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 schizophreniaTrial 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…

ByRidhi RastogiOctober 15, 2025

NEWS

J&J Reports US FDA’s sNDA Submission of Caplyta for Schizophrenia Relapse Prevention

Shots:The US FDA has received sNDA of Caplyta (lumateperone) for the prevention of relapse in schizophrenia; sNDA of Caplyta as an adjunctive therapy for MDD is under FDA’s reviewsNDA was supported by withdrawal P-III (Study 304) trial assessing Caplyta (42mg, QD) for 18wk. open-label phase followed by a double-blind phase, where pts received…

ByRidhi RastogiJuly 9, 2025

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 & IndiaAs 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 &…

ByRidhi RastogiJune 18, 2025

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 2040sNDA is backed by various iloperidone trials, incl. 2 in acute schizophrenia, 1…

ByRidhi RastogiMay 6, 2025

NEWS

BMS Reports Topline P-III (ARISE) Trial Data of Cobenfy as an Adjunctive Therapy for Schizophrenia

Shots:The P-III (ARISE) trial assessed Cobenfy (xanomeline & trospium chloride) vs PBO as an adj. therapy to atypical antipsychotics in adults with inadequately controlled schizophrenia symptoms; eligible pts could enter a 52wk. OLE studyAt Wk. 6, trial showed a PANSS score change (1EP) of -14.3 vs -12.2, which was not statistically significant, &…

ByRidhi RastogiApril 23, 2025

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 disorderErzofri 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…

ByRidhi RastogiApril 7, 2025

NEWS

Otsuka and Lundbeck Receive the EC’s Approval for Rxulti to Treat Schizophrenia in Adolescents

Shots:The EC has approved Rxulti (brexpiprazole) to treat schizophrenia in pts (≥13yrs.) following CHMP’s positive opinion in Jan 2025 Approval was based on P-III trial assessing Rxulti (2 to 4mg/day, PO, QD) vs PBO vs Aripiprazole in adolescents (n=316) for 6wks. that showed greater reduction in symptom severity compared to PBO as measured by…

ByRidhi RastogiMarch 13, 2025

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…

BySaurabh ChaubeyOctober 14, 2024

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…

ByDipanshu DixitSeptember 26, 2024

INSIGHTS+

Top Performing Drug – Invega Trinza (March Edition) 

Shots:   In continuation to our previous series on the Top-Performing Drug of the month, based on 2021 revenue, this month we have selected Invega Trinza and prepared an engaging analysis for our readers Invega Trinza (3-Months injection) is an atypical antipsychotic drug used for the treatment of schizophrenia in patients after adequately being treated with…

BySenior EditorMarch 19, 2024

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

J&J Reports US FDA’s sNDA Submission of Caplyta for Schizophrenia Relapse Prevention

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

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

BMS Reports Topline P-III (ARISE) Trial Data of Cobenfy as an Adjunctive Therapy for Schizophrenia

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

Otsuka and Lundbeck Receive the EC’s Approval for Rxulti to Treat Schizophrenia in Adolescents

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

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

Top Performing Drug – Invega Trinza (March Edition)

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