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MRNA

PFE

The FDA has delayed its review of Moderna's new RSV vaccine, mRNA-1345, citing administrative constraints, with a new expected completion by the end of May 2024. Despite this delay, there are no reported issues regarding the vaccine's safety, efficacy, or quality. Moderna's vaccine showed a decline in effectiveness over time but remains a key part of its growth strategy, with an addressable market of about $10 billion. William Blair maintains a Market Perform rating on Moderna shares, which saw a 2.20% decrease in premarket trading.

Portfolio Pulse from Vandana Singh

May 10, 2024 | 1:27 pm

CNS

Cohen & Steers Inc (CNS) may issue new shares of common stock and selling stockholders may offer up to 21.1M shares in one or more offerings, according to an SEC filing.

Portfolio Pulse from Benzinga Newsdesk

May 10, 2024 | 1:11 pm

NVAX

Novavax has announced during a conference call that, in consultation with the FDA, it will seek emergency use authorization for an updated COVID-19 vaccine targeting the JN.1 variant. Additionally, the company has reduced its workforce by 30% compared to Q1 2023.

Portfolio Pulse from Benzinga Newsdesk

May 10, 2024 | 1:07 pm

NVAX

A Novavax executive announced plans to have their Covid vaccine available at U.S. distribution centers by mid-August and ready for the fall season in early September, pending FDA approval. The executive emphasized improved retail access for the vaccine during the season, as stated in a conference call.

Portfolio Pulse from Benzinga Newsdesk

May 10, 2024 | 1:06 pm

NVS

Novartis received FDA Breakthrough Designation for Scemblix, potentially accelerating its development and review process.

Portfolio Pulse from Benzinga Newsdesk

May 10, 2024 | 1:03 pm

NOTV

Inotiv has rescheduled its earnings announcement to allow additional time for completing accounting analyses related to certain matters. The company is also cooperating with the Department of Justice (DOJ) and other authorities in relation to an investigation.

Portfolio Pulse from Benzinga Newsdesk

May 10, 2024 | 12:14 pm

MNDR

Mobile-Health Network Solutions has announced the establishment of a subsidiary in Malaysia, marking a significant step in its expansion strategy in Asia. This move is aimed at tapping into the growing demand for mobile health services in the region.

Portfolio Pulse from Benzinga Newsdesk

May 10, 2024 | 12:01 pm

ALTM

Arcadium Lithium plc (NYSE:ALTM) has applied to cease being a reporting issuer in various Canadian provinces, aiming to streamline its regulatory obligations.

Portfolio Pulse from Benzinga Newsdesk

May 10, 2024 | 11:21 am

AKAM

IWM

QQQ

SPY

U.S. stocks are poised to end the week strong, with futures indicating a higher opening and the S&P 500 potentially surpassing its late-March peak. This optimism is fueled by weak data raising hopes for a Federal Reserve rate cut. The SPDR S&P 500 ETF Trust (SPY) and Invesco QQQ ETF (QQQ) saw premarket gains. Notable stock movements include Akamai Technologies (AKAM) and others due to earnings announcements. Upcoming economic data and Federal Reserve speeches are anticipated to provide further market direction.

Portfolio Pulse from Shanthi Rexaline

May 10, 2024 | 11:16 am

MRNA

Moderna has announced that the FDA, due to administrative constraints, will not complete its review of mRNA-1345, a vaccine for Respiratory Syncytial Virus, by the initially expected date of May 12. The FDA aims to conclude the review by the end of May.

Portfolio Pulse from Benzinga Newsdesk

May 10, 2024 | 11:06 am