Your immune system is built to protect you. But sometimes it gets it wrong, mistaking your own joints, skin, or gut for the enemy, and opens fire. That's the root of rheumatoid arthritis, psoriasis, and inflammatory bowel disease — and it's the battlefield that produced Humira, a drug that once made about $21 billion a year, more than any drug in history.
Bristol Myers Sotyktu Shows Two-Year PsA Efficacy in POETYK Study
Bristol Myers Squibb announced positive two-year results from the late-stage POETYK PsA-2 study of Sotyktu, or deucravacitinib, including its open-label extension. Among patients entering the extension, clinical responses improved from week 16 through week 52 and were sustained through week 104, with robust results across ACR20/50/70 and Minimal Disease Activity in both continuous Sotyktu patients and those who switched from placebo at week 16. The safety profile remained consistent through week 104 with no new safety signals; adverse events occurred in 86.6% of 604 patients exposed to Sotyktu, while serious adverse events and discontinuations due to adverse events were reported in 12.6% and 7.6% of patients, respectively. Sotyktu, an oral selective tyrosine kinase 2 inhibitor approved in the United States and numerous other countries for moderate-to-severe plaque psoriasis and active psoriatic arthritis, generated $156 million in first-half 2026 revenues, up 24% year over year. Data from the POETYK SLE-1 and SLE-2 studies in systemic lupus erythematosus are expected later in 2026, while Amgen's Otezla and Takeda's investigational zasocitinib, whose new drug application the FDA recently accepted for plaque psoriasis, remain competitive threats.
Novo's Denecimig Wins CHMP Backing for Hemophilia A in EU
Novo Nordisk said the European Medicines Agency's Committee for Medicinal Products for Human Use has issued a positive opinion recommending approval of denecimig, also known as Mim8, for the treatment of hemophilia A, with or without inhibitors, in adults and children. Denecimig is a next-generation factor VIIIa mimetic bispecific antibody given subcutaneously as routine prophylaxis, with flexible dosing that includes once-monthly, every-two-week and weekly administration, and it is being developed as a prefilled pen. Novo expects to launch the drug in the first European countries in the fourth quarter of 2026 under the brand name Frehemgo, followed by a broader rollout across the European Union beginning in early 2027. The positive opinion is supported by data from the FRONTIER clinical program, which comprises five studies evaluating denecimig as a prophylactic treatment for hemophilia A across pediatric and adult populations, with or without inhibitors; in the FRONTIER 2 study denecimig significantly reduced annualized bleeding rates, results in children younger than 12 in FRONTIER 3 were consistent with those in adolescents and adults, and in FRONTIER 5 no new safety concerns were identified when participants switched directly from emicizumab to denecimig. The candidate is also under regulatory review in the United States for routine prophylaxis in adults and children with hemophilia A, with or without inhibitors, after Novo submitted a biologics license application to the FDA in September 2025. Novo already markets Alhemo for hemophilia A and B in patients with or without inhibitors.
Trump to Announce Most Favored Nation Drug Pricing for Medicaid in All 50 States
President Trump will announce on Friday that Medicaid beneficiaries in all 50 states will receive Most Favored Nation pricing discounts on some prescription drugs. The White House Council of Economic Advisers projects the move will generate $27.6B in savings for state governments and $36.6B for the federal government over 10 years, according to Semafor, which broke the news. Trump is also scheduled to meet today with the governors of Arkansas, Mississippi, and South Dakota to discuss progress on lowering drug prices. Separately, an AARP Public Policy Institute report released in August found that applying MFN pricing to the top 10 drugs by Medicare Part D and Part B spending in 2025 would cut Medicare spending on those drugs from $273B to $76B between 2029 and 2033.
Novartis wins positive CHMP opinion for Cosentyx in polymyalgia rheumatica
Novartis announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion recommending marketing authorization for Cosentyx, also known as secukinumab, in polymyalgia rheumatica. The opinion supports use in adults who have had an inadequate response to steroids or who relapse during steroid taper, and if approved, Cosentyx would be the first interleukin-17A inhibitor licensed in Europe for the disease. The recommendation rests on the pivotal REPLENISH Phase III trial, in which all primary and secondary endpoints were met across both the Cosentyx 300mg and 150mg arms, including complete sustained remission and time until patients needed additional treatment through week 52, with no new safety signals identified. Those data were published in the New England Journal of Medicine and presented at the 2026 European Alliance of Associations for Rheumatology Congress on June 3, 2026. The European Commission is expected to issue a final decision within approximately two months.
Bristol-Myers Squibb reported positive two-year Sotyktu results in psoriatic arthritis and affirmed a quarterly dividend of US$0.63 per share for November payment. The clinical and income news arrives as the company's share price has climbed 16.37% over the past 90 days and 17.55% year to date, with a 1-year total shareholder return of 44.42%. Bristol-Myers Squibb last closed at $62.84, while the most followed narrative pegs fair value at $66.21, a small valuation gap the market has not fully closed. The company's pipeline and life-cycle management for major brands, plus strategic partnerships with BioNTech, Philochem and Bain, are seen as offsetting upcoming patent expiries, though heavy dependence on drugs facing those expiries and increasing drug pricing pressure remain key risks.
