Streetbeat News

Regulatory

AKRO

Akero Therapeutics, Inc. (NASDAQ:AKRO) reported a 36-week analysis of its 96-week Phase 2b SYMMETRY study. The study evaluates the efficacy and safety of its lead product candidate efruxifermin (EFX) in patients with compensated cirrhosis due to nonalcoholic steatohepatitis (NASH). The results showed a trend on fibrosis improvement and statistically significant results for NASH resolution, markers of liver injury and fibrosis, insulin sensitization and lip.

Portfolio Pulse from Benzinga Newsdesk

October 10, 2023 | 11:03 am

BTAI

BioXcel Therapeutics has announced overall survival data from its Phase 2 trial of BXCL701 plus Keytruda in patients with small cell neuroendocrine prostate cancer. The data shows a median overall survival of 13.6 months and a 12-month survival rate of 56.5%.

Portfolio Pulse from Benzinga Newsdesk

October 10, 2023 | 11:03 am

OCGN

The National Institute of Allergy and Infectious Diseases will conduct a trial comparing the administration of Ocugen's mucosal vaccine candidate, OCU500, via inhalation into the lungs and as nasal spray. The clinical trials are scheduled to start in early 2024. Ocugen is developing this novel anti-viral mucosal vaccine platform initially targeting COVID-19 and influenza.

Portfolio Pulse from Benzinga Newsdesk

October 10, 2023 | 10:38 am

MRK

Merck's Phase 3 KEYNOTE-671 trial of Keytruda, a perioperative treatment regimen for resectable stage II, IIIa or IIIb non-small cell lung cancer, has met its dual primary endpoint of overall survival.

Portfolio Pulse from Benzinga Newsdesk

October 10, 2023 | 10:34 am

ANNX

Annexon, Inc. (NASDAQ:ANNX), a clinical-stage biopharmaceutical company, announced that the European Medicines Agency (EMA) has granted orphan drug designation to ANX005 for the treatment of Guillain-Barré Syndrome (GBS). The U.S. Food and Drug Administration (FDA) had previously granted the same designation to ANX005.

Portfolio Pulse from Benzinga Newsdesk

October 10, 2023 | 10:31 am

PCG

The California Public Utilities Commission (CPUC) has proposed a $45 million penalty against PG&E Corporation (NYSE:PCG) in relation to the 2021 Dixie Fire. The penalty includes a $2.5 million fine to the California General Fund, $2.5 million to tribes impacted by the fire, and $40 million for capital expenditures to transition records to electronic format. The proposal will be on the CPUC’s Nov. 16, 2023, Voting Meeting agenda.

Portfolio Pulse from Shivani Kumaresan

October 10, 2023 | 10:31 am

NYC

American Strategic Investment Co. (ASIC) has filed a Solicitation/Recommendation Statement with the SEC regarding Bellevue Capital Partners' tender offer to purchase up to 350,000 shares of ASIC's Class A common stock at $10.25 per share. ASIC's board has not made a recommendation on the offer and urges stockholders to make their own decision.

Portfolio Pulse from Benzinga Newsdesk

October 10, 2023 | 10:17 am

AAPL

GOOG

GOOGL

MST

The Department of Justice's antitrust lawsuit against Alphabet, Inc. (GOOGL, GOOG) over its search business may not negatively impact Apple, Inc. (AAPL), according to Gene Munster of Deepwater Asset Management. The lawsuit concerns Alphabet's practice of paying large sums to companies, including Apple, to maintain its dominance in the search business. Munster suggests that the lawsuit could be 'net neutral to positive' for Apple, contradicting Goldman Sachs analysts' view of a negative 15% impact on Apple's earnings in 2025.

Portfolio Pulse from Shanthi Rexaline

October 10, 2023 | 9:55 am

EIS

SPY

USO

Iran's Supreme Leader has stated that Tehran was not involved in the recent Hamas attack, according to CNN. This news may have implications for the iShares MSCI Israel ETF (EIS), SPDR S&P 500 ETF Trust (SPY), and United States Oil Fund (USO).

Portfolio Pulse from Charles Gross

October 10, 2023 | 9:36 am

BABA

BIDU

FXI

NIO

ODD

XPEV

U.S.-listed Chinese stocks are trading higher in the premarket following a report by Bloomberg that China is considering new stimulus measures to meet its annual growth target. Stocks mentioned include Alibaba (BABA), Baidu (BIDU), iShares China Large-Cap ETF (FXI), JD.com (JD), Li Auto (LI), NIO Inc. (NIO), Oddball Stocks (ODD), and XPeng Inc. (XPEV).

Portfolio Pulse from Charles Gross

October 10, 2023 | 9:21 am