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FibroBiologics files for first human trial of novel psoriasis therapy

FibroBiologics (NASDAQ:FBLG) took a decisive step toward clinical-stage operations on Wednesday, filing an Investigational New Drug (IND) application with the U.S. Food and Drug Administration to begin Phase 1/2 trials for its lead psoriasis candidate, CYPS317.

Leia mais: FibroBiologics files for first human trial of novel psoriasis therapy
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Axsome jumps as FDA grants priority review for Alzheimer’s agitation drug

Axsome Therapeutics (NASDAQ:AXSM) shares edged higher Wednesday after the U.S. Food and Drug Administration (FDA) granted Priority Review to its supplemental New Drug Application (sNDA) for AXS-05, a treatment targeting the pervasive and distressing agitation associated with Alzheimer’s disease.

Leia mais: Axsome jumps as FDA grants priority review for Alzheimer’s agitation drug
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Cycurion reports $80M contracted backlog and strong liquidity

Cycurion closed 2025 with a strong financial position, reporting an $80 million contracted backlog and bolstered liquidity as the company accelerates into 2026.

For the third quarter of 2025, Cycurion, which trades on the Nasdaq under the ticker CYCU, reported revenue of $3.83 million, a 13.9% year-over-year decrease. However, total assets grew to $32.31 million, an increase of 26.4%, and cash reserves rose significantly to $3.65 million, compared to just $0.04 million at the end of 2024.

The company saw net financing inflows of $10.78 million and is forecasting a Q1 2026 run-rate revenue of approximately $4.17 million, which would annualize to around $16.66 million.

Recent business wins include a multi-year telecom deployment with potential revenue exceeding $1 million, a state and local government data modernization project, and a $1.1 million county contract. Cycurion also declared a pro-rata share dividend of $0.0080 per share, payable around December 30, 2025.

Cycurion’s strategic focus on government and commercial sectors continues to drive growth as the company strengthens its foundation for expansion into 2026.

Leia mais: Cycurion reports $80M contracted backlog and strong liquidity
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Denali’s brain-penetrant therapy shows 91% biomarker reduction in Hunter syndrome

Denali Therapeutics (NASDAQ:DNLI) announced promising Phase 1/2 results for tividenofusp alfa (DNL310) in the treatment of Hunter syndrome, with the data published in The New England Journal of Medicine supporting an FDA Priority Review. The FDA has set a Prescription Drug User Fee Act (PDUFA) date for April 5, 2026.

Leia mais: Denali’s brain-penetrant therapy shows 91% biomarker reduction in Hunter syndrome