UPB

– Company rapidly advancing Phase 3 programs designed to deliver best-in-class efficacy with convenient quarterly dosing in severe asthma and CRSwNP – – End-of-Phase 2 meetings with FDA planned for mid-2026; Phase 3 initiations in both indications expected in Q1 2027 – – Phase 2 VENTURE trial in COPD ongoing; Company to cap further enrollment; data now expected in the second half of 2027 – – Upcoming data presentations at ATS and EAACI to further elaborate the clinical profile of verekitug – WALTHAM, Mass., May 13, 2026 (GLOBE NEWSWIRE) -- Upstream Bio, Inc. (Nasdaq: UPB), a clinical-stage company developing treatments for inflammatory diseases, with an initial focus on severe respiratory disorders, today reported financial results for the first quarter ended March 31, 2026, and highlighted its continued progress in developing verekitug to deliver potential best-in-class efficacy with quarterly dosing across the Company’s three target indications: severe asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), and chronic obstructive pulmonary disease (COPD). Verekitug is the only known antagonist currently in clinical development that targets and inhibits the thymic stromal lymphopoietin (TSLP) receptor. “We continue to make strong progress advancing our clinical programs in severe asthma and CRSwNP to position verekitug as a uniquely differentiated treatment option for these diseases,” said Rand Sutherland, MD, Chief Executive Officer of Upstream Bio. “We are working diligently to deliver best-in-class efficacy with convenient quarterly at-home dosing, a profile that we believe will advance the standard of care for patients and maximize the potential commercial value of verekitug. We are continuing to prepare for our End-of-Phase 2 meetings with the FDA, which we expect to occur in mid-2026, and we remain on track to initiate Phase 3 dosing in both severe asthma and CRSwNP in the first quarter of 2027.” “In addition, our Phase 2 VENTURE study in COPD continues, with more than 400 participants enrolled to date,” continued Dr. Sutherland. “Given our goal to deliver the best efficacy profile possible in all three indications, including COPD, we intend to cap further enrollment in VENTURE as we begin preparations for a Phase 3 trial of a high-dose quarterly regimen in COPD. The placebo-controlled efficacy data from VENTURE, now expected in the second half of...

– Company to pursue Phase 3 development strategy designed to deliver best-in-class efficacy with a high-dose quarterly regimen in broad patient populations in both severe asthma and CRSwNP – – Company plans to initiate dosing in Phase 3 trials in both severe asthma and CRSwNP in Q1 2027 – – Reported positive top-line results from Phase 2 VALIANT trial of verekitug in patients with severe asthma in February 2026, demonstrating significant improvements in asthma exacerbations and lung function – – Presented additional analyses from Phase 2 VIBRANT trial at AAAAI, reinforcing verekitug’s therapeutic potential in CRSwNP – – Strong cash position of $341.5 million expected to fund planned operations through 2027 – WALTHAM, Mass., March 26, 2026 (GLOBE NEWSWIRE) -- Upstream Bio, Inc. (Nasdaq: UPB), a clinical-stage company developing treatments for inflammatory diseases, with an initial focus on severe respiratory disorders, today reported financial results for the fourth quarter and full year ended December 31, 2025, and highlighted its Phase 3 development strategy for verekitug in severe asthma and chronic rhinosinusitis with nasal polyps (CRSwNP). The Company is developing verekitug, the only known antagonist currently in clinical development that targets and inhibits the thymic stromal lymphopoietin (TSLP) receptor, in multiple severe respiratory diseases including severe asthma, CRSwNP, and chronic obstructive pulmonary disease (COPD). “Upstream Bio continues to make strong progress, highlighted by our recent positive Phase 2 VALIANT study of verekitug in patients with severe asthma,” said Rand Sutherland, MD, Chief Executive Officer of Upstream Bio. “This trial demonstrated compelling efficacy data and a favorable safety profile with extended dosing, and we believe this combination could represent a meaningful advance over currently available biologic therapies. We are working diligently to move verekitug into Phase 3 development and to realize its potential to become a leading medicine for the treatment of severe asthma and CRSwNP.” “Since reporting the top-line results from VALIANT, we have analyzed data from approximately 500 participants treated in our Phase 1 and 2 clinical trials, and this comprehensive dataset supports verekitug’s potential to deliver best-in-class efficacy with doses as high as 400 mg administered quarterly in a single injection, in b...

