LEXINGTON, KY / ACCESS Newswire / April 6, 2026 / NX Development Corp (NXDC) is pleased to announce that after successfully completing the data analysis of our MEN-301 Study of the use of Gleolan (aminolevulinic acid HCl) to enhance visualization of newly diagnosed or recurrent meningioma, we have submitted these data to the FDA for review as part of an efficacy supplement to our Gleolan New Drug Application (NDA).
"This marks the first submission of supplemental data to the FDA since our original approval for high-grade glioma in 2017, and the culmination of a great amount of hard work by our dedicated NXDC team in advancing the science of fluorescence-guided surgery," said Salvatore DeSena, MD, CEO of NX Development Corp. "Without doubt we are pleased with these results, and we look forward to the FDA review process."
"This submission to the FDA is another important milestone not only for NXDC but also for our whole group," added Dr. Ulrich Kosciessa, Chairman of the Board of NXDC and CEO of photonamic GmbH & Co. KG. "We are dedicating our full attention to provide solutions for unmet medical needs using 5-Aminolevulinic Acid (5-ALA) in the field of fluorescence-guided surgery for patients and healthcare professionals globally."
About NX Development Corp. (NXDC)
NXDC is a privately held life science company dedicated to the commercialization of Gleolan in the U.S. The company was acquired in 2018 by photonamic (PHN) GmbH & Co. KG. (Pinneberg, Germany). PHN is wholly owned by SBI ALApharma GmbH (Germany), a subsidiary of SBI Holdings, Inc. (Tokyo, Japan).
About Gleolan (aminolevulinic acid HCl)
Gleolan is an FDA-approved optical imaging agent indicated in patients with glioma [suspected World Health Organization (WHO) Grades III or IV on preoperative imaging] as an adjunct for the visualization of malignant tissue during surgery. Gleolan helps neurosurgeons see malignant tissue in real time during surgery and is provided orally (20mg/kg), 2-4 hours prior to glioma surgery. During the operation, the surgeon utilizes a surgical microscope with a specific blue light filter for the visualization of red-violet fluorescence.
Please see Full Prescribing Information.
Contact: Phone: 833-471-3282 | Email: mediamarketing@nxdevcorp.com
SOURCE: NX Development Corp
View the original press release on ACCESS Newswire:
https://www.accessnewswire.com/newsroom/en/healthcare-and-pharmaceutical/nx-development-corp-submits-supplemental-new-drug-application-to-fda-1155161
