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We are in an unprecedented time in neurotherapeutics. Medicines that address the causative disease biology underlying central nervous system

The agency’s warning letter outlines Applied Therapeutics’ failure to provide adequate information regarding the clinical trial—including a dosing error for govorestat—claims that the company said it had already addressed.

After extending its review period to evaluate additional submissions, the FDA ultimately denied Applied Therapeutics’ govorestat for galactosemia, citing “deficiencies” with the application. The biotech plans to meet with the regulator to discuss the best way forward for the drug.

Tenax Therapeutics, Inc. today announced Dr. Sanjiv Shah will present data and review the scientific basis for the use of levosimendan in PH-HFpEF.

Following disappointing results for an antibiotic candidate whose development program is now being suspended, Spero Therapeutics is looking to extend its cash runway while it focuses on other assets in its pipeline.

Tenax Therapeutics, Inc. announced that the United States Patent and Trademark Office has granted the Company a patent covering the use of TNX-103, TNX-102, TNX-101, the active metabolites of levosimendan and various combinations of cardiovascular drugs with levosimendan when used to improve exercise performance in PH-HFpEF patients.

Tenax Therapeutics, Inc. today announced it has secured global development, commercial, and IP rights to oral and subcutaneous levosimendan for the treatment of pulmonary hypertension with heart failure with preserved ejection fraction (PH-HFpEF).

Tenax Therapeutics, Inc. today announced that Stuart Rich, Tenax CMO, will moderate ”LEVEL Setting,” a scientific round-table exploration of the rationale for TNX-103 (oral levosimendan), for the treatment of PH-HFpEF.