Medincell Announces Progress in the Development of its Products Portfolio and R&D Pipeline
2024年9月4日 - 1:15AM
ビジネスワイヤ（英語）
In collaboration with AbbVie, initiation of preclinical and
supportive CMC* work to advance a first Long-Acting Injectable
candidate into clinical development
Collaboration with AbbVie
- Initiation of preclinical and supportive CMC* work to advance
LAI candidate into clinical development
Collaboration with Teva
- Reaffirming revenue guidance for 2024 by Teva: c.$80
million
- Exploring an additional indication for the treatment of Bipolar
I Disorder in adults
- No PDSS** observed after completion of c.95% of the targeted
injections for submission (July 31, 2024)
- Full phase 3 safety results on track for H2 2024
Other in-house and partnered assets
- mdc-CWM (post operative pain): ongoing review of completed
phase 3 study by Medincell partner Arthritis Innovation Corporation
(AIC) with plans to meet with FDA in Q4 2024 to discuss additional
studies required for approval
- mdc-WWM (contraception): CMC activities ongoing for initiation
of clinical phase 1 activities in 2025
- mdc-STM (malaria): CMC activities ongoing for initiation of
clinical phase 1 activities in 2025
- Over 10 in-house or partnered active programs currently at
formulation stage
ACCESS HERE FOR THE FULL PRESS RELEASE
*CMC (Chemistry, Manufacturing, and Controls) in the
pharmaceutical industry refers to the essential documentation and
processes related to the chemical composition, manufacturing
methods, and quality control measures of a drug, ensuring it meets
regulatory standards for safety, efficacy, and quality.
**PDSS = Post injection Delirium/Sedation Syndrome
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version on businesswire.com: https://www.businesswire.com/news/home/20240903430030/en/
David Heuzé - Head of Corporate and Financial Communications,
and ESG david.heuze@medincell.com / +33 (0)6 83 25 21 86
Grace Kim - Head of US Financial Strategy and IR
grace.kim@medincell.com / +1 (646) 991-4023
Investors Relations France Louis-Victor
Delouvrier/Alban Dufumier medincell@newcap.eu / +33 (0)1 44 71
94 94
Media Relations Nicolas Mérigeau
medincell@newcap.eu / +33 (0)1 44 71 94 94
Medincell (EU:MEDCL)
過去 株価チャート
から 9 2024 まで 10 2024
Medincell (EU:MEDCL)
過去 株価チャート
から 10 2023 まで 10 2024
