[Featured Stock] GemVax Rises on Expectations of FDA Approval for Biogen's Alzheimer's Treatment in the US

[Asia Economy Reporter Hyunseok Yoo] GemVax is showing strong performance. This is interpreted as being influenced by the news that an FDA reviewer gave a positive opinion on the approval of Biogen's Alzheimer's treatment Aducanumab last night.

As of 9:46 AM on the 5th, GemVax was trading at 22,850 KRW, up 2.93% (650 KRW).

According to foreign media on the 4th (local time), the FDA reviewer stated in the drug review document posted on the website, "Biogen's late-stage clinical trial results are convincing and provide substantial evidence of Aducanumab's efficacy."

New drug development company GemVax recently received a proposal from the FDA to expand the indication for the phase 2 clinical trial of the Alzheimer's treatment 'GV1001.' In addition to the clinical trials targeting patients with moderate or severe Alzheimer's disease already approved in the U.S., they plan to apply for approval of clinical trials expanding indications to mild Alzheimer's disease and mild cognitive impairment. In Korea, phase 3 clinical trials are being prepared.

GV1001 is a peptide drug composed of 16 amino acids derived from telomerase. GemVax announced that the results of the phase 2 clinical trial of GV1001 for Alzheimer's disease conducted in Korea showed a remarkable improvement effect (7.11 points) in the primary endpoint, Severe Impairment Battery (SIB), and excellent statistical significance in secondary endpoints such as Neuropsychiatric Inventory (NPI) and Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL).

Meanwhile, PeopleBio, a company specializing in early diagnosis kits for Alzheimer's, and FutureChem, a company specializing in early diagnostic pharmaceuticals for Alzheimer's, are also rising by more than 12% and 6%, respectively.

This content was produced with the assistance of AI translation services.