Neurizon Updates Market on ALS Regulatory and Clinical Progress
Neurizon® Therapeutics Limited (ASX: NUZ) has provided an update on the regulatory and development status of its lead investigational asset, NUZ-001, for the treatment of Amyotrophic Lateral Sclerosis (ALS). The Company confirmed receipt of correspondence from the US Food and Drug Administration advising that Fast Track Designation has not been granted at this stage. While acknowledging ALS as a serious condition with significant unmet need, the FDA indicated that additional clinical data would be required to demonstrate NUZ-001’s differentiation from existing approved therapies.
Neurizon views this feedback as constructive and intends to assess the outlined requirements as clinical development progresses. Separately, NUZ-001 has advanced into the next operational phases of the HEALEY ALS Platform Trial, with regulatory submissions, site activations and trial start-up activities underway. The Company expects initial patient enrolment early in the year, supported by recently secured funding that provides visibility through completion of the pivotal Phase 2/3 program.
Customer Notice:
Nextgen Global Services Pty Ltd trading as Kapitales Research (ABN 89 652 632 561) is a Corporate Authorised Representative (CAR No. 1293674) of Enva Australia Pty Ltd (AFSL 424494). The information contained in this website is general information only. Any advice is general advice only. No consideration has been given or will be given to the individual investment objectives, financial situation or needs of any particular person. The decision to invest or trade and the method selected is a personal decision and involves an inherent level of risk, and you must undertake your own investigations and obtain your own advice regarding the suitability of this product for your circumstances. Please be aware that all trading activity is subject to both profit & loss and may not be suitable for you. The past performance of this product is not and should not be taken as an indication of future performance.
Kapitales Research, Level 13, Suite 1A, 465 Victoria Ave, Chatswood, NSW 2067, Australia | 1800 005 780 | info@kapitales.com.au
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Neurizon Updates Market on ALS Regulatory and Clinical Progress
Neurizon® Therapeutics Limited (ASX: NUZ) has provided an update on the regulatory and development status of its lead investigational asset, NUZ-001, for the treatment of Amyotrophic Lateral Sclerosis (ALS). The Company confirmed receipt of correspondence from the US Food and Drug Administration advising that Fast Track Designation has not been granted at this stage. While acknowledging ALS as a serious condition with significant unmet need, the FDA indicated that additional clinical data would be required to demonstrate NUZ-001’s differentiation from existing approved therapies.
Neurizon views this feedback as constructive and intends to assess the outlined requirements as clinical development progresses. Separately, NUZ-001 has advanced into the next operational phases of the HEALEY ALS Platform Trial, with regulatory submissions, site activations and trial start-up activities underway. The Company expects initial patient enrolment early in the year, supported by recently secured funding that provides visibility through completion of the pivotal Phase 2/3 program.
Customer Notice:
Nextgen Global Services Pty Ltd trading as Kapitales Research (ABN 89 652 632 561) is a Corporate Authorised Representative (CAR No. 1293674) of Enva Australia Pty Ltd (AFSL 424494). The information contained in this website is general information only. Any advice is general advice only. No consideration has been given or will be given to the individual investment objectives, financial situation or needs of any particular person. The decision to invest or trade and the method selected is a personal decision and involves an inherent level of risk, and you must undertake your own investigations and obtain your own advice regarding the suitability of this product for your circumstances. Please be aware that all trading activity is subject to both profit & loss and may not be suitable for you. The past performance of this product is not and should not be taken as an indication of future performance.
Kapitales Research, Level 13, Suite 1A, 465 Victoria Ave, Chatswood, NSW 2067, Australia | 1800 005 780 | info@kapitales.com.au