v3.26.1
SCHEDULE OF SIGNIFICANT EXPENSE CATEGORIES (Details) - USD ($)
$ in Thousands
 3 Months Ended 6 Months Ended
Jun. 30, 2026
Jun. 30, 2025
Jun. 30, 2026
Jun. 30, 2025
Revenues:        
Total revenues $ 11,380 $ 400 $ 20,100 $ 400
Cost of sales 4,177 6,873
Royalties 100 100
Research and development costs:        
Total research and development costs 5,021 5,943 14,576 15,884
Selling, general and administrative costs:        
Net (loss) income (20,191) 108,833 (37,266) 96,804
Product [Member]        
Revenues:        
Total revenues 11,380 20,100
License [Member]        
Revenues:        
Total revenues 400 400
Single Reportable Segment [Member]        
Revenues:        
Total revenues 11,380 400 20,100 400
Cost of sales 4,177 6,873
Royalties 100 100
Research and development costs:        
Salaries & related costs 1,926 2,235 3,659 6,916
Non-cash stock-based compensation 294 232 517 902
Other research and development costs [1] 2,801 3,476 10,400 8,066
Total research and development costs 5,021 5,943 14,576 15,884
Selling, general and administrative costs:        
Salaries & related costs 7,254 7,456 15,599 11,109
Non-cash stock-based compensation 3,075 2,598 5,809 4,629
Commercial costs 2,015 2,290 3,817 3,497
Other selling, general and administrative costs [2] 3,491 4,805 10,112 7,700
Total selling, general and administrative costs 15,835 17,149 35,337 26,935
Other segment items, net [3] (6,538) 131,625 (580) 139,323
Net (loss) income (20,191) 108,833 (37,266) 96,804
Single Reportable Segment [Member] | Product [Member]        
Revenues:        
Total revenues 11,380 20,100
Single Reportable Segment [Member] | License [Member]        
Revenues:        
Total revenues $ 400 $ 400
[1] Other research and development costs include, but are not limited to preclinical lab supplies, preclinical and development costs, clinical trial costs, preclinical manufacturing and manufacturing facility costs, costs associated with preclinical regulatory approvals, preclinical depreciation on lab supplies and manufacturing facilities, and preclinical consultant-related expenses.
[2] Other selling, general and administrative costs primarily consist of office facility costs, public company reporting related costs, professional fees (e.g., legal expenses), regulatory costs, production costs not attributable to cost of sales and other general operating expenses not otherwise included in research and development expenses.
[3] Other segment items include interest income, interest expense, change in fair value of warrant liabilities, gain on sale of priority review voucher, other income and income tax (benefit) expense.