{"name":"FDA Office of Orphan Products Development","slug":"fda-office-of-orphan-products-development","ticker":"","exchange":"","domain":"","description":"","hq":"","founded":0,"employees":"","ceo":"","sector":"","stockPrice":0,"stockChange":0,"stockChangePercent":0,"marketCap":"","metrics":{"revenue":0,"revenueGrowth":0,"grossMargin":0,"rdSpend":0,"netIncome":0,"cash":0,"dividendYield":0,"peRatio":0,"fiscalYear":"FY2026"},"revenueBreakdown":[],"timeline":[{"date":"2026-07-28","label":"Q2 2026 Earnings","type":"earnings","sentiment":"neutral"},{"date":"2026-10-28","label":"Q3 2026 Earnings","type":"earnings","sentiment":"neutral"},{"date":"2027-01-28","label":"Q4 2027 Earnings","type":"earnings","sentiment":"neutral"},{"date":"2027-04-28","label":"Q1 2027 Earnings","type":"earnings","sentiment":"neutral"},{"date":"2027-07-28","label":"Q2 2027 Earnings","type":"earnings","sentiment":"neutral"},{"date":"2027-10-28","label":"Q3 2027 Earnings","type":"earnings","sentiment":"neutral"}],"diseaseAreas":[{"name":"Other","slug":"other","revenue":0,"percentOfTotal":0,"drugCount":1,"colorKey":"oncology","drugs":[{"name":"ADI PEG","genericName":"ADI PEG","slug":"adi-peg","indication":"Other","status":"phase_1"}]},{"name":"Immunology","slug":"immunology","revenue":0,"percentOfTotal":0,"drugCount":1,"colorKey":"immunology","drugs":[{"name":"chondrocyte-alginate gel suspension","genericName":"chondrocyte-alginate gel suspension","slug":"chondrocyte-alginate-gel-suspension","indication":"Cartilage repair for osteoarthritis","status":"phase_3"}]},{"name":"Oncology","slug":"oncology","revenue":0,"percentOfTotal":0,"drugCount":1,"colorKey":"cardiovascular","drugs":[{"name":"monoclonal antibody cA2","genericName":"monoclonal antibody cA2","slug":"monoclonal-antibody-ca2","indication":"Relapsed or refractory B-cell non-Hodgkin lymphoma","status":"phase_3"}]}],"pipeline":[{"name":"ADI PEG","genericName":"ADI PEG","slug":"adi-peg","phase":"phase_1","mechanism":"Small molecule","indications":[],"catalyst":""},{"name":"chondrocyte-alginate gel suspension","genericName":"chondrocyte-alginate gel suspension","slug":"chondrocyte-alginate-gel-suspension","phase":"phase_3","mechanism":"Chondrocyte-alginate gel suspension is a cell-based therapy that delivers chondrocytes to repair damaged cartilage.","indications":["Cartilage repair for osteoarthritis"],"catalyst":""},{"name":"monoclonal antibody cA2","genericName":"monoclonal antibody cA2","slug":"monoclonal-antibody-ca2","phase":"phase_3","mechanism":"cA2 targets the CD19 protein on B cells to induce their destruction.","indications":["Relapsed or refractory B-cell non-Hodgkin lymphoma","Relapsed or refractory follicular