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Regulatory

PDSB

PDS Biotechnology Corporation (NASDAQ:PDSB) has aligned with the FDA on the next steps for its Phase 3 VERSATILE-003 trial targeting HPV16-positive head and neck cancer. The trial is set to begin in Q4 2024. A conference call will be held today at 8:00 a.m. ET to discuss the details.

Portfolio Pulse from Benzinga Newsdesk

August 01, 2024 | 11:51 am

TNXP

Tonix Pharmaceuticals (NASDAQ:TNXP) has received FDA Fast Track designation for its fibromyalgia treatment, TNX-102 SL. This designation facilitates the development and review process, potentially bringing the drug to market sooner. TNX-102 SL has shown significant improvements in fibromyalgia symptoms in Phase 3 trials and is well tolerated. Tonix plans to submit a New Drug Application (NDA) in the second half of the year and may request Priority Review.

Portfolio Pulse from Benzinga Newsdesk

August 01, 2024 | 11:49 am

IMRX

Immuneering shares are trading higher after the company announced that IMM-1-104 was granted Fast Track designation from the FDA.

Portfolio Pulse from Benzinga Newsdesk

August 01, 2024 | 11:46 am

IDA

IDACORP has raised the lower-end of its FY24 earnings guidance to a range of $5.30-$5.45 per share, citing additional tax credits from Idaho Power's 2023 battery storage projects and regulatory mechanisms.

Portfolio Pulse from Benzinga Newsdesk

August 01, 2024 | 11:38 am

RCM

Trading has been halted for a company at 7:26:46 a.m. ET due to pending news. This halt indicates that significant information is expected to be released soon, which could impact the stock price.

Portfolio Pulse from Benzinga Newsdesk

August 01, 2024 | 11:26 am

ABUS

Trading for ABUS was halted at 7:25:00 a.m. ET due to pending news. Investors should stay tuned for further updates.

Portfolio Pulse from Benzinga Newsdesk

August 01, 2024 | 11:25 am

ICLN

TSM

Researchers have identified a 'Trump Dump' effect, where former President Donald Trump's public criticisms lead to significant stock market declines in targeted companies and sectors. Notable impacts include a 17% drop in Taiwan Semiconductor (TSM) and a 10% decline in the iShares Global Clean Energy ETF (ICLN). The phenomenon raises concerns about potential market instability if Trump wins a second term.

Portfolio Pulse from Navdeep Yadav

August 01, 2024 | 11:07 am

EWU

The U.K. has decided to maintain its interest rate at 5.00%, matching the estimated rate and down from the previous rate of 5.25%.

Portfolio Pulse from Benzinga Newsdesk

August 01, 2024 | 11:04 am

GLD

QQQ

SPY

UUP

On July 31, U.S. stock markets closed higher with significant gains in the S&P 500 and Nasdaq, driven by a rally in chip stocks and the Federal Reserve's decision to keep interest rates unchanged. U.S. pending home sales rose 4.8% in June, and private businesses added 122,000 jobs in July. In Asia, Japan's Nikkei 225 fell sharply due to a hawkish stance from the BOJ, while Australia's S&P/ASX 200 and India's Nifty 50 saw gains. European markets declined, and commodities like gold and crude oil saw price increases. The U.S. dollar strengthened.

Portfolio Pulse from Akanksha Bakshi

August 01, 2024 | 10:52 am

MRNA

Moderna has revised its 2024 expected net product sales from its respiratory franchise to $3B-$3.5B, down from prior guidance of $4B. The revision is due to low EU sales, potential revenue deferrals, and increased competition in the U.S. Cost of sales is expected to be 40-50% of product sales, with R&D expenses at $4.5B, SG&A expenses at $1.3B, and capital expenditures at $0.9B. Year-end cash and investments are projected to be $9B.

Portfolio Pulse from Benzinga Newsdesk

August 01, 2024 | 10:39 am