Streetbeat News

Regulatory

DVAX

The FDA issued a Complete Response Letter to Dynavax, indicating that the sBLA for its four-dose HEPLISAV-B regimen lacked sufficient data for a full evaluation of effectiveness or safety.

Portfolio Pulse from Benzinga Newsdesk

May 14, 2024 | 12:35 pm

SPY

The S&P 500 index experienced a decline following the release of April's Producer Price Index (PPI) data, which came in hotter than anticipated. This suggests inflationary pressures that could influence the Federal Reserve's monetary policy decisions.

Portfolio Pulse from Benzinga Newsdesk

May 14, 2024 | 12:33 pm

SPY

The Core Producer Price Index (PPI) for the month increased by 0.5%, surpassing the estimated 0.2%. This indicates higher than expected inflationary pressures at the production level, which could influence future consumer prices and monetary policy decisions.

Portfolio Pulse from Benzinga Newsdesk

May 14, 2024 | 12:30 pm

HYFM

Hydrofarm Holdings Group, Inc. (HYFM) reported a year-over-year decrease in Q1 sales and gross profit but narrowed its net loss and saw an improvement in adjusted EBITDA. The company remains optimistic about future growth, citing operational productivity and a positive outlook on cannabis rescheduling in the U.S.

Portfolio Pulse from Jelena Martinovic

May 14, 2024 | 12:23 pm

LIFE

aTyr Pharma announced that the Data Safety Monitoring Board (DSMB) has recommended the ongoing Phase 3 EFZO-FIT study of Efzofitimod to continue without any modifications. This decision indicates a positive outlook on the safety and potential efficacy of Efzofitimod in its current trial phase.

Portfolio Pulse from Benzinga Newsdesk

May 14, 2024 | 12:18 pm

PLUG

Plug Power Inc. has received a conditional commitment for a loan guarantee up to $1.66 billion from the Department of Energy to finance the development, construction, and ownership of up to six green hydrogen production facilities.

Portfolio Pulse from Benzinga Newsdesk

May 14, 2024 | 12:07 pm

PTCT

PTC Therapeutics announced that the FDA has accepted and granted priority review to its Biologics License Application (BLA) for Upstaza, a potential treatment for a specific medical condition. This marks a significant milestone for the company, potentially accelerating the approval process.

Portfolio Pulse from Benzinga Newsdesk

May 14, 2024 | 11:31 am

SPWR

SunPower shares are trading higher due to the return of trader 'Roaring Kitty' to social media and the Biden administration's decision to raise tariffs on Chinese solar panels. These factors are contributing to increased interest in high-short interest stocks, including SunPower.

Portfolio Pulse from Benzinga Newsdesk

May 14, 2024 | 11:14 am

AMC

GME

HD

QQQ

SPY

Market sentiment is cautious as traders await inflation reports and Federal Reserve officials' speeches, including Chairman Jerome Powell. Home Depot reported disappointing revenue but met earnings expectations, hinting at consumer discretionary spending softness. Premarket trading saw slight gains in SPDR S&P 500 ETF Trust and Invesco QQQ ETF. GameStop and AMC Entertainment saw significant premarket surges. Upcoming economic data includes the producer price inflation report and speeches by Fed officials.

Portfolio Pulse from Shanthi Rexaline

May 14, 2024 | 11:06 am

LYRA

A new post-hoc analysis of pooled Phase 3 data reveals that INPEFA (Sotagliflozin) significantly reduces the risk of heart failure events in patients with preserved ejection fraction. This finding could have substantial implications for the treatment of heart failure, potentially positioning INPEFA as a leading therapeutic option in this patient population. The analysis, which draws on data from several Phase 3 trials, underscores the drug's efficacy in a condition that has historically been challenging to manage.

Portfolio Pulse from Benzinga Newsdesk

May 14, 2024 | 11:04 am