Not a month after reports of three deaths in autoimmune trials for Novartis' CAR T cell therapy ignited a debate about the use of these treatments in nonfatal diseases, Kyverna Therapeutics reported data bolstering its case to bring to market the first CAR T for an autoimmune disease.

Original title: “Weighing the risks of CAR T in autoimmune disease as Kyverna nears market”

Not a month after reports of three deaths in autoimmune trials for Novartis' CAR T cell therapy ignited a debate about the use of these treatments in nonfatal diseases, Kyverna Therapeutics reported data bolstering its case to bring to market the first CAR T for an autoimmune disease.

Original title: “Weighing the risks of CAR T in autoimmune disease as Kyverna nears market”

Trial follows promising MAR002 Phase 1 clinical trial results that demonstrated deep and durable IGF-1 suppression with PK properties that may enable dosing as infrequently as once every two weeks, compared to the daily... Trial follows promising MAR002 Phase 1 clinical trial results that demonstrated deep and durable IGF-1 suppression with PK properties that may enable dosing as infrequently as once every two weeks, compared to the daily subcutaneous injections required by the current standard of care 05, 2026 (GLOBE NEWSWIRE) -- Marea Therapeutics, LLC (“Marea”), a subsidiary of Lisata Therapeutics, Inc. (Nasdaq: LSTA) (“Lisata”), a clinical-stage biotechnology company harnessing the latest advances in human genetics to develop first-in-class, next-generation medicines for cardioendocrine diseases, today announced the first patient has been dosed in its Phase 2 clinical trial of MAR002 for the treatment of acromegaly. Acromegaly is a rare, chronic, progressive endocrine disorder caused by prolonged exposure to excess growth hormone (GH), most commonly due to a GH-secreting pituitary adenoma, resulting in elevated insulin-like growth factor-1 (IGF-1). These characteristics support its potential to offer an effective and convenient treatment for patients with acromegaly, if approved. About Marea Therapeutics Marea Therapeutics is a clinical-stage biotechnology company harnessing the latest advances in human genetics to develop first-in-class, next-generation medicines for cardioendocrine diseases. After completing the 10-week treatment period, eligible participants will have an option to enroll in an open-label extension clinical trial. About Acromegaly Acromegaly is an orphan disease characterized by the excess secretion of growth hormone (GH) from a benign pituitary adenoma.

Original title: “Marea Therapeutics, a Subsidiary of Lisata Therapeutics, Announces First Patient Dosed in Phase 2 Clinical Trial of MAR002, a Potential Best-in-disease Investigational Therapy for the Treatment of Acr”

Over two years, patients experienced ... Travere Therapeutics. "In FSGS, the DUPLEX analysis adds to the evidence supporting the use of FILSPARI for patients without nephrotic syndrome, with higher complete proteinuria remission rates and lower observed rates of kidney failure compared to irbesartan. Together, these data reinforce the clinical value of FILSPARI across two rare, progressive kidney diseases.” · The final data readout from the Phase 2 SPARTAN Study, an open-label trial evaluating ... Over two years, patients experienced high rates of complete proteinuria remission and near physiologic eGFR decline, highlighting the potential for an oral, non-immunosuppressive therapy to address both key treatment goals early in the disease course," said Jula Inrig, M.D., chief medical officer of Travere Therapeutics. "In FSGS, the DUPLEX analysis adds to the evidence supporting the use of FILSPARI for patients without nephrotic syndrome, with higher complete proteinuria remission rates and lower observed rates of kidney failure compared to irbesartan. Together, these data reinforce the cli SAN DIEGO--(BUSINESS WIRE)--Oct 2, 2026--Travere Therapeutics, Inc. (Nasdaq: TVTX) today announced that it will share nine new data presentations, including five oral presentations, at the American … Incident Patients With IgA Nephropathy (IgAN) Demonstrated Stable eGFR With First-Line Sparsentan (SPAR) Over 2 Years in the SPARTAN Final Analysis Poster: TH-PO0453 Poster session: Glomerular Diseases: Clinical, Outcomes, and Therapeutics Research - IgAN Exhibit Hall A; October 22, 10:00 a.m.-12:00 p.m. MDT · Spatial transcriptomics reveals sparsentan-associated remodelling of complement-active renal niches in IgA Nephropathy Abstract: SA-OR048 Oral Abstract Session: Glomerular Diseases: Clinical Trial Results Mile High Ballroom 4A; October 24, 4:30 p.m.-6:00 p.m. Sparsentan (SPAR) vs Irbesartan (IRB) in Patients (Pts) With Focal Segmental Glomerulosclerosis (FSGS) Without Nephrotic Syndrome (NS) in the Phase 3 DUPLEX Trial Poster: FR-PO0645 Poster session: Glomerular Diseases: Clinical, Outcomes, and Therapeutics Research – ANCA/FSGS Exhibit Hall A; October 23, 10:00 a.m.-12:00 p.m.

