BPC November 19 update

Biotech Stock watch list - upcoming catalysts as of November 21 1016

Weekly watchlist

Two binary events from the previous Biotech Stock Watch List hit the trading screens last week.

On Monday, Dynavax Technologies Corporation (NASDAQ:DVAX) shares plummeted over 64% following news that it received a Complete Response Letter (CRL) from the FDA for its Biologics License Application (BLA) for HEPLISAV-B for the treatment of hepatitis B infection. Followed on Tuesday by The Medicines Company (Nasdaq:MDCO) and Alnylam Pharmaceuticals, Inc. (Nasdaq:ALNY) which released data from their Phase 2 ORION -1 trial, which caused prodigious intra-day price and volume spikes.

The last trading week was dominated by micro-cap biotech stocks surging, at times by more than 20% on essentially no news. The next six weeks will see a full calendar of binary data events hitting your screens.

The FDA Calendar has been through a spring clean with all events up until and including 1Q 2017 double checked. FDA Calendar binary events from 2Q 2017 onward will be checked for accuracy over the weekend now that most companies have reported 3Q earnings. In excess of 40 Phase 2 and 3 readouts are due this quarter. With less than 30 trading days left in the year we should see plenty of catalysts hitting the wires, in particular in December. 

Please find below a selection from the 40+ binary events remaining for 4Q 2016.

Drug Stage Catalyst

Smoking cessation

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

Bladder cancer

Phase 2 Phase 2 trial did not meet primary endpoint - November 30, 2016.

Relapsed/refractory multiple myeloma

Phase 1 Phase 1 interim data released November 30, 2016 - 78% ORR. Pivotal trial to be initiated 2017. Updated data at ASCO June 5, 2017. Abstract 3010

Wet age-related macular degeneration (Wet-AMD)

Phase 3 Phase 3 data released December 12, 2016 - primary endpoint not met.

Migalastat HCl monotherapy (012)
Fabry Disease

Phase 3 Additional trials required following feedback from FDA. Enrollment to commence 2017 with data due in 2019.

Pulmaquin - ORBIT-3 and ORBIT-4
Non-cystic fibrosis bronchiectasis (non-CF BE).

Phase 3 Phase 3 data released December 1, 2016. One of two trials met primary endpoint.

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.

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

sNDA Filing Phase 3 data from first and second trials met primary endpoints - December 9 and 22, 2016. sNDA filing submitted - announced March 27, 2017.

Plazomicin - EPIC trial
Complicated urinary tract infections (cUTI)

Phase 3 Phase 3 data released December 12, 2016 - primary endpoint met. NDA filing due 2H 2017.