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Apellis Pharmaceuticals declines afters CHMP's third negative opinion on Syfovre
European regulators on Friday upheld its negative opinion on Apellis Pharmaceuticals' (NASDAQ:APLS) proposed treatment for its eye disease therapy for the third time this year. Apellis reported that the Committee for Medicinal Products for Human Use,
Apellis Receives Negative CHMP Opinion for Pegcetacoplan for Geographic Atrophy (GA) in the EU Following Re-Examination
This CHMP opinion was made despite broad support for pegcetacoplan from the European retina community and multiple dissenting votes by CHMP members who supported a path to approval.” “We have seen the profound impact this medicine has had for GA patients in the U.
Apellis: CHMP Once Again Recommends Against Syfovre
The CHMP's final opinion follows two earlier negative votes this year on the drug, which is marketed as Syfovre in the U.S. and generated $154.6 million in U.S. net product revenue for Apellis in the second quarter.
2d
Geographic Atrophy (GA) Market Size to Hit USD 50.0 Billion by 2032 with a 8.6% CAGR – SNS Insider
Robust Growth in the Geographic Atrophy Market Driven by Aging Population and Technological AdvancesPune, Sept. 20, 2024 ...
3d
Floppy limbs, weak coughs: Key warning signs of spinal muscular atrophy in babies
Delays in treatment for the rare genetic condition could lead to progressive muscle weakness and irreversible loss in motor ...
Too Old to Operate
4d
Phenotypic Clusters and Atrophy Patterns in Genetic FTD
The following is a summary of “Frequency and Longitudinal Course of Behavioral and Neuropsychiatric Symptoms in Participants ...
The American Journal of Managed Care
1d
New Research Unearths Evidence of Global Metabolic Disruption in Patients With SMA
A recent analysis investigated the state of metabolic disruption experienced by patients with spinal muscular atrophy (SMA), ...
BioPharma Dive
2d
Apellis eye drug again turned back in Europe
The decision against Syfovre’s approval follows efforts by Apellis to have reviewers reevaluate clinical evidence multiple times and, according to an analyst, will lead to a restructuring of the ...
2d
on MSN
What's Going With Apellis Pharmaceuticals Stock Friday?
Apellis Pharmaceuticals, Inc. (NASDAQ:APLS) shares are moving lower Friday after the Committee for Medicinal Products for ...
Managed Healthcare Executive
2d
Although Gene Therapy Offers Hope, SMA Patients Still Face Significant Health Challenges
Children with spinal muscular atrophy (SMA) experience benefits from receiving a disease-modifying gene therapy, but many ...
News Medical
2d
Glycemic control contributes to neuroprotective effects of Mediterranean diet on brain age
Findings suggest Mediterranean and green-MED diets improve brain health, with polyphenols contributing to younger brain age ...
Daily
3d
Oral Gildeuretinol may reduce Geographic Atrophy lesions Secondary to Age-Related Macular Degeneration: SAGA trial
Phase 3 SAGA trial has revealed that Gildeuretinol clinically, meaningfully and safely reduced geographic atrophy lesions ...
SMA
2d
Standardized SMA newborn screening may aid early treatment
Differences in SMA newborn screening practices in the U.S. could impact referral patterns or the timing of therapeutic ...
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