8 PDUFA Dates to Watch in August

Published: Aug 02, 2017

8 PDUFA Dates to Watch in August August 1, 2017
By Mark Terry, BioSpace.com Breaking News Staff

The biotech industry did okay in July. The NYSE ARCA Biotech Index and the iShares NASDAQ Biotechnology Index (ETF) grew about 1.9 percent and 2.9 percent, respectively last month. There have been 26 new molecular entity (NME) approvals so far this year. With that figure in mind, here are eight companies looking at PDUFA dates in August.

1. Bristol-Myers Squibb

The company has a priority review for a supplementary Biologics License Application (sBLA) for Opdivo on August 2. Opdivo has been approved for a number of oncology indications, including melanoma, head and neck, lung, kidney and blood cancers. This time around, they’re looking for an approval to treat patients with mismatch repair deficient or microsatellite instability high metastatic colorectal cancer after previous chemotherapy.

Bristol-Myers Squibb is currently trading for $55.70.

2. AbbVie

AbbVie , with Enanta Pharmaceuticals await a new drug application (NDA) decision for glecaprevir/pibrentasvir for hepatitis C (HCV) on August 2. It received priority review status on February 2. It is a combination therapeutic of glecaprevir, an NS3/4A protease inhibitor for all major genotypes of chronic HCV.

AbbVie is currently trading for $70.02.

Enanta is trading for $38.24.

3. Dynavax

Yesterday the U.S. Food and Drug Administration (FDA)’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 12 to 1 to recommend Heplisav-B in adults 18 years or older. Three members of the committee abstained. The PDUFA date is August 10. There are some safety concerns, but the efficacy of the vaccine is very effective.

Dynavax is currently trading for $14.87.

4. Pfizer

Pfizer ’s Besponsa (inotuzumab ozagamimcin) to treat relapsed or refractory acute lymphoblastic leukemia (ALL) has a PDUFA date of August 21. It is an anti-CD22 antibody-drug conjugate and received priority review status after a breakthrough therapy designation in October 2015. In July, the European Commission approved it as a monotherapy for the same indication.

Pfizer is currently trading for $32.73.

5. Valeant Pharmaceuticals International

Valeant has a PDUFA date of August 24 for atanoprostene bonud, an intraocular-pressure lowering eye drop to treat open angle glaucoma or ocular hypertension. Valeant’s Bausch & Lomb division and Nicox resubmitted the application on February 27 with additional data that supported it as the first nitric-oxide donating prostaglandin F2alpha analog for ophthalmic use.

Valeant is currently trading at $16.61.

6. Adamas Pharmaceuticals

Adamas ’ ADS-5102 (amantadine hydrochloride) extended release capsules for levodopa-induced dyskinesia in Parkinson’s disease is up for approval on August 24. Dyskinesia is the involuntary movements that levodopa therapy for Parkinson’s causes.

Adamas is currently trading for $17.20.

7. Novo Nordisk

Novo Nordisk ’s Victoza (liraglutide) has a PDUFA date for a supplementary new drug application (sNDA) to reduce the risk of cardiovascular death in type 2 diabetes patients of August 25. The FDA Advisory Committee voted 17-2 for the drug, which means a likely approval.

Novo Nordisk is currently trading for $42.34.

8. Kamada Ltd.

Kamada has a BLA decision on August 29 for KamRAB, a human anti-rabies immunoglobulin (IgG) therapy. KamRAB is currently marketed in 10 countries. Via a strategic agreement with Kedrion S.p.A, if approved by the FDA, will be marked as KedRAB in the U.S. About 10 million people worldwide require treatment against rabies annually, with about 40,000 post-exposure prophylaxis treatments each year in the U.S.

Kamada is currently trading for $4.60.

Back to news