AbbVie (NYSE: ABBV) announced Friday September 11, 2026 positive topline results from the Phase 3 LUNA trial evaluating Qulipta (atogepant, an oral calcitonin gene-related peptide receptor antagonist small molecule) for the preventive treatment of menstrual migraine in adults. LUNA is a multicenter randomized double-blind placebo-controlled trial that enrolled 468 adult women with pure menstrual migraine or menstrually-related migraine across sites in Europe and Asia; participants took atogepant for 7 consecutive days starting 3 days before the onset of menses, repeated over 3 menstrual cycles. Atogepant reduced perimenstrual migraine days by a mean of 1.20 days versus 0.40 days with placebo (0.80 fewer migraine days versus placebo, p<0.0001) and met all 8 ranked secondary endpoints (p<0.0001). No treatment is currently FDA-approved specifically for menstrual migraine. AbbVie plans to submit the LUNA data to health authorities and present at future medical congresses. Qulipta is already approved in the U.S. for adults with episodic migraine and chronic migraine — the LUNA readout supports a distinct short-term perimenstrual dosing regimen and potentially a dedicated label expansion. CGRP is a neuropeptide involved in migraine pathophysiology; atogepant is a small-molecule CGRP receptor antagonist rather than a peptide itself.
Insmed Incorporated (NASDAQ: INSM) presented late-breaking Phase 3b ENCORE results for ARIKAYCE (amikacin liposome inhalation suspension) in an oral session Sunday September 6, 2026 at the European Respiratory Society Congress in Barcelona. The 12-month study evaluated ARIKAYCE plus multidrug therapy (azithromycin 250 mg plus ethambutol 15 mg/kg) versus multidrug therapy alone in patients with a new occurrence of Mycobacterium avium complex (MAC) lung infection who had not received antibiotics — a substantially different population from ARIKAYCE's current U.S. label limited to refractory MAC. ENCORE met its primary endpoint of improvement in respiratory symptom score at month 13 and all multiplicity-controlled secondary endpoints; culture conversion at month 6 was 87.8% with ARIKAYCE plus multidrug versus 57.0% with multidrug alone. Insmed plans to file a supplemental new drug application in the second half of 2026 to expand the U.S. label to newly diagnosed MAC lung disease and convert the current accelerated approval in refractory MAC to traditional approval. Five Insmed abstracts total were accepted at the meeting including brensocatib (Brinsupri, DPP1 inhibitor) bronchiectasis analyses.
Amylyx Pharmaceuticals (NASDAQ: AMLX) announced Monday evening August 18, 2026 that the registrational Phase 3 LUCIDITY clinical trial of avexitide in post-bariatric hypoglycemia (PBH) met the FDA-agreed-upon primary endpoint with a 55% reduction in the composite rate of Level 2 (blood glucose < 54 mg/dL) and Level 3 (severe cognitive impairment requiring external assistance) hypoglycemic events versus placebo (p=0.000003). The trial enrolled 78 participants with PBH following Roux-en-Y gastric bypass surgery, randomized 3:2 to avexitide 90 mg once-daily subcutaneous injection or placebo for 16 weeks across 21 US sites. All secondary endpoints were met: consistent, highly statistically significant, and clinically substantial reductions in Level 2 events by self-monitoring of blood glucose (SMBG), Level 2 events by continuous glucose monitoring (CGM), and Level 3 hypoglycemic events. Avexitide was generally well-tolerated with a favorable safety profile. Mechanism: avexitide is exendin (9-39), a 30-amino-acid peptide that binds the GLP-1 receptor without activating it, blocking excessive endogenous GLP-1 signaling that drives postprandial hypoglycemia in the reconfigured gastrointestinal anatomy after Roux-en-Y gastric bypass. Amylyx plans to submit a New Drug Application (NDA) to the FDA by end of 2026 with potential commercial launch in 2027 if approved. If approved, avexitide would be the first FDA-approved therapy for post-bariatric hypoglycemia (which has no currently approved drug therapy) and the first Phase 3 success for a GLP-1 receptor antagonist mechanism (the mechanistic opposite of the semaglutide/tirzepatide agonist class).