Streetbeat News

Regulatory

FEMY

Femasys has received CE Mark approval from the EU MDR for its FemaSeed, FemVue, FemCerv, and FemCath products. This approval allows Femasys to market these products in the European Union, potentially expanding its market reach and revenue.

Portfolio Pulse from Benzinga Newsdesk

June 20, 2024 | 12:34 pm

MBOT

Microbot Medical has announced an agreement with Brigham and Women's Hospital to conduct a pivotal human clinical trial for its LIBERTY Endovascular Robotic Surgical System. The trial is part of an IDE application, and following FDA approval, site initiation has begun with multiple robotic systems already received to support the trial.

Portfolio Pulse from Benzinga Newsdesk

June 20, 2024 | 12:26 pm

SOLUSD

Martin Shkreli claims that Barron Trump launched the TrumpCoin (DJT) token with Donald Trump's approval. The token is based on Solana (SOL) and is valued at $158 million. Shkreli stated he only provided advice and did not directly deploy the token. The news has sparked mixed reactions, especially given the political implications.

Portfolio Pulse from Murtuza Merchant

June 20, 2024 | 12:21 pm

LOCL

Local Bounti has announced that the New York Stock Exchange (NYSE) has accepted its plan to regain compliance with listing standards. This development is crucial for the company to maintain its listing on the NYSE.

Portfolio Pulse from Benzinga Newsdesk

June 20, 2024 | 12:13 pm

CNTG

Centogene and the Critical Path Institute (C-Path) have signed a Memorandum of Understanding (MOU) to collaborate on research and drug development for lysosomal diseases. This partnership aims to leverage Centogene's expertise in rare disease diagnostics and C-Path's experience in regulatory science to accelerate the development of new treatments.

Portfolio Pulse from Benzinga Newsdesk

June 20, 2024 | 12:12 pm

ANRO

Alto Neuroscience has initiated a Phase 2 study of ALTO-101, a treatment for cognitive impairment associated with schizophrenia.

Portfolio Pulse from Benzinga Newsdesk

June 20, 2024 | 12:06 pm

TNXP

Tonix Pharmaceuticals has received formal minutes from the FDA for a pre-NDA meeting regarding Tonmya for fibromyalgia management. The company has aligned with the FDA on key CMC topics and completed the second pre-NDA meeting. Tonix plans to submit the NDA in the second half of 2024.

Portfolio Pulse from Benzinga Newsdesk

June 20, 2024 | 12:03 pm

MCHP

Microchip Technology has announced that its JAN transistors are now qualified to Enhanced Low Dose Radiation Sensitivity (ELDRS) standards, meeting MIL-STD-750 and various MIL-PRF specifications for defense applications.

Portfolio Pulse from Benzinga Newsdesk

June 20, 2024 | 12:01 pm

ADIL

Adial Pharmaceuticals announced the publication of Phase 3 ONWARD study results in the European Journal of Internal Medicine, showing the efficacy of AD04 in reducing heavy drinking days among patients with specific genetic profiles. The study found minimal adverse events and high compliance, suggesting a promising treatment for alcohol use disorder.

Portfolio Pulse from Vandana Singh

June 20, 2024 | 12:00 pm

LLY

NVO

Eli Lilly & Co. (NYSE: LLY) has intensified its legal actions against counterfeit versions of its obesity drug, Zepbound, by filing lawsuits against various establishments for trademark violations, false advertising, and unfair competition. The company is addressing safety concerns related to counterfeit products and has made significant investments to meet the growing demand for its weight-loss and diabetes medications.

Portfolio Pulse from Benzinga Neuro

June 20, 2024 | 11:44 am