Tonix Pharmaceuticals ’ PTSD Phase 3-Ready Drug Candidate, TNX-102 SL, Granted Breakthrough Therapy Designation by the FDA

Responding to AtEase study results in military-related PTSD population, FDA agrees to work closely with Tonix to develop and review TNX-102 SL for PTSD as efficiently as possible
 
NEW YORK, Dec. 19, 2016 -- Tonix Pharmaceuticals Holding Corp. (Nasdaq:TNXP) (Tonix), which is developing a next-generation treatment for PTSD, announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to TNX-102 SL* for the treatment of posttraumatic stress disorder (PTSD).
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Pulmatrix Receives Patents Important to its Inhaled Drug Delivery Technology

The patents significantly broaden protection for the technology--and for its use to treat a wide variety of diseases
 
LEXINGTON, Mass., Dec. 19, 2016 -- Pulmatrix, Inc. (NASDAQ: PULM), a clinical stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary diseases, today announced that it has received five patents over the last 12 months.
 
"These new patents are further proof that our iSPERSE™ inhaled drug technology is innovative," said Robert W. Clarke, Ph.D., Chief Executive Officer for Pulmatrix. "These patents give us stronger composition of matter and method of use intellectual property protection as we move forward to develop drugs for COPD, fungal infections, and other diseases." 
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New Preclinical Data Show Can-Fite's Namodenoson (CF102) Inhibits Liver Fibrosis -- Supports Potential Efficacy in Treatment of NASH

Phase II trial to treat NAFLD/NASH expected to commence in 2017
 
PETACH TIKVA, Israel, Dec. 16, 2016 -- Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (TASE:CFBI), a biotechnology company with a pipeline of proprietary small molecule drugs being developed to treat inflammatory diseases, cancer and sexual dysfunction, today announced that new preclinical data show its liver disease drug candidate Namodenoson (CF102) inhibited, in a dose dependent manner, the growth and proliferation of the liver fibrosis cells. This outcome suggests the anti-fibrotic effect of the drug and supports its development as an agent to combat non-alcoholic fatty liver disease (NAFLD), the precursor to non-alcoholic steatohepatitis (NASH).
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Evoke Receives Positive NDA Submission Guidance from US FDA for Gimoti

SOLANA BEACH, Calif., Dec. 15, 2016 -- Evoke Pharma, Inc. (NASDAQ:EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, today announced positive guidance from a recent second pre-NDA (New Drug Application) meeting to discuss clinical data for inclusion in a 505(b)(2) NDA for Gimoti™ with the US Food and Drug Administration (FDA).  This pre-NDA meeting was the second for Gimoti™, Evoke’s patented nasal delivery formulation of metoclopramide for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in adult women. 
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Aptevo Therapeutics Announces Publication of Phase 2 Clinical Data for Otlertuzumab

SEATTLE, Dec. 16, 2016 -- Aptevo Therapeutics Inc. (Nasdaq:APVO) a biotechnology company focused on developing novel oncology and hematology therapeutics, today announced the publication of positive data from a Phase 2 clinical trial evaluating its proprietary humanized monospecific anti-CD37 protein therapeutic, otlertuzumab. The results were recently published in the British Journal of Haematology (BJH).
 
“We’re very encouraged by the Phase 2 data, which demonstrated a significant increase in median progression free survival, from approximately 10 to 16 months in patients receiving combination otlertuzumab/bendamustine therapy,” said Marvin L. White, President and Chief Executive Officer.  “These data, coupled with additional results from ongoing studies of otlertuzumab used in combination with current CLL therapies should help position otlertuzumab for a potential partnership to advance into Phase 3 clinical development.”
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