Galmed Pharmaceuticals Ltd, a renowned clinical-stage biopharmaceutical company specializing in liver, metabolic, and fibrotic diseases, has encountered an unexpected delay in the commencement of its Primary Sclerosing Cholangitis (PSC) Phase 2a Study. This setback, announced today, is projected to extend the initiation timeline by at least six months.
The announcement had an immediate impact on the company’s stock performance. Galmed Pharmaceuticals experienced a notable decline, with its shares closing Monday’s trading session at $0.43. Tuesday morning saw the stock commence trading at $0.34, and it is currently listed at $0.30.
At the time of this publication, Galmed Pharmaceuticals Ltd stock (GLMD) has witnessed a decline.
Galmed Pharmaceuticals Ltd
Current Price: $0.30
Change : -0.14
Change (%): (-31.98%)
Volume: 818.6K
Source: Tomorrow Events Market Data
In a strategic move revealed in May 2023, Galmed had redirected its clinical program to assess the safety and efficacy of its lead compound, Aramchol meglumine, for the treatment of PSC. The entire effort was meticulously orchestrated to pave the way for the initiation of a proof-of-concept Phase 2a study in the final quarter of 2023. Prior to launching the Phase 2a study, Galmed Pharmaceuticals had initially planned to conclude a Phase 1 pharmacokinetic (PK) study. This PK study aimed to determine the bioavailability of the newly enhanced Aramchol meglumine formulation and subsequently submit a new Investigational New Drug (IND) application for Aramchol meglumine for PSC to the United States Food and Drug Administration (FDA).
However, unforeseen events on October 7th threw a wrench into Galmed’s meticulously laid plans. In light of these unexpected developments, Galmed acknowledges its inability to adhere to the original timelines for the Phase 1 study. The company now relies on time estimates from its US and European partners and vendors, forecasting a delay of 6-9 months in initiating the Phase 2a PSC Study.
Allen Baharaff, the CEO and President of Galmed Pharmaceuticals, addressed the situation, stating, “The brutal attack of Hamas on October 7th resulted in a disruption of our work. Notwithstanding Israel’s declaration of ‘being at war,’ over the past few weeks, we have been returning to full activity together with our local vendors and consultants. The unfortunate events result in delays that would prohibit us from meeting our original timelines. We are diligently working together with our local and international partners to mitigate the delays and will continue to update as soon as practical.”
Galmed Pharmaceuticals is now actively engaged in overcoming the challenges posed by the unexpected events, with a commitment to providing timely updates on their progress. The pharmaceutical industry, investors, and stakeholders will be closely monitoring developments as Galmed strives to navigate through this unanticipated setback.
