6 Biotechs Still Awaiting December Catalysts

The bottom half of December will prove to be a busy one for the biotechnology sector. Below are six biotech companies with catalysts still ahead for the end of the year.

Roche Holding

Roche Holding Ltd. (ADR) RHHBY's Genentech unit's OCREVUS's Prescription Drug User Fee Act (PDUFA) date is set for December 28.

The therapy has already been granted a priority review designation by the U.S. Food and Drug Administration (FDA), while the European Medicines Agency (EMA) granted a Marketing Authorization Approval.

Advanced Accelerator Application

Advanced Accelerator Application SA(ADR) AAAP also has a PDUFA date of December 28 for its Lutathera therapy.

The FDA has accepted the company's NDA and accorded it preview review.

Acadia Pharmaceuticals

ACADIA Pharmaceuticals Inc. ACAD is expected to release top-line results from its Phase 2 study of Pimavanserin by the end of 2016.

Pimavanserin has already been approved for the treatment of Parkinson's disease psychosis.

Cempra

Cempra Inc CEMP said in a press release back in August that its Solithromycin therapy was granted qualified infectious diseases product (QIDP) designation which entitled the new drug applications (NDAs) to eight month priority reviews, resulting in PDUFA dates of December 27 and December 28, 2016, respectively.

Egalet

Egalet Corp EGLT said in its third-quarter earnings report in early November that it expects the FDA to finalize the review of its ARYMO ER in time for a potential launch in the first quarter of 2017.

On November 14, the company said the FDA would not meet its PDUFA date for ARYMO ER, which was scheduled for the same day. Egalet did note that the FDA needed additional time in its review and that no additional scientific information or data is needed for the application.

Egalet also told Benzinga on November 19 that it doesn't "have any idea of timing" related to FDA's decision. On the other hand, a notable analyst Benzinga spoke with suggested that a typical delay to approval on opioids runs two to four weeks.

Synergy Pharmaceuticals

Synergy Pharmaceuticals Inc SGYP is a biopharmaceutical company that is focused on the development and commercialization novel gastrointestinal therapies.

One of the company's lead product candidates, plecanatide, is currently being evaluated for the treatment of chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C).

The company's executive vice president and chief strategy officer Marino Garcia said in an interview with Benzinga that he expects the second trial for the treatment of IBS-C to be positive and read out by the end of year and will be followed up by a supplementary NDA in 2017.

At Last Check

• Acadia shares were down 0.71 percent at $25.10.
• Advanced Accelerator Application shares were down 6.89 percent at $27.43.
• Cempra shares were down 1.99 percent at $7.40.
• Egalet shares were down 3.2 percent at $7.87.
• Roche shares were up 2.68 percent at $28.46.
• Synergy shares were down 4.35 percent at $4.72.