Autoimmune & Immunology Therapeutics

Novartis agreed in September 2025 to acquire Tourmaline Bio, Inc. for approximately $1.4 billion, with the IL-6 inhibitor pacibekitug as the central strategic asset. Novartis described pacibekitug as Phase III-ready and positioned it as a complement to its cardiovascular portfolio, gaining access to its global cardiovascular infrastructure, development capabilities, payer relationships and launch expertise. The deal follows positive topline results from the Phase II TRANQUILITY trial reported by Tourmaline Bio in May 2025, in which monthly dosing at 15 mg produced an hs-CRP reduction of more than 85% and 50 mg quarterly dosing achieved a reduction of more than 86%, with all treatment arms reaching p< 0.0001 compared with placebo and adverse event rates comparable to placebo. Pacibekitug is an investigational, long-acting fully human IgG2 monoclonal antibody that selectively binds to and neutralizes IL-6 signaling, designed for low-volume subcutaneous administration with an extended half-life that may support quarterly dosing. Originally developed by Pfizer Inc. for autoimmune diseases including Crohn's Disease and Systemic Lupus Erythematosus, the asset has since been repositioned for atherosclerotic cardiovascular disease, Chronic Kidney Disease with elevated inflammation, Thyroid Eye Disease and other inflammatory conditions. A new ResearchAndMarkets.com report forecasts pacibekitug sales and market size through 2034 across the seven major markets of the United States, EU4, the United Kingdom and Japan, covering cardiovascular disorders, Graves ophthalmopathy, kidney disorders and abdominal aortic aneurysm.

A Delaware federal judge on Monday rejected requests from Pfizer, BioNTech and Moderna to dismiss lawsuits filed by Bayer's Monsanto unit over their use of US Patent No. 7,741,118, a patent related to mRNA technology, with Judge William Bryson saying the companies failed to prove the patent was invalid or not infringed by their COVID-19 vaccines. Sanofi agreed to a deal worth up to $8B, including $1B upfront, with Regeneron to jointly develop four long-acting immunology therapies, led by the clinical-stage IL-13 monoclonal antibody REGN20423. China's Abogen Biosciences signed a licensing and option agreement with Novartis worth up to $7.8B, comprising a $575 million upfront payment and up to approximately $7.2 billion in potential milestone payments if all options on all programs are exercised, covering an exclusive worldwide license to Abogen's lead asset ABO2203. Jiangsu Hengrui Pharmaceuticals agreed to license global rights to its experimental obesity drug HRS-1596 to Novo Nordisk in a deal worth up to $2.6B, with $300M upfront and the transaction expected to close in Q4 2026. Meanwhile, the S&P 500 Health Care Sector Index slipped 2.66% for the week, with Incyte down 6.93% and Regeneron down 6.71% among the top decliners, while McKesson rose 4.11% and Cardinal Health gained 3.67%.

Merck reported positive Phase 2b results for tulisokibart in moderate to severe hidradenitis suppurativa on 1 October 2026. The investigational anti TL1A monoclonal antibody met its Phase 2b efficacy goals in patients with this chronic inflammatory skin condition, and Merck stated that the data support advancing the program into Phase 3 trials in hidradenitis suppurativa. The company said the readout backs the idea that tulisokibart can anchor a new immunology franchise rather than patch a niche condition, helping Merck argue it is building multiple disease-area pillars next to oncology, in contrast to peers like AbbVie and Johnson & Johnson that already lean heavily on immunology blocks. The bear case is that one successful readout does not erase execution risk across the rest of the late stage portfolio, especially with analysts already flagging profit margin pressure and safety questions on assets such as remigromig. Merck is a global healthcare group headquartered in GB that develops medicines across multiple disease areas.

