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Actionable news in ACOR: Acorda Therapeutics, Inc.,

STML meets primary endpoint +29%; MYL price fixing claims -7%

Price and Volume Movers

Stemline Therapeutics, Inc. (Nasdaq:STML) shares surged to close up 29% to $13.65 following its announcement that its pivotal Phase 2 trial of SL-401 in blastic plasmacytoid dendritic cell neoplasm (BPDCN) met its primary endpoint. In Stage 3 of the trial, 13 first-line BPDCN patients were enrolled. A complete response rate of 54% (7/13) and overall response rate (ORR) of 77% (10/13) were recorded. A Biologics License Application (BLA) filing will be submitted in 4Q 2017 or 1Q 2018. Detailed data are due at ASH in early December.

Mylan N.V. (NASDAQ:MYL) shares slid in the morning session to close down 7% to $35.71 following the naming of Rajiv Malik, Mylan’s president and executive director, in price fixing allegations in 46 states. The company responded noting that it "has deep faith in the integrity of its President, Rajiv Malik, and stands behind him fully. Mylan and Rajiv Malik both intend to defend this case vigorously, and we look forward to the opportunity to present a full defense."

AstraZeneca plc (NYSE:AZN) announced that the FDA has granted accelerated approval for Calquence (acalabrutinib) for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.

Other major price movers (stocks priced > $1.00, volume > 50k):

Refer to the BioPharmCatalyst Biotech Stocks page for Top 10 Gainers/Losers/Unusual Volume INCLUDING sub-$1 stocks.

ADVANCERS:

Sunesis Pharmaceuticals, Inc. (NASDAQ:SNSS): $2.56; +19%.

Mustang Bio Inc (NASDAQ:MBIO): $11.75; +18%.

CARDIOME PHARMA CORP (NASDAQ:CRME): $1.76; +16%.

Bioblast Pharma Ltd (NASDAQ:ORPN): $2.51; +10%.

Soligenix, Inc. (NASDAQ:SNGX): $2.01; +9%.

DECLINERS:

Ampio Pharmaceuticals Inc (NYSEAMERICAN:AMPE): $1.06; -13%.

Invivo Therapeutics (NASDAQ:NVIV): $1.30; -10%.

Insys Therapeutics Inc (NASDAQ:INSY): $5.15; -10%.

Onconova Therapeutics Inc (NASDAQ:ONTX): $2.00; -10%.

Applied Genetic Technologies Corp (NASDAQ:AGTC): $3.40; -8%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst

ACOR
INBRIJA (CVT-301)
OFF episodes of Parkinson’s disease (PD)

NDA Filing Phase 3 data released February 9, 2017 - primary endpoint met. NDA filing announced June 29, 2017. However, FDA issued a Refuse-To-File letter August 30, 2017. NDA to be refiled 4Q 2017.

ADRO
CRS-207 with pembrolizumab
Mesothelioma - cancer

Phase 2 Phase 2 trial to be initiated 2Q 2017 with early data due 2H 2017.

ACOR
Tozadenant
Parkinson’s disease (PD)

Phase 3 Phase 3 data due 1Q 2018.

AKCA
AKCEA-APOCIII-LRx
Hyperlipoproteinemia(a) and established cardiovascular disease

Phase 2b Phase 2b trial to be initiated in 2H 2017.

ARRY
ARRY 797
LMNA A/C-related dilated cardiomyopathy (DCM)

Phase 2 Phase 2 data presented at the European Society of Cardiology on August 30, 2016. Phase 3 trial planned.

ARRY
ARRY-382 and Keytruda
Non-small cell lung cancer

Phase 1/2 Phase 1/2 initial effiacy data to be presented in poster November 10, 2017 at SITC.

AZN
Acalabrutinib
Relapsed or Refractory Mantle Cell Lymphoma

Approved Priority Review announced August 2, 2017. Approval announced October 31, 2017.

BPMC
BLU-285
Gastrointestinal stromal tumors (GIST) harboring a PDGFRα D842V

Phase 1 Phase 3 trial planned 1H 2018.

CPRX
Firdapse
Lambert-Easton Myasthenic Syndrome (LEMS)

Phase 3 Refusal to file letter reported on February 17, 2016. Data from second Phase 3 trial due early December 2017.

INCY
Epacadostat with Keytruda - ECHO-301
Cancer - first-line metastatic melanoma.

Phase 3 Phase 3 initiated June 2016. Initial data due 1H 2018.

INCY
Ruxolitinib - REACH 1
Graft versus host disease

Phase 3 Phase 2 pivotal trial dosing initiation announced December 30, 2016. Data due 1H 2018.

MRNS
Ganaxolone
Refractory status epilepticus (RSE)

Phase 2 Phase 2 data due 2018.

MRNS
Ganaxolone
Postpartum depression

Phase 2 Phase 2 data due early 2018.

NVS
Kymriah (CTL019 )- JULIET
Cancer - Diffuse Large B-Cell Lymphoma (DLBCL)

BLA Filing Phase 2 pivotal primary analysis released June 14, 2017. sBLA filing announced October 31, 2017.

RYTM
Setmelanotide
Bardet-Biedl Syndrome

Phase 2 Preliminary Phase 2 data due released October 31, 2017. 4 of 5 patients showed weight loss of 10-12%.

SBPH
SB 9200
Hepatitis B (HBV)

Phase 2a Phase 2a initial data released May 23, 2017. Additional data from first cohort presented September 7, 2017. Second cohort enrollment has completed with top-line results due 4Q 2017.

SELB
SEL-212
Tophaceous gout

Phase 2 Phase 2 dosing commenced late October 2016. Initial data released at EULAR June 15, 2017. Updated data due November 7, 2017.

STML
SL-401
Blastic plasmacytoid dendritic cell neoplasm (BPDCN) cancer

Phase 2 Phase 2 enrollment completed - noted March 23, 2017. Update on patients enrolled in Stages 1 and 2 at EHA June 23, 2017. Top-line data from Stage 3 met primary endpoint - October 31, 2017 CR rate of 54% (7/13), with detailed data at ASH 2017.

VSTM
Duvelisib - DUO
Cancer - relapsed/refractory chronic lymphocytic leukemia (CLL)

Phase 3 Phase 3 data released September 6, 2017 - primary endpoint met with NDA filing due 1Q 2018.

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