Coultreon Biopharma’s lead drug candidate, acquired from Galapagos, is a small molecule designed to selectively inhibit a novel immunology target called SIK3. The Series A financing will support Phase 2 clinical trials in psoriasis and ulcerative colitis.

The post Immunology-Focused Coultreon Adds $125M for Pills That Pack the Punch of Injectable Biologics appeared first on MedCity News.

Insmed drug Brinsupri failed to beat a placebo in a mid-stage clinical trial testing the daily pill as a treatment for hidradenitis suppurativa, a chronic inflammatory skin disorder. Brinsupri is still projected to become a blockbuster seller in non-cystic fibrosis bronchiectasis, where it is the first approved therapy for this chronic lung condition.

The post Trial Failure in the Skin Does Not Dent Insmed Drug’s Potential in the Lungs appeared first on MedCity News.

Startup Pinnacle Medicines is developing peptide drugs with the same efficacy as biologic medicines and the dosing convenience of oral small molecules. The lead program of OrbiMed-incubated Pinnacle is on track to enter the clinic in asthma and chronic obstructive pulmonary disease.

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Alumis’s genomic research guided its development of envudeucitinib, a TYK2 inhibitor that some analysts now view as best in class. The Phase 3 results that will support a planned FDA submission in plaque psoriasis are scheduled for presentation this weekend during the American Academy of Dermatology annual meeting in Denver.

The post Taking a Page From Cancer Drugs, Autoimmune Biotech Alumis Aims for Precision Immunology appeared first on MedCity News.

Gilead Sciences is acquiring Ouro Medicines, a startup developing T cell engagers for a range of autoimmune diseases. Separately, Gilead is negotiating a deal with Galapagos to share in the development and potential commercialization of the Ouro drug.

The post Gilead Sciences Gains an Opportunity for Immune System Reset With $1.7B Ouro Acquisition appeared first on MedCity News.

FDA approval of Icotyde covers the treatment of adults and adolescents with moderate-to-severe plaque psoriasis. This once-daily pill, developed by partners Johnson & Johnson and Protagonist Therapeutics, offers an easier dosing option compared to injectables and is projected to become a blockbuster seller across several immunological indications.

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Aldeyra said the FDA did not ask for another clinical trial for reproxalap in dry eye disease, but there is a “lack of substantial evidence” that warrants exploration about the reasons for trial failures to identify the appropriate patients for the eye drop. AbbVie holds an option to collaborate on reproxalab’s commercialization.

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Povetacicept, a Vertex Pharmaceuticals immunology drug designed to block two targets, met the main goal of a Phase 3 clinical trial in the rare kidney disease immunoglobulin A nephropathy. The fusion protein came from Vertex’s acquisition of Alpine Immune Sciences, and analysts say the drug has best-in-class potential.

The post Vertex Pharma to Seek Speedy FDA Approval for Kidney Disease Drug From $4.9B Acquisition appeared first on MedCity News.

Boehringer Ingelheim receives rights to oral small molecules from Sitryx with potential applications in multiple autoimmune disorders. Depending on the progress of Boehringer’s research, Sitryx could receive more than $500 million.

The post Boehringer Boosts Pipeline, Adding Oral Small Molecules With Broad Immunology & Inflammation Potential appeared first on MedCity News.

CSL Limited retains rights to clazakizumab in end-stage kidney disease. Eli Lilly gets rights to the the IL-6-blocking antibody in other indications that could put it in competition with Novo Nordisk and Novartis.

The post Eli Lilly Joins Chase for Hot Inflammation Target, Paying $100M for Rights to CSL Drug appeared first on MedCity News.

Evommune’s EVO301 met the goals of a placebo-controlled Phase 2a study in atopic dermatitis. The biologic drug neutralizes a signaling protein involved in multiple inflammatory pathways, which could differentiate it from the blockbuster Sanofi and Regeneron Pharmaceuticals immunology drug Dupixent.

The post Evommune Starts Making Case to Challenge Dominance of Sanofi’s Dupixent in Atopic Dermatitis appeared first on MedCity News.

Brepocitinib is on track for pivotal testing after meeting the goals of a proof-of-concept study in cutaneous sarcoidosis, a rare inflammatory skin disorder with no FDA-approved therapies. Roivant Sciences subsidiary Priovant Therapeutics licensed the dual JAK1 and TYK2 inhibitor from Pfizer.

The post Clinical Trial Win Bolsters Blockbuster Prospects for Roivant Rare Disease Drug Licensed From Pfizer appeared first on MedCity News.

Rapt Therapeutics brings to GSK ozureprubart, a long-acting antibody that inhibits the validated immunology target immunoglobulin E (IgE). If GSK is able to bring this drug to the market, it would complete with the blockbuster Genentech and Novartis allergy drug Xolair.

The post GSK Grows in Immunology, Buying Rapt Therapeutics and Food Allergy Drug in $2.2B Deal appeared first on MedCity News.

Ventyx Biosciences’ lead program, an oral small molecule inhibitor of NLRP3, has encouraging clinical data from separate mid-stage tests in cardiovascular disease and Parkinson’s disease. Eli Lilly said Ventyx’s pipeline has potential applications in cardiometabolic health, neurodegeneration, and autoimmunity.

The post Eli Lilly Boosts Its Immunology Drug Pipeline With $1.2B Ventyx Bio Acquisition appeared first on MedCity News.

Takeda said more than half of plaque psoriasis patients treated with zasocitinib achieved clear or almost clear skin in two Phase 3 studies. Regulatory submissions for the TYK2 inhibitor are planned for 2026 and clinical trials are ongoing in other indications.

