Invest-in-America
11 meses hace
CDTX: Keep an eye on it. (Important news, but maybe the EU just ain't 'TRENDING'??? Or, since the subject Disease is primarily a WOMENS affliction, therefore Planet Earth is NOT interested???)
PS: I guess of late any SOARING stock must be a MYSTERY play??? E.g., just got a De-Listing or Low-Price warning??? Or, 'There is no news, etc., from the Firm, but SOMETHING must be happening because its PRICE is suddenly SOARING & the VOLUME is way up'.
MiamiGent
2 años hace
CDTX Just added @ .95
https://stockcharts.com/h-sc/ui?s=CDTX
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AS OF 3/27/2023 12:22PM ET
Presently $0.94 -$0.22 (-18.966%)
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Deadly fungal infection sweeps across U.S.
Mar. 22, 2023 12:23 PM ETSCYNEXIS, Inc. (SCYX), PFE, CDTXGSKBy: Dulan Lokuwithana, SA News Editor 231 Comments
Candida auris, a pathogenic yeast that causes candidiasis and has acquired multiple drug resistance.
selvanegra
Update 12.23 PM EST: Adds comments from Cantor Fitzgerald
A rare and often deadly fungal species is fast spreading across the U.S., infectious-disease specialists have warned, amid concerns of potential drug resistance.
The fungus, a type of yeast called Candida auris, first detected about 15 years ago in Japan, has made a comeback in the U.S., accounting for at least 2,377 infections in 2022, up from 53 in 2016, according to the Centers for Disease Control and Prevention (CDC).
The CDC added that Candida auris cases, once mostly found in New York City and Chicago, have now been reported across at least 35 states and Washington, D.C.
The infection has a mortality rate of up to 60%, with a particular impact on older or immunologically weaker people.
Most Candida auris infections do not always lead to symptoms, but there can be severe consequences if the microbe spreads to the bloodstream, wounds, or organs. The commonest symptoms linked to Candida infection are fever and chills.
The disease transmission has so far mostly spread in healthcare facilities that provide long-term care to severely ill patients, a group of CDC researchers said in a study published in the Annals of Internal Medicine on Monday.
"Seeing the number of cases was alarming," The Wall Street Journal reported, quoting CDC epidemiologist Dr. Meghan Lyman, the study's lead author.
While common disinfectants are unlikely to combat Candida auris, deep cleaning and special disinfectants that destroy fungal spores are required to limit its transmission, said Andrej Spec, an associate professor of medicine at Washington University School of Medicine in St. Louis.
Pharmaceutical companies advancing treatments against Candida auris include Pfizer (NYSE:PFE) and SCYNEXIS (NASDAQ:SCYX).
The news has prompted Cantor Fitzgerald to reaffirm its bullish views on SCYNEXIS (SCYX) as well as Cidara Therapeutics (NASDAQ:CDTX), another biopharma focused on developing antifungal treatments.
"Both of these companies have potentially positive catalysts in the next 12 to 18 months," Cantor analyst Louise Chen wrote in a research note on Tuesday. According to Chen, a major concern is data pointing to a three-fold rise in 2021 C. auris cases resistant to antifungal echinocandins.
"The rapid rise and geographic spread of cases are concerning and emphasize the need for a new effective treatment, in our view," the analyst added.
SCYNEXIS (SCYX) shares have rallied ~18%, recording the biggest intraday rise in over four years, while Cidara (CDTX) has shed ~6% ahead of an FDA decision on its marketing application for candidiasis treatment, rezafungin on Wednesday.
tw0122
2 años hace
$1.74 News was good but naked shorting took over.
March 22, 2023 - 5:23 pm
– REZZAYO is a novel, once-weekly, next-generation echinocandin indicated for the treatment of candidemia and invasive candidiasis in adults with limited or no alternative treatment options –
– REZZAYO is the first new FDA-approved echinocandin in over a decade –
SAN DIEGO and PARSIPPANY, N.J., March 22, 2023 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (Nasdaq: CDTX) and Melinta Therapeutics, LLC today announced that the U.S. Food and Drug Administration (FDA) approved REZZAYO™ (rezafungin for injection) for the treatment of candidemia and invasive candidiasis in adults with limited or no alternative treatment options. REZZAYO is the first new treatment option approved for patients with candidemia and invasive candidiasis in over a decade.
“The FDA approval of REZZAYO represents a significant milestone for Cidara, and for patients confronted with difficult-to-treat and often deadly candidemia and invasive candidiasis,” said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. “I am extremely proud of all of the Cidara employees who collectively advanced REZZAYO from preclinical development to NDA approval and am grateful to the many patients and healthcare teams who have participated in the clinical studies.”
George Thompson, M.D., principal investigator in the ReSTORE trial and professor of clinical medicine at the University of California, Davis, School of Medicine, added, “The FDA approval of REZZAYO is tremendous news for those of us who have been hoping for a new option to treat our patients with these deadly fungal infections. Based on the totality of clinical data generated, REZZAYO has the potential to simplify the management of invasive candidiasis and enhance the continuity of echinocandin care.”
