In a disappointing turn of events, Clene Inc reported on Thursday that data from its experimental therapy designed to treat amyotrophic lateral sclerosis (ALS) failed to meet the criteria set by the US Food and Drug Administration (FDA) for accelerated approval. The company, specializing in innovative neurological treatments, experienced a substantial decline in its stock value, which opened trading at a mere $0.31 on Friday following the announcement.
At the time of this publication, Clene Inc stock (CLNN) has witnessed a decline.
Clene Inc
Current Price: $0.32
Change : -0.20
Change (%): (-38.83%)
Volume: 107.9K
Source: Tomorrow Events Market Data
ALS is a rare and debilitating neurological disease that targets nerve cells in the brain and spinal cord, responsible for essential muscle movements. The progressive breakdown of these cells leads to paralysis and, ultimately, fatal consequences for affected individuals.
During a pivotal meeting to discuss the regulatory trajectory for Clene’s ALS drug, the FDA determined that initial findings from mid-stage studies did not provide sufficient support for an accelerated nod, dealing a significant blow to the company’s aspirations.
Despite this setback, Clene highlighted promising data indicating that its treatment successfully led to a reduction in levels of the neurofilament protein. This protein is widely believed to be linked to the progression of ALS. The contrasting outcome with Biogen’s ALS drug, which secured accelerated approval from the FDA in April based on reduced protein levels, adds a layer of complexity to the regulatory landscape for ALS therapies.
Clene remains resilient in its pursuit of approval, expressing its intent to furnish supplemental data for further discussions with the FDA during the first half of the upcoming year. The company, which asserts having sufficient financial resources to sustain operations until the third quarter of 2024, is yet to submit a marketing application for its ALS drug.
Notably, the Neurofilament protein, or NFL, serves as a crucial marker for nerve cell degeneration. Elevated levels of this protein are indicative of a more rapid decline in clinical function and pose a greater risk of death for ALS patients. This insight underscores the urgency in developing effective treatments for the approximately 16,000 to 32,000 individuals in the U.S. grappling with ALS, according to government data.
As Clene navigates the challenges posed by the FDA’s decision, the company remains committed to advancing its ALS therapy, offering a ray of hope to those affected by this devastating neurological disease. The unfolding developments in the first half of the next year, as supplemental data is presented and discussions with the FDA ensue, will undoubtedly shape the future trajectory ofthe pursuit of approval for its innovative ALS treatment ny Clene.
