Komori
Delta-Fly Pharma (4598) · InitiativeFirst statedLatest Management planning (2026-10-07): "Advanced"

Discussions with the U.S. FDA toward a conditional NDA for DFP-10917 monotherapy

First written in FY2026. 4 of 7 entries say "Advanced", first in 2026-06-03. Latest entry: 2026-10-07.

7entries
1years
6from disclosures
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ProgressHeldSoftenedWorseAdvanced2026-06-03 – 2026-06-22First statedFY2026 – 2026-07-22Advanced2026-08-07 – 2026-10-072026: 72026
Same theme, other companies
DFP-10917単剤の条件付きNDAに向けたFDA協議A theme 1 companies write about · 0 as a headwind · 1 as a tailwind

No other company in this theme has enough history to compare yet.

Full recordFilings, disclosures and news, newest first
  2. FY2026First statedAnnual report

    「Accordingly, we are preparing for discussions with the U.S. FDA toward a conditional NDA (new drug application).」

    Following discontinuation of the U.S. Phase 3 comparative trial for DFP-10917 monotherapy, preparations for discussions with the U.S. FDA toward a conditional NDA are presented as a new regulatory initiative based on efficacy observed in a specific subgroup.
Moved together

"Advancing the clinical development of multiple candidates in stages" moved the same way as this thread, in the same document, in 3 of its 7 moves.

33222★12345
  1. ★This thread
  2. 1Advancing the clinical development of multiple candidates in stages3×
  3. 2Preparation for the Phase 2 clinical trial of DFP-112073×
  4. 3Issuance and redemption of bonds2×
  5. 4Securing partnership companies in Japan and overseas2×
  6. 5Development of combination therapy with DFP-10917 and venetoclax2×

★ is this thread; numbers match the list above. The number on a line is how many documents both moved the same way in; lines between the other threads count the documents they moved together in too. Threads that move together often sit closer.

When this could move next
No upcoming earnings preview for Delta-Fly Pharma yet. It last moved in the Management planning of 2026-10-07: "Advanced".
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