes a clinical trial, there can be massive upside.

In simpler terms, these updates within the industry have the potential to make or break biopharma companies.

Here 24/7 Wall St. has included a calendar of some of the biggest companies expecting clinical trial and U.S. Food and Drug Administration (FDA) updates in July.

It’s worth mentioning that these dates may be subject to change due to various internal and outside factors. Some of these changes are positive developments and 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.

AbbVie Inc. (NYSE: ABBV) and Neurocrine Biosciences Inc. (NASDAQ: NBIX) are expecting to have a PDUFA date in July for their New Drug Application (NDA) for elagolix in endometriosis-associated pain. If approved, elagolix will be the first new oral medical management treatment option for endometriosis-associated pain in more than a decade.

Durect Corp. (NASDAQ: DRRX) is also expecting a PDUFA date for its NDA of RBP-7000 in late July. The schizophrenia treatment has a target action date of July 28, 2018.

GlaxoSmithKline PLC (NYSE: GSK) has a meeting with the FDA’s Pulmonary-Allergy Drugs Advisory Committee scheduled for July 25. The meeting is in regards to the firm’s supplementary Biologics License Agreement (sBLA) for its chronic obstructive pulmonary disease (COPD) treatment, mepolizumab.

Zynerba Pharmaceuticals Inc. (NASDAQ: ZYNE) is scheduled to present data of ZYN002 at the 16th NFXF (National Fragile X Foundation) International Fragile X Conference in Cincinnati, July 11 to 15. ZYN002 is the first and only pharmaceutically produced cannabidiol, a non-psychoactive cannabinoid, formulated as a patent-protected permeation-enhanced gel for transdermal delivery through the skin and into the circulatory system. ZYN002 is being developed for patients suffering from Fragile X syndrome and certain refractory epilepsies.

24/7 Wall St.
2018 Dow Laggards Could Offer Material Upside Into 2019

Progenics Pharmaceuticals Inc. (NASDAQ: PGNX) has a PDUFA date set for July 30 for its malignant pheochromocytoma and paraganglioma treatment, Azedra.

Catalyst Biosciences Inc. (NASDAQ: CBIO) is scheduled to present interim data from its Phase 2 study of Marzeptacog alfa (MarzAA) on July 18. This data will be pertaining to the subcutaneous efficacy trial in individuals with hemophilia A or B with inhibitors to evaluate the ability of MarzAA to minimize spontaneous bleeding episodes.

Theravance Biopharma Inc. (NASDAQ: TBPH) is expected to report data from its Phase 2a study in patients with symptomatic neurogenic orthostatic hypotension by end of July 2018. Specifically, this data is in regards to its TD-9855 (norepinephrine serotonin reuptake inhibitor).