BPC December 23 update

Upcoming Biotech Stock Catalysts for final week of 2016

Weekly watchlist

Partnerships, reverse mergers and three calls by the FDA dominated biotech stocks over the past week.

The FDA released made three key announcements which saw shares of the respective companies move sharply to the upside. On Friday the agency announced that it accepted the New Drug Application (NDA) filed by Portola Pharmaceuticals Inc (NASDAQ:PTLA) for betrixaban and awarded a priority review which sent shares up 34%. It also issued two early approval decisions for Clovis Oncology, Inc. (NASDAQ:CLVS) for Rubraca (rucaparib) and Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) for SPINRAZATM (nusinersen).

On the partnership front, Conatus Pharmaceuticals Inc. (NASDAQ:CNAT) shares soared over 140% on Tuesday following its license agreement for emricasan with Novartis (NYSE:NVS) and Merus NV (NASDAQ:MRUS) surged over 40% on Wednesday after its collaboration with Incyte Corporation (NASDAQ:INCY).

At the other end of the spectrum, two companies at the end of their tether took the reverse merger route which resulted in much price volatility. Dipexium Pharmaceuticals, Inc. (NASDAQDPRX) shares rose 25% following news of its reverse merger with PLx Pharma Inc, while Tokai Pharmaceuticals Inc (NASDAQ:TKAI) saw an intra day spike of over 60% before closing the week more or less flat.

Looking ahead on the catalyst calendar, there are still about half a dozen data releases scheduled for the remaining four trading days of 2016. Whether the companies concerned stick to their guidance is another matter however. Three such companies are noted below (OPK, AVIR and ANTH) together with two PDUFA decisions from CEMP and EGLT, although the latter is less clear. Egalet noted in its mid-November investor presentation that regulatory action was expected by the FDA regarding its NDA for ARYMO ER during 4Q 2016. No updates have been provided since.

To round the list off, three other binary events scheduled within the next three weeks are noted below (OTIC, AGRX and ITEK).


A special Merry Christmas to all subscribers of the Biotech Weekly Watch List. The final Watch List for 2016 will be delivered to your inbox as per normal next Saturday.

Weekly Watch List in detail below:

Drug Stage Catalyst

CEMP
Solithera - oral
Community-acquired bacterial pneumonia (CABP)

CRL CRL announced December 29, 2016. Further trials required.

EGLT
Egalet-001 (ARYMO ER)
Abuse-Deterrent Morphine

Approved Approved January 9, 2017.

OTIC
OTIPRIO
Acute otitis externa

sNDA Filing Phase 3 trial met primary endpoint - January 5, 2017. sNDA filing to be submitted 1H 2017.

ITEK
Trabodenoson
Primary open-angle glaucoma (POAG)

Phase 3 Phase 3 top-line data released January 3, 2017. Primary endpoint not met.

ANTH
Sollpura (liprotamase)
Cystic fibrosis who suffer from exocrine pancreatic insufficiency

Phase 3 Top-line data released December 27, 2016 - missed primary endpoint. New trial to be initiated 1Q 2017.

AVIR
BTA585
Respiratory syncytial virus (RSV)

Phase 2a Phase 2a enrollment completed November 2016. Top-line data due during the next few weeks - as of January 9, 2017. No firm date given. Date listed in FDA Calendar is a BPC estimate only as to the latest possible date (i.e. possibly earlier).

OPK
hGH-CTP
Adults - growth hormone deficiency

Phase 3 Phase 3 data released December 30, 2016 - primary endpoint not met.

PLX
AIR DNase (PRX-110)
Cystic Fibrosis

Phase 2 Phase 2 interim data released January 3, 2017. Full data due 1Q 2017.

AGRX
Twirla
Contraceptive patch

NDA Filing CRL issued 2013. Phase 3 top-line data released January 3, 2017 - poor data but intends to reflile NDA 1H 2017.