ABBVIE

AbbVie submitted a BLA to the FDA for accelerated approval of telisotuzumab vedotin (Teliso-V) in EGFR wild type, nonsquamous NSCLC with c-Met overexpression, supported by Phase 2 LUMINOSITY trial data. Teliso-V received FDA Breakthrough Therapy Designation in December 2021.

FDA approves Bristol Myers Squibb's Cobenfy, the first new schizophrenia drug in 30 years, targeting cholinergic receptors. Cobenfy, priced at $22,500/year, is expected to be widely covered by mid-2025, offering a new alternative to current antipsychotic medications. The approval opens opportunities for other drugs in the market.

AbbVie announced positive results from the phase III TEMPO-1 study, showing tavapadon significantly improved early Parkinson’s disease symptoms in 26 weeks. The drug met primary and secondary endpoints, with a consistent safety profile. AbbVie plans to seek regulatory approval using these data.

AbbVie submits Biologics License Application to USFDA for Telisotuzumab Vedotin (Teliso-V), an ADC for previously treated nonsquamous NSCLC with c-Met overexpression.

AbbVie's Phase 3 TEMPO-1 trial for tavapadon, a D1/D5 dopamine receptor partial agonist, met primary endpoint in early Parkinson’s disease. The trial showed significant reduction in MDS-UPDRS scores at week 26, with safety profile consistent with previous studies. Full results will support regulatory submissions, with TEMPO-2 topline results expected by year-end.

NSCLC, the most common lung cancer, has high mortality rates. c-Met protein overexpression in NSCLC is linked to poor prognosis. Telisotuzumab vedotin, targeting c-Met, shows promise for treating c-Met overexpressing NSCLC, with FDA Breakthrough Therapy Designation and ongoing Phase 3 trials.

Leerink Partners' David Risinger maintains a Hold rating on AbbVie (ABBV) stock, citing positive Phase 3 tavapadon trial results but cautious about sales projections, remaining trials, and market competition.

The FDA approved Bristol Myers Squibb's Cobenfy, the first novel schizophrenia medication in decades, offering better tolerability and a new treatment approach by blocking muscarinic cholinergic receptors. Developed by Karuna Therapeutics, Cobenfy targets M1 and M4 receptors in the brain, avoiding peripheral side effects. Approved based on Phase 3 trials showing significant symptom reduction, it has gastrointestinal side effects but lacks a black box warning. Expected to be available in October, it may be prescribed for patients unresponsive to other antipsychotics.

New concepts in rheumatoid arthritis (RA) management, including early treatment and targeting stromal cells, could revitalize current approaches, according to Arthur Kavanaugh, MD, at the 2024 Congress of Clinical Rheumatology West.

Bristol Myers Squibb receives FDA approval for Cobenfy, a new antipsychotic drug for schizophrenia, the first in decades. Cobenfy, also known as KarXT, lacks warnings about increased mortality in elderly patients and common side effects like weight gain and movement disorders. Bristol Myers expects $2.5 billion in U.S. sales by 2030 and plans to launch the drug at $1,850 a month. The approval is based on studies showing significant symptom reduction, targeting cholinergic receptors instead of dopamine. Cobenfy's side effects include vomiting and nausea, and it is not recommended for patients with urinary retention or severe kidney/liver disease.