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ACLX

The FDA has lifted the partial clinical hold on Arcellx Inc's iMMagine-1 Phase 2 Clinical Program. The decision comes after modifications were made to the trial protocol to better manage the risk of adverse events. Arcellx has retrained clinical sites and expanded treatment options for therapies that patients can receive. Preliminary data from the study is expected in the second half of 2024. Arcellx's shares are down 0.09% at $33.66 premarket.

Portfolio Pulse from Vandana Singh

August 15, 2023 | 1:05 pm

DSGN

Design Therapeutics Inc (NASDAQ:DSGN) reported initial results from its Phase 1 clinical trial of DT-216 in patients with Friedrich ataxia (FA). The results showed that DT-216 was generally well-tolerated and achieved a significant increase in frataxin (FXN) mRNA levels. However, injection site reactions were observed, leading the company to plan a reformulation of the drug. A new Phase 1 study is planned for the second half of 2024. DSGN shares are down 45.7% in premarket trading.

Portfolio Pulse from Vandana Singh

August 15, 2023 | 1:05 pm

NVDA

PSTG

Chungbuk Technopark has built its AI environment around the NVIDIA DGX A100 system and selected Pure Storage FlashBlade for seamless integration with its DGX systems. This has resulted in increased data processing performance, improved GPU server's data read speed, expanded GPU usage, and enhanced performance, scalability, and data availability for the AI development environment. Pure Storage's FlashBlade also allows Chungbuk Technopark to increase performance and capacity without any downtime or data migrations.

Portfolio Pulse from Benzinga Newsdesk

August 15, 2023 | 1:03 pm

AVGO

Broadcom Inc. (NASDAQ:AVGO) has announced the availability of its new Gen 7 64G Fibre Channel Director, the Brocade X7 Directors, and the Brocade 7850 Extension Switch. These products are part of Broadcom's Brocade 64G Fibre Channel portfolio and are designed to enhance data center infrastructure security and resiliency. The Brocade X7 Directors offer high-density storage and reduce operational costs, while the Brocade 7850 Extension Switch extends security over distance to protect critical data being replicated across data centers.

Portfolio Pulse from Happy Mohamed

August 15, 2023 | 1:02 pm

GLTO

Galecto announced that its Phase 2b GALACTIC-1 trial of GB0139 for idiopathic pulmonary fibrosis did not meet its primary endpoint. As a result, the company plans to discontinue the development of GB0139. This news has led to a decrease in Galecto's share price.

Portfolio Pulse from Benzinga Newsdesk

August 15, 2023 | 1:02 pm

RNA

Avidity Biosciences has received FDA Orphan Drug Designation for AOC 1044, a treatment for Duchenne Muscular Dystrophy (DMD) in people with mutations amenable to exon 44 skipping. AOC 1044 is currently in Phase 1/2 EXPLORE44™ clinical trial. Results from the healthy volunteer portion of the trial are expected in Q4 2023. AOC 1044 received FDA Fast Track designation in April 2023.

Portfolio Pulse from Benzinga Newsdesk

August 15, 2023 | 1:01 pm

LVOX

LiveVox (NASDAQ:LVOX), a cloud CCaaS platform, has announced a partnership with Jenne, Inc., a leading cloud services broker and technology solutions distributor. The partnership will provide Jenne's resellers throughout North America with access to the LiveVox platform, enabling their clients to transition from on-premise contact center solutions to robust capabilities, including AI and automation. The partnership aims to accommodate the accelerating shift to the cloud in contact centers.

Portfolio Pulse from Happy Mohamed

August 15, 2023 | 1:01 pm

SNX

TD SYNNEX (NYSE:SNX) has launched Destination AI, a program aimed at helping partners gain a competitive edge through AI services and resources. The program is part of TD SYNNEX's strategy to stay ahead of rapidly growing marketplace demands. It includes enablement assets, reference architectures, AI solution demos, and support from technical AI and Edge Intelligence experts. The launch comes as 40% of organizations expect to increase their overall AI investment, according to a global survey by McKinsey & Company.

Portfolio Pulse from Happy Mohamed

August 15, 2023 | 1:01 pm

PHG

Koninklijke Philips N.V. (NYSE:PHG) is recalling several ventilators due to dust and dirt detected in the air path of some devices. The FDA has classified this as its most serious type of recall, as the use of these devices could cause serious injuries or death. Philips has started the recall process on March 29 and has recalled 73,000 devices in the U.S. The company has received 542 reports about this issue, with two reported injuries and one death attributable to the issue.

Portfolio Pulse from Vandana Singh

August 15, 2023 | 12:57 pm

PFE

The FDA has granted accelerated approval to Pfizer's Elrexfio, a therapy for adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy. The approval is based on Phase 2 trial results and is contingent upon verification of clinical benefit in confirmatory trials. Pfizer expects the therapy to generate more than $4 billion in potential peak revenue. Pfizer's shares are down 0.42% in premarket trading.

Portfolio Pulse from Vandana Singh

August 15, 2023 | 12:56 pm