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

PDUFA PDUFA date August 24, 2017.

VBLT
VB-111
Recurrent glioblastoma (rGBM) cancer

Phase 3 Phase 3 completion of enrollment announced January 6, 2017. Interim analysis due mid 2017. Full data due early 2018.

CFRX
CF-301
Serious infections caused byStaph aureus including MRSA

Phase 2 Announced January 6, 2017 that its Phase 2 trial initiation has been delayed until mid-2017. Previous guidance was for 4Q 2016.

RGNX
RGX-111
Mucopolysaccharidosis Type I (MPS I)

Phase 1/2 Phase 1/2 enrollment to be initiated 2H 2017.

RGNX
RGX-501
Homozygous familial hypercholesterolemia (HoFH)

Phase 1/2 Phase 1/2 enrollment to be initiated 1H 2017.

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

Phase 2 Phase 2 preliminary data due 2H 2017.

XLRN
ACE-083
Facioscapulohumeral muscular dystrophy

Phase 2 Phase 2 dosing initiation announced December 22, 2016. Open label initial data due late 2017, with randomized part of trial to be initiated in 2018.

XLRN
Luspatercept - BELIEVE
b -thalassemia

Phase 3 Phase 3 enrollment to be completed 2H 2017.

XLRN
Luspatercept - MEDALIST
Myelodysplastic syndromes (MDS) cancer

Phase 3 Phase 3 enrollment to be completed 2H 2017.

ARNA
APD371
Pain associated with Crohn's disease

Phase 2 Phase 2 to be initiated 2017 with data due by the end of 2017.

ARNA
APD334
Ulcerative colitis

Phase 2 Phase 2 data due by the end of 2017.

ARNA
Ralinepag
Pulmonary Arterial Hypertension

Phase 2 Phase 2 data due 3Q 2017.