UCB SA agreed to pay $2 billion up front to acquire bispecific T-cell engager (TCE)-maker Candid Therapeutics Inc. and lead BCMA/CD3 TCE asset cizutamig (CND-106), continuing big pharma’s spree for China-made autoimmune assets in 2026. Under the terms announced May 3, Brussels-based UCB will pay $2 billion in up-front payments and up to $200 million in potential future milestone payments to purchase privately-held Candid. The deal is expected to close by the end of the second or third quarter of 2026. “This acquisition demonstrates our inorganic innovation strategy in action,” UCB CEO Jean-Christophe Tellier said. Cizutamig, a BCMA/CD3-directed bispecific TCE, and the drug class “exemplifies the next wave of therapies to treat immune-mediated diseases and reflects our commitment to setting new standards to achieve immune reset,” Tellier said.

Volixibat phase IIb comes through in PSC for Mirum

Mirum Pharmaceuticals Inc. (NASDAQ:MIRM) rolled out phase IIb data from the Vistas trial with oral ileal bile acid transporter inhibitor volixibat in primary sclerosing cholangitis (PSC). Vistas reached its primary endpoint, showing a 1.64-point placebo-adjusted reduction in the Adult Itch Reported Outcome scale from baseline (p-value less than 0.0001). Mirum plans to request a pre-NDA meeting with the U.S. FDA, eyeing a regulatory submission in the second half of this year to seek approval in PSC, a rare chronic liver disease. Shares of the Foster City, Calif.-based firm (NASDAQ:MIRM) were trading at $107.94, up $11.42, or 11%.

USTR calls out trade partners for Rx, med-tech pricing policies

For the first time in 13 years, the U.S. Trade Representative (USTR) singled out one of the U.S. trading partners as the worst of the worst when it named Vietnam as a Priority Foreign Country in its newly released Special 301 Report. The annual report also relisted six countries, including China and India, on its Priority Watch List and placed 19 trading partners, including the EU, on the Watch List. Altogether, the listings account for about a fourth of more than 100 U.S. trading partners. While the countries are selected based on actions and policies negatively impacting many U.S. industries, the trade report specifically references pricing and intellectual property issues affecting biopharma and med-tech industries.

Celcuity rises on gedatolisib on top-line data in breast cancer

Celcuity Inc. is slated to present detailed data at the upcoming American Society of Clinical Oncology meeting, but a positive top-line readout from the Viktoria-1 trial testing gedatolisib in the PIK3CA-mutant cohort of breast cancer patients was enough to send the company’s shares (NASDAQ:CELC) trading up 18% at midday. The study, which evaluated gedatolisib plus fulvestrant, with or without palbociclib, in patients with HR-positive, HER2-negative, PIK3CA-mutant locally advanced or metastatic breast cancer following progression on or after treatment with a CDK4/6 inhibitor and an aromatase inhibitor, showed a statistically significant and clinically meaningful improvement in progression-free survival when compared to approved PI3Kα inhibitor Piqray (alpelisib, Novartis AG) and fulvestrant. Based on those findings, Celcuity anticipates filing a supplemental NDA for use in the PIK3CA-mutant population. Meanwhile, its initial NDA filing seeking approval of gedatolisib in the PIK3CA wild-type population is under review at the FDA, with a PDUFA date of July 17.

Bio Korea 2026: US policy risks shift to execution framework

Regulatory uncertainty that dominated the life science sector in 2025 is transitioning into an execution framework for biotechnology companies, provided companies can tailor regulatory strategies early, and across the entire development cycle. The resounding theme at Bio Korea 2026 was that U.S. FDA approval is just one part of biotech success; regulatory strategy that reflects major legislative and policy changes, commercialization pathways and market access (reimbursement) is essential from the beginning and at every step of development. Sean Kim, partner at Ice Miller, told the audience April 30 that the Biosecure Act, signed into law Dec. 18, 2025, as part of the National Defense Authorization Act, is “increasingly shaping how science is executed and how partnerships are formed.” What was once a legislative debate has become federal law, he stressed, and it’s affecting entire supply chains.

Liposomes displaying Env trimers drive HIV apex-focused responses

A new vaccination strategy designed to induce antibodies that recognize the apex of the HIV Env protein uses Env trimers displayed on liposomes to increase their density and orient them correctly. This presentation enhanced apex-focused antibody responses in macaques, and the monoclonal antibodies isolated after immunization showed binding modes and structural features resembling human broadly neutralizing antibodies, indicating that the vaccine can steer the antibody response toward this vulnerable site. “We make liposomes, which are just like little vesicles. But one of the lipids we use has a maleimide group that then we can couple covalently to our trimers if they have a free cysteine. That is unique to our design,” Richard Wyatt told BioWorld. Wyatt, who is a professor at the Department of Immunology and Microbiology at The Scripps Research Institute, co-directed the project with Gunilla Karlsson Hedestam, professor at the Department of Microbiology, Tumor and Cell Biology at the Karolinska Institutet in Stockholm.

Also in the news

Arrowhead, Ascendant Health Sciences, Astrazeneca, Axsome, Cocrystal, Contineum, Corcept, Cue, Esperion, Eton, J&J, MRM, Nanalysis, Noema, Northwest, Noxopharm, Oberland, Orchestra, Rein, Resmed, Restore, Retia, Rhythm, Royal Philips, Senseonics, Stoked, Taewoong, Techcyte, Tela, Telix