Streetbeat News

Regulatory

LXRX

Lexicon Pharmaceuticals' new analysis of Phase 3 data shows that INPEFA benefits heart failure patients regardless of diabetes duration, with greater benefits for those with longer diabetes duration. The findings were presented at the ESC Congress 2024.

Portfolio Pulse from Benzinga Newsdesk

September 03, 2024 | 12:20 pm

ESPR

Esperion has secured additional commercial and Medicare formulary coverage for its drugs NEXLETOL and NEXLIZET, now covering over 65% of Medicare insured lives and 92% of commercially insured lives. This expanded coverage follows FDA approval of expanded indications, making it easier for healthcare providers to prescribe these non-statin drugs.

Portfolio Pulse from Benzinga Newsdesk

September 03, 2024 | 12:18 pm

MRNA

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has approved an adapted version of Moderna's Spikevax COVID-19 vaccine, which targets the JN.1 subvariant. This approval could potentially boost Moderna's market position and sales.

Portfolio Pulse from Benzinga Newsdesk

September 03, 2024 | 12:14 pm

COGT

Cogent Biosciences has completed patient enrollment for its Phase 3 PEAK trial evaluating Bezuclastinib with Sunitinib. The trial enrolled 413 patients, and an interim analysis recommended continuation. Top-line results are expected by the end of 2025.

Portfolio Pulse from Benzinga Newsdesk

September 03, 2024 | 12:10 pm

MAXN

Maxeon is facing significant market challenges, including competitive pressures, project delays, and U.S. Customs detentions affecting shipments. As a result, they have withdrawn financial guidance for Q3 and FY24, expecting a significant revenue decline. The company is taking steps to stabilize and improve its financial position.

Portfolio Pulse from Benzinga Newsdesk

September 03, 2024 | 12:06 pm

RXRX

Recursion Pharmaceuticals has announced the Phase 2 SYCAMORE trial of REC-994, focusing on safety and tolerability in treating symptomatic cerebral cavernous malformation. This development is crucial for the company's pipeline and future growth.

Portfolio Pulse from Benzinga Newsdesk

September 03, 2024 | 12:04 pm

BIVI

BioVie has received FDA authorization for an investigational new drug application to conduct a Phase 2 trial of Bezisterim for Long COVID. This authorization enables the company to receive an additional $12.6 million grant from the US Department of Defense and proceed with the trial.

Portfolio Pulse from Benzinga Newsdesk

September 03, 2024 | 12:01 pm

SNY

Sanofi's investigational drug tolebrutinib showed mixed results in phase 3 trials for multiple sclerosis. While it met the primary endpoint in the HERCULES study for non-relapsing secondary progressive multiple sclerosis, it failed in the GEMINI studies for relapsing forms. Despite concerns over liver safety and effectiveness, analysts see a potential $1-2 billion opportunity.

Portfolio Pulse from Vandana Singh

September 03, 2024 | 11:56 am

PWUP

Trading for an unspecified asset was halted at 7:55 a.m. ET due to pending news. This indicates that significant information is expected to be released, which could impact the asset's price once trading resumes.

Portfolio Pulse from Benzinga Newsdesk

September 03, 2024 | 11:55 am

PWUPW

Trading for PWUPW has been halted as of 7:55:00 a.m. ET due to pending news. This indicates that significant information regarding the company is expected to be released, which could impact its stock price.

Portfolio Pulse from Benzinga Newsdesk

September 03, 2024 | 11:55 am