Caspofungin

Melinta Therapeutics Announces Publication of the Outcomes by Candida Species from the ReSTORE Phase 3 trial and Recently Approved Rezafungin CLSI Breakpoints for Candida glabrata and Candida auris

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Giovedì, Maggio 23, 2024
Surgery, FDA, Hospitals, Clinical Trials, Biotechnology, Other Health, Managed Care, Health, Pharmaceutical, Patient, CLSI, Candida auris, Fungemia, Restore, Therapy, Microbiology, Safety, Candida glabrata, Melinta Therapeutics, Mortality, Echinocandin, Society, Clinical, Caspofungin, Laboratory, CDC, Pharmaceutical industry

Melinta Therapeutics, LLC today announced the peer-reviewed publication of data from the completed ReSTORE phase 3 global clinical trial evaluating REZZAYO® (rezafungin for injection) for the treatment of candidemia and invasive candidiasis (IC) in adults.

Key Points: 
  • Melinta Therapeutics, LLC today announced the peer-reviewed publication of data from the completed ReSTORE phase 3 global clinical trial evaluating REZZAYO® (rezafungin for injection) for the treatment of candidemia and invasive candidiasis (IC) in adults.
  • The data analyses in the article, “Outcomes by Candida spp.
  • in the ReSTORE Phase 3 trial of rezafungin versus caspofungin for candidemia and/or invasive candidiasis,” published in the American Society for Microbiology Antimicrobial Agents and Chemotherapy, demonstrates the efficacy of rezafungin in adult patients across a variety of Candida species.
  • Rates of global cure and mycological eradication at day 14 and all-cause mortality at day 30 were generally comparable between the two treatment groups.

Cidara Therapeutics Provides Corporate Update and Reports Fourth Quarter and Full Year 2023 Financial Results

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Lunedì, Aprile 22, 2024
CD73, Research, IND, Form, IO, AACR, Fungemia, Immunotherapy, Congress, Annual report, ESMO, Janssen, Tax, DFC, Therapy, SAN, Tavarua, Safety, Annual general meeting, SITC, Collaboration, Caspofungin, Society, Workplace, European, The San Diego Union-Tribune, CDTX, Patient, Bank statement, Pharmaceutical industry

“2023 included significant accomplishments throughout our business within both our Cloudbreak® drug-Fc conjugate (DFC) and our REZZAYO® (rezafungin) programs,” said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara.

Key Points: 
  • “2023 included significant accomplishments throughout our business within both our Cloudbreak® drug-Fc conjugate (DFC) and our REZZAYO® (rezafungin) programs,” said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara.
  • Presented at IDWeek 2023: In October 2023, Cidara presented new preclinical and clinical data on Novel Cloudbreak Influenza Drug-Fc Conjugate CD388 at IDWeek 2023.
  • Net loss for the three months ended December 31, 2023 was $3.2 million, compared to a net loss of $13.6 million for the three months ended December 31, 2022.
  • Net loss for the full year ended December 31, 2023 was $22.9 million, compared to a net loss of $33.6 million for the year ended December 31, 2022.

Cidara Therapeutics Receives $11.14 Million Milestone Payment Following European Approval of REZZAYO

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Lunedì, Febbraio 12, 2024
SAN, European Commission, Committee, CDTX, Tavarua, Caspofungin, FDA, Standard of care, Fungemia, Civil service commission, Therapy, CHMP, Patient, DFC, IND, Immune system, CD73, Pharmaceutical industry

SAN DIEGO, Feb. 12, 2024 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company using its proprietary Cloudbreak® platform to develop drug-Fc conjugate (DFC) immunotherapies designed to save lives and improve the standard of care for patients facing serious diseases, today announced receipt of an $11.14 million milestone payment from Mundipharma following the European approval of REZZAYO™ (rezafungin acetate), a novel, once-weekly echinocandin antifungal approved for the treatment of invasive candidiasis in adults.

Key Points: 
  • SAN DIEGO, Feb. 12, 2024 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company using its proprietary Cloudbreak® platform to develop drug-Fc conjugate (DFC) immunotherapies designed to save lives and improve the standard of care for patients facing serious diseases, today announced receipt of an $11.14 million milestone payment from Mundipharma following the European approval of REZZAYO™ (rezafungin acetate), a novel, once-weekly echinocandin antifungal approved for the treatment of invasive candidiasis in adults.
  • The drug was previously approved by the United States Food and Drug Administration (FDA) for the treatment of candidemia and invasive candidiasis in patients with limited or no treatment options.
  • “The European approval of REZZAYO marks a significant milestone for patients who are in need of new treatment options for invasive candidiasis, and we look forward to seeing Mundipharma bring it to the EU market,” said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara.
  • Its lead oncology DFC, CBO421, is a potential best-in-class inhibitor of CD73, a validated target highly expressed on tumor cells.

