Simulations Plus Inc

Simulations Plus announced that the U.S. Food and Drug Administration's Cosmetics Regulatory Science Branch has licensed its ADMET Predictor software platform to support computational research for modern cosmetic safety assessment. The contract expands the use of Simulations Plus technology within the FDA and underscores the growing role of predictive modeling and mechanistic science in regulatory research. ADMET Predictor combines artificial intelligence and machine learning with high-throughput pharmacokinetic modeling and predictive ADMET and toxicity assessments, giving FDA researchers a unified computational framework to evaluate both potential exposure and intrinsic hazard. The development supports the FDA's ongoing research into New Approach Methodologies. The announcement builds on Simulations Plus' 2024 research collaboration with the International Collaboration on Cosmetics Safety to evaluate physiologically based kinetic modeling approaches for animal-free safety assessment of cosmetics and other non-pharmaceutical ingredients. Chief Executive Officer Shawn O'Connor said the FDA's adoption expands the company's relationship with one of the world's leading regulatory organizations and highlights the versatility of its technology beyond pharmaceutical research.

Simulation Plus returned to profitability in the third quarter of 2026, reporting net income of $3.58 million compared with a loss of $67.32 million a year earlier, as the prior-year period included impairment charges of $77.22 million. Total revenues rose 7% to $21.89 million from $20.36 million. Adjusted net income declined to $6.10 million from $9.03 million, and adjusted earnings per share fell to $0.30 from $0.45. The company, which is being acquired by affiliates of Altaris for $375 million, expects the deal to close in the fourth quarter of calendar 2026.

Simulations Plus is building the agentic layer of its Composer platform using the NVIDIA BioNeMo Agent Toolkit. The initiative expands a collaboration announced in May 2026, combining AI reasoning, scientific literature, validated computational engines, and scalable compute. Initial focus areas include grounding scientific reasoning in trusted evidence by extracting and structuring information from literature with NVIDIA Nemotron Parse, and accelerating quantitative systems pharmacology at scale through nvQSP, a CUDA-optimized ODE solver initiative. These capabilities are being incorporated into Composer to coordinate scientific workflows while maintaining provenance and validated science.

Altaris has agreed to acquire Simulations Plus in an all-cash transaction valued at approximately $375 million. Simulations Plus shareholders will receive $18.50 per share, a 26% premium to the 60-day volume-weighted average price as of 15 June 2026. The company's board unanimously approved the deal, which is expected to close in the fourth quarter of 2026, subject to shareholder and regulatory approvals. Altaris plans to combine Simulations Plus with its portfolio company Chemical Computing Group to build a more comprehensive biosimulation platform for drug discovery and development. Following the acquisition, Simulations Plus will become a privately held subsidiary of Altaris, its shares will be delisted from the Nasdaq, and its main office will remain in Research Triangle Park, North Carolina.

CervoMed shares soared more than 80% on Tuesday with key clinical trial catalysts ahead, leading a group of biotech gainers. The company's lead drug candidate Neflamapimod is in development for dementia with Lewy bodies, with a Phase 3 trial planned for the second half of 2026, and has been selected for the EXPERTS-ALS platform in the UK, with first patient dosing anticipated in the fourth quarter of 2026. Simulations Plus agreed to be acquired by affiliates of Altaris for $375 million, or $18.50 per share, a 26% premium to its 60-day volume-weighted average price. NeOnc Technologies received its first international regulatory clearance from the Department of Health - Abu Dhabi to begin a Phase 2 trial of NEO212 for aggressive brain tumors. Lunai Bioworks regained compliance with Nasdaq's minimum bid price requirement, securing its listing. Other notable movers included Conexeu Sciences, which expanded its board and appointed a chief commercial officer, and Certara, which integrated its D360 platform with Secondary Intelligence software to improve off-target safety risk evaluation.