ORTX - Orchard Therapeutics stock jumps 13% as FDA accepts BLA for OTL-200
2023-09-18 15:13:48 ET
Orchard Therapeutics ( NASDAQ: ORTX ) stock jumped 13% in afternoon trading Monday after the company said that its Biologics License Application for its drug OTL-200 had been accepted by the FDA under its priority review program, with a decision expected by March 18.
Orchard is seeking to have OTL-200 approved for the treatment of early onset metachromatic leukodystrophy, a rare and often fatal genetic disease. In addition to priority review, the product has also received Rare Pediatric Disease and Regenerative Medicine Advanced Therapy designations from the FDA.
OTL-200 has already been approved by regulators in the EU and UK, where it is marketed under the brand name Libmeldy.
More on Orchard Therapeutics
- Seeking Alpha’s Quant Rating on Orchard Therapeutics
- Historical earnings data for Orchard Therapeutics
- Financial information for Orchard Therapeutics
- Orchard Therapeutics: A Reassessment
- Orchard Therapeutics plc ( ORTX ) Q2 2023 Earnings Call Transcript
- Orchard Therapeutics: Highly Valued Once, Undervalued Today
- Orchard Therapeutics GAAP EPS of -$0.07 beats by $0.55, revenue of $7.3M beats by $0.81M
- Orchard raises additional $34M, initiates BLA for drug OTL-200
For further details see:
Orchard Therapeutics stock jumps 13% as FDA accepts BLA for OTL-200