With the arrival of the holiday season, we would like to share with you a summary of 2025 — a year that has marked a decisive turning point in the history of Biogenera.
It has been a year of intense work, concrete achievements, and significant progress bringing us closer — more than ever before — to the company’s primary goal: to bring new treatments to children and adults affected by aggressive tumors, where current alternatives are scarce or nonexistent.
Today, we can proudly say: we have entered the closest stage to the clinic since our foundation.
A historic milestone: the first BGA002 clinical vials are ready
We are delighted to share with you this symbolic image: the first sterile clinical vials of the new antitumor drug BGA002 — based on PNA technology — have now been officially produced.
This is tangible confirmation that our development path is moving forward in the right direction, and with success. From idea, to research, to preclinical validation — and now, to the clinical vial. A moment in which vision becomes reality.
GMP production completed: a breakthrough achievement
In 2025, we successfully completed:
- the GMP production of the BGA002 API,
- the large-scale industrial process
This is the first time in the world that an anti-gene PNA oligonucleotide has been produced at industrial scale under full GMP standards for human use.
Orphan Drug Designation: U.S. recognition for Soft Tissue Sarcomas
In the final quarter of 2025, BGA002 received Orphan Drug Designation from the U.S. FDA for soft tissue sarcomas.
We are already working to extend the designation to additional oncology indications. This recognition reflects: scientific validation - regulatory prioritization - commercial and development advantages - enhanced intellectual property protection
Regulatory dossier advancement: EMA authorization for Phase I/II clinical trial
Biogenera is currently finalizing the regulatory dossier addressed to the EMA (European Medicines Agency), required to obtain authorization to begin the Phase I/II clinical trial of BGA002.
The study will enroll pediatric patients affected by aggressive tumors with MYCN gene alteration who do not respond to conventional treatments.
This is a crucial step in the clinical development of the drug, marking a fundamental transition: from laboratory to human clinical testing. It confirms the scientific and regulatory strength of the project, while also demonstrating full industrial readiness for BGA002’s entry into the European clinical environment.
Active international collaborations
In 2025, we strengthened our global scientific network with leading partners, including:
- University of Chicago, where joint studies on MYCN and neuroblastoma are ongoing
- additional academic institutions in Italy, France, and Germany
- expanding preclinical activities in adult oncology
Longevity Initiative
2025 also marked the preliminary launch of the Longevity Initiative: a new strategic area aimed at applying PNA technology to aging and preventive medicine — opening therapeutic and diagnostic opportunities.
A path designed to generate value, partnerships, and new industrial directions.
Our presence worldwide
Throughout 2025, Biogenera took part in major global events and international conferences, including:
- Swiss Biotech Day (Switzerland)
- BIO International (USA)
- ISPE (USA)
- SIOP (Netherlands)
- BIO Europe (Italy & Austria)
Looking Ahead
2026 will be a key year:
- anticipated start of the BGA002 Phase I clinical trial
- expansion of international collaborations
- growth of the pipeline
- renewed evaluation of potential listing scenarios
We are ready to enter a new dimension of growth.
Thank you
On behalf of the entire Biogenera team, we wish to express our sincere appreciation — this journey would not have been possible without each of you.
The path is demanding, but progress is real, solid, and visible.
We wish you a peaceful Christmas and a 2026 full of health, confidence, and new achievements.
With appreciation,
Biogenera SpA
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