🧑‍🔬 Spotlight: Industry Experts Leading You To Better Returns 💵 

By Imagine Biotech

 FDA Approves Drug with New Mechanism of Action for Treatment of Schizophrenia

Yesterday, the U.S. Food and Drug Administration approved Cobenfy (xanomeline and trospium chloride) capsules for oral use for the treatment of schizophrenia in adults. It is the first antipsychotic drug approved to treat schizophrenia that targets cholinergic receptors as opposed to dopamine receptors, which has long been the standard of care.
 
“Schizophrenia is a leading cause of disability worldwide. It is a severe, chronic mental illness that is often damaging to a person’s quality of life,” said Tiffany Farchione, M.D., director of the Division of Psychiatry, Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research. “This drug takes the first new approach to schizophrenia treatment in decades. This approval offers a new alternative to the antipsychotic medications people with schizophrenia have previously been prescribed.”

🔦 Newest Advisory Board Member 🧑‍🔬 

Chris Slater - Toxicology - MS

Key Focus Areas: Human and Veterinary Pharmaceuticals, IND Study Design, Infusion Toxicology

Chris Slater is a highly experienced toxicologist with more than three decades of work in the non-clinical field. His extensive experience spans both human and veterinary pharmaceuticals, having worked with renowned companies like Hoffmann-La Roche and Merial Limited. He has also collaborated with several contract research organizations, including SNBL USA, Experimur, and Charles River Labs.

• Chris's contributions to the biotech industry include assisting numerous companies with IND study design, monitoring, data interpretation, and regulatory filings. He has played a key role in initiating and expanding portfolios focused on infusion toxicology in various species.

📰 The Latest in Biotech and Pharma 🔬 

• 📈 Amgen's eczema drug, rocatinlimab, showed promising phase 3 results, with 32.8% of patients achieving a 75% improvement in symptoms (EASI-75), compared to 13.7% in the placebo group. However, the drug faces stiff competition from Regeneron and Sanofi’s Dupixent, which demonstrated stronger results in similar trials. While rocatinlimab met its primary endpoints, analysts are questioning its potential to compete in a crowded market. Investors will watch closely as Amgen advances the broader ROCKET program to carve out market share.

• ❌ Merck's attempt to tackle microsatellite stable (MSS) metastatic colorectal cancer with a combination of Keytruda and the anti-LAG-3 antibody favezelimab has failed to improve overall survival in the KEYFORM-007 trial. Despite earlier success with Keytruda in microsatellite instability-high cancers, MSS colorectal cancer remains resistant to checkpoint inhibitors. While this setback closes one path, Merck is continuing to explore other Keytruda-based combinations and has ongoing trials with favezelimab in other cancer types, including Hodgkin lymphoma, with a completion date expected in 2027.

• 🤝 OncoC4 has announced an all-stock merger with AcroImmune, acquiring 100% of its equity and expanding its pipeline. The merger adds AcroImmune’s preclinical bispecific antibody AI-081, targeting PD-1 and VEGF, with an IND submission expected later this year. OncoC4 also gains AI-071, a phase 2-ready siglec agonist aimed at treating acute respiratory failure and immune-related adverse events. The merger strengthens OncoC4's position with in-house clinical manufacturing capabilities in China, as it advances its immunotherapy programs, including a phase 3 anti-CTLA-4 candidate in partnership with BioNTech.

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Our array of services range from sophisticated molecular modeling density functional methods (DFT) to the first-of-its-kind integration package of ADMET and PK predictions to academic risk.

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