Streetbeat News

Regulatory

GSK

The European Medicines Agency's CHMP has recommended approval of GSK plc's momelotinib for treating splenomegaly or symptoms in bone marrow cancer patients. The drug is for patients with myelofibrosis who are either Janus kinase inhibitor naïve or have been treated with ruxolitinib. The recommendation is based on data from the MOMENTUM study and SIMPLIFY-1 phase 3 trial. If approved, momelotinib, to be named Omjjara in the EU, would be the only medicine for myelofibrosis patients with moderate to severe anemia in the EU. GSK's stock saw a slight increase following the news.

Portfolio Pulse from Vandana Singh

November 13, 2023 | 4:44 pm

BTCUSD

Jay Biancamano believes that the approval of a Bitcoin ETF will have a 'halo effect', positively influencing the perception of the technology behind it, although it won't alter the stance of regulators. This could lead to increased appreciation of the technology by asset management firms.

Portfolio Pulse from Benzinga Newsdesk

November 13, 2023 | 4:15 pm

KYMR

Kymera Therapeutics announced positive Phase 1 trial results for KT-474, published in Nature Medicine. KT-474, an IRAK4 degrader, showed robust degradation and pathway inhibition with a favorable safety profile in HS and AD patients. The trial indicated a reduction in inflammatory biomarkers and improvement in symptoms. Sanofi is conducting Phase 2 trials of KT-474 for HS and AD. Kymera's stock symbol is KYMR.

Portfolio Pulse from Benzinga Newsdesk

November 13, 2023 | 4:04 pm

COIN

Kevin O'Leary, Chairman of O'Shares ETFs, emphasized the need for regulatory clarity before getting excited about a Bitcoin ETF. He stated that institutions are ready to buy Bitcoin but are waiting for a compliant exchange, suggesting Coinbase Global Inc (COIN) as a leading candidate. O'Leary believes a spot Bitcoin ETF is over a year away due to SEC Chair Gary Gensler's stance. He also highlighted the challenges of 24/7 trading for institutional rebalancing. Bitcoin's price was down slightly at the time of the article.

Portfolio Pulse from Adam Eckert

November 13, 2023 | 3:54 pm

ESPR

Esperion (NASDAQ:ESPR) presented results from a CLEAR Outcomes analysis at the American Heart Association Scientific Sessions 2023, showing that higher baseline inflammation is linked to an increased risk of cardiovascular events. The study found that bempedoic acid, found in Esperion's products NEXLETOL and NEXLIZET, reduced the vascular inflammatory marker hsCRP by 21.6% in patients, which may differentiate it from other LDL-lowering therapies. These results were also published in the journal Circulation.

Portfolio Pulse from Benzinga Newsdesk

November 13, 2023 | 3:31 pm

ACHR

BLDE

JOBY

Joby Aviation's eVTOL aircraft is expected to fly in New York City, demonstrating the progress of electric-aircraft technology towards commercial application. Archer Aviation (ACHR) also has an eVTOL but won't fly it. Boeing (BA) and Airbus (AIR.France) are involved in eVTOL development, while Blade Air Mobility (BLDE) operates a network of aircraft and is profitable. Joby has delivered an aircraft to the Air Force and is advancing in FAA certification. Archer plans flight testing in mid-2024. Joby and Archer stocks have risen over the past year, while Blade's shares have fallen.

Portfolio Pulse from Benzinga Newsdesk

November 13, 2023 | 3:29 pm

CBOE

Cboe Digital announced it will launch margined Bitcoin and Ether futures on January 11, 2024, becoming the first U.S. regulated crypto native exchange and clearinghouse to offer spot and leveraged derivatives trading on a single platform. Supported by firms from both crypto and traditional finance sectors, the launch aims to provide capital efficiency and operational benefits. Cboe Digital will initially offer financially settled contracts, with plans for physically delivered products pending regulatory approval.

Portfolio Pulse from Benzinga Newsdesk

November 13, 2023 | 3:12 pm

AAPL

AMZN

GOOG

META

MSFT

NVDA

QQQ

SPY

TSLA

Moody's has downgraded the U.S. credit outlook to negative, citing large federal deficits as a key driver. The deficits persist post-pandemic due to spending programs like the Inflation Reduction Act and Infrastructure Act. The downgrade occurred after market close on Friday with minimal immediate market reaction. Prudent investors are advised to diversify investments globally and across asset classes, and consider shorting strategies. Boeing (BA) is boosted by potential Chinese orders and Dubai Air Show prospects. Early trades show positive money flows in TSLA, NVDA, MSFT, and mixed in SPY and QQQ; negative in AAPL, AMZN, GOOG, META. Bitcoin is range-bound with speculation on ETF approval and BlackRock's Ethereum ETF filing. The Arora Report suggests a protection band strategy for investors.

Portfolio Pulse from The Arora Report

November 13, 2023 | 3:06 pm

QQQ

SPY

The conflict between Israel and Hamas continues to escalate, with Gaza's main hospital facing a severe fuel shortage and increasing casualties. The IDF has struck Hezbollah targets in Lebanon in response to attacks. Israeli Prime Minister Netanyahu is working to release hostages held by Hamas. The U.S. has expressed concerns over civilian casualties and is working with Qatar to provide humanitarian aid to Gaza. Additionally, the U.S. conducted airstrikes in Syria against Iranian targets. The Israeli shekel remained flat, while the Tel Aviv 125 index fell. U.S. ETFs SPY and QQQ saw gains in their last trading sessions.

Portfolio Pulse from Piero Cingari

November 13, 2023 | 2:55 pm

TENX

Tenax Therapeutics Inc (NASDAQ:TENX) stock surged 105% to $0.32 after receiving FDA clearance for the IND of TNX-103, an oral levosimendan for treating pulmonary hypertension with heart failure with preserved ejection fraction (PH-HFpEF). The clearance facilitates the launch of the Phase 3 LEVEL Study in Q4 2023, streamlining the process and potentially addressing a significant medical need as there are no FDA-approved treatments for PH-HFpEF. The company has already selected over two-thirds of the targeted research sites for the study.

Portfolio Pulse from Henry Khederian

November 13, 2023 | 2:47 pm