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Mark Your Calendars: 4 Biotechs Facing FDA Decision Dates in May 2017

Written by: | | Dated: Thursday, April 27th, 2017


Mark Your Calendar: 4 Biotechs Facing FDA Decision Dates in May
April 27, 2017
By Mark Terry, Breaking News Staff

Some basic vocabulary. The Prescription Drug User Fee Act (PDUFA) date refers to the deadline the U.S. Food and Drug Administration (FDA) has to meet when it’s reviewing a New Drug Application (NDA). Another important acronym is CRL, or complete response letter, which is an FDA term for what would otherwise be called a rejection letter—when they turn down an NDA.
With the relevant vocabulary out of the way, here are four biotech companies with PDUFA dates in May. A thumbs-up can be a major catalyst for company stocks, while a thumbs-down can induce a drop.

1. TherapeuticsMD

Based in Boca Raton, Fla., TherapeuticsMD (TXMD) focuses on women’s health. The company has a May 7 PDUFA date for TX-004HR, which is an investigational bio-identical 17beta-estradiol vaginal softgel capsule to treat moderate-to-severe vaginal pain during sexual intercourse. This is a symptom of vulvar vaginal atrophy (VVA) in postmenopausal women.

Apparently, the FDA had some issues with the NDA—not necessarily with the product itself—but TherapeuticsMD indicated on April 19 that it has been in communication with the agency concerning the deficiencies in the NDA and “intends to resolve them as quickly as possible.”

TherapeuticsMD stock is currently trading for $5.19.


2. Merck & Co.

On January 10, the FDA accepted Merck & Co. (MRK)’s (MRK) supplemental Biologics License Application (sBLA) for Keytruda (pembrolizumab), its anti-PD-1 therapy, plus chemotherapy (pemetrexed plus carboplatin) to be the first-line treatment for patients with metastatic or advanced non-squamous non-small cell lung cancer (NSCLC) regardless of PD-L1 expression, also regardless of EGFR or ALK genomic tumor aberrations. The FDA gave it a Priority Review. It is the first application for Keytruda in combination with another treatment. The PDUFA date is May 10.

“Through our monotherapy and combination studies, we are working to find new approaches to help a broad range of patients with lung cancer,” said Roger Dansey, Merck Research Laboratories (MRK)’ senior vice president and therapeutic area head, oncology late-stage development, in a January statement. “Keytruda in combination with chemotherapy has shown promise versus chemotherapy alone in the first-line treatment of non-squamous metastatic non-small cell lung cancer, regardless of PD-L1 levels. If approved, this could be the first regimen combining chemotherapy with an immuno-oncology agent for patients with advanced non-small cell lung cancer.”

The company also has a May 27 PDUFA date for Isentress to treat HIV-1.

Merck stock is currently trading for $62.70.


3. Novartis

On Nov. 14, 2016, the FDA granted Priority Review to Novartis (NVS)’ (NVS) PKC412 (midostaurin)’s NDA to treat acute myeloid leukemia (AML) in newly-diagnosed adults with an FMS-like tyrosine kinase-3 (FLT3) mutation, in addition to the treatment of advanced systemic mastocytosis (SM).

At the same time, the company’s premarket approval application (PMA) for the PKC412 (midostaurin) FLT3 companion diagnostic, which was developed with Invivoscribe Technologies (IVS), was accepted for review. The European Medicines Agency (EMA) also accepted the marketing authorization application for PCK412. The PDUFA date is estimated for May 14, 2017.

“FLT3-mutated AML and advanced SM are devastating and rare diseases, with significant unmet needs due to limited existing treatment options,” said Bruno Strigini, Novartis Oncology (NVS)’s chief executive officer, in a November 2016 statement. “This regulatory designation signifies the importance of midostaurin as a potential therapy for these patients who haven’t had the benefit of targeted medicines.”

Novartis stock is currently trading for $76.35.


4. Novo Nordisk

On April 4, the FDA’s Blood Products Advisory Committee (BPAC) met to discuss the company’s Biologics License Application (BLA) for nonacog beta pegol, an investigational glycoPEGylated extended-half-life recombinant factor IX product for hemophilia B. The Committee discussed the data, but did not vote on a recommendation. The PDUFA date is May 16.

The final vote will take into consideration the Committee’s feedback. In Europe, the Committee for Medicinal Products for Human Use (CHMP) gave a positive opinion on the drug on March 23.

Novo Nordisk (NVO) is committed to addressing the serious unmet medical needs of the hemophilia community and to delivering safe and effective medicines to patients,” said Stephanie Seremetis, Novo Nordisk’s chief medical officer and corporate vice president of Hemophilia, in a statement. “We are encouraged by today’s discussion and look forward to working with the FDA to bring nonacog beta pegol to people with hemophilia B who may benefit from the protection of sustained, high factor IX activity in a once-weekly dose.”

Novo Nordisk (NVO) stock is currently trading for $37.36.

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