Medical Mycology

SCYNEXIS Reports Full Year 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Thursday, March 28, 2024
Antimalarial medication, Research, FURI, Congress, Conference, Biotechnology, TIMM, Aspergillosis, GSK, Sale, Mucorales, LAMB, National Institutes of Health, NIH, Trial of the century, IND, AAAM, Investment, Data analysis, Medical Mycology, Pharmaceutical industry

“SCY-247 continues to demonstrate highly encouraging preclinical results, with potent activity against a broad range of fungal pathogens, including mucormycosis.

Key Points: 
  • “SCY-247 continues to demonstrate highly encouraging preclinical results, with potent activity against a broad range of fungal pathogens, including mucormycosis.
  • In March 2023, SCYNEXIS and GSK entered into an exclusive license agreement for the development, manufacturing and commercialization of ibrexafungerp (BREXAFEMME).
  • Presented preclinical data on SCY-247 at the 11th Congress on Trends in Medical Mycology (TIMM) held in Athens, Greece October 20-23, 2023.
  • Cash, cash equivalents and investments totaled $98.0 million on December 31, 2023, compared to $73.5 million on December 31, 2022.

BIOHM Health Inc. Partners with Virginia Tech to Accelerate Bacterial and Fungal Microbiome-Based Product Development and Commercialization through A.I.

Retrieved on: 
Thursday, March 7, 2024
Senior, Research, Intelligence, Dietary supplement, Health, Medical Mycology, Mycology, Dysbiosis, Data, Bacteria, Biomarker, Metadata, Case Western Reserve University, Longevity, Machine learning, Publication, A.I, Partnership

BIOHM's dataset, one of the largest in the world, combines bacterial and fungal genetic sequencing with over 50 metadata points.

Key Points: 
  • BIOHM's dataset, one of the largest in the world, combines bacterial and fungal genetic sequencing with over 50 metadata points.
  • This collaboration marks a significant step forward in the development and commercialization of condition specific dietary supplements based on a more complete understanding of the microbiome.
  • BIOHM Health Inc. is renowned for its groundbreaking work in microbiome research, leveraging its dataset to develop the next generation of targeted microbiome-based products.
  • The partnership between BIOHM Health Inc. and Virginia Tech represents a collaborative effort to push the boundaries of microbiome research and product development.

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

Retrieved on: 
Friday, December 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.

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

Retrieved on: 
Friday, December 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

SCYNEXIS Reports Third Quarter 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Monday, November 13, 2023
NDA, Security (finance), IND, Investment, Risk, GSK plc, Tablet, Biotechnology, Hansoh Pharmaceutical, Mucorales, VVC, Research, Data analysis, Medical Mycology, Antimalarial medication, FDA, FURI, GSK, Candidiasis, NIH, TIMM, Phase, Congress, Candida auris, Cryptocurrency, Pharmaceutical industry, Beauty salon

Under the agreement, SCYNEXIS has received the $90 million upfront payment as well as the first development milestone of $25 million.

Key Points: 
  • Under the agreement, SCYNEXIS has received the $90 million upfront payment as well as the first development milestone of $25 million.
  • SCYNEXIS became aware that a non-antibacterial beta-lactam drug substance was manufactured using equipment common to the manufacturing process for ibrexafungerp.
  • Cash, cash equivalents and investments totaled $105.2 million on September 30, 2023, compared to $73.5 million on December 31, 2022.
  • Based upon the company’s current operating plan, SCYNEXIS believes that its existing cash, cash equivalents and investments provides a cash runway beyond two years.

FDA Approves Expanded Use of CRESEMBA® (isavuconazonium sulfate) in Children with Invasive Aspergillosis and Invasive Mucormycosis

Retrieved on: 
Friday, December 8, 2023
Disease, Capsule, Immunodeficiency, Single-use medical devices, Safety, Food, Risk, Patient, Medical Mycology, FDA, Trial of the century, Pharmacokinetics, Azole, COVID-19, Bone marrow, TIMM, Pharmaceutical industry, IM, Astellas Pharma

NORTHBROOK, Ill., Dec. 8, 2023 /PRNewswire/ -- Astellas Pharma US, Inc. (President: Mark Reisenauer, "Astellas") today announced that the U.S. Food and Drug Administration (FDA) has approved CRESEMBA® (isavuconazonium sulfate), an azole antifungal drug, for the treatment of invasive aspergillosis (IA) and invasive mucormycosis (IM) in pediatric patients. CRESEMBA for injection is approved for adults and now for pediatric patients 1 year of age and older. CRESEMBA capsules are approved for adults and now for pediatric patients 6 years of age and older who weigh 16 kilograms (kg) and greater. With this approval, CRESEMBA is now the only azole antifungal therapy approved for the treatment of IA and IM in patients as young as one.

Key Points: 
  • CRESEMBA for injection is approved for adults and now for pediatric patients 1 year of age and older.
  • CRESEMBA capsules are approved for adults and now for pediatric patients 6 years of age and older who weigh 16 kilograms (kg) and greater.
  • With this approval, CRESEMBA is now the only azole antifungal therapy approved for the treatment of IA and IM in patients as young as one.
  • "IA, currently the most common invasive mold infection in these patients, and IM are associated with significant morbidity and high fatality rates.

SCYNEXIS Presents New Preclinical Data on Second Generation Fungerp SCY-247 at the 11th Congress on Trends in Medical Mycology (TIMM)

Retrieved on: 
Tuesday, October 24, 2023
Yeast, TIMM, European Confederation, IV, Antimalarial medication, Auris, Candida albicans, Biotechnology, Congress, Professor, ECMM, Mouse, Candida auris, University of Graz, University, Medical Mycology, Fungal infection, Patient, Associate, Mycology, Pharmaceutical industry

JERSEY CITY, N.J., Oct. 24, 2023 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, today announced the presentation of preclinical data on its second generation fungerp candidate, SCY-247, against a broad panel of fungal pathogens.

