Every 8-K that Upstream Bio, Inc. (UPB) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 8-K covers material events a company has to report between its quarterly reports, so if you follow UPB and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full UPB filings page.
Upstream Bio, Inc. (UPB) outlined pivotal Phase 3 development plans for its lead drug candidate verekitug in severe asthma and chronic rhinosinusitis with nasal polyps (CRSwNP). The company will run one placebo-controlled Phase 3 trial in each indication using a single high-dose 400 mg subcutaneous regimen administered every 12 weeks, enrolling approximately 1,500 patients in total.
Primary endpoints include annualized asthma exacerbation rates over 48 weeks for asthma and co-primary nasal polyp and congestion scores at 48 weeks for CRSwNP. Upstream Bio plans to initiate both Phase 3 trials in the first quarter of 2027 and, with supportive results, expects to submit BLAs to the FDA for both indications, targeting potential U.S. launch of verekitug as early as 2030. Verekitug has already been studied in more than 500 participants with positive Phase 2 results in severe asthma and CRSwNP and is also being evaluated in an ongoing Phase 2 COPD trial.
Upstream Bio, Inc. reported second quarter 2026 results and provided an update on development of its lead asset, verekitug, for severe inflammatory respiratory diseases. As of June 30, 2026, cash, cash equivalents and short‑term investments totaled $261.3 million, which the company expects will fund planned operations through 2027.
For the quarter ended June 30, 2026, collaboration revenue was $0.8 million. Research and development expenses were $36.1 million and general and administrative expenses were $7.1 million, leading to a net loss of $39.7 million, similar to the $40.0 million net loss a year earlier.
Operationally, Upstream highlighted progress toward planned Phase 3 trials of verekitug in severe asthma and CRSwNP targeted for the first quarter of 2027, completion of enrollment in the Phase 2 VENTURE COPD trial with 481 participants, and additional supportive Phase 2 data presentations in CRSwNP and severe asthma.
Upstream Bio, Inc. reported the results of its 2026 annual stockholder meeting. Stockholders elected Class II directors H. Edward Fleming, Jr., M.D. and Liam Ratcliffe, M.B.Ch.B., Ph.D., M.B.A. to serve until the 2029 annual meeting, with each nominee receiving strong majority support.
Stockholders also ratified the appointment of PricewaterhouseCoopers LLP as independent registered public accounting firm for the fiscal year ending December 31, 2026. The meeting had a quorum, with most outstanding shares represented in person or by proxy, and no other matters were submitted for a vote.
Upstream Bio, Inc. reported first quarter 2026 results and highlighted progress across its verekitug clinical programs in severe asthma, CRSwNP and COPD. The company held cash, cash equivalents and short-term investments of $294.6 million as of March 31, 2026, which it expects will fund planned operations through 2027.
Collaboration revenue was $1.0 million for the quarter. Research and development expenses rose to $36.6 million, and general and administrative expenses were $8.1 million, reflecting higher clinical, manufacturing and personnel costs. Net loss widened to $40.6 million compared with $27.3 million a year earlier.
The company is preparing for End-of-Phase 2 FDA meetings in mid-2026 and plans to initiate Phase 3 trials of verekitug in severe asthma and CRSwNP in the first quarter of 2027. It is also capping enrollment in its Phase 2 VENTURE COPD study, with efficacy data expected in the second half of 2027.
Upstream Bio, Inc. entered into a Sales Agreement with Leerink Partners LLC to establish an at-the-market equity program. Under a related prospectus supplement, the company may offer and sell shares of its common stock in an aggregate amount of up to $150,000,000 through or to the agent.
Leerink Partners will use commercially reasonable efforts to place shares on Nasdaq or other trading markets and will receive a commission of up to 3.0% of gross proceeds from each sale. Neither party is obligated to sell a minimum amount, and the company or the agent may suspend or terminate the program at any time, subject to the agreement’s terms.
The shares will be issued under Upstream Bio’s automatic shelf registration statement on Form S-3ASR and the prospectus supplement filed on March 26, 2026. Legal opinions from Goodwin Procter LLP regarding the validity of the shares are included as exhibits.
