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COSCIENS Biopharma Inc. (NASDAQ: CSCI) announced top-line results for its Phase 3 DETECT-trial evaluating macimorelin for diagnosing Childhood Onset Growth Hormone Deficiency (CGHD). The study did not meet its primary efficacy endpoint as defined in the protocol, despite macimorelin demonstrating its ability to stimulate growth hormone release. The trial enrolled 102 subjects aged 3 to 17 years across multiple countries.
Key findings include:
- An unexpectedly high 'optimal' growth hormone cut-off point of 25.59 ng/mL
- Potential high false positive rate from comparator tests (arginine and clonidine)
- Confirmation of macimorelin's safety in the pediatric population
The company plans further analysis of the results and discussions with health authorities to determine the next steps for macimorelin in CGHD diagnosis.
COSCIENS Biopharma Inc. (NASDAQ: CSCI) reported its Q2 2024 financial results, highlighting a net loss of $1.4 million ($0.64 per share) compared to $0.9 million ($0.47 per share) in Q2 2023. The company ended the quarter with $27.8 million in cash. Total revenue increased to $2.3 million from $1.4 million in the same period last year, driven by higher sales of Avenanthramides, Oat Beta Glucan, and Oat Oil.
Operating expenses rose to $4.5 million from $1.9 million, primarily due to increased R&D costs and administrative expenses related to the recent Aeterna-Ceapro acquisition. The company expects to announce top-line data from its DETECT-trial evaluating macimorelin for childhood-onset growth hormone deficiency diagnosis in Q3 2024.
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