New Shrimadhopur DFC Station

Cidara Therapeutics Provides Corporate Update and Reports Third Quarter 2023 Financial Results

Retrieved on: 
Thursday, November 2, 2023
Research, Medicare, Influenza, Treatment, European Directive on Traditional Herbal Medicinal Products, New Drug Application, Centers for Medicare & Medicaid Services, Fungal infection, Translation, DFC, CHMP, Committee for Medicinal Products for Human Use, CDTX, European Medicines Agency, Invasive candidiasis, EMA, Safety, CD73, Therapy, Patient, European Commission, ATM, Respect, Committee, Conference, NTAP, New Shrimadhopur DFC Station, Janssen Pharmaceuticals, Tavarua, FDA, IND, EC, Senior, Johnson & Johnson, CMS, SAN, Pharmaceutical industry, Vaccine, Cryptocurrency, Security (finance), Janssen, Mundipharma, Melinta Therapeutics

Nicole is a practicing oncology physician and joins us from Genentech/Roche where she has had substantial cancer-focused product development experience.

Key Points: 
  • Nicole is a practicing oncology physician and joins us from Genentech/Roche where she has had substantial cancer-focused product development experience.
  • Presented at IDWeek 2023: In September 2023, Cidara delivered an oral presentation and two poster presentations highlighting the safety and efficacy of CD388.
  • For the nine months ended September 30, 2023 and 2022, net loss was $17.3 million and $16.4 million, respectively.
  • During the three months ended September 30, 2023, Cidara did not sell shares of common stock pursuant to its at-the-market (ATM) sales agreement.

Cidara Therapeutics Announces Janssen’s Election to Proceed Under its License Agreement Relating to Novel Drug-Fc Conjugates Targeting Influenza

Retrieved on: 
Wednesday, September 6, 2023
Pharmacokinetics, Tavarua, CDTX, Janssen Pharmaceuticals, DFC, Patient, SAN, Johnson & Johnson, New Shrimadhopur DFC Station, Therapy, Safety, Sales, Vaccine, Janssen

SAN DIEGO, Sept. 06, 2023 (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, has announced that Janssen Pharmaceuticals, Inc. (Janssen), one of the Janssen Pharmaceutical Companies of Johnson & Johnson, has delivered to Cidara its Election to Proceed Notice for CD388 (JNJ-0953) which is being developed for the universal prevention of influenza A and B. Responsibility for future development, manufacturing and commercialization activities of CD388 will be assumed by Janssen, which intends to transfer its rights and obligations under the agreement to another entity.

Key Points: 
  • “The Election to Proceed notice represents an important accomplishment for CD388, the most advanced Cloudbreak ® DFC program,” said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara.
  • “The clinical and nonclinical data for CD388 support the potential for a single dose to provide universal protection from seasonal and pandemic influenza strains A and B.
  • Cidara will receive a $7 million milestone payment from Janssen for the election to proceed for CD388 and other influenza DFCs.
  • Under the collaboration agreement, Cidara is eligible to potentially receive an additional $685 million in development, regulatory and commercial milestones, plus tiered royalties on worldwide sales.

Cidara Therapeutics Receives $11.1 Million Milestone Payment from Mundipharma

Retrieved on: 
Tuesday, October 4, 2022
Melinta Therapeutics, Securities Act of 1933, Association, Securities Exchange Act of 1934, NASDAQ, Adult, Time, Respect, QIDP, Private Securities Litigation Reform Act, Drug Quality and Security Act, U.S. Securities and Exchange Commission, Fungemia, Restore, FDA, COVID-19, CDTX, MAA, Therapy, Safety, Biotechnology, Janssen, SAN, European Medicines Agency, Security (finance), Patient, Forward-looking statement, New Shrimadhopur DFC Station, EMA, Tavarua, Marketing, GLOBE, Mycosis, Pharmaceutical industry, Mundipharma, EU

SAN DIEGO, Oct. 04, 2022 (GLOBE NEWSWIRE) --  Cidara Therapeutics, Inc. (NASDAQ: CDTX), a biotechnology company developing long-acting therapeutics designed to improve the standard of care for patients facing serious diseases, today announced receipt of an $11 million milestone payment from Mundipharma under the licensing agreement established between the two companies in September 2019. The payment was made in association with the European Medicines Agency (EMA) acceptance of the marketing authorization application (MAA) for rezafungin for the treatment of candidemia and invasive candidiasis in adult patients.

Key Points: 
  • SAN DIEGO, Oct. 04, 2022 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (NASDAQ: CDTX), a biotechnology company developing long-acting therapeutics designed to improve the standard of care for patients facing serious diseases, today announced receipt of an $11 million milestone payment from Mundipharma under the licensing agreement established between the two companies in September 2019.
  • With the $11 million milestone payment from Mundipharma, Cidara remains eligible to receive additional non-dilutive capital of up to approximately $108 million in development and regulatory milestones from our existing partnerships based on successful completion of activities planned for the next two years, said Jeffrey Stein, Ph.D., President and Chief Executive Officer of Cidara.
  • Cidara retains the rights to rezafungin in Japan and has licensed the commercial rights to Melinta Therapeutics in the U.S. and Mundipharma Medical in all other geographies.
  • Cidara is developing long-acting therapeutics designed to improve the standard of care for patients facing serious diseases.

Cidara Therapeutics and Mundipharma Announce Positive Topline Results from the Global Phase 3 Pivotal ReSTORE Trial of Rezafungin for the Treatment of Candidemia and Invasive Candidiasis

Retrieved on: 
Tuesday, December 14, 2021
Forward-looking statement, Hospital, Fluconazole, McNeil Consumer Healthcare, Aplastic anemia, FDA, NDA, QIDP, Mycosis, Restore, Physician, Securities Exchange Act of 1934, Drug Quality and Security Act, Candidiasis, Private Securities Litigation Reform Act, Transplant, COVID-19, Securities Act of 1933, Integrity, U.S. Securities and Exchange Commission, Safety, Posaconazole, Patient, Therapy, Security (finance), Pain management, Chronic myelogenous leukemia, Acute lymphoblastic leukemia, Lymphoma, Acute myeloid leukemia, New Shrimadhopur DFC Station, Webcast, Fungemia, Heart, Pharmaceutical industry, Respect, Pneumocystidomycetes, Aspergillus

SAN DIEGO and CAMBRIDGE, United Kingdom, Dec. 14, 2021 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (NASDAQ: CDTX) and Mundipharma today announced positive topline data from the pivotal ReSTORE Phase 3 clinical trial evaluating the efficacy and safety of its once-weekly antifungal candidate rezafungin as a potential first-line treatment for candidemia and invasive candidiasis.

Key Points: 
  • The trial is enrolling adults with underlying conditions including acute myeloid leukemia, acute lymphoblastic leukemia, chronic myelogenous leukemia, myelodysplastic syndrome(s), lymphoma and aplastic anemia.
  • 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).
  • Mundipharma is a global healthcare company with a presence across Africa, Asia Pacific, Canada, Europe, Latin America, and the Middle East.