Streetbeat News

Regulatory

AQST

Aquestive Therapeutics, Inc. (NASDAQ:AQST) has received acceptance from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for Libervant™ (diazepam) Buccal Film for pediatric patients aged two to five. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of April 28, 2024.

Portfolio Pulse from Benzinga Newsdesk

September 11, 2023 | 12:08 pm

BIVI

BioVie has presented data highlighting the baseline characteristics of the study population in its Phase 3 trial of NE3107 in mild to moderate Alzheimer's disease.

Portfolio Pulse from Bill Haddad

September 11, 2023 | 12:07 pm

ENVB

Enveric Biosciences has filed a provisional patent application for AI-based computational methods for identifying and optimizing novel tryptamine derivatives. This move could potentially lead to the development of new therapeutic solutions.

Portfolio Pulse from Benzinga Newsdesk

September 11, 2023 | 12:06 pm

CATX

Perspective Therapeutics presented preclinical data from two independent studies at the World Molecular Imaging Congress. The studies show the potential of lead-based targeted alpha particle therapy using VMT-α-NET for neuroendocrine tumors. The administration of fractionated doses of [212Pb]VMT-α-NET shows 100% survival in a robust model of metastatic neuroblastoma.

Portfolio Pulse from Benzinga Newsdesk

September 11, 2023 | 12:05 pm

ARDX

Ardelyx has presented data on Ibsrela (Tenapanor) at the 2023 Gastroenterology & Hepatology Advanced Practice Providers Annual Conference. The FDA has approved Ibsrela for the treatment of Irritable Bowel Syndrome with constipation in adults.

Portfolio Pulse from Benzinga Newsdesk

September 11, 2023 | 12:02 pm

LFLY

Leafly Holdings Inc. (NASDAQ:LFLY) is undergoing a strategic shift from a cannabis news agency to a marketplace and education platform. The company's CCO, Carlos Pinto, highlighted their recent partnership with GetGreenlane and the importance of education-focused content for consumers. Pinto also discussed the potential reclassification of cannabis from Schedule I to Schedule III by the Department of Health and Human Services (HHS), expressing cautious optimism about the regulatory shift and its implications for the industry.

Portfolio Pulse from Nicolás Jose Rodriguez

September 11, 2023 | 11:59 am

PRTK

Paratek Pharmaceuticals has received six demands under Section 220 of the Delaware General Corporation Law for certain books and records of the company. Without admitting any liability or wrongdoing, the company is making supplemental disclosures to its proxy statement.

Portfolio Pulse from Bill Haddad

September 11, 2023 | 11:57 am

COIN

Coinbase Global, Inc (NASDAQ:COIN) has been facing regulatory challenges in India, leading to the suspension of new user sign-ups and trading services. The company's CEO, Brian Armstrong, attempted to launch the exchange in India by adding support for the local UPI payment instrument, but the overseeing body refused to acknowledge Coinbase's launch. The company is also involved in a lawsuit with the U.S. SEC for allegedly operating an unregistered exchange.

Portfolio Pulse from Anusuya Lahiri

September 11, 2023 | 11:30 am

FXE

GLD

SPY

USO

US markets ended higher on Friday, September 8, driven by energy stocks following the decision by Saudi Arabia and Russia to extend supply cuts. However, key indexes saw weekly declines due to investor concerns over interest rates and upcoming US inflation data. Asian markets were mixed, with Japan's Nikkei 225 and Hong Kong's Hang Seng falling, while Australia's S&P/ASX 200 and China's Shanghai Composite rose. The European STOXX 600 index, Germany's DAX index, France's CAC 40, and the U.K.'s FTSE 100 all traded higher. The European Commission downgraded the Eurozone's economic growth outlook due to high inflation and Germany's recession. Commodities saw crude oil and natural gas fall, while gold, silver, and copper rose. US futures and the U.S. Dollar Index were down.

Portfolio Pulse from Akanksha Bakshi

September 11, 2023 | 11:13 am

IVVD

Invivyd has announced the dosing of the first participant in its CANOPY Phase 3 trial of Vyd222, a monoclonal antibody for the prevention of symptomatic Covid-19. The trial is expected to enroll approximately 750 patients.

Portfolio Pulse from Benzinga Newsdesk

September 11, 2023 | 11:12 am