KalVista Pharmaceuticals brings to Chiesi Group the product Ekterly, the first FDA-approved oral drug for acute treatment of swelling attacks from the rare disease hereditary angioedema. Ekterly’s tablet formulation offers a dosing edge compared to injectable HAE medications.

The post Chiesi Group Grows Again in Rare Disease With $1.9B KalVista Acquisition appeared first on MedCity News.

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.

The post Pinnacle Medicines Adds $89M for Oral Peptides With Properties of Injectable Biologics appeared first on MedCity News.

Biogen’s Apellis Pharmaceuticals acquisition comes nearly two years after the drugmaker purchased immunology startup Human Immunology Biosciences. CEO Chris Viehbacher said Apellis accelerates Biogen’s expansion in nephrology, supporting a HI-Bio drug currently in pivotal testing for three kidney conditions.

The post Why Biogen Is Paying $5.6B to Buy Apellis Pharma appeared first on MedCity News.

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.

The post J&J Gets FDA Nod for Plaque Psoriasis Pill Positioned to Compete With Injectables appeared first on MedCity News.

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.

Along with the reverse merger, Candid Therapeutics announced $505 million in private financing to support its pipeline of T cell engagers for autoimmune disease. Lead program cizutamig is on track to begin global Phase 2 testing in myasthenia gravis and interstitial lung disease.

The post Candid Therapeutics Strikes Up Merger With Rallybio to Advance Its Autoimmune Drug Pipeline 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.

Cancer drugs are always popular biotech investments, but autoimmune disease also figures prominently in the startup financings announced during the annual J.P. Morgan Healthcare Conference this year.

The post JPM Deals Recap: Boston Scientific Acquisition, a Mega Round for Parabilis, Enodia Emerges & More 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.

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.

With the new capital infusion, Sanofi Ventures’ total assets under management now tops $1.4 billion. Our recap of other financings includes startups raising money for novel therapies in development for autoimmune disease, neurological disorders, cancer, and more.

The post Sanofi Pumps $625M Into Venture Arm to Back Breakthroughs in Early-Stage Startups 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.

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.

Vor Bio is licensing global rights to a fusion protein that inhibits two targets to potentially treat the neuromuscular disorder generalized myasthenia gravis. It’s a pivot for Vor, which last month ceased its cancer R&D and announced it would explore strategic alternatives.

The post Vor Bio Reinvents Itself as an Autoimmune Biotech With In-Licensed Phase 3 Asset and $175M in Funding appeared first on MedCity News.

AstraZeneca’s R&D collaboration with CSPC Pharmaceutical Group includes an oral small molecule for immunological diseases, which would offer a dosing edge over currently available injectable medications. The agreement follows a 2024 licensing agreement that granted AstraZeneca rights to an oral CSPC drug candidate in development for a metabolic disorder.

The post AstraZeneca Turns to CSPC Pharma Again, Putting Up $110M to Start Multi-Drug R&D Pact appeared first on MedCity News.

The $6.5 billion raised by biopharmaceutical companies in the first quarter of 2025 is down nearly 20% year over year, according to a report from GlobalData. The firm says investors continue to favor later-stage companies with clinical data.

The post Investor Caution Leads to Dip in Biotech Financings, GlobalData Report Shows appeared first on MedCity News.

Merida Biosciences is developing antibody-like drugs designed to selectively eliminate disease-driving autoantibodies while sparing healthy components of the immune system. Graves’ disease, which stems from the immune system’s attack on the thyroid gland, is the startup’s lead disease target.

The post Immunology Startup Merida Bio Unveils $121M and a Lead Program for Graves’ Disease appeared first on MedCity News.

BridgeBio Pharma’s approval of Beyonttra comes three months after the drug landed FDA approval for cardiomyopathy caused by transthyretin amyloidosis. Our recap of recent regulatory news also spans approvals in cancer, immunology, vaccines, and more.

The post On Heels of FDA Nod, BridgeBio’s Rival to Blockbuster Pfizer Drug Wins European Approval appeared first on MedCity News.