FBIO Shares Rally After Unit Sells Priority Review Voucher For $205 Million: Retail Now Pins Hopes On Gene Therapy

Fortress said that its majority-owned unit Cyprium Therapeutics has entered into a definitive asset purchase agreement to sell its Rare Pediatric Disease Priority Review Voucher to Sentynl Therapeutics.

• The unit is selling the voucher for $205 million, the company said. 
• 20% of the proceeds from the voucher sale is owed to the Eunice Kennedy Shriver National Institute of Child Health and Human Development. 
• The voucher was issued upon approval of ZYCUBO last month for the treatment of Menkes disease, a rare genetic disorder, in pediatric patients.

Shares of Fortress Biotech, Inc. (FBIO) rose 10% on Monday after the company announced that its majority-owned unit will sell its voucher for expedited review of a drug application by the U.S. Food and Drug Administration (FDA) for $205 million.

Fortress said that its unit Cyprium Therapeutics, Inc. has entered into a definitive asset purchase agreement to sell its Rare Pediatric Disease Priority Review Voucher (PRV) to Sentynl Therapeutics, Inc, a U.S.-based biopharmaceutical company wholly-owned by Zydus Lifesciences Limited.

Twenty percent of the proceeds from the voucher sale is owed to the Eunice Kennedy Shriver National Institute of Child Health and Human Development, the company said, while also noting that the transaction is subject to customary closing conditions.

The PRV program aims to incentivize drug development for rare pediatric diseases.

Cyprium, Sentynl History

Sentynl took over responsibility for the development and commercialization of the drug ZYCUBO from Cyprium in December 2023. Zycubo was approved by the FDA in January for the treatment of Menkes disease, a rare genetic disorder, in pediatric patients. The voucher was issued upon approval of ZYCUBO.

Fortress said on Monday that it remains eligible to receive tiered royalties on net sales of ZYCUBO and up to $129 million in aggregate development and sales milestones from Sentynl.

“With the PRV sale and three FDA approvals received in the last 15 months for Emrosi, UNLOXCYT, and ZYCUBO, in addition to the recent sale of our former subsidiary Checkpoint Therapeutics to Sun Pharma, we believe that we are well positioned to continue to execute on our portfolio,” said Fortress CEO Lindsay A. Rosenwald.

Cyprium’s Pipeline

Menkes disease is a rare genetic disorder leading to impaired copper transport throughout the body. It causes low copper levels in the brain, resulting in rapid neurodegeneration, seizures, and more. Cyprium is also developing a gene therapy to deliver working copies of the copper transporter that is defective in patients with Menkes disease, and to be used in combination with ZYCUBO. The gene therapy is currently in pre-clinical development.

How Did Stocktwits Users React?

On Stocktwits, retail sentiment around FBIO shares jumped from ‘bearish’ to ‘bullish’ territory over the past 24 hours, while message volume rose from ‘low’ to ‘high’ levels.

A Stocktwits user expressed optimism for the gene therapy trial data sending the stock skyrocketing. In the short term, the user expects the company to be buoyed by royalties from its Menkes drug, and in the long term, from the gene therapy.

FBIO stock has more than doubled over the past 12 months. 

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