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Aytu and Fabre-Kramer

Aytu BioPharma Collaborates with Fabre-Kramer Pharmaceuticals to Commercialize Exxua (Gepirone) in the US for Major Depressive Disorder

Shots: Aytu has collaborated with Fabre-Kramer to commercialize Exxua in the US for treating major depressive disorder; launch is expected in Q4’25 As per the deal, Fabre-Kramer has received $3M upfront & is eligible to receive $3M within 45 days of the Exxua’s 1yr. commercial sale, increasing to $5M if net sales reach $35M as…

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Vanda Pharmaceuticals

Vanda Pharmaceuticals Reports the US FDA’s NDA Acceptance of Bysanti (Milsaperidone) for Acute Bipolar I Disorder & Schizophrenia

Shots: The US FDA has accepted NDA of Bysanti, an active metabolite of iloperidone to treat acute bipolar I disorder & schizophrenia (PDUFA: Feb 21, 2026). If approved, Bysanti may receive 5yrs. of data exclusivity, with pending patents extending into the 2040s NDA is backed by various iloperidone trials, incl. 2 in acute schizophrenia, 1…

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