This section highlights FDA-related milestones and regulatory updates for drugs developed by BeyondSpring (BYSI).
Over the past two years, BeyondSpring has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Plinabulin, plinabulin, and DUBLIN. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
Plinabulin (Trial 103 - DUBLIN-3) FDA Regulatory Timeline and Events
Plinabulin (Trial 103 - DUBLIN-3) is a drug developed by BeyondSpring for the following indication: Refractory - Non small cell lung cancer (NSCLC).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Plinabulin (Trial 103 - DUBLIN-3)
- Announced Date:
- April 22, 2026
- Indication:
- Refractory - Non small cell lung cancer (NSCLC)
Announcement
BeyondSpring Inc. today reported new preclinical data at the 2026 Annual Meeting of the American Association for Cancer Research (AACR) demonstrating that Plinabulin has the potential to enhance both the efficacy and tolerability of ADC therapy — potentially boosting anticancer responses while keeping patients on treatment long enough to benefit.
AI Summary
At AACR 2026, BeyondSpring reported preclinical data showing Plinabulin dramatically improves complete response rates and survival when added to leading ADCs such as trastuzumab deruxtecan and datopotamab deruxtecan, with or without PD‑1/PD‑L1 immune checkpoint inhibitors. In laboratory and animal models, the combinations produced deeper tumor shrinkage and longer survival than the ADCs alone, suggesting stronger anticancer activity across topoisomerase inhibitor–based ADC regimens.
Plinabulin acts as a GEF‑H1 agonist that matures dendritic cells, helps replenish cancer‑fighting blood cells, disrupts tumor blood vessels, and reduces treatment‑related chromosomal instability. These complementary effects both boost efficacy and lower toxicity, which could help patients stay on therapy long enough to benefit. The findings support testing Plinabulin as a potential backbone agent for multiple ADC combinations and justify advancing combination studies into clinical evaluation.
Read Announcement- Drug:
- Plinabulin (Trial 103 - DUBLIN-3)
- Announced Date:
- September 16, 2024
- Indication:
- Refractory - Non small cell lung cancer (NSCLC)
Announcement
BeyondSpring Inc. presented final data on Dublin-3 study (2L/3L EGFR wild-type NSCLC) focusing on safety outcomes on September 14, 2024 at European Society for Medical Oncology (ESMO) Congress 2024 in Barcelona, Spain. Full data on Dublin-3 study was published on September 9, 2024 in the Lancet Respiratory Medicine
AI Summary
BeyondSpring Inc. recently presented final data on the Dublin-3 study at the European Society for Medical Oncology (ESMO) Congress 2024 in Barcelona on September 14, 2024. This study focused on 2L/3L EGFR wild-type non-small cell lung cancer (NSCLC) patients and mainly evaluated the safety outcomes of its treatment regimen. The findings indicated a favorable safety profile, with adverse effects that were manageable and consistent with expectations for patients in this setting. The full set of data from the Dublin-3 study was published in the Lancet Respiratory Medicine on September 9, 2024, offering detailed insights into the treatment’s tolerability and potential for addressing unmet needs in advanced lung cancer care. These results underscore BeyondSpring’s ongoing efforts to develop and refine innovative therapies for NSCLC, aiming to improve safety and outcomes for patients with challenging cancer profiles.
Read Announcement- Drug:
- Plinabulin (Trial 103 - DUBLIN-3)
- Announced Date:
- September 10, 2024
- Indication:
- Refractory - Non small cell lung cancer (NSCLC)
Announcement
BeyondSpring Inc. announces Dublin-3 final phase 3 efficacy data of its late clinical-stage agent Plinabulin in combination with docetaxel in second/third line (2L/3L) advanced and metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) wild-type.
