Streetbeat News

Regulatory

Square Inc (NASDAQ:SQ) has announced a partnership with Jane Technologies, an online ordering service for cannabis dispensaries, to develop commerce solutions for the growing recreational cannabis industry in Canada. The move is part of Square's strategy to solve sellers' pain points and navigate the complex regulatory landscape of the cannabis industry. The company is also considering expansion into more provinces in Canada and exploring ways to offer sellers more products at competitive price points. The partnership with Jane Technologies is seen as a significant opportunity to create better business solutions for the recreational cannabis industry in Canada.

Portfolio Pulse from Javier Hasse

October 16, 2023 | 12:13 pm

ALDX

Aldeyra Therapeutics has been informed by the FDA that its drug, Reproxalap, for signs and symptoms of dry eye disease, lacks sufficient data to support its clinical relevance. The FDA has suggested that Aldeyra conduct an additional clinical trial to satisfy efficacy requirements. This could delay the approval of the NDA for Reproxalap beyond the target action date of November 23, 2023.

Portfolio Pulse from Benzinga Newsdesk

October 16, 2023 | 12:11 pm

SGEN

Seagen Inc. (NASDAQ:SGEN) will present detailed results from two pivotal Phase 3 studies at the ESMO Congress 2023. The studies focus on PADCEV (EV-302) for bladder cancer and TIVDAK (innovaTV 301) for cervical cancer. Both studies met their primary endpoints of overall survival and progression-free survival. The results will be used for global submissions and as confirmatory trials for U.S. accelerated approval. Seagen is also sharing early clinical data from a Phase 1 study of SGN-B7H4V, a wholly owned vedotin ADC directed to B7-H4.

Portfolio Pulse from Benzinga Newsdesk

October 16, 2023 | 12:08 pm

BNTX

MRNA

NVAX

PFE

Novavax Inc (NASDAQ:NVAX) faces a setback as the European Medicines Agency (EMA) delays a decision on its variant-tailored COVID-19 vaccine. The EMA has requested more information about the vaccine's potency and consistency across different production sites. The delay comes at a challenging time for Novavax, grappling with declining demand for COVID-19 vaccines. The impact of EMA approval on Novavax's revenues remains uncertain due to market saturation.

Portfolio Pulse from Vandana Singh

October 16, 2023 | 12:04 pm

EDIT

The FDA has granted Regenerative Medicine Advanced Therapy Designation to Editas Medicine's EDIT-301, a gene editing medicine, for severe sickle cell disease.

Portfolio Pulse from Benzinga Newsdesk

October 16, 2023 | 12:04 pm

RNAZ

Transcode Therapeutics has reported successful treatment of preclinical melanoma tumors using its immunotherapy candidate, TTX-RIGA. The study showed a significant inhibition of tumor growth.

Portfolio Pulse from Benzinga Newsdesk

October 16, 2023 | 12:02 pm

AMAM

Ambrx Biopharma has announced that two abstracts detailing updated safety and efficacy data from the ongoing Phase 1/2 trial, APEX-01 of ARX517 for metastatic castration-resistant prostate cancer were made available at the European Society of Medical Oncology.

Portfolio Pulse from Benzinga Newsdesk

October 16, 2023 | 12:00 pm

BTTX

Better Therapeutics, Inc. (NASDAQ:BTTX) has announced the commercial launch of AspyreRx, the first cognitive behavioral therapy (CBT) app to receive FDA authorization as a Class II device to treat adults with type 2 diabetes. The app, backed by a randomized controlled trial, demonstrated significant reductions in A1c at 90 and 180 days, improvements in blood pressure, weight, mood, and quality of life, and lower medication utilization and fewer adverse events compared to the control group.

Portfolio Pulse from Benzinga Newsdesk

October 16, 2023 | 11:56 am

EIS

SPY

USO

The UN Security Council is set to vote on rival draft resolutions on Israel and Gaza, according to Reuters citing diplomats. The outcome of the vote could potentially impact the geopolitical landscape in the Middle East.

Portfolio Pulse from Charles Gross

October 16, 2023 | 11:44 am

BABA

BIDU

COST

KWEB

WMT

Alibaba's stock is trading lower, in line with the broader index KraneShares CSI China Internet ETF, due to reports of tighter U.S. curbs on technology exports to China and the escalating Israel-Hamas conflict. The U.S. is considering stricter regulations on selling graphics chips for AI purposes and advanced chip-making equipment to Chinese companies, which could impact Alibaba's AI ambitions. However, Alibaba's Freshippo supermarket chain plans to transform approximately 350 offline stores into discount supermarkets by 2024, potentially boosting its market share.

Portfolio Pulse from Anusuya Lahiri

October 16, 2023 | 11:32 am