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VALN-News
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Major Averages Broadly Lower Near Noon
The major averages were broadly lower near noon as investors continue to balance easing inflation pressures and strong corporate earnings against renewed geopolitical risks.The inflation backdrop remains supportive for equities. July CPI and PPI both came in softer than expected, reducing concerns that the Federal Reserve will need to raise interest rates at its September meeting. PPI was unchanged in July after declining 0.1% in June, while the latest CPI data showed inflation continuing to moderate. The market is increasingly focused on whether the combination of cooling inflation and a weakening labor market will give the Fed room to ease policy later this year.Get caught up quickly on the top news and calls moving stocks with these five Top Five lists.1. STOCK NEWS:Applied Materialsreportedand provided upbeat Q4 earnings guidanceU.S. President Donald Trumpand their parts and componentsRedditwasAvalonBayin the S&P 500 at the August 18 openTeslaredesigned Roadster may have flying capabilities,OpenAI is on pace to generate annualized revenue of over $40B based on its present performance,2. WALL STREET CALLS:New StreetMicronto Buy, sees multi-trillion market cap by 2030SanDiskwith a raised Overweight rating at JPMorganCiscoto Hold at HSBCWayfairto Outperform at BernsteinFox Corp.to Overweight at Wells Fargo and JPMorgan3. AROUND THE WEB:Nokiais closing its research and development unit in Hangzhou, China, and cutting 1,600 jobs, Helsingin saysCharter Communicationsreceived final approval from California regulators to buy Cox Communications for $21.9B, WSJ reportsGoldman Sachsis courting investors to participate in Nvidia's$500B AI infrastructure financing initiative, leveraging its longstanding Nvidia relationship to secure a key role in mobilizing capital for the AI buildout, Reuters saysBPand UAE-based XRG have secured an exploration and production license for Venezuela's Loran offshore gas field, which holds an estimated 4 trillion cubic feet of recoverable gas and straddles the Venezuela-Trinidad and Tobago maritime boundary, WSJ reportsApplehas trained a large language model in partnership with Alibabafor China's market, Reuters reports4. MOVERS:Capricor Therapeuticsgains afterand announcing the FDA is "willing" to review the company's BLA amendment for its HOPE-3 studyValnevaincreases in New York after announcing with Pfizerthat the EMA has validated theIntermexhigher after providing an update on itsfor Western Union'spending acquisition of the companyKinderCarefalls afterand cutting its guidance for FY26Merlinand York Space Systemslower in New York after5. EARNINGS/GUIDANCE:Heartflowand raised its outlook for FY26Midera Food, with CEO Mark Salman commenting, "We saw continued momentum in the second quarter, with orders up 16% and the backlog reaching $446 million"Teamsharesand backed its outlook for FY26DLocal, with CEO Pedro Arnt commenting, "TPV growth has remained above 50% year-over-year for seven consecutive quarters, with the last three quarters at or above 70%"FocalThericsand backed its outlook for FY26INDEXES:Near midday, the Dow was down 0.19%, or 103.36, to 53,736.63, the Nasdaq was down 0.48%, or 128.01, to 26,675.02, and the S&P 500 was down 0.21%, or 16.73, to 7,782.26.
Valneva Files to Sell 31.79M Ordinary Shares
Valneva files to sell 31.79M ordinary shares for holders
Pfizer and Valneva Announce Lyme Disease Vaccine Trial Results
Pfizer (PFE) and Valneva (VALN) announced topline results from the Phase 3 VALOR clinical trial of its investigational 6-valent OspA-based Lyme disease vaccine candidate PF-07307405 demonstrating: In the pre-specified analyses: Efficacy of 73.2% from 28 days post-dose 4 (season 2) in reducing the rate of confirmed Lyme disease cases compared to the placebo arm; Efficacy of 74.8% from 1-day post-dose 4 (season 2) in reducing the rate of confirmed Lyme disease cases compared to the placebo arm; Fewer than anticipated Lyme disease cases were accrued over the study period, and the pre-determined statistical criterion was not met in the first pre-specified analysis. Given the clinically meaningful efficacy and the fact that the 95% confidence interval lower bound was above 20 in the second pre-specified analysis, Pfizer is confident in the vaccine's potential and is planning submissions to regulatory authorities.
Elaris Signs Exclusive Global License Agreement with Valneva
Elaris FlexCo announced an exclusive global license agreement with Valneva for technology related to Valneva's Clostridioides difficile vaccine candidate, VLA84. Under the agreement, Elaris obtains an exclusive global license to Valneva's antigen technology targeting Clostridioides difficile. Building on this technology, Elaris plans to advance a next-generation vaccine program incorporating additional proprietary components designed to broaden protective immune responses. The agreement strengthens Elaris' intellectual property position and supports advancement of its lead vaccine program. Elaris plans to advance the program through IND-enabling development with the goal of initiating clinical studies around 2027.
Valneva Voluntarily Withdraws Ixchiq Vaccine Applications
Valneva SE announced that the company has decided to voluntarily withdraw the biologics license application, BLA, and Investigational New Drug, IND, application for its chikungunya vaccine, Ixchiq, in the United States, following suspension of the license by the U.S. Food and Drug Administration, FDA, in August 2025. The Company had been awaiting further information with respect to its formal response to the vaccine license suspension. Valneva was recently informed of the FDA's further decision to now place the Investigational New Drug, IND, on clinical hold pending an investigation of a newly reported foreign Serious Adverse Event, SAE. There are currently no clinical studies involving Ixchiq that are actively vaccinating participants, and the Company intends to move forward with its planned post-marketing clinical activities, subject to further discussions with relevant regulatory authorities.
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