In addition to a high rate of deaths, ADC Therapeutics’ Zynlonta plus rituximab showed no overall survival benefit in patients with diffuse large B cell lymphoma, casting doubt on its value as a second-line treatment in this indication.

Original title: “ADC Therapeutics nosedives on 27 deaths in confirmatory trial for lymphoma drug”

Commission authorisation expands access to passive measles prophylaxis for vulnerable patients

Original title: “European approval enables measles protection with CSL’s immunoglobulin Privigen”

Early clinical activity supports expansion into broader IgA‑mediated conditions

Original title: “JJP Biologics reports positive interim phase 1b data for nebaprubart”

Adding durvalumab to chemoradiation helps people avoid having their bladder removed

Original title: “Immunotherapy boost can spare more bladder cancer patients major surgery”

The estimated mean annualized rate of treated bleeding events decreased by 96.4% in patients treated with denecimig once a week and by 98.7% in those treated once a month, compared with those who continued on-demand treatment. These results support the potential of denecimig as a preventive treatment option for patients with hemophilia A with or without inhibitors, according to Anna Windle, PhD, the head of clinical development, medical, & regulatory affairs at Novo Nordisk US Operations. This article originally appeared on Rare Disease Advisor During the trial, 17 patients continued on-demand treatment, 21 received denecimig once a week, and 20 received denecimig once a month. The estimated mean annualized rate of treated bleeding events was 15.76 in patients continuing on-demand therapy, while it was 0.57 in patients given denecimig once a week and 0.20 in patients given the treatment once a month, corresponding to a relative decrease of 96.4% and 98.7%, respectively. Prophylactic treatment with denecimig is better than on-demand treatment and prophylaxis with clotting factor concentrate in terms of annualized rate of treated bleeding events in patients with hemophilia A. This finding stems from the results of an open-label, randomized, phase 3 clinical trial called FRONTIER2 (NCT05053139), which were published in the New England Journal of Medicine (NEJM). FDA Moves to Real-Time Clinical Trial Patient Monitoring, Faster Drug Review

Original title: “Clinical Trial Results Support the Potential of Denecimig in Hemophilia A - Hematology Advisor”

May 4, 2026 Kyverna Therapeutics Appoints Nadia Dac, Seasoned Commercial Leader in Neurology and Rare Disease, as Chief Commercial Officer · Apr 21, 2026 Kyverna Presents Registrational Trial Primary Analysis for Miv-cel in Stiff Person Syndrome Demonstrating Statistically Significant, Durable Clinical ... May 4, 2026 Kyverna Therapeutics Appoints Nadia Dac, Seasoned Commercial Leader in Neurology and Rare Disease, as Chief Commercial Officer · Apr 21, 2026 Kyverna Presents Registrational Trial Primary Analysis for Miv-cel in Stiff Person Syndrome Demonstrating Statistically Significant, Durable Clinical Benefit Across All Endpoints in an Oral, Late-Breaker Session at AAN Annual Meeting Updated Phase 1 COMPARE data at EULAR 2026 show miv-cel’s deep B-cell depletion, 66.6% ACR70 at Week 36, and no high-grade CRS or ICANS; Phase 2 enrolled. Data reinforce miv-cel’s differentiated clinical profile and opportunity to change the treatment paradigm across a variety of autoimmune diseases · EMERYVILLE, Calif., June 03, 2026 (GLOBE NEWSWIRE) -- Kyverna Therapeutics, Inc. (Nasdaq: KYTX), a late-stage clinical biopharmaceutical company developing cell therapies for patients with autoimmune diseases, today announced the presentation of updated data from the Phase 1 portion of COMPARE, a Phase 1/2 investigator-initiated trial (IIT) evaluating miv-cel (mivocabtagene autoleucel, KYV-101) in patients with active anti-citrullinated protein antibody (ACPA)-positive, treatment-refractory rheumatoid arthritis (RA). The use of miv-cel (KYV-101) in the IH setting is not a substitute for, nor intended to replace, Kyverna’s clinical trials. The goal is not to assess the effectiveness of a potential therapy, but rather to provide an individual patient with a possible efficacious approach when all other treatment options have failed, as determined by the patient’s physician. Kyverna reported that a single miv-cel dose reduced disease activity in all six patients.

