On May 18, 2026 BeyondSpring Inc. (NASDAQ: BYSI) ("BeyondSpring" or the "Company"), a clinical-stage company developing transformative therapies for the treatment of cancer and other diseases, reported an upcoming poster presentation of Study 303, an investigator-initiated study supported by Merck, known as MSD outside of the United States and Canada, and BeyondSpring, in patients with 2L/3L NSCLC who progressed on PD-1/PD-L1 inhibitors, at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place May 29 through June 2 in Chicago, IL.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Presentation details are as follows:

Title: A Phase 2 Study of Plinabulin (Plin)/Docetaxel (Doc) plus Pembrolizumab (Pemb) in Metastatic NSCLC (mNSCLC) After Acquired Resistance (AR) to Anti-PD-1/L1 Alone or in Chemotherapy Combination: Efficacy and Immunophenotyping
Presenter/Authors: Yan Xu, Minjiang Chen, Xiaoxing Gao, Huiyu Huang, Yue Chang, Xiao-Yian Liu, Wei Zhong, Jing Zhao, RuiLi Pan, Taisheng Li, Mengzhao Wang
Presentation Time: Sunday, May 31, 2026, from 9:00 a.m. to 12:00 p.m. CDT
Location: McCormick Place, Chicago, IL
Session: Lung Cancer – Non-Small Cell Metastatic
Abstract Number: 8567
Poster Board Number: 357

(Press release, BeyondSpring Pharmaceuticals, MAY 18, 2026, View Source [SID1234665850])

On May 18, 2026 Parabilis Medicines reported a strategic research collaboration with Regeneron Pharmaceuticals, Inc. to discover and develop multiple therapeutic candidates based on Parabilis’s Helicon peptide platform, with a particular focus on Antibody-Helicon Conjugates (AHCs), a novel class of therapeutics designed to target challenging and historically "undruggable" targets.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Helicons are stabilized, cell-penetrant alpha-helical peptides designed to engage intracellular protein targets, including flat surfaces not well suited to traditional small molecule binding. The collaboration is designed to explore the use of Helicons both as stand-alone therapies and as part of AHCs.

Antibody–drug conjugates traditionally use antibodies to selectively deliver drug payloads into target cells to drive cell death from within. The AHCs envisioned by this collaboration are underpinned by the same delivery principle: pairing antibody-targeted cell access with Helicon payloads designed to selectively modulate specific intracellular proteins, including some long considered undruggable.

"Through our own pipeline, we have demonstrated the potential of Helicon peptides to directly inhibit or degrade several disease-driving proteins in oncology that have long been considered out of reach," said Mathai Mammen, M.D., Ph.D., Chairman, CEO and President of Parabilis Medicines. "We are thrilled to enter into a collaboration with Regeneron that builds on this foundation, combining the intracellular access and binding capabilities of our Helicons against challenging targets with antibodies from Regeneron."

Under the terms of the agreement, Parabilis is to receive $125 million from Regeneron in the form of a $50 million upfront payment and a commitment to invest $75 million in Parabilis’s next equity financing, subject to certain conditions. Parabilis is also eligible to receive milestone payments for development, regulatory, and commercial milestones, as well as tiered royalties up to the low double digits on future net sales of any approved medicines resulting from the collaboration. With five initial targets, the agreement provides the potential for up to approximately $2.2 billion in total milestone payments to Parabilis. Under the terms of the agreement, additional targets may be pursued upon additional option payments from Regeneron.

The agreement provides for the parties to collaborate to discover new Helicons and AHCs, which Regeneron will then be responsible for advancing through development, manufacturing and worldwide commercialization.

