Healthcare Business

10 Major Pharma and FDA Catalysts Coming in December

Biotech and pharmaceutical companies are generally involved in the lengthy process of getting their drug candidates to market through clinical trials. There is a fair amount of risk to a great amount of risk involved, should a study come back negative or should a candidate not be approved. Conversely, if a drug is approved or passes a clinical trial, there can be massive upside.

The long and short of the matter is that updates within this industry, as well as U.S. Food and Drug Administration (FDA) rulings, can make or break these companies.

24/7 Wall St. has collected several catalysts that are coming up on the calendar in the month of December and added some color, along with the trading range and price target. Note that, due to many outside and internal factors, there are no assurances that the dates will remain static. Some date changes are positive developments, and some can be disasters if a company is not deeply financed.

As a side note about the Prescription Drug User Fee Act (PDUFA): a Priority Review designation is granted to medicines that the FDA determines have the potential to provide significant improvements in the treatment, prevention or diagnosis of a disease.

Repros Therapeutics

Repros Therapeutics Inc. (NASDAQ: RPRX) noted that it will participate as a sponsor in a forthcoming public advisory committee meeting of the FDA’s Bone, Reproductive and Urologic Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to the FDA on the FDA’s regulatory issues. The meeting, to be held on December 6, and will be public.

Shares of Repros were last seen trading up nearly 6% at $1.87, with a consensus analyst price target of $5.25 and a 52-week trading range of $0.80 to $3.48.

Dynavax Technologies

Dynavax Technologies Corp. (NASDAQ: DVAX) is scheduled to have its PDUFA hearing date on December 15, 2016 for its Heplisav-B drug for the treatment of hepatitis B.

Shares of Dynavax were trading up over 5% at $4.95. The consensus price target is $22.00, and the 52-week range is $3.20 to $29.86.

Spectrum Pharmaceuticals

Spectrum Pharmaceuticals Inc. (NASDAQ: SPPI) has a PDUFA target action date with the FDA scheduled for December 11. The FDA has accepted Spectrum’s EOquin (apaziquone for intravesical instillation) New Drug Application (NDA) for review. The FDA also indicated that it plans to hold an advisory committee meeting regarding the NDA.

Spectrum shares were trading up 1% at $4.04, with a consensus price target of $9.00 and a 52-week range of $3.21 to $7.74.

And Others

In December, other potential clinical catalysts include the release of Phase 1 data for INT-767 for Intercept Pharmaceuticals Inc. (NASDAQ: ICPT) and the release of topline data from the Juvenile Diabetes Research Foundation (JDRF) study of sotagliflozin in young adults with Type 1 Diabetes (early December) and topline data from the second Phase 3 for sotagliflozin (late December) for Lexicon Pharmaceuticals Inc. (NASDAQ: LXRX).

Another potential regulatory catalyst for Intercept includes EU approval of Ocaliva for primary biliary cholangitis.

Shares of Intercept were trading up nearly 3% at $102.53, with a consensus price target of $190.94 and a 52-week range of $89.76 to $177.93.

Shares of Lexicon were up 4% at $15.60. Its consensus price target is $22.79, and the 52-week range is $7.65 to $19.62.

Also on December 6, Regulus Therapeutics Inc. (NASDAQ: RGLS) is hosting its R&D Day. Analysts are anticipating that the company could announce a new product candidate and give an overview of its pipeline.

Shares of Regulus were up nearly 9% at $2.72, with a consensus price target of $9.75 and a 52-week range of $2.13 to $10.18.

On the business development front, December may see a potential pipeline and/or GPCR partnership by Omeros Corp. (NASDAQ: OMER), a potential regional exUS EXPAREL partnership by Pacira Pharmaceuticals Inc. (NASDAQ: PCRX), possibly a new TransCon partnership announcement by Ascendis Pharma A/S (NASDAQ: ASND) and receipt of a milestone payment and announcement of an out licensing agreement for Xoma Corp. (NASDAQ: XOMA).

Wedbush anticipates the release of Symphony Health November sales estimate on December 21 for Pacira’s EXPAREL as well.

Shares of Omeros were down 2.6% at $10.63. The consensus price target is $37.33, and the 52-week range is $7.20 to $16.80.

Pacira traded up 1.7% at $30.75, within a 52-week trading range of $29.95 to $80.25. The consensus price target is $49.55.

Ascendis shares were last seen at $20.31. The consensus analyst target is $29.67. The 52-week trading range is $11.92 to $21.79.

Shares of Xoma were up 2.4% at $5.48, with a consensus price target of $12.75. The 52-week range is $0.34 to $7.62.