United Therapeutics' Challenges FDA Over Liquidia's Drug Approval Process, Clocks Strong Q4 Earnings [Yahoo! Finance]
Liquidia Corporation (LQDA)
Last liquidia corporation earnings: 3/11 07:00 am
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Source: Yahoo! Finance
Corporation (NASDAQ: LQDA ) to deviate from established rules in the drug approval process The litigation focuses on the FDA's handling of Liquidia's amendment to a pending new drug application (NDA) related to its proposed inhaled dry powder treprostinil product, seeking to add a second indication for pulmonary hypertension associated with interstitial lung disease (PH-ILD). Also Read: This United Therapeutics Analyst Is No Longer Bearish, Expects Mid-Decade $4B Revenue Run Rate United Therapeutics contends that FDA rules require a new NDA for such a second indication rather than an amendment to an existing one. The company also asserts that, under the Hatch-Waxman Act, Liquidia's decision to file an amendment instead of a new NDA allowed it to avoid a potential 30-month stay on approval for PH-ILD. This stay would be triggered if a timely patent infringement action is filed, preventing FDA approval until the litigation is resolved. United Therapeutics had previously sued
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News
- Earnings Preview: Liquidia Technologies, Inc. (LQDA) Q1 Earnings Expected to Decline [Yahoo! Finance]Yahoo! Finance
- When Will Liquidia Corporation (NASDAQ:LQDA) Become Profitable? [Yahoo! Finance]Yahoo! Finance
- Liquidia Co. (NASDAQ: LQDA) had its "buy" rating re-affirmed by analysts at Needham & Company LLC. They now have a $28.00 price target on the stock.MarketBeat
- Liquidia Corporation (NASDAQ:LQDA) has caught the attention of institutional investors who hold a sizeable 38% stake [Yahoo! Finance]Yahoo! Finance
- Liquidia Corporation to Present at 23rd Annual Needham Virtual Healthcare Conference [Yahoo! Finance]Yahoo! Finance
LQDA
Earnings
- 11/7/23 - Miss
LQDA
Sec Filings
- 4/29/24 - Form ARS
- 4/29/24 - Form DEFA14A
- 4/29/24 - Form DEF
- LQDA's page on the SEC website