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Cidara Therapeutics Announces Divestiture of Rezafungin to Mundipharma* to Focus on Advancing the Clinical Development of Cloudbreak DFC Pipeline

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星期三, 四月 24, 2024

Melinta Therapeutics, Sale, Tavarua, Health care, IND, Disease, CDTX, Patent, Patient, CMC, Asset, Intellectual property, DFC, Therapy, SAN, Respect, Pharmaceutical industry

Mundipharma currently has commercial rights to rezafungin outside the U.S. and Japan.

Key Points:

Mundipharma currently has commercial rights to rezafungin outside the U.S. and Japan.
Mundipharma purchased the assets in consideration of its assumption of the ongoing obligation to conduct and fund the ReSPECT Phase 3 clinical trial, the costs of the rezafungin patent portfolio and CMC and regulatory obligations.
The purchased assets also include all rezafungin intellectual property rights, product data, regulatory approvals, rezafungin product and comparator inventory, specified prepaid assets and specified contracts.
*Assets and rights acquired by Napp Pharmaceutical Group Limited, a member of the international network of Mundipharma independent associated companies.

Cidara Therapeutics Reacquires Global Development and Commercial Rights to CD388 and Announces Private Placement Financing of $240 Million

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星期三, 四月 24, 2024

Doctor of Philosophy, Sale, Tavarua, Safety, Johnson & Johnson, Vaccine, CDTX, Patient, Acquisition, BVF, DFC, Therapy, SAN, Pharmaceutical industry

SAN DIEGO, April 24, 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 that it has entered into a definitive agreement with Johnson & Johnson1 to reacquire the exclusive global development and commercial rights to CD388, which is in development for the prevention of all strains of influenza A and B.

Key Points:

The proceeds from the private placement fund the upfront payment under the agreement with Johnson & Johnson and are expected to provide runway beyond topline data from CD388’s Phase 2b trial.
CD388 is a long-acting antiviral investigational drug invented and developed by Cidara that became the subject of an exclusive worldwide license and collaboration agreement established with Johnson & Johnson in April 2021.
In exchange for reacquiring the exclusive global development and commercial rights to CD388, Johnson & Johnson has received from Cidara a one-time upfront payment of $85 million and is eligible to receive potential additional development, regulatory, and commercial milestone payments.
“We have followed the development of CD388 over time with great interest,” said Dr. Tadvalkar.

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

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星期一, 四月 22, 2024

“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 Presents Promising New Data on Novel Drug-Fc Conjugate Candidates at the American Association for Cancer Research (AACR) Annual Meeting 2024

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星期五, 四月 5, 2024

CDTX, Colorectal cancer, Drug, Adenosine, Patient, SAN, Tavarua, AACR, Therapy, Cancer, Pathology, CCR5, CD73, DFC, San Diego Convention Center, Oleclumab, Escape Room, Vaccine

SAN DIEGO, April 05, 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, announced the company will deliver four poster presentations, including one late-breaking poster presentation, at this year’s American Association for Cancer Research (AACR) Annual Meeting being held April 5-10, 2024 at the San Diego Convention Center in San Diego, California. The presentations highlight data on the company’s multispecific CD73/PD-1 drug Fc-conjugate (DFC), its CCR5-targeting DFC, and CBO421, its lead oncology DFC candidate targeting CD73.

Key Points:

The presentations highlight data on the company’s multispecific CD73/PD-1 drug Fc-conjugate (DFC), its CCR5-targeting DFC, and CBO421, its lead oncology DFC candidate targeting CD73.
“Our Cloudbreak platform has quickly produced DFC candidates effective in preclinical studies across various cancers with specific disease targets.
This week, we are sharing data on our CCR5 DFC program for the first time, which has demonstrated robust efficacy as a monotherapy in mouse models of colorectal cancer.
Targeting CCR5 has the potential to improve response rates to immune checkpoint inhibitor therapies, which could have a greater impact for patients unresponsive to these current treatment options.

New Survey Results from Cloudbreak Pharma Highlight Disease Burden, Need for Non-surgical Treatment Options for Underdiagnosed and Undertreated Ocular Disease

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星期五, 四月 5, 2024

“Simple tasks like putting in contact lenses, applying makeup and using a computer or phone are made significantly more difficult, if not impossible, for those with pterygium.

Key Points:

“Simple tasks like putting in contact lenses, applying makeup and using a computer or phone are made significantly more difficult, if not impossible, for those with pterygium.
As ophthalmologists, we need to listen closely to our patients and coordinate with optometrists to fully understand the impact of pterygium.
More information about this trial is available here: Safety and Efficacy of CBT-001 Ophthalmic Solution in Patients With Pterygium .
The survey was designed with multiple-choice questions, rating questions and open-ended questions.2

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

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星期一, 二月 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.