AstraZeneca's Tozorakimab Cuts COPD Flare-Ups by 30% in Late-Stage Trials
AstraZeneca PLC released full results from two successful late-stage trials of tozorakimab, an experimental chronic obstructive pulmonary disease drug that reduced moderate and severe flare-ups by roughly 30% across a broad patient population. The two trials showed reductions in moderate-to-severe COPD exacerbations of 29% to 34%, with the highest-eosinophil subgroup seeing a 43% reduction, and benefits appearing regardless of eosinophil levels, smoking status, or disease severity. The biologic, which blocks the inflammatory protein IL-33, is under priority review at the FDA with a decision expected in the first quarter of 2027, and AstraZeneca forecasts more than $5 billion in peak annual sales, an estimate CEO Pascal Soriot said the drug's commercial potential could exceed. AstraZeneca believes tozorakimab could reach a broader group of COPD patients than existing biologics such as Regeneron and Sanofi's Dupixent and GSK's Nucala, which only target those with high eosinophil counts. The company's oncology and respiratory portfolio made $14.1 billion in first-half 2026 revenue, up 15% year over year, as AstraZeneca targets $80 billion in annual revenue by 2030, though the drug still needs FDA approval and faces patent-expiry pressure on established products including Farxiga and Brilinta.
Ten ministries jointly release the 15th Five-Year Plan for the pharmaceutical industry, bringing major positives to the innovative drug sector
On September 18, the Ministry of Industry and Information Technology, the National Development and Reform Commission, and eight other ministries jointly released the 15th Five-Year Plan for the Development of the Pharmaceutical Industry, proposing that by 2030, biopharmaceutical R&D and application will rank among the world's leaders, and the biopharmaceutical industry will accelerate its rise as a national emerging pillar industry. The plan sets 10 expected indicators covering industrial scale and efficiency, innovative development, enterprise cultivation, and cluster development, including operating revenue of pharmaceutical industrial enterprises above designated size exceeding 3.5 trillion yuan, an average annual growth rate of the innovative drug industry scale exceeding 20 percent, more than 5 products with global annual sales exceeding 1 billion US dollars, first-in-class innovative drugs accounting for more than 25 percent of the global total, more than 200 innovative medical devices launched, 50 pharmaceutical industrial enterprises with annual operating revenue exceeding 10 billion yuan, and 20 pharmaceutical industrial parks at the 100-billion-yuan level. Boosted by this news, the three major stock indices all rose more than 1 percent in early trading that day. Huatian Technology hit the daily limit up, with turnover of 6.065 billion yuan, nearly 1.47 million lots of sealed buy orders on the limit-up board, and nearly 3.3 billion yuan of main capital rushing in, ranking first in the A-share market. Zhou Sicong, fund manager of Ping An Pharmaceutical Select, believes innovative drugs are likely to become an important growth theme, and CITIC Securities said China's innovative drugs have entered a stage of global value realization. According to statistics from Securities Times Data Treasure, since September, Chengdu Leading Pharmaceutical, Asymchem Laboratories, Porton Pharma Solutions, and Hunan Warrant Pharmaceutical have led gains, all rising more than 10 percent, with Chengdu Leading Pharmaceutical up a cumulative 16.87 percent.
Takeda's Zasocitinib Wins FDA Priority Review for Psoriasis
Takeda Pharmaceutical Company Limited announced on September 14 that the FDA accepted its New Drug Application for zasocitinib under priority review for adults with moderate-to-severe plaque psoriasis, with a target action date in the first quarter of calendar 2027. The investigational once-daily oral treatment inhibits tyrosine kinase 2, or TYK2, which participates in inflammatory signaling. The application includes the pivotal Phase 3 LATITUDE PsO 3001 and 3002 studies, in which 71.4% and 69.2% of zasocitinib-treated patients achieved clear or almost clear skin on the static Physician Global Assessment at week 16, compared with 10.7% and 12.6% receiving placebo. Takeda also reported positive topline results in June from a head-to-head study against deucravacitinib, in which zasocitinib achieved statistical superiority at week 16 on complete skin clearance, or PASI 100. In the pivotal trials, treatment-emergent adverse events through week 16 occurred in 62.1% of patients receiving zasocitinib versus 46.9% receiving placebo, and the eventual label, coverage restrictions and net pricing will determine how much of the opportunity becomes revenue.
Aethlon Medical to merge with North Immunology in all-stock deal
Aethlon Medical has agreed to an all-stock merger with North Immunology, sending its shares up 346% in premarket trading on Thursday. The transaction, approved by both boards, is expected to close in the first quarter of 2027. The merger and a concurrent private placement are expected to provide approximately $180M in gross proceeds and to position the combined company to advance development of NOR-101, a half-life extended IL-13 x IL-18 bispecific antibody being developed for atopic dermatitis and other immune-mediated diseases. Under the merger agreement, pre-merger Aethlon stockholders are expected to own about 4.75% of the combined company, while pre-merger North Immunology stockholders are expected to own about 95.25%, giving the combined company a pro forma equity value of roughly $346.5m inclusive of the private placement. Upon completion, the combined entity will operate as North Immunology, Inc. and trade on the Nasdaq Capital Market under the new ticker symbol NRTX.
Dualitas Therapeutics and Roche Launch Bispecific Antibody Collaboration Worth Up to $1 Billion
Dualitas Therapeutics announced a research collaboration and license agreement with Roche to discover and develop novel bispecific antibodies for immunology and inflammation diseases using Dualitas' DualScreen Bispecific Discovery Engine. Under the deal, Dualitas will functionally screen more than 300,000 novel bispecific combinations, which the company describes as one of the largest-scale bispecific discovery endeavors, while Roche will handle all subsequent preclinical development, regulatory, manufacturing and commercial activities. Dualitas will receive $36.5 million in upfront payments and is eligible for research, development and commercial milestone payments plus tiered royalties for a potential total deal value of up to $1 billion. Forbes Huang, co-founder, chief operating officer and chief business officer of Dualitas, called the partnership a first-of-its-kind collaboration to functionally screen and develop novel proximity bispecific antibodies at a scale previously unachievable. Boris L. Zaïtra, Head of Corporate Business Development at Roche, said bispecific antibodies remain central to Roche's portfolio strategy across many disease areas, and Karim Dabbagh, chief executive officer and board member of Dualitas, said the collaboration underscores the potential of the company's technologies to identify bispecific antibodies that harness novel proximity mechanisms.
