BPC December 03 update

Upcoming biotech stock catalysts for December 2016

Weekly watchlist

Nine companies listed in the FDA Calendar with 4Q biotech binary events released catalyst related material during the last trading week. On the press release menu were ARDM, BLUE, CERC, CYTR, FOLD, HTBX, NOVN, NVLS and REPH. 

Two of the nine companies  (BLUE and NOVN) saw their shares react positively to their respective news, while shares of REPH initially saw favor from investors before finishing the week in the red. The remaining six companies saw their shares close down for the week, some more significantly than others, with ARDM, CERC, FOLD and HTBX the major decliners.

Two other companies with 4Q binary events gave updated guidance. Advanced Accelerator Application SA (NASDAQ:AAAP) noted that its PDUFA date for Lutathera is likely to be delayed, while Phase 3 data for Inotek Pharmaceuticals Corp (NASDAQ:ITEK), previously scheduled for 4Q 2016, are now due in early January 2017.

How does this leave the catalyst map for the final four trading weeks of 2016?

We still have 30+ key biotech catalysts on the table of which ten are highlighted below.

A caveat regarding one of the catalysts. Repros Therapeutics Inc. (Nasdaq:RPRX) will attend as a sponsor at the Bone, Reproductive and Urologic Drugs Advisory Committee Meeting on December 6, 2016 where clinical trial design features, including acceptable endpoints for secondary hypogonadism will be discussed. It should be noted that the Advisory Committee will not be meeting to give an approval opinion, rather the company will only be attending as a sponsor. However, shares might still garner some attention from traders leading up to and on the day of the event.

Ten Upcoming Biotech Catalysts due for December, 2016.

Drug Stage Catalyst

Wet age-related macular degeneration (Wet-AMD)

Phase 3 Phase 3 data released December 12, 2016 - primary endpoint not met. Data from third trial released August 14, 2017- primary endpoint not met.

mGluR mutation positive ADHD

Phase 2/3 Phase 2/3 data released March 20, 2017 - primary endpoint not met. Subset of data released April 20, 2017 - to be presented April 21, 2017.

Smoking cessation

Phase 2 Phase 2 top-line data released December 5, 2016 - endpoint not met.

Clonidine gel
Painful diabetic neuropathy (PDN)

Phase 2b Phase 2b data released December 13, 2016 - primary endpoints not met.

Complicated urinary tract infections (cUTI)

NDA Filing Phase 3 data released December 12, 2016 - primary endpoint met. NDA filing announced October 26, 2017.

Moderate to severe vasomotor symptoms (VMS)

Phase 3 Phase 3 data released December 5, 2016. NDA filing due December 2017.

Sollpura (liprotamase)
Cystic fibrosis who suffer from exocrine pancreatic insufficiency

Phase 3 Top-line data released December 27, 2016 - missed primary endpoint.

Trulance (plecanatide)
Constipation-predominant irritable bowel syndrome (IBS-C)

PDUFA Phase 3 data from first and second trials met primary endpoints - December 9 and 22, 2016. PDUFA date January 24, 2018.

Pimavanserin - Harmony
Alzheimer’s disease psychosis

Phase 3 Phase 3 trial initiation announced October 4, 2017.