Cidara Therapeutics Announces Approval of REZZAYO by the MHRA for the Treatment of Invasive Candidiasis in Adults
Cidara Therapeutics, Inc. (Nasdaq: CDTX) announces that the United Kingdom (U.K.) Medicines and Healthcare products Regulatory Agency (MHRA) has approved REZZAYO (rezafungin acetate) for the treatment of invasive candidiasis in adults, expanding treatment options for patients globally. The approval follows positive results from the ReSTORE Phase III clinical trial, demonstrating statistical non-inferiority for weekly-dosed rezafungin compared to the standard of care. Cidara has partnered with Mundipharma, entitled to receive a $2.8 million milestone payment for the MHRA approval.
Positive
Positive results from the ReSTORE Phase III clinical trial
Statistical non-inferiority for weekly-dosed rezafungin compared to the standard of care
Partnership with Mundipharma for commercial rights outside the U.S. and Japan
Entitled to receive a $2.8 million milestone payment from Mundipharma for the MHRA approval
The approval of REZZAYO by the UK MHRA represents a significant milestone for Cidara Therapeutics, as it expands the market reach of their antifungal treatment, rezafungin. In the context of market dynamics, this approval could potentially increase the revenue streams for Cidara, considering the milestone payment of $2.8 million from Mundipharma, which is a substantial financial benefit. The approval also signals a positive regulatory trend, following previous nods from the U.S. FDA and European Commission, enhancing investor confidence in the company's ability to navigate international regulatory landscapes.
From a market penetration perspective, the introduction of rezafungin in the UK market addresses a gap for new treatments in the antifungal space, particularly since it's the first in 15 years. This could lead to increased adoption rates among healthcare providers, given the clinical trial results showing non-inferiority to the standard of care. The potential for market expansion and increased adoption rates is a positive indicator for future earnings and stock performance, making Cidara an interesting case for investors looking at the biotechnology sector.
The clinical significance of rezafungin's approval for invasive candidiasis cannot be understated. Invasive candidiasis is a serious infection with high morbidity and mortality rates and the introduction of a new treatment option after a 15-year hiatus is a major advancement. The ReSTORE Phase III clinical trial data indicating non-inferiority to caspofungin, which has been a standard of care, suggests that rezafungin could become an essential part of antifungal therapy regimens. Its weekly dosing regimen offers a more convenient treatment protocol compared to the daily dosing of current treatments, potentially improving patient compliance and outcomes.
For stakeholders, this translates to a promising long-term value proposition. If rezafungin demonstrates real-world effectiveness and safety consistent with clinical trials, it could lead to a paradigm shift in the management of invasive candidiasis. This could further solidify Cidara's market position and result in increased market share and long-term revenue growth.
Examining the financial implications of the MHRA approval for Cidara Therapeutics, the immediate milestone payment of $2.8 million adds to the company's cash flow, which is vital for biotech firms that often operate at a loss due to high research and development costs. Additionally, the approval could be indicative of future royalty streams from Mundipharma's sales outside the U.S. and Japan, providing a recurring revenue source that can be reinvested into the company's pipeline or used to strengthen its financial position.
Investors should also consider the potential impact on the company's stock valuation. Regulatory approvals are typically viewed as positive catalysts and this event could lead to an uptick in investor sentiment and stock price. However, the actual impact on stock performance will depend on the market's perception of the approval's significance, competition in the antifungal market and Cidara's ability to capitalize on this new opportunity in terms of marketing and sales execution.
01/29/2024 - 04:30 PM
The UK MHRA approval follows approvals by the U.S. FDA and the European Commission Cidara is entitled to receive a milestone payment of approximately $2.8 million from Mundipharma SAN DIEGO, Jan. 29, 2024 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company developing therapies designed to save lives and improve the standard of care for patients facing serious diseases, today announced that the United Kingdom (U.K.) Medicines and Healthcare products Regulatory Agency (MHRA) has approved REZZAYO (rezafungin acetate) for the treatment of invasive candidiasis in adults.
“Today’s announcement by the MHRA expands treatment options to even more patients suffering from life-threatening invasive candidiasis infections globally,” said Taylor Sandison, M.D. M.P.H., Chief Medical Officer at Cidara. “Our team, in partnership with Mundipharma, is proud to help bring the first new treatment option in 15 years to patients with this disease.”
