Streetbeat News

Regulatory

CVM

CEL-SCI Corporation (NYSE:CVM) issued a shareholder letter detailing progress on Multikine, a pre-surgical cancer therapy for head and neck cancer. The therapy showed significant survival benefits in a specific patient population, leading to regulatory filings for marketing clearance. CEL-SCI completed its manufacturing facility commissioning and is in discussions with major regulatory bodies including the FDA, EMA, MHRA, and Health Canada. The company plans to seek immediate patient access to Multikine through conditional approvals.

Portfolio Pulse from Benzinga Newsdesk

March 06, 2024 | 1:47 pm

DTIL

Precision BioSciences has announced that its partner, iECURE, received MHRA approval to expand the Phase 1/2 clinical trial of the ARCUS gene editing program for treating OTC deficiency. This development marks a significant step forward in the application of gene editing technologies in addressing genetic disorders.

Portfolio Pulse from Benzinga Newsdesk

March 06, 2024 | 1:45 pm

NVNO

EnVVENO Medical announced positive topline efficacy data from its VenoValve pivotal trial, to be presented at VENOUS2024. The data shows 97% of patients experienced clinical improvement, with 74% showing meaningful benefit. The average improvement was 8 points on the rVCSS, significantly above the threshold for clinical relevance. The company plans to seek FDA approval for VenoValve in Q4 2024.

Portfolio Pulse from Benzinga Newsdesk

March 06, 2024 | 1:42 pm

NEPT

Neptune Wellness Solutions Inc. (NASDAQ:NEPT) announced its common shares will be delisted from Nasdaq following a decision by the Nasdaq Hearings Panel. The decision came after Neptune failed to meet the minimum bid price and stockholders' equity requirements for continued listing. Despite an appeal, the Panel upheld the delisting determination. Trading of Neptune's common shares on Nasdaq will be suspended starting March 7, 2024. Neptune is seeking to have its shares quoted on the OTCQB Venture Market.

Portfolio Pulse from Benzinga Newsdesk

March 06, 2024 | 1:42 pm

SPY

Federal Reserve Chairman Jerome Powell indicated that the Fed is on track to cut interest rates this year, citing a notable easing in inflation. However, he emphasized the need for greater confidence in the inflation trajectory before proceeding with rate cuts. Powell also suggested that the current Fed rate is likely at its peak for this cycle, implying that rate cuts could be appropriate later in the year.

Portfolio Pulse from Benzinga Newsdesk

March 06, 2024 | 1:34 pm

CELZ

CRWD

MEDS

CrowdStrike Holdings (CRWD) shares surged 27% after reporting better-than-expected Q4 earnings and revenues, with positive guidance for Q1 and FY25, leading to raised price targets by analysts. Creative Medical Technology Holdings, Inc. (CELZ) saw an 85% increase after receiving FDA Orphan Drug Designation for CELZ-101. TRxADE Health, Inc. (MEDS) announced a special cash dividend of $8/share, resulting in a 67% stock price increase.

Portfolio Pulse from ryanfaloona@benzinga.com

March 06, 2024 | 1:33 pm

TNXP

Tonix Pharmaceuticals has partnered with EVERSANA to support the launch and commercial planning of Tonmya, a non-opioid analgesic for fibromyalgia management, in the U.S. Tonmya has shown significant results in Phase 3 trials and plans to submit a New Drug Application to the FDA in the second half of 2024. EVERSANA will help Tonix navigate the fibromyalgia market and develop a go-to-market strategy.

Portfolio Pulse from Benzinga Newsdesk

March 06, 2024 | 1:12 pm

GOOGL

Google (NASDAQ:GOOGL) has made significant changes to comply with the European Union's Digital Markets Act (DMA), which aims to increase competition among tech giants by imposing specific obligations. These changes include a new search page layout for European users, removal of Google Flights data from search results, and providing new browser and search choice screens for Android users in the European Economic Area. This comes after Google and Microsoft decided not to contest the new EU regulation and follows a series of regulatory challenges Google faced in the EU.

Portfolio Pulse from Benzinga Neuro

March 06, 2024 | 1:07 pm

ITRM

Iterum Therapeutics announced it expects to resubmit its New Drug Application (NDA) for oral Sulopenem to the FDA earlier than initially planned, aiming for the first half of Q2 2024. This update indicates progress in the company's efforts to bring its antibiotic treatment to market.

Portfolio Pulse from Benzinga Newsdesk

March 06, 2024 | 1:04 pm

FXI

STLA

Stellantis has received approval from Chinese regulators to form a joint venture with LeapMotor, according to Reuters citing sources. This move marks a significant step for Stellantis in expanding its presence in the Chinese market.

Portfolio Pulse from Charles Gross

March 06, 2024 | 12:58 pm