Johnson & Johnson also gains an exclusive option to acquire Sail Biosciences for $2.58 billion. The deal puts J&J in the mix of pharmaceutical companies developing next-generation cell therapies for applications in autoimmune diseases.
Argenx’s first acquisition is the buyout of Forte Biosciences, a company with a lead drug that has early clinical validation in celiac disease and vitiligo. Argenx executives say this antibody complements its blockbuster product Vyvgart, offering a different mechanism of action but similar pipeline-in-a-product potential.
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Crystalys’s dotinurad is currently in pivotal testing for gout, a prevalent inflammatory disorder with few treatment options. The drug has the same mechanism of action as a molecule that Sobi added to its pipeline through a $950 million acquisition.
Spero Therapeutics enters immunology with an antibody licensed from Innovent Biologics. The lead indication is a rare autoimmune condition where Spero aims to offer advantages over the Amgen drug that is currently the only approved treatment.
Viridian Therapeutics’ Lumvoa is approved for treating both the chronic and active phases of thyroid eye disease. This drug will offer patients an alternative to Tepezza, an Amgen drug that had been the only approved therapy for this inflammatory eye disorder.
A European Medicines Agency committee now recommends withdrawing marketing authorization for Tavneos, an Amgen drug marketed in Europe by a CSL Limited subsidiary. Meanwhile, an FDA proposal to withdraw the drug from the U.S. market is set to go to a hearing.
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Apogee Therapeutics brings AbbVie a long-acting antibody ready for Phase 3 testing in atopic dermatitis, also called eczema. This therapy’s pipeline in a product potential includes respiratory conditions such as asthma — as a monotherapy and as part of novel drug combinations.
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Bionyra Pharma’s pipeline includes two drugs that target the signaling protein TL1A, alone and as part of a combination approach to treat inflammatory disorders. The startup’s launch makes it a contender in an emerging drug class that includes late-clinical assets from Merck, Roche, and partners Sanofi and Teva Pharmaceuticals.
FDA concerns about Amgen’s Tavneos were sparked by securities fraud litigation against ChemoCentryx, the company that originally developed the rare disease drug. The FDA wants to withdraw Tavneos’s approval, citing safety risks and alleged manipulation of the drug’s clinical trial data.
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Blackstone Life Sciences is providing Apogee Therapeutics with up to $1.3 billion in non-dilutive financing, which the biotech will apply to a key test of its lead drug candidate in atopic dermatitis. The long-acting antibody also has potential applications in asthma and eosinophilic esophagitis.
Ulcerative colitis is the lead indication for Odyssey Therapeutics’ internally discovered lead drug candidate. With the IPO proceeds, Odyssey plans mid-stage clinical trials evaluating the small molecule in combination with Takeda’s Entyvio and as a monotherapy.
Candid Therapeutics brings to UCB two clinical-stage T cell engagers in development for autoimmune disorders. To accept UCB’s offer, Candid terminated its reverse merger with Rallybio.
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.
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.