BPC November 26 update

Keeping track of low float biotech stocks; Biotech Stock Watch List for week commencing November 28 2016

Weekly watchlist

We are approaching what promises to be an action packed last five weeks on the 2016 biotech calendar. Only 24 days remain in the trading year, yet there are still 40+ Phase 2/3 binary events slated for data release and this does not include companies appearing at the American Society of Hematology (ASH) meeting scheduled for December 3-6, of which there are currently over 20 presentations of interest noted in the FDA Calendar.

To add to the mix, we stood witness to a surge in speculative trading among nano and micro cap biotech stocks over the last couple weeks, where some stocks surged simply because of their low share floats, with many having zero near term catalysts and others having next to nothing in their pipelines after failed trials. 

One pertinent example during the last trading week was Opexa Therapeutics Inc (NASDAQ:OPXA). Shares of the company opened at $0.55 on Friday November 18 before soaring to close at $1.47 at the end of trading on Monday November 21, a gain of 167% in just two trading days. One would assume that the company surged on positive data or has an upcoming catalyst. This assumption could not be further from the truth. The company actually failed a Phase 2b multiple sclerosis trial less than a month ago and it has next to nothing in its pipeline. Why the price surge? The answer lies in its low share float, coupled with a post-election biotech rally. With only 7.14m outstanding shares to its name, daytraders can very easily move lowly priced stocks as was seen by non-biotech stock DryShips Inc. (NASDAQ:DRYS) which went parabolic from an opening price on November 10 of $4.80 to an intra-day high of $102 just five days later, a gain of 2025%! The company at the time had on 1.14m issued shares. 

Low shares floats often result from reverse splits. DryShips had one less than a month ago while Opexa had its second split in September 2015. It is advised to keep a list of biotech companies with recent reverse splits. They are generally noted in the BioPharmCatalyst Daily Updates but here is a list to start with of reverse splits occurring over the last year or so (not a complete list):


Before we look at some upcoming catalysts an announcement to readers not subscribed to our daily updates email list of a note that was included in Friday's daily updates. The 3Q earnings season is drawing to a close and with the vast majority of companies providing updates in their earnings releases and filings this has allowed most companies in both the Pipeline Drug Database and Screener and FDA Calendar to be completely updated.

Upcoming catalysts below:

Drug Stage Catalyst

Bladder cancer

Phase 2 Phase 2 trial did not meet primary endpoint - November 30, 2016.

Intravenous SCY-078

Phase 1 Clinical hold placed on the initiation of intravenous (IV) SCY-078 until the FDA completes a review of all data. Clinical hold follows three mild-to-moderate thrombotic events in healthy volunteers - announced March 2, 2017. Noted May 8, 2017 that Phase 2 trial to be initiated in 2018.

Major depressive disorder (MDD)

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

Relapsed/refractory multiple myeloma

Phase 1 Phase 1 interim data released November 30, 2016 - 78% ORR. Pivotal trial to be initiated 2017. Updated data at ASCO June 5, 2017 - ORR 89%. Pivotal trial to be initiated by the end of 2017.

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.

Clonidine gel
Painful diabetic neuropathy (PDN)

Phase 2b Phase 2b data released December 13, 2016 - primary endpoints not met.

Intravenous (IV) meloxicam
Acute pain following bunionectomy surgery

NDA Filing Phase 3 data from second trial released November 28, 2016. Primary endpoint met. Safety study to be completed May 9, 2017 - NDA filing announced July 31, 2017.

Plazomicin - EPIC trial
Complicated urinary tract infections (cUTI)

Phase 3 Phase 3 data released December 12, 2016 - primary endpoint met. NDA filing due 2H 2017.

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.

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.