LB Pharmaceuticals names James Rawls regulatory affairs head

LB Pharmaceuticals Inc (NASDAQ: LBRX) appointed James Rawls, Pharm.D., as Senior Vice President of Regulatory Affairs, the company announced Monday.

Rawls brings more than 25 years of regulatory leadership experience and has led or contributed to over a dozen successful regulatory filings and product approvals in the United States, Europe, and Japan, with specific experience in neuropsychiatric diseases.

The appointment comes as LB Pharmaceuticals prepares to advance its lead drug candidate LB-102 into Phase 3 clinical trials for schizophrenia and Phase 2 trials for bipolar depression in 2026. The company aims to make LB-102 the first benzamide antipsychotic drug approved for neuropsychiatric disorders in the United States.

"Dr. Rawls has a remarkable depth of regulatory expertise that will be instrumental as we advance LB-102," said Heather Turner, Chief Executive Officer of LB Pharmaceuticals.

Rawls joins from Boston Biodevelopment, LLC, where he served as Executive Vice President and Chief Regulatory Officer. He previously held senior regulatory leadership roles at Sumitomo Pharma America, where he built and oversaw a regulatory team of more than 60 employees. During his 15-year tenure at Sunovion, he led Global Regulatory Affairs and supported numerous global product approvals. He also spent over a decade in regulatory roles at Novartis.

LB-102 is an oral small molecule drug that showed positive results in a Phase 2 trial for acute schizophrenia earlier in 2025. The trial demonstrated statistically significant benefit versus placebo at all doses studied, according to the company.

LB Pharmaceuticals is a clinical-stage biopharmaceutical company developing therapies for schizophrenia, bipolar depression, and other neuropsychiatric diseases.

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