Element to Present Data on New Products and Multi-Omics Capabilities at AGBT

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星期一, 二月 5, 2024

Never before have so many data points been available to researchers at this cost and speed.

Key Points:

Never before have so many data points been available to researchers at this cost and speed.
Cloudbreak UltraQ is the industry's first commercial Q50 kit capable of generating 100-fold higher accuracy than currently available published specifications.
Trinity is Element's on-board enrichment solution that simplifies targeted sequencing, to provide users with a new level of convenience, flexibility, and performance.
AVITI24 streamlines these studies and data collection to enable rapid recursive learning with broad applications across systems biology.

Element Announces Expanded Customer Base, New Products, and Unprecedented Capabilities on a Benchtop Sequencer

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星期二, 一月 9, 2024

Achieving the fastest growth rate since launch among its peers, Element generated revenues in excess of $25 million in 2023.

Key Points:

Achieving the fastest growth rate since launch among its peers, Element generated revenues in excess of $25 million in 2023.
Element CEO and Co-founder Molly He presented on the following updates to AVITI at JPM:
Expert mode HD – Enhanced output options.
An instrument option that allows users to generate 20 to 70 percent more reads per run from all sequencing kits.
"When we launched AVITI in 2022 we redefined what is possible on a benchtop sequencer, offering an unprecedented combination of accuracy, speed, and cost.

UpHealth Enters into Definitive Agreement for Sale of Cloudbreak Health Business to GTCR for $180 Million

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星期四, 十一月 16, 2023

Sale, IV District, Turku, NYSE, DLA Piper, Tablet, Patient, UPH, Growth, GTCR, Tavarua

DELRAY BEACH, Fla., Nov. 16, 2023 (GLOBE NEWSWIRE) -- UpHealth, Inc. (“UpHealth,” the “Company”) (NYSE: UPH), today announced that it has entered into a definitive agreement to sell its wholly-owned subsidiary Cloudbreak Health, LLC (“Cloudbreak”), best known for its Martti translation offering, to GTCR for $180 million in cash. GTCR is a leading private equity firm that partners with management leaders to identify, acquire and build market-leading companies through organic growth and strategic acquisitions.

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UpHealth Will Focus on TTC Healthcare, A Growing, Cash Flow Positive Behavioral Health Business
DELRAY BEACH, Fla., Nov. 16, 2023 (GLOBE NEWSWIRE) -- UpHealth, Inc. (“UpHealth,” the “Company”) (NYSE: UPH), today announced that it has entered into a definitive agreement to sell its wholly-owned subsidiary Cloudbreak Health, LLC (“Cloudbreak”), best known for its Martti translation offering, to GTCR for $180 million in cash.
GTCR is a leading private equity firm that partners with management leaders to identify, acquire and build market-leading companies through organic growth and strategic acquisitions.
UpHealth will utilize the proceeds from the sale for payment in full or in part of the Company’s 2026 Unsecured and 2025 Secured Notes, as well as other expenses related to the transaction.
As part of the transaction, GTCR will acquire complete equity ownership of Cloudbreak, including the aggregate Cloudbreak employee base.

GTCR to Acquire Cloudbreak Health

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星期四, 十一月 16, 2023

Health equity, NYSE, Entrepreneurship, Barings LLC, LLP, Patient satisfaction, Kirkland & Ellis, Investment, Patient, Telecommunications, Caregiver, Health, UPH, Hospital, GTCR, Tavarua

CHICAGO, Nov. 16, 2023 /PRNewswire/ -- GTCR, a leading private equity firm, announced today that it has signed a definitive agreement to acquire Cloudbreak Health, LLC ("Cloudbreak" or "the Company"), a leading provider of tech-enabled, healthcare-focused language interpretation services, in a corporate carve-out transaction from UpHealth, Inc. ("UpHealth", NYSE: UPH). Under the terms of the agreement, the purchase price is $180 million, and the transaction is expected to close in the first quarter of 2024 following the receipt of customary regulatory and stockholder approvals and closing conditions.

Key Points:

CHICAGO, Nov. 16, 2023 /PRNewswire/ -- GTCR, a leading private equity firm, announced today that it has signed a definitive agreement to acquire Cloudbreak Health, LLC ("Cloudbreak" or "the Company"), a leading provider of tech-enabled, healthcare-focused language interpretation services, in a corporate carve-out transaction from UpHealth, Inc. ("UpHealth", NYSE: UPH).
Cloudbreak serves clinicians and patients across all types of healthcare settings, including hospitals, urgent care centers, standalone clinics and medical practices and helps improve health equity across an underserved U.S. patient population.
GTCR has substantial experience in the healthcare technology segment in which Cloudbreak operates.
"We are excited to partner with Cloudbreak and its talented team to drive this market leading business forward," added Geoffrey Tresley, Principal at GTCR.