On Monday, H.C. Wainwright initiated coverage on shares of Optinose (NASDAQ:OPTN), a pharmaceutical company, with a Buy rating and a price target of $5.00. This initiation comes ahead of a significant event for the company: the Prescription Drug User Fee Act (PDUFA) date on March 16, 2024, for the label extension of its drug-device combination nasal spray, XHANCE (fluticasone propionate).
Optinose's XHANCE is currently approved for the treatment of nasal polyps. However, the upcoming label extension could broaden its application to the full spectrum of chronic sinusitis (CS) patients, whether they have nasal polyps or not. This expansion has the potential to address a much larger patient population, which includes approximately 10 million CS patients treated annually by specialty and primary care physicians.
The label extension is particularly significant as it could make XHANCE the first comprehensive CS therapy that does not depend on the presence of nasal polyps. This is important because primary care physicians and allergists typically do not perform nasal endoscopies to confirm polyp presence, which can be a barrier to prescribing current treatments targeted only at nasal polyp patients.
XHANCE has shown promise in clinical trials, being the first nonsurgical treatment to reduce symptoms, intrasinus opacification, and exacerbations in patients with chronic sinusitis, regardless of polyp status. This was demonstrated in pivotal clinical trials that were replicated and published in the Journal of Allergy and Clinical Immunology Practice in 2023.
The potential for XHANCE to serve a broader patient base with chronic sinusitis positions Optinose for a pivotal moment in its product platform development. The analyst's positive outlook reflects this opportunity, suggesting that the label extension could significantly enhance the drug's commercial potential.
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