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Regulatory

ZVRA

The FDA’s Genetic Metabolic Diseases Advisory Committee (GeMDAC) voted in favor of Zevra Therapeutics' (NASDAQ:ZVRA) arimoclomol for treating Niemann-Pick disease type C. William Blair increased the probability of success for arimoclomol to 90% and highlighted Zevra's balanced portfolio. Zevra's stock rose 16.7% in premarket trading.

Portfolio Pulse from Vandana Singh

August 05, 2024 | 11:59 am

AAPL

BRK-A

BTCUSD

NVDA

QQQ

SPY

The stock market is set to open sharply lower on Monday due to negative sentiment from last week. Nasdaq 100 futures are down over 4%, and the VIX has spiked over 100%. Berkshire Hathaway has trimmed its equity portfolio, including selling nearly half of its Apple shares. Tech stocks, particularly Nvidia, are showing notable weakness. Bitcoin has also plunged over 15%. The global sell-off is driven by recession fears and the unwinding of yen carry trades.

Portfolio Pulse from Shanthi Rexaline

August 05, 2024 | 11:51 am

TWKS

Trading halt status for Thoughtworks Holding Inc. (TWKS) was updated at 7:40:00 AM ET. The company is expected to resume trading following the release of news and resumption times.

Portfolio Pulse from Benzinga Newsdesk

August 05, 2024 | 11:40 am

IXHL

Incannex Healthcare Inc. (NASDAQ: IXHL) has received FDA approval to conduct a Phase 2 clinical trial for its psilocybin pharmaceutical formulation, PSX-001, in patients with generalized anxiety disorder in the US and UK. The trial, PsiGAD2, will involve 94 patients and aims to measure changes in anxiety levels using the HAM-A score.

Portfolio Pulse from Benzinga Newsdesk

August 05, 2024 | 11:34 am

RZLT

Rezolute, Inc. (NASDAQ:RZLT) has received FDA clearance for its Investigational New Drug (IND) application for RZ358 to treat hypoglycemia in patients with tumor hyperinsulinism. The company plans to start patient enrollment in the first half of 2025.

Portfolio Pulse from Benzinga Newsdesk

August 05, 2024 | 11:31 am

GOOGL

META

MSFT

NVDA

Nvidia's advanced AI chips are reportedly being smuggled into China, bypassing U.S. trade restrictions, potentially aiding the Chinese military. The Biden administration plans to broaden its export ban to other countries. Nvidia is developing a compliant chip for the Chinese market, but production delays are affecting major clients.

Portfolio Pulse from Navdeep Yadav

August 05, 2024 | 11:31 am

ALZN

Alzamend Neuro Inc. (NASDAQ:ALZN) is conducting a Phase 2 clinical trial of its Alzheimer's candidate AL001 in partnership with Massachusetts General Hospital. The trial aims to compare AL001's effectiveness and safety against a commonly marketed lithium salt. The study will help meet FDA regulatory safety standards and could lead to a next-generation lithium product with an improved safety profile. Alzamend previously completed a Phase 2A trial identifying a maximum tolerated dose for AL001. The company also terminated its 'at-the-market' equity offering program to preserve shareholder value.

Portfolio Pulse from Vandana Singh

August 05, 2024 | 11:30 am

ASTS

AST SpaceMobile has received FCC approval to launch its first five commercial BlueBird satellites, marking a significant milestone for its space-based cellular network. The license allows AST SpaceMobile to operate various frequencies for essential satellite operations.

Portfolio Pulse from Benzinga Newsdesk

August 05, 2024 | 11:16 am

ATNM

The FDA has determined that Actinium Pharmaceuticals' Phase 3 Sierra Trial is not adequate to support a BLA filing for Iomab-B for relapsed or refractory acute myeloid leukemia, despite achieving its primary endpoint. Actinium will need to conduct an additional head-to-head randomized clinical trial to demonstrate overall survival benefit. The company plans to request a meeting with the FDA to discuss the specifics and will seek a strategic partner for Iomab-B in the U.S. Actinium will also focus on developing Actimab-A, Iomab-ACT, and preclinical programs.

Portfolio Pulse from Benzinga Newsdesk

August 05, 2024 | 11:12 am

ATNM

Actinium shares are trading lower after the FDA determined that its Phase 3 SIERRA trial is not adequate to support a BLA filing for Iomab-B.

Portfolio Pulse from Benzinga Newsdesk

August 05, 2024 | 11:12 am