Keros to Start Rinvatercept DMD Trial in Q1 2026, Plans ALS Regulatory Talks
Keros Therapeutics plans a phase II DMD trial of rinvatercept in Q1 2026 and regulatory talks for ALS in H2 2026. Cash stands at $383 million with runway into H1 2028.
Pulmonary arterial hypertension is a progressive pulmonary vascular disease characterized by elevated pulmonary arterial pressure and vascular remodeling, which can lead to right ventricular failure.
Keros Therapeutics plans a phase II DMD trial of rinvatercept in Q1 2026 and regulatory talks for ALS in H2 2026. Cash stands at $383 million with runway into H1 2028.
Merck & Co. is bolstering its oncology pipeline with acquisitions like Terns Pharmaceuticals and Cidara Therapeutics, while Keytruda remains the key growth driver. It expects Keytruda peak sales of $35 billion by 2028 and aims to launch 20 new drugs by 2030.
Insmed reported Q2 2026 revenues of $425.5M, with BRINSUPRI at $309.2M. It raised 2026 BRINSUPRI guidance to $1.25B-$1.40B and lifted peak revenue estimates for its lead programs to over $14B.
Merck reported Phase 2 CADENCE results showing WINREVAIR met the primary endpoint in adults with CpcPH-HFpEF. The company said the data support advancement into a registrational Phase 3 study.
Biotech investors are closely watching cystic fibrosis drug trials, rare-disease therapies and regulatory catalysts. Sionna Therapeutics is advancing a new CF drug class, while Praxis Precision Medicines targets essential tremor. FDA staffing challenges add uncertainty to approval timelines.
Phase 3 trial results show seralutinib missed its primary endpoint in PAH but showed benefit in advanced disease subgroups. Meanwhile, Winrevair demonstrated significant reductions in pulmonary vascular resistance in heart failure-related pulmonary hypertension in a Phase 2 study.
Merck will acquire Terns Pharmaceuticals for $6.7 billion to bolster its cancer pipeline ahead of Keytruda's 2028 patent expiration. The deal gives Merck access to TERN-701, an oral tyrosine kinase inhibitor for chronic myeloid leukemia. Merck projects over $70 billion in commercial opportunities from its pipeline by the mid-2030s.
Global orphan drug sales are forecast to reach $409 billion by 2032, representing one-fifth of prescription drug sales, with Johnson & Johnson and Argenx leading the market amid regulatory uncertainty.
Healthcare sector surged 10% since Q4 2025, outpacing all S&P 500 sectors as investors rotate from tech to pharmaceutical value plays. Major drugmakers demonstrate resilience following Medicare price negotiations implementation.
Insmed reported total revenues of $606.4 million for 2025, with ARIKAYCE growing 19% annually. The FDA granted orphan drug designation to treprostinil palmitil for pulmonary arterial hypertension treatment in January 2026.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07761572 |
CS1 Added to Standard of Care Therapy for Pulmonary Arterial Hypertension |
NOT_YET_RECRUITING | PHASE2 |
| NCT07751120 |
Microbiota Transplant With Antibiotic Preconditioning and Fiber Supplementation in PAH. |
NOT_YET_RECRUITING | PHASE1 |
| NCT07737522 |
Myocardial Metabolic Flux in Pulmonary Arterial Hypertension |
NOT_YET_RECRUITING | PHASE2 |
| NCT07717060 |
Extracellular Vesicle Dynamics Predicting Vascular Complications and Treatment Response in Systemic Sclerosis |
NOT_YET_RECRUITING | NA |
| NCT07700303 |
Withdrawal of Prostacyclin Pathway Therapy in Patients With Pulmonary Arterial Hypertension Receiving Sotatercept (WATERLOO) |
NOT_YET_RECRUITING | NA |
| NCT07667673 |
Multimodality RV Phenotyping for Risk Stratification and Short-Term Outcomes in Group 1 PAH |
RECRUITING | |
| NCT07646860 |
A Study of Sotatercept (MK-7962) in Japanese Children With Pulmonary Arterial Hypertension (PAH) (MK-7962-032) |
RECRUITING | PHASE2 |
| NCT07623525 |
DIAG723 in Adults With Hereditary Hemorrhagic Telangiectasia |
RECRUITING | PHASE1/PHASE2 |
| NCT07613099 |
Fibrotic Disease Activity in Cardiopulmonary Disorders Using 18F-Fibroblast Activation Protein Inhibitor (18F-FAPI-74) PET/CT Imaging |
RECRUITING | PHASE3 |
| NCT07612657 |
A Phase 3 Study of Extended-release Tacrolimus in Subjects With Pulmonary Arterial Hypertension and Functional Limitations |
NOT_YET_RECRUITING | PHASE3 |