Assertio Holdings announced that the results of its phase‑1, multicenter trial of Rolvedon (eflapegrastim‑xnst) administered on the same day as chemotherapy have been published in the peer‑reviewed journal The Oncologist. The study enrolled 53 patients with early‑stage breast cancer across 13 U.S. sites and evaluated the safety and efficacy of same‑day dosing in a taxotere‑based (TC) chemotherapy regimen.
The trial demonstrated a mean time to absolute neutrophil count recovery of 1.8 days and a single febrile neutropenia event among all participants. No new safety signals emerged, and none of the patients required hospitalization or antibiotic therapy. These findings confirm that same‑day dosing achieves neutrophil recovery and an adverse‑event profile comparable to the standard next‑day regimen, supporting the clinical convenience of Rolvedon’s dosing schedule.
Assertio’s senior medical leadership highlighted the significance of the data. Senior Vice President of Medical Howard Franklin noted that the results “demonstrate efficacy and safety similar to dosing one day after chemotherapy,” while CEO Brendan O’Grady emphasized that the study “provides evidence that Rolvedon can make a meaningful difference for patients undergoing chemotherapy.” The publication reinforces Assertio’s strategy to position Rolvedon as a first‑line febrile neutropenia prophylaxis in community oncology settings, a key driver of the company’s future growth.
Financially, Rolvedon has shown strong sales momentum. Net product sales rose to $38.6 million in Q3 2025 from $15.0 million in the prior‑year quarter, and Q2 2025 sales reached $16.1 million versus $15.1 million a year earlier. The peer‑reviewed data bolster the commercial case for expanding Rolvedon beyond the current Medicare Part B market, potentially increasing payer coverage and guideline inclusion, which could translate into higher market share and revenue growth.
The publication marks a critical milestone in Assertio’s product development pipeline. By validating same‑day dosing, the company can simplify treatment logistics for community oncology practices, reduce operational burden, and enhance patient convenience. While analyst consensus remains a moderate buy, the data provide a tangible foundation for future coverage decisions and may influence the company’s valuation trajectory as it continues to scale Rolvedon’s commercial footprint.
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