It’s a very rewarding trading day for investors in Insmed Incorporated (NASDAQ:INSM) with shares up 130%, making the stock Wall Street’s bull of the day. The reason? The drug maker just reported positive top-line data from Phase 3 CONVERT Study of amikacin liposome inhalation suspension (ALIS) in treatment-refractory NTM lung disease caused by mycobacterium avium complex (MAC).
Specifically, the study met its primary endpoint of culture conversion by Month 6 with statistical and clinical significance. The study demonstrated that the addition of ALIS to guideline-based therapy (GBT) eliminated evidence of NTM lung disease caused by MAC in sputum by Month 6 in 29% of patients, compared to 9% of patients on GBT alone (p <0.0001).
Insmed CEO commented, “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.”
Insmed Chief Medical Officer Paul Streck added, “Today marks an important advance in our quest to bring a safe and effective treatment to patients who suffer from NTM lung disease caused by MAC. This represents the first ever global Phase 3 controlled study in patients with NTM, a rare, progressive and destructive infection that is associated with irreversible lung damage and increased rates of mortality […] The current guideline-based therapy to which we were compared in this study is not approved for the treatment of this disease, but is generally regarded as the best available option for these patients. Our drug candidate, ALIS, delivers high levels of an aminoglycoside directly to the lung macrophages and pulmonary tissue where the infection resides, and we believe this accounts for the significant impact on conversion that the drug demonstrated in these trial results.”
David Griffith, Principal Investigator in the CONVERT study, stated, “I am extremely pleased with and impressed by the culture conversion results that ALIS demonstrated in treatment-refractory patients with NTM lung disease caused by MAC. The eradication of MAC is the first and most important goal for treatment of patients with MAC lung disease […] I am not only encouraged by the higher conversion rate, but also by the faster time to conversion and safety profile of patients in the ALIS arm of the study. Although it is not a parameter routinely used in clinical practice, I also find it encouraging that patients who achieved culture conversion showed improvement in 6-minute walk distance, a quality of life parameter, as was seen in a prior ALIS study.”
On the ratings front, Insmed has been the subject of a number of recent research reports. In a report issued on August 16, Evercore ISI analyst Josh Schimmer initiated coverage with a Buy rating on INSM and a price target of $28, which represents a potential upside of 128% from where the stock is currently trading. Separately, on August 3, Cowen’s Ritu Baral reiterated a Buy rating on the stock.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Josh Schimmer and Ritu Baral have a yearly average return of 10.0% and 19.9% respectively. Schimmer has a success rate of 92% and is ranked #1617 out of 4642 analysts, while Baral has a success rate of 55% and is ranked #81.
Overall, 5 research analysts have given a Buy rating to the stock. When considering if perhaps the stock is under or overvalued, the average price target is $28.25 which is 129.9% above where the stock closed on Friday.
Insmed, Inc. operates as a biopharmaceutical company focused on developing and commercializing inhaled therapies for patients battling serious lung diseases that are often life threatening. It focuses on the development and commercialization of ARIKAYCE or liposomal amikacin for inhalation (LAI), for at least two identified orphan patient populations: patients with nontuberculous mycobacteria lung disease and cystic fibrosis patients with Pseudomonas aeruginosa lung infections.