Denali

FDA 预计将于 4 月对 Denali Therapeutics $Denali(DNLI)$ 的亨特氏综合征药物 tividenofusp alfa 做出审批决定，该公司已与 Royalty Pharma 签署了一项 2.75 亿美元的协议，用于资助这款药物的潜在上市，并推进其神经退行性疾病产品线。
此前，在 Denali 提交更新的临床药理学数据后，FDA 将 ...

#药闻简讯# $Denali(DNLI)$ 宣布 FDA 延长 Tividenofusp Alfa 用于治疗 MPS II（亨特综合征）的 BLA 审评期限
PDUFA 延期至 2026 年 4 月 5 日。

$Denali(DNLI)$ 8-K Current report, items 2.02 and 9.01 Accession Number: 0001714899-25-000192  Act: 34  Size: 1 MB 网页链接

$Denali(DNLI)$ 3 Initial statement of beneficial ownership of securities Accession Number: 0001816206-25-000006  Size: 235 KB 网页链接

$Denali(DNLI)$ 4 Statement of changes in beneficial ownership of securities Accession Number: 0001816206-25-000007  Size: 7 KB 网页链接

$Denali(DNLI)$ 8-K Current report, items 7.01 and 9.01 Accession Number: 0001714899-25-000180  Act: 34  Size: 184 KB 网页链接

$Denali(DNLI)$ 144 Report of proposed sale of securities Accession Number: 0001950047-25-009799  Act: 33  Size: 4 KB 网页链接

$Denali(DNLI)$ 4 Statement of changes in beneficial ownership of securities Accession Number: 0001193125-25-319291  Size: 20 KB 网页链接

$Denali(DNLI)$ SCHEDULE 13G/A [Amend] Statement of Beneficial Ownership by Certain Investors Accession Number: 0000315066-25-002719  Act: 34  Size: 11 KB 网页链接

$Denali(DNLI)$ 8-K Current report, items 1.01 and 9.01 Accession Number: 0001714899-25-000208  Act: 34  Size: 274 KB 网页链接

$Denali(DNLI)$ 424B5 Prospectus [Rule 424(b)(5)] Accession Number: 0001628280-25-056085  Act: 33  Size: 461 KB 网页链接

$Denali(DNLI)$ 424B5 Prospectus [Rule 424(b)(5)] Accession Number: 0001628280-25-056361  Act: 33  Size: 623 KB 网页链接

$Denali(DNLI)$ 8-K Current report, items 1.01, 8.01, and 9.01 Accession Number: 0001628280-25-056363  Act: 34  Size: 813 KB 网页链接

$Denali(DNLI)$ 10-Q Quarterly report [Sections 13 or 15(d)] Accession Number: 0001714899-25-000193  Act: 34  Size: 6 MB 网页链接

$Denali(DNLI)$ 8-K Current report, items 7.01, 8.01, and 9.01 Accession Number: 0001714899-25-000209  Act: 34  Size: 20 MB 网页链接