Repros Provides Update on EU Submission of Enclomiphene for the Treatment of Secondary Hypogonadism and 3 Month Interim Results for Enclomiphene Study in Obese Secondary Hypogonadal Men

EU submission on track with anticipated registration decision expected Fall 2017
UK designated as rapporteur and France as co-rapporteur for the centralized review of the enclomiphene marketing application
3 month interim assessment of testosterone levels in obese men participating in Phase 2 diet and exercise study show statistically significant increases in testosterone in the active arms versus the placebo arm
 
THE WOODLANDS, Texas, June 01, 2016 -- Repros Therapeutics Inc.® (RPRX) today announced that it remains on track for submission of a European centralized marketing authorization application (MAA) for enclomiphene for the treatment of secondary hypogonadism. To that end, the European Medicines Agency (EMA) has assigned France and the UK as rapporteurs for the application review. The Company expects to submit the application in Fall 2016.  As part of the review process, the Company is scheduled to meet with British and French medical reviewers in June 2016. 
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Achaogen Awarded $20 Million Contract Option by BARDA to Support Development of Plazomicin for Multi-Drug Resistant Gram-Negative Infections

Option Funding Focused on Phase 3 EPIC Registration Trial of Plazomicin in cUTI; Company Expects Top-Line EPIC Study Results in the First Quarter of 2017
SOUTH SAN FRANCISCO, Calif., June 02, 2016 -- Achaogen, Inc. (AKAO), a clinical-stage biopharmaceutical company developing novel antibacterials addressing multi-drug resistant (MDR) gram-negative infections, today announced that it has been awarded $20 million for an additional option, Option 3, on its existing contract with the Biomedical Advanced Research and Development Authority (BARDA) to support the development of plazomicin. Plazomicin is the Company’s lead product candidate being developed to treat serious bacterial infections due to MDR Enterobacteriaceae, including carbapenem-resistant Enterobacteriaceae (CRE).
 
The BARDA contract was originally awarded to Achaogen under BARDA’s Broad Spectrum Antimicrobials program in August 2010. The original contract consisted of a base award as well as three options that, effective today, have all been exercised. With the granting of this last option, the unspent funding currently committed under the contract with BARDA now totals approximately $41 million. 
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Actinium Pharmaceuticals Announces Positive Safety and Efficacy Results From Phase 1 Actimab-A Trial in Patients With Newly Diagnosed Acute Myeloid Leukemia and Provides Guidance on Plans for Phase 2 Clinical Trial

NEW YORK, NY--(June 01, 2016) - Analysis of clinical trials from Actimab-A portion of Actinium's HuM195-Alpha program show low peripheral blast burden results in improved patient responses
Phase 2 trial to begin enrolling patients in 2H:2016 with revised protocol incorporating latest findings
Webinar today at 8:00 am EST to discuss results of the Phase 1 trial, key findings regarding peripheral blast burden and the Phase 2 development plan
 
Actinium Pharmaceuticals, Inc. (NYSE MKT: ATNM) ("Actinium" or the "Company"), a biopharmaceutical Company developing innovative targeted payload immunotherapeutics for the treatment of patients with advanced cancers, today announced positive results from its Phase 1 Actimab-A trial in patients newly diagnosed with acute myeloid leukemia (AML) who are over the age of 60. 
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Galena Biopharma Receives Fast Track Designation for NeuVax™ (nelipepimut-S) PRESENT Clinical Trial

SAN RAMON, Calif., June 01, 2016  -- Galena Biopharma, Inc. (GALE), a biopharmaceutical company committed to the development and commercialization of targeted oncology therapeutics that address major unmet medical needs, today announced the U.S. Food and Drug Administration (FDA) has designated NeuVax™ (nelipepimut-S), combined with recombinant granulocyte macrophage-colony stimulating factor (GM-CSF), as a Fast Track development program for the treatment of patients with early stage, node positive breast cancer with low to intermediate HER2 expression, otherwise known as HER2 1+ or 2+, following standard of care. Galena’s PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment) clinical trial is an international, Phase 3 study to evaluate NeuVax plus GM-CSF versus placebo plus GM-CSF to prevent cancer recurrence.
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NanoViricides Signs Agreement with St. Jude Children's Research Hospital for further Influenza Drug Development

SHELTON, Conn., May 31, 2016 -- NanoViricides, Inc. (NYSE MKT: NNVC (the "Company") announced today that it has entered into an agreement with St. Jude Children's Research Hospital, Memphis, TN, for further drug development in its anti-influenza program.
 
NanoViricides, Inc. has previously held a pre-IND meeting with the US FDA on its anti-influenza drug development program, and obtained valuable guidance. Since then, the Company has been performing necessary CMC (chemistry, manufacture, and control) studies and production scale-up for the identified development candidate, namely, FluCide™-I. The Company has also continued further anti-influenza drug development that is anticipated to result in additional candidates superior to FluCide-I.
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