ORTX - Orchard raises additional $34M initiates BLA for drug OTL-200

2023-06-26 14:29:18 ET

Orchard Therapeutics ( NASDAQ: ORTX ) said that it has closed on a second $34M financing as part of a larger agreement that could garner the company up to $188M if certain regulatory milestones are met.

The second financing included the issuance of 4.25M American Depositary Shares plus warrants at $8 per unit. The company closed on an initial $34M financing in March that was led by RA Capital. The two financings extend the company's cash runway into mid-2025, Orchard said.

Orchard added that it could receive capital of up to $188M through the larger financing agreement, inclusive of the $68M it has already raised, if it achieves certain US regulatory milestones for its drug candidate OTL-200 for metachromatic leukodystrophy, or MLD. A condition of the second closing was evidence of the company's intention initiate a biologics license application, or BLA, with the FDA for the product.

The biotech company said it expects the BLA to be completed mid-year, with possible FDA approval during the first half of 2024.

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