Biogen's litifilimab produced clear or almost clear skin and reduced disease activity in cutaneous lupus erythematosus patients after one year of treatment, according to long-term phase 2 data. In the phase 2 portion of the AMETHYST Phase 2/3 study, 27.2% of patients on litifilimab met the clinical endpoint of clear or almost clear skin at week 52, as measured by a Cutaneous Lupus Activity Investigators' Global Assessment Revised erythema score of 0 or 1, up from 19% at week 24. The Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity-70, a measure of disease activity reduction, also improved with longer treatment, reaching 28.8% at week 52 compared with 21.7% at week 24. Biogen noted that patients who began the study on placebo and switched to litifilimab mid-study saw improvements as early as four weeks after starting active treatment, and by week 52, 33.7% of the crossover participants had clear or almost clear skin.

Pfizer reported that its oral drug LITFULO significantly improved facial and total body repigmentation in adults with nonsegmental vitiligo across two Phase 3 trials, and said it intends to submit the data to regulators globally, including the U.S. Food and Drug Administration and the European Medicines Agency. In the TRANQUILLO 2 study of 100 mg LITFULO and the TRANQUILLO study of 50 mg LITFULO, 21.86% and 12.47% of patients achieved F-VASI75, a 75% or greater improvement in the Facial Vitiligo Area Scoring Index, compared with 2.40% and 2.48% on placebo, while 13.02% and 8.98% achieved T-VASI50, a 50% or greater improvement in the Total Vitiligo Area Scoring Index, compared with 2.40% and 1.98% on placebo. Improvements began as early as Week 24 and increased through Week 36 and Week 52, and LITFULO also reduced patient-reported facial and overall disease severity at Week 52. The Phase 3 TRANQUILLO program, the largest to date evaluating an oral systemic therapy for nonsegmental vitiligo, enrolled 2,174 patients across 271 sites worldwide, with TRANQUILLO 2 testing 100 mg once daily in 1,567 adults and TRANQUILLO testing 50 mg once daily in 607 patients aged 12 years and older. The safety profile was consistent with that established in alopecia areata, with no new safety signals; treatment-emergent adverse events occurred in 67.7% of patients on LITFULO 100 mg versus 62.0% on placebo in TRANQUILLO 2, and in 81.0% versus 77.1% in TRANQUILLO. The results were presented in a late-breaking oral presentation at the 35th European Academy of Dermatology and Venereology Annual Congress in Vienna, Austria.

Pfizer Inc. on Thursday presented detailed Phase 2 results showing its experimental eczema drug tilrekimig (PF-07275315) achieved significant skin clearance in adults with moderate-to-severe atopic dermatitis. The ongoing trial met its primary endpoint, with a statistically significant increase in participants achieving EASI-75 at Week 16 across all evaluated doses compared to placebo. In Stage 1, subcutaneous tilrekimig at 450 mg every two weeks produced EASI-75 in 62.5% of patients versus 19.9% for placebo, while Stage 2 monthly dosing of 400 mg, 200 mg, or 50 mg yielded EASI-75 rates of 58.5%, 61.0%, and 47.8%, respectively, representing absolute improvements of 49.4%, 51.9%, and 38.7% over the 9.1% placebo rate. Key secondary endpoints measuring clear or almost clear skin showed 30.3% achievement in Stage 1 versus 11.8% for placebo, and 26% to 27% across monthly cohorts in Stage 2 versus 0% for placebo. Tilrekimig is a potential first-in-class trispecific antibody targeting IL-4, IL-13, and TSLP, with an extended half-life of approximately 37 days supporting monthly dosing, and was well-tolerated with no dose-dependent safety signals. Pfizer shares were down 1.23% at $28.17 at the time of publication.

