Bictegravir/Emtricitabine/Tenofovir Alafenamide Fumarate

The Artistry-2 win comes a month after Gilead reported a separate positive trial result for the investigational regimen. With a second late-stage trial win for its investigational HIV combo in the books, Gilead Sciences is moving full steam ahead toward regulatory filings for the novel HIV regimen.In Gilead's Artistry-2 study, the company's single-tablet regimen of bictegravir and lenacapavir matched up to Gilead's own megablockbuster HIV medicine Biktarvy when assessing patients' treatment responses, Gilead said in a Dec. 15 release. The trial enrolled adults with HIV who had achieved virologic suppression on Biktarvy and randomized them 2-1 to either switch to the novel regimen or continue receiving Biktarvy.In top-line results shared Monday, Gilead said the bictegravir 75-mg/lenacapavir 50-mg regimen was noninferior to Biktarvy, meeting the trial's primary endpoint. The primary endpoint looked at the percentage of participants with HIV-1 RNA levels ≥50 copies/mL at Week 48. The investigational combo was generally well tolerated, Gilead added.“These data support the potential of BIC/LEN as a meaningful additional treatment option for adults with HIV who are virologically suppressed," Gilead's Jared Baeten, M.D., Ph.D., senior vice president of clinical development and virology therapeutic area head, said in a statement. "We look forward to sharing the full Phase 3 data from the ARTISTRY-1 and ARTISTRY-2 trials next year and submitting these data for regulatory approval.”The news comes about a month after Gilead reported a top-line win in the Artistry-1 study. The trials were similar in design, but Artistry-1 enrolled patients who were on complex multi-tablet regimens at baseline. Bictegravir, an integrase strand transfer inhibitor, is one of the three active ingredients in Biktarvy, alongside the antivirals emtricitabine and tenofovir alafenamide. Lenacapavir is a capsid inhibitor used in the company's long-acting HIV treatment Sunlenca and its twice-yearly PrEP drug Yeztugo.When Gilead reported the Artistry-1 win, Citi analyst Geoffrey Meacham, Ph.D., wrote that the novel regimen "targets a key unmet need within the HIV market (~6-8%), who are not candidates for the standard-of-care" drug Biktarvy. Thus, the combo could allow Gilead to expand its reach in HIV without "cannibalizing its flagship product," Meacham wrote.In the wake of the Artistry-2 readout, Meacham explained in a note to clients that the novel offering could find use in the "Biktarvy switch market." "Indeed, today's positive results will enable Gilead to position the combo strategically and retain patients who might otherwise switch to other 2 drug regimen," Meacham wrote. "Overall the positive results across both ARTISTRY (1&2) trials will allow Gilead to provide a simplified 2-drug regimen and provide an alternative for the specific market segments that prefer fewer medications."Meacham's team is projecting 2030 sales of $630 million for the combo product. After planned filings next year, Gilead could launch the drug in 2027, the analyst wrote.

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 agencys statement. That voucher, the 16th granted so far, could shorten an evaluation of that combination to as little as one to two months. Ben FidlerPfizer 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. Pfizers earnings per share guidance comes in about 5% lower than consensus estimates, but isnt 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 FidlerGilead 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 Gileads Biktarvywere randomized to either continue on therapy or switch to a single-tablet form of Gileads bictegravirand 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 & Johnsons 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 WuSanofi 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 thats 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 FidlerSanofi also licensed a potential Alzheimers 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 compoundsin the alliance. Ben Fidler '