While MapLight Therapeutics’ oral schizophrenia candidate reached the main endpoint of a Phase 2 trial, analysts say Bristol Myers Squibb’s Cobenfy is likely to hold its market share.
MapLight Therapeutics’ schizophrenia drug showed comparable efficacy to Bristol Myers Squibb’s Cobenfy in a highly anticipated Phase 2 trial, but missed “a home run scenario,” according to Jefferies analysts.
The twice-daily schizophrenia pill from MapLight, dubbed ML-007C-MA, met the primary endpoint of the ZEPHYR trial with a statistically significant and clinically meaningful reduction in symptoms based on the Positive and Negative Syndrome Scale (PANSS) at five weeks. In the modified intent-to-treat population, participants saw a 4.5-point improvement in PANSS total score versus placebo, according to the biotech’s Monday release.
A separate arm exploring once-daily dosing failed to meet its endpoint, however. MapLight had been hoping to offer an easier dosing regimen than Cobenfy with no fasting and a shorter titration period.
Analysts said MapLight’s candidate fell short of posing a major competitive risk to BMS’s Cobenfy, approved in 2024 as the first muscarinic agonist targeting cholinergic receptors to reduce the symptoms of schizophrenia.
The results for ML-007C-MA, also a muscarinic agonist, “muted” the competitive threat to Cobenfy, according to a Monday note from BMO Capital Markets. In particular, the PANSS score “failed to beat what Cobenfy demonstrated in its Phase 3 program,” the analysts wrote. The drug posted an 8 to 10 point reduction in a pair of Phase 3 trials dubbed EMERGENT, according to BMO.
Shares of MapLight fell more than 60% to $13.96 on Monday morning.
While noting that MapLight’s pill could be more impactful in older adults with schizophrenia alongside Alzheimer’s disease, due to lower rates of symptoms such as dry mouth, blurry vision and constipation, BMO said the effect will likely not be enough to derail Cobenfy’s leadership from a market share perspective.
Still, industry watchers haven’t written off MapLight’s potential. Stifel wrote in a Monday note that the biotech still has “an argument for differentiation” with improved tolerability over Cobenfy. But the PANSS score “was smaller than seen across Cobenfy trials,” the analysts said.
BMS, which will report second-quarter earnings Thursday, has sought to reach patients with Alzheimer’s disease psychosis, citing Cobenfy’s safety profile compared to other antipsychotic medications. But the drug has met with less-than-stellar commercial results, bringing in just $51 million in the fourth quarter of 2025, 3% below expectations.
Still, prescriptions for Cobenfy have remained steady with sizable insurance coverage and the pole position in the competitive landscape, BMS leaders pointed out at the time.
Some investors have flagged gastrointestinal side effects and the twice-a day dosing as challenges to Cobenfy uptake, leaving room for a rival to steal market share, Jefferies said in a Monday note.
For MapLight, consensus is that the path to market remains open, and the company plans to discuss a late-stage trial with U.S. regulators based on the Phase 2 results. Notably, MapLight recorded improvement in cognitive performance independent of improvement in psychotic symptoms, which could give the candidate an edge in later regulatory discussions.
“We are very encouraged by these results, which show that ML-007C-MA delivered clinically meaningful antipsychotic efficacy alongside a favorable tolerability profile designed to translate into real-world use,” MapLight CEO Chris Kroeger said in the Monday release. “Cognitive impairment affects the majority of people living with schizophrenia and remains an area where no therapy has yet been approved.”
