1. RemeGen's RC148 approved for Phase II trials in the U.S. 2. The antibody targets PD-1 and VEGF for solid tumors. 3. FDA approval accelerates the global development of RC148. 4. Current trials are ongoing in China for the same treatment. 5. RC148 is a significant innovation in cancer therapy.
FDA clearance tends to positively affect stock prices; precedent examples show price surges following similar approvals in biotech. For instance, companies like Moderna saw significant stock growth after FDA validation of their candidates.
The article discusses a major milestone for RemeGen’s product that could attract investor interest, influencing stock performance significantly. The successful advancement of RC148 displays RemeGen's capacity for innovation and market reach.
Immediate market reaction is anticipated due to FDA approval, historically leading to short-term price increases as investors respond. Companies typically benefit from short-term momentum post-regulatory announcements.
YANTAI, China, Aug. 8, 2025 /PRNewswire/ -- On August 8th, RemeGen Co., Ltd. (688331.SH/09995.HK) announces clearance of IND application by Food and Drug Administration (FDA) for phase II clinical trials for its independently-developed bispecific antibody, RC148, for the treatment of multiple advanced malignant solid tumors in the US.
RC148 is a PD-1 and VEGF-targeting bispecific antibody, an innovative molecule developed by RemeGen using its bispecific antibody technology platform. Currently, the clinical trials of RC148 as monotherapy and combination therapy for the treatment of advanced solid tumor are proceeding in China.
The clearance of IND application by the FDA is a significant milestone for RC148 which should expedite its global development process.
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SOURCE RemeGen Co., Ltd