Announced details
Treatment combining OBP-301 with radiation for unresectable gastroesophageal cancer
OBP-301 received Fast Track designation from the FDA.
The U.S. drug regulatory authority. In the document, it is described as the agency administering a program that prioritizes the review of drugs for serious diseases or diseases with no satisfactory treatment options.
Fast Track designation; Orphan Drug designation
U.S. Food and Drug Administration (FDA)
No impact on the Company's financial results for the fiscal year ending December 2026
The company does not address Contract Value / Offering price.
| Item | Details |
|---|---|
| Names of Products / Services Covered | OBP-301 |
| Counterparty | U.S. Food and Drug Administration (FDA) |
| Counterparty overview | The U.S. drug regulatory authority. In the document, it is described as the agency administering a program that prioritizes the review of drugs for serious diseases or diseases with no satisfactory treatment options. |
| Relationship with the Company | OBP-301 received Fast Track designation from the FDA. |
| Applicable area | Treatment combining OBP-301 with radiation for unresectable gastroesophageal cancer |
| Award/certification name | Fast Track designation; Orphan Drug designation |
| Awarding / certifying body | U.S. Food and Drug Administration (FDA) |
| Impact on Business Performance | No impact on the Company's financial results for the fiscal year ending December 2026 |
Items this document does not state (10)
These are items the company does not state in this document. We do not leave them blank, nor fill them in from other sources or by inference.
The reasons the company gives
The company's own explanation, not something inferred from the numbers.Fast Track is a program intended to prioritize the review of drugs for serious diseases or diseases with no satisfactory treatment options and make them available to patients sooner.