MapLight dims preclinical programs to make phase 3-ready schizophrenia drug shine brighter

Now accepting nominations for the Fierce Innovation Awards - Submit your application today Biotech MapLight dims preclinical programs to make phase 3-ready schizophrenia drug shine brighter By James Waldron Aug 14, 2026 4:38am MapLight Therapeutics schizophrenia autism spectrum disorders Parkinson's disease Despite mixed results for its experimental schizophrenia treatment last month, MapLight Therapeutics is going all-in on the asset—at the expense of its preclinical programs. In July, MapLight saw a twice-daily dose of its M1/M4 muscarinic agonist, dubbed ML-007C-MA, tied to significant reductions in disease severity in the phase 2 Zephyr trial of patients with acute episodes of worsened psychosis. While that result hit the study’s primary endpoint, a once-daily dose of the drug didn’t manage to score a similar win.

In its second-quarter earnings results on Aug. 13, MapLight reaffirmed its plans to arrange a meeting with the FDA to align on a path toward an approval application for ML-007C-MA in schizophrenia. The near-term aim is to launch a phase 3 study that would read out topline results in 2028.

Meanwhile, the Bay Area biotech is already enrolling patients in a phase 2 Vista study of ML-007C-MA in patients with Alzheimer’s disease psychosis (ADP), which has an estimated topline readout timeline of the second half of next year. To help fund these plans, MapLight announced a $150 million private placement earlier this month. Along with the $351.3 million that the biotech had in the bank at the end of June, the company expects to be able to finance its ML-007C-MA plans through the end of 2028.

“With positive phase 2 data from Zephyr and continued progress in Vista, we are focusing our efforts on advancing ML-007C-MA in both schizophrenia and ADP,” MapLight CEO Chris Kroeger said in the earnings release. “Together with our recent private placement and continued focus on capital discipline, we believe we are well positioned to execute on both programs through these key milestones,” Kroeger added. One way MapLight is hoping to free up cash is by easing up on its less-advanced pipeline.

In the release, the biotech disclosed that its new operating plan will involve the company “pausing further investment in preclinical and discovery-stage programs and foregoing advancement of those programs into clinical development.” The company had previously set out plans to take a next-generation M1/M4 muscarinic agonist called ML-055 into the clinic this year for the treatment of various neuropsychiatric conditions. As recently as March, MapLight was touting in vitro and in vivo studies as having demonstrated ML-055’s “significantly greater potency relative to ML-007 and the potential for once-daily dosing and a long-acting injectable formulation.” The rest of MapLight’s preclinical pipeline had consisted of a GPR52-positive allosteric modulator for hyperactivity, as well as an M4 antagonist for Parkinson’s disease. MapLight debuted on the Nasdaq in October 2025 with a $250 million IPO to raise funds for the Zephyr trial, all with the goal of taking on Bristol Myers Squibb’s Cobenfy, which became the first new schizophrenia medicine in decades when it was approved in 2024.

The comany's focus on ML-007C-MA has also been made easier by the failure of ML-004—an extended-release form of the approved migraine drug Zomig—in a phase 2 study of patients with autism spectrum disorder in June. MapLight said at the time that it would meet with the FDA to decide on a path forward for ML-004. But in the wake of that meeting, the biotech said yesterday that it was considering “potential strategic collaborations and/or funding alternatives” for the asset.

MapLight Therapeutics schizophrenia autism spectrum disorders Parkinson's disease Alzheimer's disease Biotech