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IVVD News
IVVD Events
Invivyd Receives FDA Termination Notice for Pemgarda EUA
Invivyd announced that the FDA has sent Invivyd a notice of termination for the Pemgarda Emergency Use Authorization, or EUA, following the U.S. Department of Health and Human Services', or HHS, announcement of advanced notice of termination of the COVID-19 EUA declaration on June 30, with an effective date of June 29, 2027. Consequently, the EUA for Pemgarda is set to terminate on June 29, 2027. Pemgarda is Invivyd's investigational monoclonal antibody authorized by the FDA under an EUA since March 2024 for the pre-exposure prophylaxis of COVID-19 in certain adults and adolescents who have moderate-to-severe immune compromise due to certain medical conditions or receipt of certain immunosuppressive medications or treatments and are unlikely to mount an adequate immune response to COVID-19 vaccination.
Invivyd Completes Enrollment for LIBERTY Clinical Trial
Invivyd announced enrollment of participants in its Phase 3 LIBERTY clinical trial is complete. The trial is comparing the safety and tolerability of the company's investigational COVID-19 monoclonal antibody VYD2311 with an mRNA COVID-19 vaccine. The trial is also evaluating the safety and immune response when both are given together. VYD2311 is being developed as an alternative to vaccines for preventing COVID-19. The LIBERTY study is a randomized, double-blind trial involving healthy adults. A primary endpoint of the trial is to assess the side effects and tolerability of COVID antibody versus vaccine through Day six, for a total of seven days. Invivyd expects to report initial results from the study in the third quarter of 2026. These results may be released alongside data from the company's pivotal DECLARATION clinical trial.
Invivyd Completes Enrollment in DECLARATION Trial for VYD2311
Invivyd announced the completion of enrollment in the DECLARATION trial evaluating VYD2311, an investigational monoclonal antibody candidate for the prevention of symptomatic COVID-19. DECLARATION is the company's biologics license application, or BLA-enabling, Phase 3 randomized, placebo-controlled clinical trial to evaluate VYD2311 efficacy and safety in prevention of symptomatic COVID in a broad population of participants including adults and adolescents. Top-line results continue to be expected in approximately late Q3.
Major Averages Close Higher as Oil Prices Rise 5%
The major averages closed higher despite the price of oil having gained roughly 5% as investors continue to monitor developments in the Middle East. While the U.S. and Iran ceasefire deal remains intact, cracks have emerged as ongoing military activity in Lebanon, disputes over compliance, and continued restrictions in the Strait of Hormuz are all raising doubts.Get caught up quickly on the top news and calls moving stocks with these five Top Five lists.1. STOCK NEWS:Meta Platformsand CoreWeaveannounced aAres ManagementWhitestone REITfor $1.7BConstellation Brandsreportedand provided its outlook for FY27Disneyis planning to make "sizable" layoffs for up to 1,000 positions,Amazonadvanced after awas seen as validating the company's potential with AI2. WALL STREET CALLS:Texas Instrumentsto Buy at StifelDatadogto Buy at GuggenheimInstacartto Outperform at Raymond JamesCircle Internetto Sell at Compass PointZscalerto Neutral at BTIG3. AROUND THE WEB:The U.S. Department of Justice has opened an investigation into the National Football League over alleged anticompetitive tactics, WSJ saysTeslahas contacted suppliers recently to discuss the details on developing a smaller, cheaper electric SUV, Reuters reportsRene Haas, CEO of chip designer Arm, is in line to lead much of the international business of parent company SoftBank, while retaining his current position at Arm, The Financial Times saysAI cloud company Nebiusis in talks to acquire Israeli AI company AI21 Labs after Nvidiapulled out of negotiations with the firm, The Information reportsSamsungis planning to invest $4B to construct a chip packaging plant in northern Vietnam as the company expands it footprint in the country, Bloomberg reports4. MOVERS:Staar Surgicalwas higher after Canaccord upgraded the stock to BuyInvivydincreased after announcing the discovery and advancement of a measles antibody candidate while also providing an update on itsAehr Test Systemsgained after entering into aStubHubwas lower after the company agreed to pay $10M to settleApplied Digitalfell after5. EARNINGS/GUIDANCE:Beyond MeatreportedSimply Good Foodsand provided guidance for Q3 and FY26BlackBerry, with EPS and revenue beating consensusOrthofixreportedand reaffirmed its guidance for FY26Neogenand raised its guidance for FY26INDEXES:The Dow rose 275.88, or 0.58%, to 48,185.80, the Nasdaq gained 187.42, or 0.83%, to 22,822.42, and the S&P 500 advanced 41.85, or 0.62%, to 6,824.66.
Major Averages Rise as Oil Prices Surpass $100
The major averages were higher near noon despite the price of oil having jumped back above the $100 per barrel mark as investors continue to monitor developments in the Middle East after the U.S. and Iran agreed to a two-week ceasefire. While the ceasefire remains intact on paper, cracks have emerged as ongoing military activity in Lebanon, disputes over compliance, and continued restrictions in the Strait of Hormuz are all raising doubts.Get caught up quickly on the top news and calls moving stocks with these five Top Five lists.1. STOCK NEWS:Meta Platformsand CoreWeaveannounced aAres ManagementWhitestone REITfor $1.7BConstellation Brandsreported uand provided its outlook for FY27Disneyis planning to make "sizable" layoffs for up to 1,000 positions,The U.S. Department of Justice has opened an investigation into the National Football League over alleged anticompetitive tactics,2. WALL STREET CALLS:Texas Instrumentsto Buy at StifelDatadogto Buy at GuggenheimInstacartto Outperform at Raymond JamesCircle Internetto Sell at Compass PointZscalerto Neutral at BTIG3. AROUND THE WEB:Teslahas contacted suppliers recently to discuss the details on developing a smaller, cheaper electric SUV, Reuters reportsRene Haas, CEO of chip designer Arm, is in line to lead much of the international business of parent company SoftBank, while retaining his current position at Arm, The Financial Times saysAI cloud company Nebiusis in talks to acquire Israeli AI company AI21 Labs after Nvidiapulled out of negotiations with the firm, The Information reportsSamsungis planning to invest $4B to construct a chip packaging plant in northern Vietnam as the company expands it footprint in the country, Bloomberg reportsNissanwill deliver roughly 1,400 vehicles that were originally meant for the Middle East to the U.S. amid disruptions to its export plans caused by the Iran war, Nikkei Asia reports4. MOVERS:Staar Surgicalhigher after Canaccordthe stock to BuyInvivydincreases after announcing theof a measles antibody candidate while also providing an update on its Phase 3 DECLARATION study of VYD2311Aehr Test Systemsgains after entering into aSpire Globallower afterat $14Applied Digitalfalls after5. EARNINGS/GUIDANCE:Beyond MeatSimply Good Foodsand provided guidance for Q3 and FY26BlackBerrywith EPS and revenue beating consensusOrthofixand reaffirmed its guidance for FY26Neogenand raised its guidance for FY26INDEXES:Near midday, the Dow was up/down xxx%, or xxx, to xxx, the Nasdaq was up/down xxx%, or xxx, to xxx, and the S&P 500 was up/down xxx%, or xxx, to xxx.
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