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

Biotech stocks had a fairly decent outing in February, with the iShares NASDAQ Biotechnology Index IBB adding roughly 2.7 percent for the month compared to the 3 percent gain for the S&P 500 Index. After the government shutdown-related slackness in January, FDA review picked up in February.

New molecular entity, or NME approvals totaled three thus far this year, with Novartis AG NVS's Egaten (liver fluke infestation), Sanofi SA SNY's Cablivi (autoimmune-based blood clotting disorder) and Evolus Inc EOLS's Jeuveau (severe glabellar lines/frown lines) among the new molecules approved.

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 events scheduled for March.

J&J Braces For Cheer From Approval For Depression Drug

Company: Johnson & Johnson JNJ
Type of Application: NDA
Candidate: Spravato (Esketamine)
Indication: treatment-resistant depression
Date: March 4

J&J's Janssen unit submitted the NDA for the Spravato nasal spray CIII Sept. 4, 2018. A joint sitting of the FDA's Psychopharmacologic Drug Advisory Committee and Drug Safety and Risk Management Advisory Committee, which met Feb. 12, voted 14-2 in support of the favorable benefit-risk profile of the investigational drug.

"If approved, SPRAVATO would provide the first new mechanism of action in 30 years to treat this debilitating mental illness," J&J said.

Regeneron/Sanofi Seeks Approval For Expanded Use Of Skin Inflammation Drug

Company: Regeneron Pharmaceuticals Inc REGN & Sanofi
Type of Application: sBLA
Candidate: Dupixent
Indication: adolescents with moderate-to-severe atopic dermatitis.
Date: March 11

Dupixent, which is being evaluated by Regeneron and Sanofi, for a broad range of clinical development programs for diseases driven by allergic and other Type 2 inflammation, is currently approved for treating adults with moderate-to-severe atopic dermatitis, and as an add-on maintenance treatment for patients 12 years and older with moderate-to-severe asthma with an eosinophilic phenotype or with oral-corticosteroid-dependent asthma.

For the indication which approval is being sought, the drug has received both Breakthrough Therapy designation and priority review status.

Roche's Tecentriq For Triple-Negative Breast Cancer With PD-L1 Expression

Company: Roche Holdings AG Basel ADR RHHBY and Celgene Corporation CELG
Type of Application: sBLA
Candidate: Tecentriq plus chemotherapy Abraxane
Indication: first-line treatment of unresectable locally advanced or metastatic triple-negative breast cancer in people whose disease expresses PD-L1 protein, as determined by PD-L1 biomarker testing
Date: March 12

If approved, the Tecentriq combination would be the first cancer immunotherapy regimen for the treatment of PD-L1-positive, metastatic TNBC, Roche said in a November release communicating the receipt of priority review status for the regulatory application.

Tecentriq has already been approved for previously treated metastatic non-small cell lung cancer and for certain types of untreated or previously-treated metastatic urothelial carcinoma, and Abraxane is a registered trademark of a Celgene subsidiary.

Aerie's Seeks FDA Blessings For Combo Drug For Eye Pressure

Company: Aerie Pharmaceuticals Inc AERI
Type of Application: NDA
Candidate: Roclatan (netarsudil/latanoprost ophthalmic solution 0.02% /0.005%)
Indication: once-daily eye drop designed to reduce intraocular pressure in patients with glaucoma or ocular hypertension
Date: March 14

The FDA accepted the NDA for review July 23.

Roche's Tecentriq For A Type Of Lung Cancer

Company: Roche
Type of Application: sBLA
Candidate: Tecentriq, in combination with carboplatin and etoposide (chemotherapy)
Indication: first-line treatment of people with extensive-stage small cell lung cancer, or SCLC
Date: March 18

The review of the combo treatment was accorded priority review designation, and there has been no new initial treatment option for extensive-stage SCLC for about 20 years now.

Will Sage Get Nod For Post-Partum Depression Drug After Three Month Delay?

Company: SAGE Therapeutics Inc SAGE and Ligand Pharmaceuticals Inc. LGND
Type of Application: NDA
Candidate: Brexanolone
Indication: Post-partum depression
Date: March 19

The FDA extended the original PDUFA of Dec. 19 by three months after Sage submitted a proposed Risk Evaluation and Mitigation Strategies program with Elements to Ensure Safe Use in response to the FDA's request.

A FDA panel, which reviewed the NDA, voted 17-1, recommending approval of the drug.

Jazz Losing Sleep Over Excessive Sleepiness Drug

Company: Jazz Pharmaceuticals PLC JAZZ
Type of Application: NDA
Candidate: JZP-110
Indication: treatment of excessive sleepiness in adult patients with narcolepsy or obstructive sleep apnea
Date: March 20

The FDA accepted the NDA, with an initial PDUFA date of Dec. 20, which was subsequently extended by three months, as it determined that a submission made by Jazz during the course of discussions regarding draft labeling constituted a major amendment to the NDA.

Sanofi-Lexicon Awaits Sweet Tidings For Diabetes Drug

Company: Sanofi and Lexicon Pharmaceuticals, Inc. LXRX
Type of Application: NDA
Candidate: Zynquista, chemically Sotagliflozin
Indication: oral anti-diabetic drug
Date: March 22

Zynquista is an investigational oral treatment to be used in addition to insulin therapy to improve blood sugar control in adults with type 1 diabetes. It's a dual inhibitor of SGLT-1 and SGLT-2, proteins that influence how the intestines and kidneys absorb and eliminate sugar, resulting in improved glucose control and additional clinical benefits.

Can Second Time Be Charm For Recro?

Company: Recro Pharma Inc REPH
Type of Application: NDA
Candidate: intravenous (IV) meloxicam
Indication: management of moderate to severe pain
Date: March 24

Recro's NDA for the pipeline asset faced a setback after it was issued a complete response letter last May, with the FDA reasoning that data from ad hoc analyses and selective secondary endpoints suggested that the analgesic effect of the asset doesn't meet its expectations.

Following the resubmission of the NDA, the FDA deemed the response as complete and set the new PDUFA data.

Novartis Looks To Add One More Drug To Its Multiple Sclerosis Portfolio

Company: Novartis
Type of Application: NDA
Candidate: oral, once-daily siponimod, or BAF312
Indication: secondary progressive multiple sclerosis, or SPMS, in adults
Date: March (exact date not mentioned)

More than 80 percent of people with relapsing-remitting multiple sclerosis go on to develop SPMS, with or without relapse, according to Novartis. It already markets Gilenya and Extavia for various forms of multiple sclerosis, while its Sandoz generic unit markets Teva Pharmaceutical Industries Ltd TEVA's multiple sclerosis drug Copaxone in the U.S.