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Regulatory

ASND

The FDA has approved Ascendis Pharma's Yorvipath (Palopegteriparatide; developed as TransCon PTH) for the treatment of hypoparathyroidism in adults. Ascendis is finalizing the manufacturing process for the U.S. market and expects the initial supply to be available in Q1 of 2025.

Portfolio Pulse from Benzinga Newsdesk

August 12, 2024 | 11:05 am

MRKR

Marker Therapeutics, Inc. (NASDAQ:MRKR) has been awarded a $2 million grant from the NIH SBIR program to support the clinical investigation of MT-601 in relapsed non-Hodgkin's lymphoma patients. This funding will aid the Phase 1 APOLLO study, evaluating the safety and efficacy of MT-601.

Portfolio Pulse from Benzinga Newsdesk

August 12, 2024 | 11:03 am

ASND

Trading has been halted for a company at 6:55:00 a.m. ET due to pending news.

Portfolio Pulse from Benzinga Newsdesk

August 12, 2024 | 10:55 am

PFE

Pfizer Inc. (NYSE:PFE) announced positive results from a Phase 3 clinical trial for its ABRYSVO vaccine in immunocompromised adults at risk of severe RSV. The vaccine showed strong safety and immunogenicity, generating a robust neutralizing response against RSV-A and RSV-B. Pfizer plans to present these findings at a scientific conference and submit them to regulatory agencies.

Portfolio Pulse from Benzinga Newsdesk

August 12, 2024 | 10:47 am

TSLA

Elon Musk acknowledged that Tesla's naming conventions for its Full Self-Driving (FSD) software versions are becoming 'a bit silly.' Tesla recently rolled out version 12.5.1.3 of its FSD software, which includes both major upgrades and minor enhancements. Musk also mentioned that Tesla has a 'clear path' to improving FSD performance and plans to release several versions in quick succession. The fully autonomous FSD technology is still pending technological advancements and regulatory approval.

Portfolio Pulse from Anan Ashraf

August 12, 2024 | 10:11 am

SCPH

The FDA has approved scPharmaceuticals' supplemental new drug application to expand the indication for Furoscix. Previously indicated for NYHA Class II and III chronic heart failure patients, Furoscix can now be used for all classes, including Class IV.

Portfolio Pulse from Benzinga Newsdesk

August 12, 2024 | 10:06 am

GOOG

TSLA

Tesla's long-term success hinges on the deployment of its robotaxi service, which relies on its Full Self-Driving (FSD) technology. A poll by Gary Black of Future Fund LLC revealed that nearly 50% of respondents expect FSD approval by 2025. Tesla's latest FSD version, 12.5.1.3, is rolling out, but regulatory approval is complex and state-specific. Tesla's robotaxi network will likely roll out in stages, with significant infrastructure and licensing requirements.

Portfolio Pulse from Shanthi Rexaline

August 12, 2024 | 10:01 am

TSLA

Former Tesla executive Rohan Patel stated that the Inflation Reduction Act (IRA) passed by the Democratic Party has significantly benefited Tesla, contrary to claims that the company was sidelined. Tesla's involvement in various incentivized activities under the IRA, such as solar deployment and battery manufacturing, puts it in a favorable position compared to legacy automakers. Despite Tesla CEO Elon Musk's endorsement of Donald Trump, the Democratic Party has continued to support Tesla. Musk believes that the elimination of EV subsidies, as proposed by Trump, would slightly impact Tesla but devastate its competitors.

Portfolio Pulse from Anan Ashraf

August 12, 2024 | 9:15 am

LIPO

Lipella Pharmaceuticals Inc. (NASDAQ:LIPO) has started dosing patients in its Phase 2a clinical trial for LP-310, a treatment for Oral Lichen Planus (OLP). The trial involves adult subjects with OLP, a chronic inflammatory condition affecting the mouth. The study is expected to conclude in mid-2025, with top-line data anticipated by the end of 2024.

Portfolio Pulse from Benzinga Newsdesk

August 12, 2024 | 9:01 am

HYMTF

MBGAF

VWAGY

South Korea is considering a mandate for automakers to disclose the brands of batteries used in their EVs following a recent fire incident involving a Mercedes-Benz EV. This move aims to address rising safety concerns and could impact automakers like Hyundai, Mercedes-Benz, and Volkswagen.

Portfolio Pulse from Benzinga Neuro

August 12, 2024 | 8:41 am