BPC December 27 update

ANTH plummets on Phase 3 Sollpura trial failure; Seattle Genetics (SGEN) hit with clinical hold – shares drop 15%

Price and Volume Movers

Anthera Pharmaceuticals, Inc. (NASDAQ:ANTH) shares are currently down 65% to $0.70 in the after-hours session following its release of top line results of its Phase 3 SOLUTION trial of Sollpura in cystic fibrosis patients with exocrine pancreatic insufficiency (EPI).  The trial missed its primary endpoint. The company noted that it intends to initiate a new trial in 1Q 2017, with a potential Biologics License Application (BLA) filing around 1Q 2018.

Seattle Genetics, Inc. (Nasdaq:SGEN) shares dropped 15% to $52.36 on 4x average volume following its announcement that a clinical hold or partial clinical hold has been placed on several early stage trials of vadastuximab talirine (SGN-CD33A) in acute myeloid leukemia (AML) after four patient deaths. The phase 1/2 trial of SGN-CD33A monotherapy in pre- and post-allogeneic transplant AML patients has been placed on full clinical hold while its Phase 3 CASCADE trial in older AML patients will continue with enrollment.

Shares of Cyclacel Pharmaceuticals Inc (NASDAQ:CYCC) surged by 31% to $5.17 on 23x average volume. Top-line data from its Phase 3 SEAMLESS trial of oral sapacitabine are due late 2016 or early 2017. The company noted in December 2014 that interim analysis suggested that the trial will fail.

Amphastar Pharmaceuticals, Inc., (NASDAQ:AMPH) announced that the FDA issued a Complete Response Letter (CRL) for PrimateneMist (epinephrine inhalation aerosol) for the treatment of asthma. Changes to the label and packaging together with a further Human Factor validation study study to assess consumers' ability to use the product without the guidance of a doctor or pharmacist, were recommended by the FDA. The company anticipates that it will be able to address the issues by mid-2017. Shares of the company dropped by 9% to $18.57 on 2x average volume.

Other major price movers (+10%):


Moleculin Biotech Inc (NASDAQ:MBRX): $2.75; +40%; 59x average volume.

Conatus Pharmaceuticals Inc (NASDAQ:CNAT): $6.11; +38%; 12x average volume.

Kalvista Pharmaceuticals Inc (NASDAQ:KALV): $7.27; +14%; 1.5x average volume.

XBiotech Inc (NASDAQ:XBIT): $10.73; +15%; 2x average volume.

Protalix Biotherapeutics Inc (NYSEMKT:PLX): $0.35; +12%; 3x average volume.

Acasti Pharma Inc (NASDAQ:ACST): $1.48; +11%.

Neos Therapeutics Inc (NASDAQ:NEOS): $7.00; +11%.

Vericel Corp (NASDAQ:VCEL): $3.15; +11%.


Syros Pharmaceuticals Inc (NASDAQ:SYRS): $12.27; -10%; 6x average volume.

Full pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst

Sollpura (liprotamase)
Cystic fibrosis who suffer from exocrine pancreatic insufficiency

Phase 3 Top-line data released December 27, 2016 - missed primary endpoint.

Primatene Mist (epinephrine inhalation aerosol)

CRL CRL issued December 27, 2016.

Vadastuximab Talirine (SGN-CD33A)
Myelodysplastic syndrome (MDS)

Phase 1/2 Phase 1/2 clinical hold placed on December 27, 2016 was lifted March 6, 2017. Enrollment halted June 19, 2017 due to safety.

Cancer - metastatic triple-negative breast cancer

Phase 3 Phase 3 enrollment due to commence early 4Q 2017. BLA filing due between December 2017 and March 2018. Phase 2 data to be used for accelerated approval.

Naloxone Intranasal
Opioid overdose

CRL CRL announced February 21, 2017.