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Cidara Therapeutics, Inc. (CDTX), headquartered in San Diego, California, is a pioneering biotechnology company focused on the discovery, development, and commercialization of novel anti-infectives and immunotherapies. The company's mission is to address diseases inadequately treated by current standard of care therapies. Utilizing its proprietary Cloudbreak® platform, Cidara develops drug-Fc conjugates (DFCs) aimed at saving lives and improving patient outcomes for serious diseases such as cancer, viral infections, and autoimmune diseases.
The company's core portfolio includes:
- Rezafungin (REZZAYO™): An FDA and EC-approved treatment for invasive candidiasis, licensed to multiple partners for commercialization in the U.S. and internationally.
- CD101 IV: A potential once-weekly intravenous therapy for systemic fungal infections.
- CD101 Topical: The first topical application of the echinocandin class of anti-fungals for vulvovaginal candidiasis (VVC).
- CD388: A long-acting antiviral investigational drug for the prevention of all strains of influenza A and B, currently in Phase 2b development.
Recent achievements include significant data presentations at prestigious conferences and strategic realignments to focus on the most promising components of their pipeline. Cidara’s financial stability is reinforced by a $240 million private placement led by RA Capital Management, with participation from top-tier investors like Bain Capital Life Sciences and Biotech Value Fund (BVF).
Noteworthy partnerships include collaborations with Johnson & Johnson for CD388 and Mundipharma for the divestiture of rezafungin, which has led to substantial cost savings and allows Cidara to focus on its Cloudbreak platform. The company is also preparing for a Phase 2b clinical trial of CD388, aiming to deliver universal, season-long protection against influenza.
For more information, visit www.cidara.com.
Cidara Therapeutics (Nasdaq: CDTX) has announced the initiation of its Phase 2b NAVIGATE trial, evaluating CD388 for the prevention of seasonal influenza. The study has begun dosing the first subjects and aims to enroll 5,000 healthy unvaccinated adults across clinical sites in the US and UK.
The trial is designed as a randomized, double-blind, controlled study with three CD388 dose groups and a placebo group. Subjects will receive a single dose at the start of the flu season and be monitored for breakthrough cases. The study will compare rates of laboratory and clinically confirmed influenza between the CD388 and placebo groups.
CD388, developed using Cidara's proprietary Cloudbreak® platform, is a drug-Fc conjugate (DFC) immunotherapy. Unlike vaccines, it does not rely on an immune response, potentially offering protection regardless of immune status. The therapy has shown promise in preventing infection by both seasonal and pandemic strains of influenza A and B.
Cidara Therapeutics (Nasdaq: CDTX) has announced the appointment of four renowned infectious disease experts to its Scientific Advisory Board (SAB). The new members are Rick Bright, Ph.D., Philip Krause, M.D., Mario Barro, Ph.D., and Frederick G. Hayden, M.D., FACP. These appointments aim to strengthen Cidara's expertise in pandemic preparedness, clinical and regulatory strategy, and infectious disease research.
The new SAB members will provide guidance on the development of CD388, Cidara's drug candidate currently entering a Phase 2b trial to test a single dose for season-long protection against influenza A & B. Each expert brings extensive experience in various aspects of infectious diseases, vaccine development, and regulatory affairs, which aligns with Cidara's focus on developing drug-Fc conjugate (DFC) immunotherapies using its proprietary Cloudbreak® platform.
Cidara Therapeutics (Nasdaq: CDTX) has announced a strategic restructuring, reducing its workforce by approximately 30%. This decision aims to focus resources on the clinical development of CD388, their novel drug-Fc conjugate (DFC) candidate for influenza A and B prevention. The company plans to proceed with Phase 2b trials and potential subsequent studies for CD388 as a single-dose, universal preventative.
Cidara continues business development discussions for its oncology DFC programs, including CBO421, a CD73 inhibitor that recently received IND-clearance for a Phase 1 study. The restructuring is expected to substantially reduce capital needs and streamline operations, positioning Cidara for long-term success in its mission to develop innovative immunotherapies for serious diseases.
