Cidara Therapeutics, Inc. - CDTX STOCK NEWS

Cidara Therapeutics (NASDAQ: CDTX) reported a strong Q1 2022, achieving $7.1 million in revenue, up from $2.4 million in Q1 2021, primarily due to a collaboration with Janssen Pharmaceuticals. The company advanced its product pipeline, notably initiating a Phase 1 trial of CD388, an influenza drug, and preparing to submit a New Drug Application for rezafungin in mid-2022. However, cash reserves decreased to $38 million from $62 million.

The Phase 3 ReSTORE trial of rezafungin by Cidara Therapeutics (NASDAQ: CDTX) met its primary endpoints, demonstrating non-inferiority to caspofungin for treating candidemia and invasive candidiasis. Results showed 23.7% all-cause mortality at day 30 for rezafungin against 21.3% for caspofungin. Early mycological efficacy was high, with 53.7% negative blood cultures at 24 hours for rezafungin. Tolerability profiles were similar, with no concerning treatment emergent adverse events reported. NDA submission to the FDA is anticipated in mid-2022.

Cidara Therapeutics (NASDAQ: CDTX) and Mundipharma are set to present new clinical data on rezafungin, a novel echinocandin for treating candidemia and invasive candidiasis, at the 32nd European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) from April 23-26, 2022. The data includes results from the global Phase 3 ReSTORE trial and analyses from STRIVE Phase 2 trials. Notably, there will be two late-breaking presentations, highlighting the significant advancements in this promising treatment.

Cidara Therapeutics (Nasdaq: CDTX) has initiated a Phase 1 trial for CD388, a long-acting antiviral immunotherapy aimed at universal prevention of seasonal and pandemic influenza. The trial, conducted in collaboration with Janssen Pharmaceuticals, is a randomized, double-blind study assessing the safety and pharmacokinetics of CD388 in healthy volunteers. Initial safety and pharmacokinetics data are expected in the second half of 2022. CD388 targets a conserved region on the influenza virus, presenting a novel approach to improve flu prevention, especially for high-risk patients.

Cidara Therapeutics (CDTX) reported financial results for Q4 and full year 2021, showcasing substantial progress in its development pipeline. Q4 revenue reached $7.2 million, with full-year revenue of $49.6 million, up from $12.1 million in 2020. The company plans to file a New Drug Application for rezafungin in mid-2022, following positive Phase 3 trial results. Cidara also announced FDA acceptance of an IND for its lead influenza drug, CD388. Cash reserves stood at $62.3 million as of December 31, 2021, while net loss improved to $42.5 million for the year, down from $72.1 million in 2020.

Cidara Therapeutics (NASDAQ: CDTX) and Mundipharma have announced that the UK Medicines and Healthcare Products Regulatory Agency (MHRA) has granted rezafungin Promising Innovative Medicine (PIM) designation for treating invasive candidiasis, a life-threatening systemic fungal infection. This designation indicates a high unmet medical need, as the mortality rate for invasive candidiasis can reach 40%. Both companies plan to submit an application for the Early Access to Medicines Scheme in Q3 2022, aimed at providing early access to this potential advance in treatment.

Cidara Therapeutics (NASDAQ: CDTX) has received FDA approval for its Investigational New Drug application for CD388, a long-acting antiviral immunotherapy targeting influenza. The company plans to begin a Phase 1 trial in Q1 2022, focusing on universal prevention and treatment of seasonal and pandemic flu. Cidara collaborates with Janssen Pharmaceuticals for development and commercialization, with Janssen covering Phase 1 trial costs. The DFC platform aims to improve flu vaccine efficacy. This milestone supports Cidara's efforts to address unmet needs in flu prevention, particularly for high-risk patients.

Cidara Therapeutics, Inc. (CDTX) announced the grant of stock options and restricted stock units totaling 17,000 shares to three new employees under its 2020 Inducement Incentive Plan. The options have an exercise price of $1.27 per share, equal to the stock's closing price on the grant date (December 31, 2021). The awards are intended as inducements for the new hires, in compliance with Nasdaq Listing Rule 5635(c)(4). Cidara focuses on long-acting therapeutics, including its lead Phase 3 antifungal candidate, rezafungin.

Cidara Therapeutics announced positive topline results from the ReSTORE Phase 3 trial of rezafungin, a once-weekly antifungal treatment for candidemia and invasive candidiasis. The trial met FDA's all-cause mortality endpoint at Day 30 and EMA's global cure endpoint at Day 14, demonstrating non-inferiority to the standard daily treatment, caspofungin. Rezafungin was well tolerated, showing a comparable safety profile. The company aims to file for regulatory approvals by mid-2022, highlighting the potential of this novel treatment in critical care settings.