– Verekitug provided statistically significant and clinically meaningful reductions in annualized asthma exacerbation rate (AAER) with 100 mg q12 and 400 mg q24 week dosing – – Verekitug also delivered clinically meaningful improvements in lung function (FEV1) and exhaled nitric oxide (FeNO) with both dose regimens – – Verekitug was generally well tolerated, with a safety profile consistent with prior studies – – Over 90% of eligible patients have rolled over to the Phase 2 VALOUR long-term extension study – – Upstream Bio to advance verekitug into Phase 3 trials in severe asthma and CRSwNP following planned regulatory interactions – – Management will host a live webcast today at 8:00 a.m. ET – WALTHAM, Mass., Feb. 11, 2026 (GLOBE NEWSWIRE) -- Upstream Bio, Inc. (Nasdaq: UPB), a clinical-stage company developing treatments for inflammatory diseases, with an initial focus on severe respiratory disorders, today announced positive top-line results from the Phase 2 VALIANT clinical trial evaluating the safety and efficacy of verekitug in adults with severe asthma. Verekitug is the only known clinical-stage antagonist targeting the receptor for thymic stromal lymphopoietin (TSLP). VALIANT met the study’s primary endpoint of a statistically significant and clinically meaningful reduction in the annualized asthma exacerbation rate (AAER) with both every 12 week (q12w) and every 24 week (q24w) dosing, with verekitug demonstrating a reduction in AAER of 56% (p<0.0003) when dosed at 100 mg q12w and 39% (p<0.02) when dosed at 400 mg q24w, as compared with placebo. Placebo-adjusted improvement in lung function, as measured by the forced expiratory volume in one second (FEV1), was 122 mL at week 60 with verekitug 100 mg q12w, and 139 mL at week 60 with 400 mg q24w. At week 60, verekitug also suppressed exhaled nitric oxide (FeNO) compared to placebo by 20.4 ppb (p<0.0003) when dosed at 100 mg q12w, and by 26.3 ppb (p<0.0001) when dosed at 400 mg q24w. These data represented a mean 43.5% (p=0.03) reduction from baseline in the 100 mg q12w group and a mean 44.9% (p=0.03) reduction from baseline in the 400 mg q24w group. A third low-dose treatment group, 100 mg q24w, demonstrated a statistically significant effect on AAER, but did not provide consistent improvements in other endpoints. Additional pre-specified analyses of secondary outcomes at week 24 revealed statistically...

– Webcast to be held Wednesday, February 11, 2026, at 8:00 a.m. ET – WALTHAM, Mass., Feb. 10, 2026 (GLOBE NEWSWIRE) -- Upstream Bio, Inc. (Nasdaq: UPB), a clinical-stage company developing treatments for inflammatory diseases, with an initial focus on severe respiratory disorders, today announced it will report top-line results from the Phase 2 VALIANT trial of verekitug, the only known antagonist currently in clinical development that targets and inhibits the thymic stromal lymphopoietin (TSLP) receptor, on Wednesday, February 11, 2026 at 8:00 a.m. ET. The VALIANT trial (NCT06196879) is a Phase 2 global, randomized, double-blind, placebo-controlled, dose-ranging, parallel group clinical trial that evaluated the safety and efficacy of verekitug for up to 60 weeks, with a minimum of 24 weeks of treatment, in 478 patients with severe asthma. Participants were randomized into one of four groups, receiving either 100 mg of verekitug every 24 weeks, 400 mg of verekitug every 24 weeks, 100 mg of verekitug every 12 weeks, or placebo, administered subcutaneously. Webcast Information Upstream Bio’s webcast to discuss the top-line results from the Phase 2 VALIANT trial will begin Wednesday, February 11, 2026, at 8:00 a.m. ET. The live webcast can be accessed via this link or on the Events tab on the Investors section of the Company’s website at https://investors.upstreambio.com/news-events/events. A replay of the webcast will be available on the website following the call. About Upstream Bio Upstream Bio is a clinical-stage biotechnology company developing treatments for inflammatory diseases, with an initial focus on severe respiratory disorders. The Company is developing verekitug, the only known antagonist currently in clinical development that targets the receptor for thymic stromal lymphopoietin (TSLP), a cytokine which is a clinically validated driver of inflammatory response positioned upstream of multiple signaling cascades that affect a variety of immune mediated diseases. The Company has advanced this highly potent monoclonal antibody into separate Phase 2 trials for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP), severe asthma, and chronic obstructive pulmonary disease (COPD). Upstream Bio’s team is committed to maximizing verekitug’s unique attributes to address the substantial unmet needs for patients underserved by today’s standard of...