Cidara Therapeutics (Nasdaq: CDTX), a biotechnology company specializing in drug-Fc conjugate (DFC) immunotherapies, has announced its participation in the H.C. Wainwright 26th Annual Global Investment Conference. The company's President and CEO, Jeffrey Stein, Ph.D., will present on Monday, September 9, 2024, at 7:00 am ET.
The presentation will be available via webcast and can be accessed through a provided link. Additionally, an on-demand replay will be accessible in the investors section of Cidara's website for 90 days following the event. This conference appearance provides an opportunity for Cidara to showcase its Cloudbreak® platform and its efforts in developing innovative therapies for serious diseases.
Cidara Therapeutics (Nasdaq: CDTX) has appointed Jim Beitel as its new Chief Business Officer (CBO). This strategic move comes as Cidara focuses on advancing its Cloudbreak DFC pipeline, which offers numerous partnering and licensing opportunities. Beitel brings over 20 years of experience in life science corporate development, including strategy, business development, and commercialization.
Beitel's appointment is expected to enhance Cidara's business development efforts, particularly as the company prepares for the Phase 2b trial of CD388, its universal influenza preventative, set to begin this fall. His track record includes successful partnering activities that have generated over $4 billion in upfront payments and collaboration revenues, and contributed to raising over $1 billion in equity financings.
Cidara Therapeutics (Nasdaq: CDTX) reported its Q2 2024 financial results and provided a corporate update. Key highlights include:
1. Reacquired global rights to CD388, an influenza prevention drug candidate, from J&J.
2. Closed a $240 million private placement led by RA Capital Management.
3. Divested rezafungin to Mundipharma, estimating $128 million in cost savings.
4. Received IND clearance for CBO421.
5. Q2 revenue was $0.3 million, down from $5.1 million in Q2 2023.
6. Cash and equivalents totaled $164.4 million as of June 30, 2024.
7. Net loss for Q2 2024 was $91.2 million, compared to $13.6 million in Q2 2023.
8. Phase 2b study for CD388 set to start in fall 2024 with 5,000 subjects.
Cidara Therapeutics announced the granting of a non-qualified stock option award and restricted stock units (RSUs) to new employee Corrina Pavetto. The award consists of 10,275 shares of common stock under the 2020 Inducement Incentive Plan. The stock option's exercise price is set at $11.94, equal to the closing price on the grant date, June 28, 2024. The options vest over four years, with 25% of shares vesting after one year, followed by equal monthly installments. RSUs also vest annually over four years. The grant complies with Nasdaq Listing Rule 5635(c)(4) and aims to incentivize new employees.
Cidara Therapeutics (Nasdaq: CDTX) announced it will present preclinical data on CD388 at the ASM Microbe 2024 conference, from June 13-17, 2024, in Atlanta, Georgia. CD388 is a novel Drug-Fc Conjugate (DFC) being developed for influenza prevention, using Cidara's proprietary Cloudbreak® platform. The presentation, led by Dr. Voon Ong, will focus on comparing different allometric scaling approaches to project human pharmacokinetics (PK) of CD388. The session, titled 'AAR07 Saturday Antimicrobial Pharmacokinetics and Pharmacodynamics,' will take place on June 15, 2024, from 10:00 AM to 5:00 PM ET at the Exhibit Hall, poster board number AAR-SATURDAY-494.
Cidara Therapeutics (CDTX) announced its Q1 2024 financial results and corporate updates. The company reacquired the global rights to CD388, a universal influenza preventative, from Janssen, and sold its rezafungin program to Mundipharma, aiming to save around $128 million in costs. Cidara raised $240 million through a private placement, led by RA Capital Management. Q1 2024 revenue was $8.5 million, down from $26.1 million in Q1 2023. The company reported a net loss of $10.3 million, compared to a net income of $3.0 million in Q1 2023. R&D expenses decreased to $11.6 million, while SG&A expenses increased to $6.0 million. Cidara conducted a 1-for-20 reverse stock split in April 2024.
Cidara Therapeutics (Nasdaq: CDTX) announced it has regained compliance with Nasdaq's continued listing rules as of May 14, 2024. The company received confirmation from the Nasdaq Listing Qualifications Department. However, the Nasdaq Hearing Panel has imposed a discretionary monitor until May 14, 2025. During this period, any failure to maintain compliance will result in a delist determination letter and a subsequent hearing to address the issue.
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