BPC February 13 update

Aviragen (AVIR) suffers further trial setback - shares slump 45%; Zosano (ZSAN) surges on Phase 3 data +42%; SAGE releases Phase 2 MDD data - shares +12%

Price and Volume Movers

Aviragen Therapeutics (NASDAQ:AVIR) announced back-to-back trial failures when it announced today that top-line data from its Phase 2b SPIRITUS trial, in moderate to severe asthmatics with a rhinovirus (RV) infection, did not meet the primary endpoint. Shares have slumped 45% to $0.59 in the after hours session.

Shares of Zosano Pharma Corporation (NASDAQ:ZSAN) soared in the morning session following its announcement that it achieved both co-primary endpoints of pain freedom and most bothersome symptom freedom at 2 hours in its Phase 3 trial of M207 for the treatment of migraine. M207 was not associated with any Serious Adverse Events (SAEs). Shares of the nano-cap company closed up 42% to $1.70 on its session lows after being up over 100% earlier in morning trading.

Sage Therapeutics (NASDAQ:SAGE) announced top-line data from its Phase 2 trial of SAGE-217 for the treatment of major depressive disorder (MDD), an open-label 13 patient trial. The trial measured the effect of SAGE-217 on the Hamilton Rating Scale for Depression (HAM-D) total score. 85% (11 of 13) of patients exhibited at least a 50% reduction of their HAM-D and 62% (8 of 13) of patients achieving remission. The company will now proceed to the double-blind, placebo-controlled part of the Phase 2 trial. Investors reacted positively to the data, sending shares higher to close up 12% to $52.99.

Axovant Sciences (NYSE: AXON) announced preliminary results from the first 11 patients in its Phase 2 study of nelotanserin in Lewy body dementia patients. It achieved the primary endpoints of the trial. However, secondary endpoints were not met. The news sent shares lower, closing down 6% to $11.85. Axovant expects the full study to complete in mid-2017 and plans to present detailed results at a scientific meeting in 2017. It expects to initiate a Phase 3 program in 2H 2017.

Allergan plc (NYSE:AGN) announced that it will acquire ZELTIQ Aesthetics, Inc. (NASDAQ:ZLTQ), a medical technology company, for $56.50 per share, or $2.475b.

XOMA Corporation (Nasdaq:XOMA) announced that it will issue 1.2m shares and 5,003 shares of convertible preferred stock in a registered direct offering for gross proceeds of approximately $25m. Shares traded higher, closing up 20% to $4.82.


Other major price movers:

ADVANCERS:

Rexahn Pharmaceuticals, Inc. (NYSEMKT:RNN): $0.285; +40%.

Protalix Biotherapeutics Inc (NYSEMKT:PLX): $1.31; +30%

Navidea Biopharmaceuticals Inc (NYSEMKT:NAVB): $0.43; +25%.

Cerulean Pharma Inc (NASDAQ:CERU): $1.54; +18%.

Aurinia Pharmaceuticals Inc (NASDAQ:AUPH): $3.62; +12%.

DECLINERS:

Celsion Corporation (NASDAQ:CLSN): $0.388; -14%.

Dipexium Pharmaceuticals Inc (NASDAQ:DPRX): $1.20; -11%.

Cara Therapeutics Inc (NASDAQ:CARA): $13.51; -9%.

Chiasma Inc (NASDAQ:CHMA): $1.70; -8%.

Pulmatrix Inc (NASDAQ:PULM): $4.34; -7%.

 

 Full pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst

AVIR
Vapendavir - SPIRITUS trial
Human rhinovirus (HRV)

Phase 2b Phase 2b top-line data released February 13, 2017 - primary endpoint not met.

AXON
Nelotanserin
Visual hallucinations in subjects with Lewy body dementia

Phase 2 Phase 2 preliminary data released February 13, 2017. Primary endpoint hit, secondary endpoints missed. Top-line data due January 2018.

RDHL
BEKINDA -GUARD
Gastroenteritis

Phase 3 Phase 3 top-line data released June 14, 2017 - primary endpoint met. Outcome from FDA Type B meeting due October 2017.

SAGE
SAGE-217
Major Depressive Disorder (MDD)

Phase 2 Phase 2 initiation announced December 19, 2016. Part B data due 4Q 2017.

ZGNX
ZX008 - Study 1504
Dravet syndrom

Phase 3 Phase 3 data due 2Q 2018.

ZSAN
M207
Migraine

Phase 3 Phase 3 trial data due released February 13, 2017 - primary endpoints met.