Original title: “New RA cell therapy clears disease-driving B cells in early trial”

Celcuity’s gedatolisib doubled progression-free survival versus standard of care in certain patients with advanced breast cancer. Still, the biotech’s stock dropped more than 25% Tuesday.

Original title: “Celcuity slides even after ‘practice-changing’ late-stage breast cancer data”

All six non-Hodgkin lymphoma patients on Legend Biotech’s CAR T therapy responded to treatment—findings that could make the biotech an attractive takeover target, according to analysts at Oppenheimer.

Original title: “Legend soars on ‘best-in-class,’ ‘best-in-disease’ in vivo CAR T in early lymphoma study”

Gedatolisib could “establish a new standard of care” for PIK3CA-mutated breast cancer, an investigator said, but the results nonetheless appeared to disappoint investors.

Original title: “Celcuity breast cancer drug misses ‘lofty’ expectations in ASCO-spotlighted trial”

/PRNewswire/ -- Rise Therapeutics, a clinical-stage biotechnology company advancing novel oral immunotherapies for autoimmune diseases, today announced the... ROCKVILLE, MD, June 2, 2026 /PRNewswire/ -- Rise Therapeutics, a clinical-stage biotechnology company advancing novel oral immunotherapies for autoimmune diseases, today announced the completion of full enrollment in the 4-week dose expansion cohort of its Phase 1b clinical trial (NCT05961592) evaluating orally dosed R-2487 in patients with active rheumatoid arthritis (RA). This recommendation marks an important advancement for the R-2487 clinical program and enables continued evaluation of the therapy over an extended treatment period. Data from the 4-week dose expansion cohort will be presented at upcoming national and international rheumatology and immunology conferences, as appropriate and as analyses become available. Dr. Fanger added: "In parallel with the ongoing clinical expansion cohorts evaluating extended dosing and enrolling patients with overlapping RA and Sjögren's disease, we are preparing R-2487 for the next stage of clinical development. This includes advancing clinical protocol design, dose selection strategy, and regulatory engagement to support a Phase 2 clinical evaluation. We are also scaling key operational capabilities, including GMP manufacturing, to enable an efficient transition into the next phase of development for this program." RA is a multi-billion-dollar global market with continued demand for therapies that combine early intervention, improved tolerability, and disease-modifying potential. With internal GMP manufacturing capabilities and a growing clinical pipeline, Rise Therapeutics is positioned to advance multiple programs targeting autoimmune and inflammatory diseases while pursuing value-creating partnerships and strategic growth opportunities, including the continued advancement of R-2487 into Phase 2 clinical development.

Original title: “Rise Therapeutics Completes Enrollment in Four-Week Dose Expansion Cohort for the R-2487 Rheumatoid Arthritis Clinical Trial”

The U.S. Food and Drug Administration (FDA) today issued draft guidance to help developers bring promising gene therapies to patients more efficiently by making greater use of existing scientific and regulatory knowledge.

Original title: “FDA Issues Draft Guidance to Help Accelerate Cell and Gene Therapies for Patients”

Aragen scales Daretabart to commercial-ready production following rapid 9‑month tech transfer

Original title: “Aragen to manufacture Renaissance Pharma’s FDA Fast Track mAb”

In addition to eliciting 17.3 months median overall survival vs. 8.5 months for patients given standard of care treatment in a prior study, Immuneering’s atebimetinib demonstrated a robust tolerability profile—something CEO Ben Zeskind said equates highly with survival.

Original title: “ASCO: Biopharma has pancreatic cancer ‘surrounded’ as Immuneering’s drug adds 9 quality months”

Revolution Medicines and its RAS inhibitor daraxonrasib stole the show at the American Society of Clinical Oncology’s annual meeting this weekend, as Truist Securities predicts a possible third quarter launch for the pancreatic cancer drug.

Original title: “ASCO: Revolution poised to capture RAS space as pancreatic cancer dataset ‘derisks’ approval”

Analysts, investors and partner Summit Therapeutics had all been keenly awaiting the overall survival update, after previous data from Akeso’s HARMONi-6 trial left them wanting.

Original title: “ASCO: Akeso’s VEGF/PD-1 boosts lung cancer survival, relieving pressure on US partner Summit”