FDA Discussion Prompts Voluntary Withdrawal of BLA for I-DXd in ES-SCLC
Daiichi Sankyo and Merck withdrew the BLA for I-DXd in ES-SCLC after FDA discussions. The phase 2 trial data did not meet accelerated approval requirements. The phase 3 trial is ongoing. I-DXd is an investigational B7-H3-directed ADC. The FDA previously granted priority review for this indication.
How this was made
The 30-second read
Why it matters
Regulatory withdrawal removes near‑term revenue expectations and may cause short‑term stock pressure, but ongoing trials could mitigate long‑term impact.
Market read
The withdrawal is a fresh regulatory development affecting two listed biotech companies, likely prompting short‑term price pressure.
What to watch
Potential for accelerated filing after phase 3 results; investors may focus on long‑term pipeline rather than short‑term regulatory news.
Background
The article reports the voluntary withdrawal of a biologics license application for ifinatamab deruxtecan (I-DXd) by Daiichi Sankyo and Merck after FDA feedback, and notes ongoing phase 3 trials.
Ticker impact
Merck and Daiichi Sankyo withdrew the BLA for I-DXd in ES-SCLC after FDA discussion, a fresh regulatory setback.
likely pressure on MRK and DAI stocks as investors reassess pipeline prospects
Regulatory withdrawals typically depress share price, especially for biotech assets with high expectations.
Market effects
May dampen sentiment for ADC oncology assets and could affect peer biotech valuations.
U.S. biotech sector may see modest pullback; Japanese market exposure via Daiichi Sankyo could be affected.
Limited to oncology drug development community; broader market impact minimal.
Counterpoint
If the phase 3 trial later shows strong efficacy, the withdrawal could be seen as a temporary setback, limiting downside.
Key entities
- CompanyDaiichi Sankyo
Japanese pharmaceutical firm co‑developing I-DXd.
- CompanyMerck
U.S. pharmaceutical giant co‑developing I-DXd.
- RegulatorFDA
U.S. Food and Drug Administration, provided feedback leading to withdrawal.
