Abbisko Therapeutics' NDA for Pimicotinib Accepted by FDA, Promising Significant Tumor Treatment Improvements
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 1h ago
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Source: PRnewswire
- NDA Acceptance: Abbisko Therapeutics' New Drug Application for the oral small-molecule CSF-1R inhibitor, pimicotinib (ABSK021), targeting tenosynovial giant cell tumor (TGCT), has been formally accepted by the FDA, marking a significant step towards global market entry and promising effective treatment options for patients.
- Clinical Trial Results: The Phase III MANEUVER trial demonstrated that TGCT patients treated with pimicotinib achieved a statistically significant improvement in objective response rate (ORR) at Week 25, highlighting the drug's potential to enhance patient quality of life and its clinical significance.
- Broad Market Potential: Pimicotinib has received approval from the NMPA in China and is progressing through regulatory submissions in other markets, expected to address the urgent treatment needs of TGCT patients and enhance Abbisko's competitive position in the market.
- Strategic Partnership: Abbisko has entered into a licensing agreement with Merck KGaA for the global commercialization of pimicotinib, further strengthening the company's market positioning and resource integration capabilities to support its expansion in international markets.
Analyst Views on 02256
Wall Street analysts forecast 02256 stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for 02256 is USD with a low forecast of USD and a high forecast of USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
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About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
