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biotechs: Archive

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FDA Grants Priority Tag to Bayer's Oncology Drug for First-Line NSCLC

BAYRY wins FDA priority review for sevabertinib in first-line HER2-mutant NSCLC, building momentum for the oral TKI.

BAYRYPositive Net Change LQDAPositive Net Change IMCRPositive Net Change INDVPositive Net Change

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ImmunityBio Secures Five U.S. Patents for Anktiva in Bladder Cancer

IBRX secures five U.S. patents for Anktiva in bladder cancer, extending franchise protection through 2035 amid strong sales growth.

IMCRPositive Net Change IBRXPositive Net Change INDVPositive Net Change

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Bayer Gets FDA Priority Review for Asundexian NDA in Stroke Prevention

BAYRY gains FDA Priority Review for asundexian NDA after phase III data showed a 26% cut in ischemic stroke risk without more major bleeding.

BAYRYPositive Net Change LQDAPositive Net Change IMCRPositive Net Change INDVPositive Net Change

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Regeneron's Late-Stage Melanoma Study Misses Primary Goal

REGN's melanoma combo misses the primary endpoint in a phase III study despite longer median PFS versus Keytruda monotherapy.

REGNPositive Net Change BMYPositive Net Change MRKNegative Net Change

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AZN, Daiichi's Enhertu Gets FDA Nod for Two New Breast Cancer Settings

AstraZeneca and Daiichi win FDA approval for Enhertu in two new HER2-positive early breast cancer treatment settings.

AZNPositive Net Change RHHBYPositive Net Change LQDAPositive Net Change IMCRPositive Net Change

Sundeep Ganoria

Here's How Neuroscience Drugs Boost AbbVie's Q1 Sales Growth

ABBV's neuroscience sales jump 26% in Q1, driven by Vraylar, migraine drugs and Botox as new therapies fuel growth.

BIIBNegative Net Change JNJNegative Net Change ABBVNegative Net Change

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AstraZeneca Gets FDA Nod for New Hypertension Drug Baxfendy

AZN's Baxfendy wins FDA nod as the first aldosterone synthase inhibitor for adults with uncontrolled hypertension.

AZNPositive Net Change AMRNPositive Net Change LQDAPositive Net Change IMCRPositive Net Change

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Roche's Tecentriq Wins FDA Nod for Label Expansion in Bladder Cancer

RHHBY wins FDA approval for Tecentriq label expansion as a ctDNA-guided adjuvant therapy for bladder cancer patients at high risk of recurrence.

RHHBYPositive Net Change AMRNPositive Net Change IMCRPositive Net Change INDVPositive Net Change

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Keros Q1 Loss Wider Than Expected, Revenues Plunge Year Over Year

KROS posts a wider Q1 loss as revenues fall due to the absence of license revenues. The company advances rinvatercept and elritercept studies.

AMRNPositive Net Change LQDAPositive Net Change KROSPositive Net Change INDVPositive Net Change

Sundeep Ganoria

How Important Are Skyrizi and Rinvoq to AbbVie's Q1 Results?

ABBV's Q1 beat is powered by Skyrizi and Rinvoq, whose strong sales growth offset Humira declines and boosts 2026 guidance.

JNJNegative Net Change LLYNegative Net Change ABBVNegative Net Change