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Regulatory

SGEN

Seagen Inc. (NASDAQ:SGEN) announced that the Phase 3 HER2CLIMB-02 clinical trial of TUKYSA in combination with the antibody-drug conjugate ado-trastuzumab emtansine (Kadcyla) met its primary endpoint of progression-free survival (PFS) in patients with previously treated HER2-positive metastatic breast cancer. The company plans to present the data at an upcoming medical meeting and discuss the results with the FDA.

Portfolio Pulse from Happy Mohamed

August 16, 2023 | 12:02 pm

ET

Trading of Energy Transfer LP shares has been halted due to pending news.

Portfolio Pulse from Happy Mohamed

August 16, 2023 | 12:00 pm

SPY

VGK

Russian President Vladimir Putin is set to hold a meeting to discuss currency controls following the recent slide of the Rouble, according to the Financial Times. The article may mention US-listed ETFs SPY and VGK.

Portfolio Pulse from Charles Gross

August 16, 2023 | 11:56 am

SONN

Sonnet BioTherapeutics has announced that the FDA has accepted the company's IND for the SB221 clinical trial of SON-1010 combined with Atezolizumab in the US.

Portfolio Pulse from Benzinga Newsdesk

August 16, 2023 | 11:31 am

INTC

NVDA

SFTBF

SFTBY

TSEM

Tower Semiconductor's stock fell after it and Intel agreed to terminate their takeover deal due to lack of regulatory approval from China. Intel will pay a termination fee of $353 million to Tower. This follows a similar situation where Nvidia and Softbank's deal for Arm Ltd also faced regulatory opposition.

Portfolio Pulse from Anusuya Lahiri

August 16, 2023 | 11:26 am

PLUR

Pluri has published an article in the peer-reviewed journal Nature Bone Marrow Transplantation, demonstrating that PLX-R18 increases blood cell counts and reduces the need for transfusions in a Phase 1 study.

Portfolio Pulse from Benzinga Newsdesk

August 16, 2023 | 11:18 am

XHR

Xenia Hotels & Resorts has filed for a mixed shelf offering, although the size of the offering has not been disclosed.

Portfolio Pulse from Charles Gross

August 16, 2023 | 11:12 am

CYN

Cyngn Inc. (NASDAQ:CYN), a developer of AI-powered autonomous driving solutions for industrial applications, has announced that it has been granted 10 patents by the United States Patent and Trademark Office for autonomous vehicle technologies.

Portfolio Pulse from Benzinga Newsdesk

August 16, 2023 | 11:06 am

BLUE

The FDA has confirmed that it will not schedule an Advisory Committee meeting for bluebird bio's Lovo-Cel gene therapy for Sickle Cell Disease. The agency had previously accepted the Lovo-Cel Biologics Licensing Application (BLA) for Priority Review and set a Prescription Drug User Fee Act (PDUFA) goal date of December 20, 2023.

Portfolio Pulse from Benzinga Newsdesk

August 16, 2023 | 11:02 am

MSFT

Microsoft Corp. has updated its terms of service for Bing Chat, powered by OpenAI's ChatGPT, to store the conversations of its users. The new terms, effective from September 30, state that Microsoft will process and store user inputs and outputs from the service for monitoring purposes and to prevent abusive use. However, Microsoft and OpenAI have clarified that they will not use this data to train Bing Chat. The new terms apply to non-enterprise users, while enterprise users' conversations will not be saved.

Portfolio Pulse from Rounak Jain

August 16, 2023 | 10:50 am