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NEWS

Johnson & Johnson Reports the US FDA’s Approval of Caplyta (Lumateperone) for Major Depressive Disorder

Shots: The US FDA has approved Caplyta as an adjunctive therapy with antidepressants for treating adults with major depressive disorder (MDD). An sNDA for schizophrenia relapse prevention is also submitted Approval was based on 2 P-III (Study 501 & 502) trials assessing Caplyta vs PBO, both in combination with an antidepressant in MDD pts Trial…
November 7, 2025

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NEWS

Boehringer Ingelheim and Click Therapeutics Report P-III (CONVOKE) Trial Data on CT-155 for Schizophrenia

Shots: The P-III (CONVOKE) trial assessed CT-155 (BI 3972080) vs a digital control app as an adjunct to SoC antipsychotic therapy in pts (≥18yrs.) with experiential negative symptoms of schizophrenia Trial met its 1EP with 6.8 vs 4.2-point improvement in negative symptom severity on the CAINS-MAP at 16wks., achieving a Cohen’s D of -0.36; most…
October 15, 2025

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NEWS

Avata Biosciences Enters a Co-Development and Licensing Deal with Oceanus Bio for AVAT-021 and AVAT-022 to Treat Epilepsy and Schizophrenia

Shots: Avata has entered into a co-development & licensing deal with Oceanus Bio for exclusive rights to AVAT-021 & AVAT-022 in Japan & Asia, excl. China & India As per the deal, Avata will receive $95M in co-development contributions, regulatory & sales milestones, plus double-digit royalties on sales, while Oceanus will lead regulatory activities &…
June 18, 2025

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Vanda Pharmaceuticals
NEWS

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…
May 6, 2025

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Luye Pharma
NEWS

Luye Pharma Launches Erzofri in the US for Schizophrenia and Schizoaffective Disorder

Shots: Luye Pharma has launched Erzofri extended-release injectable suspension in the US to treat adults with schizophrenia & as monotx. or adjunct therapy for adults with schizoaffective disorder Erzofri was approved by the US FDA based on a multiple-dose, parallel-group study evaluating its PK profile & relative bioavailability at steady state vs reference product, demonstrating…
April 7, 2025

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Viewpoints_Stella Sarraf
VIEWPOINTS

Enhancing Neurodegenerative Care: Stella Sarraf from Spinogenix in an Enlightening Dialogue Exchange with PharmaShots

Shots:  With a broad portfolio of candidates in ALS, Alzheimer’s disease, Schizophrenia, and Fragile X Syndrome, Spinogenix initiated the P-II study evaluating SPG302 for the treatment of patients with Alzheimer’s disease  SPG302, a synaptic regenerative therapy, is aimed to provide an effective and patient-friendly solution as a daily pill for ALS and Alzheimer’s disease  Today…
October 14, 2024

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Bristol Myers Squibb
NEWS

BMS’ Cobenfy (Xanomeline and Trospium Chloride) Receives the US FDA Approval for Treating Schizophrenia 

Shots:     The US FDA has granted approval to BMS’ Cobenfy for treating schizophrenia in adults, based on its EMERGENT studies  The EMERGENT studies comprised of P-III (EMERGENT-2 & 3) trials, evaluating the safety, efficacy & tolerability of Cobenfy vs PBO in schizophrenic adults for over 5wks., as well as two open-label trials assessing long-term safety…
September 26, 2024

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