Condensed Consolidated Statements of Operations and Comprehensive Income (Loss) (Unaudited) - USD ($) $ in Thousands |
3 Months Ended | 9 Months Ended | ||
|---|---|---|---|---|
Sep. 30, 2025 |
Sep. 30, 2024 |
Sep. 30, 2025 |
Sep. 30, 2024 |
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| Revenues: | ||||
| License and other revenues | $ 400 | |||
| Costs and expenses: | ||||
| Cost of sales | 488 | 488 | ||
| Royalties | 100 | |||
| Research and development | 4,216 | 8,941 | 20,100 | 25,366 |
| Selling, general and administrative | 19,314 | 6,404 | 46,249 | 22,173 |
| Total costs and expenses | 24,018 | 15,345 | 66,937 | 47,539 |
| Loss from operations | (24,018) | (15,345) | (66,537) | (47,539) |
| Interest income | 1,672 | 1,189 | 4,009 | 3,223 |
| Interest expense | (901) | (1,102) | (2,856) | (3,126) |
| Change in fair value of warrant and derivative liabilities | 2,760 | (15,156) | 4,617 | (7,530) |
| Gain from sale of priority review voucher, net | 152,366 | |||
| Other income | 129 | 145 | 359 | 531 |
| Income (loss) before income taxes | (20,358) | (30,269) | 91,958 | (54,441) |
| Income tax (benefit) expense | (15,197) | 315 | ||
| Net (loss) income | $ (5,161) | $ (30,269) | $ 91,643 | $ (54,441) |
| Basic (loss) income per common share | $ (0.10) | $ (0.63) | $ 1.76 | $ (1.41) |
| Dilutive (loss) income per common share | $ (0.10) | $ (0.63) | $ 1.35 | $ (1.41) |
| Weighted average number of common shares outstanding: | ||||
| Basic | 54,242,507 | 48,081,758 | 52,198,290 | 38,504,273 |
| Dilutive | 54,242,507 | 48,081,758 | 65,780,650 | 38,504,273 |
| Other comprehensive income (loss): | ||||
| Change in unrealized gains related to available-for-sale debt securities | $ 55 | $ 50 | $ 2 | $ (18) |
| Comprehensive (loss) income | $ (5,106) | $ (30,219) | $ 91,645 | $ (54,459) |
| X | ||||||||||
- Definition Gain from sale of priority review voucher, net. No definition available.
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| X | ||||||||||
- Definition Amount after tax of increase (decrease) in equity from transactions and other events and circumstances from net income and other comprehensive income, attributable to parent entity. Excludes changes in equity resulting from investments by owners and distributions to owners. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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| X | ||||||||||
- References No definition available.
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| X | ||||||||||
- Definition The aggregate costs related to goods produced and sold and services rendered by an entity during the reporting period. This excludes costs incurred during the reporting period related to financial services rendered and other revenue generating activities. Reference 1: http://www.xbrl.org/2003/role/exampleRef
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- Definition Total costs of sales and operating expenses for the period. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- References No definition available.
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| X | ||||||||||
- Definition The amount of net income (loss) for the period per each share of common stock or unit outstanding during the reporting period. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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| X | ||||||||||
- Definition The amount of net income (loss) for the period available to each share of common stock or common unit outstanding during the reporting period and to each share or unit that would have been outstanding assuming the issuance of common shares or units for all dilutive potential common shares or units outstanding during the reporting period. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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| X | ||||||||||
- Definition Amount of expense (income) related to adjustment to fair value of warrant liability. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition Amount of income (loss) from continuing operations, including income (loss) from equity method investments, before deduction of income tax expense (benefit), and income (loss) attributable to noncontrolling interest. Reference 1: http://www.xbrl.org/2003/role/exampleRef
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| X | ||||||||||
- Definition Amount of current income tax expense (benefit) and deferred income tax expense (benefit) pertaining to continuing operations. Reference 1: http://www.xbrl.org/2003/role/exampleRef
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| X | ||||||||||
- Definition Amount of interest expense classified as operating and nonoperating. Includes, but is not limited to, cost of borrowing accounted for as interest expense. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition Amount of operating interest income, including, but not limited to, amortization and accretion of premiums and discounts on securities. Reference 1: http://www.xbrl.org/2003/role/exampleRef
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- Definition The portion of profit or loss for the period, net of income taxes, which is attributable to the parent. Reference 1: http://www.xbrl.org/2003/role/exampleRef
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- Definition The aggregate amount of income or expense from ancillary business-related activities (that is to say, excluding major activities considered part of the normal operations of the business). Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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| X | ||||||||||
- Definition The net result for the period of deducting operating expenses from operating revenues. Reference 1: http://www.xbrl.org/2003/role/exampleRef
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| X | ||||||||||
- Definition Amount, after tax and adjustment, of unrealized gain (loss) on investment in debt security measured at fair value with change in fair value recognized in other comprehensive income (available-for-sale) and unrealized gain (loss) on investment in debt security measured at amortized cost (held-to-maturity) from transfer to available-for-sale. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition Amount of expense for research and development. Includes, but is not limited to, cost for computer software product to be sold, leased, or otherwise marketed and writeoff of research and development assets acquired in transaction other than business combination or joint venture formation or both. Excludes write-down of intangible asset acquired in business combination or from joint venture formation or both, used in research and development activity. Reference 1: http://www.xbrl.org/2003/role/exampleRef
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- References No definition available.
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| X | ||||||||||
- Definition Amount, excluding tax collected from customer, of revenue from satisfaction of performance obligation by transferring promised good or service to customer. Tax collected from customer is tax assessed by governmental authority that is both imposed on and concurrent with specific revenue-producing transaction, including, but not limited to, sales, use, value added and excise. Reference 1: http://www.xbrl.org/2003/role/exampleRef
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| X | ||||||||||
- Definition Amount of expense related to royalty payments under a contractual arrangement such as payment for mineral and drilling rights and use of technology or intellectual property. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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| X | ||||||||||
- Definition The aggregate total costs related to selling a firm's product and services, as well as all other general and administrative expenses. Direct selling expenses (for example, credit, warranty, and advertising) are expenses that can be directly linked to the sale of specific products. Indirect selling expenses are expenses that cannot be directly linked to the sale of specific products, for example telephone expenses, Internet, and postal charges. General and administrative expenses include salaries of non-sales personnel, rent, utilities, communication, etc. Reference 1: http://www.xbrl.org/2003/role/exampleRef
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| X | ||||||||||
- Definition The average number of shares or units issued and outstanding that are used in calculating diluted EPS or earnings per unit (EPU), determined based on the timing of issuance of shares or units in the period. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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| X | ||||||||||
- References No definition available.
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| X | ||||||||||
- Definition Number of [basic] shares or units, after adjustment for contingently issuable shares or units and other shares or units not deemed outstanding, determined by relating the portion of time within a reporting period that common shares or units have been outstanding to the total time in that period. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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