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TRAW 資訊
TRAW 事件
Traws Pharma Files $139.19M Mixed Securities Shelf
Traws Pharma files $139.19M mixed securities shelf
Traws Pharma Updates Toxicology Data Package for MHRA Requirements
Traws Pharma announced that an updated toxicology data package is in the process of being developed in response to information requirements from the United Kingdom's Medicines and Healthcare Products Regulatory Agency for the planned testing of tivoxavir marboxil in a Phase 2a human influenza Challenge study. The updated data package is expected to be resubmitted to MHRA during the third quarter of 2026. Following Traws' announcement on June 12, the MHRA provided more detailed feedback that has enabled the company to prepare additional preclinical safety information for inclusion in the TXM data package. Following the resubmission, the company expects a formal response from MHRA within 30 days.
U.S. Stock Futures Surge as Investors Eye U.S.-Iran Peace Agreement
Stock futures are markedly higher this morning as investors return from the weekend focused on a preliminary U.S.-Iran peace agreement that could reopen the Strait of Hormuz and significantly ease pressure on global energy markets.Brent crude has dropped to roughly three-month lows after the announced agreement, easing concerns about supply disruptions and helping reduce inflation fears that had weighed on stocks throughout the spring.AI-related stocks are rebounding after last week's volatility, supported by falling Treasury yields and renewed optimism that the Federal Reserve may not need to become more aggressive on rates if energy-driven inflation continues to cool. Investors are also closely watching the strong post-IPO performance of SpaceX, which has helped reignite enthusiasm.This week's key event is the Federal Reserve meeting under Chair Kevin Warsh. Markets overwhelmingly expect no change in interest rates, but traders will scrutinize the Fed's outlook for inflation, growth, and the possibility of future rate hikes. Falling oil prices have reduced some of the urgency around inflation concerns heading into the meeting.In pre-market trading, S&P 500 futures rose 1.29%, Nasdaq futures rose 2.08% and Dow futures rose 1.03%.Check out this morning's top movers from around Wall Street, compiled by The Fly.HIGHER -SpaceXup 6%, building on the advance seen after Friday's IPOParamount Skydanceup 3% after the Antitrust Division of the U.S. Department of Justice gave approval to the proposed acquisition of Warner Bros. DiscoveryNano Dimensionup 2% after entering into a non-binding term sheet for a proposed business combination with Infinite EpigeneticsRokuup 1% after announcing a definitive agreement under which Fox will acquire Roku for $160.00 per share in a combination of cash and Fox Class A common stock, valuing Roku at approximately $22B in enterprise valueUP AFTER EARNINGS -Comtechup 6%Coda Octopusup 7%DOWN AFTER EARNINGS -Canopy Growthdown 1%LOWER -Elicio Therapeuticsdown 62% after announcing its AMPLIFY-7P study did not meet its pre-specified primary DFS endpoint in the intent-to-treat populationTraws Pharmadown 17% after reporting that the planned test of tivoxavir marboxil in a Phase 2a human influenza challenge study has been deferred due to a negative review of the program by the United Kingdom's Medicines and Healthcare Products Regulatory AgencyFoxdown 14% after announcing a definitive agreement under which Fox will acquire Roku for $160.00 per share in a combination of cash and Fox Class A common stockFiservdown 6% after noting Mike Lyons has stepped down as CEO and member of the board of directors to become CEO of Truist FinancialCheesecake Factorydown 1% after Northcoast downgraded the stock to Neutral, citing valuation
Traws Pharma Defers Tivoxavir Marboxil Testing
Traws Pharma announced that the planned test of tivoxavir marboxil in a Phase 2a human influenza challenge study has been deferred due to a negative review of the program by the United Kingdom's Medicines and Healthcare Products Regulatory Agency, or MHRA. "Tivoxavir marboxil demonstrated potent efficacy in three animal models of highly pathogenic avian influenza and a pharmacokinetic profile consistent with its use for bird flu treatment and prevention," said C. David Pauza, chief science officer for Traws Pharma, "The product candidate retains potential for emergency use in a bird flu outbreak and for prevention in high-risk populations." The Company has a portfolio of back-up influenza antiviral compounds and is actively advancing candidates with TXM's long-duration pharmacokinetic and antiviral profile and devoid of any mutagenic potential."
Traws Pharma Advances Novel Broad-Spectrum Antiviral Agent Development
Traws Pharma announced the advancement of a novel proprietary broad-spectrum combination anti-viral agent in its portfolio. The investigational combination utilizes a unique "dual-strike" mechanism of action that hijacks host cell pathways to force viral eradication. Importantly, both components of the combination have been safely evaluated in human studies as single agents. The company is advancing non-clinical development and evaluating the therapeutic combination in validated animal models of Hantavirus and Ebola. The critical studies will be conducted within Biosafety Level 3 and Biosafety Level 4 Laboratories.
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