(Press release, Parabilis Medicines, MAY 18, 2026, View Source [SID1234666534])

On May 17, 2026 ImPact Biotech, a clinical-stage biotechnology company focused on developing Padeliporfin Vascular Targeted Photodynamic therapy (VTP) to treat a range of solid tumors, reported updated results from ENLIGHTED, the Company’s ongoing Phase 3 study of Padeliporfin VTP treatment in patients with low-grade upper tract urothelial carcinoma (UTUC). These data will be shared during a podium presentation and in an interactive poster at the American Urological Association (AUA) Annual Meeting taking place May 15-18, 2026, in Washington, D.C.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"These updated efficacy and durability results from the Phase 3 ENLIGHTED trial continue to reinforce Padeliporfin VTP’s potential to become an attractive alternative, minimally invasive ureteroscopic treatment option for patients with low-grade UTUC," said Eyal Morag, M.D., Chief Medical Officer of ImPact Biotech. "The promising complete response rate and encouraging durability observed to date, alongside a well-established safety profile, further support the opportunity to provide a meaningful organ-sparing treatment for patients with limited options in UTUC and additional solid tumor indications. We look forward to sharing topline data from ENLIGHTED later this year and preparing for regulatory submission in 2027, while exploring strategic opportunities to commercialize the program and maximize Padeliporfin VTP’s impact for UTUC patients facing great unmet need."

Key updated results from the ongoing Phase 3 ENLIGHTED study of Padeliporfin VTP:

As of April 20, 2026, the data cut-off for the poster presentation at AUA 2026, 82 patients had begun treatment, of which 72 had completed PRE and were evaluable for efficacy.

Efficacy Profile:

Overall response rate: 88%
50 of the 72 (70%) response-evaluable patients achieved a CR at the end of PRE.
13 of the 72 (18%) response-evaluable patients achieved a partial response (PR) at the end of PRE.

Durability Profile:

18 of the 21 (85.7%) response-evaluable patients who completed the Maintenance Treatment Phase (MTP) sustained CRs in the treated area for at least 12 months as of the data cutoff date, with additional patients ongoing the MTP that have yet to complete the 12-month evaluation period. Padeliporfin VTP treatment has demonstrated evidence of efficacy and durability.
The current median duration of response (DoR) in the treated area for evaluable patients is 23.9 months based on available follow-up, with ongoing responses still being observed.

Safety and Tolerability Profile:

Padeliporfin VTP was well-tolerated with a safety profile consistent with the previous data obtained from the Phase 1 study and previously announced preliminary Phase 3 results. Padeliporfin VTP treatment has demonstrated a consistent and acceptable safety profile.
Adverse events (AEs): the majority of treatment-emergent adverse events (TEAEs) were mild or moderate, primarily related to the ureteroscopic procedure, and resolved within a few days. Two patients had Grade 3 serious adverse events related to VTP treatment which resolved within two days. No TEAEs of special interest were reported and no TEAE led to discontinuation of the study treatment.

While the Company is pursuing strategic partnering opportunities to support the commercialization of its low-grade UTUC program, ImPact recently presented initial data supporting the advancement of Padeliporfin VTP in locally advanced pancreatic ductal adenocarcinoma (LA-PDAC) at the Society of Interventional Radiology (SIR) 2026 Annual Meeting, which demonstrated a consistent tolerability profile alongside early signs of clinical efficacy, showing potential to convert patients with unresectable stage III LA tumors to surgically resectable candidates.

Additional updates from both programs will be presented at the American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place May 29 – June 2, 2026, in Chicago, IL.

AUA Presentation Details:

Interactive Poster Title: The ENLIGHTED Phase 3 Trial: Advancing Treatment of Low-Grade Upper Tract Urothelial Carcinoma (LG UTUC) with Padeliporfin Vascular-Targeted Photodynamic Therapy (VTP)
Presenter: Vitaly Margulis, M.D., Professor of Urologic Oncology, University of Texas Southwestern Medical Center
Poster Number: IP30-04
Session Title: Bladder Cancer: Upper Tract Transitional Cell Carcinoma I
Session Date & Time: Saturday, May 16, 2026 at 7:00 AM ET

