Streetbeat News

Regulatory

FOLD

The FDA has approved Amicus Therapeutics' (NASDAQ:FOLD) Pombiliti and Opfolda for Pompe disease, a rare inherited disease. The two-component therapy is indicated for adults with late-onset Pompe disease who are not improving on their current enzyme replacement therapy. The approval was based on data from the Phase 3 pivotal study (PROPEL). Despite the approval, FOLD shares are down 6.65% at $12.03.

Portfolio Pulse from Vandana Singh

September 28, 2023 | 4:41 pm

ACRGF

MSOS

Rebecca Kirk, Executive Vice President of Operations at Acreage Holdings, has highlighted the challenges faced by the Northeast in the cannabis industry. These include lack of experience, high costs, and difficulty of entry.

Portfolio Pulse from Benzinga Newsdesk

September 28, 2023 | 4:35 pm

BNTX

PFE

Pfizer Canada ULC and BioNTech SE have received Health Canada authorization for their Omicron XBB.1.5-adapted monovalent COVID-19 vaccine for individuals aged 6 months and older. The updated vaccine will be available in Canada in the coming weeks. The authorization is based on previous clinical, non-clinical, and real-world evidence supporting the safety and efficacy of the Pfizer-BioNTech COVID-19 Vaccines.

Portfolio Pulse from Benzinga Newsdesk

September 28, 2023 | 4:26 pm

SPY

The U.S. Senate has gathered enough votes to advance a bill aimed at averting a government shutdown. The voting process is still ongoing.

Portfolio Pulse from Benzinga Newsdesk

September 28, 2023 | 4:24 pm

MSOS

The Benzinga Cannabis Capital Conference is discussing the potential for the Northeast to become a major hub for cannabis. The ETF MSOS is mentioned in the context of the conference.

Portfolio Pulse from Benzinga Newsdesk

September 28, 2023 | 4:16 pm

IONS

Ionis Pharmaceuticals, Inc. (NASDAQ:IONS) announced that The Journal of the American Medical Association published positive results from the Phase 3 NEURO-TTRansform study of eplontersen, a treatment for hereditary transthyretin-mediated amyloid polyneuropathy (ATTRv-PN). The study showed that eplontersen halted disease progression and improved quality of life at 35-, 66- and 85-week analyses. Ionis and AstraZeneca are seeking regulatory approval for eplontersen in the U.S. and other parts of the world. The FDA granted a PDUFA action date of Dec. 22, 2023.

Portfolio Pulse from Benzinga Newsdesk

September 28, 2023 | 4:06 pm

ASTI

BCLI

BNOX

BXRX

CHS

GCT

KMX

U.S. stocks traded higher with the Nasdaq Composite gaining 1%. CarMax Inc reported weaker-than-expected earnings for its second quarter with a revenue decline of 13.2% YoY to $7.07 billion. Bionomics Limited shares shot up 247% after the ATTUNE trial met its primary endpoint. Baudax Bio, Inc. shares boosted by 86% after the FDA granted orphan drug designation for TI-168. Chico's FAS, Inc. shares were up by 62% following its acquisition by Sycamore Partners. Ascent Solar Technologies, Inc. shares dropped 62% after announcing pricing of a public offering of units. Brainstorm Cell Therapeutics Inc. shares were down 54% after the FDA Advisory Committee voted that NurOwn did not demonstrate substantial evidence of effectiveness for ALS treatment. GigaCloud Technology Inc. fell 26% after Culper Research issued a short report on the stock.

Portfolio Pulse from Lisa Levin

September 28, 2023 | 3:53 pm

APDN

Applied DNA Sciences has filed a U.S. patent application #20230304083 for methods and systems of producing single stranded DNA via PCR using biotin-labeled primers.

Portfolio Pulse from Charles Gross

September 28, 2023 | 3:51 pm

MSOS

Illinois Governor Pritzker spoke at the Benzinga CCC, discussing the state's efforts to create a cannabis industry that promotes genuine equity. The Cannabis Social Equity Program aims to allow those historically impacted by the drug war to participate and benefit from the cannabis industry.

Portfolio Pulse from Benzinga Newsdesk

September 28, 2023 | 3:47 pm

MSOS

Illinois Governor Pritzker stated at the Benzinga Cannabis Capital Conference that Illinois has become a hub for some of the largest cannabis companies in the nation, creating over 30,000 jobs.

Portfolio Pulse from Benzinga Newsdesk

September 28, 2023 | 3:43 pm