Spyre Therapeutics announced on September 8 that SPY003, its anti-IL-23 antibody, hit its primary endpoint in Part A of the Phase 2 SKYLINE trial, posting a 10.0-point reduction in Robart's Histopathology Index score at Week 12 with a p-value below 0.0001. The result completes proof-of-concept for all three molecules behind the company's inflammatory bowel disease combination strategy, following SPY001 and SPY002, which posted RHI reductions of 9.2 points and 10.7 points respectively in the same open-label monotherapy portion of the trial. SPY003 delivered a 20% clinical remission rate and 30% endoscopic improvement, while SPY001 and SPY002 posted remission rates of 40% and 33%, and all three monotherapies were described as well tolerated. Spyre held $1.1 billion in cash, cash equivalents, and marketable securities as of June 30, a position built in part on a $435.2 million stock offering in April, which management says funds operations into the second half of 2029. The combination thesis remains unproven: Part B, which tests the pairwise combinations SPY120, SPY130, and SPY230 against placebo, is still enrolling, with topline induction data not expected until 2027, while the company used $69.9 million in operating activities in the second quarter of 2026 and posted a net loss of $36.2 million.
Wolfe Research Upgrades Biogen and AbbVie to Outperform With $300 Targets
Wolfe Research upgraded both Biogen Inc. and AbbVie Inc. to Outperform from Peer Perform on August 13, assigning each a $300 price target. For Biogen, Wolfe cited late-stage programs it says the market undervalues, including litifilimab, which it believes could be the first biologic approved for cutaneous lupus erythematosus, and felzartamab in antibody-mediated transplant rejection, alongside the Apellis Pharmaceuticals acquisition and the completed RayThera deal on August 6. For AbbVie, Wolfe said the 2027 earnings multiple of 14.6x is too low for a company forecasting high-single-digit revenue growth for the rest of the decade, noting the expected generic entry date for Rinvoq has been pushed back to 2037 while the company continues to defend the patent securing Skyrizi. Hedge fund ownership of Biogen fell from 64 funds in the first quarter to 59 in the second, while AbbVie's rose from 87 to 88. Wolfe's thesis rests on the view that the market has been overly conservative on pharmaceutical valuations, with Biogen offering more catalyst-driven upside and AbbVie a more stable, patent-dependent case.
Hengrui Medicine announced that its subsidiary Fujian Shengdi has received the Drug Clinical Trial Approval Notice for HRS-4139 tablets issued by the National Medical Products Administration, approving the product to proceed with clinical trials for moderate-to-severe plaque psoriasis. HRS-4139 tablets are a Class 1 innovative drug independently developed by the company, which effectively improved psoriasis symptoms and inhibited inflammatory responses in animal models. According to available information, no drugs targeting the same mechanism have been approved for marketing domestically or internationally, and the cumulative research and development investment for this project is approximately 20.4 million yuan. The company cautioned that after obtaining clinical trial approval, the drug still needs to undergo clinical trials and receive review and approval from the National Medical Products Administration before it can be produced and marketed. Drug development and marketing involve a long cycle and many steps, with inherent uncertainties, and investors should be aware of the risks.
Johnson & Johnson Targets Double-Digit Growth by End of Decade
Johnson & Johnson said it remains on track to grow through biosimilar competition for STELARA and expects its medicines, medical devices and pipeline to support accelerating growth through the end of the decade. Speaking at a Morgan Stanley event, Chief Executive Officer and Chairman Joaquin Duato said the company's current guidance calls for 6.5% adjusted operational sales growth and 7.3% adjusted earnings-per-share growth in 2026, with total revenue expected to exceed $100 billion for the first time. Duato said 2027 should be a better year than 2026 and that the company has line of sight to double-digit growth by the end of the decade, with more detail to come at an enterprise business review in early December. John Reed, executive vice president of Innovative Medicine and R&D, said Johnson & Johnson has 12 molecules that have achieved proof of concept and are in Phase III development, and that beyond DARZALEX it has 10 marketed medicines still early in their product life cycles. Capital allocation priorities center on launches such as ICOTYDE, INLEXZO, RYBREVANT, IMAAVY and the OTTAVA robotic surgical system, plus pipeline funding and earlier-stage business development, including the recent acquisitions of Halda Therapeutics and Firefly Bio and a collaboration with an option to acquire Sail. Duato said the company can reach double-digit growth this decade without acquisitions but views M&A as a way to reinforce growth into the following decade.
Teva Says Pivot to Growth Accelerating as Branded Drugs and Biosimilars Expand
Teva Pharmaceutical Industries said its "Pivot to Growth" strategy has entered its second phase, with management pointing to branded-medicine momentum, a stabilized generics business, an expanding biosimilars portfolio and a strengthened balance sheet. Speaking at a Morgan Stanley event, President and Chief Executive Officer Richard Francis said the strategy, launched in 2023, rests on four pillars: delivering on the growth engine, stepping up innovation, creating a generics powerhouse, and focusing the business and capital allocation. Francis said Teva has cut debt and secured investment-grade ratings from all three major agencies more than a year ahead of its projection, completed an oversubscribed refinancing in the prior week, and converted ADS shares into ordinary shares to broaden investor access. He reiterated confidence that AUSTEDO can eventually exceed $3 billion in sales, ahead of the prior $2.5 billion target, and said AJOVY is approaching the $1 billion threshold faster than expected, while UZEDY and long-acting olanzapine together represent a $1.5 billion to $2 billion opportunity. Teva has 11 biosimilars on the market and expects to add roughly nine more by the end of the decade, and Francis said the company is on track to exceed its $800 million biosimilars target for 2027 a year early. Chief Medical Officer Eric Hughes said the TL1A therapy duvakitug, developed with Sanofi for ulcerative colitis and Crohn's disease, showed the highest phase 2 results reported for the class, and that ecopipam, a first-in-class D1 antagonist for Tourette's disease, received priority review with a potential launch in the first half of 2027.
