Replimune Group (NASDAQ:REPL) said its newly launched melanoma therapy TUDRIQEV gained early traction during its first weeks on the market, with leading cancer centers placing the product on formulary, ordering treatment and beginning to treat patients.
Chief Executive Officer Sushil Patel called the launch a “defining moment” for the company, as TUDRIQEV is the first commercial product from Replimune’s RPx platform. The company said the treatment’s broad label permits use in patients whose disease has progressed on PD-1-based therapy, without requiring prior BRAF-targeted treatment.
Early launch metrics
Chief Commercial Officer Michelle DiNapoli said Replimune had proactively engaged with more than 70% of its initial 200 target accounts. About 20 accounts had placed TUDRIQEV on formulary, while more than 15 institutions had written one or more prescriptions as of the prior Friday, less than 20 business days after launch.
During the question-and-answer session, DiNapoli said the number of accounts that had ordered product and established workflows was closer to 20. She said the company expects several more facilities to complete formulary processes in November and could “sort of double” the number of accounts that have initiated patients by the end of the year.
DiNapoli cited Moffitt Cancer Center and Memorial Sloan Kettering among high-volume melanoma institutions that moved quickly to add TUDRIQEV to formulary and treat patients. Some other sites have expedited or bypassed typical formulary review processes to provide the therapy to patients, according to the company.
The commercial team has held more than 50 meetings with melanoma treaters and facilities to establish treatment workflows. Replimune said its customer-facing organization includes account managers and an operational excellence team composed of oncology nurses, pharmacists and interventional radiology experts.
Management said both oncologists and interventional radiologists have used TUDRIQEV, including for superficial and image-guided injections. Patel said the company is seeing use of both superficial and deeper image-guided injections in the early launch period, though it is too early to provide conclusions on volumes by lesion type or location.
Coverage and commercial expansion
Replimune said TUDRIQEV was added to National Comprehensive Cancer Network guidelines as a Category 2A recommendation. The company also said commercial payer policies covering use consistent with the label, including retreatment when clinically appropriate, represent a majority of commercially covered lives. Medicare coverage has also been established, according to management.
The product is currently being billed with a miscellaneous J-code. Replimune has applied for a permanent J-code and expects it to be in place by April 2027. DiNapoli said the permanent code is expected to support broader adoption, particularly in community settings.
Replimune’s initial commercial focus is on 200 accounts, which the company said represent about 30% of melanoma patients treated annually in the U.S. The company intends to assess expansion into a subsequent group of about 250 accounts representing another 20% of the melanoma population, though Patel said management wants to ensure the initial rollout is executed effectively before accelerating further.
DiNapoli said 23 account management positions are in place and the operational excellence team is nearly fully staffed. Management said the remaining work for the commercial organization is primarily training, completing engagement with the initial 200 accounts and expanding to subsequent accounts.
Fiscal second-quarter results and outlook
For the fiscal second quarter ended Sept. 30, 2026, Replimune reported no product revenue because its first commercial shipments occurred in early October. The company said it expects to report its first product revenue in the fiscal third quarter but is not providing revenue guidance.
- Research and development expense was $34.4 million, compared with $49.3 million in the prior fiscal quarter.
- Selling, general and administrative expense was $21.9 million, compared with $19 million in the prior quarter, reflecting commercial hiring, launch readiness and patient support programs.
- Net loss was $57.1 million, compared with a $69.8 million loss in the fiscal first quarter.
- Cash and cash equivalents totaled $307.8 million at quarter-end, including $141 million in net proceeds from an August offering.
Chief Financial Officer Emily Hill said the company expects its cash position to fund operations for more than 12 months under its current operating plan. That plan includes commercial launch spending, continued funding for the IGNYTE-3 confirmatory melanoma study and support for the REVEAL study of RP2 in uveal melanoma.
TUDRIQEV has a list price of $450,000 per course of therapy before rebates and discounts. Hill said actual cost per patient will vary based on tumor burden and the number of treatment cycles, with patients potentially receiving eight or more cycles. Because product is shipped for each treatment visit and treatment can extend across several months, revenue from a patient may be recognized over more than one quarter.
Management said it is too early to provide average patient-volume or revenue assumptions. The company expects to gain greater visibility after a cohort of patients has completed eight or more cycles of treatment.
About Replimune Group (NASDAQ:REPL)
Replimune Group, Inc is a clinical-stage biotechnology company developing cancer immunotherapies designed to stimulate the immune system to recognize and attack tumors. The company’s approach focuses on oncolytic immunotherapy, using genetically engineered viruses intended to selectively infect and destroy tumor cells while also activating broader antitumor immune responses.
Replimune’s lead product candidate is RP1, also known as vusolimogene oderparepvec, an engineered oncolytic herpes simplex virus type 1 designed to replicate within tumors and promote systemic immune activity.
