CDTX only lost 2 cents today... "Biotech can be wildly under or over valued"... Ya got that right.
I wish I had more dry powdah, opportunity seems to abound.
Here's today's "bad" news:
Mundipharma and Cidara Therapeutics, Inc. (NASDAQ: CDTX) today announced that the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK has granted rezafungin Promising Innovative Medicine (PIM) designation for the treatment of invasive candidiasis. Invasive candidiasis is a severe, life-threatening systemic Candida infection of the bloodstream and/or deep/visceral tissues.
This press release features multimedia. View the full release here: businesswire.com
For the MHRA to grant a PIM designation, medicinal products must meet the following criteria:(2)
The condition should be life-threatening or seriously debilitating with a high unmet need for which there is no method of treatment, diagnosis or prevention available or where existing methods have serious limitations. The medicinal product is likely to offer major advantage over methods currently used in the UK. The potential adverse effects of the medicinal product are likely to be outweighed by the benefits, allowing for the reasonable expectation of a positive benefit risk balance.
A PIM designation is a pre-requisite for application to the UK's Early Access to Medicines Scheme (EAMS). This scheme aims to give patients with life threatening or seriously debilitating conditions such as invasive candidiasis, access to medicines that do not yet have a marketing authorisation. Mundipharma and Cidara plan to submit an EAMS application for rezafungin in Q3 2022.
Brian Sheehan, Ph.D., Chief Scientific Officer at Mundipharma, commented, "Despite currently available treatments, the mortality rate for patients with invasive candidiasis remains high, demonstrating that there is still a clear unmet need for new treatment options to address this serious disease. Rezafungin, as a next generation echinocandin, has the potential to help critically ill, vulnerable patients battling invasive Candida infections. We would like to thank the MHRA for this recognition and look forward to working closely with them to ensure that patients in the UK can benefit from rezafungin."
"This PIM designation for once-weekly rezafungin is indicative of the potential that this product may have in helping patients to fight deadly Candida infections," said Taylor Sandison, M.D., Chief Medical Officer at Cidara.
Cidara has partnered with Mundipharma who has commercial rights to rezafungin outside the U.S. and Japan.
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%.(1) 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.(3)
About Rezafungin
Rezafungin is a next-generation once-weekly echinocandin being developed for both the treatment and prevention of serious fungal infections, such as invasive candidiasis and candidemia. The structure and properties of rezafungin are specifically designed to improve upon a clinically validated mechanism intended to enhance its efficacy and safety potential for patients. Cidara has completed a Phase 3 clinical trial with rezafungin for the first-line treatment of candidemia and/or invasive candidiasis (ReSTORE trial).(4)
In this ReSTORE trial, rezafungin met the primary endpoint for the U.S. Food and Drug Administration (FDA) New Drug Application (NDA) submission of all-cause mortality at Day 30, and also met the primary endpoint for the European Medicines Agency (EMA) Marketing Authorization Application (MAA) submission of global cure at Day 14. Both results demonstrated statistical non-inferiority of rezafungin dosed once-weekly, versus caspofungin dosed once-daily, the current standard of care. Rezafungin was generally well tolerated and had a similar safety profile to caspofungin.(4)
Cidara is also currently conducting a second Phase 3 clinical trial of rezafungin for the prevention of invasive fungal disease in patients undergoing allogeneic blood and marrow transplantation (ReSPECT trial).
Rezafungin has been designated a Qualified Infectious Disease Product (QIDP) with Fast Track status by the FDA and has been granted Orphan Drug Designation for its use in the treatment of invasive candidiasis in both the U.S. and EU.(5,6)
About Cidara Therapeutics
Cidara is developing long-acting therapeutics designed to improve the standard of care for patients facing serious diseases. The Company's portfolio is comprised of new approaches aimed at transforming existing treatment and prevention paradigms, first with its lead Phase 3 antifungal candidate, rezafungin, in addition to drug-Fc conjugates (DFCs) targeting viral and oncology diseases from Cidara's proprietary Cloudbreak(R) platform. Cidara is headquartered in San Diego, California. For more information, please visit www.cidara.com.
About Mundipharma
Mundipharma is a global healthcare company with a presence across Africa, Asia Pacific, Canada, Europe, Latin America, and the Middle East.
Mundipharma is dedicated to bringing innovative treatments to patients in the areas of Pain Management, Infectious Disease and Consumer Healthcare as well as other severe and debilitating disease areas. Our guiding principles, centered around Integrity and Patient-Centricity, are at the heart of everything we do. For more information visit www.mundipharma.com.
Forward-Looking Statements
This release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, |
