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Attention Biotech Investors: Brace For These January PDUFA Events

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Attention Biotech Investors: Brace For These January PDUFA Events
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The biotech sector rebounded in 2017, with the iShares NASDAQ Biotechnology Index (ETF) (NASDAQ: IBB) rallying more than 21 percent. This follows an underwhelming performance in 2016, when the IBB lost 21.6 percent.

The performance of IBB in 2017 edged ahead of S&P 500's 19.82 percent gain, but trailed the 28.91 percent jump by the Nasdaq Composite Index.

One of the reasons for the reversal in sentiment toward the biotech space is the brisk pace of new product approvals in the year. The year saw the approval of 46 new molecular entities, or NMEs, compared to 22 approvals in 2016.

Will the sector keep pace with the innovation in 2017 or better it? Here are the PDUFA action dates for the month of January.

Synergy Seeks Approval for Expanded Use Of Its Constipation Drug

  • Company: Synergy Pharmaceuticals Inc (NASDAQ: SGYP)
  • Type of Application: Supplemental New Drug Application, or sNDA
  • Candidate: Trulance (plecanatide)
  • Indication: Treating adults with irritable bowel syndrome with constipation
  • Date: Jan. 24, 2018

Trulance a once-a-daily tablet, has already been approved for treating adults with chronic idiopathic constipation. The sNDA is supported by positive data from the first and second Phase 3 trials, which evaluated safety and efficacy. Trulance is a guanylate cyclase-C (GC-C) agonist.

Advanced Accelerator Application's Second Try

  • Company: Advanced Accelerator Application SA(ADR) (NASDAQ: AAAP)
  • Type of Application: New Drug Application, or NDA
  • Candidate: Lutathera
  • Indication: Treating gastroenteropancreatic neuroendocrine tumors
  • Date: Jan. 26, 2018

France's Advanced Accelerator Application, which has agreed to be bought by Novartis AG (ADR) (NYSE: NVS), is knocking the FDA for a second time regarding its cancer drug Lutathera.

Following the original submission, the FDA handed the company a complete response letter in December 2016, seeking new subgroup data, a safety update, and that revisions be made to the previously submitted data. The FDA accepted the resubmission for review in August 2017.

Lutathera, chemically lutetium oxodotreotide, is a RadioLigand Therapy product for neuroendocrine tumors. The EU had approved it for gastroenteropancreatic neuroendocrine tumors in September.

See Also: Analyst: La Jolla Pharma A Buy Ahead Of February FDA Date

Aradigm Dual D-date for Linhaliq

  • Company: Aradigm Corporation (NASDAQ: ARDM)
  • Type of Application: NDA
  • Candidate: Linhaliq
  • Indication: Treating non-cystic fibrosis bronchiectasis, or NCFBE, patients with chronic infections with Pseudomonas aeruginosa.
  • Date: Jan. 26, 2018

Linhaliq is being evaluated under priority review by the FDA. NCFBE is a severe, chronic and rare disease characterized by abnormal dilatation of the bronchi and bronchioles, frequently associated with chronic lung infections. Among the two Phase 3 trials, data from one met the primary endpoint.

Aradigm is also set to meet with the FDA's Antimicrobial Drugs Advisory Committee on Jan. 11 as part of the review process of Linhaliq.

Sucampo's sNDA For Pediatric Constipation Drug

  • Company: Sucampo Pharmaceuticals, Inc. (NASDAQ: SCMP)
  • Type of Application: sNDA
  • Candidate: Lubriprostone
  • Indication: Treating children aged 6 to 17 years with pediatric functional constipation.
  • Date: Jan. 28, 2018

Sucampo Pharma's tryst with the FDA regarding its pediatric constipation drug is on Jan. 28. The drug was accorded priority review status and was accepted for review in September 2017.

Lubriprostone is indicated for use in the U.S. for the treatment of adults with CIC and opioid induced constipation, or OIC.

Adcom Meeting

A FDA Advisory Committee Meeting, or Adcom meeting, is a meeting of a company, which has one of its treatment candidates being evaluated by the FDA, with a relevant committee, which in turn provides the FDA with independent advice from outside experts.

Lipocine Inc (NASDAQ: LPCN) is set to meet with the Bone, Reproductive and Urologic Drugs Advisory Committee on Jan. 10 to discuss about its TLANDO (LPCN 1021), its oral testosterone product candidate for testosterone replacement therapy, or TRT, in adult males for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism.

Following the issue of a CRL in June 2016, the company resubmitted the NDA, with the FDA acknowledging the resubmission in August 2017. The PDUFA action date is now set for Feb. 8, 2018.

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