Napp announces authorisation of REZZAYO® (rezafungin) in Great Britain by the UK Medicines and Healthcare Products Regulatory Agency for the treatment of invasive candidiasis in adults1

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Venerdì, Febbraio 2, 2024
Biotechnology, Infectious Diseases, Health, Pharmaceutical, Clinical Trials, Multimedia, Hypokalemia, Tremor, Mortality, Mycology, Immunodeficiency, Hospice and palliative medicine, Nausea, MHRA, Immune system, UV, Candidiasis, Anemia, Caspofungin, Disease, Wheeze, Patient, Safety, DRC, Abdominal pain, Flushing, Diagnosis, Erythema, Hyponatremia, Rash, Sensation, Royal College of Pathologists, Radiation, Hypotension, Constipation, Risk, Vomiting, Restore, Medication, Phototoxicity, Infection, Medicine, Common, ODD, Diarrhea, Mitt, Pharmaceutical industry

Napp Pharmaceuticals Limited, a member of the international network of Mundipharma independent associated companies, today announced that the Medicines and Healthcare Products Regulatory Agency (MHRA) has authorised rezafungin for the treatment of invasive candidiasis in adults in Great Britain (GB).1,2

Key Points: 
  • Napp Pharmaceuticals Limited, a member of the international network of Mundipharma independent associated companies, today announced that the Medicines and Healthcare Products Regulatory Agency (MHRA) has authorised rezafungin for the treatment of invasive candidiasis in adults in Great Britain (GB).1,2
    This press release features multimedia.
  • Common adverse reactions include anaemia, hypomagnesaemia, hypophosphataemia, hypotension, wheezing, vomiting, nausea, abdominal pain, constipation, erythema, and rash.
  • Increased blood alkaline phosphatase, hepatic enzymes, alanine aminotransferase, aspartate aminotransferase and blood bilirubin were also common.
  • Transient infusion-related reactions have occurred with rezafungin, characterised by flushing, sensation of warmth, nausea, and chest tightness.2
    Rezafungin may cause increased risk of phototoxicity.

Cidara Therapeutics Announces Approval of REZZAYO by the MHRA for the Treatment of Invasive Candidiasis in Adults

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Lunedì, Gennaio 29, 2024
Patient, MHRA, Therapy, Medication, Health care, Biotechnology, Partnership, Standard of care, Civil service commission, European Commission, CDTX, FDA, Caspofungin, Pharmaceutical industry

“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.

Key Points: 
  • “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.
  • Rezafungin’s safety and efficacy are further supported by the STRIVE Phase II clinical trials and an extensive nonclinical development program.
  • 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.

Human medicines European public assessment report (EPAR): Mycamine, micafungin, Date of authorisation: 25/04/2008, Revision: 18, Status: Authorised

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Martedì, Gennaio 9, 2024
Fungal infection, Liver, Marketing, Chills, INN, Risk, Leukopenia, Hypotension, Fungus, Hypertension, Nausea, DNA, Inflammation, Liver disease, Anatomy, IIA, CHMP, Diarrhea, Fever, Infection, ATC, Hepatomegaly, European, Neutrophil, Neoplasm, HIV, Tachycardia, Anemia, Hypocalcemia, Hypokalemia, Patient, Medical Subject Headings, Caspofungin, European Commission, Echinocandin, Kidney failure, International, Bilirubin, Neutropenia, Blood, Language, Thrombocytopenia, Magnesium, Select, Medicine, Vomiting, Phlebitis, Amphotericin B, Allergy, Fluconazole, Headache, Rat, Haematopoiesis, Committee, Checklist, Alkaline phosphatase, Rash, Medical device

Human medicines European public assessment report (EPAR): Mycamine, micafungin, Date of authorisation: 25/04/2008, Revision: 18, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Mycamine, micafungin, Date of authorisation: 25/04/2008, Revision: 18, Status: Authorised

Cidara Therapeutics Announces European Approval of REZZAYO® (rezafungin) for the Treatment of Invasive Candidiasis in Adults

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Venerdì, Dicembre 22, 2023
Phase, European Commission, Caspofungin, Medical Mycology, Immune system, EMA, Candidiasis, Disease, Mortality, European, SAN, Civil service commission, CDTX, Therapy, European Medicines Agency, Committee, Patient, Collaboration, Mycology, CHMP, Pharmaceutical industry

REZZAYO represents the first new treatment option in over 15 years for patients with invasive candidiasis.

