BPC November 11 update

Biotech Stock watch list for week of November 14 2016

Weekly watchlist

The U.S. election dominated biotech headlines sending stocks soaring as investors viewed Donald Trump’s victory as a positive for biotech. On each of the last three trading days we saw on average almost 10% of stocks tracked by BioPharmCatalyst rising by at least 10%.

Just seven weeks remain in the trading year, yet over 50 binary data events are still slated for release this quarter. Please find below ten such biotech catalysts to keep on your watch list.

Drug Stage Catalyst

EIGR
Lonafarnib - LOWR HDV
Chronic hepatitis delta virus (HDV)

Phase 2 Phase 2 end of trial data released April 21, 2017. Meeting with FDA scheduled for 4Q 2017.

MDCO
Inclisiran
Hypercholesterolemia

Phase 3 Phase 3 trial to commence in 2017. Data due by end of 2019.

RTRX
Sparsentan
Focal segmental glomerulosclerosis (FSGS)

Phase 3 Phase 3 trial protocol to be finalized with FDA 2H 2017, with initiation due thereafter.

CERC
CERC-301
Major depressive disorder (MDD)

Phase 2 Phase 2 top-line data released November 29, 2016 failed to meet primary endpoint.

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.

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.

DVAX
HEPLISAV-B
Hepatitis B

PDUFA CRL February 25, 2013 and November 14, 2016. Original PDUFA date set for August 10, 2017 but noted August 3, 2017 a 3-month extension to August 10.. Advisory Committee Meeting July 28, 2017 voted 21 -1 in favor of recommending approval.

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

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

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.

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.