Avacta Wins FDA IND Clearance for Second pre|CISION® Cancer Drug AVA6103

The latest update is out from Avacta Group plc ( (GB:AVCT) ).

Avacta Group plc has secured U.S. Food and Drug Administration clearance for its Investigational New Drug application for FAP-Exatecan (AVA6103), the company’s second pre|CISION® medicine and its first peptide drug conjugate using the potent topoisomerase I inhibitor exatecan. The IND approval allows Avacta to advance AVA6103 from preclinical work into a Phase 1 clinical trial in the U.S., expected to start later in the first quarter of 2026, assessing safety, preliminary efficacy and dose in adults with pancreatic, cervical, gastric and small cell lung cancers using two dosing schedules, with initial data anticipated in the second half of 2026. Management frames the rapid 24‑month progression from program inception to IND as an important validation of the pre|CISION® platform and its sustained-release mechanism, which is designed to enhance anti-tumor activity while limiting toxicities seen with exatecan alone, potentially strengthening Avacta’s position in next-generation oncology therapeutics and providing clinical proof-of-concept that could support broader application of its capping group and linker technologies across multiple payloads.

The most recent analyst rating on (GB:AVCT) stock is a Hold with a £51.00 price target. To see the full list of analyst forecasts on Avacta Group plc stock, see the GB:AVCT Stock Forecast page.

Spark’s Take on GB:AVCT Stock

According to Spark, TipRanks’ AI Analyst, GB:AVCT is a Neutral.

Avacta Group plc’s overall stock score is primarily impacted by its weak financial performance and bearish technical indicators. While there is some progress in clinical programs, financial constraints and lack of partnerships remain significant risks. The stock’s valuation is unattractive due to negative earnings and no dividend yield.

To see Spark’s full report on GB:AVCT stock, click here.

More about Avacta Group plc

Avacta Therapeutics, part of Avacta Group plc, is a clinical-stage life sciences and biopharmaceutical company focused on oncology. It is developing its proprietary pre|CISION® tumor-activated drug delivery platform, which uses fibroblast activation protein (FAP) to release highly potent payloads such as peptide and Affimer® drug conjugates within the tumor microenvironment, aiming to improve efficacy while reducing systemic toxicity compared with traditional antibody-drug conjugates.

Average Trading Volume: 2,722,416

Technical Sentiment Signal: Sell

Current Market Cap: £240.6M

Learn more about AVCT stock on TipRanks’ Stock Analysis page.