Pfizer Guides 2026 Revenue of $60.5B-$62.5B as Patent Cliff Looms
Pfizer is guiding 2026 total revenues to between $60.5 billion and $62.5 billion, a slight decline from 2025 revenues of $62.6 billion, as it absorbs the loss of exclusivity on key products and lower COVID-19 sales. The company expects the patent cliff to hurt sales by approximately $1.1 billion in 2026, with Eliquis, Ibrance, Xeljanz and Xtandi facing expirations during the 2026-2030 period. Adjusted earnings per share for 2026 are guided to $2.80-$3.00, down from 2025 EPS of $3.22, reflecting the dilutive impact of the 3SBio and Metsera deals, lower COVID revenues and higher taxes. Pfizer is leaning on recently launched and acquired products, which posted double-digit growth in both the first and second quarters of 2026, plus a high single-digit revenue CAGR target over five years starting from year-end 2028, to return to growth from 2029 onward. The Zacks Consensus Estimate for 2026 earnings per share has risen from $2.96 to $2.98 and for 2027 from $2.86 to $2.94 over the past 60 days, while Pfizer shares trade at 9.40 forward earnings versus 17.86 for the industry.
Coultreon Biopharma Names Nate Massari Chief Business Officer
Coultreon Biopharma has appointed Nate Massari as Chief Business Officer, the clinical-stage biotechnology company announced. Massari brings more than 25 years of experience in business development, strategy, and commercialization, including roles at Johnson & Johnson, AstraZeneca, Endo Pharmaceuticals, and Cencora, as well as the startups Anjarium Biosciences and Rumpus Therapeutics, where his previous Chief Business Officer roles led to successful exits. Over his career he has led numerous transactions totaling greater than $6 billion in capital, and his immunology expertise includes the launch of inflammatory bowel disease indications in ulcerative colitis and Crohn's disease. Coultreon said his experience will support advancement of its lead program COL-5671, a first-in-class SIK3 inhibitor in clinical development for autoimmune diseases including ulcerative colitis and psoriasis. CEO Pierre Raboisson said Massari's business development and commercial accomplishments, together with his immunology and inflammatory bowel disease expertise, will be instrumental to the company's mission to help patients with chronic inflammatory diseases of high unmet medical need.
Study finds Trump's Medicare drug price crackdown risks pushing drugmakers to raise prices or withdraw medicines worldwide
A new study published in the medical journal The Lancet suggests that the Trump administration's efforts to cut U.S. drug spending could give pharmaceutical companies an incentive to raise prices or reduce sales of medicines in other countries around the world to offset lost revenue in the U.S. market. The Trump administration wants prices for drugs under the federal Medicare health program to align with levels in other wealthy countries, but researchers found that for about three in four of the medicines studied, if companies had to cut the prices they charge Medicare to match those of cheaper reference countries, the revenue lost in the U.S. would exceed the drug's entire sales in the reference country. The study analyzed 195 patented drugs, accounting for a total of 87.9 billion dollars in Medicare spending in 2024, comparing them with drug prices in 19 reference countries. It found that aligning the prices Medicare pays with those of the reference countries would save the two pilot programs the U.S. government uses to test the measure about 11.6 billion dollars. But if the 17 drugmakers that struck separate pricing agreements with the White House were exempted, the savings would fall to just 3.3 billion dollars. The effects are already emerging: Astellas Pharma said it was able to negotiate a higher price for a new eye disease treatment in Japan this year, while Chris Viehbacher, chief executive of Biogen, said the company would launch Zurzuvae, a treatment for postpartum depression, in only a few European countries, and Roche Holding said it may not launch a new oral breast cancer drug, which has not yet been approved in Switzerland, the company's home country.
Odyssey Therapeutics Posts $433.1 Million Cash, Widens Loss to $52.8 Million
Odyssey Therapeutics reported second-quarter financial results on August 4, closing the quarter with $433.1 million in cash as of June 30, 2026, a runway that stretches into the second half of 2028. The clinical-stage biopharmaceutical company said its net loss widened to $52.8 million from $41.2 million a year earlier, while research and development spending rose to $36.2 million from $30.2 million and general and administrative costs fell to $10.5 million from $13.2 million. Adjusted net loss came to $38.4 million, nearly flat against $38.1 million a year earlier, after backing out an $8.7 million non-cash charge tied to the fair value of contingent consideration and stock-based compensation. Odyssey finished dosing patients in the Phase 2a expansion cohort for OD-001, its RIPK2 scaffolding inhibitor, and will present the complete data set at United European Gastroenterology Week this October, with two additional studies planned before year-end: a Phase 2b trial of OD-001 alone and a Phase 2a trial pairing it with vedolizumab. Behind that program sits OD-002, an oral compound targeting the SLC15A4 B-cell pathway, on pace for a clinical trial application by the end of 2026 and a first-in-human study in the first half of 2027. Hedge fund ownership jumped from zero funds in the prior quarter to 24, while 5.25% of the float remains sold short.
