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Moderna takes on traditional flu vaccines with global filings for mRNA-1010

Moderna (NASDAQ:MRNA) officially moved to challenge the multi-billion-dollar seasonal influenza market today, submitting marketing authorization applications for its investigational vaccine, mRNA-1010, to regulators in the U.S., Europe, Canada, and Australia.

Leia mais: Moderna takes on traditional flu vaccines with global filings for mRNA-1010
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Zenas BioPharma announces positive Phase 3 results for obexelimab in IgG4-related disease

Zenas BioPharma (NASDAQ:ZBIO), a clinical-stage global biopharmaceutical company focused on developing transformative immunology-based therapies for autoimmune diseases, today announced positive topline results from the Phase 3 INDIGO registrational trial evaluating obexelimab in patients with Immunoglobulin G4-Related Disease (IgG4-RD).

Leia mais: Zenas BioPharma announces positive Phase 3 results for obexelimab in IgG4-related disease
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Neumora’s Alzheimer’s candidate slashes agitation scores in early trial

Neumora Therapeutics (NASDAQ:NMRA), a clinical-stage biopharmaceutical company focused on developing novel therapies for neuropsychiatric disorders and neurodegenerative diseases, today reported positive topline results from a Phase 1b signal-seeking study evaluating NMRA-511 as a potential treatment for agitation in patients with Alzheimer's disease.

Leia mais: Neumora’s Alzheimer’s candidate slashes agitation scores in early trial
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Gyre Therapeutics clears regulatory path for first-in-class liver fibrosis drug in China

Gyre Therapeutics (NASDAQ:GYRE) is moving toward a landmark commercial entry in China after securing alignment with the Center for Drug Evaluation (CDE) on a conditional approval pathway for its lead anti-fibrotic candidate, Hydronidone (F351).

Leia mais: Gyre Therapeutics clears regulatory path for first-in-class liver fibrosis drug in China
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HUTCHMED advances to Phase III in promising pancreatic cancer trial

HUTCHMED (NASDAQ:HCM) announced today that it has initiated the Phase III stage of its ongoing Phase II/III trial evaluating the combination of surufatinib, camrelizumab, nab-paclitaxel, and gemcitabine (S+C+AG) as a first-line treatment for patients with metastatic pancreatic ductal adenocarcinoma (PDAC) in China.

Leia mais: HUTCHMED advances to Phase III in promising pancreatic cancer trial
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Mesoblast reshuffles board for commercial pivot as Ryoncil sales surge

Mesoblast (NASDAQ:MESO) has implemented a sweeping reorganization of its Board of Directors, effective January 1, 2026, signaling a definitive shift from a research-heavy biotech to a revenue-driven commercial entity.

The leadership transition follows the company's most transformational period, highlighted by the December 2024 FDA approval and subsequent 2025 launch of Ryoncil (remestemcel-L).

Leia mais: Mesoblast reshuffles board for commercial pivot as Ryoncil sales surge
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Evotec names Sarah Fakih as global comms and IR chief

Evotec SE (NASDAQ: EVO) announced on January 2, 2026, the appointment of Dr. Sarah Fakih as Executive Vice President, Head of Global Communications and Investor Relations.

In this newly created strategic role, Dr. Fakih will lead an integrated function designed to synchronize Evotec’s corporate messaging with its capital markets strategy.

Leia mais: Evotec names Sarah Fakih as global comms and IR chief
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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