BPC December 20 update

TSRO receives priority review - PDUFA June 30; ACAD releases Phase 2 ADP data

Price and Volume Movers

Akebia Therapeutics, Inc. (NASDAQ: AKBA) shares surged to close up 19% to $9.97 on 15x average volume following its announcement that it has entered into a license agreement with Otsuka Pharmaceutical Co. for vadadustat, in development for the treatment of anemia associated with chronic kidney disease (CKD). The companies intend to share equally all costs and revenue in the US. Akebia will receive $265m in addition to potential development and commercial milestones of up to $765m. 

ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD) shares closed up 12% to $28.56 on 8x average volume after the company announced top-line data from its Phase 2 trial of pimavanserin in patients with Alzheimer’s disease psychosis (AD Psychosis). The company noted that pimavanserin met the primary endpoint showing a statistically significant reduction in psychosis versus placebo as measured by the Neuropsychiatric Inventory-Nursing Home (NPI-NH) Psychosis score at week 6 of dosing (p=0.0451). However, pimavanserin did not meet the secondary endpoint at Week 12.

Conatus Pharmaceuticals Inc. (NASDAQ:CNAT) shares maintained Monday’s after-hours surge to close up 141% to $4.73 on 191x average volume. The company announced on Monday that it has entered into a license agreement for emricasan with Novartis (NASDAQ:NVS), which includes $50m upfront in addition to milestone payments, potential royalties and funding for development costs of emricasan clinical trials.

Galectin Therapeutics Inc (NASDAQ:GALT), which similar to Conatus is developing a candidate for Non-alcoholic steatohepatitis (NASH), saw its shares rise 10% to $0.97 on 7x average volume after spiking up over 20% in the morning session.

TESARO, Inc. (NASDAQ:TSRO) announced that the FDA has granted Priority Review for the niraparib New Drug Application (NDA) as a treatment for patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer following response to platinum-based chemotherapy. The PDUFA date is June 30, 2017. Shares of the company closed up 7% to $136.47 on average volume.

Sucampo Pharmaceuticals, Inc. (NASDAQ:SCMP) announced in the after-hours session yesterday it intends to offer, $225m of convertible senior notes. Shares closed down 21% to $13.27 on 11 x average volume.

Celsion Corporation (NASDAQ:CLSN) shares slumped over 25% to $0.34 on 10x average volume following an announcement during trading hours of an offering of 5.2m shares at a price of $0.35 for net proceeds of $1.6m. Warrants , exercisable at $0.46, were also included in the package.


Other major price movers (10%+):

ADVANCERS:                                                                     

Alcobra Ltd (NASDAQ:ADHD): $2.14; +15%; 6x average volume.

Prima BioMed Ltd (ADR) (NASDAQ:PBMD): $0.70; +14%; 3x average volume.

Fortress Biotech Inc (NASDAQ:FBIO): $2.23; +12%; 1.5x average volume.

Curis, Inc. (NASDAQ:CRIS): $3.42; +12%; 3x average volume.

Arca Biopharma Inc (NASDAQ:ABIO): $2.60; +11%; 12x average volume.

DECLINERS:

Zosano Pharma Corp (NASDAQ:ZSAN): $0.86; -20%; 3x average volume.

Cempra Inc (NASDAQ:CEMP): $6.30; -13%


Full pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst

TSRO
Niraparib - NOVA (Niraparib Ovarian)
Cancer - ovarian

PDUFA priority review Phase 3 data met endpoints - June 2016. PDUFA date under priority review is June 30, 2017. No advisory committee meeting planned.

ACAD
Pimavanserin
Alzheimer’s disease psychosis

Phase 2 Phase 2 top-line data released December 20, 2016. Primary endpoint met. Key secondary endpoint missed.

NEOS
Cotempla XR-ODT
Attention deficit hyperactivity disorder (ADHD)

NDA Filing CRL issued November 2015. NDA resubmission announced December 20, 2016.

PTIE
Remoxy
Chronic pain

CRL CRL issued September 26, 2016. Announced December 20, 2016 that meeting is scheduled with FDA on February 13, 2017 to discuss path forward - will provide details of the meeting after receipt of final meeting minutes.

DRRX
Remoxy
Chronic pain

CRL CRL issued September 26, 2016. Partner PTIE announced December 20, 2016 that meeting is scheduled with FDA on February 13, 2017 to discuss path forward - will provide details of the meeting after receipt of final meeting minutes.

GLPG
GLPG1837
Cystic Fibrosis

Phase 2 Phase 2 top-line data released December 20, 2016.

NBRV
Lefamulin
Moderate to severe Community Acquired Bacterial Pneumonia (CABP)

Phase 3 Phase 3 top line data from two trials due 2H 2017.