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Mediwound Ltd ($MDWD) stock jumped over 9% in Tuesday trading session as the company announced final positive results from the Company’s second Phase 2 clinical trial evaluating EscharEx® for debridement of dead or damaged tissue in chronic and other hard-to-heal wounds. It also reported data from the follow-up period of six months from last treatment or three months from wound closure.
EscharEx is based on the same propriety proteolytic enzyme technology used in MediWound’s NexoBrid®, which is approved and commercially available in Europe, Israel and Argentina for the removal of eschar in adults with deep partial- and full-thickness thermal burns. Based on the Final Clinical Study Report, the Phase 2 trial met its statistically-powered primary endpoint, the incidence of complete debridement at the end of the debridement period. Patients treated with EscharEx demonstrated a higher incidence of complete debridement (55% or 27/49) compared with patients treated with the hydrogel vehicle (29% or 7/24) with p=0.047.
The study included secondary endpoints that provide further insight on a number of efficacy and safety parameters. The Company will share these final data with the U.S. Food and Drug Administration (FDA) as part of its submitted request for a meeting with the Agency to discuss a U.S. pivotal clinical program for EscharEx.

Palatin Technologies Inc. ($PTN) recently announced the closing of its licensing agreement with AMAG Pharmaceuticals, Inc. ($AMAG) for exclusive North American rights to develop and commercialize Rekynda™ (bremelanotide). The drug is an investigational product designed for on-demand treatment of hypoactive sexual desire disorder (HSDD) in pre-menopausal women.
The licensing agreement is expected to close in the first quarter of this year. Rekynda has been successfully evaluated in two phase III studies. A New Drug Application for Rekynda is expected to be filed in early 2018, with an anticipated approval and launch by early 2019.
Palatin stock had a rocky start this year as it saw near 20% fall in its value. The stock may see rebound as it is trading close to its 52 weeks low value.

 

• Durect ($DRRX) reported that the FDA has asked for additional information with regard to its IND filed in December 2016 for lead product candidate DUR-928. The request is mainly related to additional non-clinical information, specifically drug-drug interaction data. The agency has also suggested changes to the proposed protocol of its Phase 2 study in fatty liver disease.
• Aeterna Zentaris ($AEZS) announced reaching the clinical endpoint in its Phase 3 study, ZoptEC, assessing Zoptrex (zoptarelin doxorubicin) in women with treatment-resistant advanced endometrial cancer. The primary endpoint for the study is overall survival compared to doxorubicin alone. Data lock and the release of top-line results is expected in April.

• BioCryst Pharmaceuticals ($BCRX) reported that The European Medicines Agency (EMA) has accepted its Marketing Authorization Application (MAA) seeking approval of peramivir for the treatment of symptoms of influenza in adult patients at least 18 years old, for review. The drug is already approved in the U.S. in December 2014 and is marketed under the brand name Rapivab.
• Xoma Corporation ($XOMA) reported that it has established proof-of-concept for its product candidate 358 in congenital hyperinsulinism (CHI) and hypoglycemia post-bariatric surgery (PBS). The CHI acute studies met their objectives of establishing initial safety and 358 proof-of-concept in CHI patients aged 12 and up across several dosing levels.

 
• Psychmedics ($PMD) reported that it is not involved with the lawsuit between independent distributor Psychemedics Brasil Exames Toxicologicos Ltda. and Omega Labs' representative Laboratorios Omega Brasil Ltda. Therefore, the financial penalty, if any, will be the responsibility of the Brazil organization. Psychemedics expects its business in Brazil to continue as usual.
• Tenax Therapeutics ($TENX) announced that its lead product candidate levosimendan failed to beat placebo in a Phase 3 clinical trial (LEVO-CTS) assessing the use of the calcium sensitizer administered during cardiac surgery to reduce the incidence of low cardiac output syndrome and associated morbidity and mortality. The drug also failed to demonstrate a statistically valid treatment benefit versus placebo as determined by all-cause mortality at day 30 following surgery or the use of a mechanical assist device through day 5.

• Summit Therapeutics ($SMMT) received Buy rating from Oppenheimer. The price target for the stock has been set at $24.
• Endo International ($ENDO) received Hold rating from RBC Capital. The price target for the stock has been set at $15.

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