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News and Press Releases

IMAAVY (nipocalimab)▼shows over two years of sustained disease control in a broad population with generalised myasthenia gravis (gMG)

Through 120 weeks of follow-up, nipocalimab delivered sustained clinical improvements and reductions in total IgG in antibody-positive adult patients including anti-AChR+ and anti-MuSK+ Patients achieving sustained minimal symptom expression (MSE)...

Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: April 22, 2026

Johnson & Johnson Innovative Medicine
mediaenquiries@its.jnj.com
Janssen-Cilag Limited 50-100 Holmers Farm Way High Wycombe Buckinghamshire HP12 4EG

U.S. FDA Grants Priority Review to sBLA for PADCEV + Keytruda as Perioperative Treatment for Muscle-Invasive Bladder Cancer Regardless of Cisplatin Eligibility

Submission based on statistically significant event-free and overall survival data from the Phase 3 EV-304 trial Building on the existing indication in cisplatin-ineligible muscle-invasive bladder cancer (MIBC), if approved, this...

Category: Biotechnology, Clinical Trials, Other, Pharmaceutical
Posted: April 20, 2026

Astellas
2-5-1, Nihonbashi-Honcho, Chuo-Ku, Tokyo 103-8411, Japan

FundaMental Pharma to showcase groundbreaking approach to treatment-resistant depression at Bio-Neuroscience Conference

Presentation will highlight lead clinical candidate FMP374, a novel dual-acting NMDAR modulator advancing toward IND-enabling studies for TRD 17 February 2026 -- Heidelberg, Germany -- FundaMental Pharma GmbH, a preclinical-stage...

Category: Biotechnology, Drug Discovery, Other, Pharmaceutical
Posted: February 17, 2026

FundaMental Pharma
info@fundamentalpharma.com
Nikola-Tesla-Straße 1 D-69124 Heidelberg / Germany

Newron Notes Publication Highlighting Clinically Meaningful Benefits of Evenamide as an Adjunctive Treatment in Schizophrenia

Publication presents clinical findings highlighting evenamide’s glutamatergic modulation as a therapeutic strategy for patients with inadequate response or treatment-resistant schizophrenia (TRS) By targeting the hippocampus region of the brain, evenamide...

Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: February 3, 2026

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

MetP Pharma’s Neural Targeting Drug Delivery Technology Sets a New Benchmark for Brain Delivery of Peptides

Intranasal nose-to-brain delivery achieves superior brain exposure with low systemic burden, outperforming transporter-based BBB technologies in preclinical studies 29 January 2026 -- Emmetten, Switzerland -- MetP Pharma AG, a pioneer...

Category: Biotechnology, Drug Delivery, Other, Pharmaceutical
Posted: January 29, 2026

MetP Pharma
info@mattern-pharma.com
Schynweg 7 Office: St. Anna-Weg 16 P.O.Box 138 6376 Emmetten / Switzerland

Bial Achieves Key Milestone in Phase 2b ACTIVATE Study ofBIA 28-6156 in GBA1-Associated Parkinson’s Disease

75% of patients have completed the Week 78 Last Study Visit Topline results expected in mid-2026 27 January 2026 -- Porto, Portugal -- Bial, an innovation-driven biopharmaceutical company focused on...

Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: January 27, 2026

Bial
À Avenida da Siderurgia Nacional 4745-457 Coronado (S. Romão e S. Mamede) Portugal

Recipharm expands manufacturing to meet demanding FDA requirements

Established a new, dedicated non-bacterial beta-lactam manufacturing facility in response to FDA guidance Secured a strategic partnership with an innovative biopharma company seeking rapid regulatory compliance Developed a scalable platform...

Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: January 26, 2026

Recipharm

Journal of Prevention of Alzheimer’s Disease publishes trial results showing HMTM potentially offers accessible oral treatment option for patients with early Alzheimer’s disease

26 January 2026 -- Scotland, UK -- TauRx Therapeutics Management Ltd today announced results from its Phase III LUCIDITY trial evaluating the efficacy and safety of hydromethylthionine mesylate (HMTM) in...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: January 26, 2026

TauRx Therapeutics
andy.groundwater@taurx.com
395 King Street Aberdeen AB24 5RP United Kingdom

MetP Pharma’s Enabling Technology Creates a New Brain-Targeted GLP-1 Opportunity

Preclinical data in rats demonstrate dose-dependent and rapid brain targeting of intranasal semaglutide with low systemic exposure 22 January 2026 -- Emmetten, Switzerland -- MetP Pharma AG, a pioneer in nose-to-brain...

Category: Biotechnology, Clinical Trials, Drug Delivery, Other, Pharmaceutical
Posted: January 22, 2026

MetP Pharma
info@mattern-pharma.com
Schynweg 7 Office: St. Anna-Weg 16 P.O.Box 138 6376 Emmetten / Switzerland

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

Meeting with Two Scientific Poster Presentations and Hot Topic Presentation

16 January 2026 -- New York, US -- AtaiBeckley Inc, a clinical-stage biotechnology company on a mission to transform patient outcomes by developing rapid-acting, durable and convenient mental health treatments,...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: January 16, 2026

Atai Beckley
250 West 34th Street New York, NY 10119

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

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