BPC January 21 update

Biotech week in review + upcoming catalysts to watch for week of January 23, 2017

Weekly watchlist

This latest weekly newsletter looks at two relatively unknown nano-cap companies with upcoming catalysts, while we also look back at key events over the past week.

Late in the week Bristol-Myers Squibb (NYSE:BMY) dropped a bombshell when it announced on Thursday that it will not pursue an accelerated approval for the combination of Opdivo plus Yervoy in first-line lung cancer. The news put a dent in its share price, plummeting over 11% on Friday, wiping off $10b from its market cap. Rival Merck & Co (NYSE:MRK) clearly benefited from the news that saw its shares close up 4%.

In commercial news, Forward Pharma A/S (NASDAQ:FWP) shares surged up 48% on Tuesday following news it will receive $1.25b from Biogen Inc (NASDAQ: BIIB) for its intellectual property following a dispute regarding the multiple sclerosis drug Tecfidera, while the following day CoLucid Pharmaceuticals, Inc. (Nasdaq:CLCD) announced it will be acquired by Eli Lilly and Company (NYSE:LLY) for $46.50 per share or approximately $960m, sending shares up 33%.

On the clinical and regulatory front, Alcobra Ltd. (Nasdaq:ADHD) delivered disappointing news that it did not meet the primary endpoint in its Phase 3 trial for Metadoxine Extended Release (MDX) for the treatment of ADHD. Shares slumped 51%, while shares of Synergy Pharmaceuticals (NASDAQ:SGYP) also sold off despite its FDA approval for Trulance (plecanatide) for the treatment of Chronic Idiopathic Constipation (CIC) in adult patients as investors weighed up the need to raise cash or initiate talks of a possible acquisition or partnership.

Before listing the watch list, some reasoning as to why two of the stocks are noted. On their own they might not be considered major catalysts but certain events might put these stocks in play.

Asterias Biotherapeutics, Inc. (NYSE MKT: AST) reported the first look at its efficacy data from its AST-OPC1 SCiSTAR Phase 1/2a clinical trial in cervical spinal cord injury patients on September 14, 2016. One week prior to the release it announced it would hold a conference call on September 14 to discuss the data. During this one-week period the stock appreciated from $2.95 to $3.90 (+33%) as catalyst traders saw an open opportunity to participate in the speculative run towards a defined release date.

Fast forward four months to January 18 when the company noted similarly that in one week (January 24), six-month efficacy data will be discussed in an after-hours conference call. Let’s be honest though, the data to be presented is not a major catalyst and there is definitely no guarantee that the catalyst traders will get on board and it might eventuate into a complete fizzer but the fact that there is a defined date might garner some attention among short-term traders on Monday and Tuesday. Asterias is a subsidiary of BioTime, Inc (NYSEMKT:BTX).

Catabasis Pharmaceuticals Inc (NASDAQ:CATB) is another similar stock in the sense that it might garner attention, not because there is a defined catalyst date but rather due to the fact that more traders that might not have been aware of the company prior to last week are aware now, and they also have been alerted to news that the company has data coming up before mid-February.

Catabasis issued what really was a meaningless press release on Thursday that data from its Phase 1 trial of Edasalonexent in adults were published in a medical journal. Edasalonexent is currently in Phase 2 trials for Duchenne muscular dystrophy (DMD). The press release alone was insignificant. However, traders for one reason or another pushed the price up to be at one stage over 25% in early trading. Although the stock justifiably sold off on Friday, what Thursday’s trading action has done has made more day and swing traders aware of the nano-cap company who will no doubt have added the ticker to their own watch lists. Coupled with the fact that the company indicated that Phase 2 top-line data are due by mid-February for a much talked about condition, Duchenne muscular dystrophy (DMD), should put it in play especially amongst short term traders. One to watch over the next few weeks.

Noted below are a few other short-term catalysts plus two to keep an eye on for later in the quarter. 

Drug Stage Catalyst

ACOR
Ampyra
Improve walking in patients with multiple sclerosis

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

ACOR
INBRIJA (CVT-301)
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. NDA to be refiled 4Q 2017.

AST
AST-OPC1 SCiSTAR
Cervical spinal cord injury

Phase 1/2 Phase 1/2 six and nine-month data released January 24, 2017. 10 and 20 million cell cohort 6-month top-line data due January 2018. Cohort 2 12-month data due later in 2017.

CATB
Edasalonexent (CAT-1004)
Duchenne muscular dystrophy (DMD)

Phase 3 Phase 1/2 top-line data released January 31 - primary endpoint not met. Data from open-label presented October 4, 2017 deemed sufficient to proceed to Phase 3 development - to commence 1H 2018 with data due 2020.

DMTX
DTX101
hemophilia B

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

FGEN
Roxadustat
Anemia in chronic kidney disease

Phase 3 NDA filing due 2018.

NKTR
NKTR-181
Lower back pain

Phase 3 Phase 3 data released March 20, 2017 - endpoints met.

TENX
Levosimendan
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.