After two rejections, Replimune has made it across the regulatory finish line with its twice-rejected therapy for advanced melanoma. Meanwhile, the last of the major pharmas, including Eli Lilly and Novo Nordisk, reported second quarter earnings, and psychedelics made headlines once again.
After a drama-filled year that included two FDA rejections, Replimune has finally secured market approval for its oncolytic immunotherapy RP1 to treat advanced melanoma. The greenlight came after a contentious advisory committee meeting and after its scheduled PDUFA date, but analysts think RP1—to be sold as Tudriqev—could reach peak sales of $1.3 billion.
In its second quarter earnings, Eli Lilly reported revenue of $23 billion, a 48% increase over Q2 2025. However, the pharma’s oral GLP-1 Foundayo is not selling as well as Novo Nordisk’s oral Wegovy. Foundayo took in $98 million for its first quarter on the market, while Novo previously reported $355 million for the Wegovy pill in Q1 after its December approval. Next up, Lilly’s next-generation obesity asset, retatrutide, which is currently at the heart of a legal dispute between the FDA and Lilly over whether it should be classified as a biologic.
Meanwhile, Novo addressed various recent setbacks on its second quarter earnings call, including two head-to-head trials pointing to the superiority of Lilly’s assets and the late-stage IL-6 fail reported last week. BioSpace also covered earnings from Gilead, Amgen, BioMarin and Denali, among others.
Finally, Compass Pathways and Definium Therapeutics both anticipate near-term catalysts. This comes as the federal focus government throws its support behind the space—and works to “curb psychiatric overprescribing.”
Also check out what Insilico Medicine CEO Alex Zhavoronkov has to say about how he built the AI drug hunter into one of pharma’s most-sought after partners.
