Wedbush Cuts Price Target on Insmed (INSM) Following FDA Requests for Additional Tox Studies
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Price: $123.74 -2.05%
Rating Summary:
32 Buy, 1 Hold, 1 Sell
Rating Trend: = Flat
Today's Overall Ratings:
Up: 13 | Down: 14 | New: 11
Rating Summary:
32 Buy, 1 Hold, 1 Sell
Rating Trend: = Flat
Today's Overall Ratings:
Up: 13 | Down: 14 | New: 11
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Wedbush is reiterating its Outperform rating on shares of Insmed (NASDAQ: INSM) while reducing its price target from $15 to $9.
The FDA reported that it does not have enough information to assess the risks of ARIKACE in CF patients and has asked that the company conduct a 9-month inhalation toxicity study in dogs. INSM was also requested to propose a CF patient population or disease state where the risk-benefit profile is more favorable.
Also, the FDA has not gotten back with the company in regards to the clinical hold on their Phase III program in Nontuberculous mycobacteria. Management wishes to hold a meeting with the FDA following their response to discuss plans to proceed with tox studies and Phase III trials.
An analyst at Wedbush comments, "Given the potential for delay of Phase III programs, we are pushing our drug launch estimates out from 2015 to 2016 for both programs and adjusting our R&D spend for 2011 and 2012. We now assume that the FDA will require that the 9-month dog inhalation studies occur and report out prior to lifting the clinical hold for both programs."
To go inline with market trends and the company's pipeline, Wedbush is raising its 2011 and 2012 EPS estimates from ($1.62) and ($1.80) to ($1.35) and ($1.21).
For more ratings news on Insmed click here and for the rating history of Insmed click here.
Shares of Insmed closed at $4.35 yesterday.
The FDA reported that it does not have enough information to assess the risks of ARIKACE in CF patients and has asked that the company conduct a 9-month inhalation toxicity study in dogs. INSM was also requested to propose a CF patient population or disease state where the risk-benefit profile is more favorable.
Also, the FDA has not gotten back with the company in regards to the clinical hold on their Phase III program in Nontuberculous mycobacteria. Management wishes to hold a meeting with the FDA following their response to discuss plans to proceed with tox studies and Phase III trials.
An analyst at Wedbush comments, "Given the potential for delay of Phase III programs, we are pushing our drug launch estimates out from 2015 to 2016 for both programs and adjusting our R&D spend for 2011 and 2012. We now assume that the FDA will require that the 9-month dog inhalation studies occur and report out prior to lifting the clinical hold for both programs."
To go inline with market trends and the company's pipeline, Wedbush is raising its 2011 and 2012 EPS estimates from ($1.62) and ($1.80) to ($1.35) and ($1.21).
For more ratings news on Insmed click here and for the rating history of Insmed click here.
Shares of Insmed closed at $4.35 yesterday.
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