Trial Profile
Phase 1/2 study of RP L102 in the patients with Fanconi's-anaemia
Status:
Recruiting
Phase of Trial:
Phase I/II
Latest Information Update: 03 Apr 2024
Price :
$35
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At a glance
- Drugs Mozafancogene autotemcel (Primary)
- Indications Fanconi's anaemia
- Focus Therapeutic Use
- Acronyms FANCOLEN-I
- 02 Apr 2024 According to a Rocket Pharmaceuticals media release, the European Medicines Agency (EMA) accepted the Marketing Authorization Application (MAA) for RP-L102 for Fanconi Anemia (FA).MAA acceptance was based on positive, previously disclosed data from the global RP-L102 Phase 1/2 clinical trial.
- 06 Nov 2023 According to a Rocket Pharmaceuticals media release, Product filings for RP-L102 anticipated in the first half of 2024 in the U.S. and Europe. The company is finalizing the CMC package with the FDA.
- 09 Jan 2023 According to a Rocket Pharmaceuticals media release, BLA filling for FA is on track for Q4 2023.