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Regulatory

ALLO

Allogene Therapeutics has initiated a Phase 2 trial (ALPHA3) to investigate Cemacabtagene Ansegedleucel (Cema-cel) as part of the first-line treatment for patients with large B-cell lymphoma (LBCL) likely to relapse. The trial aims to improve cure rates and incorporates Foresight Diagnostics's CLARITY™ test to identify patients with minimal residual disease (MRD). The trial is expected to complete enrollment in the first half of 2026, with a BLA submission anticipated in 2027.

Portfolio Pulse from Benzinga Newsdesk

June 20, 2024 | 12:38 pm

NXL

Nexalin Technology shares are trading higher after being awarded a patent by the USPTO for its deep intracranial frequency stimulation device aimed at treating Alzheimer's and dementia.

Portfolio Pulse from Benzinga Newsdesk

June 20, 2024 | 12:37 pm

FEMY

Femasys shares are trading higher after receiving CE Mark approval from the EU MDR for its FemaSeed, FemVue, FemCerv, and FemCath products.

Portfolio Pulse from Benzinga Newsdesk

June 20, 2024 | 12:37 pm

NXL

Nexalin Technology has been awarded a patent by the USPTO for its Deep Intracranial Frequency Stimulation device, which is used for the treatment of Alzheimer's and dementia.

Portfolio Pulse from Benzinga Newsdesk

June 20, 2024 | 12:36 pm

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