Novartis Doses First Patient in Phase 2 Sjögren's Trial, Triggering $50M Payment to Monte Rosa
Monte Rosa Therapeutics announced on September 8 that partner Novartis has dosed the first patient in a Phase 2 trial of the VAV1-targeted drug MRT-6160, also known as DDY391, in people with Sjögren's disease, triggering a $50 million milestone payment to Monte Rosa and marking the first step in a collaboration that could eventually be worth up to $2.1 billion. Novartis is footing the entire bill for the study, which will track participants for as long as a year of treatment and compare the drug against placebo across multiple sites to select the right dose before a Phase 3 program begins, and Monte Rosa stands to collect further payments each time a new Phase 2 study opens for MRT-6160 in other immune conditions. In an earlier Phase 1 trial, the molecule knocked down VAV1 protein levels by over 90% in patients' T cells and calmed key markers of inflammation without triggering any serious side effects. Monte Rosa also reported on August 6 that enrollment and dosing had wrapped up in its GFORCE-1 study of MRT-8102 in people with elevated cardiovascular risk, with results due later in 2026, and that its MODeFIRe-1 study pairing MRT-2359 with the prostate cancer drug apalutamide is up and running, backed by $626 million in cash, equivalents, and marketable securities as of June 30 that management says can fund operations into 2029. The progress has come at a cost: collaboration revenue fell to $9.0 million in the second quarter of 2026 from $23.2 million a year earlier, research spending rose to $48.0 million from $30.7 million, administrative costs climbed to $10.1 million from $8.1 million, and the quarterly net loss ballooned to $43.4 million, more than triple the $12.3 million loss in the same period of 2025. Hedge fund ownership edged up to 36 funds from 35, while 21.52% of the float is sold short, an unusual pairing that suggests the market has not settled on whether the milestone cash flow outweighs the widening losses.
Biogen Touts 10 Phase III Programs as It Diversifies Beyond Neurology
Biogen executives said the company is advancing 10 Phase III programs with clinical readouts beginning in the fourth quarter as it works to offset declines in its legacy multiple sclerosis business and return to growth. Speaking at a Wells Fargo conference, Chief Financial Officer Robin Kramer said the pipeline is at a pivotal point for growth, with the Fit for Growth initiative redirecting investment from the MS portfolio into newer launches including LEQEMBI, SKYCLARYS and ZURZUVAE. Head of corporate development Adam Keeney said Biogen has expanded into immunology and nephrology through deals including the HI-Bio acquisition and its felzartamab asset, whose initial focus is antibody-mediated rejection in kidney transplantation, where there are no approved therapies and roughly 11,000 U.S. patients experience secondary rejection. The Apellis acquisition added commercial products and nephrology capabilities, including SYFOVRE in geographic atrophy, and Biogen expects the deal to be dilutive in 2026 mainly on interest expense while targeting roughly $250 million in annualized cost savings exiting next year and paying down the related debt by the end of 2027. Keeney said Biogen expects to focus more on earlier-stage business development through 2027, particularly in immunology, rare disease and neurology, and is not financially constrained for early-stage transactions.
Eli Lilly Immunology Sales Reach $2.6 Billion as Pipeline and Deals Expand
Eli Lilly's immunology portfolio generated $2.6 billion in revenues in the first half of 2026, up approximately 9% year over year, accounting for about 6.1% of the company's total revenues of $42.7 billion during the period. Taltz, an IL-17A inhibitor, remained the largest contributor with $1.6 billion in revenues in the first half of 2026, roughly 62% of Lilly's immunology sales. The portfolio also comprises Ebglyss, Omvoh and Olumiant, and Lilly is advancing a broader pipeline including late-stage studies of Omvoh with tirzepatide in ulcerative colitis and Crohn's disease, Ebglyss in perennial allergens and chronic rhinosinusitis with nasal polyps, and two phase II studies of brenipatide in irritable bowel syndrome. Lilly has also used acquisitions to build the franchise, including the $2.4 billion purchase of DICE Therapeutics completed in 2023, the 2024 acquisition of Morphic Holding, and a definitive agreement announced last month to acquire clinical-stage biotech Merida Biosciences for around $2.9 billion, adding MER511, in phase I development for Graves' disease and thyroid eye disease, and the early-stage program MER769. Lilly's second-quarter results showed revenues from its immunology, oncology and neuroscience key products collectively increased 121% year over year, and the Zacks Consensus Estimate for 2026 has risen from $35.38 to $35.93 per share over the past 60 days, while that for 2027 has risen from $44.93 to $45.93 per share over the same timeframe.
Yarrow Bioscience Prices $150M Public Offering at $26 Per Share
Yarrow Bioscience announced the pricing of an underwritten public offering of 5.77 million shares of common stock at $26.00 per share, for expected gross proceeds of approximately $150 million. The company granted underwriters a 30-day option to purchase up to an additional 865,384 shares. Net proceeds will be used to advance research and development across Yarrow's autoimmune thyroid disease pipeline and to support general corporate purposes, including working capital and capital expenditures. All shares in the offering are being sold directly by Yarrow, and the transaction is scheduled to close on September 14, 2026.
Novartis's Remibrutinib Beats Sanofi's Aubagio in Two Late-Stage MS Trials
Novartis's oral drug remibrutinib outperformed Sanofi's older multiple-sclerosis treatment teriflunomide in reducing relapses across two late-stage studies, REMODEL-1 and REMODEL-2, marking the first major success from three closely watched pipeline programs expected to produce clinical data in 2026. Novartis said remibrutinib also showed clinically meaningful results in slowing disability progression and was well tolerated with no liver-safety issues, a key point for a Bruton's tyrosine kinase inhibitor, a class that has previously faced regulatory problems over liver toxicity. UBS analyst Matt Weston called it potentially a best-in-class oral treatment. Novartis plans to submit remibrutinib for global regulatory approval and will present full results at a medical conference in Toronto; the drug is already approved for one chronic inflammatory skin condition involving severe hives, sold as Rhapsido, which generated $64 million in second-quarter sales. Analysts estimate remibrutinib could generate as much as $9 billion in peak annual sales across all indications, though that figure assumes successful development and approvals in multiple sclerosis, additional skin disease, and food allergies, and two patients died during the studies, which analysts said were unrelated to treatment but still intend to examine in the detailed safety data. Remibrutinib is the first of three programs, alongside pelacarsen and del-desiran, collectively seen generating more than $10 billion in peak annual sales as Novartis faces generic pressure on its blockbuster heart-failure medicine Entresto.
