Liquidia Corporation Stock Price, News & Analysis

Liquidia Corporation (NASDAQ: LQDA) announced on June 2, 2021, that the FDA accepted its New Drug Application (NDA) resubmission for LIQ861, an inhalation powder for treating pulmonary arterial hypertension (PAH). The resubmission is a complete, class 2 response to a prior FDA action letter from November 24, 2020. The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of November 7, 2021, for potential approval. However, final approval may be subject to ongoing legal issues with United Therapeutics and a regulatory stay that ends in October 2022.

Liquidia Corporation (NASDAQ: LQDA) announced that CEO Damian deGoa will present at the Jefferies Virtual Healthcare Conference on June 2, 2021, from 2:30 to 2:55 p.m. EDT. The session aims to provide an overview and update on the company's business strategies and developments. Investors and interested parties can access the live webcast through the Liquidia website, and an archived version will be available for 90 days post-event. Liquidia is focused on developing treatments for pulmonary hypertension using its proprietary PRINT® Technology.

Liquidia Corporation announced the availability of Sandoz Treprostinil Injection, a generic version of Remodulin®, for both subcutaneous and intravenous administration to treat pulmonary arterial hypertension (PAH). This is the first fully-substitutable generic option, providing lower-cost treatment alternatives. The RG 3ml Medication Cartridge has been cleared by the FDA, allowing for the SC administration of the medication, previously restricted. Liquidia aims to maintain high support levels while offering competitive pricing for patients.

Liquidia Corporation (NASDAQ: LQDA) announced a significant market expansion for Treprostinil Injection due to the introduction of subcutaneous delivery, nearly doubling its addressable market. The company also resubmitted its NDA for LIQ861 (treprostinil) Inhalation Powder to the FDA, aiming for a six-month review. Financially, they improved their position with a private placement raising $21.7 million and new credit facilities. First-quarter revenue stood at $3.1 million compared to none last year, and a net loss of $9.2 million was reported.

Liquidia Corporation (NASDAQ: LQDA) has resubmitted its New Drug Application (NDA) for LIQ861, targeting pulmonary arterial hypertension (PAH). The FDA issued a Complete Response Letter (CRL) in November 2020, citing incompleteness. Following a Type A meeting in January, the new NDA now includes additional chemistry and manufacturing details, but no new clinical data was required. The FDA plans to classify this resubmission as a Class 2, which entails a six-month review cycle. Liquidia is ready for required on-site inspections delayed by COVID-19.

Liquidia Corporation (NASDAQ: LQDA) will announce its first quarter 2021 financial results on May 13, 2021. The company will conduct a conference call at 8:30 a.m. EDT to discuss these results and provide a corporate update. Interested parties can join the call by dialing 1-877-707-8711 domestically or 1-857-270-6219 internationally, using conference code: 2007727. The event will also be available via webcast on Liquidia's website, with an archive for later viewing.

Liquidia Corporation (NASDAQ: LQDA) announced a private placement agreement with accredited investors to sell 8,626,037 shares of common stock at $2.52 per share, raising approximately $21.7 million. The closing is set for today, with David Johnson from Caligan Partners LP joining the board. This funding aims to enhance commercial capabilities for LIQ861 and Treprostinil Injection, supporting growth initiatives. The company has agreed to file a registration statement to register the resale of shares within 180 days post-closing.

Liquidia Corporation (NASDAQ: LQDA) announced that CEO Damian deGoa will present a business overview at the 20th Annual Needham Virtual Healthcare Conference on April 14, 2021, from 1:30 to 2:10 p.m. EST. This event can be accessed via a live webcast on Liquidia's website, with a recorded version available for 90 days post-event. Liquidia focuses on pulmonary hypertension treatments and utilizes its PRINT® Technology for developing innovative products like LIQ861 and LIQ865.

Liquidia Corporation (LQDA) announced that the addressable market for generic Treprostinil Injection has more than doubled following FDA clearance of the RG 3ml Medication Cartridge for use with the CADD-MS® 3 pump. This breakthrough allows Treprostinil to be administered subcutaneously, expanding patient access for pulmonary arterial hypertension (PAH) treatment. The cartridge enables the first subcutaneous administration of the generic drug, previously limited to intravenous use.