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Co-Diagnostics seeks FDA clearance for new PCR Flu A/B & RSV test, prepping for U.S. launch.

Market News
18 Aug 2026
PRNewsWire
View Source
Bullish
Co-Diagnostics seeks FDA clearance for new PCR Flu A/B & RSV test, prepping for U.S. launch.

Co-Diagnostics, a molecular diagnostics firm, announced its submission of a 510(k) premarket notification to the FDA for its Co-Dx PCR Flu A/B & RSV multiplex test on the Co-Dx PCR Pro® platform. This test, developed during the pandemic, is pending FDA clearance and aims to expand PCR diagnostic access globally. The company is preparing for a potential U.S. launch while pursuing international regulatory approvals. Their Chief Commercialization Officer also recently discussed medical device innovation and AI impacts at a Salt Lake City industry event.

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Celldex Therapeutics upgraded to Buy after positive Phase 3 trial results for skin drug barzolvolimab.

Celldex Therapeutics upgraded to Buy after positive Phase 3 trial results for skin drug barzolvolimab.

Celldex Therapeutics received a Buy rating upgrade from H.C. Wainwright, with the price target raised to $64 from $42, following successful Phase 3 clinical trials of barzolvolimab. The drug showed rapid and lasting benefits for patients with a chron...

Analyst Insights
Bullish
3 hours ago
dLocal drives growth in emerging markets with single integration, trades at discount to peers amid margin pressures

dLocal drives growth in emerging markets with single integration, trades at discount to peers amid margin pressures

dLocal offers a unified payment gateway enabling global merchants to access over 60 emerging markets, fueling strong transaction volume and revenue growth. Although its take-rate has compressed to 0.71%, this is mainly due to merchant mix, volume tie...

Analyst Insights
Bullish
4 hours ago
Qualcomm launches Snapdragon 8 Elite Gen 6 chips focused on AI for premium Android phones.

Qualcomm launches Snapdragon 8 Elite Gen 6 chips focused on AI for premium Android phones.

Qualcomm introduced its Snapdragon 8 Elite Gen 6 chipsets, designed for high-end Android smartphones with enhanced on-device AI capabilities. Built using TSMC's 2-nanometer process, these chips target premium brands like Motorola, Xiaomi, and ZTE ami...

Market News
Bullish
4 hours ago
Simmons First National to hold Investor Day on Dec 10, outlining future strategies in NYC.

Simmons First National to hold Investor Day on Dec 10, outlining future strategies in NYC.

Simmons First National Corporation announced it will host an Investor Day on December 10, 2026, in New York City. The event will feature presentations by CEO Jay Brogdon, CFO Daniel Hobbs, and other executives discussing the company's strategic prior...

Market News
Neutral
4 hours ago
Quest Diagnostics to report Q3 2026 earnings on October 22 before market opens

Quest Diagnostics to report Q3 2026 earnings on October 22 before market opens

Quest Diagnostics announced it will release its third quarter 2026 financial results on October 22, 2026, before the market opens. The company will hold a conference call at 8:30 a.m. Eastern Time to discuss the results, accessible via phone and webc...

Company Fundamentals
Neutral
4 hours ago
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