Acorda Therapeutics to Acquire Civitas Therapeutics

• Obtains global rights for Phase 3 Parkinson’s disease treatment

• Acquisition leverages existing Acorda development and commercial capabilities

• Company to host webcast at 8:30 a.m. Eastern

ARDSLEY, N.Y.-- Acorda Therapeutics, Inc. (Nasdaq:ACOR) today announced that it entered into an agreement to acquire Civitas Therapeutics, a privately-held biopharmaceutical company, for $525 million in cash. Acorda will obtain worldwide rights to CVT-301, a Phase 3 treatment candidate for OFF episodes of Parkinson’s disease (PD). The acquisition also includes rights to Civitas’ proprietary ARCUS^TM pulmonary delivery technology and manufacturing facility with commercial-scale capabilities based in Chelsea, MA.

Lipocine Announces Positive Top-Line Results in Its Phase 3 Study of LPCN 1021 for Oral Testosterone Replacement Therapy

• Met primary efficacy endpoint by successfully restoring testosterone levels to the normal range in 88% of the subjects
• Lower limit of the 95% confidence interval was 82%
• 85% of the subjects reached final dose with no more than one dose titration
• Majority of subjects ended on 225 mg BID
• Proportion of subjects with maximum serum concentrations generally met FDA pre-specified targets
• LPCN 1021 treatment was well tolerated with no drug related serious adverse events

Navidea Awarded $1.67M Fast Track NIH SBIR Grant for Evaluation of Lymphoseek® in Cervical Cancer

DUBLIN, Ohio--- Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB), today announced the receipt of an initial notice of award for a Fast Track Small Business Innovation Research (SBIR) grant providing for up to $1.67 million from the National Cancer Institute (NCI), National Institutes of Health (NIH), to fund evaluation of Lymphoseek^® (technetium Tc 99m tilmanocept) Injection in women with cervical cancer. The multicenter, clinical study in patients with early cervical cancer will seek to assess and provide data in support of the use of Lymphoseek in sentinel lymph node biopsy (SLNB) procedures which identify and evaluate the lymph nodes most likely to harbor additional cancer.

Galmed Pharmaceuticals Announces U.S. FDA Approval of Fast Track Designation of Aramchol for the Treatment of NASH

TEL AVIV, Israel, Sept. 23, 2014 -- Galmed Pharmaceuticals Ltd. (GLMD) ("Galmed"), a clinical-stage biopharmaceutical company focused on the development and commercialization of a once-daily, oral therapy for the treatment of liver diseases and cholesterol gallstones, announced today that the U.S. Food and Drug Administration, or the FDA, approved its request for Fast Track Designation of its product candidate, aramchol, for the treatment of Non-Alcoholic Steato-Hepatitis, or NASH.