BPC January 07 update

Biotech Week and Review; Upcoming January and 1Q catalysts; JPM conference

Weekly watchlist

Despite the shortened four-day trading week the stream of biotech news continued to hit trading screens with volume. News flow from biotech binary events, license deals and a preview of next week’s J.P.Morgan Health Conference dominated the headlines. 

Inotek Pharmaceuticals Corporation (NASDAQ:ITEK) opened up the trading week on Tuesday with news that it failed to meet the primary endpoint in its Phase 3 trial of trabodenoson for the treatment of primary open-angle glaucoma (POAG) or ocular hypertension (OHT), sending shares plunging 71%.

It was quickly joined by Agile Therapeutics, Inc.  (Nasdaq:AGRX) which released disappointing data from its Phase 3 trial of its contraceptive patch, Twirla. While recovering from being down over 70% in the after-hours session on Tuesday, shares still closed on Friday down 46% following the release.

To cap off the disappointing release of data for the first week of 2017,  Aeterna Zentaris Inc. (NASDAQ: AEZS) announced on Wednesday that it failed its Phase 3 trial of Macrilen for patients with growth hormone deficiency in adults (AGHD). Shares initially fall over 30% before recovering some ground later in the week as investors eyed up its next Phase 3 catalyst this quarter.

On the license front among microcaps, CymaBay Therapeutics Inc (NASDAQ:CBAY) inked a deal with Kowa Pharmaceuticals that included $15m upfront that saw it close up 30% on the week to $2.26 while Pieris Pharmaceuticals, Inc. (NASDAQ: PIRS) shares closed the week up 34% to $1.88 following its announcement of a license deal with French pharmaceutical company, Servier, which included a $31.3m upfront payment.

The week ended with firms taking the opportunity to release business outlooks for 2017 and slide presentations ahead of the 35th J.P.Morgan Health Conference which will kick off next week on January 9. The conference is regarded as the premier healthcare conference for small to large cap biotech companies. Investors will be keeping an eye on any news of license deals, data and general drug pipeline updates. While BioPharmCatalyst focuses on micro to mid-cap biotech firms, a significant number of biotechs featuring on BioPharmCatalyst (approx 100 firms) will be presenting at the conference.

A full schedule of the conference can be accessed HERE.

The smaller biotechs will have their own conference at the Biotech Showcase also commencing on January 9. Schedule available HERE.

For the week ahead most eyes will be on the two conferences, in particular J.P.Morgan.

Some other January and 1Q catalysts of note:

Drug Stage Catalyst

hemophilia B

Phase 1/2 Phase 1/2 initial data released January 31, 2017. Announced May 10, 2017 that program will be discontinued.

Reduce the incidence of low cardiac output syndrome during cardiac surgery

Phase 3 Phase 3 top line data released January 31, 2017 - primary endpoints not met. Met with FDA May 10, 2017 to discuss potential NDA submission.

Trulance (plecanatide)
Chronic idiopathic constipation (CIC)

Approved Approved January 19, 2017.

OFF episodes of Parkinson’s disease (PD)

NDA Filing Phase 3 data released February 9, 2017 - primary endpoint met. NDA filing announced June 29, 2017. However, FDA issued a Refuse-To-File letter August 30, 2017 (i.e. NDA not accepted).

Improve walking in patients with multiple sclerosis

Decision on Inter Partes Review (IPR) released March 10, 2017 - patents upheld.

Cystic fibrosis

Phase 2 Phase 2 28-day data due 4Q 2017.