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Regulatory

ANIX

Anixa Biosciences has announced a Phase 2 study plan for its breast cancer vaccine. The trial will evaluate the vaccine's efficacy when administered in the neoadjuvant setting, in combination with Keytruda and chemotherapy.

Portfolio Pulse from Benzinga Newsdesk

September 24, 2024 | 12:32 pm

MDAI

Spectral AI has achieved 25% patient enrollment in its US Burn Pivotal Study and has added two new clinical trial sites. This progress is significant for the company's research and development efforts.

Portfolio Pulse from Benzinga Newsdesk

September 24, 2024 | 12:17 pm

ICCM

IceCure Medical Ltd. (NASDAQ: ICCM) announced the publication of its ICE3 trial results in the Annals of Surgical Oncology, showing a 96.3% recurrence-free rate for early-stage, low-risk breast cancer treated with ProSense cryoablation. The publication precedes an FDA Advisory Panel Meeting for marketing authorization of ProSense, scheduled for November 7, 2024.

Portfolio Pulse from Benzinga Newsdesk

September 24, 2024 | 12:17 pm

NVRO

Nevro has launched HFX AdaptivAI, the first AI-powered spinal cord stimulation technology, after receiving FDA approval. This technology aims to provide personalized pain relief.

Portfolio Pulse from Benzinga Newsdesk

September 24, 2024 | 12:16 pm

TRNR

Interactive Strength's shares rose after announcing that its product, CLMBR, met EU-wide compliance requirements, potentially expanding its market reach.

Portfolio Pulse from Benzinga Newsdesk

September 24, 2024 | 12:14 pm

ARQT

The FDA has accepted Arcutis Biotherapeutics' supplemental new drug application for ZORYVE foam, targeting scalp and body psoriasis in individuals aged 12 and over. The PDUFA target action date is set for May 22, 2025.

Portfolio Pulse from Benzinga Newsdesk

September 24, 2024 | 12:13 pm

AZTR

Azitra, Inc. (NYSE:AZTR) will present new findings on ATR-04, a treatment for EGFR inhibitor-induced skin toxicity, at the EADV Congress 2024. ATR-04 is a live biotherapeutic product in Phase 1/2 trials and has received Fast Track designation from the FDA.

Portfolio Pulse from Benzinga Newsdesk

September 24, 2024 | 12:03 pm

CAPR

Capricor Therapeutics plans to file a Biologics License Application (BLA) for deramiocel, targeting Duchenne muscular dystrophy cardiomyopathy. The BLA will be supported by existing cardiac data and a rolling submission is set to begin in October 2024.

Portfolio Pulse from Benzinga Newsdesk

September 24, 2024 | 12:02 pm

BABA

BIDU

JD

NIO

PDD

Shares of US-listed Chinese companies are trading higher following the announcement of a new stimulus package by China's Central Bank.

Portfolio Pulse from Benzinga Newsdesk

September 24, 2024 | 11:49 am

OCTO

Eightco Holdings Inc. has received a formal notice from Nasdaq confirming that the company has regained compliance with the minimum bid price requirement. This development is crucial for maintaining its listing on the Nasdaq exchange.

Portfolio Pulse from Benzinga Newsdesk

September 24, 2024 | 11:23 am