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INSM

Insmed

$24.38

(0.00%)

17:33
08/07/18
08/07
17:33
08/07/18
17:33

FDA advisory committee votes in favor of Insmed's ALIS for lung disease patients

Insmed Incorporated announced that the U.S. Food and Drug Administration's Antimicrobial Drugs Advisory Committee voted 12 to 2 in favor of the safety and effectiveness of ALIS, or amikacin liposome inhalation suspension, for adults with nontuberculous mycobacterial lung disease caused by Mycobacterium avium complex who have limited or no treatment options. The committee also voted in favor of the surrogate endpoint of sputum culture conversion used in the Phase 3 CONVERT study being reasonably likely to predict clinical benefit. If approved, ALIS will be the first and only therapy in the U.S. specifically indicated for the treatment of patients with NTM lung disease caused by MAC. The advisory committee's recommendation was based on briefing materials developed from Insmed's new drug application for ALIS, which was submitted under accelerated approval provisions and includes data from the Phase 3 CONVERT study. The study met its primary endpoint of culture conversion by Month 6 with statistical significance for once-daily ALIS when added to guideline-based therapy compared with GBT alone in patients with refractory NTM lung disease due to MAC. In a separate vote, the committee voted against the safety and effectiveness of ALIS in the broadest population of adult patients with NTM lung disease caused by MAC.

  • 07

    Aug

  • 28

    Sep

INSM Insmed
$24.38

(0.00%)

07/23/18
GSCO
07/23/18
INITIATION
Target $32
GSCO
Neutral
Insmed initiated with a Neutral at Goldman Sachs
Goldman Sachs analyst Dana Flanders started Insmed with a Neutral rating and $32 price target. The analyst is taking a more conservative stance on the initial launch of Alis relative to consensus estimates. Flanders does, however, see a high unmet need in treating nontuberculous mycobacterial lung disease.
08/03/18
HCWC
08/03/18
NO CHANGE
Target $35
HCWC
Buy
H.C. Wainwright bullish on Insmed into Tuesday's FDA panel
H.C. Wainwright analyst Andrew Fein is bullish on shares of Insmed into Tuesday's FDA panel meeting. The collective strength of the Amikacin Liposome Inhalation Suspension data "essentially removes the regulatory risks," Fein tells investors in a research note. With no effective treatment available, the analyst expects a positive panel vote. He reiterates a Buy rating on Insmed with a $35 price target. The analyst adds that if he were to assume a 100% probability of success for ALIS, he "could easily justify" a valuation north of $50 per share.
08/06/18
JMPS
08/06/18
DOWNGRADE
JMPS
Market Perform
Insmed downgraded to Market Perform from Outperform at JMP Securities
08/06/18
08/06/18
DOWNGRADE

Market Perform
Insmed downgraded to Market Perform ahead of AdComm vote at JMP Securities
As previously reported, JMP Securities analyst Liisa Bayko downgraded Insmed to Market Perform from Outperform as she has less confidence in Amikacin Liposome Inhalation Suspension after hosting a call last week with Dr. Lee Simon, an ex-FDA Division Director, who confirmed some concerns she had and "pointed out a few new insights" that left Bayko feeling more cautious. Following her call with the regulatory expert, and ahead of the FDA Advisory Committee meeting on Tuesday, Bayko lowered her odds on the probability of success for ALIS to 60% from 80%.

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