This approval comes after positive results from the ReSTORE Phase III clinical trial, which demonstrated statistical non-inferiority for weekly-dosed rezafungin compared to the standard of care, daily-dosed caspofungin. Rezafungin’s safety and efficacy are further supported by the STRIVE Phase II clinical trials and an extensive nonclinical development program. Rezafungin is already approved by the United States Food and Drug Administration (FDA) and European Commission (EC).
Cidara Therapeutics has partnered with Mundipharma, which has commercial rights to rezafungin outside the U.S. and Japan. The company is entitled to receive a $2.8 million milestone payment from Mundipharma for the MHRA approval.
About Cidara Therapeutics
Cidara is using its proprietary Cloudbreak® platform to develop novel drug-Fc conjugates (DFCs). These targeted immunotherapies offer the unique opportunity to create “single molecule cocktails” comprised of targeted small molecules and peptides coupled to a human antibody fragment (Fc). DFCs are designed to save lives and improve the standard of care for patients facing cancers and other serious diseases by inhibiting specific disease targets while simultaneously engaging the immune system. In addition, Cidara received FDA and EC approval for REZZAYO® (rezafungin for injection), which it has licensed to multiple partners to commercialize in the U.S. and ex-U.S. Cidara is headquartered in San Diego, California. For more information, please visit www.cidara.com.
About invasive candidiasis
Invasive candidiasis (IC) continues to be an area of significant unmet need, especially for critically ill patients in hospitals and patients with compromised immune systems. Despite a number of available treatments, the mortality rate for patients with invasive candidiasis is as high as 40% . IC is characterized as a severe, life-threatening systemic Candida infection of the bloodstream and/or deep/visceral tissues, known as candidemia and deep-seated tissue candidiasis.
About REZZAYO® (rezafungin for injection)
REZZAYO (rezafungin for injection) is a novel once-weekly echinocandin approved in the United States for the treatment of candidemia and invasive candidiasis in adults. REZZAYO is currently being studied for the prevention of invasive fungal diseases in adults undergoing allogeneic blood and marrow transplantation. The structure and properties of REZZAYO are specifically designed to improve upon a clinically validated mechanism.
INDICATIONS AND USE
REZZAYO has not been studied in patients with endocarditis, osteomyelitis, and meningitis due to Candida.
IMPORTANT SAFETY INFORMATION
REZZAYO may cause infusion-related reactions, including flushing, sensation of warmth, urticaria, nausea, or chest tightness. If these reactions occur, slow or pause the infusion.
REZZAYO may cause photosensitivity. Advise patients to use protection from sun exposure and other sources of UV radiation.
Abnormalities in liver tests have been seen in clinical trial patients treated with REZZAYO. Monitor patients who develop abnormal liver tests and evaluate patients for their risk/benefit of continuing REZZAYO therapy.
Most common adverse reactions (incidence 5% ) are hypokalemia, pyrexia, diarrhea, anemia, vomiting, nausea, hypomagnesemia, abdominal pain, constipation, and hypophosphatemia.
Please see the full Prescribing Information for REZZAYO (rezafungin for injection), available at www.rezzayo.com.
Forward-Looking Statements , and the likelihood that rezafungin will be prescribed by physicians in the UK. Such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements. These and other risks are identified under the caption “Risk Factors” in Cidara’s most recent Quarterly Report on Form 10-Q and other filings subsequently made with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. Cidara does not undertake any obligation to publicly update any forward-looking statements, whether as a result of the receipt of new information, the occurrence of future events or otherwise.
INVESTOR CONTACT: britchie@lifesciadvisors.com
MEDIA CONTACT: veames@lifescicomms.com
What is the ticker symbol for Cidara Therapeutics, Inc.?
The ticker symbol for Cidara Therapeutics, Inc. is CDTX.
What is the approval from the U.K. MHRA for?
The approval is for REZZAYO (rezafungin acetate) for the treatment of invasive candidiasis in adults.
What milestone payment is Cidara entitled to receive?
Cidara is entitled to receive a $2.8 million milestone payment from Mundipharma for the MHRA approval.
What were the results of the ReSTORE Phase III clinical trial?
The trial demonstrated statistical non-inferiority for weekly-dosed rezafungin compared to the standard of care.
Who has commercial rights to rezafungin outside the U.S. and Japan?
Mundipharma has commercial rights to rezafungin outside the U.S. and Japan in partnership with Cidara Therapeutics.
What is the safety and efficacy of rezafungin supported by?
Rezafungin's safety and efficacy are supported by the STRIVE Phase II clinical trials and an extensive nonclinical development program.
