BPC December 10 update

Biotech Stock Watch List for week commencing December 12 2016.

Weekly watchlist

As we look back at the last trading week, several biotechs reported key data from binary events. Cerecor Inc. (NASDAQ: CERC) commenced the week with delivery of disappointing data from its Phase 2 trial of CERC-501, which was followed up later on Thursday by news from Horizon Pharma (NASDAQ:HZNP) that its Phase 3 trial of ACTIMMUNE for the treatment of Friedreich’s ataxia (FA) did not meet its primary endpoint.

To the upside, both Neuroderm Ltd (NASDAQ:NDRM) and SAGE Therapeutics Inc (NASDAQ:SAGE) announced positive feedback from the FDA, potentially accelerating their paths to approval, while speculative interest continued to revolve around micro-cap companies, with the likes of Sunshine Heart Inc (NASDAQ:SSH) and Opexa Therapeutics Inc (NASDAQ:OPXA) just some of the companies with low share floats to exhibit volatile trading action.

One biotech stock that continues to trade with great volatility is Ophthotech Corp (NASDAQ:OPHT). Shares of the company bounced around for much of the week, before settling higher on Friday as investors position themselves ahead of the most keenly awaited catalyst left on the calendar for December. Phase 3 data from its trial of Fovista are due this month. As a side point, Nektar Therapeutics (NASDAQ:NKTR) is entitled to royalties on any net sales of Fovista and other payments based upon Ophthotech’s meeting certain regulatory and sales milestones.

Ophthotech leads this week’s Biotech Watch List below:

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.

Complicated urinary tract infections (cUTI)

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

Clonidine gel
Painful diabetic neuropathy (PDN)

Phase 2b Phase 2b data released December 13, 2016 - primary endpoints 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.

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

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

Focal chondral cartilage defects in the knee.

Approved FDA Approval announced December 13, 2016 ahead of PDUFA date of January 3 2017.

Type 1 Diabetes

Phase 3 Phase 3 data released September 9, 2016 met primary endpoint. Secondary endpoint data due May 2017. Data from second trial released December 21, 2016 - primary endpoint met. Data from third trial also met primary endpoint - June 9, 2017.

Pimavanserin - Harmony
Alzheimer’s disease psychosis

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