Podium Presentation Title: ENLIGHTED Phase 3 Trial of Non-Thermal, Drug-Activated Padeliporfin Vascular-Targeted Photodynamic Therapy (VTP) for Low-Grade Upper Tract Urothelial Carcinoma (LG UTUC)
Presenter: Jonathan Coleman, M.D., Urologic Surgeon, Memorial Sloan Kettering Cancer Center
Session Title: Clinical Trials in Progress: Bladder Cancer
Session Date & Time: Sunday, May 17, 2026 at 9:16 AM ET

About ENLIGHTED
The Phase 3 ENLIGHTED study is a single arm, non-randomized, open-label, pivotal trial evaluating Padeliporfin VTP for the treatment of low-grade UTUC. Across 29 clinical sites globally, ImPact is targeting enrollment of up to 100 patients with new or recurrent low-grade, non-invasive UTUC of
the kidney or ureter. The study consists of two parts – an Induction Treatment Phase (ITP) and Maintenance Treatment Phase (MTP) – across which Padeliporfin, a photosensitizing drug, is administered intravenously and VTP therapy is performed, via an ureteroscopy which applies a laser fiber illumination for 10 minutes in the proximity of the tumor, leading to local activation of Padeliporfin in the tumor. ITP consists of one-to-three treatments with VTP therapy at four-week intervals or until a complete response (CR) is achieved; MTP follows with standard-of-care treatment alongside VTP therapy administered every three months for up to 12 months. The study’s primary objective is to assess the response rate to Padeliporfin VTP treatment at the end of ITP, with secondary objectives evaluating safety, tolerability and duration of response.

(Press release, ImPact Biotech, MAY 17, 2026, View Source [SID1234665816])

On May 17, 2026 EORTC reported final results from a landmark EORTC randomised trial with more than 20 years of follow-up show that irradiation of the internal mammary and medial supraclavicular lymph nodes reduces breast cancer mortality but does not improve overall survival. The findings highlight the importance of very long-term follow-up when evaluating cancer treatments, particularly in patients with otherwise favourable prognosis.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The results stem from EORTC trial 22922/10925 and were presented at the ESTRO 2026 Congress in Stockholm during the plenary session: Joint Green Journal – The Lancet Oncology Top Clinical Trials. Reflecting the strength and clinical relevance of these findings, the planned 20-year analysis of the full trial population has been simultaneously published in CA: A Cancer Journal for Clinicians, while The Lancet Oncology has accepted to publish soon a complementary paper reporting an unplanned subset analysis in the patients with node-negative (pN0) breast cancer.

Between 1996 and 2004, the trial enrolled 4,004 patients with stage I–III breast cancer at 46 centres in 13 countries. Patients were randomised to receive postoperative radiation therapy with or without elective irradiation of the internal mammary and medial supraclavicular (IM-MS) lymph nodes. At final analysis, the median follow-up was 22.2 years — the longest planned, as well as median, follow-up of any randomised breast cancer radiation therapy trial.

Long‑term outcomes across the overall trial population
At 20 years, overall survival was similar in patients treated with or without IM-MS irradiation. However, breast cancer–related mortality was significantly lower among patients who received IM-MS irradiation. This benefit was counterbalanced over time by an increase in deaths from causes other than breast cancer, which emerged after approximately 15 years, resulting in no survival advantage.

Long-term cardiac and pulmonary toxicity was reported more frequently after IM-MS irradiation, although severe side effects remained very uncommon. Of note, patients were treated using radiation therapy techniques available more than two decades ago.

Outcomes in node-negative breast cancer patients
The proffered paper presented at ESTRO also included the subset analyses on the 1,778 patients with node-negative (pN0) breast cancer and centrally or medially located tumours. Despite a lower absolute risk of breast cancer death in this group, the long-term pattern closely mirrored that of the overall trial population.

Reductions in breast cancer mortality were again offset by a later increase in non–breast cancer–related deaths, resulting in no improvement in overall survival. These findings suggest that long‑term trade‑offs must be considered even in patients with a favourable prognosis and call for careful evaluation of nodal irradiation in axillary‑node‑negative disease.