Key Points: 
  • JERSEY CITY, N.J., Oct. 24, 2023 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, today announced the presentation of preclinical data on its second generation fungerp candidate, SCY-247, against a broad panel of fungal pathogens.
  • “We are excited to see the progress in the development of this novel compound from the fungerp family,” said Dr. Martin Hoenigl, FECMM, Associate Professor of Translational Mycology at University of Graz, Austria and president of the European Confederation of Medical Mycology (ECMM).
  • Results illustrated the potent and broad-spectrum in vitro activity of SCY-247, including against a large array of yeasts, molds and dimorphic fungi.
  • Results also demonstrated SCY-247’s extensive tissue distribution in mice, including brain penetration.

F2G and Shionogi Present Full Data Set from Pivotal Phase 2b Study at Trends in Medical Mycology (TIMM) 2023 Demonstrating Positive Therapeutic Responses in Patients with Invasive Fungal Infections Treated with Oral Olorofim

Retrieved on: 
Saturday, October 21, 2023
Standard of care, TIMM, Immunodeficiency, Congress, MD, EORTC, Doctor of Philosophy, Fungus, Research, Coccidioidomycosis, DRC, Shionogi, UZ Leuven, Hematology, OASIS, Scopulariopsis, World Health Organization, Risk, Antifungal, Medical Mycology, ACM, Fungal infection, Goodyear F2G Corsair, Patient, Infection, Birth control, Pharmaceutical industry, Coccidioides, F2G

These findings were submitted as a late breaking abstract and exceptionally accepted for an oral presentation during the 11th Congress on Trends in Medical Mycology (TIMM) 2023 held in Athens, Greece, from 20-23 October 2023.

Key Points: 
  • These findings were submitted as a late breaking abstract and exceptionally accepted for an oral presentation during the 11th Congress on Trends in Medical Mycology (TIMM) 2023 held in Athens, Greece, from 20-23 October 2023.
  • F2G and Shionogi & Co., Ltd. are collaborating to develop and commercialise olorofim, bringing the novel antifungal therapy to patients with invasive fungal infections.
  • F2G has commercial responsibility for olorofim in North America, and Shionogi has commercial responsibility for olorofim in Europe and Asia Pacific.
  • F2G and Shionogi are currently enrolling patients with invasive aspergillosis in a global Phase 3 study (OASIS) to compare treatment with olorofim versus AmBisome® followed by standard of care ( NCT05101187 ).

SCYNEXIS to Present Preclinical Data on Second Generation Fungerp SCY-247 at the 11th Congress on Trends in Medical Mycology (TIMM) October 20-23 in Athens, Greece

Retrieved on: 
Monday, October 16, 2023
Congress, Medical Mycology, Antimalarial medication, TIMM, EEST, Biotechnology, EDT, Pharmaceutical industry, Aspergillus

JERSEY CITY, N.J., Oct. 16, 2023 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, today announced the presentation of preclinical data on its second generation fungerp candidate SCY-247 against a broad panel of fungal pathogens, including echinocandin-resistant Candida and Aspergillus, in an oral presentation at the 11th Congress on Trends in Medical Mycology (TIMM) being held in Athens Greece, October 20-23, 2023.

Key Points: 
  • JERSEY CITY, N.J., Oct. 16, 2023 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, today announced the presentation of preclinical data on its second generation fungerp candidate SCY-247 against a broad panel of fungal pathogens, including echinocandin-resistant Candida and Aspergillus, in an oral presentation at the 11th Congress on Trends in Medical Mycology (TIMM) being held in Athens Greece, October 20-23, 2023.
  • Title: SCY-247, a Second-generation IV/Oral Triterpenoid Antifungal: In Vitro Activity Against Broad-spectrum of Fungal Pathogens, and Dose-Dependent Tissue Distribution In Vivo
    Time: 3:35 p.m EEST / 8:35 a.m. EDT

Cidara Therapeutics and Mundipharma receive positive CHMP opinion for rezafungin for the treatment of Invasive Candidiasis in adults(1)

Retrieved on: 
Friday, October 13, 2023
European, Infection, Restore, Committee for Medicinal Products for Human Use, CHMP, Fungal infection, European Medicines Agency, DFC, CDTX, Mortality, European Commission, Tavarua, Safety, Disease, EMA, Medical Mycology, FDA, Therapy, Phase, EC, Mycology, Committee, Immune system, SAN, News, Candidiasis, Civil service commission, Caspofungin, Patient, Medical device, Pharmaceutical industry, Vaccine, Mundipharma

A new treatment option for these serious infections is a much-needed addition.”

Key Points: 
  • A new treatment option for these serious infections is a much-needed addition.”
    “We would like to thank the CHMP for their careful consideration of the use of rezafungin.
  • This positive opinion represents an important step on the journey towards approval and brings us closer to providing clinicians with an alternative treatment option for invasive Candida infections, giving hope to patients battling this infection and their families,” said Brian Sheehan, Ph.D., Chief Scientific Officer at Mundipharma.
  • The CHMP’s positive opinion on rezafungin for the treatment of serious fungal infections, such as invasive candidiasis in adults, will be referred to the European Commission (EC), which will deliver a final decision in approximately two months.
  • Cidara Therapeutics has partnered with Mundipharma, which has commercial rights to rezafungin outside the U.S. and Japan.