Analysts expect Replimune’s newly approved Tudriqev to reach $1.3 billion in peak sales in 2035.
After a come-from-behind victory, Replimune finally has an FDA approval in hand for Tudriqev in advanced melanoma. The achievement shifts the biotech from fighting through a regulatory nightmare to becoming a commercial enterprise.
“We are incredibly grateful to those internally and externally who fought so hard for patient access to this innovative and important therapy,” CEO Sushil Patel said on a Thursday afternoon conference call.
BMO Capital Markets models $1.3 billion in peak revenue for Tudriqev in 2035, particularly since the FDA granted a broad label with few restrictions. Replimune will now enter the PD-1-refractory melanoma market—where few options exist—and will likely become the preferred treatment option, the firm said.
“We expect Tudriqev to eventually command a meaningful share in the U.S. refractory melanoma market, shifting the REPL story from binary approval risk toward commercial execution,” BMO wrote in a Friday morning note.
The approval sent Replimune’s shares up more than 8% at close to $12.86 on Thursday. At the lowest point of the FDA regulatory saga in April, the stock had fallen to $1.70 apiece.
The achievement caps a tough period for Replimune, as the therapy was twice rejected by the FDA, which in a briefing document released prior to an advisory committee meeting last week called data from the Phase 1/2 IGNYTE clinical trial that underpinned the application “not interpretable.”
The agency called an adcomm meeting to discuss the therapy at the end of July, which ultimately supported Tudriqev. Some of the committee members, however, expressed reservations.
The company had many powerful backers, including physicians in the melanoma space who lobbied for patient access to the treatment.
In the end, the FDA erred on the side of providing access for patients with few existing options.
Now, with the adcomm in the rearview, the company will have to launch a medicine. Patel brushed off concerns that the contentious meeting will have any bearing on the launch.
“One of the benefits of the adcomm was just the tremendous public and physician support and awareness it’s created for RP1,” he said. “When you listen to the open public forum, it was very clear that this is a treatment that patients very much need and physicians want.”
Patel also does not think the issues the FDA had with the IGNYTE Phase 1/2 trial will roll over to the confirmatory Phase 3 IGNYTE program. The primary endpoint of the trial will be overall survival, which is very different from the response criteria that the FDA took issue with.
“The response criteria and assessment really has no impact on whether the patient ultimately lives longer or not,” Patel explained. “As you heard from physicians, I think they’re very excited about having a different option that treats this really-hard-to-treat patient population, and given the safety and efficacy profile, and the fact that we can treat a broad range of patients, I think that’s going to trump any conversations or downside from the adcomm.”
In fact, Patel said that Replimune received “significant proactive requests for engagement immediately following approval.”
The confirmatory trial is enrolling now. Replimune expects topline data in 2030. Chief Medical Officer Kostas Xynos said the study is already about 1/3 enrolled.
On the label, BMO said that the FDA left physicians with a lot of choice. There are no requirements for previous BRAF treatment or restrictions on tumor selection, the company explained on the call.
“Favorable labeling for Tudriqev reflects real-world clinical practice, allowing physicians room to individualize treatment and potentially lowering treatment-related adoption barriers,” the analysts wrote.
Replimune is planning a slow and steady launch, with 200 early adopter accounts targeted in the first six months, expanding to 450 at 9-12 months and 1,200 long term, Patel explained. The initial target accounts for about 30% of melanoma patients treated annually. The total patient population annually is about 10,000.
The company is prepared to begin shipping the product in about 60 days, CFO Emily Hill said. The cost of an average round of treatment will be about $450,000, although this will vary based on tumor burden and the number of rounds required.
To support the launch, Patel said Replimune is rehiring its commercial team. The company is about a third of the way through that process, with a goal of adding about 50 people, including 20 sales reps.
Replimune was forced to conduct a round of layoffs after Tudriqev was rejected for the second time in April. The CEO said that many of these people are eager to come back.
“What’s been really exciting is that a number of the team have actually come back to Replimune because I think they very much believe in the mission and what we’re trying to do for patients,” Patel said.