Takeda Pharmaceutical reported Phase 3 data showing its investigational oral TYK2 inhibitor zasocitinib, also known as TAK-279, achieved statistically superior complete skin clearance versus deucravacitinib and outperformed apremilast in adults with moderate-to-severe plaque psoriasis, with results presented at the 2026 European Academy of Dermatology & Venereology Congress. Zasocitinib delivered more than 2.5 times as many patients with complete skin clearance at week 16 compared with deucravacitinib, reinforcing its potential to shift treatment choices if approved in major markets. The readout follows the FDA's Priority Review for zasocitinib, with a decision expected in early 2027, and the combination of strong head-to-head data and an accelerated regulatory timeline highlights how central the asset has become to Takeda's pipeline-driven recovery narrative, alongside other launches such as oveporexton and rusfertide. Takeda's narrative projects ¥4,976.1 billion in revenue and ¥401.3 billion in earnings by 2029, requiring 2.5% yearly revenue growth and an earnings increase of about ¥564.7 billion from -¥163.4 billion today, while the most optimistic analysts assume annual revenue of about ¥5,072.4 billion and earnings of roughly ¥423.0 billion. The key catalyst remains upcoming regulatory decisions, and the biggest risk is that late-stage assets collectively fall short of expectations.

AbbVie reported late-breaking Phase 3 data showing that RINVOQ (upadacitinib) 15 mg once daily produced continued facial and total body repigmentation in non-segmental vitiligo through week 76. In the ongoing Viti-Up-1 and Viti-Up-2 studies, patients who continued RINVOQ in the open-label extension saw F-VASI 75 response rates rise from 33.1% at week 48 to 55.1% at week 76 in Viti-Up-1 and from 27.6% to 47.4% in Viti-Up-2, while T-VASI 50 rates increased from 29.2% to 42.5% and from 26.2% to 40.1%, respectively. A phototherapy substudy of 84 adults who failed to achieve T-VASI 90 at week 48 found numerically higher responses with RINVOQ plus whole-body narrowband ultraviolet B phototherapy than with RINVOQ alone, with F-VASI 75 of 59.3% versus 37.0% and T-VASI 50 of 63.0% versus 33.3% at week 28 in patients who had received RINVOQ in Period A. Safety results through week 76 and week 28 were consistent with the known profile of upadacitinib, with no new safety signals. RINVOQ is the first and only systemic medication approved in the European Union for non-segmental vitiligo in patients 12 years and older who are candidates for systemic therapy, and its use in the condition is under regulatory review by the U.S. FDA.

Teva Pharmaceutical and Samsung Bioepis said Thursday they have entered a global license, development, and commercialization agreement for up to six potential biosimilar candidates, of which two are confirmed investigational candidates: SB41, referencing Fasenra, and SB44, referencing Ilaris. Under the terms, Samsung Bioepis will handle development, regulatory registration, and manufacturing of the biosimilars, while Teva will commercialize them in global markets including the United States, Europe, and Canada, with an option to expand the partnership to other territories. The deal reinforces the long-standing partnership between the two companies, which has already produced the U.S. commercialization of EPYSQLI. The companies also expanded that earlier agreement to include OPUVIZ in Canada, reflecting a shared approach to combining complementary capabilities to broaden access to biosimilar medicines across global markets.

MoonLake Immunotherapeutics has submitted a Biologics License Application to the US FDA seeking approval of sonelokimab for hidradenitis suppurativa. The company has completed two phase 3 studies of the tri-specific nanobody in adults, VELA-1 and VELA-2, and also has the phase 3 VELA-TEEN trial for adolescent patients. Sonelokimab binds with high affinity to the cytokines IL-17A and IL-17F, is administered via subcutaneous injection, and is given every four weeks. If approved, sonelokimab will likely compete against UCB's Bimzelx, also known as bimekizumab. Hidradenitis suppurativa is an inflammatory skin condition characterized by boil-like lumps.

