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News and Press Releases

Dawnzera (donidalorsen) granted European Union marketing authorisation for the prevention of hereditary angioedema

Donidalorsen is a first-in-class RNA-targeted prophylactic therapy for patients with hereditary angioedema (HAE) Donidalorsen demonstrated a significant reduction in HAE attack rate compared with placebo in the Phase 3 OASIS-HAE...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: January 21, 2026

Otsuka Pharmaceutical Europe Ltd
medical.information@otsuka-europe.com
Gallions Wexham Springs Framewood Road Wexham SL3 6PJ

Levicept Announces FDA Acceptance of IND Application for LEVI-04, a Potentially Disease-Modifying Treatment for Osteoarthritis

20 January 2026 -- Sandwich, UK -- Levicept Ltd, a biotechnology company focused on the development of LEVI-04, a first-in-class treatment for osteoarthritis (OA), today announces the US Food and...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: January 20, 2026

Levicept
info@levicept.com
Innovation House Discovery Park Ramsgate Road Sandwich Kent CT13 9ND

Brainomix e-Lung AI Imaging Technology Selected as Co-Primary Endpoint in Boehringer Ingelheim Phase 3 Clinical Trial in Pulmonary Fibrosis 

The DROP-FPF trial is the first Phase 3 trial in interstitial lung disease (ILD) to use automated, quantitative high-resolution CT scan (HRCT) imaging biomarkers as a co-primary endpoint 20 January...

Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: January 20, 2026

Brainomix
investors@brainomix.com
First Floor, Seacourt Tower West Way Oxford OX2 0JJ

Neurizon Secures Global Trademark Protection Across Key Markets

Neurizon has secured registered trademark protection for NEURIZON across all priority global markets, including the United States, the European Union, the United Kingdom, Australia and Japan Completion of the US...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: January 20, 2026

Neurizon Therapeutics
enquiries@neurizon.com
Level 4, 96-100 Albert Road South Melbourne, VIC 3205 Australia

Exciva raises €51 million ($59m) in Series B funding round co-led by Gimv and EQT

20 January 2026 -- Heidelberg, Germany -- Exciva GmbH, a biopharmaceutical company developing novel therapeutic compounds for the treatment of neuropsychiatric conditions, today announces the closing of a €51 million ($59m)...

Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: January 20, 2026

Exciva
info@exciva.com
Hauptstrasse 25, 69117 Heidelberg, Germany

Axsome Therapeutics Initiates FORWARD Phase 3 Trial of AXS-14 for the Management of Fibromyalgia

15 January 2026 -- New York, US -- Axsome Therapeutics, Inc, a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced the first patient...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: January 15, 2026

Axsome Therapeutics
info@axsome.com
One World Trade Center, New York, NY 10007

Samsung Epis Holdings Delivers Business Updates at the 44th J.P. Morgan Healthcare Conference

Samsung Bioepis plans to secure 20 biosimilars in its products and pipeline by 2030 The new pipeline will include dupilumab, guselkumab, ixekizumab, fam-trastuzumab deruxtecan-nxki, vedolizumab, and ocrelizumab, in addition to...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: January 15, 2026

Samsung Bioepis
76, Songdogyoyuk-ro, Yeonsu-gu, Incheon

Alto Neuroscience Strengthens Intellectual Property Portfolio with Issuance of New Method-of-Treatment Patent for ALTO-207 in Depression

Issued and pending claims expected to protect ALTO-207 into the mid-2040s 14 January 2026 -- California, US -- Alto Neuroscience, Inc, a clinical-stage biopharmaceutical company focused on the development of...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: January 14, 2026

Alto Neuroscience
info@altoneuroscience.com
650 Castro Street, Suite 450 Mountain View, CA 94041

Adial Pharmaceuticals Announces Publication of International PCT Patent Application to Protect Core Assets and Extend IP Exclusivity to at least 2045

New patent based on treatment of populations identified to be particularly responsive to ondansetron treatment after examination of Adial’s clinical data and information 14 January 2026 -- Virginia, US --...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: January 14, 2026

Natera Announces Next Breakthrough in MRD-Based Risk Stratification, Leveraging Multi-Modal AI Modeling

New AI-derived model integrates longitudinal ctDNA and clinical data with digital pathology and tumor sequencing data, to refine recurrence risk assessment and outcomes prediction 13 January 2026 -- Texas, US...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: January 13, 2026

Natera
13011 McCallen Pass Building A Suite 100 Austin, TX 78753

ConcertAI and Foundation Medicine Integrate Genomic and Clinical Data to Transform Translational Research and Efficient Drug Development

ConcertAI now offers industry’s most comprehensive clinically-linked dataset to life science organizations Dataset encompasses ConcertAI’s full network of industry partners, representing nearly half a million patients Applications span entire drug...

Category: Biotechnology, Drug Discovery, Other, Pharmaceutical
Posted: January 12, 2026

Foundation Medicine
Biopharma.leads@foundationmedicine.com
400 Summer Street, Boston, MA 02210

Relmada Therapeutics Provides Regulatory Update Confirming FDA Alignment on Registrational Studies Design for NDV-01 for Two Separate Indications

FDA written feedback supports: a single-arm, open-label registrational trial in 2nd-line refractory high-grade NMIBC with CIS a randomized vs observation single trial in intermediate-risk NMIBC in the adjuvant setting Phase...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: January 12, 2026

Relmada Therapeutics
info@relmada.com
2222 Ponce de Leon Blvd. Floor 3 Coral Gables, FL 33134

MindMed Rebrands to Definium Therapeutics, Advancing a Leading Late-Stage Psychiatry Pipeline with Three Phase 3 Readouts Expected in 2026

Topline Data from Three Phase 3 Studies Evaluating DT120 Orally Disintegrating Tablet (ODT) for GAD and MDD Expected in 2026: Voyage in 2Q, Panorama in 2H, and Emerge Mid-Year Company...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: January 12, 2026

Definium Therapeutics
Media@definiumtx.com
One World Trade Center Suite 8500 New York, NY 10007, United States

AskBio Announces FDA Acceptance of Investigational New Drug (IND) Application for AB-1009 Gene Therapy for Treatment of Late-Onset Pompe Disease (LOPD)

AB-1009 program advances to Phase 1/Phase 2; clinical trial initiated in the United States Therapy granted United States Food and Drug Administration (FDA) Fast Track and Orphan Drug designations Pompe...

Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: January 8, 2026

AskBio
info@askbio.com
20 T.W. Alexander Drive Suite, 110 Research Triangle Park, NC 27709

MapLight Therapeutics Receives Fast Track Designation for ML-007C-MA for Alzheimer’s Disease Psychosis

5 January 2026 -- California and Massachusetts, US -- MapLight Therapeutics, Inc today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ML-007C-MA, an...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: January 5, 2026

MapLight Therapeutics
info@maplightrx.com
800 Chesapeake Drive, Redwood City, California 9406