In a blow to Rapt Therapeutics, the US Food and Drug Administration (FDA) has imposed a hold on two mid-stage trials of the company’s promising drug aimed at treating eczema and asthma. This decision comes in the wake of a concerning incident where liver failure was observed in one of the patients undergoing treatment with Rapt’s drug.
Shares of the San Francisco-based biotech company plummeted to a record low of $8.5 in early trading as investors reacted to the news. Rapt, however, has moved swiftly to address the issue, stating that it is rigorously analyzing the patient’s medical history and deeming the liver toxicity as an “isolated event.”
At the time of this publication, RAPT Therapeutics Inc stock (RAPT) has witnessed a decline.
RAPT Therapeutics Inc
Current Price: $9.44
Change : -16.54
Change (%): (-63.67%)
Volume: 5.8M
Source: Tomorrow Events Market Data
According to Rapt CEO Brian Wong, the affected patient had a known drug allergy to Dupixent, a medication developed by Regeneron (REGN.O) and Sanofi (SASY.PA) for similar conditions. Additionally, the patient had been undergoing thyroid hormone replacement therapy for Hashimoto’s disease, an autoimmune disorder. Notably, the patient was also battling a COVID-19 infection at the time of the incident and was using ashwagandha, an herbal supplement linked to liver failure.
While the clinical hold presents a significant setback for Rapt, with Stifel analyst Alex Thompson noting its potential to cause a “meaningful delay in trial timelines,” the company reassured stakeholders that no other instances of liver toxicity were observed among the hundreds of patients enrolled in the trials.
Previously, Rapt had anticipated reporting results from the trials, focusing on atopic dermatitis and asthma, in mid-2024. However, in light of the intervention by FDA, Rapt Therapeutics has ceased dosing existing patients and halted enrollment of new participants while it conducts a thorough investigation into the adverse event.
The outcome of this investigation will not only shape the future of Rapt’s drug development efforts but also serve as a pivotal moment for the broader biotech industry, highlighting the delicate balance between innovation and patient safety in the pursuit of groundbreaking treatments. Investors and industry observers alike will be closely monitoring the response of Rapt Therapeutics and the subsequent actions taken by FDA as the situation unfolds.
