Streetbeat News

Regulatory

MOTS

Motus GI Holdings, Inc. (NASDAQ:MOTS) has received approval from the Israeli Ministry of Health to initiate commercial sales of the Pure-Vu EVS System in Israel. The Pure-Vu EVS System, which is already cleared by the U.S. FDA, integrates with standard and slim colonoscopes to improve visualization during colonoscopy. The system is designed to provide better-quality exams, especially for high acuity patients.

Portfolio Pulse from Happy Mohamed

August 10, 2023 | 1:10 pm

GOVX

GeoVax has announced the vaccination of the first patients in a Phase 2 clinical trial of its COVID-19 vaccine booster in patients with Chronic Lymphocytic Leukemia. The company is seeking to improve immune response compared to mRNA vaccines. Full patient enrollment is expected within six months.

Portfolio Pulse from Benzinga Newsdesk

August 10, 2023 | 1:08 pm

VTGN

AffaMed Therapeutics and its partner Vistagen Therapeutics (NASDAQ:VTGN) have reported positive top-line results from the Phase 3 PALISADE-2 trial of fasedienol nasal spray for social anxiety disorder. The trial met its primary and secondary endpoints, demonstrating a significant reduction in patient-reported distress and a significant difference in the proportion of responders compared to placebo. The companies plan to commercialize the product in China, South Korea, and Southeast Asia.

Portfolio Pulse from Happy Mohamed

August 10, 2023 | 1:02 pm

VRPX

Virpax Pharmaceuticals has filed a provisional patent application for its Epoladerm product, an over-the-counter diclofenac topical spray film for pain associated with Osteoarthritis. The company has completed its IND enabling trials for Epoladerm and expects the patent to expand protection and increase the patent life for this formulation.

Portfolio Pulse from Happy Mohamed

August 10, 2023 | 12:59 pm

GRTX

Galera Therapeutics has received a Complete Response Letter from the FDA for avasopasem manganese, causing its shares to trade lower.

Portfolio Pulse from Benzinga Newsdesk

August 10, 2023 | 12:53 pm

ZIMV

ZimVie announced that it has received FDA approval for its new Mobi-C implant, leading to a rise in its share prices.

Portfolio Pulse from Benzinga Newsdesk

August 10, 2023 | 12:51 pm

INDP

Indaptus Therapeutics, Inc. (NASDAQ:INDP) has completed the first cohort of patients in its INDP-D101 trial of Decoy20 and initiated a new cohort. The first cohort showed a significant immune response and short-lived symptoms consistent with the mechanism of Decoy20. The company expects the next cohort will help determine the recommended phase 2 dose. The company plans for multi-dosing and combination studies in 2024.

Portfolio Pulse from Happy Mohamed

August 10, 2023 | 12:48 pm

SPY

UUP

The US Consumer Price Index (CPI) rose 3.2% in July 2023, below the expected 3.3%, easing concerns about Federal Reserve interest rate hikes. Core inflation fell from 4.8% to 4.7% YoY. The Labor Department reported an increase in initial jobless claims for the week ending Aug. 5, from 227,000 to 248,000. The dollar and Treasury yields declined, while S&P 500 and Nasdaq 100 futures rose. The Invesco DB USD Index Bullish Fund ETF (UUP) and the SPDR S&P 500 ETF Trust (SPY) were directly affected.

Portfolio Pulse from Piero Cingari

August 10, 2023 | 12:47 pm

CTXR

Citius Pharmaceuticals, Inc. (NASDAQ:CTXR) has announced reaching a significant milestone in its Phase 3 clinical trial for Mino-Lok, an antibiotic lock solution for patients with catheter-related bloodstream infections. The company believes all 92 events required to complete the trial have been achieved, pending confirmation from an independent review committee. The trial is being conducted in the U.S. and India, with several patients still in active treatment.

Portfolio Pulse from Benzinga Newsdesk

August 10, 2023 | 12:44 pm

BFRI

Biofrontera Inc. (NASDAQ:BFRI) has completed patient enrollment for its Phase 3 clinical study evaluating Ameluz-PDT in combination with the BF-RhodoLED lamp for the treatment of basal cell carcinoma (BCC). The study is a significant step in the company's strategy to expand the Ameluz label beyond actinic keratosis (AK). The results of the study are expected in mid-2024.

Portfolio Pulse from Happy Mohamed

August 10, 2023 | 12:41 pm