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

Biotech stocks came under selling pressure in March, but much of the FDA decisions of the month produced positive results.

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.

Here are the key PDUFA catalysts for the month of April.

Will FDA Keep Up Tryst With Evoke After Pre-Approval Hiccups?

• Company: Evoke Pharma Inc EVOK
• Type of Application: NDA
• Candidate: Gimoti (EVK-001)
• Indication: for treating symptoms in adult women with acute and recurrent diabetic gastroparesis.
• Date: April 1

Evoke Pharma submitted the NDA for the spray formulation of the product last June and the application was accepted in August. Gastroparesis is a debilitating disorder that manifests as slow or delayed gastric emptying of stomach contents after meals.

The company informed of the receipt of a multi-disciplinary review letter from the FDA on March 1, outlining deficiencies in chemistry, clinical and clinical pharmacology. The company responded to the letter March 14 and said the FDA granted its request for a meeting on March 21.

Can Second Time Be Charm For ADMA?

• Company: ADMA Biologics Inc ADMA
• Type of Application: BLA
• Candidate: RI-002
• Indication: for treating Primary Immune Deficiency Disease, or PIDD
• Date: April 2

ADMA's lead product candidate RI-002 is a specialty plasma-derived polyclonal intravenous immune globulin. The BLA was issued a CRL in July 2016. Following a resubmission, the FDA acknowledged the receipt of it last September and deemed it a Class 2 response.

Merck's Wonder Cancer Awaits Approval For Yet Another Indication

• Company: Merck & Co., Inc. MRK
• Type of Application: sBLA
• Candidate: Keytruda
• Indication: as monotherapy for first-line treatment of locally advanced or metastatic non-small cell lung cancer, or NSCLC, In patients whose tumors express PD-L1 without EGFR or ALK genomic tumor aberrations
• Date: April 11

The sBLA was submitted based on the results of the Phase 3 KEYNOTE-042. Following a recent resubmission of additional data and analyses to the FDA, the agency extended the original PDUFA date by three months to April 11.

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GlaxoSmithKline Unit Seeks Approval For Two-Drug HIV-1 Regimen

• Company: ViiV Healthcare, which is majority owned by GlaxoSmithKline plc GSK
• Type of Application: NDA
• Candidate: single-tablet, two-drug regimen of Dolutegravir + lamivudine
• Indication: HIV-1 infection
• Date: Estimated April 17 (assuming the application is accorded priority review status)

AbbVie's Psoriasis Drug Up Before FDA Altar

• Company: AbbVie Inc ABBV
• Type of Application: BLA
• Candidate: Risankizumab
• Indication: moderate to severe plaque psoriasis
• Date: April 24 (estimated)

Risankizumab is an investigational compound that selectively inhibits IL-23 by binding to its p19 subunit. It's developed as part of a collaboration between Boehringer Ingelheim and AbbVie, with the latter leading future development and commercialization. The BLA was supported by four Phase 3 studies of over 2,000 patients.

Sanofi-Regeneron Seek Label Expansion For Praluent

• Company: Regeneron Pharmaceuticals Inc REGN and Sanofi SA SNY
• Type of Application: sBLA
• Candidate: Praluent injection
• Indication: Label Updation to include the effect of the drug in reducing the overall risk of major adverse cardiovascular events, or MACE
• Date: April 28

MACE is a term used to denote a host of outcomes, including heart attack, ischemic stroke, death from coronary heart disease and unstable angina requiring hospitalization. The BLA is supported by data from the ODYSSEY study.

Praluent, a PCSK9 inhibitor, is approved for use as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with HeFH or clinical atherosclerotic cardiovascular disease (ASCVD) who require additional lowering of LDL-C.

Can Heron's Non-Opioid Pain Medication Pass The FDA Muster?

• Company: Heron Therapeutics Inc HRTX
• Type of Application: NDA
• Candidate: HTX-011 (a fixed-dose combination of the local anesthetic bupivacaine and nonsteroidal anti-inflammatory drug meloxicam)
• Indication: application into the surgical site to reduce postoperative pain and the need for opioid analgesics for 72 hours
• Date: April 30

Nabriva's Infection Drug Awaits FDA Verdict

• Company: Nabriva Therapeutics PLC – ADR NBRV
• Type of Application: NDA
• Candidate: Contepo
• Indication: treatment of several serious infections, including complicated urinary tract infections, or cUTI
• Date: April 30

The FDA had accelerated the decision day from June 30 to April 30 due to a clarification of the classification and subsequent expedited review period.