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Fabre-Kramer Pharmaceuticals Inc. (Fabre-Kramer) is pleased to announce that the U.S. Food and Drug Administration (FDA) has approved Exxua™ (gepirone hydrochloride extended-release tablets) for the treatment of major depressive disorder (MDD) in adults.

After several rejections over 20-plus years, Fabre-Kramer Pharmaceuticals has secured the FDA’s approval for its major depressive disorder drug gepirone hydrochloride, now marketed under the brand name Exxua.

Fabre-Kramer Pharmaceuticals, Inc. (Fabre-Kramer) today announced that on December 23, 2022, it filed an NDA Amendment with the Food and Drug Administration (FDA) for its novel mechanism antidepressant EXXUA™ (gepirone ER) for treatment of Major Depressive Disorder (MDD).

HOUSTON, Jan. 24, 2023 /PRNewswire/ -- Fabre-Kramer Pharmaceuticals announced today it received on January 20, 2023 acknowledgement and acceptance of its December 23, 2022 NDA Amendment for EXXUA (gepirone hydrochloride) extended release tablets for the treatment of Major Depressive Disorder (MDD).

Kinnate Biopharma Inc. (Nasdaq: KNTE) (“Kinnate” or the “Company”), a clinical-stage precision oncology company, and Pierre Fabre Médicament, SAS (“Pierre Fabre Laboratories”), a global player in oncology, today announced their agreement to the sale of the Company’s investigational pan-RAF inhibitor, exarafenib, and other pan-RAF program assets pursuant to the APA entered into by the parties.

The European Commission (EC) has authorized the marketing of OBGEMSA™ (vibegron) by Pierre Fabre Laboratories for the symptomatic treatment of overactive bladder syndrome in adults, a particularly debilitating condition affecting over 70 million patients* in Europe.

Kinnate has entered into an Asset Purchase Agreement (the “APA”) with Pierre Fabre Laboratories for global rights to exarafenib and other pan-RAF program assets.

Pierre Fabre Laboratories announced the filing of an investigational new drug application to the U.S. Food and Drug Administration to initiate a first-in-human Phase I/II clinical trial with PFL-002/VERT-002 for solid tumors including non-small cell lung cancer.