Articles from Neurotech Pharmaceuticals, Inc.

Neurotech Pharmaceuticals, Inc. (the “Company”) today provided an update on its ongoing transition to a commercial‑stage company following the first anniversary of the FDA’s approval of ENCELTO™ (taroretcel-lwey), the Company’s encapsulated cell‑based gene therapy for adults with idiopathic Macular Telangiectasia Type 2 (MacTel). ENCELTO continues to be integrated into retina practices nationwide, supported by expanding access and established commercial manufacturing capabilities.

Neurotech Pharmaceuticals, Inc., a private biotech company focused on developing transformative therapies for chronic eye diseases, today announced that the Centers for Medicare & Medicaid Services (CMS) has assigned a permanent J-Code (J3403) to ENCELTO™, effective October 1, 2025. ENCELTO is approved in the U.S. to treat adults with idiopathic Macular Telangiectasia Type 2 (MacTel), a retinal disease that causes progressive vision loss.

Neurotech Pharmaceuticals, Inc., a private biotech company focused on developing transformative therapies for chronic eye diseases, today announced that Peter J. McDonnell, M.D., has been appointed to the Company’s Board of Directors.

Neurotech Pharmaceuticals, Inc., a private biotech company focused on developing transformative therapies for chronic eye diseases, announced the first commercial manufacturing, shipment, and surgical procedure for ENCELTOTM (revakinagene taroretcel-lwey), an encapsulated cell-based gene therapy and the first and only FDA-approved treatment for adults with idiopathic Macular Telangiectasia Type 2 (MacTel).

Neurotech Pharmaceuticals, Inc., a private biotech company focused on developing transformative therapies for chronic eye diseases, announced the appointment of Beth Marsh as Chief Commercial Officer, effective April 28, 2025. In this role, Beth will lead the commercial organization, including preparing for the U.S. launch of ENCELTOTM (revakinagene taroretcel-lwey), the first and only approved treatment for adults with idiopathic Macular Telangiectasia Type 2 (MacTel).

Neurotech Pharmaceuticals, Inc., a private biotech company focused on developing transformative therapies for chronic eye diseases, announced that the U.S. Food and Drug Administration (FDA), has approved ENCELTO™ (revakinagene taroretcel-lwey) for the treatment of Macular Telangiectasia type 2 (MacTel).

Neurotech Pharmaceuticals, Inc., an innovator in sustained drug delivery for chronic retinal diseases, today announced that the U.S. Food and Drug Administration (FDA), has extended the Prescription Drug User Fee Act (PDUFA) goal date by three months to allow time required for the FDA to review additional data provided by the Company in response to recent requests from the FDA. The new PDUFA goal date for the biologics license application (BLA) of NT-501 (revakinagene taroretcel) as a treatment for Macular telangiectasia type 2 (MacTel) is March 18, 2025.

Neurotech Pharmaceuticals, Inc., an innovator in sustained drug delivery for chronic retinal diseases, announces that the U.S. Food and Drug Administration (FDA), has determined that the Biologic License Application (BLA) for NT-501, an investigational encapsulated cell therapy for the treatment of MacTel, is sufficiently complete to permit a substantive review. The application has a prescription drug user fee act (PDUFA) goal date of December 17, 2024.

Neurotech Pharmaceuticals, Inc., a private clinical stage biotech company, announced today that Alex Gorsky has been elected to Neurotech’s board as Lead Director. Gorsky is the former Chairman and CEO of Johnson & Johnson.

Neurotech Pharmaceuticals, Inc., a clinical stage biotech company, today announced the expansion of its executive team with the appointment of Scott Hunter as Chief Commercial Officer bringing two decades of eyecare experience across both rare disease and specialty markets.

Neurotech Pharmaceuticals, Inc., a clinical stage biotech company, today announced positive topline results in two replicative Phase 3 clinical trials with their investigational encapsulated cell therapy (ECT) for the treatment of Macular telangiectasia type 2 (MacTel), an orphan, slowly progressive degenerative disease of the macula that results in gradual deterioration of central vision. The multicenter, randomized, sham-controlled studies were designed to evaluate the safety and efficacy of the investigational NT-501 implant. The studies demonstrated statistical significance for the pre-specified primary endpoint, rate of change in ellipsoid zone (EZ) area loss from baseline through 24 months. The rate of change in area loss translates to and demonstrates a change in the rate of photoreceptor loss.

Neurotech Pharmaceuticals, a biotechnology company developing transformational, sight-saving therapeutics for the treatment of chronic eye diseases, announced today that Thomas Aaberg, Jr., M.D. has been appointed to the position of Chief Medical Officer (CMO). Dr. Aaberg’s responsibilities will include the execution of clinical studies, patient safety, and the management of Medical Affairs; supporting the required regulatory submissions; and supporting the Company’s development and commercial objectives. Dr. Aaberg replaces Dr. John Pollack who recently stepped down as Neurotech’s CMO.