Insmed Catapults Into Breakout Territory On A 'Home Run' For Its Rival To United, Liquidia
Insmed stock catapulted into breakout territory early Tuesday after the biotech company hit a "home run" with its treatment for PAH.
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8 hours ago
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Insmed's Pulmonary Hypertension Drug Data Exceeded Even Bullish Outlook, Analysts Boost Price Forecast
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 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. 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. Read Next:Photo via Shutterstock 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 UNLOCKED: 5 NEW TRADES EVERY WEEK. Click now to get top trade ideas daily, plus unlimited access to cutting-edge tools and strategies to gain an edge in the markets. Get the latest stock analysis from Benzinga? INSMED (INSM): Free Stock Analysis Report This article Insmed's Pulmonary Hypertension Drug Data Exceeded Even Bullish Outlook, Analysts Boost Price Forecast originally appeared on © 2025 Benzinga does not provide investment advice. All rights reserved. Sign in to access your portfolio
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a day ago
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Insmed Stock Soars on Pulmonary Arterial Hypertension Drug Trial Results
Shares of Insmed (INSM) jumped nearly 30% Tuesday after the biopharmaceutical company reported positive results from a Phase 2 trial for its treatment of pulmonary arterial hypertension. The Bridgewater, N.J.-based company said the study was "evaluating the efficacy and safety of treprostinil palmitil inhalation powder" in patients with pulmonary arterial hypertension, or PAH, and that the trial "met its primary endpoint and all secondary efficacy endpoints." Pulmonary hypertension, which develops when the blood pressure in your lungs is higher than normal, affects about 1% of people globally, per the National Heart, Lung, and Blood Institute. Insmed said it would "immediately 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 before the end of 2025 and a Phase 3 trial in patients with PAH in early 2026." The news caused Insmed shares to soar nearly 28% Tuesday afternoon to around $90, their highest level in nearly a quarter century. Shares of United Therapeutics (UTHR), which makes rival PAH treatments, recently sank almost 14% to about $283, their lowest level since April. Read the original article on Investopedia Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
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a day ago
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Gyre Therapeutics Announces First Dosing in Phase 1 Trial of F230 for Pulmonary Arterial Hypertension in China
SAN DIEGO, June 10, 2025 (GLOBE NEWSWIRE) -- Gyre Therapeutics ('Gyre') (Nasdaq: GYRE), an innovative, commercial-stage biopharmaceutical company dedicated to advancing fibrosis-first therapies across organ systems affected by chronic disease, today announced that the first volunteer has been successfully dosed in a Phase 1 clinical trial evaluating F230, a novel endothelin A ('ETA') receptor antagonist, for the treatment of pulmonary arterial hypertension ('PAH').This milestone marks Gyre's entry into the PAH field, a rare, progressive, and high-mortality cardiovascular condition with limited treatment options. PAH is recognized in China's National Rare Disease Catalog, underscoring its significance in public health. According to Frost & Sullivan, China's PAH market was valued at $370 million in 2023 and is projected to grow to $480 million by 2031.F230, originally discovered by Eisai Co., Ltd. and exclusively licensed by GNI Group Ltd. to Gyre, is a fully synthetic small molecule designed to selectively block the ETA receptor. By targeting this pathway, F230 is designed to reduce pulmonary vascular remodeling and lower pulmonary pressure, key contributors to PAH Phase 1 trial is designed to evaluate safety, tolerability, and pharmacokinetics in healthy volunteers. The trial represents the latest expansion of Gyre's fibrosis-first strategy beyond the liver, leveraging a robust clinical development platform and commercial infrastructure in China.F230 joins Gyre's pipeline alongside lead candidate Hydronidone (F351), which met the primary endpoint in a pivotal Phase 3 trial for CHB-fibrosis. A New Drug Application ('NDA') submission to China's National Medical Products Administration ('NMPA') is planned for the third quarter of 2025, and a pre-IND meeting with the U.S. Food and Drug Administration is being planned for an expected Phase 2 trial in metabolic dysfunction-associated steatohepatitis ('MASH') Gyre TherapeuticsGyre Therapeutics is a biopharmaceutical company headquartered in San Diego, CA, primarily focused on the development and commercialization of Hydronidone for liver fibrosis, including MASH, in the U.S. Gyre's strategy builds on its experience in mechanistic studies using MASH rodent models and clinical studies in CHB-induced liver fibrosis. In the People's Republic of China, Gyre is advancing a broad pipeline through its indirect controlling interest in Gyre Pharmaceuticals, including therapeutic expansions of ETUARY, and development programs for F573, F528, and StatementsThis press release contains 'forward-looking statements' within the meaning of the 'safe harbor' provisions of the Private Securities Litigation Reform Act of 1995, which statements are subject to substantial risks and uncertainties and are based on estimates and assumptions. All statements, other than statements of historical facts included in this press release, are forward-looking statements, including statements concerning the expectations regarding Gyre's research and development efforts and timing of expected clinical trials, including an NDA submission to the NMPA for F351, the expected clinical benefits of F230 and expectations regarding interactions with regulators. In some cases, you can identify forward-looking statements by terms such as 'may,' 'might,' 'will,' 'objective,' 'intend,' 'should,' 'could,' 'can,' 'would,' 'expect,' 'believe,' 'design,' 'estimate,' 'predict,' 'potential,' 'plan' or the negative of these terms, and similar expressions intended to identify forward-looking statements. These statements reflect our plans, estimates, and expectations, as of the date of this press release. These statements involve known and unknown risks, uncertainties and other factors that could cause our actual results to differ materially from the forward-looking statements expressed or implied in this press release. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation: Gyre's ability to execute on its clinical development strategies; positive results from a clinical trial may not necessarily be predictive of the results of future or ongoing clinical trials; the timing or likelihood of regulatory filings and approvals; competition from competing products; the impact of general economic, health, industrial or political conditions in the United States or internationally; the sufficiency of Gyre's capital resources and its ability to raise additional capital. Additional risks and factors are identified under 'Risk Factors' in Gyre's Annual Report on Form 10-K for the year ended December 31, 2024 filed on March 17, 2025 and in other filings Gyre may make with the SEC. Gyre expressly disclaims any obligation to update any forward-looking statements whether as a result of new information, future events or otherwise, except as required by Contact:David ZhangGyre in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
