Theriva Biologics Aktie

Theriva presented results from the randomized phase-2b VIRAGE study at the AACR annual meeting, comparing VCN-01 plus gemcitabine/nab-paclitaxel with standard therapy. The poster presentation includes tumor response, biomarker and subgroup analyses and, according to the company, shows improved outcomes in several subgroups, including patients with liver metastases, as well as indications of an immune-mediated mechanism of action for VCN-01. Theriva reports consultations with the FDA and EMA on a planned registrational phase-3 trial and plans additional studies to optimize dosing. The stock trades low at about $0.25 with a small market capitalization, though analysts have price targets between $1 and $4. » Plus sur de.investing.com

The extraordinary shareholders' meeting of Theriva Biologics could not be held because not enough shares were present or represented; votes were to be held on the exercise of warrants and a motion to adjourn. Under an agreement with investors, the company must now convene a new meeting every 60 days until approval is granted, waived, or the warrants expire. With a market capitalization of around USD 11 million, Theriva continues to burn cash, making proceeds from warrant exercises important for operations. At the same time, Theriva received the FDA's agreement in principle on the Phase‑3 study design for VCN‑01 in combination with standard chemotherapy for metastatic pancreatic cancer. » Plus sur de.investing.com

The CHMP of the EMA has broadly endorsed the design proposed by Theriva Biologics for a pivotal phase‑3 study of VCN‑01 in combination with standard chemotherapy for metastatic pancreatic cancer, including sample size, repeated dosing, an adaptive approach and the proposed macrocycle dosing regimen. The EMA acknowledged improved survival data after multiple doses of VCN‑01 from earlier studies. The news triggered a 25.4% rise in pre‑market trading. Theriva plans an end‑of‑phase‑2 meeting with the FDA in H1 2026 to finalize a multinational phase‑3 protocol and is also evaluating a phase‑2/3 study for retinoblastoma; cash and equivalents amounted to USD 15.5 million as of 10 Nov 2025, sufficient through Q1 2027 assuming additional partnerships for manufacturing and studies. » Plus sur de.investing.com