Insmed Incorporated (NASDAQ:INSM), a global biopharmaceutical company focused on the unmet needs of patients with rare diseases, today announced that it has withdrawn its Marketing Authorization Application (MAA) from the European Medicines Agency (EMA) for ARIKAYCE™ for the treatment of nontuberculous mycobacteria (NTM) lung disease.
The MAA filing was based on data from the company’s completed phase 2 study. During the May 2016 Committee for Medicinal Products for Human Use (CHMP) meeting, the CHMP indicated that the phase 2 study did not provide a sufficient amount of evidence to support an approval. Insmed intends to resubmit its MAA when clinical data from its ongoing global phase 3 study are available.
“We remain on track to complete patient enrollment later this year in our landmark global phase 3 CONVERT study,” said Will Lewis, president and chief executive officer ofInsmed. “ARIKAYCE has the potential to make a significant difference to patients whose NTM lung disease persists despite long-term courses of multi-drug regimens. We are committed to achieving our ultimate goal of making ARIKAYCE available to patients in the US, Europe, and Asia who are living with the devastating effects of this disease.”
The company will continue to support numerous compassionate use programs in Europe for certain patients whose physicians believe they may benefit from ARIKAYCE but are unable to participate in the clinical study. Compassionate use programs are generally intended to make products available on a named-patient basis before they are approved or commercially available in accordance with local regulations. The company is currently supporting the compassionate use of ARIKAYCE in France, Germany, and the Netherlands. The company also expects to support a compassionate use program in Italy. (Original Source)
Shares of Insmed are falling over 18% to $9.80 in after-market trading. INSM has a 1-year high of $28.66 and a 1-year low of $10.39. The stock’s 50-day moving average is $11.96 and its 200-day moving average is $13.65.
On the ratings front, Cowen analyst Ritu Baral reiterated a Buy rating on INSM, with a price target of $25, in a report issued on May 8. The current price target implies an upside of 108.2% from current levels. According to TipRanks.com, Baral has a yearly average return of 7.7%, a 48% success rate, and is ranked #318 out of 3903 analysts.
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. The company is focused 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.