lymphoma"],"catalyst":""}],"recentEvents":[],"realNews":[{"url":"https://news.google.com/rss/articles/CBMinwJBVV95cUxNeDVHcnl2NHRxTFRVVk5nZC1zZjFYbk5NalNwYnF3WDFNR2VpNWVZVmVQTVFQWVIxLW9CTG4yREVJd2xOZS1PQjRIcUlrbUVqT1ZvOVV3Q0ZKVGRHY2xRczJDS2hBc0hRX1lTeXhWX1BhLU12X2tSV3p1c0ZHWThhVGhfVTFlWWUtbXdxZTBObFVueWpmVWFYX1lKYTUyOHVOZy1neTA4cFhDSF85MkJwb1V6eTcteTU0enpidEVMN0dTeUxMblBpTm8tSGpDRW9nb0VzN01BaGY0SElPQ0xYTnFLVGNsTnN0cHZicHc1ZWF0cW1yUFRmc3JoeWVOSUxxcEhVa3Q0NjJvT3JSTUYyT0tpdW03OXVFNGhWNUU5aw?oc=5","date":"2026-04-08","type":"pipeline","source":"The Providence Journal","summary":"Measles Rare Pediatric Disease Drug Designation Application Filed for NV-387, PRV Provides for Strong Business Case, Says NanoViricides - The Providence Journal","headline":"Measles Rare Pediatric Disease Drug Designation Application Filed for NV-387, PRV Provides for Strong Business Case, Say","sentiment":"neutral"},{"url":"https://news.google.com/rss/articles/CBMi5AFBVV95cUxOazFpOG54WWd0akFWWXZBbTFJaDFSYkd6b2FmSUtaZnA0TGVVSUgxS0RUQkNkRVR4bnJyeWFodFhwblJMbjQ2RHdhaVV5cTlGWXdicV8xdFMwd1RUR1B0a0JNRE9hNmJ3ZlR1TnI2UnAwb2RXWUlqdDduRGVPcVktbXEwXzcxTkViY3JLeDVkQmdra2RFZWZhM1V0MVEyOVJuazNlTkYxamNQdGIyWVpxX3VzMkdSU0JBRzkyOUgtdWJSTEE4WENFaVFnZHY5OUlBU3NRWnNoSW1tQTc1WGc1ck9uRHY?oc=5","date":"2026-02-12","type":"pipeline","source":"ACCESS Newswire","summary":"MPox Orphan Drug Designation Application Filed for NV-387, Declares NanoViricides - ACCESS Newswire","headline":"MPox Orphan Drug Designation Application Filed for NV-387, Declares NanoViricides","sentiment":"neutral"},{"url":"https://news.google.com/rss/articles/CBMi0AFBVV95cUxNbUhGdXlOaWdJN0FlY3lFdzJsRHZNYkx3YmR4MWJFWGthSnpsYjVYWHZ0aXFyM0c3ckJkejMyZ250eml4OEJ2Q0VJTUJLQU5HVzJydmhGRUZVNzBEOENxcVI2elp0Y0FUc0V5VVhhMmRfVkZLV0JGcnNwMGY5QXFVNGdnRlVYWHhCN2F1aWxwaGZKbmlFNnhDRjZWWDcxUExSSjYwZnIzMDUtREM2akhoVnVjdVhnUXNNN2VTeXVPbllTS0VJbE1KYzdfSmdxWWxG?oc=5","date":"2026-02-10","type":"pipeline","source":"USA Today","summary":"Measles Orphan Drug Designation Application Filed for NV-387, Declares NanoViricides - USA Today","headline":"Measles Orphan Drug Designation Application Filed for NV-387, Declares NanoViricides","sentiment":"neutral"},{"url":"https://news.google.com/rss/articles/CBMiggFBVV95cUxNS3gwLWI5NUU5UnA0aU13MmlubkdMNWQtRmN4MTdLaFMyWDhuRWp0NjIyUlZ4RzZEb2Eta0p3Z0l5TzVPNFc2ZV80aVI3SjlpOVhBRTNDMkR4LUh4c2xkcnZoTFc4V2R6SHFqeTFmV01QVDFjU3B3b2NIbHdDSDhfZG13?oc=5","date":"2025-10-10","type":"regulatory","source":"endpoints.news","summary":"Head of FDA’s orphan drug office is removed from role - endpoints.news","headline":"Head of FDA’s orphan drug office is removed from role","sentiment":"neutral"},{"url":"https://news.google.com/rss/articles/CBMi0AFBVV95cUxOX1VvTFVsQzk1dzkxVDhvc0NaZVdTWTZwUlBjMzR3RHBEZ0FPdUQwbDRvU2k5MHVnTUdaUzc5Q2w3M0M5MkNhTnF1RmdmUk9ydDRuRW44ckdVejBVTi1mSFd0eGh2OVJGb3ZYQXNNVU05YnlMT0xsMlR4UTVaOEx3Zmp5OEp3Q3ZOZzVfenNGYlZyU0d5Njd0NVdZQldZUHFibTU4c3ptb29JQ2hGVXJXVzFmMlRfQzFYRkZobWl5M0JXQWsxV0JLSFlLSjBLNGZQ?oc=5","date":"2025-05-08","type":"regulatory","source":"BioSpace","summary":"Notice