Estrella

6月，“放宽对CGT早期临床试验监管”成为FDA举办CGT圆桌会议上的核心议题。同月，FDA宣布取消自体CAR-T风险评估与缓解策略（REMS），包含6款当前已获批的BCMA、CD19 CAR-T产品。
无需REMS即可确保CAR-T免疫疗法的安全性与有效性，被解读为监管方认可安全管理体系逐步成熟，行业具备规模化扩展...

$Estrella(ESLA)$ S-1 General form for registration of securities under the Securities Act of 1933 Accession Number: 0001213900-25-124247  Act: 33  Size: 15 MB 网页链接

$Estrella(ESLA)$ 8-K Current report, item 3.01 Accession Number: 0001213900-26-003998  Act: 34  Size: 241 KB 网页链接

$Estrella(ESLA)$ S-1/A [Amend] General form for registration of securities under the Securities Act of 1933 Accession Number: 0001213900-26-006410  Act: 33  Size: 284 KB 网页链接

$Estrella(ESLA)$ 10-Q Quarterly report [Sections 13 or 15(d)] Accession Number: 0001213900-25-109198  Act: 34  Size: 4 MB 网页链接

$Estrella(ESLA)$ 424B5 Prospectus [Rule 424(b)(5)] Accession Number: 0001213900-26-001686  Act: 33  Size: 356 KB 网页链接

$Estrella(ESLA)$ 8-K Current report, items 1.01, 3.02, 7.01, and 9.01 Accession Number: 0001213900-26-001777  Act: 34  Size: 1 MB 网页链接

$Estrella(ESLA)$ 8-K Current report, items 8.01 and 9.01 Accession Number: 0001213900-25-118097  Act: 34  Size: 261 KB 网页链接

$Estrella(ESLA)$ S-1/A [Amend] General form for registration of securities under the Securities Act of 1933 Accession Number: 0001213900-26-005233  Act: 33  Size: 18 MB 网页链接

$Estrella(ESLA)$ EFFECT Notice of Effectiveness Accession Number: 9999999995-26-000279  Act: 33  Size: 1 KB 网页链接