AbbVie reported Phase 2 APEX Part B data for zumilokibart in moderate to severe atopic dermatitis at the EADV Congress, and selected a mid dose of the drug for Phase 3 development after the study showed significant clinical improvements in patients. The company also joined the Antibody Developability Consortium as a founding member and started a new AI driven R&D collaboration with Valkai. The zumilokibart Phase 2 results and the new AI alliances feed into AbbVie's core research and development engine as it works to replace aging blockbusters with new immunology and neuroscience drugs alongside Skyrizi, Rinvoq, Vraylar and Vyalev. The next test is whether AbbVie converts the announcements into hard pipeline milestones, with investors watching for the full APEX Part B dataset and Phase 3 trial design updates for zumilokibart after EADV 2026, along with any 2027 commentary on AI enabled cycle time or cost savings in R&D.

Eli Lilly and Company said its drug EBGLYSS, also known as lebrikizumab-lbkz, met its primary and secondary endpoints at Week 16 in the Phase 3b ADtouch study of adults and adolescents with moderate-to-severe hand and foot atopic dermatitis. In the trial, 53% of patients on EBGLYSS monotherapy achieved clear or almost clear skin on their hands and feet, measured as HF-IGA 0/1 with at least a 2-point improvement, versus 27% on placebo, with significant skin clearance seen as early as Week 4 at 17% versus 6%. Itch relief was also rapid, with 57% of EBGLYSS patients reaching at least a 4-point improvement on the HF-Peak Pruritus NRS at Week 16 versus 19% on placebo, and 16% versus 1% as early as Week 2. Pain improvement of at least 4 points on the HF-Peak Pain NRS was reported in 59% of EBGLYSS patients at Week 16 versus 19% on placebo, while in first-of-its-kind patient satisfaction data, 77% of EBGLYSS patients were satisfied or very satisfied with hand clearance at Week 16 versus 40% on placebo. Lilly has submitted the data to the U.S. Food and Drug Administration and plans to file with select global regulators for a potential label update covering localized atopic dermatitis with moderate-to-severe hand and foot involvement, with the late-breaking results presented at the European Academy of Dermatology and Venereology Congress in Vienna.

Galderma is presenting new three-year data from the ARCADIA long-term extension study showing that Nemluvio, also known as nemolizumab, is well-tolerated and delivers sustained improvements in skin lesions, itch, sleep disturbance and quality of life in adults and adolescents with moderate-to-severe atopic dermatitis. The findings will be shared in an oral presentation at the 2026 European Academy of Dermatology and Venereology Congress in Vienna on Thursday, October 1, by ARCADIA investigator Dr. Matthias Augustin. At Week 152, up to 91% of patients achieved at least 75% improvement in eczema severity, up to 75% achieved at least 90% improvement, up to 67% achieved clear or almost clear skin, up to 88% achieved clinically meaningful itch relief and up to 92% reported clinically meaningful improvements in dermatology-related quality of life, with no new safety signals identified. Lead investigator Professor Jonathan Silverberg of George Washington University School of Medicine and Health Sciences said the improvements were not only achieved but sustained over time, while Galderma global program head Christophe Piketty said the data underscore the company's commitment to addressing patients' long-term needs. Additional EADV 2026 presentations include a post-hoc analysis concluding Nemluvio has a favorable cutaneous safety profile over two years in atopic dermatitis and prurigo nodularis, and analyses identifying clinically meaningful sleep-disturbance improvements linked to itch intensity and skin lesion severity. Nemluvio, the first approved monoclonal antibody targeting IL-31 signaling, was initially developed by Chugai Pharmaceutical and is approved for both moderate-to-severe atopic dermatitis and prurigo nodularis in more than 40 countries.

