BPC January 13 update

BioPharmCatalyst expands coverage; Biotech week in review; Six upcoming January catalysts

Weekly watchlist

Before we review the biotech week that was, an important announcement regarding expansion plans to include coverage of large cap biotech companies on BioPharmCatalyst.

BioPharmCatalyst is pleased to announce that over the next few days 35-40 extra PDUFA action dates will be added to the FDA and PDUFA Calendars. These extra entries will feature large cap companies (e.g. CELG, BMY, GILD, AZN, BIIB) that were previously not featured on BioPharmCatalyst. Clinical catalysts focusing on Phase 3 binary events will also be added where possible.

The key catalyst for this move was last week’s J.P.Morgan Healthcare Conference where most large cap healthcare companies presented updated guidance and pipelines.

There were a number of acquisitions made during the week of the conference, including those of Merrimack Pharmaceuticals (NASDAQ:MACK) and Derma Sciences Inc (NASDAQ:DSCI) but the major buyout headline of the week went the way of Ariad Pharmaceuticals, Inc. (NASDAQ:ARIA). Ariad announced on Monday it reached a most favorable deal where it will be acquired by Japanese pharmaceutical company, Takeda, for $24 per share. This sent shares surging to close up 73%.

However, the upbeat mood at the conference was dealt a blow on Wednesday when the sector was hit by comments made by President-elect Donald Trump in regard to drug pricing, amongst other matters.

We’re the largest buyer of drugs in the world and yet we don’t bid properly. We’re going to start bidding. We’re going to save billions of dollars over a period of time”

Trump’s comments sent two closely followed biotech ETFs (Exchange Traded Funds) sharply down with the iShares NASDAQ Biotechnology Index ETF (NASDAQ:IBB) closing down 3% while the SPDR S&P Biotech (ETF) (NYSEARCA:XBI) dropped 3.4%.

With the J.P.Morgan and Biotech Showcase conferences taking up most of the news flow it was a relatively quiet week in terms of clinical and regulatory news. One exception though was Egalet Corporation (Nasdaq: EGLT), which announced its long-awaited approval for its morphine treatment, ARYMO ER. On the face of it an approval is usually good news. However, when it was noted that there would be no oral abuse deterrence on the label, investors swiftly applied selling pressure to the stock.

Merck & Co., Inc. (NYSE:MRK) on the other hand delivered bullish news from the FDA when it announced its lung cancer supplemental Biologics License Application (sBLA) of KEYTRUDA plus chemotherapy was granted a priority review with a PDUFA action date of May 10, 2017, potentially giving it a jump on other rivals in the market.

On the nano and microcap front, reverse split fever hit again as companies with low share floats as a result of recent reverse splits garnered much attention. All that is often required for a low float stock to gather momentum is a press release of any nature attracting a few buyers. With little supply (i.e. a low float) there is generally only one direction the stock is initially going to move. EnteroMedics Inc (NASDAQ:ETRM) was one example where it surged a cumulative 1225% by Tuesday over only four trading days. In these situations, though, what goes up must come down and the stock closed the week down over 50% from Tuesday's close.

Next week is a four-day trading week with Monday being Martin Luther King Day. There are a number of catalysts left for January, some of which are noted below. Also keep an eye out for abstracts that will be released on January 17 (Tuesday) for next week’s ASCO GI meeting. One of which is noted below:

Drug Stage Catalyst

FGEN
Pamrevlumab (FG-3019)
Pancreatic cancer

Phase 2 Phase 2 ongoing. Data due late 2017 or 1Q 2018.

FGEN
Roxadustat FG-4592
Anemia in chronic kidney disease

Phase 3 Phase 3 data from China trial released January 30, 2017. Primary endpoints met with China NDA to be filed 3Q 2017.

NBIX
INGREZZA
Tourette syndrome - adults

Phase 2 Phase 2 data released January 18, 2017 did not meet primary endpoint.

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.

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.

SGYP
Trulance (plecanatide)
Chronic idiopathic constipation (CIC)

Approved Approved January 19, 2017.