– Positive top-line results from VIBRANT Phase 2 trial of verekitug in CRSwNP reported in September showed statistically significant and clinically meaningful effects on primary and key secondary endpoints when administered once every 12 weeks – – On-track to report top-line results from VALIANT Phase 2 trial in severe asthma in the first quarter of 2026 – – Enrollment ongoing in VENTURE Phase 2 trial in COPD; first patient dosed in July – WALTHAM, Mass., Nov. 05, 2025 (GLOBE NEWSWIRE) -- Upstream Bio, Inc. (Nasdaq: UPB), a clinical-stage company developing treatments for inflammatory diseases, with an initial focus on severe respiratory disorders, today reported financial results for the third quarter ended September 30, 2025, and provided a summary of recent business highlights. The Company is developing verekitug, the only known antagonist currently in clinical development that targets and inhibits the thymic stromal lymphopoietin (TSLP) receptor, in multiple severe respiratory diseases including chronic rhinosinusitis with nasal polyps (CRSwNP), severe asthma, and chronic obstructive pulmonary disease (COPD). Verekitug’s unique pharmacology may lead to differentiated efficacy and an extended dosing interval as compared to the current standard of care. “During this quarter we reached an important milestone in verekitug’s development and shared positive top-line results from VIBRANT, our Phase 2 trial in CRSwNP, which reinforced verekitug’s differentiated clinical profile, including its potential for efficacy meeting or exceeding that of available biologics, with administration only four times per year,” said Rand Sutherland, MD, Chief Executive Officer of Upstream Bio. “We also continued to bolster our understanding of verekitug through translational research, including with the presentation of new data identifying structural and mechanistic drivers of verekitug’s potent disruption of TSLP signaling by antagonism of the TSLP receptor at the European Respiratory Society Congress in September.” “We remain on track to report top-line results from VALIANT, our Phase 2 trial in severe asthma, in the first quarter of 2026. Guided by these data, and following discussion with regulators, we will be well-positioned to advance our Phase 3 development plans for verekitug in both CRSwNP and severe asthma,” added Dr. Sutherland. “In addition, we continue to make inves...

– In this 24-week study, VIBRANT met its primary endpoint, with verekitug dosed every 12 weeks leading to a statistically significant and clinically meaningful reduction from baseline in placebo-adjusted endoscopic nasal polyp score (NPS) of -1.8 (p<0.0001) – – Significant and clinically meaningful improvements were observed in key secondary endpoints, including -0.8 (p=0.0003) reduction in nasal congestion score and 76% (p=0.03) reduction in need for surgery or systemic corticosteroids – – No serious adverse events (SAEs) observed; generally well tolerated safety profile consistent with previous studies – – Observed clinical effect on endoscopic NPS in this Phase 2 trial suggests verekitug meets or exceeds that of other biologics in CRSwNP at 24 weeks – – Management will host a conference call and webcast today at 8:00 a.m. ET – WALTHAM, Mass., Sept. 02, 2025 (GLOBE NEWSWIRE) -- Upstream Bio, Inc. (Nasdaq: UPB), a clinical-stage company developing treatments for inflammatory diseases, with an initial focus on severe respiratory disorders, today announced positive top-line results from the Phase 2 VIBRANT trial evaluating verekitug in participants with chronic rhinosinusitis with nasal polyps (CRSwNP). Verekitug is the only known clinical-stage monoclonal antibody targeting the receptor for thymic stromal lymphopoietin (TSLP). Over the 24-week treatment period, verekitug, dosed 100mg every 12 weeks, met the primary endpoint and key secondary endpoints, demonstrating statistically significant and clinically meaningful reductions in both endoscopic nasal polyp score (NPS) and nasal congestion score (NCS), with a generally well tolerated safety profile consistent with previous studies. Treatment with verekitug also resulted in a significant reduction in the need for surgery or systemic corticosteroids. VIBRANT (NCT06164704) was a Phase 2 global, randomized, double-blind, placebo-controlled, parallel group clinical trial that evaluated the efficacy and safety of verekitug over 24 weeks in 81 adults with CRSwNP. The trial met its primary endpoint, demonstrating a statistically significant and clinically meaningful, placebo-adjusted reduction in NPS of -1.8 (p<0.0001) at Week 24 compared with baseline. The trial also showed a meaningful placebo-adjusted reduction from baseline in the patient-reported NCS, a key secondary endpoint, by -0.8 (p=0.0003). Significant i...

Net loss: US$40.0m (loss widened by 104% from 2Q 2024). US$0.74 loss per share. This technology could replace computers: discover the 20 stocks are working to make quantum computing a reality. All figures shown in the chart above are for the trailing 12 month (TTM) period Revenue exceeded analyst estimates by 196%. Earnings per share (EPS) missed analyst estimates by 21%. Looking ahead, revenue is forecast to grow 61% p.a. on average during the next 3 years, compared to a 19% growth forecast for the Biotechs industry in the US. Performance of the American Biotechs industry. The company's shares are up 3.5% from a week ago. You should learn about the 3 warning signs we've spotted with Upstream Bio (including 1 which doesn't sit too well with us). Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) simplywallst.com. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.

