LB Pharmaceuticals Appoints James Rawls, Pharm.D., as Senior Vice President of Regulatory Affairs

Rhea-AI Summary

LB Pharmaceuticals (Nasdaq: LBRX) appointed James Rawls, Pharm.D. as Senior Vice President of Regulatory Affairs on October 14, 2025.

Dr. Rawls brings 25+ years of regulatory leadership, with experience at Novartis, Sunovion, Sumitomo Pharma America, and Boston Biodevelopment, and has contributed to multiple global regulatory filings and product approvals. The company said his expertise will support advancing LB-102 into a Phase 3 schizophrenia trial and a Phase 2 bipolar depression trial planned for 2026.

Positive

• Appointed SVP Regulatory with 25+ years regulatory experience
• Plans to advance LB-102 into Phase 3 schizophrenia in 2026
• Plans to start Phase 2 bipolar depression for LB-102 in 2026

Negative

• LB-102 remains investigational and is not approved for use

NEW YORK, Oct. 14, 2025 (GLOBE NEWSWIRE) -- LB Pharmaceuticals Inc (“LB Pharmaceuticals” or the “Company”) (Nasdaq: LBRX) today announced the appointment of James Rawls, Pharm.D., as Senior Vice President of Regulatory Affairs. Throughout his career, Dr. Rawls has led or contributed to more than a dozen successful regulatory filings and product approvals in the United States, Europe, and Japan, with specific experience in neuropsychiatric diseases.

“Dr. Rawls has a remarkable depth of regulatory expertise that will be instrumental as we advance LB-102 into a Phase 3 clinical trial in schizophrenia and a Phase 2 clinical trial in bipolar depression in 2026,” said Heather Turner, Chief Executive Officer of LB Pharmaceuticals. “His experience leading successful FDA and global regulatory engagements, particularly in neuropsychiatry, will be invaluable as we continue to execute on our work to make LB-102 the first benzamide antipsychotic drug approved for neuropsychiatric disorders in the United States.”

Dr. Rawls has more than 25 years of regulatory leadership experience across global biopharmaceutical companies, with a strong track record of successful interactions with global health authorities, regulatory approvals, and team building. He joins LB Pharmaceuticals from Boston Biodevelopment, LLC, where he served as Executive Vice President and Chief Regulatory Officer, leading regulatory strategy and execution for multiple small and mid-sized biopharma clients. Prior to that, he held senior regulatory leadership roles at Sumitomo Pharma America, where he built and oversaw a regulatory team of more than 60 employees following the integration of seven subsidiaries, including Sunovion. During his 15-year tenure at Sunovion, Dr. Rawls led the Global Regulatory Affairs function and supported numerous global product approvals and lifecycle expansions across multiple therapeutic areas. He also spent over a decade in increasingly senior regulatory roles at Novartis. He is a Doctor of Pharmacy graduate from the University of Michigan and completed a postdoctoral fellowship in Regulatory Affairs and Clinical Research at Novartis and Rutgers University.

Dr. Rawls added, “The complexity of neuropsychiatric drug development demands thoughtful, evidence-driven regulatory strategy that is bold but pragmatic. I’m energized by LB Pharmaceuticals’ mission and look forward to working with the highly skilled and experienced team at LB Pharmaceuticals as we advance LB-102 in the clinic with the goal of delivering a new treatment option for patients with neuropsychiatric disorders.”

About LB-102

LB-102 is a Phase 3-ready oral, small molecule and a methylated derivative of amisulpride. In early 2025, LB Pharmaceuticals announced positive data from a four-week placebo-controlled, double-blinded, Phase 2 trial in patients with acute schizophrenia. The Phase 2 trial demonstrated statistically significant benefit versus placebo at all doses studied, a potentially class leading safety profile among D2 antagonists and partial agonists, and positive effects on negative symptoms and cognition. LB-102 is advancing into a Phase 3 clinical trial for acute schizophrenia and a Phase 2 clinical trial for bipolar depression. Additional expansion opportunities for LB-102 could include major depressive disorder (MDD), predominantly negative symptoms of schizophrenia, Alzheimer’s disease psychosis and agitation, as well as bipolar mania and cognitive impairment associated with schizophrenia.

About LB Pharmaceuticals

LB Pharmaceuticals is a clinical-stage biopharmaceutical company developing novel therapies for the treatment of schizophrenia, bipolar depression, and other neuropsychiatric diseases. The Company is building a pipeline that leverages the broad therapeutic potential of its lead product candidate, LB-102, which the Company believes has the potential to be the first benzamide antipsychotic drug approved for neuropsychiatric disorders in the United States. LB-102, if approved, has the potential to become a mainstay of psychiatric practice by offering a potentially attractive alternative to branded and generic therapeutics for the treatment of schizophrenia, bipolar depression, and other neuropsychiatric diseases.

Cautionary Note Regarding Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Words such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “design,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “positioned,” “potential,” “predict,” “seek,” “should,” “target,” “will,” “would” or similar expressions are intended to identify forward-looking statements. All statements other than statements of historical facts contained in this press release are forward-looking statements. These forward-looking statements include, but are not limited to, statements concerning the expected clinical development and regulatory pathway and therapeutic benefits of LB-102 and continuing advancement of LB-102 and the Company’s portfolio. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, among others: the Company’s limited operating history and historical losses; the Company’s ability to raise additional funding to complete the development and any commercialization of LB-102; the Company’s dependence on the success of its lead product candidate, LB-102; the Company’s ability to obtain regulatory approval of and successfully commercialize its product candidate; the early stages of clinical development of the Company’s lead product candidate, LB-102; any undesirable side effects or other properties of the Company’s product candidate; that the Company may be delayed in initiating, enrolling or completing any clinical trials; competition from third parties that are developing products for similar uses; the Company’s ability to obtain, maintain and protect its intellectual property; and the Company’s dependence on third parties in connection with manufacturing, clinical trials and preclinical studies.

These and other risks are described more fully in the Company’s filings with the Securities and Exchange Commission (the “SEC”) and its other documents to be subsequently filed with or furnished to the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except to the extent required by law, the Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Contacts

Media: 
Michael Tattory
LifeSci Communications
Mtattory@lifescicomms.com

Investor Relations: 
ir@lbpharma.us

FAQ

Who is James Rawls and what role did LB Pharmaceuticals (LBRX) announce on October 14, 2025?

LB Pharmaceuticals named James Rawls, Pharm.D. as Senior Vice President of Regulatory Affairs on October 14, 2025.

How will James Rawls' appointment affect LB Pharmaceuticals' LB-102 clinical plans (LBRX)?

Company says Dr. Rawls' regulatory experience will support advancing LB-102 into Phase 3 schizophrenia and Phase 2 bipolar depression in 2026.

What is James Rawls' regulatory experience cited by LB Pharmaceuticals (LBRX)?

The company notes 25+ years in regulatory leadership including roles at Novartis, Sunovion, Sumitomo Pharma America, and Boston Biodevelopment.

When are LB-102 clinical trials expected to start according to LB Pharmaceuticals (LBRX)?

LB Pharmaceuticals indicated plans to advance LB-102 into clinical trials in 2026 (Phase 3 for schizophrenia and Phase 2 for bipolar depression).

Does James Rawls have prior experience with regulatory approvals relevant to neuropsychiatry for LBRX?

The company states Dr. Rawls has led or contributed to multiple regulatory filings and approvals with specific experience in neuropsychiatric diseases.