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

Shanthi Rexaline

Biotech stocks had a fairly decent outing in February, with the iShares NASDAQ Biotechnology Index (NASDAQ: 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 (NYSE: NVS)'s Egaten (liver fluke infestation), Sanofi SA (NASDAQ: SNY)'s Cablivi (autoimmune-based blood clotting disorder) and Evolus Inc (NASDAQ: 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.

Related Link: Novavax Re-Enters Penny Stock Territory After Respiratory Disease Vaccine Flunks Late-Stage Trial

J&J Braces For Cheer From Approval For Depression Drug

  • Company: Johnson & Johnson (NYSE: 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 (NASDAQ: 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 (OTC: RHHBY) and Celgene Corporation (NASDAQ: 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 (NASDAQ: 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 (NASDAQ: SAGE) and Ligand Pharmaceuticals Inc. (NASDAQ: 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 (NASDAQ: 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. (NASDAQ: 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 (NASDAQ: 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 (NYSE: TEVA)'s multiple sclerosis drug Copaxone in the U.S.

Pfizer's Breast Cancer Biosimilar Up Before FDA

  • Company: Pfizer Inc. (NYSE: PFE)
  • Type of Application: BLA
  • Candidate: PF-05280014, a a proposed biosimilar to Roche's Herceptin
  • Indication: HER2 receptor positive breast cancer
  • Date: First Quarter

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