- The U.S. Food and Drug Administration (FDA) has approved Axsome Therapeutics’ AXSM lead asset AUVELITY (dextromethorphan HBr -bupropion HCl) extended-release tablets for the treatment of major depressive disorder (MDD) in adults. Axsome shares traded in a range of $50.5 to $61.11 on a day volume of 21.95 million shares, closed regular trading session at $59.55.
- The Swiss Agency for Therapeutic Products (Swissmedic) has approved Cara Therapeutics’ CARA lead candidate KORSUVA (difelikefalin) injection for the treatment of moderate-to-severe pruritus associated with chronic kidney disease in adult hemodialysis patients. Cara shares traded in a range of $10.88 to $11.29 on a day volume of 266.29 thousand shares, closed regular trading session at $11.26.
- Verona Pharma plc VRNA announces its development partner, Nuance Pharma, has received clearance from the Center of Drug Evaluation (CD") for its Investigational New Drug (IND) application to conduct both Phase 1 and Phase 3 studies with ensifentrine for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in mainland China. Verona shares traded in a range of $11.95 to $12.84 on a day volume of 409.89 thousand shares, closed regular trading session at $12. The company shares are currently trading at $11.65, down 2.92 percent in the after-hours trading session.
- Moleculin Biotech MBRX announced preliminary results from the third cohort of the first-in-human Phase 1a study of WP1122, consisted of 10 subjects dosed with 32 mg/kg or placebo in the dose escalation trial evaluating the safety and pharmacokinetics (PK) of WP1122 in healthy volunteers in the United Kingdom (UK). Moleculin shares traded in a range of $1.68 to $1.77 on a day volume of 33.61 thousand shares, closed regular trading session at $1.68.
- Sorrento Therapeutics SRNE announced the IND clearance by the China National Medical Products Administration (NMPA) for a Phase I study of its oral main viral protease inhibitor, STI-1558, in subjects with COVID-19 in a MAD study in China. Sorrento shares traded in a range of $1.84 to $2.01 on a day volume of 11.35 million shares, closed regular trading session at $1.86.
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