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News and Press Releases

Alzheon to Present Multiple Clinical, Neuroimaging and Modeling Results for Oral Valiltramiprosate/ALZ-801 from Phase 2 and 3 Studies at CTAD Conference in San Diego, December 1–4, 2025

Valiltramiprosate Demonstrates Potential as the First Oral Disease-Modifying Agent to Slow Alzheimer’s Pathology, Indicated by Both Clinical and Volumetric MRI Data Nine Posters Showcase Consistent Benefits of Oral Valiltramiprosate in...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: November 19, 2025

Alzheon
111 Speen Street, Suite 306 Framingham, MA 01701

Annovis Announces FDA Meeting to Discuss Parkinson’s Disease Dementia Program; Reaffirms FDA Alignment on Pivotal Phase 3 Alzheimer’s Disease Study

18 November 2025 -- Pennsylvania, US -- Annovis Bio, Inc, a late-stage clinical drug platform company pioneering transformative therapies for neurodegenerative diseases such as Alzheimer's disease (AD) and Parkinson's disease...

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

Annovis
info@annovisbio.com
101 Lindenwood Drive, Suite 225 Malvern, PA 19355

ONWARD Medical Receives FDA 510(k) Clearance Expanding ARC-EX System Indication for Home Use

US FDA clearance now allows use of the ARC-EX System both in clinics and homes ARC-EX is the first and only FDA-cleared technology demonstrated to improve hand strength and sensation...

Category: Biotechnology, Other, Pharmaceutical
Posted: November 17, 2025

ONWARD Medical
investors@onwd.com
Schimmelt 2. 5656 AE, Eindhoven, the Netherlands

Eisai presents 4-year Leqembi (lecanemab) open-label extension data from post-hoc sub-group analysis at German neurology congress

Clarity AD open-label extension data show that after four years of continuous lecanemab treatment in apolipoprotein E ε4 (ApoE ε4*) non-carriers and heterozygotes, patients continued to accrue benefit relative to...

Category: Clinical Trials, Other, Pharmaceutical
Posted: November 12, 2025

Eisai
4-6-10 Koishikawa, Bunkyo-ku, Tokyo 112-8088, Japan

Commit Biologics achieves proof-of-concept for novel Complement Engager platform in non-human primates

Novel approach harnessing the power of the complement system to drive potent cell depletion Single-dose study shows rapid and sustained immune cell depletion in blood and tissues with a very...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: November 11, 2025

Commit Biologics
info@commitbio.com
Universitetsbyen 83 8000 Aarhus C, Denmark

Heidelberg Pharma’s Lead ATAC Candidate HDP-101 Shows Progress in Phase I/IIa Trial in Multiple Myeloma

Evidence of clinical activity observed in Cohort 8, including stringent complete remission in two patients from Cohort 8 HDP-101 continues to demonstrate a favorable safety profile with no dose-limiting toxicities...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: November 6, 2025

Heidelberg Pharma
info@hdpharma.com
Gregor-Mendel-Straße 22 68526 Ladenburg Deutschland

Valneva Reports Positive Results for Phase 1 Trial of Second-Generation Zika Vaccine Candidate

Immune response successfully improved with second generation vaccine candidate4 November 2025 -- Saint-Herblain, France -- Valneva SE, a specialty vaccine company, today announced positive results of its Phase 1 clinical...

Category: BioManufacturing, Biotechnology, Clinical Trials, Drug Delivery, Other, Pharmaceutical
Posted: November 4, 2025

Valneva
communications@valneva.com
6 rue Alain Bombard, 44800 Saint-Herblain, France

Intellia Therapeutics Provides Update on MAGNITUDE Clinical Trials of Nexiguran Ziclumeran (nex-z)

27 October 2025 -- Massachusetts, US -- Intellia Therapeutics, Inc, a leading clinical-stage gene editing company focused on revolutionizing medicine with CRISPR-based therapies, today announced that the company has temporarily...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: October 27, 2025

Intellia Therapeutics
medicalinformation@intelliatx.com
40 Erie Street, Suite 130, Cambridge, MA 02139

Heidelberg Pharma’s Lead ADC Candidate HDP-101 Granted Fast Track Designation by US FDA for the Treatment of Multiple Myeloma

Recognizes the potential of HDP-101 to address a serious or life-threatening condition with high unmet medical needs Enables more frequent engagement with FDA and eligibility for rolling review to support...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: October 23, 2025

Heidelberg Pharma
info@hdpharma.com
Gregor-Mendel-Straße 22 68526 Ladenburg Deutschland

SOM Biotech secures clear registrational path for SOM3355 in Huntington’s disease after FDA End‑of‑Phase 2 Meeting

20 October 2025 -- Barcelona, Spain -- SOM Biotech, a clinical-stage company dedicated to the discovery and development of innovative therapies for rare central nervous system disorders, announces today that it...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: October 20, 2025

SOM Biotech
Baldiri Reixac, 4 (08028) Barcelona, Spain

Iksuda presents encouraging IKS014 Phase 1 data at ESMO

New safety, efficacy and pharmacokinetic results presented from dose escalation portion of the study Anti-tumour activity observed across all dose levels and in various tumour indications 20 October 2025 --...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: October 20, 2025

Iksuda
The Biosphere, Draymans Way, Newcastle Helix Newcastle upon Tyne NE4 5BX

NuCana Presents Encouraging Data on NUC-7738 in Combination with PD-1 Inhibitors using Primary Patient-Derived Organoids and Autologous Tumor-Infiltrating Lymphocytes at the ESMO Congress 2025

NUC-7738 Synergizes with PD-1 Inhibitors to Promote Cancer Cell Death Data Reinforces Mechanism of Action along with Efficacy and Safety Profile of NUC-7738. 18 October 2025 -- Berlin, Germany --...

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

NuCana
https://www.nucana.com/
https://www.nucana.com/

ANI Pharmaceuticals Announces NEW DAY Clinical Trial Results to be Presented in Late-Breaking Oral Presentation at the American Academy of Ophthalmology 2025 Meeting

Presentation at AAO 2025 part of ongoing NEW DAY data dissemination at medical meetings 16 October 2025 -- New Jersey, US -- ANI Pharmaceuticals, Inc today announced that results from...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: October 16, 2025

ANI Pharmaceuticals
210 Main Street West Baudette, MN 56623

Tonix Pharmaceuticals Presented an Update on Fc-modified anti-CD40L mAb, TNX-1500, at the 61st Annual Congress of the Japan Society for Transplantation

14 October 2025 -- New Jersey, US -- Tonix Pharmaceuticals Holding Corp, a fully integrated biotechnology company with marketed products and a pipeline of development candidates, today announced that Seth...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: October 14, 2025

Tonix Pharmaceuticals
info@tonixmedicines.com

Iksuda to present IKS014 Phase 1 data at ESMO

14 October 2025 -- Newcastle, UK -- Iksuda Therapeutics (Iksuda), the developer of class-leading antibody drug conjugates (ADCs), will present new data from its Phase 1 study of IKS014, a...

Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: October 14, 2025

Iksuda
The Biosphere, Draymans Way, Newcastle Helix Newcastle upon Tyne NE4 5BX