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Regulatory

NVTA

The U.S. Food and Drug Administration (FDA) has granted de novo marketing authorization for the Invitae Common Hereditary Cancers Panel, a DNA test that can detect genetic variants associated with an elevated risk of developing certain cancers. This is the first test of its kind to be granted FDA marketing authorization. The test evaluates DNA from a blood sample to identify variants in 47 genes known to be associated with an elevated risk of developing certain types of cancer.

Portfolio Pulse from Benzinga Newsdesk

October 02, 2023 | 1:43 pm

MG

MISTRAS Group, Inc. (MG: NYSE) has announced the implementation of the first Project Phoenix initiative, a reorganization of the Company's Products & Systems segment expected to increase Adjusted EBITDA by $4.0 Million in Fiscal 2024. The company also announced the appointment of Gennaro (Jerry) D'Alterio as Executive Vice President and Chief Commercial Officer. These initiatives are part of the company's strategy to accelerate the transition into faster growing markets and improve the performance of its traditional energy-related market operations.

Portfolio Pulse from Benzinga Newsdesk

October 02, 2023 | 1:16 pm

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New York State Senator Liz Krueger claims that large corporations are causing challenges for the state's cannabis program. She suggests that these corporations are trying to dominate the industry and are behind many lawsuits slowing the market roll-out. Among the public companies operating in New York's medical marijuana sector are The Cannabist Company Holdings Inc (CCHWF), Curaleaf Holdings (CURLF), MedMen Enterprises (MMNFF), and Acreage Holdings (ACRHF). Other companies involved in lawsuits include Green Thumb Industries (GTBIF) and Leafly Holdings (LFLY).

Portfolio Pulse from Nina Zdinjak

October 02, 2023 | 1:15 pm

NVTA

The FDA has approved Invitae's DNA test for assessing certain cancers, leading to a rise in the company's stock.

Portfolio Pulse from Benzinga Newsdesk

October 02, 2023 | 1:12 pm

NKTR

Nektar Therapeutics (NASDAQ:NKTR) announced that it will present two abstracts on rezpegaldesleukin, a first-in-class selective regulatory T-cell therapy, at the 2023 European Academy of Dermatology and Venereology Congress. The presentations will cover Phase 1b safety and efficacy data for rezpegaldesleukin in moderate to severe atopic dermatitis and the design of a Phase 2b study. The company plans to advance the program into a robust Phase 2b study later this month.

Portfolio Pulse from Benzinga Newsdesk

October 02, 2023 | 1:04 pm

NTRA

Natera, Inc. (NASDAQ:NTRA) has submitted the first module of its premarket approval (PMA) application to the U.S. Food and Drug Administration (FDA) for Signatera, a personalized and tumor-informed molecular residual disease (MRD) test. The submission is part of a series of applications for multiple cancer types, starting with a companion diagnostic (CDx) assay for patients with muscle-invasive bladder cancer (MIBC). The remaining modules, including software, analytical and clinical validation data, are expected to be submitted through 2025.

Portfolio Pulse from Benzinga Newsdesk

October 02, 2023 | 1:01 pm

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ETHUSD

Invesco and Galaxy Digital have filed for a spot Ethereum ETF named Invesco Galaxy Ethereum ETF. This move involves Galaxy Digital Funds which will manage the sale of Ethereum. The ETF will directly hold ether. Futures-based Ether ETFs are expected to open trade soon. Other companies such as VanEck, Valkyrie, Bitwise, and Hashdex are also preparing to launch their Ether ETFs.

Portfolio Pulse from Khyathi Dalal

October 02, 2023 | 1:00 pm

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IceCure's ProSense Cryoablation has been validated as a safe and effective outpatient procedure for breast cancer with a 96.8% success rate, boosting ICCM shares by 119%. Coinbase (COIN) shares rose by 5.75% after the company secured a payment institution license from the Monetary Authority of Singapore. Viatris (VTRS) shares increased by 4% following the company's announcement of an offer to sell its OTC business and an agreement to sell its Women's Healthcare and API businesses in India.

Portfolio Pulse from ryanfaloona@benzinga.com

October 02, 2023 | 12:48 pm

SGHC

Super Group (SGHC) has announced its exit from the Indian market due to changes in the Indian Goods and Services Tax, which have made the market no longer commercially viable for the company. Despite this, SGHC reaffirms its full year financial projections for 2023.

Portfolio Pulse from Benzinga Newsdesk

October 02, 2023 | 12:41 pm

MBRX

Moleculin Biotech has begun dosing subjects in the Phase 2 portion of its clinical trial evaluating Annamycin in combination with Cytarabine for the treatment of Acute Myeloid Leukemia (AML). The Phase 1B portion of the study demonstrated a preliminary CR/CRi rate of 33%. Annamycin has received Fast Track Status and Orphan Drug Designation from the FDA for the treatment of AML.

Portfolio Pulse from Benzinga Newsdesk

October 02, 2023 | 12:41 pm