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News and Press Releases

Personalis Pioneers Advancement in MRD Testing with the Launch of its Real-Time Variant Tracker

New NeXT Personal extension empowers clinicians to identify emerging resistance and therapeutically targetable mutations during disease monitoring and surveillance 12 January 2026 -- California, US -- Personalis, Inc, a leader...

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

Personalis
info@personalis.com
6600 Dumbarton Circle Fremont, CA 94555 USA

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

VectorY Therapeutics Receives FDA Fast Track Designation for VTx-002, a Firstin-Class Vectorized Antibody Targeting Underlying Disease Biology in ALS

Designation enables an enhanced development path for VTx-002 and underscores its disease-modifying potential in ALS, a universally fatal disease with no cure Milestone follows recent IND clearance and supports continued...

Category: BioManufacturing, Drug Discovery, Other, Pharmaceutical
Posted: January 8, 2026

VectorY Therapeutics
info@vectorytx.com
Science Park Matrix Innovation Center 408 1098 XH Amsterdam

Acuitas Therapeutics Expands Collaboration with RNATechnologies & Therapeutics Through Strategic Investment

The investment will expand RNA Technologies & Therapeutics’ operations and allow partners of both companies to leverage combined expertise in RNA-LNP therapeutics 8 January 2026 -- British Columbia, Canada --...

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

Acuitas Therapeutics
info@acuitastx.com
6190 Agronomy Road, Suite 205. Vancouver, BC V6T 1Z3

Allogene Therapeutics Positions 2026 as a Program-Defining Year for Scalable, Real-World Allogeneic CAR T

1H 2026 Catalyst Stack Anticipated to Validate Scalable, Off-the-Shelf CAR T in Oncology and Autoimmune Disease Interim Futility Analysis of MRD Clearance from the Pivotal Phase 2 ALPHA3 Trial with...

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

Allogene Therapeutics
210 E. Grand Avenue South San Francisco, CA 94080

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

Newron Further Expands Intellectual Property Portfolio for Evenamide with New EU Composition of Matter Patent

EP4615820 – “Crystalline Forms of Evenamide” is expected to extend asset exclusivity in EU into 2044 Evenamide is currently being investigated in Newron’s global ENIGMA-TRS Phase III development program, enrolling...

Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: January 6, 2026

Newron Pharmaceuticals
info@newron.com
via Antonio Meucci 3 20091 Bresso (Mi) Italy

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

GH Research Announces FDA Lifts Clinical Hold on GH001, Clearing Path for Global Phase 3 Initiation in 2026

GH001 cleared by FDA for U.S. clinical investigation, enabling U.S. subject enrollment Company to seek FDA alignment on global Phase 3 program replicating Phase 2b design Phase 3 initiation targeted...

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

GH Research
info@ghres.com
Joshua Dawson House Dawson Street Dublin 2, D02 RY95 Ireland

Samsung Bioepis Begins Commercialization of BYOOVIZ, Biosimilar to Lucentis (Ranibizumab), in Europe

Samsung Bioepis completes full transfer of commercial rights from Biogen back to Samsung Bioepis for BYOOVIZ BYOOVIZ becomes the fourth biosimilar directly commercialized by Samsung Bioepis in Europe, following EPYSQLI...

Category: Logistics, Other, Pharmaceutical
Posted: January 2, 2026

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

MindMaze Therapeutics: Consolidating a Global Approach to Reimbursement for Next-Generation Therapeutics

23 December 2025 -- Geneva, Switzerland -- MindMaze Therapeutics Holding SA, a commercial-stage company delivering evidence-based, precision digital treatments for neurological diseases, today outlined the evolution of its global reimbursement...

Category: Logistics, Other, Pharmaceutical
Posted: December 23, 2025

MindMaze Therapeutics
info@mindmaze.com
Chemin de Roseneck 5 1006 Lausanne, Switzerland

Brainomix AI Technology Reveals Efficacy of Novel Neuroprotective Drug Candidate in Severe Acute Ischemic Stroke Patients

Brainomix 360 Stroke imaging was utilized to improve and standardize the grading of baseline stroke severity, prior to treatment in patients enrolled in Argenica Therapeutic’s Phase II study of neuroprotective...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: December 18, 2025

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

New Study Shows Extended-Release Buprenorphine Safely Delivers Rapid, Clinically Meaningful Reductions in Opioid Use and Supports Abstinence in High-Risk Populations

Both monthly maintenance doses (100 mg and 300 mg) improved opioid abstinence and were well-tolerated with no new safety signals identified Post-hoc analyses indicated the 300-mg monthly maintenance dose performed...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: December 17, 2025

Indivior
North Chesterfield, Virginia, USA