AbbVie Immunology Sales Hit $16.1 Billion as Skyrizi and Rinvoq Offset Humira Erosion
AbbVie's immunology franchise generated $16.1 billion in first-half 2026 sales, more than half of the company's total sales, as Skyrizi and Rinvoq continued to offset the biosimilar erosion of Humira that began in the United States in 2023. The segment's sales rose nearly 16% year over year on a reported basis, outpacing AbbVie's overall revenue growth, and the company expects combined Skyrizi and Rinvoq sales to exceed $31 billion in 2026. Rinvoq was approved in the EU in July for vitiligo and alopecia areata, and AbbVie believes those two indications alone can add up to $2 billion in combined peak sales, while phase III data for Rinvoq in hidradenitis suppurativa and systemic lupus erythematosus are expected later this year. Supported by those two drugs, AbbVie expects high-single-digit compound annual revenue growth through 2029, with no major loss-of-exclusivity events expected to materially disrupt the business through the rest of the decade. Beyond its current leaders, AbbVie is evaluating Skyrizi-based combination regimens with ABBV-382 and ABBV-701 in inflammatory bowel disease, seeking approval for a subcutaneous induction regimen of Skyrizi in Crohn's disease, and has added pipeline assets through acquisitions including Nimble Therapeutics, Capstan Therapeutics and Apogee Therapeutics, whose zumilokibart is a phase III-ready long-acting anti-IL-13 antibody for atopic dermatitis that AbbVie believes can compete with Dupixent.
Roche Wins FDA Priority Review for Enspryng in Rare MOGAD Disorder
Roche announced that the FDA has accepted its supplemental biologics license application seeking approval of Enspryng, also known as satralizumab, for the treatment of myelin oligodendrocyte glycoprotein antibody-associated disease, or MOGAD, and granted the application a priority review with a decision expected on Jan. 10, 2027. If approved, Enspryng would become the first and only disease-modifying therapy for MOGAD, a rare autoimmune disease of the central nervous system that can cause unpredictable attacks affecting the optic nerves, spinal cord or brain and for which there are currently no approved treatments. The FDA's acceptance was based on positive data from the phase III METEOROID study, which met its primary endpoint, showing that treatment with Enspryng reduced the risk of a new MOGAD relapse by 68% compared with placebo, and that at 48 weeks 87% of patients treated with Enspryng remained relapse-free compared with 67% in the placebo arm. Separately, the European Medicines Agency has validated Roche's application for Enspryng in MOGAD, with a decision from the European Commission expected in the third quarter of 2027. Enspryng is currently approved in several countries for the treatment of neuromyelitis optica spectrum disorder, including the European Union and the United States, and Roche is also evaluating it in additional neurological autoimmune and inflammatory disorders, with the FDA having accepted and granted priority review in June 2026 to a separate sBLA seeking label expansion for thyroid eye disease and a final decision expected on Oct. 15, 2026.
GSK Specialty Medicines Sales Rise 14% as HIV Patent Cliff Looms
GSK's Specialty Medicines unit, which now accounts for more than 40% of the company's sales and is expected to exceed 50% of total revenues by 2031, posted 14% sales growth at CER in the first half of 2026 on double-digit gains across HIV, Respiratory, Immunology & Inflammation and Oncology. New long-acting HIV injectables Cabenuva and Apretude account for around 25-30% of total HIV sales, while newer oncology drugs Jemperli and Ojjaara and recent launches including Blenrep, Exdensur and Penmenvy broaden the growth base, and GSK expects low double-digit percentage sales growth in the segment for 2026 at CER. The company now expects more than 20 phase III starts in 2026, more than twice the 10 originally contemplated, and has 19 assets in late-stage development or under regulatory review, with FDA decisions on bepirovirsen for chronic hepatitis B and neladalkib for non-small cell lung cancer expected later this year. GSK faces the loss of exclusivity for dolutegravir, the backbone of HIV medicines including Tivicay, Triumeq and Dovato, with patents expected to begin expiring in major markets around 2028-2029; dolutegravir-based products generated £2.74 billion in sales in the first half of 2026. GSK expects to launch twice-yearly long-acting injectables for treatment and PrEP between 2028 and 2030, and competes in Specialty Medicines with AstraZeneca, Merck, Sanofi, Gilead, Pfizer, J&J and Novartis, among others.
AbbVie Inc. finalized its acquisition of clinical-stage biotech Apogee Therapeutics for $135.11 per share in cash, a $10.9 billion deal that folds Apogee's inflammatory and immunology pipeline into AbbVie's commercial engine. On the same day, AbbVie reported positive Phase 3 results for its bispecific T-cell engager etentamig in relapsed/refractory multiple myeloma, highlighting the company's push into next-generation immunology and oncology. In Q2 2026, AbbVie posted $16.99 billion in net revenue, up 10.2% year over year, with adjusted diluted EPS rising 22.9% to $3.65, driven by immunology blockbusters Skyrizi and Rinvoq, which grew 24.4% and 24.5% respectively, offsetting a 35.9% decline in Humira revenue. AbbVie reiterated its full-year 2026 adjusted EPS guidance of $13.87–$14.07, including a $0.14 dilutive impact from the Apogee transaction. Apogee, which generated no product revenue in Q2 2026, reported a net loss of $85.9 million but held $1.3 billion in cash and marketable securities, plus a $1.3 billion non-dilutive credit collaboration with Blackstone Life Sciences to support Phase 3 trials of its lead asset zumilokibart. Investors should watch full plenary data for etentamig at the International Myeloma Society Meeting from September 23–26 and monitor Phase 3 execution for zumilokibart under AbbVie's global structure.
