Streetbeat News

Regulatory

KZIA

Kazia Therapeutics Limited (KZIA) released an abstract for the PNOC022 clinical study, which will be presented at the Society of Neuro-Oncology 2023 Annual Meeting. The study shows promising results for paxalisib in treating Diffuse Midline Glioma (DMG), with a median overall survival of 16.5 months compared to the standard of care's 8-11 months. Paxalisib has received Rare Pediatric Disease Designation from the FDA, potentially leading to a priority review voucher.

Portfolio Pulse from Benzinga Newsdesk

November 15, 2023 | 1:35 pm

CHTR

Charter Communications Inc. (NASDAQ:CHTR) has agreed to a $25M settlement with the SEC for violations related to stock buyback accounting controls. From 2017 to 2021, Charter used 'accordion' provisions in their buyback plans, allowing changes in buyback amounts and timing, which did not comply with SEC Rule 10b5-1. The SEC found Charter's actions resulted from inadequate internal accounting controls, violating Section 13(b)(2)(B) of the Exchange Act. Charter has accepted the cease-and-desist order and fine without admitting or denying the findings. The company's shares dropped 2.03% in premarket trading.

Portfolio Pulse from Akanksha Bakshi

November 15, 2023 | 1:32 pm

YTEN

The USDA-APHIS has approved Yield10 Bioscience's glufosinate tolerant Camelina for planting and breeding in the U.S. This regulatory milestone allows Yield10 to advance its product development and commercialization efforts for this genetically modified crop, which is designed to be resistant to certain herbicides, potentially offering farmers a new option for managing weeds and improving yields.

Portfolio Pulse from Benzinga Newsdesk

November 15, 2023 | 1:32 pm

DDD

3D Systems (NYSE:DDD) has received FDA 510(k) clearance for its NextDent Base material for 3D printing denture bases. This third-generation material offers high break resistance, accurate printing, and repeatable results. It is part of 3D Systems' portfolio of 30 unique NextDent resins, the largest from any dental 3D printing material supplier. The material has received positive feedback from dental professionals and is expected to contribute to the growing 3D-printed denture market, which is anticipated to reach over $2 billion by 2028. NextDent Base is available in four colors and is part of 3D Systems' digital dental workflow, which aims to improve speed, productivity, efficiency, and patient experience.

Portfolio Pulse from Benzinga Newsdesk

November 15, 2023 | 1:31 pm

CMMB

Chemomab Therapeutics Ltd (NASDAQ:CMMB) stock surged after the FDA granted Fast Track designation to CM-101 for primary sclerosing cholangitis (PSC). Fast Track can lead to more frequent FDA interactions, priority review, and accelerated approval. CM-101 is a monoclonal antibody targeting CCL24, associated with PSC. The Phase 2 SPRING trial is ongoing, with top-line results expected in the second half of 2024. CMMB shares jumped 54.10% in premarket trading.

Portfolio Pulse from Vandana Singh

November 15, 2023 | 1:29 pm

ASND

Ascendis Pharma A/S has resubmitted its NDA for TransCon PTH to the FDA for treating hypoparathyroidism. The resubmission follows a Type A meeting with the FDA and is based on positive clinical trial results and a new manufacturing control strategy. TransCon PTH has shown significant health improvements in trials and has received a positive CHMP opinion in the EU, with an EC decision expected soon.

Portfolio Pulse from Benzinga Newsdesk

November 15, 2023 | 1:11 pm

CHR

Cheer Holding has officially launched its CHEERS Telepathy APP after receiving regulatory approval. The app's release could potentially impact the company's future performance and investor sentiment.

Portfolio Pulse from Benzinga Newsdesk

November 15, 2023 | 1:09 pm

AMD

INTC

NVDA

Nvidia Corp (NASDAQ:NVDA) stock rose after announcing an upgrade to its H200 GPU, which is expected to enhance AI system development capabilities. The optimism around the Federal Reserve's interest rate hikes potentially peaking also contributed to the stock's increase. Nvidia's stock has gained over 240% in 2023, outperforming on the Nasdaq 100 and S&P 500 indexes. Analysts from Wolfe Research and Bloomberg Intelligence anticipate Nvidia's updated GPUs will maintain its market dominance. Nvidia's peers, AMD and Intel, are also launching competing chips. Nvidia is navigating U.S. sanctions by preparing new chip models for China and has formed a partnership with NTHU to foster AI innovation. NVDA shares were up 0.55% in premarket trading on Wednesday.

Portfolio Pulse from Anusuya Lahiri

November 15, 2023 | 1:02 pm

ASND

Ascendis Pharma has resubmitted its New Drug Application (NDA) for TransCon PTH to the U.S. FDA. TransCon PTH is a treatment for hypoparathyroidism, a condition where the body produces insufficient levels of parathyroid hormone. The resubmission follows previous feedback from the FDA, and the company is seeking approval to bring this treatment option to patients. No specific details about the feedback or the content of the resubmission were provided in the article.

Portfolio Pulse from Benzinga Newsdesk

November 15, 2023 | 1:01 pm

BABA

JD

Alibaba Group Holding Limited (NYSE:BABA) stock is up in sympathy with JD.Com, Inc (NYSE:JD) despite JD's mixed Q3 results, with revenue missing but earnings beating estimates. The China Securities Regulatory Commission (CSRC) is scrutinizing Alibaba's logistics arm, Cainiao Network Technology, for details on its business dependency on Alibaba and plans for spin-off listings of Alibaba's other businesses. Cainiao, which has been approved for a Hong Kong IPO, is being questioned about its shareholder structure, compliance with regulations, and its relationship with Alibaba.

Portfolio Pulse from Anusuya Lahiri

November 15, 2023 | 12:57 pm