Novartis announced on Friday, September 18, 2026 that the CHMP adopted a positive opinion for Cosentyx (secukinumab) to treat polymyalgia rheumatica (PMR) in adults who have had an inadequate response to steroids or who relapse during steroid taper. Novartis says Cosentyx would be the first IL-17A inhibitor licensed in Europe for PMR. The opinion is based on the global Phase III REPLENISH trial, run in 27 countries, in which all primary and secondary endpoints were met across both the 300 mg and 150 mg arms; Cosentyx doubled sustained remission rates and delivered steroid-sparing effects versus placebo, with no new safety signals. The data were published in the New England Journal of Medicine, and the European Commission is expected to decide within about two months.
Eisai (TSE: 4523) and Biogen (NASDAQ: BIIB) announced Wednesday August 26, 2026 that once-weekly subcutaneous lecanemab-irmb (brand name Leqembi Iqlik) is now commercially available in the United States for initiation therapy in adults with early Alzheimer's disease (AD). Approved patient population: adults with mild cognitive impairment (MCI) or mild dementia due to AD, the same patient population that was approved for the IV formulation. Mechanism: lecanemab is a humanized IgG1 monoclonal antibody targeting soluble amyloid-beta protofibrils and preventing their aggregation into amyloid plaques that drive Alzheimer's pathology. Delivery format shift: the US launch represents the anti-amyloid class's substantive transition from the existing twice-monthly IV infusion format (requiring 1 hour of infusion time plus monitoring) to a weekly subcutaneous injection that substantially improves patient accessibility and reduces the infrastructure burden that has constrained the ongoing global Leqembi launch. Practical impact on Leqembi commercial trajectory: the SC format removes several barriers including infusion center scheduling constraints, long chair time per dose, and IV line placement complications. Eisai and Biogen have been struggling with slower-than-expected Leqembi launch since initial 2023 FDA approval due to reimbursement complexity, MRI monitoring requirements for amyloid-related imaging abnormalities (ARIA), and infrastructure requirements; the SC availability addresses one substantive barrier. Q2 2026 Leqembi worldwide sales reached roughly $340 million; the SC transition is expected to accelerate the commercial trajectory in Q4 2026 and into 2027.
Johnson & Johnson (NYSE: JNJ) received FDA approval Wednesday August 26, 2026 for Imaavy (nipocalimab), an anti-neonatal Fc receptor (FcRn) monoclonal antibody administered as subcutaneous injection, for the treatment of warm autoimmune hemolytic anemia (wAIHA) in adults and pediatric patients aged 12 and older. Disease context: wAIHA is a rare autoimmune disease in which autoantibodies (primarily IgG) bind red blood cells at body temperature and trigger complement- and macrophage-mediated red blood cell destruction, causing fatigue, jaundice, splenomegaly, and in severe cases life-threatening anemia. Prior treatment has relied on corticosteroids, rituximab (an anti-CD20 monoclonal antibody), splenectomy, and other immunosuppressants, all with substantial side effects and variable efficacy. Nipocalimab mechanism: blocks the neonatal Fc receptor (FcRn) that normally rescues IgG antibodies from degradation; blocking FcRn accelerates IgG catabolism and reduces the pathogenic IgG autoantibody burden that drives wAIHA. The Imaavy approval extends the anti-FcRn therapeutic category that argenx pioneered with Vyvgart (efgartigimod alfa, IV and SC formulations) into a new autoimmune indication beyond the currently-approved indications of generalized myasthenia gravis and chronic inflammatory demyelinating polyneuropathy. The FcRn category is a growing modality with multiple companies pursuing autoimmune indications; J&J's Imaavy is now approved for wAIHA and separately in myasthenia gravis, positioning as a direct competitor to argenx's Vyvgart franchise. Approval was supported by Phase 3 clinical data documenting substantial improvements in hemoglobin levels and transfusion-independence rates compared to placebo.
Regeneron Pharmaceuticals (NASDAQ: REGN) received FDA approval Thursday August 20, 2026 for Pasatru (garetosmab-grts, an anti-activin A monoclonal antibody administered as subcutaneous injection) for the reduction of the formation of new heterotopic ossification (HO) lesions and clinician-assessed flare-ups in adults with fibrodysplasia ossificans progressiva (FOP). FOP is a rare autosomal-dominant genetic disease affecting roughly 1 in 2 million people globally (approximately 800 patients in the US) in which skeletal muscle and connective tissue progressively turn into bone through extra-skeletal ossification triggered by activin A signaling through mutated ACVR1 (activin receptor A type 1) receptors. Patients typically develop the first flare-ups in early childhood, with progressive immobilization by adulthood as ossification advances across major joints. Pasatru's mechanism: garetosmab binds activin A and blocks its signaling through the mutated ACVR1 receptors, reducing the flare-up frequency and slowing new HO lesion formation. The approval marks the second FDA-approved therapy for FOP after Ipsen's Sohonos (palovarotene, a retinoic acid receptor gamma agonist small molecule) approved in 2023. Pasatru offers a mechanistically distinct alternative for patients who cannot tolerate palovarotene or who need combination or sequential therapy. The Pasatru approval extends Regeneron's growing rare-disease commercial portfolio alongside Eylea (aflibercept for wet AMD), Dupixent (dupilumab for atopic dermatitis and asthma), and multiple antibody-drug conjugate programs in development. Pricing and launch details have not been publicly disclosed but rare-disease pricing typically runs $300,000-$500,000 per patient per year.
