Streetbeat News

Regulatory

BCLI

The FDA has stated that it does not believe there is sufficient evidence to support that any of the assessed biomarkers for Brainstorm Cell Therapeutics' ALS therapy is reasonably likely to predict clinical benefit. This has led to a decrease in the company's share price.

Portfolio Pulse from Benzinga Newsdesk

September 25, 2023 | 12:21 pm

BCLI

The FDA staff has expressed skepticism about the efficacy of Brainstorm Cell Therapeutics' ALS therapy, stating that they do not believe there is sufficient evidence to support that any of the assessed biomarkers for the therapy is reasonably likely to predict clinical benefit.

Portfolio Pulse from Benzinga Newsdesk

September 25, 2023 | 12:14 pm

HYMC

Hycroft Mining Holding Corporation (NASDAQ:HYMC) plans to file a request for a hearing before the Nasdaq Hearings Panel to present its plan to regain compliance with Nasdaq's minimum bid price requirement. The company's shares will continue to trade on Nasdaq until the Panel's decision is issued.

Portfolio Pulse from Benzinga Newsdesk

September 25, 2023 | 12:07 pm

PDSB

PDS Biotechnology has announced that its Key Opinion Leader Roundtable on addressing current and future treatments for recurrent/metastatic human papillomavirus-positive head and neck squamous cell carcinoma and the potential application of PDS0101 will take place on October 3. The event was originally scheduled for September 27, 2023.

Portfolio Pulse from Benzinga Newsdesk

September 25, 2023 | 12:05 pm

BIOR

Biora Therapeutics has submitted an Investigational New Drug (IND) application to the US FDA for its BT-600 program. The application supports the next phase of development of BT-600, a drug/device combination designed to use Biora's NaviCap™ ingestible drug delivery device with a proprietary liquid formulation of tofacitinib, for the treatment of moderate to severe ulcerative colitis.

Portfolio Pulse from Benzinga Newsdesk

September 25, 2023 | 12:01 pm

GSK

PFE

SNY

The Centers for Disease Control and Prevention (CDC) has recommended Pfizer's bivalent RSVpreF vaccine (Abrysvo) for pregnant people to protect their newborns from severe RSV illness. This is the first RSV vaccine recommended by the CDC. The vaccine has been shown to reduce the risk of RSV hospitalization for babies by 57% in the first six months after birth. Pfizer and GSK are competing in the RSV vaccine market, which could exceed $10 billion by 2030. The FDA has also approved GSK's Arexvy and an RSV antibody injection for infants from Sanofi and AstraZeneca.

Portfolio Pulse from Vandana Singh

September 25, 2023 | 11:58 am

BPTS

Biophytis and Skyepharma have entered into a partnership for the production of regulatory batches of Sarconeos (BIO101) for severe forms of Covid-19. The partnership aims to submit marketing authorization applications.

Portfolio Pulse from Benzinga Newsdesk

September 25, 2023 | 11:57 am

BABA

FXI

HUYA

KWEB

TCEHY

Alibaba Group Holding Limited (BABA), iShares China Large-Cap ETF (FXI), and KraneShares Trust KraneShares CSI China Internet ETF (KWEB) stocks are trading lower due to concerns over China's property sector, following China Evergrande Group's cancellation of creditor meetings. Poor sales led to the cancellation, impacting the property sector which accounts for 6.1% of China's economy. Additionally, China has limited the live broadcast of esports matchups, affecting Tencent Holdings Ltd (TCEHY) and Huya Inc (HUYA).

Portfolio Pulse from Anusuya Lahiri

September 25, 2023 | 11:55 am

AAPL

GOOG

MSFT

Apple's iOS 17 update allows users to choose a search engine other than Google while using the internet in private mode. This change was highlighted during the ongoing antitrust lawsuit against Google by the Justice Department. Google's agreement with Apple designates it as the default search engine for Safari, in return for a share of its advertising revenue. However, users can now opt for alternatives like Yahoo, Microsoft's Bing, DuckDuckGo, or Ecosia during private browsing sessions.

Portfolio Pulse from Anusuya Lahiri

September 25, 2023 | 11:52 am

BTCUSD

An analyst suggests that Bitcoin's value could surge to over $200,000 if BlackRock's ETF gets approved. The Securities and Exchange Commission (SEC) has delayed its decision on spot bitcoin ETF applications, affecting applicants such as BlackRock, WisdomTree, Invesco Galaxy, Wise Origin, VanEck, Bitwise, and Valkyrie Digital Assets. At the time of writing, BTC was trading at $26,182.36.

Portfolio Pulse from Mehab Qureshi

September 25, 2023 | 11:51 am