AI Summary
BeyondSpring Inc. announced final phase 3 data from the Dublin-3 study, which evaluated the efficacy of its late-stage drug Plinabulin combined with docetaxel in patients with advanced and metastatic non-small cell lung cancer (NSCLC) who have EGFR wild-type. The study, conducted in a second/third line setting after platinum-based therapy failure, showed that the plinabulin/docetaxel combination significantly improved overall survival, progression free survival, and the objective response rate compared with docetaxel alone. Additionally, the combination reduced the occurrence of severe (Grade 4) neutropenia, a common and serious side effect of docetaxel. The encouraging efficacy and safety results were presented at the ISLAC 2024 World Conference on Lung Cancer and published in Lancet Respiratory Medicine, suggesting a promising new treatment option for this challenging patient population.
Read Announcement
Plinabulin FDA Regulatory Timeline and Events
Plinabulin is a drug developed by BeyondSpring for the following indication: Patients with non-small cell lung cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- plinabulin
- Announced Date:
- December 12, 2025
- Indication:
- Patients with non-small cell lung cancer
Announcement
BeyondSpring Inc. announced results from the Asian subset (n=488) of its global Phase 3 DUBLIN-3 trial evaluating Plinabulin plus docetaxel compared to docetaxel alone in second- or third-line EGFR wild-type non-small cell lung cancer (NSCLC).
AI Summary
BeyondSpring Inc. reported results from the Asian subset (n=488) of its Phase 3 DUBLIN-3 trial testing plinabulin plus docetaxel versus docetaxel alone in second- or third-line EGFR wild-type non-small cell lung cancer. The findings were presented at ESMO Asia 2025 by Dr. Baohui Han.
In the Asian intent-to-treat group (plinabulin+docetaxel n=243; docetaxel n=245), median overall survival was 10.8 months versus 8.8 months (HR 0.81; p=0.0426). The non-squamous subgroup showed a stronger effect (HR 0.69) with a 3-month median OS gain (p=0.0064). The combination also roughly doubled 2‑ and 3‑year survival rates, suggesting durable benefit.
Safety improved markedly: grade 4 neutropenia fell from 26.5% with docetaxel alone to 3.9% with the combination (p<0.0001). Better tolerability may help patients stay on chemotherapy. BeyondSpring says the results support plinabulin’s late-stage candidacy and a global confirmatory Phase 3 study.
Read Announcement- Drug:
- plinabulin
- Announced Date:
- July 7, 2025
- Indication:
- Patients with non-small cell lung cancer
Announcement
BeyondSpring Inc. announced publication of a human clinical study in Med (Cell Press) demonstrating that Plinabulin, when combined with radiation and a checkpoint inhibitor, induces dendritic cell (DC) maturation and elicits tumor responses in patients across multiple cancer types who had failed prior ICI therapy.
AI Summary
BeyondSpring Inc. announced a human clinical study published in Med (Cell Press) showing that Plinabulin, when combined with radiation and a checkpoint inhibitor, can trigger dendritic cell maturation in patients with various cancers who had previously failed immune checkpoint inhibitor (ICI) therapy. The study found an overall response rate of 23% and a disease control rate of 54% in non-irradiated lesions, suggesting promising clinical activity. Researchers discovered that Plinabulin works through the GEF-H1–dependent pathway to mature dendritic cells, which may allow doctors to predict which patients will benefit from the treatment by examining a baseline GEF-H1 immune signature. Dr. Steven Lin highlighted the potential of this new approach to reverse resistance to ICI therapy, indicating that Plinabulin could offer renewed hope for patients with treatment-resistant cancers.
Read Announcement- Drug:
- plinabulin
- Announced Date:
- June 3, 2025
- Indication:
- Patients with non-small cell lung cancer
Announcement
BeyondSpring Inc. announces that it presented interim phase 2 data on the 303 Study, a study in 2L/3L non-small cell lung cancer (NSCLC) after disease progression on 1L PD-1/L1 inhibitors with and without chemotherapy (NCT05599789), with financial support from Merck's (Rahway, NJ USA) Investigator Studies Program and provision of study drug, at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, on May 31st, 2025 in Chicago, IL.
