New England Journal of Medicine (NEJM) to Publish Results From Savara's Pivotal Phase 3 IMPALA-2 Clinical Trial in Autoimmune Pulmonary Alveolar Proteinosis (Autoimmune PAP)
'IMPALA-2, the largest and longest Phase 3 clinical trial conducted in patients with autoimmune PAP, demonstrated that 48 weeks of once daily administration of inhaled molgramostim addresses the underlying pathophysiology of this chronic rare lung disease,' said Bruce Trapnell, M.D., Professor of Medicine and Pediatrics, University of Cincinnati College of Medicine and Lead Clinical Investigator of the IMPALA-2 trial. 'Treatment with molgramostim improved the cardinal manifestations of autoimmune PAP, namely it reduced pulmonary surfactant burden and improved pulmonary gas transfer, respiratory health-related quality of life, and patient functionality. Additionally, molgramostim was well tolerated with no notable safety concerns.'
IMPALA-2 achieved statistical significance on its primary endpoint, change from baseline in the hemoglobin-adjusted percent predicted diffusing capacity of the lungs for carbon monoxide (DLco%) at Week 24. Molgramostim significantly improved pulmonary gas transfer as measured by DLco% at Week 24 compared with placebo (9.8% vs. 3.8%; estimated treatment difference, 6.0%; P<0.001 by comparison of least-squares means [LSMs]). The beneficial effect of molgramostim on pulmonary gas transfer was maintained to Week 48 as shown by the difference in LSM change from baseline in DLco% at Week 48 between molgramostim and placebo groups (11.6% vs. 4.7%; estimated treatment difference, 6.9%; P<0.001). The mean improvements in DLco% from baseline for molgramostim (9.8% at Week 24 and 11.6% at Week 48) are similar to the minimal clinically meaningful difference (MCID) in DLco% of 10% reported for pulmonary fibrosis. 1
Molgramostim improved respiratory health-related quality of life as measured by the St. George's Respiratory Questionnaire (SGRQ) Total and Activity scores. The magnitude of LSM reduction from baseline in SGRQ Total score was significantly greater in the molgramostim group than placebo at Week 24 (-11.5 points vs. -4.9 points, estimated difference, -6.6 points; P=0.007) and remained numerically greater at Week 48 (-10.7 points vs. -5.9 points, estimated difference, -4.9 points [95% confidence interval, -10.8, 1.0]). The LSM change from baseline in SGRQ Activity score was greater for molgramostim compared with placebo at Week 24 (-13.0 points vs. -5.2 points, estimated difference, -7.8 points [95% confidence interval, -14.1, -1.5]) and at Week 48 (-13.4 vs. -7.4 points, estimated difference, -6.0 points [95% confidence interval, -13.6, 1.6]).
Molgramostim improved patient function as measured by exercise capacity (expressed as peak metabolic equivalents [METs]). A MET is a unit of resting oxygen uptake which measures energy expenditure. The LSM change from baseline in peak-METs was greater at Week 48 for molgramostim than placebo (1.1 vs. 0.6; estimated treatment difference, 0.6; [95% confidence interval, 0.1, 1.0]). Peak-METs is a clinically useful unit of measure reflecting exercise capacity, prognosis, and mortality in cardiovascular disease for which a 0.5-MET increase comprises a clinically useful measure of rehabilitation. 2 Using the treadmill test in IMPALA-2, the LSM change in peak-METs from baseline to Week 48 was 1.1 in molgramostim-treated patients and the between-group difference observed at Week 48 was 0.6 peak-METs.
Molgramostim reduced surfactant burden as measured by ground glass opacity (GGO) score, an exploratory endpoint in IMPALA-2; GGO scores were determined by two blinded radiologists from a chest CT scan, with scores ranging from 0 to 15 (higher scores are worse). The mean reduction from baseline in GGO score was greater in the molgramostim group than the placebo group at Week 24 (-2.1 vs -1.1). Further, the number of patients who received ≥1 whole lung lavage as rescue therapy during the double-blind intervention period was lower with molgramostim than placebo (6 [7%] vs. 11 [13%]).
In IMPALA-2, molgramostim was well tolerated. Most treatment-emergent adverse events (AEs) were mild or moderate, and few led to discontinuation, with 98% of patients in the molgramostim group and 96% of patients in the placebo group completing the 48-week double-blind period on treatment.
