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Atossa plans shareholder stake in potential PRV proceeds

Shareholders could be set for a cash reward if the biotech wins a voucher upon approval of (Z)-endoxifen.

Robert Barrie September 30 2026

Atossa Therapeutics has put in place a plan that would give its shareholders a share of any proceeds from the use or sale of a priority review voucher (PRV).

PRVs have become an important financing mechanism for biotechs operating in the rare disease space. A rare paediatric disease designation is one of the routes towards receiving a PRV from the US Food and Drug Administration (FDA).

Atossa has two such designations for its lead candidate, (Z)-endoxifen in Duchenne muscular dystrophy (DMD) and McCune-Albright Syndrome (MAS). If the drug is approved in either of the genetic disorders, Atossa will be eligible for a PRV.

As per the FDA’s rules, the voucher can be redeemed for any product in the company’s portfolio to slash four months off FDA review time. Companies are also able to sell vouchers for cash.

Since the PRV framework was implemented in 2014, a secondary market of vouchers has established itself. In January 2026, Jazz Pharmaceuticals reported it had sold a voucher for $200m. Other sales in 2025 hovered around the $150m price point. 

The board of directors at Atossa plans to share some of that success. It has approved a framework that plans to issue one contingent value right (CVR) per share that will entitle holders to receive cash if the company’s first qualifying PRV is harnessed. This could either be from Atossa using or selling the voucher.

Atossa’s CEO, Steven Quay, said: "We believe shareholders should have a direct opportunity to participate if our rare disease programmes create the added value of a priority review voucher. This CVR would make that commitment tangible. It links a meaningful share of any qualifying voucher proceeds to the people who own Atossa, while allowing us to continue pursuing the development opportunities for (Z)-endoxifen."

By offloading a voucher for cash or recouping R&D expenses in a more lucrative market, the rare paediatric disease designation acts as an incentive for more rare diseases to be pursued in pipeline strategies. Both strategies aim to increase the margins of revenues for companies.

Under the CVR agreement, Atossa’s holders would receive 25% of net proceeds from what Atossa calls a “monetisation event”, with returns to shareholders capped at $50m.

This is not the first case of shareholders yielding PRV proceeds. In March 2026, Fortress sold a PRV for $205m after approval of Zycubo (copper histidinate) for a rare neurodegenerative disorder, subsequently declaring a $118.6m cash dividend to shareholders. However, Atossa appears to be the first biotech to entitle shareholders to a slice of the pie via a CRV before a voucher has even been awarded.

The rare paediatric disease legislation returned to the US pharma landscape earlier this year after a lengthy period in regulatory limbo. Patient advocacy groups and pharma industry bodies welcomed its return, calling it a win for children living with the rare diseases.

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