Biogen (NASDAQ: BIIB) and Chinese partner TJ Biopharma announced Monday August 17, 2026 that felzartamab for injection (branded Jingfei in China), an anti-CD38 monoclonal antibody, has been approved by China's National Medical Products Administration (NMPA) for use with lenalidomide and dexamethasone in adults with multiple myeloma who have received at least one prior line of therapy. Anti-CD38 mechanism context: CD38 is a transmembrane glycoprotein highly expressed on multiple myeloma plasma cells and less on normal cells, making it a validated target for monoclonal antibody therapy. Felzartamab represents an alternative anti-CD38 mechanism to Sanofi's SARCLISA (isatuximab) and Johnson & Johnson's DARZALEX (daratumumab), the two commercial anti-CD38 monoclonal antibodies that have anchored the anti-CD38 multiple myeloma commercial segment since first approvals in 2015 (daratumumab) and 2020 (isatuximab). Felzartamab's specific differentiation lies in a distinct epitope-binding domain on CD38 that may translate to different infusion-reaction profiles and combination-therapy potential. The China NMPA approval marks TJ Biopharma's first regional commercial launch for felzartamab and extends the Biogen-China partnership approach for both ex-China drug development and in-China commercial positioning. Beyond multiple myeloma, felzartamab is being studied for anti-neutrophil cytoplasmic antibody-associated vasculitis (ANCA vasculitis), IgA nephropathy, and antibody-mediated kidney transplant rejection in ex-China trials that Biogen leads.
Acumen Pharmaceuticals (NASDAQ: ABOS) will present data on its Enhanced Brain Delivery (EBD) technology and early Alzheimer's disease insights for sabirnetug (ACU193) at AAIC 2026 in London (July 12-15, both in-person and online). Sabirnetug is a humanized monoclonal antibody discovered and developed based on its selectivity for soluble amyloid-beta oligomers (AβOs, a highly toxic and pathogenic form of Aβ) relative to Aβ monomers and amyloid plaques. Soluble AβOs bind to neurons, inhibit synaptic function, and induce neurodegeneration; the mechanism differentiates sabirnetug from plaque-directed anti-amyloid antibodies (lecanemab, donanemab) that clear fibrillar Aβ. Acumen advances sabirnetug in the ongoing Phase 2 ALTITUDE-AD trial in early symptomatic AD, following positive Phase 1 INTERCEPT-AD results. Topline ALTITUDE-AD results are expected in late 2026. The Enhanced Brain Delivery technology component further connects to the day's broader BBB-delivery theme anchored on Denali's opening plenary and the Lonza-Nona deal.
Vaccinex (NASDAQ: VCNX) announced Wednesday July 8, 2026 that it will present new glial biomarker data from the Phase 1/2 SIGNAL-AD study of pepinemab and plans for the expanded Phase 2B SIGNAL-AD2 trial at the Alzheimer's Association International Conference (AAIC) 2026 in London on July 13. Elizabeth Evans, PhD, Chief Operating Officer and Senior VP of Discovery and Translational Medicine, will chair the Featured Research Session. Pepinemab is a humanized IgG4 monoclonal antibody targeting Semaphorin 4D (SEMA4D). The mechanism blocks SEMA4D signaling through astrocyte plexin-B1 receptors, reducing reactive astrocyte activation and downstream neuroinflammation — a disease-modifying approach mechanistically distinct from amyloid- or tau-targeting strategies. Pepinemab is a monoclonal antibody rather than a peptide, but the SEMA4D program sits in the peptide-and-biologic neurodegeneration territory this site tracks alongside the Vera Therapeutics Trutakna (atacicept fusion protein) approval covered yesterday. AAIC readouts to watch: cerebrospinal-fluid glial fibrillary acidic protein (GFAP) and neurofilament light chain (NfL) biomarker shifts on pepinemab treatment.
Marea Therapeutics (Endocrine News Pharma Friday, June 19) released Phase 1 first-in-human data for MAR002, a first-in-class half-life-extended allosteric human monoclonal antibody growth hormone receptor antagonist (GHRA), at ENDO 2026 in Chicago. The Phase 1 readout supports a potential best-in-disease profile across safety, tolerability, pharmacodynamic IGF-1 lowering, and pharmacokinetics, with a long duration of action compatible with infrequent subcutaneous dosing — potentially once every two weeks — versus the daily subcutaneous administration required for pegvisomant (Somavert). MAR002 sits at the intersection of acromegaly's existing somatostatin (octreotide, lanreotide, Palsonify), GH-receptor (pegvisomant), and dopamine agonist (cabergoline) approaches and reframes the GHR antagonist class around an antibody, not a pegylated protein. Acromegaly's US/EU prevalence is roughly 40-70 per million.