Key Points: 
  • REZZAYO represents the first new treatment option in over 15 years for patients with invasive candidiasis.
  • Cidara is entitled to receive a milestone payment of approximately $11.14 million from Mundipharma for the European Medicines Agency (EMA) approval.
  • SAN DIEGO, Dec. 22, 2023 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (Nasdaq: CDTX) today announced REZZAYO (rezafungin acetate) has been approved in the European Union (EU) for the treatment of invasive candidiasis in adults.
  • Cidara Therapeutics has partnered with Mundipharma, which has commercial rights to rezafungin outside the U.S. and Japan.

Cidara Therapeutics Announces Completion of Enrollment in Phase 3 Restore Trial of Rezafungin in China

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Mercoledì, Dicembre 6, 2023
Food, Caspofungin, Biotechnology, Melinta Therapeutics, EMA, Burn, European, SAN, Therapy, CDTX, European Medicines Agency, MPH, Patient, Safety, Food and Drug Administration, Fungemia, CHMP, Pharmaceutical industry

SAN DIEGO, Dec. 06, 2023 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology developing therapies designed to save lives and improve the standard of care for patients facing serious diseases, today announced the company, along with Mundipharma, has completed enrollment in the Phase 3 ReSTORE trial in China evaluating the efficacy and safety of rezafungin as a treatment for candidemia and invasive candidiasis.

Key Points: 
  • The portion of the trial conducted in China included 52 patients diagnosed with candidemia and/or invasive candidiasis.
  • ReSTORE ( NCT03667690 ) is a global, randomized, double-blind, controlled Phase 3 pivotal clinical trial evaluating the efficacy and safety of once-weekly intravenous dosing of rezafungin compared to once-daily dosing of caspofungin, the current standard of care, to treat patients with candidemia and/or invasive candidiasis.
  • “The completion of this trial enrollment marks a significant step in our efforts to bring an important treatment option to patients living with difficult to treat candidemia and invasive candidiasis,” said Taylor Sandison, M.D., MPH, chief medical officer of Cidara.
  • Melinta Therapeutics has the exclusive commercialization rights to REZZAYOTM (rezafungin for injection) in the U.S. and Mundipharma has the commercialization rights to rezafungin in all geographies other than the U.S. and Japan.

Mundipharma announces European approval of REZZAYO® (rezafungin) for the treatment of Invasive Candidiasis in adults

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Venerdì, Dicembre 22, 2023
Health, Infectious Diseases, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Phase, European Commission, Caspofungin, Medical Mycology, Immune system, Medicine, Disease, Mortality, European, Civil service commission, Candidiasis, Committee, Patient, Mycology, Infection, CHMP

Mundipharma today announced rezafungin (rezafungin acetate) has been approved in the European Union (EU) for the treatment of invasive candidiasis in adults.

Key Points: 
  • Mundipharma today announced rezafungin (rezafungin acetate) has been approved in the European Union (EU) for the treatment of invasive candidiasis in adults.
  • Today’s announcement by the European Commission marks an important moment that could enable the healthcare professional community to manage invasive candidiasis patients in a different way using a new treatment option.”
    “The European approval is a culmination of years of developing an additional treatment option for invasive candidiasis patients and underscores our commitment to supporting management of infectious diseases,” said Yuri Martina, Chief Development and Medical Officer at Mundipharma.
  • *To meet the pre-specified limit of non-inferiority, the upper (for all-cause mortality) and lower (for global cure) 95% confidence limits for the difference between arms must be within 20%.
  • Both endpoints met the pre-specified 20% limit, establishing non-inferiority.1

Melinta Therapeutics & Cidara Therapeutics Announce Publication of Pooled Data from Phase 3 Pivotal ReSTORE Trial & Phase 2 STRIVE Trial of REZZAYO® (rezafungin for injection) for the Treatment of Candidemia & Invasive Candidiasis in The Lancet ID

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Martedì, Dicembre 5, 2023
Other Health, Research, Managed Care, Pharmaceutical, Hospitals, Clinical Trials, Science, Surgery, Biotechnology, FDA, Other Science, Health, CDTX, Lancet, NDA, Priority review, Disease, Safety, Food, Melinta Therapeutics, European Medicines Agency, Therapy, NTAP, Injection, Randomized controlled trial, QIDP, The Lancet, MAA, Mortality, Restore, EMA, Patient, Caspofungin, CHMP, Marketing, Advanced Therapy Medicinal Product, New Drug Application, CMS, MPH, Medicare, Hospital, Pharmaceutical industry, MD, Fungemia

These findings are of clinical importance given the ongoing morbidity and mortality caused by candidemia and invasive candidiasis.

Key Points: 
  • These findings are of clinical importance given the ongoing morbidity and mortality caused by candidemia and invasive candidiasis.
  • On March 22, 2023, the FDA approved REZZAYO 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 fifteen years.
  • In October, the EMA Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for rezafungin (rezafungin acetate) for the treatment of invasive candidiasis in adults.