Autolus Surges 12% on Key UK Recommendation for Leukemia Drug
NICE backs CAR-T therapy Aucatzyl, paving the way for NHS reimbursement and an imminent commercial launch in England and Wales.
Shares of Autolus Therapeutics (NASDAQ: AUTL) jumped as much as 12% in Tuesday trading after the UK's National Institute for Health and Care Excellence (NICE) issued positive draft guidance recommending its CAR-T therapy, Aucatzyl, for a rare and aggressive form of leukemia.
The recommendation is a critical step toward commercialization for the London-based biopharmaceutical company, clearing a path for reimbursement and access through the state-funded National Health Service (NHS) in England and Wales. The stock closed Tuesday's session up 11.94% at $1.39 per share.
NICE has backed Aucatzyl, also known as obe-cel, for adult patients with relapsed or refractory B-cell Acute Lymphoblastic Leukemia (B-ALL). This decision provides a vital new option for patients whose cancer has returned or failed to respond to previous treatments. According to a statement from NICE, the therapy is expected to benefit more than 150 people in England over the next three years.
"This is a life-saving drug that could make a real difference to people’s lives," said Helen Knight, director of medicines evaluation at NICE. The therapy offers "real hope" for individuals who currently have limited treatment alternatives.
Autolus specializes in developing advanced T-cell therapies, a form of immunotherapy where a patient's own immune cells are genetically engineered to recognize and destroy cancer cells. Aucatzyl is designed to be a next-generation treatment with an improved safety profile, potentially leading to fewer side effects and less time spent in the hospital compared to existing therapies.
The positive guidance was supported by data from the company's FELIX clinical trial, which demonstrated high rates of remission. The company's press release highlighted the study's success in this difficult-to-treat patient population.
For Autolus, a clinical-stage company with a market capitalization of approximately $327 million, the NICE recommendation is a significant commercial de-risking event. It marks the final step before an imminent launch in the UK, its home market. The UK's Medicines and Healthcare products Regulatory Agency (MHRA) had already granted conditional marketing authorization for the drug in April.
While the therapy carries a list price of £372,000 per infusion, it will be provided to the NHS at a confidential discount. Autolus has stated it plans to seek similar patient access through the Scottish Medical Consortium.
Despite the positive news, Autolus's stock remains well below its 52-week high of $3.45. However, Wall Street analysts maintain a bullish outlook, with a consensus 'Buy' rating and an average price target of $9.63, suggesting significant potential upside from its current level. The NICE recommendation serves as a crucial validation of the company's scientific platform and its ability to navigate complex regulatory and reimbursement pathways, a key hurdle for any biotechnology firm transitioning from development to commercial operations.