Streetbeat News

Regulatory

PYPD

PolyPid has successfully passed a commercial Good Manufacturing Practice (GMP) audit by the Israeli Ministry of Health. This is a significant milestone for the company, demonstrating its commitment to maintaining high standards of manufacturing.

Portfolio Pulse from Benzinga Newsdesk

September 21, 2023 | 11:36 am

ICE

Intercontinental Exchange (ICE) is set to launch CORSIA Carbon Credit Futures Market, a platform designed to manage emissions exposure from airlines. This move is in line with global efforts to reduce carbon emissions and promote sustainable practices in the aviation industry.

Portfolio Pulse from Benzinga Newsdesk

September 21, 2023 | 11:35 am

AMZN

Amazon.com Inc (NASDAQ:AMZN) has decided to cancel its planned 2% fee on merchants not using its shipping services due to resistance from merchants and consultants. The fee was set to take effect on October 1 and would have applied to thousands of third-party merchants. The decision comes as Amazon faces an escalating antitrust investigation. The Federal Trade Commission is likely to file an antitrust case against Amazon soon. In Q2, Amazon's seller services brought in $32.3 billion, up 18% from the previous year.

Portfolio Pulse from Anusuya Lahiri

September 21, 2023 | 11:35 am

TVTX

Travere Therapeutics has announced confirmatory data from the Phase 3 PROTECT study of FILSPARI, demonstrating long-term kidney function preservation in IgA Nephropathy. Although the drug narrowly missed the eGFR total slope endpoint versus active control, Irbesartan, it achieved a clinically meaningful difference. The company plans to meet with regulators and expects to submit a supplemental New Drug Application (sNDA) in 1H 2024 for full approval in the U.S.

Portfolio Pulse from Benzinga Newsdesk

September 21, 2023 | 11:34 am

ALGS

Aligos Therapeutics has announced that it has received Investigational New Drug (IND) clearance for its Nonalcoholic Steatohepatitis (NASH) lead, ALG-055009. This clearance will allow the company to proceed with clinical trials.

Portfolio Pulse from Benzinga Newsdesk

September 21, 2023 | 11:32 am

CYBN

Cybin Inc. (NYSE:CYBN) has completed enrollment in its Phase 2 study of CYB003, a treatment for major depressive disorder. The company has reported no serious adverse events and a favorable safety profile. Cybin plans to scale the CYB003 program to a potential Phase 3 study in early 2024. The program is supported by a recently granted U.S. patent and the company anticipates potential Breakthrough Therapy designation, subject to FDA approval, in Q4 2023.

Portfolio Pulse from Benzinga Newsdesk

September 21, 2023 | 11:32 am

SNSE

Sensei Biotherapeutics presented new preclinical data at the Seventh Cri-enci-aacr International Cancer Immunotherapy Conference, reinforcing the pharmacokinetic profile, safety characteristics, and mechanism of action of SNS-101. The data from a multi-dose GLP toxicology study in cynomolgus monkeys supports the exceptional PK and safety profile of SNS-101. Mechanistic mouse data shows SNS-101 drives tumor macrophages to adopt an immunostimulatory, anti-tumor phenotype.

Portfolio Pulse from Benzinga Newsdesk

September 21, 2023 | 11:30 am

FXI

China's Premier Li has stated that the country's economy is at a major juncture of high-quality development and overcoming challenges. He emphasized the need for more precise and effective policies in response to enterprises' demands for financing support and tax incentives.

Portfolio Pulse from Charles Gross

September 21, 2023 | 11:18 am

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ABT

BDX

The Biden administration has announced that it will restart the distribution of free at-home COVID-19 tests to American households. The U.S. Department of Health and Human Services (HHS) plans to distribute these tests, which can identify current COVID variants, starting next Monday. HHS has also invested $600 million in 12 domestic COVID-19 test manufacturers, expecting to secure approximately 200 million tests from these companies.

Portfolio Pulse from Vandana Singh

September 21, 2023 | 11:16 am

EWU

The U.K. has decided to keep its interest rate unchanged at 5.25%, against an estimated 5.50%.

Portfolio Pulse from Benzinga Newsdesk

September 21, 2023 | 11:10 am