Replimune (NASDAQ: REPL) laid out its commercial launch strategy for TujuCare and provided an update on its clinical pipeline at the 12th Annual Cantor Fitzgerald Global Healthcare Conference on September 10.
TujuCare, formerly known as TUDRIQEV, received FDA approval on August 6 for use in combination with nivolumab in patients with unresectable advanced melanoma who have progressed on PD-1–containing regimens. CEO Sush Patel confirmed that product delivery to patients remains on track within the 60-day post-approval window. The company has secured approximately one year of inventory, with active pharmaceutical ingredient printed and packaging, artwork, and serialization underway through a third-party logistics provider.
Replimune appointed Michelle Donathalie as chief commercial officer in August. About 70% of the commercial team has been hired and is expected to be fully staffed by the time the product enters distribution channels; roughly one-third of hires are former Replimune employees returning to the company.
The launch will proceed in waves. The first wave targets 200 early-adopter accounts, primarily hospital and academic centers with interventional radiology capabilities and prior experience administering T-VEC or participating in Replimune trials. A second wave covering approximately 250 accounts is expected six to nine months after launch and will incorporate larger community practices. Over the long term, Replimune plans to expand to roughly 1,200 accounts representing about 80% of the market.
TujuCare carries a list price of $450,000 per patient, based on an 18-milliliter median dosing volume observed in the IGNYTE study. Dosing is calculated at approximately one milliliter per centimeter of tumor volume. Patients begin on a lower 10^6 dose—one-tenth the viral load and one-tenth the price of the 10^7 maintenance dose—meaning early revenue will be modest before blending upward as patients transition to the higher tier. The company expects to report its first quarterly earnings in the February quarter (Q1).
On the reimbursement front, a temporary J-code will be available at launch, with a permanent J-code expected by April. Replimune will rely on the buy-and-bill oncology model, using existing superficial and deep injection codes alongside image-guidance codes for ultrasound and CT procedures. Interventional radiology procedures are typically about 30 minutes long.
In its non-melanoma skin cancer franchise, the ARTICUS trial in organ transplant patients with cutaneous squamous cell carcinoma showed durable response rates of approximately 30% without organ rejection events or the need to taper steroids. Data publication is pending, and the company is considering a request for an NCCN guideline listing. Additional skin cancer indications, including Merkel cell carcinoma and basal cell carcinoma in checkpoint-refractory patients, are under review.
For metastatic uveal melanoma, the Phase 2/3 REVEAL trial is enrolling approximately 280 checkpoint-naïve patients across first- and second-line treatment regardless of HLA status, with progression-free survival and overall survival as primary endpoints. A go/no-go decision on the Phase 2/3 transition, driven predominantly by safety, is expected in early 2025, with first PFS data readout anticipated around 2028.
The confirmatory IGNYTE-3 trial in melanoma, with overall survival as its primary endpoint, is about one-third enrolled. Management said it is considering shutting down U.S. enrollment in light of TujuCare’s commercial availability while adding sites outside the United States and in Europe. The event-driven trial is tracking toward a 2030 readout. Patel expressed high confidence in hitting the OS endpoint, citing earlier IGNYTE data showing a 50% three-year survival rate among patients treated with deep lesion injections into organs such as the liver, lung, and lymph nodes.
Replimune’s stock has returned 141% over the past year and traded at $14.22 at the time of the conference, giving the company a market capitalization of $1.33 billion. The firm reported a current ratio of 5.23 and a cost of goods of approximately 10% of revenue.
