Recurrent respiratory papillomatosis is a rare HPV-associated disease characterized by recurrent benign papillomas in the respiratory tract, often affecting the larynx and causing voice and airway complications.
Class action lawsuits allege securities violations by Atara Biotherapeutics and Inovio Pharmaceuticals related to FDA submissions. Atara faces claims over manufacturing issues with its tabelecleucel BLA, while Inovio is accused of misleading statements about INO-3107 regulatory timelines and manufacturing deficiencies.
Inovio Pharmaceuticals faces a class action lawsuit alleging false statements about manufacturing deficiencies affecting its INO-3107 drug candidate. The lawsuit claims the company exaggerated its ability to file a BLA by mid-2024 and misled investors about accelerated FDA review prospects. Following FDA acceptance for standard rather than accelerated review, Inovio's stock dropped 24.45%.
Precigen reported $3.4 million in first commercial sales of PAPZIMEOS in Q4 2025 following FDA approval for recurrent respiratory papillomatosis. The drug has received standard of care endorsement from physician experts and now covers approximately 90% of insured U.S. lives. The company has $100.4 million in cash and is pursuing European regulatory approval.
Inovio Pharmaceuticals trades as a speculative micro-cap biotech on NASDAQ, with DNA medicine candidates in oncology and infectious disease facing binary clinical risks and ongoing capital needs.
Multiple law firms have filed securities class actions against Inovio Pharmaceuticals after the FDA accepted its INO-3107 BLA for standard rather than accelerated review, following earlier manufacturing delays with the CELLECTRA device.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07317154 |
Autologous Dendritic Cell Vaccine For Recurrent Respiratory Papillomatosis (RRP) Patients |
RECRUITING | PHASE1 |
| NCT06538480 |
Zopa Retreatment and Vector Shedding in Adults With RRP |
RECRUITING | PHASE4 |
| NCT06412172 |
The Natural History and Biological Study of Pulmonary Recurrent Respiratory Papillomatosis (pRRP) |
RECRUITING | |
| NCT04724980 |
Adjuvant PRGN-2012 in Adult Patients With Recurrent Respiratory Papillomatosis |
ACTIVE_NOT_RECRUITING | PHASE1/PHASE2 |
| NCT04645602 |
Merck IIT: RRP Pembro and Lenvatinib |
RECRUITING | EARLY_PHASE1 |
| NCT03707587 |
M7824 in People With Recurrent Respiratory Papillomatosis |
COMPLETED | PHASE2 |
| NCT03465280 |
Airway Intervention Registry (AIR): Recurrent Respiratory Papillomatosis (RRP) |
UNKNOWN | |
| NCT02859454 |
Avelumab for People With Recurrent Respiratory Papillomatosis |
COMPLETED | PHASE2 |
| NCT02854761 |
Safety Study of EF-022 in Adults With Recurrent Respiratory Papillomatosis (RRP) |
UNKNOWN | PHASE1 |
| NCT02632344 |
Pembrolizumab for HPV-associated Recurrent Respiratory Papilloma Patients |
COMPLETED | PHASE2 |
