Streetbeat News

Regulatory

AKTX

Akari Therapeutics has chosen the version of long-acting PAS-Nomacopan that it will advance into clinical trials. The company is on schedule for an IND submission in the first half of 2024 and the start of clinical trials in the second half of 2024.

Portfolio Pulse from Benzinga Newsdesk

July 11, 2023 | 12:05 pm

MAIA

MAIA Biotechnology, Inc. (NYSE:MAIA) has announced updates on disease control data for its ongoing THIO-101 phase 2 trial for advanced Non-Small Cell Lung Cancer (NSCLC). Of the first 11 patients enrolled, 9 (82%) met the primary endpoint of disease control. All patients have previously failed 2 or more prior lines of treatment including an immune checkpoint inhibitor and platinum-based chemotherapy for advanced NSCLC.

Portfolio Pulse from Benzinga Newsdesk

July 11, 2023 | 12:03 pm

CING

Biopharmaceutical company Cingulate Inc. (NASDAQ:CING) has announced positive top-line results from its Phase 3 adult trial of lead candidate CTx-1301 (dexmethylphenidate), a treatment for attention deficit/hyperactivity disorder (ADHD). The drug is being developed as a once-daily stimulant medication, pending approval from the U.S. Food and Drug Administration (FDA).

Portfolio Pulse from Benzinga Newsdesk

July 11, 2023 | 12:02 pm

F

The U.S. has opened a probe into 346,071 Ford Escape SUVs due to a potential issue where the vehicle door may inadvertently open while driving, according to Reuters.

Portfolio Pulse from Charles Gross

July 11, 2023 | 11:47 am

ETRN

Equitrans Midstream is disappointed with the appeals court decision to halt all construction in the Jefferson National Forest. The company is considering filing an emergency appeal to the U.S. Supreme Court. If the decision is not reversed promptly, it could jeopardize Mountain Valley's ability to complete construction by year-end 2023.

Portfolio Pulse from Benzinga Newsdesk

July 11, 2023 | 11:36 am

SNGX

Soligenix has expanded its Phase 2A trial of SGX302, a synthetic hypericin, for mild-to-moderate psoriasis after demonstrating a biological effect in the initial five subjects. The study is expected to enroll at least an additional five subjects.

Portfolio Pulse from Benzinga Newsdesk

July 11, 2023 | 11:34 am

FXI

UNG

USO

China's Commission for Deepening Reforms has approved proposals for further deepening reform of oil and gas markets. The commission aims to strengthen the construction of production, supply, storage, and marketing systems. It also plans to deepen reforms of the electric power system.

Portfolio Pulse from Charles Gross

July 11, 2023 | 11:29 am

ADCT

ADC Therapeutics has voluntarily paused enrollment in its Phase 2 LOTIS-9 trial of Zynlonta (Loncastuximab Tesirine-lpyl) and Rituximab (Lonca-r) in unfit or frail patients with previously untreated Diffuse Large B-Cell Lymphoma.

Portfolio Pulse from Benzinga Newsdesk

July 11, 2023 | 11:05 am

SYBX

The FDA has granted Fast Track designation to Synlogic's labafenogene marselecobac (previously known as SYNB1934) for Phenylketonuria. This will expedite the review process for the drug, potentially leading to quicker market entry.

Portfolio Pulse from Benzinga Newsdesk

July 11, 2023 | 11:03 am

BMY

Bristol Myers Squibb announced that a sub-study of its Phase 3 CheckMate-901 trial met its dual primary endpoints of overall survival and progression-free survival. The study showed that Opdivo in combination with cisplatin-based chemotherapy followed by Opdivo monotherapy demonstrated significant benefits compared to standard-of-care cisplatin-based combinations for patients with unresectable or metastatic urothelial carcinoma.

Portfolio Pulse from Benzinga Newsdesk

July 11, 2023 | 11:01 am