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AUUD

PCVX

SHLS

Auddia, Shoals Technologies, and Vaxcyte shares are trading higher due to significant company developments. Auddia launched new interfaces for its app, Shoals Technologies won a legal ruling, and Vaxcyte advanced a vaccine candidate to Phase 3 trials.

Portfolio Pulse from Benzinga Newsdesk

September 03, 2024 | 12:27 pm

CRBU

Caribou Biosciences has received FDA Fast Track designations for its therapies CB-010 and CB-012, aimed at treating refractory SLE and relapsed or refractory AML, respectively. This designation is intended to expedite the development and review process.

Portfolio Pulse from Benzinga Newsdesk

September 03, 2024 | 12:25 pm

AVDL

Avadel Pharmaceuticals published data from the RESTORE study showing a strong patient preference for their once-nightly LUMRYZ dosing over twice-nightly oxybates for narcolepsy. The study highlights significant benefits in sleep quality and patient satisfaction with LUMRYZ.

Portfolio Pulse from Benzinga Newsdesk

September 03, 2024 | 12:21 pm

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