Scilex Announced It Had A Successful End Of Phase II Meeting With The FDA Leading To An Agreed Path Forward To NDA Upon Completion Of Phase III Trials For Blockbuster Product Candidate, SP-103 (lidocaine Topical System) 5.4% For The Treatment Of Chronic Neck Pain Associated With Muscle Spasms
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Scilex announced a successful end of Phase II meeting with the FDA for its product candidate SP-103, a lidocaine topical system for chronic neck pain. The FDA agreed on a path forward to NDA upon completion of Phase III trials.
October 30, 2024 | 10:20 am
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Scilex's SP-103, a lidocaine topical system for chronic neck pain, received positive feedback from the FDA after Phase II trials, paving the way for NDA submission post-Phase III.
The successful end of Phase II meeting with the FDA is a significant milestone for Scilex's SP-103, indicating regulatory progress and potential market entry. This positive development is likely to boost investor confidence and positively impact SCLX's stock price in the short term.
CONFIDENCE 95
IMPORTANCE 85
RELEVANCE 90