Court filing in United/FDA case may portend decision on Yutrepia, says Needham

Needham notes that a new filing by the FDA in United Therapeutics’ (UTHR) ongoing lawsuit against FDA is drawing attention from investors in Liquidia Technologies (LQDA) and United Therapeutics. While acknowledging that the contents are unclear, the firm says that the sealed filing would be consistent with a three-day advance notice that the judge presiding over case implemented in late-March. If this is indeed the start of a three-day process, Needham would expect a decision by Thursday/Friday this week. The firm notes that the Yutrepia NDA received tentative FDA approval in November 2021 and there has been no additional data or issue to review since then. Needham thus believe there is a high likelihood for full FDA approval of Yutrepia. The decision by the judge on the other hand could go either way, but he and other judges have previously denied United’s motion for preliminary injunctions seeking to block approval and/or launch of Yutrepia, the firm adds. Needham has a Buy rating on Liquida with a price target of $25 on the shares.