About IMPALA-2
IMPALA-2 was a global, pivotal, Phase 3, 48-week, randomized, double-blind, placebo-controlled clinical trial designed to compare the efficacy and safety of molgramostim 300 mcg self-administered once daily by inhalation with matching placebo in patients with autoimmune PAP. The trial was conducted at 43 clinical trial sites across 16 countries, including the U.S., Canada, Japan, South Korea, Australia, and countries in Europe, including Turkey. The primary efficacy assessment was hemoglobin-adjusted percent predicted diffusing capacity of the lungs for carbon monoxide (DLco%), a gas transfer measure, and the primary endpoint was change from baseline to Week 24 in percent predicted DLco%, with a secondary endpoint of change from baseline to Week 48 in percent predicted DLco%. Three additional secondary efficacy variables evaluated clinical measures of patient benefit: St. George's Respiratory Questionnaire (SGRQ) Total score, SGRQ Activity score, and exercise capacity using a treadmill test, with each endpoint measured at Weeks 24 and 48. The primary time point for efficacy assessments was at Week 24; however, efficacy was assessed through Week 48 to evaluate durability of effect. Safety was assessed through Week 48. All patients who completed the 48-week double-blind treatment period continued into a 96-week open-label period during which molgramostim 300 mcg is administered once daily.
Autoimmune PAP is a rare lung disease characterized by the abnormal build-up of surfactant in the alveoli of the lungs. Surfactant consists of proteins and lipids and is an important physiological substance that lines the alveoli to prevent them from collapsing. In a healthy lung, excess surfactant is cleared and digested by immune cells called alveolar macrophages. Alveolar macrophages need to be stimulated by granulocyte-macrophage colony-stimulating factor (GM-CSF) to function properly in clearing surfactant, but in autoimmune PAP, GM-CSF is neutralized by antibodies against GM-CSF, rendering macrophages unable to adequately clear surfactant. As a result, an excess of surfactant accumulates in the alveoli, causing impaired gas transfer, resulting in clinical symptoms of shortness of breath, often with cough and frequent fatigue. Patients may also experience episodes of fever, chest pain, or coughing up blood, especially if secondary infection develops. In the long term, the disease can lead to serious complications, including lung fibrosis and the need for a lung transplant.
About Savara
Savara is a clinical stage biopharmaceutical company focused on rare respiratory diseases. Our lead program, molgramostim inhalation solution (molgramostim), is a recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) in Phase 3 development for autoimmune pulmonary alveolar proteinosis (autoimmune PAP). Molgramostim is delivered via an investigational eFlow® Nebulizer System (PARI Pharma GmbH) specifically developed for inhalation of a large molecule. Our management team has significant experience in rare respiratory diseases and pulmonary medicine, identifying unmet needs, and effectively advancing product candidates to approval and commercialization. More information can be found at www.savarapharma.com and LinkedIn.
1 Raghu G, et al. Am J Respir Crit Care Med 2022;205:e18-e47.
2 Ross R, et al. Circulation 2016;134:e653-e99; Grace SL, et al. Can J Cardiol 2014;30:945-8; Kehler DS, et al. J Cardiopulm Rehabil Prev 2017;37:250-6.
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Dayforce stock keeps climbing following Thoma Bravo takeover news News that private equity firm Thoma Bravo plans to acquire Dayforce (DAY) and take it private has continued to lift the stock this week. Shares rose 2% on Thursday afternoon, adding to their weekly gain since the deal was announced. Over the past five days, the HR software provider's stock has climbed 28%. Thoma Bravo's $12.3 billion offer represents a 32.4% premium on the stock's closing price on Aug. 15, Reuters reported. Under the terms of the deal, Dayforce shareholders will receive $70 per share in cash, representing an equity value of $11.18 billion. Read more here. News that private equity firm Thoma Bravo plans to acquire Dayforce (DAY) and take it private has continued to lift the stock this week. Shares rose 2% on Thursday afternoon, adding to their weekly gain since the deal was announced. Over the past five days, the HR software provider's stock has climbed 28%. Thoma Bravo's $12.3 billion offer represents a 32.4% premium on the stock's closing price on Aug. 15, Reuters reported. Under the terms of the deal, Dayforce shareholders will receive $70 per share in cash, representing an equity value of $11.18 billion. Read more here. US-EU trade deal impacts on pharma industry more 'manageable' than expected Anjalee Khemlani reports: Read more here. Anjalee Khemlani reports: Read more here. Cracker Barrel stock drops 11% amid conservative backlash over logo change Cracker Barrel (CBRL) shares fell as much as 11% Thursday morning as news outlets reported on the company's decision to drop the barrel from its logo, the first big brand makeover in nearly 50 years. The move was part of a broader redesign under new CEO Julie Masino, who joined the company in 2023. The logo change drew the ire of conservatives, including President Trump's son, Donald Trump Jr. That wasn't the first time Cracker Barrel sparked conservative backlash: A legal group led by Trump aide Stephen Miller in July called for a federal investigation into the