of Orphan Drug Designation for JR-446 for Mucopolysaccharidosis Type IIIB by the U.S. FDA - BioSpace","headline":"Notice of Orphan Drug Designation for JR-446 for Mucopolysaccharidosis Type IIIB by the U.S. FDA","sentiment":"neutral"},{"url":"https://news.google.com/rss/articles/CBMi1wFBVV95cUxPMW9GUXFfWElLVnBpQS0zSENXOHV6Z05SbWpKRnBLV3Z5cXNkM1VQZXZ4ekswdTNzT09UcnBWOXdrd2todS1ucFJiMXAwOFZ3c3FLNm1XcjhPU1o0MnpwU09wMnl2eG95V3ZaeUJHc3l6c1c0NUFsSVB3c1V6LVV5X1ROaXhTYnphQy1fWThHUzJGRjQxR2VkYkJJYnFCT3NmX1Z6dF8wemJESTJRMUpYQjNtQU5lUF9LRC11djBnWkdSalRSWHZCWHYyMUZsRkJLVzZQb0hrTQ?oc=5","date":"2025-01-08","type":"pipeline","source":"Healio","summary":"Cour Pharmaceuticals snags orphan drug designation for CNP-104 for the treatment of PBC - Healio","headline":"Cour Pharmaceuticals snags orphan drug designation for CNP-104 for the treatment of PBC","sentiment":"neutral"},{"url":"https://news.google.com/rss/articles/CBMioAJBVV95cUxNT2lnQTVaQldGTnlkaVFteVIzSmhNdWpuRmtKVzRTOWRJLTZ6VGpNT2tISXBtMjVxVU1kS3F5SkxZOTd1LU5NcUdsTlVCVHZZRnRIemw0OTJDdEZfVDZOR2dIMGNiNjA1U3ZCUDJOUDhrVUQyU3dRejNzVGRrd0xKWWlUOVV1Q2hmRHJyWEJEalExRG1pZEFaMUZoUU0zR21laXh4V1dqNmhXU3cxVTE0TERpSUc4dWctc0VVQTh4NEJwY3JqWDZwQVRUNHVKbE5yQnFQTi1rM2NMeVNCMDNjWHZ4TlFzcmN1NHNDa2Q5SEVPazVNT2pzTFRCXzZoQm9uTkJpdTNGOEQwWWNiMklqNjZhVGRvcE1teGlQSEVtTkE?oc=5","date":"2024-10-22","type":"regulatory","source":"PR Newswire","summary":"Remedy Pharmaceuticals Announces FDA Orphan Drug Designation Granted for the Treatment of Large Territory Acute Ischemic Stroke with CIRARA - PR Newswire","headline":"Remedy Pharmaceuticals Announces FDA Orphan Drug Designation Granted for the Treatment of Large Territory Acute Ischemic","sentiment":"neutral"},{"url":"https://news.google.com/rss/articles/CBMi4gFBVV95cUxPWGR0TURDTVdsOGE4MzkxakpDVDVUbHo3Qm04Sno1SmFhRDNUaVkySGx1YWZBbmtCellhY0pPOFhGU1NMMlhQdmNKaUk0bFVvd1FpTTZNYnFOR0NuTEFOcTBVOTFwbmFjMm1kM3VaUHptalRRd3J3Q0xiSXpacGJBVFcwV3VvTTBCaldQaVVGaFpFbU8tM0dzXzh6T3JTX3c1dXBHTEp4cXNpaC10RldyNXJYM1BMZUNTV1NESUpKUjlBaTlKQk1TWGUxWUg3aFRyV0xBV1ozTmlUSHNzS0NKZ1FR?oc=5","date":"2023-06-07","type":"regulatory","source":"BioSpace","summary":"DTx Pharma Receives FDA Orphan Drug Designation for DTx-1252 for the Treatment of Charcot-Marie-Tooth Disease Type 1A (CMT1A) - BioSpace","headline":"DTx Pharma Receives FDA Orphan Drug Designation for DTx-1252 for the Treatment of Charcot-Marie-Tooth Disease Type 1A (C","sentiment":"neutral"},{"url":"https://news.google.com/rss/articles/CBMi5wFBVV95cUxNc0tiV2huWkk2QzViOU5xanlXcnptREZ5QWJadEdxVU5mSjlCZ0JkRElRNHZxaTJHcGhRbXVxc2JLTU1GNXo1c2FQUVYyVExzazBhSThYd0FDZE05Ul9aZXE0dFdaTTZ4cTR3TnNOTzE0U21Dam9OdUpmNGx5aGR3akc3QkR5S0JmV1l2MWRYTFZYdWxXdEloVU9pTFEwRkRRb0NWeG1NZ2laZmQ2QmxqY0hIYXpleGpzS3g5Sm1EQ1VzNHBReTZtUjM4dlROdDI0ZHRPVUF3RjM1T0pmc2R5OFpwM0E5VHc?oc=5","date":"2022-11-30","type":"regulatory","source":"Mayer Brown","summary":"Orphan Exclusivity in Catalyst’s Aftermath: FDA Inaction Leaves Rare Disease Sponsors in Limbo | Insights - Mayer Brown","headline":"Orphan Exclusivity in Catalyst’s Aftermath: FDA Inaction Leaves Rare Disease Sponsors in Limbo | Insights","sentiment":"neutral"},{"url":"https://news.google.com/rss/articles/CBMi_gFBVV95cUxPeWYwdGVzaU1KSDlpS1hoYlNDZGZGT0w0Z0NMUDUwNUo5VzVKTWFIOUN2VTBnLWg5WXlWOUlnRHhpSGE1UElIZkhHeXZwdkxEWWhUaC1aUzZnQXJnbjVmRWgwbFZISU1FY09qeGlMNFVJSlFUOUx2c2NKVTlRb1FnVHFONGZtYk5tX2R2UklrRWMwMTBGS1I3TGtpWF9ETzBxLVRHcWJycEpEZG9RaTlvMDA1NEtGQ0ZabEF2QWx0UjZXSFlmcnl3Y0U1dGxpbElySmdJX2Z1bWZ0VTN4RlB1YXpDY3VlaW9Ic2JRNVZyVzljUXhVQ0k4TkhiV1lLQQ?oc=5","date":"2021-08-30","type":"pipeline","source":"businesswire.com","summary":"10% Receives 7 Years of Market Exclusivity for Adult Dermatomyositis - businesswire.com","headline":"10% Receives 7 Years of Market Exclusivity for Adult Dermatomyositis","sentiment":"neutral"},{"url":"https://news.google.com/rss/articles/CBMiggJBVV95cUxNVVowRmFHQ0ZHMHlORjVUbzJCbXhnak4zVlBQeUNONFprMUJPeUN4dW5IME9Ub1ctUXc1LTkyaThXQ25OSW13a1BxLVR6Ukpka09nYlV2cGM0QmJZMzNuVDJvMVBjRXVUYXRJbmtoMFB3QjdqY2xkdkEyZDlWUkVQcndvQXV0aWhjcG1FQlBmRXdhaWd0QnRRdllQSEsxUXZsUGZwa1owd3FqQlBJaHdHWkNWVDJwcGtRTHZUWEZxQ3hKZ3FiWUVPSWY0WG55TzdUaHRPSkJFRUJsbktuTVBVTWdVdk9xTURmYVBCWlhiSmplX0cwSEs1Si1OaElTbktMWmc?oc=5","date":"2021-06-15","type":"regulatory","source":"businesswire.com","summary":"PulmoSIM Therapeutics Granted Orphan Drug Designation for PT001 by the FDA to Treat Pulmonary Arterial Hypertension - businesswire.com","headline":"PulmoSIM Therapeutics Granted Orphan Drug Designation for PT001 by the FDA to Treat Pulmonary Arterial Hypertension","sentiment":"neutral"},{"url":"https://news.google.com/rss/articles/CBMidEFVX3lxTE1zNlZDWjBETk5hLUZsd0lsbTlLSTNDdG5MT1YxTjlwQks5b3ZvdTFqUURGRFV3UHNKY2JoQ1U4ck10Q1JWYmtNbVQwQk1IVm1rc2drU3QtbTNxbmQ4M2lEMFVKTTN0dU9selNyM0c5cHBqeFRi0gF0QVVfeXFMTWNZd3FMSXBPZTVqem9hUkw4alEwWnlfRVpvWm5Qam9IVTFlUDBLck5Bblp2dzAxbjFlUzJlN1Z5X0I5LXdFUDdicXhvemJybndTUGl1LTRTUmtteEZOZzVkY0JFaXJtcDJiUkp0T3VQckhlWmQ?oc=5","date":"2017-01-19","type":"pipeline","source":"Miami Herald","summary":"The Orphan Drug Act helps pay for rare illness meds. But pharma companies abuse it - Miami Herald","headline":"The Orphan Drug Act helps pay for rare illness meds. But pharma companies abuse it","sentiment":"neutral"}],"patents":[],"drugCount":3,"phaseCounts":{"phase_1":1,"phase_3":2},"enrichmentLevel":2,"visitCount":1,"keyCompetitors":[],"therapeuticFocus":[],"financials":null,"yahoo":null}