Johnson & Johnson reported new long-term IMAAVY data in generalized myasthenia gravis, including adolescent outcomes. The company said adolescents with gMG on IMAAVY showed sustained disease control and reduced reliance on corticosteroids, with no new safety signals. Survey findings from healthcare professionals indicated IMAAVY may address unmet needs for more consistent symptom management in gMG treatment. Johnson & Johnson, a US based pharmaceuticals group with a reported market value of about $655.4b, is pushing deeper into autoimmune neurology, where IMAAVY sits alongside a broader portfolio of therapies across multiple disease areas. The data reinforce the group's next generation immunology and neurology push as older products face loss of exclusivity, though the update does not yet clarify how widely IMAAVY will be used in real world practice or how it compares with other advanced gMG options.

argenx SE announced it will present new clinical, long-term and real-world data across its neuromuscular portfolio at the 2026 American Association of Neuromuscular & Electrodiagnostic Medicine Annual Meeting and the Myasthenia Gravis Foundation of America Scientific Session in Orlando, Florida, from September 29 to October 2, 2026. In myasthenia gravis, Phase 3 ADAPT OCULUS data showed ocular MG improvements deepened with additional VYVGART cycles, with mean MGII ocular scores improving from -4.5 to -6.8 points in AChR-Ab-positive patients and from -2.7 to -4.5 points in triple-seronegative patients, while one-year ADAPT SERON results showed mean MG-ADL improvements of approximately 5 points maintained through Week 52 in anti-AChR antibody-negative generalized MG. A real-world analysis of more than 1,100 U.S. MG patients found patients treated within a year of diagnosis had a mean MG-ADL reduction of 4.7 points over the first three months versus 3.5 points for those treated more than three years after diagnosis, with 50% reaching minimal symptom expression. In CIDP, an interim analysis of ADHERE and ADHERE+ showed approximately 40% of responding participants reached an INCAT score of 0 or 1 with follow-up beyond five years, a post hoc analysis found VYVGART Hytrulo reduced the relative risk of grip strength deterioration by 71.5%, and a Phase 4 switch study showed 87% of patients remained on VYVGART Hytrulo through 12 weeks after a one-week direct transition from IVIg. The company also reported sustained clinical benefit and consistent safety for empasiprubart in multifocal motor neuropathy from the Phase 2 ARDA+ study, and in-clinic and real-world walking improvements for adimanebart in DOK7-congenital myasthenic syndrome from a Phase 1b study.

Eli Lilly has secured U.S. FDA approval for Onswik, a once-weekly basal insulin for adults with type 2 diabetes, and won an expanded label for Olumiant to treat adolescents 12 and older with severe alopecia areata. Both approvals were supported by large Phase 3 programs showing efficacy and consistent safety profiles. The Onswik clearance adds another branded option alongside Mounjaro and Foundayo, reinforcing Lilly's push to build an integrated cardiometabolic platform rather than a single-product bet. Lilly is also broadening its pipeline and commercial reach through research collaborations, manufacturing expansion and AI-enabled discovery efforts, aiming to diversify beyond its core obesity and diabetes franchises. The company's narrative projects $118.6 billion in revenue and $49.8 billion in earnings by 2029, requiring 14.2% yearly revenue growth and a $23.1 billion earnings increase from $26.7 billion today.

Amgen announced positive topline Phase 3 results for dazodalibep in systemic Sjögren's disease on September 22, with the trial meeting its primary endpoint and showing statistically significant and clinically meaningful improvements in systemic disease activity. Following the announcement, Citi reaffirmed a Neutral rating and a $405 price target on Amgen, noting the results reduce clinical risk for what it called a potentially underappreciated Inflammation & Immunology asset, though the firm said critical details were omitted from the release and that the magnitude of efficacy and the competitive profile remain open questions until full data are presented. The bull case rests on Amgen's ability to de-risk its I&I pipeline, supported by second-quarter total revenues that climbed 10% year over year to $10.1 billion, with six key growth drivers expanding 26%, including TEZSPIRE up 42% to $486 million and UPLIZNA up 90% to $335 million, alongside Repatha up 37% to $953 million, and $3.5 billion in quarterly free cash flow. The bear case centers on execution risk and biosimilar erosion, with Prolia sales falling 32% to $759 million and XGEVA dropping 34% to $352 million in the quarter, while Enbrel slipped 4% to $580 million on Medicare Part D pricing pressure. Amgen's investment case now hinges on whether its next-generation pipeline can execute quickly enough to replace legacy cash flows.

