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APELLIS PHARMACEUTICALS, INC.

(APLS)
  Report
Delayed Nasdaq  -  04:00:00 2023-01-30 pm EST
52.74 USD   -0.06%
01/25Insider Sell: Apellis Pharmaceuticals
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01/09Transcript : Apellis Pharmaceuticals, Inc. Presents at 41st Annual J.P. Morgan Healthcare Conference, Jan-09-2023 09:00 AM
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01/09Apellis Pharmaceuticals Announces Inducement Grants Under Nasdaq Listing Rule 5635
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Apellis Announces FDA Acceptance of NDA Amendment and New PDUFA Date of February 26, 2023 for Pegcetacoplan for Geographic Atrophy (GA)

11/18/2022 | 07:00am EST

Apellis Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted Apellis' unsolicited major amendment to the New Drug Application (NDA) for intravitreal pegcetacoplan for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The updated Prescription Drug User Fee Act (PDUFA) goal date is February 26, 2023. The FDA also restated that they do not plan to hold an advisory committee meeting to discuss the application.

Apellis announced earlier this month the company's decision to submit 24-month efficacy data from the Phase 3 DERBY and OAKS studies as part of the NDA review. The 24-month data showed increasing and consistent effects with every-other-month and monthly pegcetacoplan treatment and a favorable safety profile in both studies. Apellis remains on track to submit an EU marketing authorization application, which will also include the 24-month results, to the European Medicines Agency by the end of 2022. DERBY (n=621) and OAKS (n=637) are Phase 3, multicenter, randomized, double-masked, sham-controlled studies comparing the efficacy and safety of pegcetacoplan with sham injections across a broad and representative population of patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

The primary objective of the studies is to evaluate the efficacy of pegcetacoplan in patients with GA assessed by change in the total area of GA lesions from baseline as measured by fundus autofluorescence (p-value less than 0.05) at 12 months. Patients continued to receive masked treatment for 24 months.


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All news about APELLIS PHARMACEUTICALS, INC.
01/25Insider Sell: Apellis Pharmaceuticals
MT
01/09Transcript : Apellis Pharmaceuticals, Inc. Presents at 41st Annual J.P. Morga..
CI
01/09Apellis Pharmaceuticals Announces Inducement Grants Under Nasdaq Listing Rule 5635
AQ
01/06Apellis Pharmaceuticals Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4..
GL
01/06Apellis Pharmaceuticals Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4..
AQ
01/05Apellis Pharmaceuticals, Inc. : Change in Directors or Principal Officers (form 8-K)
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01/05Apellis Appoints Leading Retina Specialist Dr. Caroline Baumal as Chief Medical Officer
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01/05Apellis Appoints Leading Retina Specialist Dr. Caroline Baumal as Chief Medical Officer
GL
01/05Apellis Appoints Retina Specialist Dr. Caroline Baumal as Chief Medical Officer
CI
01/04North American Morning Briefing: Futures Rise -2-
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Financials (USD)
Sales 2022 77,4 M - -
Net income 2022 -660 M - -
Net cash 2022 391 M - -
P/E ratio 2022 -8,41x
Yield 2022 -
Capitalization 5 830 M 5 830 M -
EV / Sales 2022 70,2x
EV / Sales 2023 27,9x
Nbr of Employees 476
Free-Float 84,6%
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Mean consensus BUY
Number of Analysts 17
Last Close Price 52,77 $
Average target price 74,69 $
Spread / Average Target 41,5%
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Managers and Directors
Cedric Francois President, Chief Executive Officer & Director
Timothy Eugene Sullivan Chief Financial Officer & Treasurer
Lok Chung Chan Chairman
Pascal Deschatelets Chief Scientific Officer
Nur Nicholson Chief Technical Operations Officer
Sector and Competitors