Posts tagged EMA
NeuroproteXeon additional Phase 2 data published in JACC

Closely-held NeuroproteXeon announced the publication of a second finding from a randomized, controlled Phase 2 trial of inhaled xenon and oxygen, combined with hypothermia, for out-of-hospital cardiac arrest (OHCA) patients.

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Molteni to commercialize Titan Pharma’s Probuphine in Europe

Titan Pharmaceuticals (NASDAQ:TTNP) has entered into a binding term sheet with L. Molteni & C. dei F.lli Alitti Società di Esercizio S.p.A. of Italy, giving Molteni an exclusive license to commercialize Probuphine in the European Union, including the UK and Northern Ireland, Switzerland, Norway, Iceland, Liechtenstein, Bosnia, Serbia, Montenegro, Macedonia and Albania.

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Dipexium gets SME designation in Europe

Dipexium Pharmaceuticals (NASDAQ:DPRX) has been granted small and medium enterprise (SME) designation by the European Medicines Agency (EMA). 

The company recently completed its pivotal Phase 3 clinical trials - OneStep-1 and OneStep-2 - with its topical antimicrobial peptide, Locilex, in mild infections of diabetic foot ulcers in the U.S. under a special protocol assessment agreement from FDA. 

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Maxim cuts Omeros price target to $19

Maxim Group lowered its price target for Omeros (NASDAQ:OMER) to $19 from $30, citing a higher risk value from its three valuation models. The stock closed at $13.38 on Tuesday.

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Maxim downgrades Radius Health to sell

Maxim Group downgraded Radius Health (NASDAQ:RDUS) to “sell” from “hold” with a $24 price target. The stock closed at $50.55 on Thursday.

“At the current valuation, we believe that Radius is back to an overvalued state,” writes analyst Jason McCarthy.

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Can-Fite submits Phase 3 RA trial protocol to EMA

Can-Fite BioPharma (NYSE MKT:CANF; TASE:CFBI) has submitted to the European Medicines Agency (EMA) a protocol design for a Phase 3 trial and registration plan for its lead compound, CF101, in the treatment of rheumatoid arthritis. The company previously had a pre-submission meeting with the EMA.

The global trial is expected to begin in either the second or third quarter of 2016. It will investigate the efficacy and safety of CF101 administered orally twice daily for 16 weeks to patients with active rheumatoid arthritis treated with conventional disease modifying drugs.

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