BPC February 09 update

Acorda (ACOR) surges on Phase 3 data; ​TRACON (TCON) fails GBM trial - shares down 12%

Price and Volume Movers

Acorda Therapeutics, Inc. (Nasdaq:ACOR) shares surged to close up 21% to $24.65 following the release of data from its Phase 3 trial of CVT-301 in patients with Parkinson’s disease experiencing OFF periods. The trial met its primary endpoint measuring the higher dosage against placebo. Data from the lower dose and secondary endpoints were not released. The company plans to file a New Drug Application (NDA) by the end of 2Q of 2017, pending results of the long-term safety studies. Two trials assessing the long-term safety of CVT-301 are being conducted. Up to 12-month data from these trials are expected by the end of 1Q 2017.

TRACON Pharmaceuticals (NASDAQ:TCON) reported top-line results from its Phase 2 trial of TRC105 in recurrent glioblastoma (GBM). The trial did not meet the primary endpoint of improving progression free survival (PFS). Shares have dropped 12% to $4.85 after hours.

BioTime, Inc. (NYSE MKT and TASE: BTX) joined a growing list of companies when it announced its intent to offer to sell shares of its common stock in an underwritten public offering. Shares are currently trading down 7% to $2.80 in the after hours session.

Sierra Oncology, Inc. (NASDAQ: SRRA) announced the pricing its public offering of 19.5m shares of its common stock at a price of $1.35 per share, with expected gross proceeds of $26.3 million. Shares of the company dropped 5% to $1.35.

Moleculin Biotech, Inc. (NASDAQ: MBRX) also announced the pricing of its public offering for proceeds of approximately $5m. The offering will be priced at $1.35 per unit, with each unit consisting of one share and warrants. Shares closed down 22% to $1.17.

The Food and Drug Administration announced on Thursday that it approved Emflaza for the treatment of Duchenne muscular dystrophy. The filing was submitted by privately run Marathon Pharmaceuticals.

Other major movers:

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ADVANCERS:

Celsion Corporation (NASDAQ:CLSN): $0.49; +33%.

Ignyta Inc (NASDAQ:RXDX): $7.35; +28%.

Actinium Pharmaceuticals Inc (NYSEMKT:ATNM): $1.55; +20%.

Caladrius Biosciences Inc (NASDAQ:CLBS): $5.72; +20%.

Protalix Biotherapeutics Inc (NYSEMKT:PLX): $0.933; +19%.

Array Biopharma Inc (NASDAQ:ARRY): $12.56; +17%.

DECLINERS:

 Atossa Genetics Inc (NASDAQ:ATOS):$1.61; -7%.

Ocera Therapeutics Inc (NASDAQ:OCRX): $0.66; -9%.

Navidea Biopharmaceuticals Inc (NYSEMKT:NAVB): $0.453; -9%.

Cerulean Pharma Inc (NASDAQ:CERU): $1.23; -8%

Protagonist Therapeutics Inc (NASDAQ:PTGX): $15.89; -6%.

 

 Full pipeline updates:

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.

AVEO
TIVO-3 - tivozanib
Third line treatment of patients with renal cell cancer

Phase 3 Phase 3 completion of enrollment noted June 20, 2017. Futility analysis released October 6, 2017 - trial to continue as planned. Top-line data due 1Q 2018.

SGEN
Vadastuximab Talirine (CASCADE)
Acute myeloid leukemia (AML) - cancer

Phase 3 Phase 3 trial discontinued due to higher rate of deaths - June 19, 2017.

SGEN
ADCETRIS
Cancer - ALCANZA trial for relapsed CD30-positive cutaneous T-cell lymphoma

Approved Approval announced November 9, 2017.

SGEN
ADCETRIS in combination with chemotherapy ECHELON-1
Frontline Hodgkin lymphoma

sNDA Filing Phase 3 data released June 26, 2017 - primary endpoint met. sBLA filing announced November 2, 2017.

SGEN
ADCETRIS in combination with chemotherapy - ECHELON-2
Frontline CD30-positive mature T-cell lymphomas - cancer

Phase 3 Phase 3 enrollment completed November 2016. Data are due in 2018.

TCON
TRC105 and Avastin
Glioblastoma - cancer

Phase 2 Phase 2 data released February 9, 2017 - primary endpoint not met.