Appili Therapeutics Announces Alignment with FDA on Development Requirements for ATI-1801 Topical Antiparasitic Product NDA Submission [Financial Post (Toronto, Ontario, Canada)]
Aditxt, Inc. (ADTX)
Company Research
Source: Financial Post
Demonstrated safety and efficacy across multiple Phase 2 and Phase 3 studies Appili provides update on Aditxt transaction and encourages shareholders to vote their shares as soon as possible for the November 6, 2024 shareholders meeting HALIFAX, Nova Scotia, Oct. 31, 2024 (GLOBE NEWSWIRE) — Appili Therapeutics Inc. (TSX: APLI; OTCPink: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on drug development for infectious diseases and medical countermeasures, today announced that the U.S. Food and Drug Administration (“FDA”) has provided positive feedback regarding the development strategy for ATI-1801, and agreed on the necessary registration package to support a New Drug Application (“NDA”). ATI-1801, a novel topical formulation of paromomycin (15% w/w), is under advanced clinical development for treating cutaneous leishmaniasis, a disfiguring skin infection affecting hundreds of thousands globally. “This positive response from the FDA simplifies and de-r
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- Appili Therapeutics Reports Financial and Operational Results for Second Quarter of Fiscal Year 2025 [Yahoo! Finance]Yahoo! Finance
ADTX
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- 11/21/24 - Form 8-K/A
- 11/21/24 - Form 8-K/A
- 11/19/24 - Form 8-K
- ADTX's page on the SEC website