A failed study is a failed study, regardless of the spin applied. You can't argue the statistical significance of a secondary endpoint when the primary endpoint doesn't work, especially when that endpoint was designed to make the drug look better. There is no way FDA will approve Arikayce without Insmed conducting another study using culture conversion as the primary endpoint, especially since the antibiotic yielded questionable data in a previous study involving cystic fibrosis patients.
we are therefore modifying our model to incorporate a subsequent Phase III study with our new launch timing pegged at mid:18 vs. our previous early:16 estimate. With the changes to our
model (including a future financing), and revised 2018 valuation year, our price target goes to $7 from $18," said Wade.
Insmed's “Underperform” Rating Reaffirmed at Wedbush ...
Wedbush Downgrades Insmed (INSM) to Underperform, PT Slashed to $7
Wedbush downgraded Insmed (NASDAQ: INSM) from Outperform to Underperform with a price target of $7.00 (from $18.00). Analyst Gregory R. Wade adjusted his model to reflect the timing associated with a U.S. Phase III for NTM approval.
"At $19 per share, we believe INSM’s stock has significant expectations baked in for an FDA-approvable result from the Phase II Nontuberculous Mycobacteria (NTM) lung infection study. Our review of the study design suggests to us that there will
be insufficient data for the FDA to approve in this setting, and we are therefore modifying our model to incorporate a subsequent Phase III study with our new launch timing pegged at mid:18 vs. our previous early:16 estimate. With the changes to our
model (including a future financing), and revised 2018 valuation
The Company plans to incorporate these results into discussions with the regulatory agencies in the United States and Europe to determine next steps for ARIKAYCE.
Insmed Incorporated today reported results from the Company's phase 2 clinical trial of ARIKAYCE^TM, or liposomal amikacin for inhalation, for the treatment of patients with treatment resistant
nontuberculous mycobacterial (NTM) lung infections. The randomized, double-blind, placebo-controlled phase 2 clinical trial compared ARIKAYCE (590 mg delivered once daily), added to standard of care treatment, versus standard of care treatment
plus placebo, in 90 adult patients with treatment resistant NTM lung disease. Eligibility for the study required patients to have been on the American Thoracic Society/Infectious Disease Society of America (ATS/IDSA) guideline therapy for at least
six months prior to screening and to continue to have persistently positive mycobacterial cultures.
The primary efficacy endpoint of the study was a semi-quantitative measurement of the change in mycobacterial density on a seven-point scale from baseline (day one) to the end of the randomized portion of the trial (day 84). ARIKAYCE did not meet the pre-specified level for statistical significance
Piper says they "talked to the co " about approvals...last time -it was they will release data for an approval ( masked as CF EU) when they upped it to $45, in other words they are basing it on nothing unless you believe the company would divulge ongoing FDA discussion with an analyst. This was for traders or a position. We need liquidity ! Michael! when will we get it? When the co has to raise money for another trial? - )