Liquidia submits NDA amendment to add PH-ILD indication for YUTREPIA; no new clinical data

Liquidia Corp

Submitted amendment to add PH-ILD indication to tentatively approved NDA for YUTREPIA; no new clinical data needed.
Final approval of PH-ILD indication possible after Tyvaso exclusivity expires March 31, 2024.
Recertified paragraph IV that YUTREPIA does not infringe Tyvaso patents; all prior patent challenges won.
Preparing for potential YUTREPIA launch between end of 2023 and mid-2024.
Third Amendment to HCR financing: $10M second tranche received; future tranches require mutual agreement.

Key facts

Extracted from this filing and checked against the source text.

Material Agreements SEC 8-K Item 1.01/1.02 confidence 0.9

Liquidia Corp amended Third Amendment to the Financing Agreement with HealthCare Royalty Partners IV, L.P. and HealthCare Royalty Management, LLC (collectively, “HCR”) valued at $10 million second tranche (effective 2023-07-27).

Action: amendment
Agreement: credit facility
Counterparty: HealthCare Royalty Partners IV, L.P. and HealthCare Royalty Management, LLC (collectively, “HCR”)
Value: $10 million second tranche
Effective: 2023-07-27

Exact text from the filing

On July 27, 2023, Liquidia Technologies and HCR entered into a Third Amendment to the Financing Agreement (the “Third Amendment”), pursuant to which, among other things, (i) HCR agreed to make payment of the $10 million second tranche under the Financing Agreement on July 27, 2023

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Source: SEC EDGAR

accession 0001104659-23-084468

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