1. Positive clinical and endoscopic improvements with TREMFYA® subcutaneous induction therapy
On May 5, 2025, Johnson & Johnson announced Phase 3 ASTRO study evaluating subcutaneous induction therapy of TREMFYA® (guselkumab) in adults with moderately to severely active ulcerative colitis (UC). TREMFYA® is a dual-acting monoclonal antibody that blocks IL-23 while binding to CD64.
At Week 24, both dosing regimens of TREMFYA® (guselkumab) demonstrated statistically significant efficacy versus placebo across all prespecified endpoints. Clinical remission was achieved in 35.3% of patients receiving 100 mg every 8 weeks (q8w) and 36.4% receiving 200 mg every 4 weeks (q4w), compared to 9.4% in the placebo arm. Symptomatic remission rates were 54.7% and 50.0% in the respective TREMFYA® cohorts, versus 25.2% with placebo. Endoscopic improvement was observed in 40.3% and 45.0% of patients receiving 100 mg q8w and 200 mg q4w, respectively, compared to 12.2% with placebo. Clinical response was achieved by 63.3% (100 mg q8w) and 61.4% (200 mg q4w) of patients, versus 30.9% in the placebo group.
Link: https://www.jnj.com/media-center/press-releases/tremfya-guselkumab-positioned-to-become-the-first-and-only-il-23-inhibitor-to-offer-subcutaneous-induction-in-ulcerative-colitis-as-demonstrated-in-new-data-through-24-weeks
2. Icotrokinra (JNJ-2113) icotrokinra achieved clear skin in 57% of plaque psoriasis patients in a Phase 3 trial
On May 9, 2025, Johnson & Johnson announced new data from the Phase 3 ICONIC-TOTAL study investigating an oral peptide, icotrokinra (JNJ-2113), which selectively blocks the IL-23 receptor. The study evaluated adults and adolescents more than 12 years old with body surface area as low as 1% and at least moderate plaque psoriasis (PsO). From the study, 57% of patients treated with once daily icotrokinra achieved the primary endpoint with an Investigator’s Global Assessment (IGA)b score of 0/1 (clear or almost clear skin) and a ≥2-grade improvement from baseline at Week 16 compared to 6% of patients on placebo. There are also improvements in specific skin sites, including genital psoriasis and hand/foot psoriasis.
Link: https://www.jnj.com/media-center/press-releases/icotrokinra-results-show-significant-skin-clearance-in-patients-with-difficult-to-treat-scalp-and-genital-psoriasis
3. Calquence received EU approval for previously untreated mantle cell lymphoma
On May 6, 2025, AstraZeneca’s Calquence (acalabrutinib) in combination with bendamustine and rituximab has been approved in the EU for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are not eligible for autologous stem cell transplant. The approval was followed by the recommendation from the CHMP and was supported by the ECHO Phase III trial. Calquence plus bendamustine and rituximab reduced the risk of disease progression or death by 27% compared to standard-of-care chemoimmunotherapy. The median progression-free survival (PFS) was 66.4 months for patients treated with the Calquence combination versus 49.6 months with chemoimmunotherapy alone. The combination therapy has also been previously approved by the U.S. FDA.
Link: https://www.astrazeneca.com/media-centre/press-releases/2025/calquence-combination-approved-in-eu-for-1l-mcl.html
4. Enhertu followed by THP therapy significantly improved pathologic complete response in early breast cancer
On May 7, 2025, Daiichi Sankyo and AstraZeneca’s Phase III trial DESTINY-Breast11 showed Enhertu (trastuzumab deruxtecan) followed by paclitaxel, trastuzumab and pertuzumab (THP) therapy demonstrated a statistically significant and clinically meaningful improvement in pathologic complete response (pCR) rate versus standard of care in patients with high-risk, locally advanced HER2-positive early-stage breast cancer. The secondary endpoint of event-free survival (EFS) was not mature yet, but showed positive trends. This is the first phase 3 trial to demonstrate the benefit of ENHERTU in early breast cancer.
Link: https://www.astrazeneca.com/media-centre/press-releases/2025/enhertu-improved-pcr-in-early-stage-breast-cancer.html
https://www.daiichisankyo.com/files/news/pressrelease/pdf/202505/20250507_E.pdf
5. Linerixibat significantly improved itch severity and sleep interference in adults with cholestatic pruritus due to primary biliary cholangitis
On May 8, 2025, GSK announced positive results from the GLISTEN phase III trial evaluating linerixibat, an investigational targeted inhibitor of the ileal bile acid transporter (IBAT), in adults with cholestatic pruritus (relentless itch) in primary biliary cholangitis (PBC). It is a chronic and rare autoimmune liver disease characterised by progressive destruction of small bile ducts within the liver.
The study met the primary endpoint of change from baseline in monthly itch score and showed linerixibat significantly improved the symptoms versus placebo over 24-weeks, Monthly itch score evaluated the worst weekly itch of each month over the 24-week treatment period. The trial also met key secondary endpoints with improvements in itch-related sleep interference.
Link: https://www.gsk.com/en-gb/media/press-releases/glisten-phase-iii-trial-results-show-linerixibat-significantly-improves-cholestatic-pruritus/
6. Zepbound (tirzepatide) achieved superior weight and waist circumference reduction compared to Wegovy (semaglutide)
On May 11, 2025, Eli Lilly and Company announced results from SURMOUNT-5, a Phase 3b clinical trial, evaluating the safety and efficacy of Zepbound (tirzepatide), a dual GIP and GLP-1 receptor agonist, compared to Wegovy (semaglutide) in adults living with obesity, or overweight with at least one weight-related medical problem and without diabetes.
At 72 weeks, Zepbound met the primary endpoint, where participants treated with Zepbound achieved an average weight reduction of 20.2% compared to 13.7% with Wegovy. In the key secondary endpoints, participants treated with Zepbound achieved a superior average waist circumference reduction of 7.2 in (18.4 cm), while those treated with Wegovy showed an average reduction of 5.1 in (13.0 cm).
Link: https://investor.lilly.com/news-releases/news-release-details/zepbound-tirzepatide-showed-superior-weight-loss-over-wegovy
7. Bulevirtide maintained long-term virologic suppression in chronic hepatitis delta patients
On May 7, 2025, Gilead Sciences announced results from the Phase 3 MYR301 study, revealing that 36% (23 out of 64) of adults living with chronic hepatitis delta virus (HDV) treated with the bulevirtide at either a 2 mg or 10 mg dose maintained virologic suppression for almost two years after stopping treatment after achieving undetectable HDV RNA at end of treatment (EOT). 90% (9/10) of those who had HDV RNA undetectability for ≥ 96 weeks at end of treatment remained HDV undetectable off-treatment. HDV is the most severe form of viral hepatitis with more rapid progression towards liver cancer and liver-related death. Bulevirtide blocks the HDV receptor sodium taurocholate co-transporting polypeptide (NTCP), preventing HDV entry into hepatocytes.
Link: https://www.gilead.com/news/news-details/2025/final-data-from-the-phase-3-myr301-study-demonstrated-longer-treatment-with-bulevirtide-was-associated-with-sustaining-undetectability-after-stopping-treatment
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