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Karolinska Development's portfolio company PharmNovo receives approval to initiate a phase 2a trial of its drug candidate PN6047 in Spain
Globenewswire· 2025-10-09 17:24
STOCKHOLM, SWEDEN – October 9, 2025. Karolinska Development AB (Nasdaq Stockholm: KDEV) today announces that its portfolio company PharmNovo has received approval from the Spanish regulatory authorities to initiate a phase 2a clinical trial of its drug candidate, PN6047, being developed as a treatment for neuropathic pain. The trial will be conducted in the EU, but has been fully aligned with the requirements defined by the U.S. Food and Drug Administration (FDA), earlier this year. The Spanish Health Autho ...
Interim Report - January-March 2025
Globenewswire· 2025-04-30 06:00
Core Insights - Karolinska Development AB reported high developmental intensity levels in its portfolio companies during Q1 2025, with many making significant progress [1] Significant Events During Q1 - AnaCardio secured SEK 205 million in a Series A extension financing round and reported positive results from a phase 1b/2a study of AC01 for heart failure [4] - Dilafor completed regulatory meetings with the FDA and European Health Agencies for tafoxiparin, aligning on pivotal Phase 3 study designs [4] - Promimic published positive results on bacterial growth reduction on its HAnano Surface implant [4] - AnaCardio initiated dosing for the phase 2a part of the GOAL-HF1 clinical study, with results expected by year-end [4] - PharmNovo received positive feedback from the FDA regarding its drug candidate PN6047 in a pre-IND meeting [4] - Umecrine Cognition faced delays in its clinical trial for golexanolone due to production issues but reported no safety concerns [4] - Umecrine Cognition presented preclinical data on golexanolone at an international conference [4] - Viktor Drvota took over as CEO of Umecrine Cognition while remaining CEO of Karolinska Development [4] Financial Update for Q1 - The net profit/loss for Q1 was SEK -14.2 million, compared to SEK 0.2 million in Q1 2024 [4] - Earnings per share were SEK -0.05, down from SEK 0.00 in Q1 2024 [4] - Change in fair value of shares in portfolio companies was SEK -3.5 million, influenced by a downturn in Modus Therapeutics' share price [4] - Total fair value of the portfolio was SEK 1,434.2 million, a decrease of SEK 17.3 million from the previous quarter [9] - Net asset value was SEK 1,230.4 million, with a per-share value of SEK 4.6 [9] - Net sales were SEK 0.5 million, unchanged from Q1 2024 [9] - Karolinska Development invested SEK 15.5 million in portfolio companies during Q1 2025, up from SEK 12.0 million in Q1 2024 [9] - Cash and cash equivalents increased by SEK 9.0 million, totaling SEK 51.1 million by March 31, 2025 [9]