Simulations Plus (SLP) Highlights FDA Alignment as Citizens Maintains Market Perform

Simulations Plus, Inc. (NASDAQ:SLP) is one of the best healthcare AI stocks to buy now. On December 9, Simulations Plus, Inc. (NASDAQ:SLP) issued a press release highlighting how its technologies align with the FDA’s new regulatory direction. On December 2, the FDA released a draft guidance focused on streamlined nonclinical safety studies for monospecific monoclonal antibodies. This guidance, the FDA said, promotes a shift away from extensive animal testing by prioritizing mechanistic understanding, pharmacokinetics data, and integrated weight-of-evidence (WoE) assessments to support safety decisions in drug development.

In their response, Simulations Plus stated that its existing platforms already support the FDA’s emphasized approaches. The company also announced ongoing investments in biologics modeling, with planned updates to some of its platforms to further enhance capabilities for monoclonal antibodies, antibody-drug conjugates, and immune-related pathways.

Separately, on December 2, Citizens stuck with a Market Perform rating on Simulations Plus stock, arguing that the company is fairly valued right now. Even though the company has some clear strengths, the analysts stated, its expected growth remains modest. As such, the current stock price already reflects what investors can reasonably expect.

Specifically, Citizens highlighted modest growth expectations across fiscal years 2026 and 2027. This, noted the analysts, keeps the valuation in check and prevents the stock from being seen as undervalued. The firm maintained its existing fiscal year 2026 revenue and EBITDA estimates without changes, showing no major shift in outlook after reviewing recent developments.

Simulations Plus, Inc. (NASDAQ:SLP) develops advanced modeling and simulation software for drug discovery and development. The company’s platforms integrate AI and machine learning to accelerate pharmacokinetics, quantitative systems pharmacology, and clinical trial design.

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Disclosure: None. This article is originally published at Insider Monkey.