Subsequent Events |
12 Months Ended |
|---|---|
Mar. 31, 2026 | |
| Subsequent Events [Abstract] | |
| Subsequent Events |
13. Subsequent Events
On
April 23, 2026, the Company received a CRL from the FDA in response to their
NDA for GTx-104. The CRL referenced certain items related to the chemistry,
manufacturing, and controls (CMC) and other non-clinical sections of the
application, including items related to additional leachable data time points for
commercial product, non-clinical product toxicology risk assessments, and cGMP
deficiencies at their CMO. A Type A meeting with the FDA has been scheduled to
potentially clarify the path forward and determine the appropriate next steps.
In order to prioritize resolving the items cited in the FDA’s CRL, the Company
does not plan to resume internal development funding for GTx-102 or GTx-101
under its current operating plan. Accordingly, the Company determined that the
remaining carrying value of the GTx-102 and GTx-101 IPR&D assets of $9,196
and $4,337, respectively, are no longer recoverable on an internal-development
basis. The Company expects to recognize an impairment charge for the full
remaining carrying value in the first quarter of fiscal year 2027.
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