FDA & Biotech
15 minutes ago

Skye Bioscience Stock Plummets 60% on Failed Obesity Drug Trial

Nimacimab monotherapy misses primary weight-loss endpoint, though combination with semaglutide shows promise, raising questions for the drug's future.

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FDA & Biotech
3 hours ago

Spruce Biosciences Stock Soars Over 1400% on FDA Drug Designation

FDA grants Breakthrough Therapy status for a promising new drug targeting the rare and fatal Sanfilippo Syndrome Type B.

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FDA & Biotech
4 hours ago

Arcutis Stock Climbs on FDA Nod for Children's Eczema Cream

The biotech firm secured its sixth approval for the ZORYVE franchise, expanding its dermatology treatment to children as young as two.

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Earnings
7 hours ago

Aehr Test Systems Stock Dives Over 12% on Mixed Q1 Earnings Report

Despite a revenue beat, the semiconductor equipment supplier's net loss and missed earnings per share estimates sent shares tumbling in after-hours trading.

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FDA & Biotech
19 hours ago

Alvotech Gains EU Agency Acceptance for Xolair Biosimilar

The marketing application for AVT23, a biosimilar to the multi-billion dollar asthma drug Xolair, marks a key regulatory step for Alvotech in the European market.

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Earnings
23 hours ago

Constellation Brands Earnings to Test Consumer Spending Appetite

Investors are closely watching the beverage giant's Q3 results on Monday for insights into the health of the alcoholic beverage market.

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FDA & Biotech
23 hours ago

Nyxoah Begins US Commercial Rollout of Genio Sleep Apnea Implant

First patients implanted with the novel neurostimulator marks a key step in challenging market leader Inspire Medical after recent FDA approval.

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FDA & Biotech
1 day ago

Alto Neuroscience Soars 56% on FDA Fast Track for Schizophrenia Drug

The designation for ALTO-101 targets cognitive impairment, a debilitating condition with no currently approved treatments, signaling a major regulatory milestone.

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