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Regulatory

ASND

TAK

The FDA has approved Ascendis Pharma's (NASDAQ:ASND) Yorvipath (palopegteriparatide) for treating hypoparathyroidism in adults, making it the first and only treatment available after Takeda's (NYSE:TAK) Natpar/Natpara was discontinued due to supply issues. Ascendis plans to launch Yorvipath with patient services and anticipates initial supply availability in Q1 2025.

Portfolio Pulse from Vandana Singh

August 12, 2024 | 2:42 pm

QQQ

SPY

Last week, the SPDR S&P 500 ETF Trust (SPY) and NASDAQ Invesco QQQ Trust (QQQ) experienced significant volatility, with dramatic market swings driven by macroeconomic uncertainty and a weak July jobs report. The S&P 500 had its best and worst days since 2022, reflecting investor anxiety over recession fears and the collapse of the yen carry trade. Historical precedents suggest that such volatility may continue, especially with upcoming macroeconomic indicators, company earnings, Federal Reserve decisions, and geopolitical conflicts. The 2024 election year is also expected to contribute to market volatility.

Portfolio Pulse from Hayden Buckfire

August 12, 2024 | 2:17 pm

BNO

USO

Oil prices are trading higher due to ongoing Middle East tensions, with recent reports suggesting a potential attack by Iran on Israel.

Portfolio Pulse from Benzinga Newsdesk

August 12, 2024 | 2:11 pm

PSIG

PS International Group (PSIG) shares have resumed trading after a temporary halt. The company has not provided specific reasons for the halt, but investors are closely monitoring the situation for any updates.

Portfolio Pulse from Benzinga Newsdesk

August 12, 2024 | 2:08 pm

CNP

Texas Attorney General has initiated an investigation into CenterPoint Energy's conduct during Hurricane Beryl last month.

Portfolio Pulse from Benzinga Newsdesk

August 12, 2024 | 1:31 pm

HUMA

The FDA has announced a delay in the review of Humacyte Inc.'s Biologic License Application for its acellular tissue-engineered vessel (ATEV) for vascular trauma injuries. The original PDUFA date was August 10, 2024, but the new action date is currently undisclosed. This delay has caused Humacyte's stock to drop by 8.98% in premarket trading.

Portfolio Pulse from Vandana Singh

August 12, 2024 | 1:21 pm

WVE

Wave Life Sciences shares are trading higher after the company announced that the FDA has granted Rare Pediatric Disease Designation to WVE-N531 for the treatment of Duchenne muscular dystrophy.

Portfolio Pulse from Benzinga Newsdesk

August 12, 2024 | 1:19 pm

SXTP

60 Degrees Pharma has granted the University of Kentucky the right of reference to its New Drug Application (NDA) for ARAKODA. This will facilitate a Phase IIb clinical study of SJ733 for Vivax malaria, combining SJ733 with a single dose of Tafenoquine.

Portfolio Pulse from Benzinga Newsdesk

August 12, 2024 | 1:14 pm

JHG

Janus Henderson (JHG) announces the acquisition of Victory Park Capital, a global private credit manager. The deal involves a mix of cash and Janus Henderson common stock and is expected to be neutral-to-accretive to earnings per share by 2025. The acquisition is anticipated to close in Q4 2024, pending regulatory approvals.

Portfolio Pulse from Benzinga Newsdesk

August 12, 2024 | 1:05 pm

SCPH

scPharmaceuticals Inc. (NASDAQ:SCPH) received FDA approval for expanded use of Furoscix to include NYHA Class IV heart failure patients. The company also secured $125 million in non-dilutive financing to support commercialization efforts and released positive topline results from a pharmacokinetic study of SCP-111. Additionally, scPharmaceuticals announced a proposed public offering of shares and pre-funded warrants.

Portfolio Pulse from Vandana Singh

August 12, 2024 | 1:02 pm