The FDA approval of once-weekly REZZAYO was based on clinical data from Cidara’s global ReSTORE Phase 3 trial and supported by the STRIVE Phase 2 clinical trial and extensive non-clinical development program. In clinical studies, REZZAYO, dosed once-weekly, met the FDA and EMA primary endpoints, demonstrating statistical non-inferiority versus caspofungin, a current once-daily standard of care. In addition, overall rates of adverse events and serious adverse events were comparable in patients receiving REZZAYO and caspofungin, while rates of adverse events leading to study drug discontinuation were also similar for REZZAYO and caspofungin. Based on Qualified Infectious Disease Product (QIDP) designation, REZZAYO was approved under Priority Review.
Christine Ann Miller, president and chief executive officer of Melinta Therapeutics, added, “We are thrilled that the FDA has approved REZZAYO, and are firmly committed to offering this innovative therapy to address unmet medical needs and simplify the treatment for patients suffering from invasive Candida infections. We intend to leverage our expansive commercial infrastructure and experience launching anti-infective drugs into acute care settings. We are working closely with Cidara and anticipate bringing REZZAYO, a differentiated once-weekly treatment to patients, this summer.”
Last year, Melinta announced that it had acquired the exclusive rights to commercialize REZZAYO in the U.S. from Cidara. Cidara retains the rights to rezafungin in Japan and has licensed the commercial rights to Melinta Therapeutics in the U.S. and Mundipharma in all other geographies. The European Medicines Agency (EMA) accepted the marketing authorization application (MAA) for rezafungin in August 2022 and it is currently under review.
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.
tw0122
2 años hace
Cidara expects to be assigned a Prescription Drug User Fee Act (PDUFA) target action date in the first quarter of 2023, if the NDA is accepted for review following application validation. The NDA submission for rezafungin was based on positive results from Cidara’s global ReSTORE Phase 3 and STRIVE Phase 2 trials. ReSTORE met the primary endpoints for both the FDA and the European Medicines Agency (EMA). Rezafungin dosed once-weekly demonstrated statistical non-inferiority versus caspofungin, the current standard of care, dosed once-daily.
“The NDA submission for rezafungin for the treatment of candidemia and invasive candidiasis is an important milestone for Cidara,” said Jeffrey Stein, Ph.D., President and Chief Executive Officer of Cidara. “If approved, rezafungin would represent an important new treatment option for patients at risk of these potentially deadly diseases. We thank our clinical investigators, the patients who participated in the global study, as well as our partner, Mundipharma, whose collaboration and insights in their licensed territory outside the U.S. and Japan was instrumental in the execution of the pivotal study for rezafungin. We believe our new partner, Melinta, with its existing U.S. commercial infrastructure and significant experience in commercializing infectious disease products, including once-weekly antibiotics, is ideally positioned to bring rezafungin to the U.S. market and patients in need.”
Under the terms of the agreement with Melinta, in exchange for granting Melinta exclusive commercialization rights to rezafungin in the U.S., Cidara will receive a $30 million upfront payment, and is eligible to receive $60 million in regulatory milestone payments and up to $370 million in commercial milestone payments, representing a total potential transaction value of $460 million, plus royalties on tiers of annual net sales of rezafungin in the U.S., subject to offset for certain expenses incurred by Melinta. Cidara will be responsible for completing the ongoing global Phase 3 ReSPECT prophylaxis study, CMC and other activities required by the FDA to obtain NDA approval of rezafungin in the treatment and prophylaxis indications in the U.S. Cidara retains the rights to rezafungin in Japan, while Mundipharma retains the commercial rights to rezafungin outside the U.S. and Japan.
"Our ability to rapidly commercialize rezafungin in the U.S. makes this partnership a win for Cidara, a win for Melinta and, most importantly, a win for patients in need,” said Christine Miller, President and CEO of Melinta. “Our deep experience commercializing infectious disease products, especially within the hospital and acute care settings, means we have not only the commercial infrastructure but a commercial team with the expertise, passion and drive needed to put rezafungin in the hands of physicians and their patients. We are excited about adding this highly differentiated once-weekly antifungal to complement our antibiotic lineup, a move that will continue to strengthen our ambition to become the recognized leader in acute care."
Dr. Stein added, “This transaction eliminates the need for Cidara to build commercial infrastructure to launch rezafungin in the U.S. The upfront proceeds and additional expected near-term payments from this partnership and our current collaborations with Mundipharma and Janssen provide multiple sources of non-dilutive capital that could support the completion of the rezafungin development program and enable us to further advance our Cloudbreak DFC platform programs. In addition, as we approach the potential approval of rezafungin in the U.S., we will prioritize streamlining our operating costs accordingly, which may further extend our cash runway. We also remain focused on identifying an appropriate partner for rezafungin in Japan. In the interim, we continue to execute on generating compelling preclinical and clinical data from our oncology and antiviral Cloudbreak programs.”
About Rezafungin
Rezafungin is a novel once-weekly echinocandin being developed for both the treatment and prevention of serious fungal infections, such as candidemia and invasive candidiasis. 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) and is 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 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.
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 vira
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