Today, a brief rundown of news involving Replimune Group and Johnson & Johnson, as well as updates from Omega Funds, iTeos Therapeutics and Roche that you may have missed.

The Food and Drug Administration on Tuesday rejected a melanoma drug developed by Replimune. According to the Massachusetts-based biotechnology company, the agency said in a complete response letter that it did not consider the single-arm study Replimune ran to be an “adequate and well-controlled clinical investigation that provides substantial evidence of effectiveness.” The FDA also cited differences among the patients enrolled and issues it had with Replimune’s design of a confirmatory trial. In a statement, Replimune CEO Sushil Patel said the company was “surprised” by the FDA’s decision, as the agency had not previously raised those issues in prior meetings. Analysts saw evidence of changing approval standards in the rejection: “It is obvious [Replimune] got caught in a changing FDA regulatory landscape,” Cantor Fitzgerald’s Li Watsek wrote in a client note. — Ned Pagliarulo

Johnson & Johnson on Monday asked the FDA to approve a new immune disease drug called icotrokinra that it and Protagonist Therapeutics developed for moderate-to-severe plaque psoriasis. The drug blocks a protein called IL-23 that’s targeted by other available medicines, but, unlike those therapies, is delivered as a pill instead of an injection. J&J’s application is backed by data from four trials that showed treatment could reliably clear skin. The company is also studying icotrokinra in ulcerative colitis and other immune diseases mediated by IL-23. — Ned Pagliarulo

Biotech venture firm Omega Funds closed a $647 million fund, its eighth, to help fund investments in life sciences companies in the U.S. and Europe. Omega said Monday it exceeded its $600 million target, with “strong support” from both new and existing limited partners. Omega has raised more than $2.5 billion since its inception in 2004 and, since then, its portfolio companies have been involved in 47 initial public offerings and 50 acquisitions, among them the recent buyouts of Scorpion Therapeutics and Morphic Therapeutic, the firm said. — Ben Fidler

Cancer drug developer iTeos Therapeutics will sell itself to Concentra Biosciences as part of a plan to wind down and disburse cash to its shareholders. The company, which revealed plans to liquidate in May, announced on Monday a deal through which Concentra will buy its assets for a little over $10 per share. Stockholders could receive additional consideration via a “contingent value right” if Concentra sells certain iTeos assets within six months or the company’s cash holdings exceed $475 million at closing. The deal is the latest in a series of recent acquisitions for Concentra, a vehicle controlled by hedge fund Tang Capital Partners that buys struggling biotechs and shuts them down. — Ben Fidler

Roche is debating next steps for an experimental lung disease drug it’s been developing after reporting split results from two clinical studies of people with chronic obstructive pulmonary disease. While the drug, astegolimab, significantly reduced the annual attack rate in a Phase 2b trial, results from a similarly sized Phase 3 study didn’t reach statistical significance, Roche said Monday. The observed reductions in annualized rate were about 15% in each study, but Roche noted that the total number of these “exacerbations” was lower than its scientists had expected when designing the trials. Roche Chief Medical Officer Levi Garraway said the company would discuss the data with health regulators. — Ned Pagliarulo