Passive Immunization: The Expanding Role of Monoclonal Antibodies in Preventive Medicine
For governments and health systems, monoclonal antibodies represent not just another drug class, but a strategic shift toward precision prevention.
Inflammation Startup Bionyra Launches With $165M and Ex-Sanofi Exec at the Helm
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.
presented by
Amgen Defends Rare Disease Drug in FDA Crosshairs
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.
Apogee’s Royalty Deal With Blackstone Will Fund Pivotal Test in Eczema and More
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.
Odyssey’s IPO Brings In $304M for Quest to Develop Better Immunology Drugs
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.
UCB Joins the Chase for Immune System Reset With $2B Acquisition
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.
presented by
The Power of Real World Data to Study Women’s Health at Scale
Veradigm examines key clinical trends, comorbidity profiles, and treatment trends across adolescence, reproductive years, and peri-/post-menopause. Download it today!
Immunology-Focused Coultreon Adds $125M for Pills That Pack the Punch of Injectable Biologics
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.
Trial Failure in the Skin Does Not Dent Insmed Drug’s Potential in the Lungs
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.
Pinnacle Medicines Adds $89M for Oral Peptides With Properties of Injectable Biologics
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.
Taking a Page From Cancer Drugs, Autoimmune Biotech Alumis Aims for Precision Immunology
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.
presented by
Inside an Automated Healthcare Practice: Redesigning Care Around People, Not Paperwork
By reducing administrative burden and redesigning workflows around human needs, it creates space for what matters most: connection between clinicians and patients.
Gilead Sciences Gains an Opportunity for Immune System Reset With $1.7B Ouro Acquisition
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.
J&J Gets FDA Nod for Plaque Psoriasis Pill Positioned to Compete With Injectables
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.
Lacking Evidence, FDA Rejects Aldeyra Dry Eye Disease Drug
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.
Vertex Pharma to Seek Speedy FDA Approval for Kidney Disease Drug From $4.9B Acquisition
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.
Boehringer Boosts Pipeline, Adding Oral Small Molecules With Broad Immunology & Inflammation Potential
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.