Insmed Incorporated (NASDAQ:INSM) on Tuesday released topline results from its Phase 2b study of treprostinil palmitil inhalation powder (TPIP), administered once daily in patients with pulmonary arterial hypertension.
The study met its primary endpoint and all secondary efficacy endpoints. For the primary endpoint, the placebo-adjusted reduction from baseline in pulmonary vascular resistance (PVR) was 35%, with a Least Squares (LS) mean ratio of 0.65.
The placebo-adjusted improvement in six-minute walk distance (6MWD) was 35.5 meters for the secondary efficacy endpoints.
Also Read: Lung Disease-Focused Insmed ‘Is An Attractive Midcap Biotech,’ Analyst Says
The placebo-adjusted reduction from baseline in N-terminal pro-b-type natriuretic peptide (NT-proBNP) concentrations, a biomarker for cardiac stress, was 60%, with an LS mean ratio of 0.40.
These results demonstrate the durability of TPIP’s therapeutic effect as a once-daily therapy based on efficacy evaluated approximately 24 hours after administering therapy.
Insmed will engage with the U.S. Food and Drug Administration (FDA) regarding the Phase 3 trial design for PAH.
Insmed plans to initiate a Phase 3 trial in patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD) before the end of 2025 and a Phase 3 trial in patients with PAH in early 2026.
Once-daily TPIP therapy was well tolerated in the study.
What Analysts Are Saying
Bank of America Securities (BofA) said TPIP data ‘exceeded even our bullish outlook.’
Analyst Jason Zemansky sees “clear potential for TPIP to become foundational in PAH/ PH-ILD, given the strength of the data and treprostinil’s well-established role in the paradigm.”
BofA analyst says that overall, the data looks strong, and there’s little to criticize. TPIP seems to have a top-tier profile, especially in how it’s administered. Plus, there’s good reason to think its effectiveness will improve with higher doses, and safety concerns may decrease with longer dose adjustments.
On Tuesday, BofA increased the price forecast from $94 to $109, reiterating its Buy rating.
BofA still sees several short-term factors that could drive shares higher, but these aren’t fully reflected in the current price. One is the upcoming FDA decision on brensocatib, expected by August 12.
Although there are good reasons to be optimistic, investor skepticism remains around management’s ambitious goal of over $5 billion in peak sales.
Meaningful insights into the launch likely won’t come until around the first quarter of 2026. However, early feedback from doctors and insurers in the second half of 2025 could help ease some doubts.
HC Wainwright maintained a Buy rating on Insmed and has raised the price forecast from $90 to $120.
Wells Fargo maintained an Overweight rating on Insmed and has raised the price forecast from $107 to $119.
Morgan Stanley maintained an Overweight rating on Insmed and has raised the price forecast from $90 to $102.
RBC Capital maintained an Outperform rating on Insmed and has raised the price forecast from $99 to $106.
Mizuho maintained an Outperform rating on Insmed and has raised the price forecast from $96 to $110.
Price Action: INSM stock is trading higher by 7.04% to $97.33 at last check Wednesday.
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Latest Ratings for INSM
|
Date |
Firm |
Action |
From |
To |
|---|---|---|---|---|
|
Feb 2022 |
SVB Leerink |
Maintains |
Outperform |
|
|
Dec 2021 |
JP Morgan |
Initiates Coverage On |
Overweight |
|
|
Oct 2021 |
Cantor Fitzgerald |
Initiates Coverage On |
Overweight |
View More Analyst Ratings for INSM
View the Latest Analyst Ratings
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This article Insmed’s Pulmonary Hypertension Drug Data Exceeded Even Bullish Outlook, Analysts Boost Price Forecast originally appeared on Benzinga.com
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