Durham, NC – July 16, 2025 – MAA Laboratories is pleased to announce that it has received formal written scientific advice from the Federal Institute for Drugs and Medical Devices (BfArM) in Germany for its Dasatinib Nanoparticle Tablets.

The advice supports MAA’s ongoing development efforts and provides regulatory clarity for advancing the program in the European Union. Importantly, the feedback from BfArM is consistent with guidance previously received from the U.S. Food and Drug Administration (FDA), further validating the Company’s development strategy and the scientific strength of its NanoCont™ platform.

“We are grateful for BfArM’s constructive guidance,” said Dr. Anjani Jha, CEO of MAA Laboratories. “The alignment between U.S. and EU regulators provides strong validation for our regulatory and clinical approach and reinforces our confidence in the potential of our nanoparticle-based therapies.”

MAA Laboratories remains committed to delivering differentiated therapies that improve patient outcomes through enhanced drug delivery, tolerability, and systemic performance. The Company looks forward to initiating clinical studies and advancing its broader pipeline across global markets.

For press and other inquiries, please contact:
Email: info@maalaboratories.com
Phone: +1 (919)271.7868

Durham, NC – July 2, 2025 — MAA Laboratories Inc., a specialty pharmaceutical company focused on developing clinically differentiated, value‑added drug products, today announced that the U.S. Food and Drug Administration (FDA) has granted Investigational New Drug (IND) clearance for its Methotrexate Nanoparticle Tablets. This novel oral formulation was developed using MAA’s proprietary NanoCont™ technology platform, which was accepted into the FDA’s Emerging Technology Program in August 2024.

This regulatory milestone paves the way for MAA Laboratories to initiate its Phase I clinical study in healthy volunteers under the 505(b)(2) regulatory pathway.

“We are thrilled to receive IND clearance from the FDA for our lead asset,” said Anjani Jha, Founder and CEO of MAA Laboratories. “This milestone validates not only the scientific integrity of our Methotrexate Nanoparticle Tablets but also the broader potential of our NanoCont™ platform. We believe this formulation could significantly improve methotrexate’s safety and tolerability profile—a longstanding unmet need for patients with autoimmune diseases and certain cancers.”

Key Highlights

• IND clearance granted for Methotrexate Nanoparticle Tablets
• 505(b)(2) regulatory pathway confirmed for BA/BE studies in healthy volunteers
• Developed using NanoCont™, an FDA‑recognized Emerging Technology
• Designed to improve safety, tolerability, and systemic exposure
• Potential for label differentiation post‑approval

About Methotrexate Nanoparticle Tablets

This next‑generation formulation is designed to reduce dose‑dependent toxicity and gastrointestinal side effects commonly associated with conventional methotrexate while maintaining therapeutic efficacy. By enhancing absorption and minimizing variability, the nanoformulation aims to improve patient adherence across both autoimmune and oncology indications.

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Email: info@maalaboratories.com
Phone: +(1) 919.271.7868

August 15, 2024 – Durham, NC

MAA Laboratories is pleased to announce its acceptance into the FDA’s Emerging Technologies Program (ETP) for its cutting-edge NanoCont™ platform. Participation in the program opens a new avenue for communication with FDA experts, significantly benefiting the application of our proprietary drug delivery technology. The NanoCont™ platform, known for its nanoparticle approach and advanced manufacturing techniques, aligns with Quality by Design and Continuous Manufacturing principles. ETP membership facilitates early feedback, streamlined reviews, and regulatory clarity, enhancing our development strategy and market appeal. This is another indication of the value of NanoCont™ as an innovation in pharmaceutical technology.

For press and other inquiries, please contact:

Email: info@maalaboratories.com
Phone: 919.271.7868

May 21, 2018 – Raleigh, NC

The MAA Laboratories team will attend the BIO 2018 convention on June 4-7 in Boston. For inquiries related to product licensing and development partnerships, or to arrange a meeting with MAA Laboratories, please contact our business development team at BD@maalaboratories.com.

For press and other inquiries, please contact:
Email: info@maalaboratories.com
Phone: +(1) 919.271.7868

January 2, 2018 – Raleigh, NC

The MAA Laboratories team will attend the 36^th annual JP Morgan Healthcare Conference on January 8 – 11 in San Francisco, California. For inquiries related to product licensing and development partnerships, or to arrange a meeting with MAA Laboratories, please contact our business development team at BD@maalaboratories.com.

For press and other inquiries, please contact:
Email: info@maalaboratories.com
Phone: +1 (919)271.7868