Positive Phase III Data for Obesity Drug Orforglipron
Lilly announced positive topline results from the ATTAIN-1 Phase III trial of orforglipron, an oral GLP-1 receptor agonist, in people with obesity without diabetes.
Patients on the highest dose of orforglipron lost over 27 pounds (12.4% of body weight), with notable improvements in metabolic markers such as blood pressure, cholesterol, and inflammation.
The safety profile was consistent with the injectable GLP-1 class, with gastrointestinal side effects being most common and low discontinuation rates (5-10%).
Lilly plans to submit orforglipron for regulatory approval globally within the year, with additional Phase III trials ongoing in diabetes, weight maintenance, and other indications.
Progress and Pipeline Advancements with Notable Regulatory Approvals
AbbVie received FDA approval for EMRELIS in non-squamous non-small cell lung cancer and Rinvoq for GCA, marking significant milestones in oncology and rheumatology.
The company announced positive Phase III results for Rinvoq in alopecia areata, demonstrating superior efficacy with 54% of patients reaching 80% scalp coverage at 24 weeks.
Regulatory submission of TrenibotE, a first-in-class short-acting toxin for aesthetics, is underway, with potential to expand AbbVie's aesthetic portfolio.
Impact of FDA Inspection Delay on EYLEA HD and BLA for Odronextamab
EYLEA HD regulatory application delays caused by FDA site inspection at Catalent Indiana LLC, which was not specific to EYLEA HD.
Novo Nordisk expects to file a comprehensive response next week, anticipating an expeditious resolution.
BLA for odronextamab, a bispecific antibody for follicular lymphoma, was impacted by the same site inspection, resulting in a Complete Response Letter (CRL) issued earlier this week.
Management remains optimistic about resolving these issues quickly based on Novo's communication and progress with third-party fillers.
FDA Label Expansion for EMPAVELI in C3G and Primary IC-MPGN
FDA approved a label expansion for EMPAVELI for patients 12 years and older with C3 myelopathy and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN).
This is the company's third FDA approval in 4 years, highlighting scientific strength and regulatory success.
The approval enables treatment with a C3-targeting therapy that achieves outcomes across proteinuria reduction, eGFR stabilization, and C3 deposit clearance.
Launch is underway, expanding into rare nephrology and underserved populations, including pediatric patients and post-transplant recurrence.
Strategic Merger of Pelthos and Channel Therapeutics
The merger involved a reverse merger process, creating a new public entity, Pelthos Therapeutics, which launched Zelsuvmi, a treatment for Molluscum contagiosum.
Pelthos's market forecast suggests capturing fewer than 100,000 patients in a 16.7 million patient market, with potential royalties of around $23 million annually in the U.S.
Ligand's strategic ownership of the nitric oxide platform and pipeline of late-stage programs offers multiple future royalty streams, emphasizing its focus on high-value assets.
Progress and Strategic Opportunities for SGR-1505 MALT1 Inhibitor
Initial Phase I data for SGR-1505 showed a well-tolerated profile with responses in heavily pretreated CLL and Waldenstrom's macroglobulinemia patients, with 3 of 17 CLL patients responding and all 5 Waldenstrom's patients responding.
The program has received FDA Fast Track designation, highlighting its potential as a promising therapeutic in refractory hematologic cancers.
Schrodinger is exploring strategic opportunities to accelerate clinical development and maximize the potential of SGR-1505, rather than pursuing independent late-stage trials.
The company plans to provide further updates on dose escalation, translational data, and regulatory feedback later this year.
The emerging profile of SGR-1505 suggests best-in-class potential, with early evidence supporting its use in refractory disease, especially in patients previously exposed to BTK and BCL2 inhibitors.
Successful Launch and Early Adoption of YUTREPIA in 11 Weeks
Liquidia's new inhaled prostacyclin, YUTREPIA, achieved over 900 prescriptions and 550 patient starts within just 11 weeks of launch, indicating an unprecedented market response.
The launch was executed with high precision and purpose, leading to rapid adoption across both specialty centers and community practices.
The product's ease of use, tolerability, and dose escalation capabilities have been highly praised by physicians and patients, surpassing initial expectations.
Market access strategies, including co-pay assistance and free vouchers, contributed to a 75% script-to-start conversion rate in the first six weeks.
The early momentum was achieved despite typical market entry barriers, suggesting strong unmet needs and product differentiation.
Advancement of Avexitide and Market Potential for PBH
Amylyx's lead asset, Avexitide, is an investigational GLP-1 receptor antagonist with FDA breakthrough therapy designation for postbariatric hypoglycemia (PBH).
The company has initiated a pivotal Phase III LUCIDITY trial, with recruitment expected to complete by year-end and top-line data anticipated in the first half of 2026.
Market research and prevalence models suggest approximately 160,000 Americans suffer from medically important PBH, with around 119,000 experiencing recurrent, severe episodes that require medical attention.
Amylyx is preparing for a potential commercial launch in 2027, focusing on building market access strategies and educating healthcare providers and patients.
The company’s collaboration with Gubra aims to develop long-acting GLP-1 receptor antagonists, with promising early proof of concept data indicating extended half-lives and potency.
Innovative Tissue-Selective Weight Loss Drug Demonstrates Promising Phase 2b Results
Veru's drug candidate Inovasaram has shown in Phase 2b that it can selectively target fat tissue while preserving lean mass in older patients, a significant advancement over existing GLP-1 therapies.
The Phase 2b trial demonstrated a 42% greater fat loss with the 6 mg dose of Inovasaram combined with semaglutide, with statistical significance (p=0.017).
Inovasaram preserved 100% of lean mass during the trial, reducing the risk of muscle loss associated with weight management in older adults.
Physical function, measured by stair climb test, was preserved in patients treated with Inovasaram, with a 59.8% reduction in physical decline compared to placebo.
Positive safety profile was confirmed in the maintenance extension study, with no significant adverse events related to muscle or bone health.
The company plans to develop a novel modified release oral formulation of Inovasaram, protected by patents through 2037, to improve chronic weight management.
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