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

CERC
CERC-501
Smoking cessation

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

HTBX
HS-410
Bladder cancer

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

BLUE
bb2121
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 - ORR 89%. Pivotal trial to be initiated by the end of 2017.

OPHT
Fovista
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.

FOLD
Migalastat
Fabry Disease

Phase 3 NDA filing due 4Q 2017. Noted July 11, 2017 that FDA has agreed that further trials will no longer be required, contrary to prior request for an additional Phase 3 trial.

ARDM
Linhaliq (Pulmaquin)
Non-cystic fibrosis bronchiectasis (non-CF BE).

NDA Filing Phase 3 data released December 1, 2016. One of two trials met primary endpoint. NDA filing announced July 28, 2017.

GNMX
NFC-1 - SAGA
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.

SGYP
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.

AKAO
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.