restaurant chain for its equity-related policies — part of the administration's broader attack on corporate DEI (diversity, equity, and inclusion). Cracker Barrel (CBRL) shares fell as much as 11% Thursday morning as news outlets reported on the company's decision to drop the barrel from its logo, the first big brand makeover in nearly 50 years. The move was part of a broader redesign under new CEO Julie Masino, who joined the company in 2023. The logo change drew the ire of conservatives, including President Trump's son, Donald Trump Jr. That wasn't the first time Cracker Barrel sparked conservative backlash: A legal group led by Trump aide Stephen Miller in July called for a federal investigation into the restaurant chain for its equity-related policies — part of the administration's broader attack on corporate DEI (diversity, equity, and inclusion). Intel stock extends losses, reversing earlier gains Intel (INTC) shares fell nearly 2% Thursday morning after sinking 7% in Wednesday's trading session. The chipmaker's declines reversed gains earlier in the week after the announcement of a $2 billion investment from SoftBank and news that the Trump administration was exploring taking a 10% stake in the company. The stock's jump came even as Wall Street voiced concerns that those votes of confidence wouldn't be enough to fix Intel's problems. Shares fell Wednesday as CNBC reported that Intel was in talks with other large investors to get an equity infusion at a discounted price. Intel stock is down nearly 8% over the past six months but up 7% from a year ago. Intel (INTC) shares fell nearly 2% Thursday morning after sinking 7% in Wednesday's trading session. The chipmaker's declines reversed gains earlier in the week after the announcement of a $2 billion investment from SoftBank and news that the Trump administration was exploring taking a 10% stake in the company. The stock's jump came even as Wall Street voiced concerns that those votes of confidence wouldn't be enough to fix Intel's problems. Shares fell Wednesday as CNBC reported that Intel was in talks with other large investors to get an equity infusion at a discounted price. Intel stock is down nearly 8% over the past six months but up 7% from a year ago. Manufacturing activity hits a more than three-year high in August US economic output hit an eight-month high in August while activity in the manufacturing sector reached its highest level in more than three years. S&P Global's flash US composite PMI survey, which captures activity in both the services and manufacturing sectors, came in at 55.4 in August, up from 55.1 in July. Increased factory activity drove the gains: The preliminary manufacturing PMI reading rose to 53.3, its highest level in 39 months. Meanwhile, the service PMI reading declined to 55.4 in August, down slightly from 55.7 and marking a two-month low for the index. 'A strong flash PMI reading for August adds to signs that US businesses have enjoyed a strong third quarter so far," S&P Global Market Intelligence chief business economist Chris Williamson said in the release. "The data are consistent with the economy expanding at a 2.5% annualized rate, up from the average 1.3% expansion seen over the first two quarters of the year." The gains didn't come without hiccups, though. Both the services and manufacturing sectors saw their second-largest monthly input price increase since January 2023. 'The resulting rise in selling prices for goods and services suggests that consumer price inflation will rise further above the Fed's 2% target in the coming months," Williamson said. US economic output hit an eight-month high in August while activity in the manufacturing sector reached its highest level in more than three years. S&P Global's flash US composite PMI survey, which captures activity in both the services and manufacturing sectors, came in at 55.4 in August, up from 55.1 in July. Increased factory activity drove the gains: The preliminary manufacturing PMI reading rose to 53.3, its highest level in 39 months. Meanwhile, the service PMI reading declined to 55.4 in August, down slightly from 55.7 and marking a two-month low for the index. 'A strong flash PMI reading for August adds to signs that US businesses have enjoyed a strong third quarter so far," S&P Global Market Intelligence chief business economist Chris Williamson said in the release. "The data are consistent with the economy expanding at a 2.5% annualized rate, up from the average 1.3% expansion seen over the first two quarters of the year." The gains didn't come without hiccups, though. Both the services and manufacturing sectors saw their second-largest monthly input price increase since January 2023. 'The resulting rise in selling prices for goods and services suggests that consumer price inflation will rise further above the Fed's 2% target in the coming months," Williamson said. The Dow leads stocks down at the open US stocks fell on Thursday after Walmart (WMT) earnings came in below expectations and weekly jobless claims came in higher than expected to hit the highest level since June. The Dow Jones Industrial Average (^DJI) dropped nearly 0.6%, while the S&P 500 (^GSPC) moved down more than 0.4%. The tech-heavy Nasdaq Composite (^IXIC) also backed off about 0.4%. US stocks fell on Thursday after Walmart (WMT) earnings came in below expectations and weekly jobless claims came in higher than expected to hit the highest level since June. The Dow Jones Industrial Average (^DJI) dropped nearly 0.6%, while the S&P 500 (^GSPC) moved