Eloxx Pharmaceuticals (ELOX) finalized its planned Phase 2 EXPRESS study design for exaluren in nonsense-mutation autosomal dominant polycystic kidney disease (ADPKD). Approximately 60 adults with confirmed PKD1 or PKD2 nonsense mutations will be randomized 1:1 to exaluren or placebo for 52 weeks. The primary endpoint is annualized growth in height-adjusted total kidney volume (htTKV), measured by MRI. Eloxx expects first dosing in 3Q 2027 and topline results in 1H 2029.
FDA feedback identified a substantial, durable htTKV effect with supporting kidney-function and safety data as a potential basis for Breakthrough Therapy Designation. Expedited pathways depend on results and further FDA discussions. Exaluren received US orphan drug designation for ADPKD, adding to Europe. Eloxx appointed T.R. Srinivas as chief medical officer. Peer-reviewed preclinical data showed restoration of full-length polycystin-1 in cells carrying PKD1 nonsense mutations.
Eloxx Pharmaceuticals (Nasdaq: ELOX) appointed Geno Germano to its Board of Directors, with the appointment effective October 19, 2026.
Germano brings more than 35 years of biopharmaceutical leadership experience, including service as Group President of Pfizer's Global Innovative Pharmaceutical business. He currently serves as Chairman of Entera Bio and a director of Precision BioSciences. Eloxx is a clinical-stage biopharmaceutical company developing exaluren for rare kidney diseases.
Eloxx Pharmaceuticals (ELOX) has dosed the first two patients in the EXACT Study, a Phase 2b trial of exaluren in nonsense mutation Alport syndrome (NMAS).
The study is evaluating exaluren in patients whose Alport syndrome is driven by nonsense mutations, a group for which there is currently no FDA-approved therapy targeting the underlying genetic cause. The company expects topline data from the initial 16-week placebo-controlled portion of the study in mid‑2027, with a final readout anticipated by the end of 2027. Company leadership and external clinical experts describe this as an important step for an underserved patient population that can progress to kidney failure in early adulthood.
Eloxx Pharmaceuticals (Nasdaq: ELOX) reported second quarter 2026 results and a major strengthening of its capital position following a completed underwritten public offering with $66.0 million in gross proceeds and uplisting to the Nasdaq Capital Market. Net proceeds were approximately $58.3 million, contributing to $62.0 million in cash and cash equivalents as of June 30, 2026, which the company expects will fund operations into mid‑2028 and through data readouts for exaluren in Alport syndrome and ADPKD.
Eloxx obtained FDA clearance to proceed with a Phase 2b trial of exaluren in nonsense mutation Alport syndrome, targeted to start in the third quarter of 2026, with topline 16‑week data expected by mid‑2027. Exaluren has orphan drug designation for Alport syndrome in the US and EU, and in July 2026 the European Commission granted orphan designation for exaluren in ADPKD. A Phase 2 ADPKD trial is planned for 2027. Second quarter 2026 net loss was $4.5 million, compared with $1.9 million a year earlier, driven by higher R&D and G&A expenses as clinical and corporate activities expanded.
Eloxx Pharmaceuticals (Nasdaq:ELOX) priced a public offering totaling approximately $66.0 million, consisting of 2,975,000 common shares at $11.00 and pre-funded warrants for up to 3,025,000 shares at $10.99. The common stock is expected to begin trading on the Nasdaq Capital Market on June 9, 2026, with closing targeted for June 10, 2026, subject to customary conditions.
Eloxx Pharmaceuticals (OTC: ELOX) announced key updates from its proof-of-concept trial in nonsense mutation Alport Syndrome (NMAS) patients. New protein analyses confirmed production of collagen alpha 4 and 5 in patients treated with ELX-02, with one patient showing a 34% increase in collagen a4 immunostaining intensity and a 6-fold increase in collagen a4 levels. These results justify conducting a larger clinical trial.
Additionally, the FDA has allowed continued dosing of subjects in the Phase 1 trial of ZKN-013 for treating recessive dystrophic epidermolysis bullosa and junctional epidermolysis bullosa. Eloxx awaits confirmation from Almirall to proceed with the study.
Eloxx Pharmaceuticals has dosed the first two subjects in its Phase 1 clinical trial of ZKN-013, aimed at treating diseases caused by nonsense mutations like RDEB, JEB, and FAP. The company received favorable feedback from the FDA during a pre-IND meeting, paving the way for a Phase 2 trial of ELX-02 for Alport syndrome in the US. Additionally, Eloxx secured $3.2 million in financing to advance its clinical programs.
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