TENX - Tenax Therapeutics gains North American rights to oral levosimendan; shares +14%

Tenax Therapeutics (TENX) +14% premarket, has amended its existing licensing agreement with Orion Corporation to include the rights to develop and commercialize an oral formulation of levosimendan for use with Type 2 pulmonary hypertension in heart failure patients with preserved ejection fraction (PH-HFpEF), or other heart disorder related indications in the U.S. and Canada.The Company recently completed a Phase 2 study in PH-HFpEF using an intravenous formulation of levosimendan, which the Company has exclusive rights to in U.S. and Canada under the existing license agreement.Tenax now plans to utilize the oral formulation in its upcoming Phase 3 trial in PH-HFpEF. Currently, there are no approved products for treating PH-HFpEF. “Use of the currently available 1mg capsule of levosimendan should allow us to conduct our upcoming Phase 3 trial with significantly faster enrollment versus the IV formulation,” stated CEO Anthony DiTonno. The amendment allows Tenax to access all of the manufacturing, preclinical and clinical data generated on oral levosimendan to

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Tenax Therapeutics gains North American rights to oral levosimendan; shares +14%