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Regulatory

LQDA

Liquidia shares are trading lower after the FDA granted tentative approval for YUTREPIA inhalation powder to treat pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease.

Portfolio Pulse from Benzinga Newsdesk

August 19, 2024 | 11:55 am

MIRA

MIRA Pharmaceuticals Inc. (NASDAQ:MIRA) is nearing the submission of its Investigational New Drug (IND) application for Ketamir-2 by the end of the year. The company has strengthened its leadership with the appointment of Dr. Itzchak Angel as Chief Scientific Advisor. Significant progress has been made with Ketamir-2, a novel oral ketamine analog, which has shown a superior safety profile and efficacy in preclinical studies. Additionally, MIRA-55, a novel oral pharmaceutical marijuana analog, has demonstrated promising results and is not classified as a controlled substance by the DEA.

Portfolio Pulse from Benzinga Newsdesk

August 19, 2024 | 11:35 am

GLUE

Monte Rosa Therapeutics has initiated dosing in a Phase 1 study of MRT-6160, targeting VAV1 for systemic and neurological autoimmune diseases. Initial data is expected in Q1 2025.

Portfolio Pulse from Benzinga Newsdesk

August 19, 2024 | 11:11 am

AIOT

Powerfleet, Inc. (NASDAQ:AIOT) has received clearance from the SEC regarding its recent merger with MiX Telematics Ltd. This allows Powerfleet to file its Transition Report on Form 10-KT and its Quarterly Report on Form 10-Q. The company will report its first fiscal quarter results on August 22, 2024.

Portfolio Pulse from Benzinga Newsdesk

August 19, 2024 | 11:09 am

INVE

Identiv, Inc. (NASDAQ:INVE) has received approval from the Committee on Foreign Investment in the United States (CFIUS) to sell its Physical Security Business to Vitaprotech for $145 million. The transaction is expected to close within 30 days, significantly strengthening Identiv's financial position and allowing it to focus on its IoT solutions business.

Portfolio Pulse from Benzinga Newsdesk

August 19, 2024 | 11:07 am

SUPN

Supernus Pharmaceuticals has resubmitted its new drug application for an apomorphine infusion device for Parkinson's disease to the FDA, with a decision expected by February 2025.

Portfolio Pulse from Benzinga Newsdesk

August 19, 2024 | 11:03 am

BMY

The European Medicines Agency (EMA) has validated Bristol Myers Squibb's application to expand the use of Breyanzi for treating relapsed follicular lymphoma. This validation allows the scientific review to begin.

Portfolio Pulse from Benzinga Newsdesk

August 19, 2024 | 11:01 am

LQDA

Liquidia announced that the FDA has granted tentative approval for YUTREPIA (Treprostinil) Inhalation Powder to treat adults with Pulmonary Arterial Hypertension (PAH) and Pulmonary Hypertension associated with Interstitial Lung Disease (PH-ILD). The drug has met all regulatory standards but must wait for the expiration of regulatory exclusivity of a competing product before final approval.

Portfolio Pulse from Benzinga Newsdesk

August 19, 2024 | 10:01 am

AOGO

Arogo Capital is facing a potential delisting from Nasdaq due to its low market value.

Portfolio Pulse from Benzinga Newsdesk

August 19, 2024 | 7:26 am

VIOT

Viomi Technology has restored compliance with Nasdaq's minimum bid price standard, ensuring its continued listing on the exchange.

Portfolio Pulse from Benzinga Newsdesk

August 19, 2024 | 7:13 am