Streetbeat News

Regulatory

CMND

Clearmind Medicine has received approval from the Israeli Ministry of Health to begin a Phase I/IIa clinical trial for treating Alcohol Use Disorder. This marks a significant step forward in the development of their treatment.

Portfolio Pulse from Benzinga Newsdesk

March 13, 2024 | 12:15 pm

IMNN

IMUNON, Inc. (NASDAQ:IMNN) has filed an IND application with the FDA for IMNN-101, a DNA-based vaccine for COVID-19, with Phase 1 human trials expected to start in Q2 2024. The vaccine utilizes IMUNON's proprietary PlaCCine platform and aims to demonstrate superior durability and immune response compared to mRNA vaccines. Preclinical data shows promising results, and the company aims to attract partners for further development.

Portfolio Pulse from Happy Mohamed

March 13, 2024 | 12:07 pm

PDSB

PDS Biotechnology Corporation (NASDAQ:PDSB) announced the publication of preclinical research and the grant of a U.S. patent for its Infectimune® platform, demonstrating significant advancements in influenza vaccine development. The research showed Infectimune®'s ability to improve the quantity and quality of CD4 T cells, positioning it as a leading candidate for next-generation vaccines. The USPTO granted Patent Number 11,904,015 for vaccine compositions using Infectimune®, enhancing PDS Biotech's intellectual property portfolio.

Portfolio Pulse from Happy Mohamed

March 13, 2024 | 12:04 pm

NRBO

NeuroBo Pharmaceuticals has received approval from the Safety Review Committee to proceed with its Phase 2a clinical trial for DA-1241, a treatment for MASH.

Portfolio Pulse from Benzinga Newsdesk

March 13, 2024 | 12:04 pm

CPRX

Catalyst Pharmaceuticals announced the U.S. commercial launch of AGAMREE for Duchenne Muscular Dystrophy (DMD) treatment in patients aged two and older. AGAMREE, approved by the FDA on October 26, 2023, is now available by prescription. It offers a novel alternative to current steroid treatments, potentially reducing side effects and improving quality of life for DMD patients. Catalyst's Pathways Program supports patient access and education. AGAMREE has shown comparable efficacy to standard corticosteroids with a better side effect profile in clinical trials.

Portfolio Pulse from Benzinga Newsdesk

March 13, 2024 | 12:01 pm

GOOGL

Google has implemented restrictions on its AI chatbot, Gemini, to limit responses to election-related queries, aiming to prevent misinformation. This move is part of Google's election integrity strategy, especially relevant as India approaches its elections. The restrictions are already in effect in India, where Gemini directs users to Google Search for questions about elections in the U.S., U.K., and South Africa, but still answers queries on Indian politics. This decision aligns with global concerns over AI's role in spreading election misinformation and follows regulatory actions in India requiring tech companies to seek approval before deploying certain AI tools.

Portfolio Pulse from Benzinga Neuro

March 13, 2024 | 12:01 pm

AAPL

GOOG

SPOT

Spotify Technology SA (NYSE:SPOT) is rolling out a beta version of music videos for premium users in 11 markets, featuring artists like Ed Sheeran and Doja Cat. This move, aimed at enhancing user engagement, follows similar offerings by Alphabet Inc.'s (NASDAQ:GOOG) YouTube Music. Spotify's initiative comes amid a subscription fee increase in France due to a new tax and a recent antitrust win against Apple Inc. (NASDAQ:AAPL). Spotify's shares saw a slight decrease of 0.18% to close at $257.62.

Portfolio Pulse from Rounak Jain

March 13, 2024 | 11:52 am

PRTC

PureTech Health announced that the FDA has granted Orphan Drug Designation to LYT-200 for the treatment of Acute Myeloid Leukemia. This designation could potentially accelerate LYT-200's development and approval process, offering a new treatment option for patients with this condition.

Portfolio Pulse from Benzinga Newsdesk

March 13, 2024 | 11:24 am

BCDA

BioCardia has entered into a long-term partnership with StemCardia to advance the latter's investigational pluripotent stem cell product candidate for treating heart failure. BioCardia will be the exclusive biotherapeutic delivery partner throughout the FDA approval process for an investigational new drug application (IND) and the expected Phase I/II clinical trials.

Portfolio Pulse from Benzinga Newsdesk

March 13, 2024 | 11:14 am

PCRX

Pacira Biosciences announced that the FDA has granted Regenerative Medicine Advanced Therapy (RMAT) designation to its gene therapy product, PCRX-201 (Enekinragene Inzadenovec), for the treatment of knee osteoarthritis. This designation could expedite the development and review process for PCRX-201, potentially bringing it to market faster.

Portfolio Pulse from Benzinga Newsdesk

March 13, 2024 | 11:12 am