Upstream Bio, Inc. reported a larger net loss but strong clinical progress as it prepares for late-stage trials. For the quarter ended December 31, 2025, collaboration revenue was $668,000 and net loss was $42.5 million, compared with a net loss of $21.2 million a year earlier, mainly from higher research spending on verekitug.
Research and development expenses rose to $40.2 million from $21.8 million, while general and administrative expenses increased to $6.7 million from $5.2 million. The company ended 2025 with cash, cash equivalents and short-term investments of $341.5 million, which it expects will fund planned operations through 2027.
The company highlighted positive Phase 2 VALIANT data in severe asthma, with statistically significant reductions in asthma exacerbations at multiple dosing regimens, and supportive analyses from the Phase 2 VIBRANT study in chronic rhinosinusitis with nasal polyps. Upstream Bio plans to advance verekitug into Phase 3 trials in severe asthma and CRSwNP, aiming to start dosing in the first quarter of 2027, and continues enrollment in the Phase 2 VENTURE trial in COPD.
Upstream Bio, Inc. reported preliminary unaudited cash, cash equivalents and short-term investments of approximately $341.5 million as of December 31, 2025, which it expects will fund planned operations through 2027. The company also presented top-line Phase 2 VALIANT trial results for its severe asthma drug candidate verekitug.
Verekitug met the primary endpoint, showing statistically significant reductions in annualized asthma exacerbation rates, including a 56% reduction at 100 mg every 12 weeks and a 39% reduction at 400 mg every 24 weeks versus placebo. Both regimens delivered clinically meaningful improvements in lung function (FEV1) and exhaled nitric oxide (FeNO), and verekitug was generally well tolerated with a safety profile consistent with prior studies.
The company plans integrated analyses of Phase 2 data in severe asthma and CRSwNP, continued Phase 2 development in COPD, and to begin Phase 3 trials in severe asthma and CRSwNP, while continuing investments in manufacturing and device development.
Upstream Bio, Inc. reported positive top-line results from its Phase 2 VALIANT trial of verekitug in 478 adults with severe asthma. Verekitug cut the annualized asthma exacerbation rate by 56% at 100 mg every 12 weeks and 39% at 400 mg every 24 weeks versus placebo, meeting the primary endpoint.
The drug also improved lung function, with placebo-adjusted FEV1 gains of 122 mL and 139 mL at week 60 for the 100 mg q12w and 400 mg q24w regimens, and substantially lowered exhaled nitric oxide. Verekitug was generally well tolerated with a safety profile consistent with prior studies.
More than 90% of eligible VALIANT patients have rolled into the VALOUR long-term extension study. Based on VALIANT and prior CRSwNP data, Upstream Bio plans to advance verekitug into Phase 3 trials in severe asthma and CRSwNP, while continuing the Phase 2 VENTURE trial in COPD.
Upstream Bio, Inc. furnished an update on operations by announcing its results and business highlights for the quarter ended September 30, 2025. The company submitted a Form 8-K noting that a detailed press release was provided as Exhibit 99.1.
The information under Item 2.02, including Exhibit 99.1, is being furnished and is not deemed filed under the Exchange Act. Upstream Bio’s common stock trades on the Nasdaq Global Select Market under the symbol UPB.
Upstream Bio, Inc. reported positive top-line results from its Phase 2 VIBRANT trial of verekitug in adults with chronic rhinosinusitis with nasal polyps (CRSwNP). The 24-week, global, randomized, double-blind, placebo-controlled study enrolled 81 participants who received either 100 mg of verekitug or placebo subcutaneously every 12 weeks.
The trial met its primary endpoint, showing a statistically significant and clinically meaningful, placebo-adjusted reduction in endoscopic nasal polyp score of -1.8 (p<0.0001) at Week 24 from baseline. A key secondary endpoint, patient-reported nasal congestion score, also improved with a placebo-adjusted reduction of -0.8 (p=0.0003). Additional secondary measures, including sinus opacification, total symptom score, and reduced need for systemic corticosteroids or nasal polyp surgery, also improved.
Verekitug was generally well tolerated, with a favorable safety profile consistent with previous studies and no serious adverse events observed. The company shared these results via a press release and webcast presentation furnished as exhibits.