– On track to report top-line data from Phase 2 trial in chronic rhinosinusitis with nasal polyps (CRSwNP) in the third quarter of 2025 – – Completed enrollment in Phase 2 trial in severe asthma in June 2025; top-line data expected in the first quarter of 2026 – – First patient dosed in Phase 2 trial in chronic obstructive pulmonary disease (COPD) in July 2025 – WALTHAM, Mass., Aug. 06, 2025 (GLOBE NEWSWIRE) -- Upstream Bio, Inc. (Nasdaq: UPB), a clinical-stage company developing treatments for inflammatory diseases, with an initial focus on severe respiratory disorders, today reported financial results for the second quarter ended June 30, 2025, and provided a summary of recent business highlights. The Company is developing verekitug, the only monoclonal antibody currently in clinical development that targets and inhibits the thymic stromal lymphopoietin (TSLP) receptor, in multiple severe respiratory diseases including CRSwNP, severe asthma, and COPD. Verekitug’s unique pharmacology may lead to differentiated efficacy and an extended dosing interval as compared to the current standard of care. “We continued to build momentum this quarter with strong execution across our clinical development programs for verekitug in severe respiratory diseases,” said Rand Sutherland, MD, Chief Executive Officer of Upstream Bio. “Notably, in June, we completed enrollment in our Phase 2 trial in severe asthma, with top-line data expected in the first quarter of 2026. We also initiated our Phase 2 trial in COPD in July, marking the start of development in a third major respiratory indication. Additionally, we remain on track to report top-line results from our Phase 2 trial in CRSwNP in the third quarter of this year.” “Our development efforts are centered on severe forms of common respiratory diseases where we see significant potential for clinical impact and commercial opportunity,” Dr. Sutherland continued. “We believe verekitug’s differentiated mechanism and extended dosing profile may offer meaningful advantages over biologics currently used to treat these diseases. Our upcoming readouts in CRSwNP and severe asthma represent key program milestones and an opportunity to further demonstrate the potentially unique profile of TSLP receptor inhibition across multiple inflammatory airway diseases.” Upcoming Milestones and Recent Business Highlights Two key upcoming top-line re...

– Top-line data from Phase 2 clinical trial of verekitug in patients with chronic rhinosinusitis with nasal polyps expected in the third quarter of 2025 – – Top-line data from Phase 2 clinical trial of verekitug in patients with severe asthma now expected in the first half of 2026 – – First patient in Phase 2 clinical trial of verekitug in patients with chronic obstructive pulmonary disease to be dosed in mid-2025 – WALTHAM, Mass., May 06, 2025 (GLOBE NEWSWIRE) -- Upstream Bio, Inc. (Nasdaq: UPB), a clinical-stage company developing treatments for inflammatory diseases, with an initial focus on severe respiratory disorders, today reported financial results for the first quarter ended March 31, 2025, and provided a summary of recent business highlights. The Company is developing verekitug, the only monoclonal antibody currently in clinical development that targets and inhibits the thymic stromal lymphopoietin (TSLP) receptor, in multiple severe respiratory diseases including chronic rhinosinusitis with nasal polyps (CRSwNP), severe asthma and chronic obstructive pulmonary disease (COPD). “This quarter we made excellent progress in our development of verekitug, positioning us well to deliver on our upcoming clinical milestones. We are pleased to accelerate our guidance on several near-term events, including the top-line data readout from our Phase 2 clinical trial of verekitug in patients with CRSwNP, expected in the third quarter of this year,” said Rand Sutherland, MD, Chief Executive Officer of Upstream Bio. “In addition, we now anticipate reporting top-line data from our Phase 2 clinical trial in severe asthma in the first half of 2026. We also now expect to dose the first patient in our Phase 2 clinical trial in COPD in mid-2025. We look forward to sharing further updates as we reach these key milestones.” Dr. Sutherland continued, “Verekitug is the only known molecule currently in clinical development targeting the TSLP receptor. Early clinical data suggest that this unique mechanism of action has the potential to meaningfully impact disease activity in patients with these severe respiratory diseases through both differentiated efficacy and an extended dosing interval, and we are testing the therapeutic implications of these observations across our development programs.” First Quarter 2025 and Recent Business Highlights Top-line data from Phase 2 clinica...