Attention Biotech Investors: Mark Your Calendar For These January PDUFA Dates

After a strong 2017, biotech stocks are on track to end the year in the red despite a record 59 new molecular entity approvals, some noteworthy M&A deals and several breakthrough developments in drug discovery and research.

Will the new year mark a reversal in fortunes for these firms? Here're a few PDUFA catalysts scheduled for January.

PDUFA dates are deadlines for the FDA to review new drugs. The FDA is normally given 10 months to review new drugs. If a drug is selected for priority review, the FDA is allotted six months to review the drug. These time frames begin on the date that an NDA is accepted by the FDA as complete.

1. Starpharma Awaiting The Star Turn

  • Type of Application: NDA
  • Candidate: VivaGel
  • Indication: Water-based vaginal gel for the treatment of bacterial vaginosis, or BV, and prevention of recurrent BV.
  • Date: Early January (estimated)

The FDA on July 9 announced its acceptance of the NDA with priority review status, implying a six-month review period, rendering the PDUFA action date around early January.

BV is estimated to affect around 30 percent of women in the U.S., with a high probability of repeat occurrences, the company said. There's no approved therapy for BV in the U.S. VivaGel is already approved in Europe and Australia.

The company has licensed sales and marketing rights of VivaGel in North America to privately-held ITF Pharma.

2. Merck's Wonder Cancer Drug Reviewed For Another Indication

  • Company: Merck & Co., Inc. MRK
  • Type of Application: sBLA
  • Candidate: Keytruda
  • Indication: First-line treatment of locally advanced or metastatic, non-squamous, or squamous, non-small cell lung cancer in patients whose tumor express PD-L1.
  • Date: Jan. 11

3. Exelixis Seeks Label Expansion For Cancer Drug

Company: Exelixis, Inc. EXEL

  • Type of Application: sNDA
  • Candidate: Cabozantinib
  • Indication: Patients with previously treated advanced hepatocellular carcinoma (HCC).
  • Date: Jan. 14

Cabozantinib has already been approved in the U.S. for treating patients with advanced renal cell carcinoma, or RCC. The sNDA filing for HCC was made based on a Phase 3 pivotal study dubbed CELESTIAL, which demonstrated statistically significant and clinically meaningful improvement with the drug in overall survival.

See Also: When Larger Firms Walk Away From Partnerships With Smaller Ones: How Bad Is The Damage?

4. Immunomedics Breast Cancer Drug On FDA Altar

  • Company: Immunomedics, Inc. IMMU
  • Type of Application: BLA
  • Candidate: Sacituzumab Govitecan
  • Indication: Treating metastatic triple-negative breast cancer, or TNBC, patients, who have previously received at least two prior therapies.
  • Date: Jan. 18

Sacituzumab Govitecan is Immunomedics' most advanced product candidate and is an antibody-drug conjugate. The FDA had accepted the application on July 18, according it priority review status.

5. Sanofi Seeks Approval For Low Dose Influenza Vaccine In Pediatric Patients

  • Company: Sanofi SA SNY
  • Type of Application: sBLA
  • Candidate: Fluzone Quadrivalent vaccine, 0.5 ml dose
  • Indication: Prevent influenza in children aged six months to 35 months
  • Date: Jan. 28

Fluzone Quadrivalent vaccine, in 0.5 ml dose, has already been approved for use by people over 35 months. For children aged six months to 35 months, the approved dose is 0.25 ml. The FDA had accepted the sBLA April 25. The filing was supported by clinical data from a Phase 4 safety and immunogenicity study conducted in nearly 2,000 children.

6. Will FDA Go Against Panel Recommendation For Alkermes' Depression Drug?

  • Company: Alkermes Plc ALKS
  • Type of Application: NDA
  • Candidate: ALKS 5461
  • Indication: adjunctive treatment of major depressive disorder, or MDD, with an inadequate response to standard antidepressant therapies
  • Date: Jan. 31

ALKS 5461 is a fixed-dose combination of buprenorphine, a partial mu-opioid receptor agonist and kappa-opioid receptor antagonist, and samidorphan, a mu-opioid receptor antagonist.

FDA's Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee, which met jointly to discuss the NDA Nov. 1, voted 2-21 against approval of the drug, citing the inadequate benefit-risk profile.

7. Aquestive's Parkinson's Treatment Awaits FDA Nod

  • Company: Aquestive Therapeutics Inc AQST
  • Type of Application: NDA
  • Candidate: APL-130277
  • Indication: motor fluctuations, or OFF episodes, experienced by people living with Parkinson's disease, when medications stop working
  • Date: Jan. 29

Aquestive is partnering with Sunovian Pharma, which is the sponsor of APL-130277 – chemically apomorphine sublingual film. As recently as this month, the FDA approved Acorda Therapeutics Inc ACOR's Inbrija for treating OFF episodes.

Adcom Meetings

A joint meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee on Jan. 11 will discuss Takeda Pharma's sNDA for Uloric tablets. Uloric is a xanthine oxidase inhibitor indicated for chronic management of hyperuricemia in patients with gout.

The Bone, Reproductive and Urologic Drugs Advisory Committee is scheduled Jan. 16 to discuss Amgen, Inc. AMGN's BLA for romosozumab injection for treating osteoporosis in postmenopausal women at high risk of fracture.

The Endocrinologic and Metabolic Drugs Advisory Committee on Jan. 17 will discuss the NDA for sotagliflozin oral tablet, codeveloped by Sanofi and Lexicon Pharmaceuticals, Inc. LXRX. The candidate is being evaluated as an adjunct to insulin therapy to improve glycemic control in adults with type 1 diabetes mellitus.

Posted In: ALKS 5461APL-130277CabozantinibFluzone QuadrivalentKeytrudaSacituzumab GovitecanVivaGelBiotechNewsPreviewsFDATop StoriesTrading Ideas