Apellis Pharmaceuticals announces TGA approval of SYFOVRE® for treating geographic atrophy in Australia, the first approved therapy.
Quiver AI Summary
Apellis Pharmaceuticals, Inc. announced that the Therapeutic Goods Administration (TGA) in Australia has approved its treatment SYFOVRE® (pegcetacoplan) for adult patients suffering from geographic atrophy (GA) secondary to age-related macular degeneration (AMD). This marks the first approved treatment for GA in Australia, offering hope to over 75,000 Australians affected by this progressive and irreversible disease that can lead to significant vision loss. SYFOVRE is designed to slow the progression of GA and is based on positive results from Phase 3 clinical studies. The company expressed excitement about expanding access to this therapy, which has already been approved in the U.S., emphasizing the importance of addressing the challenges faced by patients with GA.
Potential Positives
- The Therapeutic Goods Administration (TGA) has approved SYFOVRE® (pegcetacoplan) as the first and only treatment for geographic atrophy (GA) in Australia, expanding the market presence of Apellis Pharmaceuticals.
- This approval provides a new treatment option for more than 75,000 Australians living with GA, a significant advancement in addressing a leading cause of blindness.
- The approval is based on successful Phase 3 clinical study results, demonstrating the safety and effectiveness of SYFOVRE, which enhances the company's credibility and potential for future growth.
- This announcement builds on the existing success of SYFOVRE in the U.S., indicating strong momentum for Apellis' product portfolio and potential for further international approvals.
Potential Negatives
- Despite the approval of SYFOVRE in Australia, the lengthy and complex process for regulatory approvals highlights potential inefficiencies within the company's operations or regulatory strategy.
- The press release extensively emphasizes the treatment's impact on geographic atrophy (GA) while potentially downplaying any limitations or adverse effects revealed in the clinical studies, which could lead to public scrutiny or skepticism.
- The statement on forward-looking expectations and potential risks could raise concerns among investors regarding the company's financial stability and ability to meet projected outcomes.
FAQ
What is SYFOVRE® approved for in Australia?
SYFOVRE® (pegcetacoplan) is approved for the every-other-month treatment of adult patients with geographic atrophy (GA) due to age-related macular degeneration (AMD).
Who developed SYFOVRE®?
SYFOVRE® was developed by Apellis Pharmaceuticals, Inc., a global biopharmaceutical company focused on innovative therapies.
How does SYFOVRE® work?
SYFOVRE® targets C3 to provide comprehensive control of the complement cascade, part of the body's immune system.
What are the benefits of SYFOVRE® for GA patients?
SYFOVRE® offers the first treatment to slow the progression of geographic atrophy, addressing a significant medical need for these patients.
Where can I find more information about SYFOVRE®?
More information about SYFOVRE® can be found on the Apellis Pharmaceuticals website at http://apellis.com.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
$APLS Insider Trading Activity
$APLS insiders have traded $APLS stock on the open market 37 times in the past 6 months. Of those trades, 0 have been purchases and 37 have been sales.
Here’s a breakdown of recent trading of $APLS stock by insiders over the last 6 months:
- A. SINCLAIR DUNLOP has made 0 purchases and 2 sales selling 37,000 shares for an estimated $1,340,596.
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- JEFFREY EISELE (Chief Development Officer) has made 0 purchases and 3 sales selling 1,618 shares for an estimated $48,941.
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$APLS Hedge Fund Activity
We have seen 132 institutional investors add shares of $APLS stock to their portfolio, and 132 decrease their positions in their most recent quarter.
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Full Release
WALTHAM, Mass., Jan. 27, 2025 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) announced today that the Therapeutic Goods Administration (TGA) has approved SYFOVRE ® (pegcetacoplan) for the every-other-month treatment of adult patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD) with an intact fovea and when central vision is threatened by GA lesion growth. SYFOVRE is the first and only approved treatment for GA in Australia.
"The approval of SYFOVRE marks a significant milestone for GA patients across Australia. For the first time, Australians with GA will have a treatment to slow the progression of this irreversible form of vision loss,” said Jeffrey Eisele, Ph.D., chief development officer, Apellis. “Building on the success in the U.S., we are excited to bring SYFOVRE to even more patients who are impacted by this devastating disease.”
More than 75,000 Australians are living with GA, an advanced form of AMD and leading cause of blindness worldwide. 1 It is a progressive and irreversible disease caused by the growth of lesions, which destroy the retinal cells responsible for vision. The vision loss caused by GA severely impairs independence and quality of life.
“As a retina specialist, I have seen how GA often takes away a person’s ability to read, drive, and even see faces of their loved ones,” said Professor Robyn Guymer, AM, deputy director, Centre for Eye Research Australia. “The approval of SYFOVRE is a historic moment full of hope for the Australian GA community, who have been waiting for a treatment.”
The approval is based on results from the Phase 3 OAKS and DERBY studies at 24 months. In the studies, treatment with both every-other-month and monthly SYFOVRE slowed GA progression and showed a generally well-tolerated safety profile. The results were published in The Lancet in October 2023.
About SYFOVRE
®
(pegcetacoplan injection)
SYFOVRE
®
(pegcetacoplan injection) is the first-ever approved therapy for geographic atrophy (GA). By targeting C3, SYFOVRE is designed to provide comprehensive control of the complement cascade, part of the body’s immune system. SYFOVRE is approved in the United States and Australia.
About Apellis
Apellis Pharmaceuticals, Inc. is a global biopharmaceutical company that combines courageous science and compassion to develop life-changing therapies for some of the most challenging diseases patients face. We ushered in the first new class of complement medicine in 15 years and now have two approved medicines targeting C3. These include the first-ever therapy for geographic atrophy, a leading cause of blindness around the world. We believe we have only begun to unlock the potential of targeting C3 across many serious diseases. For more information, please visit
http://apellis.com
or follow us on
X
and
LinkedIn
.
Apellis
Forward-Looking
Statement
Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements” within the meaning of The Private Securities Litigation Reform Act of 1995. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors discussed in the “Risk Factors” section of Apellis’ Annual Report on Form 10-K with the Securities and Exchange Commission on February 27, 2024 and Quarterly Report on Form 10-Q filed on November 5, 2024 and the risks described in other filings that Apellis may make with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Apellis specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.
Media Contact:
Lissa Pavluk
[email protected]
617.977.6764
Investor Contact:
Meredith Kaya
[email protected]
617.599.8178
References
-
Keel S, Xie J, Foreman J, van Wijngaarden P, Taylor HR, Dirani M. Prevalence of Age-Related Macular Degeneration in Australia: The Australian National Eye Health Survey. JAMA Ophthalmol. Nov 1 2017;135(11):1242-1249. doi:10.1001/jamaophthalmol.2017.4182