Insmed Incorporated (NASDAQ: INSM) is having an incredibly strong time in the market this morning, and for good reason. The company released data from a Phase 3 clinical trial in which their inhaled antibiotic proved to be overwhelmingly effective in the treatment of lung disease. Of course, our partners at Trade Ideas were the first to alert us to the gains. At the moment (10:31), INSM is trading at $26.70 per share after a gain of $14.41 per share (117.25%) thus far today.
INSM Gains On Top-Line Phase 3 Data
As mentioned above, Insmed is having an incredibly strong day in the market today after releasing top-line clinical data from its Phase 3 CONVERT clinical trial. In the release, the company said that the study met its primary endpoint of culture conversion by month 6 with statistical and clinical significance.
The results show that buy adding ALIS to guideline-based therapy (GBT), evidence of NTM lung disease caused by MAC in sputum was eliminated in 29% of patients by month 6. That’s incredible, considering that only 9% of patients on GBT alone showed the same result.
Because of the strong clinical results, INSM says that it plans to pursue accelerated approval for ALIS under subpart H based on the data. The FDA had previously granted INSM breakthrough therapy designation as well as fast track status surrounding ALIS. In a statement, Will Lewis, President and CEO at INSM, had the following to offer:
“We consider these compelling top-line data to be a remarkable accomplishment in a rare disease state with no currently approved therapies… We are particularly encouraged by the consistency of these data when compared with our Phase 2 study results, and look forward to additional data as the CONVERT study continues over the next two years. We want to thank all the patients who participated in this trial around the world as well as the physicians who supported them. Treatment of this serious and potentially debilitating disease is an unmet medical need, and we expect these important data will enable us to submit for accelerated approval.”
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What We’ll Be Watching For Ahead
Moving forward, the CNA Finance team will be keeping a close eye on INSM. In particular, we’re interested in following the story surrounding ALIS through to approval. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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