OSE Immunotherapeutics Welcomes First Patient Dosed in Phase 2 RENGEVITY-201 Trial
OSE Immunotherapeutics announced that its licensee Veloxis Pharmaceuticals has dosed the first patient in the Phase 2 RENGEVITY-201 trial evaluating pegrizeprument (VEL-101) for the prevention of organ rejection in kidney transplant recipients. Pegrizeprument, an investigational immunomodulatory antibody fragment originally developed by OSE and licensed to Veloxis in 2021, is being developed for all transplant indications, with Veloxis responsible for worldwide development, manufacturing, and commercialization. The trial is part of a broader program that has already received Orphan Drug Designation from the U.S. Food and Drug Administration for liver and heart transplant indications in December 2025 and March 2026, respectively.
Alumis Plans FDA Talks After LUMUS Misses Endpoints
Alumis Inc. reported that its 408-patient Phase 2b LUMUS trial of envudeucitinib in moderate-to-severe systemic lupus erythematosus did not meet primary or secondary endpoints in the overall population, yet the company plans end-of-Phase 2 meetings with the FDA and European Medicines Agency based on a prespecified subgroup with a high interferon gene signature. In the overall population, BICLA response rates were 40.0%, 42.2%, and 41.0% for the 20-milligram once-daily, 20-milligram twice-daily, and 40-milligram twice-daily regimens, respectively, versus 35.7% for placebo, with p-values of 0.5018, 0.3455, and 0.3740. In the IFNGS-high subgroup, which comprised approximately 59% to 63% of each treatment group, numerical BICLA response rates were 40.7%, 49.5%, and 52.6% for the three doses versus 28.6% for placebo, with covariate-adjusted differences of 11.6, 21.3, and 24.0 percentage points. The company noted that the IFNGS-high share was below the approximately 70% generally expected, and that pharmacodynamic data showed dose-dependent target engagement with maximal suppression at 40 milligrams twice daily. Alumis plans to discuss Phase 3 dose, design, size, and biomarker-based enrollment criteria with regulators, though the subgroup evidence lacks confidence intervals and p-values, and the dose pattern was not uniform across endpoints.
Roivant Sciences Surges 24% on Positive Trial Results
Roivant Sciences shares rallied 24% after the pharma company reported positive Phase 2 trial results for its subsidiary Pulmovant's mosliciguat, which showed a clinically meaningful and statistically significant reduction in pulmonary vascular resistance in patients with pulmonary hypertension and interstitial lung disease. Meanwhile, Lockheed Martin edged up 0.7% after UBS upgraded the stock to buy, citing underappreciated earnings growth potential. Novartis tumbled 12% after its del-desiran drug failed to show significant improvement in a Phase 3 trial for myotonic dystrophy type 1. Peloton Interactive slid more than 4% following a Morgan Stanley downgrade to underweight, citing structural headwinds in fitness. Boston Scientific slipped over 2% after warning that a recent cyberattack likely impacted its 2026 sales and profit targets. Bloom Energy rose over 6% as it prepares to join the S&P 500 on Sept. 21, having gained about 190% this year on the AI data center buildout.
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. announced that its partner, Windward Bio, reported positive interim results from the Phase 2 portion of the POLARIS-1 trial evaluating twice-yearly dosing of SKB378/WIN378 in asthma, and the first Phase 3 study has been initiated. The interim analysis, conducted on the first 98 of 147 enrolled patients with uncontrolled moderate-to-severe asthma, showed a half-life of up to 75 days, with clinical effects consistent with twice-yearly dosing. SKB378/WIN378 produced significant and sustained effects on FEV1 (up to 174 mL mean increase, placebo-adjusted mean increase up to 256 mL, p=0.033), FeNO, and blood eosinophils, with effects seen as early as Week 2 and sustained through Week 24. The drug was well tolerated, with no treatment-related serious adverse events, withdrawals, or discontinuations; adverse events were balanced between active arms and placebo, with low rates of injection site reactions and anti-drug antibodies. Two twice-yearly doses were selected for the Phase 3 portion of POLARIS-1, and a second Phase 3 trial, POLARIS-2, is planned to begin in the first half of 2027.
AstraZeneca's Tozorakimab Cuts COPD Exacerbations in Phase III Trials
AstraZeneca announced that full results from the Phase III OBERON and TITANIA trials show tozorakimab is the first biologic to achieve statistically significant and highly clinically meaningful reductions in moderate and severe COPD exacerbations across a broad patient population, including former and current smokers and all blood eosinophil counts. Compared with placebo, tozorakimab 300mg every four weeks reduced exacerbations by 29% in former smokers in OBERON and 34% in TITANIA, and by 30% and 29% respectively in the overall population. A pooled analysis found reductions of 23% in patients with baseline eosinophils below 150, 34% in those at or above 150, and 43% in those at or above 300. The results were published in the New England Journal of Medicine and presented at the European Respiratory Society Congress 2026, and the US FDA has accepted the Biologics License Application for Priority Review with a PDUFA date anticipated in the first quarter of 2027.
Upstream Bio shares jump 8% on Phase 2 severe asthma data
Upstream Bio shares jumped 8% in premarket trading Tuesday after the company presented Phase 2 VALIANT trial data for its severe asthma candidate verekitug at the European Respiratory Society Congress 2026 in Barcelona. Verekitug is the only known antagonist in clinical development targeting the thymic stromal lymphopoietin receptor, and the trial showed statistically significant reductions in annualized asthma exacerbation rate across dose arms, along with clinically meaningful improvements in lung function and exhaled nitric oxide with every 12-week dosing. The company remains on track to initiate Phase 3 trials in severe asthma and chronic rhinosinusitis with nasal polyps in Q1 2027, evaluating a 400 mg quarterly regimen of verekitug in broad patient populations.
