BPC January 06 update

Adamas (ADMS) PDUFA date set for August 24; Nano-cap EnteroMedics (ETRM) soars 340% in two days

Price and Volume Movers

Adamas Pharmaceuticals, Inc. (Nasdaq:ADMS) announced that the FDA has accepted its New Drug Application (NDA) for ADS-5102, for the treatment of levodopa-induced dyskinesia (LID) in patients with Parkinson's disease. The PDUFA date is August 24, 2017. Shares closed up 5% to $19.02 on 4x average volume.

Shares of nano-cap EnteroMedics Inc (NASDAQ:ETRM) soared for the second consecutive day to close up 131% to $9.19 on 35x average volume for a two-day gain of 340%. Given that volume today was approximately 15x its share float, most of the trading action today can be attributed to day traders. The catalyst for the surge was an update on Thursday, albeit very minor, that its vBlocweight loss device "has now been implanted at two additional vBloc Institutes."

Shares of Zafgen Inc (NASDAQ:ZFGN) closed up 25% to $4.18 on 28x average volume. JMP Securities raised ts rating for the company from Market Perform to Market Outperform with a price target of $8.

Stemline Therapeutics Inc (NASDAQ:STML), which announced after-hours on Thursday that it should be in a position to submit a Biologics License Application (BLA) filing for SL-401 for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in 2H 2017, saw its shares close up 14% to $12.90 on 6x average volume.

OncoGenex Pharmaceuticals Inc (NASDAQ:OGXI) shares closed up 21% to $0.70 on 17x average volume. The company announced after hours on Thursday that it intends to form a reverse merger with Achieve Life Science, Inc, leaving its shareholders with a 25% share of the newly formed company.

Neuralstem, Inc. (Nasdaq:CUR) announced a 1-for-13 reverse stock split will become effective after the close of trading on Friday, January 6, 2017. Shares of the company closed down 2% to $0.308 on 5x average volume.

Other major price movers (+10%):

ADVANCERS:

Pernix Therapeutics Holdings Inc (NASDAQ:PTX): $2.93; +29%; 7x average volume.

Arrowhead Pharmaceuticals Inc (NASDAQ:ARWR): $1.96; +23%; 1.5x average volume.

Pacira Pharmaceuticals Inc (NASDAQ:PCRX): $40.05; +17%; 5x average volume.

Cempra Inc (NASDAQ:CEMP): $3.75; +15%; 1.5x average volume.

Calithera Biosciences Inc (NASDAQ:CALA): $4.45; +13%; 1.5x average volume.


DECLINERS:

Delcath Systems, Inc. (NASDAQ:DCTH): $0.58; -29%; 12x average volume.

Orexigen Therapeutics, Inc. (NASDAQ:OREX): $3.38; -11%; 4x average volume.

 

Full pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst

ADMS
ADS-5102
Levodopa-Induced Dyskinesia

Approved Approval announced August 24, 2017.

VBLT
VB-111
Recurrent glioblastoma (rGBM) cancer

Phase 3 Phase 3 completion of enrollment announced January 6, 2017. Interim analysis due late September 2017. Top-line data due 1Q 2018.

CFRX
CF-301
Serious infections caused byStaph aureus including MRSA

Phase 2 Phase 2 initiation announced May 25, 2017 - data due 4Q 2018.

RGNX
RGX-111
Mucopolysaccharidosis Type I (MPS I)

Phase 1/2 Phase 1/2 enrollment to be initiated 1H 2018.

RGNX
RGX-501
Homozygous familial hypercholesterolemia (HoFH)

Phase 1/2 Phase 1/2 dosing initiated - March 8, 2017. Interim data due by the end of 2017.

XLRN
Dalantercept - DART Study
Renal Cell Carcinoma (RCC) - cancer

Phase 2 Phase 2 data released June 12, 2017 - primary endpoint not met.

XLRN
ACE-083
Facioscapulohumeral muscular dystrophy

Phase 2 Phase 2 dosing initiation announced December 22, 2016. Initial data due late 2017.

XLRN
Luspatercept - BELIEVE
b -thalassemia

Phase 3 Phase 3 enrollment completion announced June 1, 2017 with data due mid-2018.

XLRN
Luspatercept - MEDALIST
Myelodysplastic syndromes (MDS) cancer

Phase 3 Phase 3 enrollment completion announced June 1, 2017 with data due mid-2018.

ARNA
APD371
Pain associated with Crohn's disease

Phase 2 Phase 2 data due year-end 2017 or 1Q 2018.

ARNA
Etrasimod
Ulcerative colitis

Phase 2 Phase 2 data due by end of 2017 or 1Q 2018.

ARNA
Ralinepag
Pulmonary Arterial Hypertension

Phase 2 Phase 2 data released July 10, 2017. Primary endpoint met. Secondary missed.