The approval of CAVHANZA™ follows PHYRAGO®, demonstrating a repeatable path from proprietary particle engineering to differentiated, FDA-approved medicines
NEW BRIGHTON, MN, August 11, 2026 – Flex Pharma, LLC (“Flex”) today announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for CAVHANZA™ (nilotinib) Orally Disintegrating Tablets, which was submitted through the 505(b)(2) regulatory pathway. CAVHANZATM is the second FDA-approved oncology product developed using Flex’s proprietary ElectroNanoSpray™ (ENS) technology platform, following the FDA approval of PHYRAGO® (dasatinib) Tablets1, which was also submitted as a 505(b)(2) NDA. CAVHANZA™ was developed by Flex and licensed to Cycle Pharmaceuticals for commercialization in the U.S.
The approvals of PHYRAGO® and CAVHANZA™ demonstrate the ability of the ENS platform to be applied across different molecules and dosage forms, as well as Flex’s ability to support the development of improved pharmaceutical products from proof-of-concept all the way through to FDA approval.
“Receiving FDA approval for a second product developed leveraging the ENS platform represents an important inflection point for Flex,” said Christian F. Wertz, PhD, President of Flex Pharma. “This achievement demonstrates more than just the technical potential of our particle-engineering technology—it also shows that the team behind it can repeatedly and successfully translate complex formulation science into clinically differentiated, FDA-approved products.”
Dr. Wertz continued,
“Flex has built a specialty pharmaceutical company around the combination of proprietary technology, formulation expertise, regulatory execution and intellectual property strategy. We believe this integrated capability positions Flex as a compelling partner for companies seeking to improve established molecules or address formulation challenges affecting new drug candidates.”
Flex’s proprietary ENS platform is a non-thermal, particle-engineering technology that uses controlled electric-field forces to generate fine, uniform, and amorphous drug particles. Unlike conventional spray-drying approaches, ENS operates under ambient temperature and pressure and does not require thermal drying inputs. The process is designed to provide consistent particle characteristics and performance from bench-top scale to commercial production.
Flex continues to evaluate internal pipeline programs, co-development opportunities and partnerships where ENS can be leveraged to create differentiated pharmaceutical products. The company is particularly interested in established molecules and new chemical entities affected by poor solubility, low bioavailability, significant food effects, gastric pH, drug-drug interactions, and dosage-form challenges. Pharmaceutical companies interested in assessing whether ENS may provide meaningful formulation, clinical or commercial differentiation for a product candidate are encouraged to contact Flex.
“The approvals of two products across separate 505(b)(2) applications confirm that our approach is robust and repeatable,” said Dr. Wertz. “We have demonstrated that ENS can be successfully applied across multiple drug targets while meeting the rigorous technical, clinical, manufacturing, and regulatory standards required for FDA approval.”
About Flex Pharma
Flex Pharma, LLC is a specialty pharmaceutical company and differentiated 505(b)(2) drug developer focused on transforming how complex oncology medicines are formulated and delivered. Flex develops next-generation oncology formulations that enhance drug performance using its proprietary ElectroNanoSpray™ (ENS) platform technology. For more information, please visit www.flexpharmausa.com and follow on LinkedIn.
Forward-Looking Statements
This news release contains forward-looking statements regarding Flex Pharma’s technology platform, product-development activities, pipeline opportunities, potential collaborations, strategic partnerships and the anticipated capabilities and potential benefits of the ElectroNanoSpray platform.
Forward-looking statements are based on current expectations and assumptions and are subject to risks, uncertainties and other factors that could cause actual results to differ materially from those expressed or implied. Flex Pharma undertakes no obligation to update any forward-looking statement except as required by applicable law.