1.RINVOQ® meets key endpoints in Phase III trials for severe alopecia areata, showing significant scalp hair regrowth
On July 30, 2025, Abbvie announced positive results from two pivotal studies of the Phase III UP-AA clinical program evaluating the safety and efficacy of Upadacitinib (RINVOQ®) in treating adults and adolescents with severe alopecia areata with a mean baseline SALT score of 83.8 (approximately 16% scalp hair coverage). Alopecia areata is an immune-mediated disease that can cause total hair loss.
In Study 2, both 15 mg and 30 mg, once daily doses of upadacitinib achieved the primary endpoints, with 44.6% and 54.3% of patients, respectively, achieving 80% or more scalp hair coverage (SALT score ≤ 20) at week 24, compared to 3.4% of patients in the placebo arm. Additional key secondary endpoints that were met included a higher portion of patients showing improvements in eyebrows and eyelashes in the treatment arm.
Link: AbbVie Announces Positive Topline Results from Phase 3 UP-AA Trial Evaluating Upadacitinib (RINVOQ®) for Alopecia Areata - Jul 30, 2025
2. Pirtobrutinib demonstrates non-inferior response compared to ibrutinib in lymphoma, with favorable PFS trend
On July 29, 2025, Eli Lilly and Company announced positive results from the Phase 3 BRUIN CLL-314 study of Jaypirca (pirtobrutinib), a non-covalent BTK inhibitor, compared to Imbruvica (ibrutinib), a covalent BTK inhibitor, in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL). The participants include both treatment-naïve patients as well as pre-treated patients without BTK inhibitor resistance.
The study met its primary endpoint of non-inferiority on overall response rate (ORR) in both the pre-treated and intent-to-treat populations. The secondary endpoint of progression-free survival (PFS) was not yet mature, but was trending in favour of pirtobrutinib.
3. Kisunla shows sustained cognitive benefits over 3 years in Alzheimer’s Phase 3 extension study
On July 30, 2025, Eli Lilly and Company showed Phase 3 TRAILBLAZER-ALZ 2 long-term extension study results demonstrated Kisunla (donanemab-azbt) benefits patients over three years and continues to benefit compared to the untreated cohort.
Kisunla reduced cognitive decline by -0.6 at 18 months and then -1.2 at 36 months on the Clinical Dementia Rating Sum of Boxes (CDR-SB) in patients initially treated with Kisunla in the core study compared to the matched group. People who received Kisunla in the earlier stage had a 27% reduced risk of disease progression as assessed by Clinical Dementia Rating-Global Score (CDR-G), compared to those who received Kisunla treatment later. Moreover, more than 75% of participants treated with Kisunla reached amyloid clearance within 76 weeks of starting treatment.
4. Mounjaro demonstrates cardiovascular safety and added metabolic benefits over Trulicity in Phase 3 SURPASS-CVOT trial
On July 31, 2025, Eli Lilly and Company announced results from the SURPASS-CVOT Phase III trial comparing two incretin therapies in adults with type 2 diabetes and established atherosclerotic cardiovascular disease. Mounjaro (tirzepatide), a GIP/GLP-1 dual receptor agonist, was compared to Trulicity (dulaglutide), a GLP-1 receptor agonist that has been previously shown to present cardiovascular benefits. In the study, Mounjaro achieved the primary objective by demonstrating non-inferiority of an 8% lower risk of major adverse cardiovascular events (MACE-3), including cardiovascular death, heart attack or stroke. Meanwhile, Mounjaro also showed improvements on key measures of A1C, weight, renal function and all-cause mortality.
5. FDA expands Biktarvy® indication to include treatment-experienced HIV patients to reinitiate therapy
On July 30, 2025, the U.S. FDA approved an expanded indication for Biktarvy® (bictegravir/emtricitabine/tenofovir alafenamide) to include treatment-experienced adults with HIV who are restarting antiretroviral therapy (ART) after a treatment interruption, and without documented resistance to any components of Biktarvy.
Previously, Biktarvy was primarily indicated for treatment-naïve patients or patients switching from another fully suppressive regimen without resistance. This new approval is based on data from the BRAAVE 2025 study, which demonstrated that Biktarvy achieved and maintained viral suppression in people with HIV who had discontinued treatment and were re-initiating ART. This new indication helps those people who had treatment interruptions due to life circumstances (e.g., stigma, incarceration, mental health).
Link: US FDA Approves New Biktarvy Indication For People With HIV Who Are Treatment Experienced And Restarting Antiretroviral Treatment
6. CHMP recommends TEVIMBRA® with chemotherapy for resectable NSCLC
On July 28, 2025, BeOne Medicines announced that the CHMP has recommended the approval for TEVIMBRA® (tislelizumab), in combination with platinum-containing chemotherapy for the treatment of adult patients with resectable non-small cell lung cancer (NSCLC) at high risk of recurrence. The approval was based on the Phase 3 RATIONALE-315 study. In the interim analyses, 56.2% of NSCLC patients treated with TEVIMBRA combination therapy before surgery achieved major pathologic response compared to 15.0% of patients treated with chemotherapy in combination with placebo. Moreover, 40.7% of patients on the TEVIMBRA-based regimen achieved pathological complete response, compared to 5.7% of patients in the placebo arm. Additionally,
7. FDA approves VIZZ for presbyopia with rapid and long-lasting near vision improvement
On July 31, 2025, LENZ Therapeutics announced that the U.S. FDA approved VIZZ (aceclidine ophthalmic solution) 1.44%, an aceclidine-based eye drop for the treatment of presbyopia in adults. Presbyopia is the gradual loss of your eyes' ability to focus on nearby objects. The FDA approval was based on the CLARITY 1 and CLARITY 2 trials, where both studies achieved all primary and secondary near vision improvement endpoints with near vision loss improvements within 30 minutes and lasting up to 10 hours.
8. FDA approves SEPHIENCE™ for phenylketonuria with strong efficacy in lowering phenylalanine levels
On July 28, 2025, PTC Therapeutics announced that the U.S. FDA has approved SEPHIENCE™ (sepiapterin) for the treatment of children and adults living with phenylketonuria (PKU). PKU is a rare inherited metabolic disorder caused by a deficiency of the phenylalanine hydroxylase (PAH) enzyme. Without it, phenylalanine accumulates and causes toxicity towards the host. The FDA approval was based on the evidence of significant efficacy and safety from the Phase III APHENITY trial, as well as the durability of treatment effect in the APHENITY long-term extension study.
In the Phase III APHENITY trial, 73% of participants responded to sepiapterin with a ≥15% reduction in blood phenylalanine. In the randomised phase, those treated with sepiapterin showed a 63% reduction in the phenylalanine level after six weeks, compared to 1% with the placebo. And in the long-term study, 60% of the participants were able to maintain a low phenylalanine level.
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