Today, a brief rundown of news from Johnson & Johnson and Pfizer, as well as updates from Gilead Sciences, Link Cell Therapies and Sanofi that you may have missed.

The Food and Drug Administration on Monday said it “proactively” awarded one of its new regulatory fast passes to a multiple myeloma drug regimen from Johnson & Johnson. Last week, J&J presented results at the American Society of Hematology meeting suggesting that the regimen, a combination of its medicines Tecvayli and Darzalex, could be curative when used early in patients’ disease course. The FDA read those results, consulted with in-house experts and reached out to J&J “the following day” to discuss a “national priority” review voucher, Commissioner Marty Makary said in the agency’s statement. That voucher, the 16th granted so far, could shorten an evaluation of that combination to as little as one to two months. — Ben Fidler

Pfizer issued financial forecasts for 2026 on Tuesday, predicting revenue next year of $59.5 billion to $62.5 billion and earnings per share of $2.80 to $3 apiece. Those numbers reflect an expected $1.5 billion decline in COVID-19 products between 2025 and 2026 and a $1.5 billion hit due to the loss of exclusivity of certain products. Pfizer’s earnings per share guidance comes in about 5% lower than consensus estimates, but isn’t necessarily a surprise given the “acquisition-related dilution” from the Metsera and 3SBio deals, wrote Leerink Partners’ David Risinger. The company also narrowed its 2025 revenue projections to $62 billion, from between $61 billion to $64 billion previously. — Ben Fidler

Gilead Sciences said Monday that a single-tablet combination of two of its HIV drugs succeeded in the second of two late-stage trials, paving the way for a potential approval filing. In the ARTISTRY-2 trial, study volunteers with suppressed levels of HIV and already on Gilead’s Biktarvy were randomized to either continue on therapy or switch to a single-tablet form of Gilead’s bictegravir and lenacapavir. Gilead said the new pill was “non-inferior” to Biktarvy at keeping viral levels down after 48 weeks, and that those findings, combined with positive results from another late-stage trial, will form the basis of regulatory submissions. — Delilah Alvarado

Link Cell Therapies, a cancer cell therapy startup, emerged from stealth Monday with $60 million in a Series A funding led by Johnson & Johnson’s venture arm. The South San Francisco, California-based biotechnology company is developing precise CAR-T therapies that only activate when a combination of specific protein targets are present on tumor cells. It plans to bring its lead program for kidney cancer into human testing in 2026, with a second prospect for colorectal tumors reaching clinical trials the following year. To date, Link has raised $92 million in private funding from J&J, Samsara BioCapital, Wing Venture Capital and Bristol Myers Squibb, among others. — Gwendolyn Wu

Sanofi is expanding an autoimmune disease-focused alliance with startup Dren Bio, agreeing on Monday to add another drug to their existing deal. Sanofi, in March, paid Dren $600 million to acquire a so-called myeloid cell engager for multiple inflammatory conditions. That therapy, DR-0201, is in two Phase 1 studies and so far has shown the potential to induce “sustained treatment-free remission” in people with autoimmune diseases, Dren said. The new deal will see the companies collaborate on a second therapy that’s also a “next-generation” drug able to lower levels of malfunctioning B cells. Dren will receive $100 million in guaranteed cash and is eligible for another $1.7 billion in future payouts. It can also opt into splitting development costs and future U.S. profits. — Ben Fidler

Sanofi also licensed a potential Alzheimer’s disease treatment from Korean biotech ADEL. Per deal terms, Sanofi is paying ADEL $80 million up front, and possibly $1.04 billion overall, for a prospect called ADEL-Y01. That drug targets a type of tau protein and is currently in Phase 1 testing in the U.S. Sanofi is also getting rights to certain “related backup compounds” in the alliance. — Ben Fidler