FDA Approves J&J's Caplyta for Depression with One-Week Onset; Vera Therapeutics' Atacicept Shows 46% Reduction in Proteinuria in IgA Nephropathy Phase 3 Trial

One Week to Relieve Depression! FDA Approves Johnson & Johnson's Small Molecule Therapy Again

Today, Johnson & Johnson announced that its small-molecule therapy Caplyta (lumateperone) has received another approval from the U.S. FDA as an adjunctive treatment regimen to be used in combination with antidepressants for the treatment of major depressive disorder (MDD) in adults. This approval is primarily based on two global, randomized, double-blind, placebo-controlled pivotal trials.Phase 3Results of Study 501 and Study 502. Both studies met the primary and key secondary endpoints, demonstratingCompared with oral antidepressants combined with placebo, it can bring statistically significant and clinically meaningful improvements in the total score of Montgomery-Åsberg Depression Rating Scale (MADRS) and Clinical Global Impression-Severity (CGI-S) score.

The study results showed that, at the sixth week,Caplyta showed a difference of -4.9 points on the MADRS total score compared to placebo in Study 501 and -4.5 points in Study 502, with efficacy differences observed as early as one week (Study 501) and two weeks (Study 502) compared to placebo.In terms of the CGI-S scale, both studies also showed significant improvements at week six (-0.7 points and -0.5 points). Additionally, in the pivotal study and the six-month open-label extension study,Caplyta demonstrated good safety and tolerability, with no significant adverse reactions related to weight gain or metabolic changes.

Caplyta is an oral, once-daily atypical antipsychotic. It has received FDA approval for the treatment of schizophrenia and as an adjunctive therapy for schizophrenia and depressive episodes associated with bipolar I or II disorder in adults. Although its mechanism of action has not been fully elucidated, its efficacy is known to be mediated through a combination of central serotonin 5-HT2A receptor antagonism and postsynaptic dopamine D2 receptor antagonism.

Key Disease Indicator Reduced by Nearly Half! Breakthrough Therapy Expected to Be Approved for Market Launch Next Year

Vera Therapeutics, Inc. today announced the ORIGIN clinical trial results for its investigational drug atacicept in the treatment of IgA nephropathy (IgAN).Phase 3Latest trial data. The results show that the trial met its primary endpoint:At week 36, atacicept significantly reduced proteinuria (UPCR) in patients by 46% from baseline and by 42% compared to placebo, with a highly statistically significant difference (p<0.0001).In terms of safety, atacicept performed well overall, comparable to placebo. Based on the above results,The company plans to submit a Biologics License Application (BLA) to the U.S. FDA via the accelerated approval pathway in the fourth quarter of 2025, with the potential for approval and market launch in 2026.; Meanwhile, the ORIGIN trial is still ongoing, with results expected in two years.ExpectedTo be announced in 2027.

Atacicept is a recombinant fusion protein containing the soluble transmembrane activator and calcium-modulating cyclophilin ligand interaction factor (TACI) receptor, which can bind to B-cell activating factor (BAFF) and a proliferation-inducing ligand (APRIL).These cytokines are members of the tumor necrosis factor family and can promote B cell survival and autoantibody production associated with certain autoimmune diseases, including IgAN and lupus nephritis. Vera Therapeutics believes that this candidate drug, by targeting B cells and plasma cells to reduce autoantibodies, has the potential to become a "best-in-class" drug.Atacicept has been granted Breakthrough Therapy Designation by the U.S. FDA for the treatment of patients with IgAN.

Weight Loss Exceeds 20%! Lilly's Peptide Therapy Phase 3 Trial to Begin Patient Enrollment

Eli Lilly and Company announced today that its investigational weight-loss peptide therapy, eloralintide (LY3841136), met the primary endpoint in a Phase 2 clinical trial. Based on these results,Lilly Plans to Initiate Patient Enrollment Next Month for the Phase 3 Clinical Study of Eloralintide in Obesity Treatment. Eloralintide is a once-weekly, subcutaneously injected, selective, long-acting amylin receptor agonist., with good tolerability and clear weight loss effects.

The trial enrolled a total of 263 adult subjects who were obese or overweight with at least one obesity-related comorbidity but without type 2 diabetes.At Week 48, all eloralintide treatment groups reached the primary endpoint, with average weight loss ranging from 9.5% to 20.1%, compared to only 0.4% in the placebo group, demonstrating a significant efficacy difference.In addition, the trial also showed that all doses of eloralintide achieved clinically meaningful improvements over placebo in secondary endpoints such as weight loss and reduction in body mass index (BMI). Moreover, the treatment was associated with comprehensive improvements in cardiometabolic risk indicators, including reductions in waist circumference, blood pressure, lipid levels, blood glucose control, and inflammatory marker levels.

References:

[1] FDA approval of CAPLYTA® (lumateperone) has the potential to reset treatment expectations, offering hope for remission in adults with major depressive disorder. Retrieved November 6, 2025 from https://www.prnewswire.com/news-releases/fda-approval-of-caplyta-lumateperone-has-the-potential-to-reset-treatment-expectations-offering-hope-for-remission-in-adults-with-major-depressive-disorder-302606717.html

[2] Lilly's selective amylin agonist, eloralintide, demonstrated meaningful weight loss and favorable tolerability in a Phase 2 study of adults with obesity or overweight. Retrieved November 6, 2025 from https://investor.lilly.com/news-releases/news-release-details/lillys-selective-amylin-agonist-eloralintide-demonstrated

[3] Vera Therapeutics Announces Positive ORIGIN Phase 3 Data for Atacicept in IgA Nephropathy Presented at ASN Kidney Week 2025 and Published in the New England Journal of Medicine. Retrieved November 6, 2025 from https://www.globenewswire.com/news-release/2025/11/06/3182759/0/en/Vera-Therapeutics-Announces-Positive-ORIGIN-Phase-3-Data-for-Atacicept-in-IgA-Nephropathy-Presented-at-ASN-Kidney-Week-2025-and-Published-in-the-New-England-Journal-of-Medicine.html

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