Original title: “Travere to Present New Data Supporting FILSPARI® (sparsentan) as Foundational Treatment in IgA Nephropathy and FSGS at ASN Kidney Week 2026 | Dorchester Banner”

Kailera Therapeutics and Hengrui Pharma’s weekly injection showed benefits beyond weight loss in a mid-stage trial, leading to more regular menstrual cycles in patients with polyendocrine metabolic ovarian syndrome.

Original title: “Kailera, Hengrui’s GLP-1/GIP candidate delivers weight, menstrual benefits to women with PMOS”

At its monthly meeting, EMA’s safety committee (PRAC) carried out its broad range of responsibilities to manage the safety of medicines, including the assessment of safety…, Agenda Agenda of the PRAC meeting 28 September - 1 October 2026Draft Reference Number: EMA/PRAC/204838/2026…, PRAC statistics: October 2026 Monthly figures for PRAC outcomes based on the draft agenda. © European Medicines Agency,

Original title: “Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 28 September - 1 October”

Merck has revealed detailed data for tulisokibart from a mid-stage trial in hidradenitis suppurativa that analysts say could help carve out a place in a crowded market that already includes AbbVie’s Humira and UCB’s Bimzelx.

Original title: “Merck’s antibody impresses with ‘highly competitive’ data in chronic skin disease”

Detailed results are competitive with Dupixent and Ebglyss, but the drug lacks differentiation amid an increasingly competitive landscape, one analyst argued.

Original title: “Pfizer’s eczema drug clears skin in mid-stage trial”

Despite meeting the primary endpoints in a Phase 3 trial, shares of Zealand Pharma dropped in premarket trading Thursday as the up to 9.8% weight loss reflected inferior loss to that generated by competitors.

Original title: “Zealand dips as Boehringer Ingelheim-partnered weight loss drug fails to impress—again”

Methotrexate is prescribed to roughly ... Disease Modifying Antirheumatic Drugs, which increase the risk of serious side effects and multiply treatment costs. Amplio’s hypothesis is that MTX fails many patients not because methotrexate does not work, but because too little of it is retained inside the cells that drive inflammation. The Phase 1b results directly support that hypothesis. “It is rare for a Phase ... Methotrexate is prescribed to roughly four out of five newly diagnosed RA patients, yet in only about 40% disease remission is achieved on methotrexate alone.[1, 2] The remaining 60% need add-on second-line biologics or targeted synthetic Disease Modifying Antirheumatic Drugs, which increase the risk of serious side effects and multiply treatment costs. Amplio’s hypothesis is that MTX fails many patients not because methotrexate does not work, but because too little of it is retained inside the cells that drive inflammation. The Phase 1b results directly support that hypothesis. “It is rare for a Phase 1b study to give such a clear read-out on the biomarker that matters. The question we now need to answer is whether more active methotrexate inside the cell translates into more patients reaching remission faster on first-line therapy. If it does, the impact on patients and on healthcare budgets in Europe and the United States would be substantial.” · Phase 1b study design and results The Phase 1b study was an open-label study in 12 patients with rheumatoid arthritis on stable weekly methotrexate (15 to 25 mg), conducted in the Netherlands under an approved clinical trial application (Site: CHDR, Leiden). NovoBioJect is an investigational therapy and has not been approved by any regulatory authority. A single dose of NovoBioJect increased the active form of methotrexate inside patients' immune cells by 38%, a first step toward a potential next-generation first-line treatment for rheumatoid arthritis · First clinical proof of principle. Up to 60% of patients do not achieve remission on methotrexate alone and move on to second-line therapies that cost many times more. NovoBioJect is designed to raise the first-line response rate with potential cost savings for society. AMSTERDAM, the Netherlands, October 1st, 2026 – Amplio Pharma (“Amplio”), a clinical-stage pharmaceutical company developing NovoBioJect to improve first-line treatment of rheumatoid arthritis (RA), today announced positive results from its Phase 1b study of NovoBioJect in patients with RA.

Original title: “Amplio Pharma Reports Positive Early Clinical Results for NovoBioJect, Designed to Make the World's Most-Used Rheumatoid Arthritis Drug Work for More Patients - BioSpace”

Marketing authorisation holders wishing to receive an outcome in 2026 should submit type IA annual updates, individual type IA and type IAIN variations, and super-groupings…

Original title: “Advice on ‘end-of-year’ submission dates for type I variations in 2026”

Mid-year report 2026 from the Executive DirectorEMA presented results and achievements of its operations for the first half of 2026 to the Management Board. Between January and…

Original title: “EMA Management Board: highlights of September 2026 meeting”

First pharmacological option for early intervention

Original title: “Nezglyal approved in EU for childhood cALD”