CLNN - Earnings announcements

FDA recommended biomarker analyses show statistically significant reductions in NfL and GFAP in participants treated with CNM-Au8Biomarker improvements are strongly associated with longer survival, reinforcing CNM-Au8's potential disease modifying activityCompany has requested a Type C meeting in the first quarter of 2026 to present the newly completed analyses supporting a planned NDA submission under the accelerated approval pathwayClene is hosting an investor webcast today at 8:30 am ET SALT LAKE CITY, Dec. 03, 2025 (GLOBE NEWSWIRE) -- Clene Inc. (NASDAQ:CLNN) (along with its subsidiaries, "Clene" or the "Company") and its wholly owned subsidiary Clene Nanomedicine, Inc., a late clinic

The primary endpoint of adjusted ALSFRS-R and secondary endpoints of CAFS and SVC were not met at 24 weeksPrespecified exploratory analyses of the secondary survival endpoint for the 30 mg dose demonstrated a >90% reduction in risk of death or risk of death/permanently assisted ventilation at 24 weeks Survival signal consistent with prior results from the Phase 2 RESCUE-ALS trialClene will continue the open-label extension of CNM-Au8 in the Healey ALS Platform Trial and is in discussions with the Healey & AMG ALS Center to design and offer an Expanded Access Protocol (EAP) of CNM-Au8 30mg for eligible participants of closed regimens and othersClene is pursuing multiple paths, including ongoi

SALT LAKE CITY, Sept. 30, 2022 (GLOBE NEWSWIRE) -- Clene Inc. (NASDAQ:CLNN) along with its subsidiaries "Clene" and its wholly owned subsidiary Clene Nanomedicine Inc., a clinical-stage biopharmaceutical company focused on revolutionizing the treatment of neurodegenerative disease, today announced that it will report topline results of the CNM-Au8® regimen of the HEALEY ALS Platform Trial on Monday, Oct. 3. Clene's management team will host a conference call and webcast to discuss the results. Conference Call and Webcast DetailsTime and Date: 8:30 a.m. EDT on Oct. 3, 2022Investors: 1 (888) 660-6179 (toll-free) or 1 (929) 203-1946 (toll)Conference ID: 5318408Webcast Link A live audio

CNM-Au8 met primary and secondary endpoints of Low Contrast Letter Acuity (LCLA) and modified Multiple Sclerosis Functional Composite (mMSFC) compared to placebo over 48 weeks in the mITT populationConsistent improvements favoring CNM-Au8 were seen across paraclinical biomarkers, providing physiological evidence for its potential neuroprotective and remyelinating effectsCNM-Au8 treatment was well-tolerated, and there were no significant safety findings reportedResults provide support to advance CNM-Au8 into Phase 3 clinical developmentClene to host a call and webcast at 7:30 am EDT today SALT LAKE CITY, Aug. 15, 2022 (GLOBE NEWSWIRE) -- Clene Inc. (NASDAQ:CLNN) (along with its subsidiarie

SALT LAKE CITY, Aug. 12, 2022 (GLOBE NEWSWIRE) -- Clene Inc. (NASDAQ:CLNN) along with its subsidiaries "Clene" and its wholly owned subsidiary Clene Nanomedicine, Inc., a clinical-stage biopharmaceutical company focused on revolutionizing the treatment of neurodegenerative disease, today announced that it will present results from its Phase 2 VISIONARY-MS trial at 7:30 a.m. EDT on Monday, August 15. Conference Call and Webcast Details:Presentation Time: 7:30 a.m. EDT on August 15, 2022 Investors (Toll free): 1 (888) 770-7152Conference ID: 5318408Webcast link A live audio webcast can also be accessed by visiting the Investors section of the Company's website presentations page. A replay o

RESCUE-ALS Phase 2 Trial did not meet primary MUNIX biomarker endpoint or secondary FVC endpoint at week 36; MUNIX efficacy signal was observed at week 12 (p=0.057)MUNIX trial results demonstrated protection of lower motor neurons in the pre-specified subset of limb onset ALS subjects (Wk12, p=0.0385; Wk36, p=0.0741), which represents approximately 70% of the ALS populationStatistically significant reductions in clinically relevant outcomes including ALS disease progression (p=0.0125), ALSFRS-R responder analysis (p=0.035), and improved ALS specific quality of life (p=0.018)Evidence for potential long-term survival benefit Results for Healey ALS Platform Trial Expected in the Second Half of