down more than 0.4%. The tech-heavy Nasdaq Composite (^IXIC) also backed off about 0.4%. US weekly jobless claims rise to highest since June Americans filing claims for jobless benefits rose to 235,000 for the week of Aug. 15, the largest increase since late May. Economists expected 225,000 jobless claims to be filed. Meanwhile, continuing claims jumped to 1.97 million, greater than the 1.96 million anticipated, in a sign that Americans without jobs are finding it difficult to get a new one. Read more here. Americans filing claims for jobless benefits rose to 235,000 for the week of Aug. 15, the largest increase since late May. Economists expected 225,000 jobless claims to be filed. Meanwhile, continuing claims jumped to 1.97 million, greater than the 1.96 million anticipated, in a sign that Americans without jobs are finding it difficult to get a new one. Read more here. Boeing stock rises on potential sale of 500 jets to China Boeing (BA) stock rose 1.5% in premarket trading after Bloomberg reported the company is in talks to sell up to 500 jets to China. The potential sale would mark China's largest purchase of Boeing aircraft since President Trump's visit to the country in 2017. But it's contingent on trade tensions between the US and China abating. Earlier this year, Boeing was caught in the center of the trade war between the US and China. In April, China banned deliveries of the company's planes during the height of tariff escalation but removed the ban in May. Read more here. Boeing (BA) stock rose 1.5% in premarket trading after Bloomberg reported the company is in talks to sell up to 500 jets to China. The potential sale would mark China's largest purchase of Boeing aircraft since President Trump's visit to the country in 2017. But it's contingent on trade tensions between the US and China abating. Earlier this year, Boeing was caught in the center of the trade war between the US and China. In April, China banned deliveries of the company's planes during the height of tariff escalation but removed the ban in May. Read more here. Disney's new ESPN streaming service has arrived, ushering in new era for sports and the cable bundle Yahoo Finance's Allie Canal reports: Read more here. Yahoo Finance's Allie Canal reports: Read more here. The tech trade hits pause ahead of Nvidia earnings Tech stocks remain on shaky ground after concerns about the AI trade caused them to slip again on Wednesday. And while the tech pullback wasn't anywhere close to a DeepSeek moment, Yahoo Finance's Hamza Shaban writes, Wall Street did seem alarmed by a handful of pessimistic headlines. Hamza explains the Street's discontent with tech in today's Morning Brief: Read more here. Tech stocks remain on shaky ground after concerns about the AI trade caused them to slip again on Wednesday. And while the tech pullback wasn't anywhere close to a DeepSeek moment, Yahoo Finance's Hamza Shaban writes, Wall Street did seem alarmed by a handful of pessimistic headlines. Hamza explains the Street's discontent with tech in today's Morning Brief: Read more here. Walmart stock falls after earnings miss forecasts as US sales, 2025 outlook rise Walmart (WMT) stock slid after the big-box retailer's Q2 earnings fell shy of Wall Street's expectations, even after its US sales growth beat forecasts as shoppers embraced its low prices. Yahoo Finance's Brooke DiPalma reports: Read more here. Walmart (WMT) stock slid after the big-box retailer's Q2 earnings fell shy of Wall Street's expectations, even after its US sales growth beat forecasts as shoppers embraced its low prices. Yahoo Finance's Brooke DiPalma reports: Read more here. Good morning. Here's what's happening today. Economic data: Initial jobless claims (week of Aug. 16); S&P Global US manufacturing PMI (August preliminary) S&P Global US services PMI; Existing home sales (July) Earnings: Walmart (WMT), Intuit (INTU), Workday (WDAY), Ross Stores (ROST), Zoom (ZM) Here are some of the biggest stories you may have missed overnight and early this morning: Walmart shares slip after earnings miss the mark Disney's era-ending ESPN sports streaming has arrived Fed governor Cook responds after Trump says she 'must resign' The tech trade has a wobble ahead of Nvidia earnings Short sellers reap over $5 billion as AI fears roil market El-Erian: Powell is walking a tightrope at Jackson Hole Goldman: It's time to buy the dip in momentum stocks Meta freezes AI hiring as Wall Street eyes the cost Musk must face fraud lawsuit over 2024 election sweepstakes Tencent's 'Valorant' tops iPhone chart with $1 million debut Economic data: Initial jobless claims (week of Aug. 16); S&P Global US manufacturing PMI (August preliminary) S&P Global US services PMI; Existing home sales (July) Earnings: Walmart (WMT), Intuit (INTU), Workday (WDAY), Ross Stores (ROST), Zoom (ZM) Here are some of the biggest stories you may have missed overnight and early this morning: Walmart shares slip after earnings miss the mark Disney's era-ending ESPN sports streaming has arrived Fed governor Cook responds after Trump says she 'must resign' The tech trade has a wobble ahead of Nvidia earnings Short sellers reap over $5 billion as AI fears roil market El-Erian: Powell is walking a tightrope at Jackson Hole Goldman: It's time to buy the dip in momentum stocks Meta freezes AI hiring as Wall Street eyes the cost Musk must face fraud lawsuit over 2024 election sweepstakes Tencent's 'Valorant' tops iPhone chart with $1 million debut 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