Lisraya's $35,000 Monthly Price Signals Roivant's Rare-Disease Bet
Roivant Sciences and Priovant Therapeutics have launched Lisraya, the first targeted oral treatment for dermatomyositis, at a list price of $35,000 for a 30-day supply, following FDA approval. The drug targets a US population of fewer than 5,000 patients, and Roivant, which owns 71% of Priovant, expects a full year of treatment to yield a net annual value in the low-to-mid $300,000 range per patient. Early prescriptions have already been received, and the companies project US market exclusivity until at least 2039. However, the high price and small patient pool pose access challenges, and management cautions that adoption will build gradually.
Fosun Pharma announced that its controlling subsidiary, Fosun Pharma Industrial, has received approval from the National Medical Products Administration to conduct an adaptive seamless Phase II/III clinical trial of FXS5626 tablets for the treatment of non-segmental vitiligo. FXS5626 is an oral small-molecule JAK inhibitor licensed by the group, a dual TYK2/JAK1 inhibitor, for which the group holds exclusive rights in mainland China, Hong Kong, and Macau. The drug has previously completed Phase II clinical trials for moderate-to-severe plaque psoriasis and is currently in Phase II clinical trials for non-infectious uveitis. As of August 2026, cumulative R&D investment was approximately 108 million yuan, including licensing fees.
Ulcerative Colitis Market to Reach $9.4B by 2036, Late-Stage Drugs Advance
DelveInsight projects the ulcerative colitis market across the seven major markets—the US, EU4, UK, and Japan—will grow from approximately USD 9.4 billion in 2025 at a CAGR of 7.6% through 2036, driven by novel targeted therapies and a robust pipeline of late-stage candidates. Among these, Abivax's obefazimod, a first-in-class oral miR-124 enhancer, met its primary endpoint in Phase III ABTECT induction studies, with a pooled placebo-adjusted clinical remission rate of 16.4% at Week 8. Merck's tulisokibart, acquired via Prometheus Biosciences, achieved clinical remission in the Phase 3 ATLAS-UC study, while Roche's afimkibart, from its $7.1 billion Telavant acquisition, showed a 35% remission rate in Phase IIb TUSCANY-2. Johnson & Johnson and Protagonist Therapeutics' icotrokinra, a first-in-class oral IL-23 receptor antagonist, met its primary endpoint in the Phase 2b ANTHEM-UC trial, and Teva and Sanofi's duvakitug, backed by a $400 million Blackstone funding deal, is in Phase III. These therapies target unmet needs in moderate-to-severe disease, with the market shifting toward IL-23 inhibitors and oral advanced therapies, though biosimilars and established anti-TNFs remain widely used.
Dianthus Reports Strong CIDP Data but Net Loss Widens
Dianthus Therapeutics reported second-quarter 2026 results on August 4, highlighting a 75% response rate in an interim analysis of its Phase 3 CAPTIVATE trial for claseprubart in chronic inflammatory demyelinating polyneuropathy, surpassing the 50% bar. The company also completed enrollment in its Phase 2 MoMeNtum trial for multifocal motor neuropathy at 46 patients, above the target of 36, with top-line results expected in December. Net loss widened to $50.2 million from $31.6 million a year earlier, while research and development spending rose to $48.7 million from $26.3 million. Dianthus holds about $1.2 billion in cash, funding operations into 2030, and added a new pipeline candidate, DNTH312, with Phase 1 readiness targeted by end of 2027. The company also received Orphan Drug Designation for claseprubart in myasthenia gravis and began its Phase 3 EMERGE trial in June, with results not expected until the second half of 2028.
Eli Lilly to Buy Merida Biosciences for Up to $2.88 Billion
Eli Lilly has agreed to acquire Merida Biosciences for up to $2.88 billion in cash, expanding into autoimmune diseases as it diversifies beyond its blockbuster obesity and diabetes drugs. The deal, announced on August 31, is Lilly's 13th acquisition of 2026, the most among large drugmakers, and follows two other immunology purchases: a $1.2 billion buyout of Ventyx Biosciences and a deal for Orna Therapeutics worth up to $2.4 billion. Merida, a privately held company with $121 million in funding, is developing drugs that selectively remove disease-causing autoantibodies while preserving healthy immune function. Its lead candidate, MER511, is in Phase 1 testing for Graves' disease and thyroid eye disease, and a second drug, MER769, targets food allergies and asthma. The agreement includes an upfront payment plus milestone payments, so Lilly's total cost could stay below the headline figure if the drugs fail. The deal is expected to close in the fourth quarter of 2026, but any revenue is years away, and Lilly's current valuation at a price-to-earnings ratio of 39.32 leaves little room for error.
CMS's Lumirix Approved in China for Atopic Dermatitis
China Medical System Holdings announced that its subsidiary Dermavon received approval from China's National Medical Products Administration for the New Drug Application of ruxolitinib phosphate cream, marketed as Lumirix, for the treatment of mild to moderate atopic dermatitis in patients aged two and older. This marks the second approved indication for Lumirix, which in January 2026 became China's first topical JAK inhibitor approved for vitiligo. The approval was expedited through a priority review due to its qualification as a pediatric drug. Clinical data from a Phase III trial in China showed that 63.0% of patients treated with Lumirix achieved clear or almost clear skin at week eight, compared to 9.2% for placebo, with a favorable safety profile. Dermavon is building a comprehensive treatment and care solution for atopic dermatitis, which affects over 54 million people in China, including the marketed Lumirix, an injectable biologic under review, an oral drug in Phase II trials, and a daily repair product line.