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.

WithAnthera 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


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

Major depressive disorder (MDD)

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

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

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

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.

Focal segmental glomerulosclerosis (FSGS)

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

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.

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.

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.