Apellis Pharmaceuticals Inc
118 articles with Apellis Pharmaceuticals Inc
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Apellis Pharmaceuticals to Present at Upcoming Investor Conferences - June 03, 2021
6/3/2021
Apellis Pharmaceuticals, Inc., a global biopharmaceutical company and leader in targeted C3 therapies, announced that the company will participate in the following investor conferences in June
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venBio Global Strategic Fund IV will invest primarily in drug companies focused on developing therapies for unmet medical needs.
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Positive top-line results from the phase 3 PRINCE study of pegcetacoplan in treatment-naïve patients with PNH
5/25/2021
- Pegcetacoplan demonstrated statistical superiority on the co-primary endpoints of haemoglobin stabilisation (p<0.0001) and reduction in lactate dehydrogenase (LDH) (p<0.0001) compared to standard of care, which did not include complement inhibitors, at week 26 - Mean haemoglobin levels in the pegcetacoplan group increased from 9.4 g/dL to 12.1 g/dL compared to an increase from 8.7 g/dL to 9.4 g/dL on standard of care (p=0.0019)
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Apellis and Sobi Report Positive Top-line Results from the Phase 3 PRINCE Study of EMPAVELI™ (pegcetacoplan) in Treatment-naïve Patients with PNH
5/25/2021
Apellis Pharmaceuticals, Inc. and Swedish Orphan Biovitrum AB reported positive top-line results from the Phase 3 PRINCE study evaluating the efficacy and safety of EMPAVELI™ in adults with paroxysmal nocturnal hemoglobinuria who are treatment naïve, meaning they had not received a complement inhibitor within three months before entering the study.
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Empaveli (pegcetacoplan) is the first and only targeted C3 therapy for the treatment of adults with PNH, the Waltham, Mass.-based company said in its announcement.
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Apellis Announces U.S. Food and Drug Administration (FDA) Approval of EMPAVELI™ (pegcetacoplan) for Adults with Paroxysmal Nocturnal Hemoglobinuria (PNH)
5/14/2021
Apellis Pharmaceuticals, Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in targeted C3 therapies, today announced that the U.S. Food and Drug Administration (FDA) has approved EMPAVELI™ (pegcetacoplan), the first and only targeted C3 therapy for treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH).
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Apellis to Present Long-Term Pegcetacoplan Data in PNH at the European Hematology Association Virtual Congress
5/12/2021
Seven accepted abstracts, including an oral presentation, reinforce the potential of pegcetacoplan, an investigational, targeted C3 therapy, to redefine treatment for patients with paroxysmal nocturnal hemoglobinuria (PNH) PDUFA action date of May 14, 2021 set by the U.S. Food and Drug Administration (FDA)
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May is a busy month for the U.S. Food and Drug Administration (FDA)’s calendar for new drug reviews. Here’s a look.
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London-based venture capital fund Abingworth closed on a new Clinical Co-Development Fund now at $582 million. The fund's original target was just at $350 million.
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Apellis Pharmaceuticals Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) - May 07, 2021
5/7/2021
Apellis Pharmaceuticals, Inc., a global biopharmaceutical company and leader in targeted C3 therapies, announced that the company approved the grant of equity awards to two new employees with a grant date of May 3, 2021, as equity inducement awards outside of the company's 2017 Stock Incentive Plan and material to the employees’ acceptance of employment with the company.
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Apellis Pharmaceuticals Reports First Quarter 2021 Financial Results
4/28/2021
Marketing application for pegcetacoplan for paroxysmal nocturnal hemoglobinuria (PNH) is under review by the U.S. Food and Drug Administration (FDA) with a PDUFA target action date of May 14, 2021
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Apellis Pharmaceuticals to Hold First Quarter 2021 Earnings Conference Call on April 28, 2021
4/21/2021
Apellis Pharmaceuticals , Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in targeted C3 therapies, today announced that the company will host a conference call and webcast to discuss its first quarter 2021 financial results on Wednesday, April 28, 2021 at 4:30 p.m. ET.
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Apellis to Showcase Leadership in Retina at Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting
4/16/2021
10 accepted abstracts include five oral presentations from pioneering artificial intelligence (AI) collaboration Presentations support the potential of intravitreal pegcetacoplan, an investigational targeted C3 therapy, as the first treatment for geographic atrophy (GA)
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Apellis Provides 24-Month Update from Phase 1b Study of Pegcetacoplan in Patients with Geographic Atrophy
4/13/2021
Post hoc analysis showed a 46% decrease in mean lesion growth in eight patients with bilateral GA comparing treated eye vs. untreated fellow eye at 24 months (p=0.007)
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Clinical Catch-Up: March 15-19
3/22/2021
It was a relatively quiet week in terms of clinical trial news, but there were some significant releases. Here’s a look. -
The results published in the NEJM state that pegcetacoplan met the study’s primary endpoint for efficacy, demonstrating an advantage over eculizumab with a statistically significant improvement in adjusted means of 3.8 g/dL of hemoglobin at week 16 (p<0.001). An impressive 85% of patients were tr...
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The NEJM publishes phase 3 PEGASUS study results comparing pegcetacoplan to eculizumab for PNH
3/17/2021
Pegcetacoplan, an investigational targeted C3 therapy for serious, complement-driven diseases, demonstrated superiority to eculizumab with a statistically significant improvement in haemoglobin levels and showed improvements in key clinical outcomes
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Apellis and Sobi: The New England Journal of Medicine Publishes Phase 3 PEGASUS Study Results Comparing Pegcetacoplan to Eculizumab for PNH
3/17/2021
Pegcetacoplan, an investigational targeted C3 therapy for serious, complement-driven diseases, demonstrated superiority to eculizumab with a statistically significant improvement in hemoglobin levels and showed improvements in key clinical outcomes
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Apellis Announces Two New Publications from the Positive Phase 2 FILLY Study Evaluating Pegcetacoplan in Geographic Atrophy
3/10/2021
Data published in Ophthalmology and the American Journal of Ophthalmology underscore the potential of pegcetacoplan, an investigational targeted C3 therapy, for geographic atrophy
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Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for March 9, 2021.