Novartis AG announced on September 18 that the Committee for Medicinal Products for Human Use has adopted a positive opinion recommending marketing authorization for Cosentyx, or secukinumab, to treat polymyalgia rheumatica in adults who respond inadequately to steroids or relapse during tapering. The European Commission is expected to issue a final decision within two months, and if approved, Cosentyx would become the first IL-17A inhibitor licensed in Europe for polymyalgia rheumatica, expanding its multi-billion-dollar immunology franchise into a new rheumatologic indication with high unmet demand. The recommendation reinforces Novartis's strategy of driving top-line growth through priority brands, a group that also includes Kisqali, up 43 percent at constant currencies in the second quarter of 2026, Kesimpta, up 32 percent, and Scemblix, up 89 percent. In that quarter Novartis reported $14.4 billion in net sales, up 3 percent in US dollars, a core operating income margin of 41.2 percent, and $5.6 billion in free cash flow, with $8.9 billion in the first half of 2026, supporting its $10 billion share buyback program. Generic competition remains a drag, subtracting 14 percentage points from second-quarter 2026 net sales growth and contributing to a 2 percent decline in operating income, while net debt rose to $39.4 billion as of June 30, 2026, from $21.9 billion at year-end 2025, largely on $15.3 billion in net cash outflows for M&A and asset acquisitions and $3.1 billion in treasury share transactions. The CHMP recommendation provides a clear regulatory milestone that aligns with management's reaffirmed full-year 2026 guidance.

Johnson & Johnson announced top-line findings from its Phase 4 STAR study evaluating Tremfya in biologic-naive adults with active psoriatic arthritis and axial involvement, with the drug meeting primary and secondary endpoints. The study is the first randomized, placebo-controlled trial to prospectively evaluate an IL-23 inhibitor using objective MRI assessments, showing improvements in axial symptoms alongside MRI-confirmed reductions in joint inflammation. The result supports J&J's strategy of expanding its immunology growth drivers as legacy products face pressure; in Q2 2026 the company reported operational sales growth of 5.6% to $25.3 billion, led by 6.8% operational growth in Innovative Medicine, and raised full-year 2026 sales guidance to $101.1 billion at the midpoint, or 7.3% growth, with adjusted operational EPS guidance of $11.58. J&J still faces an approximately 760-basis-point operational growth drag from declining Stelara sales due to biosimilar entry, and MedTech growth moderated to 3.6% operational growth in the quarter. Tremfya's expanded addressable population must scale rapidly to replace Stelara's multi-billion-dollar cash flow stream, while litigation reserves and restructuring charges remain near-term headwinds.

Eli Lilly and Company announced that the FDA has approved Olumiant, a once-daily oral therapy, for pediatric patients 12 years of age and older with severe alopecia areata, expanding the drug's U.S. label to include adolescents with severe hair loss. The approval was supported by 36-week results from the ongoing phase III BRAVE-AA-PEDS study, in which 42% of patients receiving Olumiant 4 mg and 27% receiving the 2-mg dose achieved a SALT score of 20 or less at week 36, corresponding to at least 80% scalp hair coverage, compared with 5% for placebo. At the same 36-week mark, 37% of patients on Olumiant 4 mg reached a SALT score of 10 or less, representing at least 90% scalp hair coverage, versus 21% for the 2-mg dose and 2% for placebo. The drug is already approved in several geographies for adults with moderately to severely active rheumatoid arthritis and adults with severe alopecia areata, and in April 2026 the European Commission approved Olumiant for adolescents aged 12 to under 18 with severe alopecia areata. Olumiant, a once-daily oral JAK inhibitor discovered by Incyte and licensed to Lilly, is also approved in the United States to treat hospitalized adults with COVID-19, and per Eli Lilly more than 33,000 patients have been prescribed it in the United States since 2017.