The post Takeda Drug From $4B Deal Succeeds in Two Pivotal Plaque Psoriasis Trials appeared first on MedCity News.

GSK’s Exdensur requires just two injections a year to treat severe asthma. Less frequent injections give this new biologic medicine a dosing edge over one of GSK’s own blockbuster respiratory products as well as severe asthma drugs from companies such as AstraZeneca, Sanofi, and Amgen.

The post GSK Gets FDA Approval for New Severe Asthma Drug With a Dosing Advantage appeared first on MedCity News.

GSK paid $85 million up front for global rights to a small-interfering RNA therapy discovered and developed by startup Empirico. The pharmaceutical giant said this drug candidate could be used as a monotherapy and as part of drug combinations for treating COPD and other inflammatory respiratory diseases.

The post GSK’s Respiratory Pipeline Adds an Early-Stage Drug Offering a Novel Approach to COPD appeared first on MedCity News.

Nilo Therapeutics’ Series A round was led by The Column Group, DCVC Bio, and Lux Capital. The preclinical startup is developing drugs targeting neural circuits that control systemic inflammation.

The post Startup Nilo Launches With $101M for Autoimmune Drugs That Target ‘Brain-Body Circuits’ appeared first on MedCity News.

Novartis drug Rhapsido is now approved as a second-line treatment for chronic spontaneous urticaria, a rare inflammatory skin disease. Additional clinical trials are ongoing to support potential expansion of the twice-daily pill to other immunological disorders.

The post Novartis Nabs FDA Approval for First-of-Its-Kind Drug for Chronic Hives appeared first on MedCity News.

Crystalys Therapeutics’ gout drug, dotinurad, inhibits a known and validated target for treating the chronic disorder, but in a way that could be safer than other drugs. The oral small molecule was discovered and developed in Japan, where it is approved and has a safety record spanning more than 1 million gout patients.

The post Startup Crystalys Therapeutics Emerges With $205M to Fill a Growing Gap in Gout Treatment appeared first on MedCity News.

Bristol Myers Squibb plaque psoriasis drug Sotyktu will be the first product available at a steep discount to eligible cash-pay patients who use BMS Patient Connect, a new online platform set to launch in January. Direct-to-patient sales could offer one way for pharma companies to address President Trump’s call for lower drug prices.

The post Immunology Drug Sotyktu Will Kick Off Bristol Myers Squibb’s New Direct-to-Patient Platform appeared first on MedCity News.

Dualitas Therapeutics designs bispecific antibodies to hit to two targets on the same immune cell, leveraging proximity biology to provide benefit beyond what’s possible with monoclonal antibody drugs. Eli Lilly and Chugai Pharmaceutical are among the investors in the immunology and inflammation startup.

The post Two Is Better Than One: Startup Dualitas Lands $65M to Bring Bispecific Drugs to Autoimmune Disease appeared first on MedCity News.

Novartis is paying $120 million up front to secure rights to a Monte Rosa molecular glue degrader drug candidate as well as options for two others. The two companies began working together last year under an alliance focused on immune mediated-diseases.

The post Novartis Adds to Its Immunology Prospects With Another Deal for Monte Rosa’s Molecular Glue Drugs appeared first on MedCity News.

Now, with the ability to measure coronary inflammation through AI-enhanced CT scans and to more accurately determine a person’s risk of heart attack, we can intervene earlier and more effectively.

The post Regulatory Shift Paves Way for AI-Driven Heart Disease Diagnosis appeared first on MedCity News.

The FDA published more than 200 complete response letters, the first step in what it describes as part of its effort to modernize the agency and improve transparency. But there are some caveats to the release of the FDA correspondence.

The post Pledging ‘Radical Transparency,’ FDA Reveals Drug Rejection Letters — With Limits appeared first on MedCity News.

AbbVie is acquiring Capstan Therapeutics, a startup with technology that enables in vivo engineering of immune cells. The University of Pennsylvania spinout’s lead program recently began a Phase 1 test as a potential treatment for B cell-mediated autoimmune disorders.

The post AbbVie’s $2.1B Acquisition Adds In Vivo Cell Therapy to Its Immunology & Inflammation Pipeline appeared first on MedCity News.

In calling for more clinical testing of vaccines in younger people and those who face a low risk of severe disease from Covid-19, the FDA said its policy will compel generation of more evidence for these groups. Our roundup of regulatory news includes notable firsts for Alzheimer’s diagnosis and migraine treatment.

The post New FDA Covid-19 Policy Supports Vaccines for High-Risk Groups, More Clinical Trials for Others appeared first on MedCity News.

GSK drug Nucala has expanded its FDA-approved uses to include maintenance treatment of chronic obstructive pulmonary disease that’s driven by eosinophils, a type of immune cell. The antibody drug will compete against the blockbuster Sanofi product Dupixent, which expanded its FDA approval to COPD last year.

The post GSK Inflammation Drug Lands New FDA Nod in COPD, Stiffening Competition With Sanofi Med appeared first on MedCity News.

The FDA approved Sanofi and Regeneron Pharmaceuticals drug Dupixent as a treatment for the inflammatory skin disorder chronic spontaneous urticaria. The regulatory decision comes two years after the agency turned down an application for the biologic drug in this indication.

The post Blockbuster Sanofi & Regeneron Drug Dupixent Notches FDA Nod for an Inflammatory Skin Disease appeared first on MedCity News.

Ampersand Biomedicines’ map of all tissue in the human body reveals “addresses,” identifying markers on disease targets that are not found on healthy tissue. The company aims to improve the targeting of biologic drugs in order to reduce on-target, off-tissue toxicity.

The post Flagship’s Ampersand Bio Adds $65M to Solve One of the Top Challenges in Medicine appeared first on MedCity News.