Streetbeat News

Regulatory

DGX

Quest Diagnostics has been granted FDA breakthrough designation for its Adeno-Associated Virus (AAV) test. Additionally, Quest has expanded its collaboration with Sarepta Therapeutics to develop AAV Companion Diagnostics for Sarepta's gene therapies.

Portfolio Pulse from Benzinga Newsdesk

August 30, 2023 | 12:41 pm

JAGX

Jaguar Health, Inc. (NASDAQ:JAGX) is focusing on developing its plant-based prescription drug, crofelemer, for two rare disease indications, short bowel syndrome (SBS) and microvillus inclusion disease (MVID). The company is supporting proof-of-concept studies in the US, EU, and Middle East/North Africa regions, with results expected by the end of 2023 and in 2024. The FDA and the European Medicines Agency have granted Orphan Drug Designation for crofelemer for both MVID and SBS.

Portfolio Pulse from Happy Mohamed

August 30, 2023 | 12:37 pm

ONDS

Ondas Holdings Inc. (NASDAQ:ONDS) has been awarded a grant of approximately $540,000 by the Israel Innovation Authority to support the development of its Iron Drone Raider counter-drone system, owned by its subsidiary Airobotics LTD. The system uses AI technologies to identify and intercept hostile drones and can be integrated into a variety of drone detection systems. The grant will fund a development program to enhance the system's capabilities for intercepting hostile drones in civil environments.

Portfolio Pulse from Happy Mohamed

August 30, 2023 | 12:37 pm

DNLI

Denali Therapeutics has announced new interim data from its Phase 1/2 study of DNL310 in MPS II at SSIEM 2023. The data shows rapid and sustained normalization of CSF heparan sulfate to normal healthy levels and improvement in lysosomal function biomarkers. The treatment is generally well tolerated and has shown positive clinical outcome changes in adaptive behavior, cognition, and auditory function. Recruitment for the global Phase 2/3 COMPASS study is ongoing.

Portfolio Pulse from Benzinga Newsdesk

August 30, 2023 | 12:35 pm

SPY

The USA Core PCE Prices for Q2 came in at 3.70%, lower than the estimated 3.80% and the prior figure of 4.90%.

Portfolio Pulse from Happy Mohamed

August 30, 2023 | 12:33 pm

SPY

The USA PCE Prices for Q2 came in at 2.5%, slightly below the estimated 2.6% and significantly lower than the prior 4.1%.

Portfolio Pulse from Happy Mohamed

August 30, 2023 | 12:32 pm

SPY

The USA GDP for Q2 has been reported at 2.1%, which is lower than the estimated 2.4%, but higher than the prior 2.0%.

Portfolio Pulse from Happy Mohamed

August 30, 2023 | 12:31 pm

SPY

The USA Core PCE Prices for Q2 came in at 3.80%, matching the estimated figure. This is a decrease from the previous quarter's figure of 4.90%.

Portfolio Pulse from Benzinga Newsdesk

August 30, 2023 | 12:30 pm

NDRA

ENDRA Life Sciences Inc.'s De Novo request for the TAEUS liver system has advanced to the substantive review stage with the U.S. Food and Drug Administration (FDA). The TAEUS system is a proprietary device for non-invasive assessment of fatty liver tissue. The FDA aims to make a decision about a De Novo request in 150 review days. If granted, it will strengthen TAEUS' competitive position.

Portfolio Pulse from Happy Mohamed

August 30, 2023 | 12:19 pm

SPY

The ADP Nonfarm Employment Change for August was reported at 177K, lower than the estimated 195K and significantly below the prior figure of 324K.

Portfolio Pulse from Happy Mohamed

August 30, 2023 | 12:15 pm