BPC November 05 update

Biotech Stock Watchlist for week of November 7 2016

Weekly watchlist

In last week’s BioPharmCatalyst Biotech Stock Watchlist, it was mentioned that among other tickers, catalysts for tickers ANTH, CEMP, INNL and PTN were all just around the corner.

As it turned out, all three delivered, with the fourth, ANTH, set for its binary event next week.

On Wednesday, Palatin Technologies, Inc. (NYSE MKT: PTN) announced that it met the primary endpoints in its Phase 3 trial of bremelanotide for the treatment of hypoactive sexual desire disorder ("HSDD"). Investors initially greeted the news by trading up the shares 56% in after hours trading. However, as concern mounted in regard to its change of primary endpoints, shares were sold off and essentially closed flat on the week.

Thursday brought the release of data from Innocoll Holdings plc (NASDAQ:INNL), which announced that its Phase 3 trials of COGENZIA in patients with moderate to severe diabetic foot infections did not meet their primary endpoint. Shares closed down 17% in Friday’s session, but had already lost significant value prior to the data release. Shares have dropped over 50% over the last two weeks.

The third of the trio, Cempra Inc (NASDAQ:CEMP), should most certainly be at the top of your stock watchlist for the upcoming week. Shares sold off sharply, dropping over 60% on Wednesday following the release of the Advisory Committee briefing documents which noted safety concerns of its pipeline candidate solithromycin. However, the panel voted on Friday 7-6 in favor that the benefits of solithromycin exceed its risks. Trading was halted on Friday so expect significant volume changing hands on Monday as investors weigh up the panel’s vote against manufacturing issues already facing the company.

With Anthera Pharmaceuticals Inc (NASDAQ:ANTH) set to release its Phase 3 lupus data next week, together with Cempra, these two stocks should be at the top of your biotech stock watchlist for the week ahead. Other companies to note are listed below:

Drug Stage Catalyst

ANTH
Blisibimod
Lupus

Phase 3 Phase 3 trial did not meet endpoints - November 10, 2016.

CERC
CERC-301
Major depressive disorder (MDD)

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

EIGR
Lonafarnib - LOWR HDV – 4
Chronic hepatitis delta virus (HDV)

Phase 2 Phase 2 presentation at AASLD November 14, 2016.

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

Phase 2 Phase 2 end of trial data due 2Q 2017. Meeting with FDA scheduled for 4Q 2017.

RTRX
Sparsentan
Focal segmental glomerulosclerosis (FSGS)

Phase 3 Phase 3 trial to be initiated 2H 2017.

FOLD
Migalastat HCl monotherapy (012)
Fabry Disease

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

OPHT
Fovista
Wet age-related macular degeneration (Wet-AMD)

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

DVAX
HEPLISAV-B
Hepatitis B

PDUFA CRL February 25, 2013 and November 14, 2016. New PDUFA August 10, 2017. Advisory Committee Meeting July 28, 2017.