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LAUSANNE, Switzerland - AC Immune SA (NASDAQ: NASDAQ:ACIU), a Swiss biopharmaceutical company, has announced a significant milestone in its collaboration with Janssen Pharmaceuticals, Inc., a Johnson & Johnson company. The company is set to receive a milestone payment of CHF 24.6 million due to the rapid prescreening rate in its Phase 2b ReTain trial for the investigational Alzheimer's treatment, ACI-35.030, now known as JNJ-2056.
The payment, triggered in September, is part of a potentially registrational study targeting around 500 participants with pre-symptomatic Alzheimer's disease (AD). This follows a previous milestone payment in December, bringing the total received for ACI-35.030 to CHF 40 million. The recent financial boost strengthens AC Immune's position, extending its operational cash runway for three years.
ACI-35.030 has gained Fast Track designation from the U.S. Food and Drug Administration (FDA) in July, marking it as the second active immunotherapy from AC Immune to receive this status. This designation is a nod to the therapy's potential in addressing the needs of patients with Alzheimer's disease.
The Phase 2b ReTain trial is groundbreaking as it is the first time an active immunotherapy is being tested in a preclinical AD population. The study aims to explore whether JNJ-2056 can delay or prevent the onset of cognitive impairment in individuals showing early signs of AD. Participants will receive intramuscular injections of either JNJ-2056 or a placebo for up to four years, with the primary endpoint measuring cognitive decline.
AC Immune's CEO, Dr. Andrea Pfeifer, expressed optimism about the potential benefits of second-generation therapeutics for early-diagnosed Alzheimer's patients. The company's technology platforms and drug development capabilities have attracted approximately CHF 425 million in milestone and upfront payments from collaboration deals, with potential future payments exceeding CHF 4.3 billion, plus royalties on potential sales.
The ReTain trial is fully funded by Janssen and is being conducted at over 40 clinical sites across the U.S., Japan, the UK, and Australia, with more expected to open soon.
AC Immune SA continues to be a leader in precision prevention for neurodegenerative diseases, with a diversified pipeline of therapeutic and diagnostic programs. This news is based on a press release statement.
In other recent news, AC Immune SA has received Fast Track Designation from the U.S. Food and Drug Administration for its Tau positron emission tomography diagnostic agent, [18F]PI-2620, and Alzheimer's disease treatment candidate, ACI-35.030. The Swiss biopharmaceutical company has also unveiled a novel therapeutic antibody drug conjugate technology, morADC, aimed at treating neurodegenerative diseases. The company's Alzheimer's disease treatment candidate, ACI-35.030, is currently in Phase 2b clinical trials conducted by Janssen Pharmaceuticals, a Johnson & Johnson company. BTIG has recognized AC Immune with a 'Buy' rating, highlighting its extensive pipeline focused on detecting and clearing toxic proteins related to neurodegenerative diseases. In addition, AC Immune has entered into a global option and license agreement with Takeda Pharmaceutical Company (NYSE:TAK) Limited for the development of ACI-24.060, a potential Alzheimer's disease treatment. These recent developments highlight AC Immune's commitment to pioneering precision medicine for neurodegenerative diseases.
InvestingPro Insights
AC Immune SA (NASDAQ: ACIU), while advancing in its clinical trials, presents a mixed financial outlook according to recent InvestingPro data. The company holds a market capitalization of $323.53 million, reflecting the biotech market's response to its developments and potential. As of the last twelve months as of Q2 2024, AC Immune reported significant revenue growth of 293.6%, indicating a strong increase in its operational activities. However, this growth comes with a caveat as the company's gross profit margin stands at a negative 283.23%, underscoring the high costs associated with its research and development efforts.
An important InvestingPro Tip to consider is that AC Immune holds more cash than debt on its balance sheet, which is a positive indicator of the company's ability to fund its operations and research initiatives without the immediate need for external financing. This is particularly crucial for a biopharmaceutical firm where cash flow is pivotal for sustaining long-term projects.
Despite the challenges, analysts have revised their earnings upwards for the upcoming period, which could signal confidence in the company's future performance. It's worth noting that AC Immune does not pay a dividend to shareholders, which is common for growth-focused biotech companies that prefer to reinvest earnings back into research and development.
For readers interested in a deeper analysis, InvestingPro offers additional tips for AC Immune SA, which can be found at Investing.com/pro/ACIU. There are a total of 9 InvestingPro Tips available, providing a comprehensive view of the company's financial health and future prospects.
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