Repros Reports Preliminary Findings: Second Pivotal Study and 6-Month Safety Study Support Androxal(R) Approvability

  • Androxal meets both co-primary endpoints in second pivotal study ZA-302
  • Testosterone normalized in 81% of patients
  • No deleterious effects on sperm function
  • No excursions above normal in 24 hour average testosterone
  • Androxal is generally well tolerated in 6 month safety study ZA-300
  • No dose dependent adverse events
  • Adverse event profile similar or superior to other approved testosterone therapies with over 90% of safety database collected
  • NDA submission on track

Repros Therapeutics Inc.(R) (RPRX) today reported topline results from both the second pivotal efficacy study as well as the 6 month safety study of Androxal(R) in the treatment of men with secondary hypogonadism.

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NovaBay Pharmaceuticals Announces Positive Results from Phase 2 Clinical Study of Auriclosene to Reduce Urinary Catheter Blockage and Encrustation

Primary Endpoints Achieved Showing Statistically Significant and Clinically Meaningful Benefits for Patients with Long-Term Indwelling Catheters

Results Pave the Way for Phase 3 Pivotal Studies

NovaBay Pharmaceuticals, Inc., an advanced clinical-stage biopharmaceutical company developing anti-microbial products, today announced positive top-line results from its recently completed Phase 2 clinical study CL1001 for auriclosene (NVC-422) to prevent urinary catheter blockage and encrustation (UCBE) of indwelling urinary catheters.

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Galectin Therapeutics Receives US Patent for Potential Ground-Breaking Treatment for Fatty Liver Disease

Galectin Therapeutics (GALT), the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, today announced that it has received a notice of issuance from the U.S. Patent and Trademark Office for Patent Application Number 13/573,454 titled "Galacto-rhamnogalacturonate compositions for the treatment of non-alcoholic steatohepatitis and non-alcoholic fatty liver disease." The patent covers the Company's carbohydrate-based galectin inhibitor compound GR-MD-02 for use in patients with fatty liver disease with or without fibrosis or cirrhosis. Fatty liver disease affects as many as 15 million Americans, results in severe scarring of the liver (cirrhosis), and there are no currently approved pharmaceutical therapies.

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Ventrus Biosciences Announces Positive Results From Clinical Dermal Safety and Pharmacokinetic Studies of Diltiazem (VEN 307)

Results From Second Pivotal Phase 3 Trial in Anal Fissures Expected First Quarter 2014

Ventrus Biosciences, Inc. (VTUS), a pharmaceutical company focused on developing and commercializing gastrointestinal products, today announced positive results from two clinical dermal safety studies and one pharmacokinetic (PK) study of diltiazem hydrochloride 2% cream (VEN 307). All three studies were conducted to support the Company's planned New Drug Application (NDA) for VEN 307 as a treatment for anal fissures (AF).

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Rockwell Medical Announces SFP Meets Primary and Key Secondary Endpoints in Phase 3 CRUISE-2 Efficacy Study as a Treatment for Iron Replacement in Chronic Kidney Disease Patients on Dialysis

In Dialysis Patients Not Receiving IV Iron, SFP Effectively Delivers Iron via Dialysate and Maintains Hemoglobin Without Increasing Stored Iron (Ferritin); Strong Safety Data Demonstrates No Anaphylactic Events and No Increase in Hypotension or Infection; Consistent, Positive Results Achieved Across Two Phase 3 Efficacy Studies; Conference Call to Be Held Today, Wednesday September 4, 2013 at 8:30am Eastern Time

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