AI Summary
BeyondSpring Inc. presented interim Phase 2 data from its 303 Study at the 2025 American Society of Clinical Oncology Annual Meeting in Chicago, IL, on May 31, 2025. The study focused on patients with metastatic non-small cell lung cancer (NSCLC) who experienced disease progression after first-line treatment with PD-1/L1 inhibitors, with or without chemotherapy. Financial support and study drug were provided by Merck’s Investigator Studies Program. In this trial involving 47 patients, the combination of Plinabulin, pembrolizumab, and docetaxel showed promising results, with a median progression-free survival of 6.8 months and a 15-month overall survival rate of 78%. These findings suggest that the triple therapy might help re-sensitize tumors to immunotherapy, offering a potential new treatment option for patients with limited choices following failure of standard PD-1/L1 therapies.
Read Announcement- Drug:
- plinabulin
- Announced Date:
- March 27, 2025
- Indication:
- Patients with non-small cell lung cancer
Announcement
BeyondSpring Inc. Highlights Key Clinical & Strategic Milestones
AI Summary
BeyondSpring Inc. marked a pivotal year in 2024 by achieving major clinical and strategic milestones. The company’s lead candidate, Plinabulin, demonstrated a statistically significant overall survival benefit in second- and third-line NSCLC (EGFR wild-type) compared to standard docetaxel treatment. These positive Phase 3 results, published in The Lancet Respiratory Medicine, support the company’s plan to submit regulatory applications in China and other regions.
Alongside this, BeyondSpring is exploring Plinabulin’s potential as an immuno-oncology agent. An ongoing Phase 2 study has shown promising results when Plinabulin is combined with PD-1 inhibitors, suggesting it may help re-sensitize tumors that have become resistant to current therapies. Additionally, the company’s co-founded SEED Therapeutics made strategic progress by entering a research collaboration with Eisai, with possible milestone payments of up to $1.5 billion, and closing a $24 million Series A-3 financing round.
Read Announcement
DUBLIN FDA Regulatory Events
DUBLIN is a drug developed by BeyondSpring for the following indication: In 2L/3L EGFR Wild-type NSCLC.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- DUBLIN
- Announced Date:
- December 11, 2025
- Indication:
- In 2L/3L EGFR Wild-type NSCLC
Announcement
BeyondSpring Inc. announced new post-hoc analyses from its global Phase 3 DUBLIN-3 Study (Lancet Resp Med 12:775, 2024), showing that Plinabulin plus docetaxel provides clinically meaningful benefit for patients with EGFR wild-type (WT) non-squamous (NSQ) non-small cell lung cancer (NSCLC) who progressed after anti-PD-(L)1 immunotherapy.
AI Summary
BeyondSpring reported post-hoc analyses from the global Phase 3 DUBLIN-3 study showing that plinabulin plus docetaxel provided clear benefits for EGFR wild-type, non-squamous NSCLC patients who progressed after anti-PD-(L)1 therapy. In this subset, median overall survival was 15.8 months with the combination versus 11.7 months with docetaxel alone (HR=0.55). Median progression-free survival was 5.6 vs. 3.8 months (HR=0.67), and objective response rate was 18.2% vs. 8.0%. Metastasis-free survival improved to 15.34 vs. 7.7 months (HR=0.52), and new brain metastases were reduced (4.32% vs. 7.83%).
Plinabulin also showed a favorable safety profile: it cut grade 4 neutropenia (5.13% vs. 33.58%) and reduced exposure-adjusted grade 3/4 adverse events (p=0.0235), which may allow longer treatment. The drug’s dendritic-cell maturation mechanism could help restore antigen presentation and T-cell function after checkpoint inhibitor resistance. BeyondSpring plans a global confirmatory Phase 3 DUBLIN-4 trial to further evaluate the combination.
Read Announcement