"Such large, decades-long trials with rigorous quality assurance, allowing clinically meaningful subgroup analyses, are only possible thanks to the sustained support and collaboration fostered by organisations like EORTC," agreed both study coordinators.

The investigators note that advances in modern radiation therapy planning and delivery, sharply reducing radiation exposure to organs such as the heart and lungs, very likely improves the balance between benefits and risks for patients treated today.

Why this trial matters
It provides the longest planned, as well as median follow-up, of any randomised breast cancer radiation therapy trial.
It shows that treatment benefits and risks continue to evolve well beyond 15–20 years.
It demonstrates that node‑negative patients experience similar long‑term trade‑offs as the overall trial population.
It informs ongoing discussions on optimising and potentially de-escalating treatments in favourable-risk breast cancer.
Conducted by the EORTC Radiation Oncology and Breast Cancer Groups, trial 22922/10925 remains a cornerstone study for understanding the long‑term impact of locoregional treatments in breast cancer and for guiding future research aimed at improving both survival and quality of life.

ESTRO 2026 presentation number: 5580 Internal Mammary and Medial Supraclavicular irradiation in stage I-III breast cancer: 20 years results of the randomised EORTC trial 22922/10925, including in pN0 patients (Presenter: Philip Poortmans & Orit Kaidar-Person)

Funding: This study was supported by donations from the La Ligue nationale contre le cancer from France; the KWF Kanker Bestrijding from the Netherlands; and from the Kom op tegen Kanker (Stand up to Cancer), the Flemish Cancer Society from Belgium.

The fellowship of Lydia Champezou was financially supported by the EORTC Cancer Research Fund (ECRF).

(Press release, EORTC, MAY 17, 2026, View Source [SID1234665809])

On May 17, 2026 Novartis reported new data from PSMAddition demonstrating improved prostate-specific antigen (PSA) responses with Pluvicto (lutetium (177Lu) vipivotide tetraxetan) combined with standard of care (SoC) in PSMA-positive metastatic hormone sensitive prostate cancer (mHSPC). Data were presented as a rapid oral presentation at the American Urological Association Annual Meeting 2026.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Results show that patients treated with Pluvicto experienced a higher frequency and depth of PSA response when combined with SoC (androgen receptor pathway inhibitor [ARPI] + androgen deprivation therapy [ADT]) compared to SoC alone. Risk of PSA progression was 58% lower (HR 0.42; 95% CI: 0.30-0.59) in patients treated with Pluvicto plus SoC compared to SoC alone.

"Our goal in hormone-sensitive prostate cancer is to attack and delay the cancer before it develops resistance," said Fred Saad, Professor and Chairman, Department of Surgery, University of Montreal. "The deep and durable PSA response observed by combining 177Lu-PSMA-617 with today’s standard of care, together with earlier reported rPFS data, suggest that treatment intensification with radioligand therapy may help patients delay disease progression."

Nearly all patients (>98%) in both arms had substantial declines in PSA levels. However, more patients treated with Pluvicto plus SoC achieved a deep PSA reduction than those treated with SoC alone, as measured by PSA nadir of <0.2 ng/mL.

Time from randomization Patients with PSA <0.2 ng/mL

Pluvicto + ARPI + ADT ARPI + ADT
Week 12 47.6% (235/494) 37.7% (169/448)
Week 24 73.7% (334/453) 59.7% (250/419)
Week 48 87.4% (320/366) 74.9% (295/394)
These results were observed at the second interim analysis for PSMAddition. The safety profile and tolerability of Pluvicto were consistent with its established profile in PSMAfore and VISION. Grade ≥3 adverse events (AEs) were reported in 50.7% of patients in the Pluvicto plus SoC arm, compared to 43% on SoC alone. The most common all-grade AEs were dry mouth, fatigue, nausea, hot flush and anemia.

"These data show that combining Pluvicto with today’s standard of care resulted in deeper PSA responses than ADT plus ARPI alone," said Mark Rutstein, M.D., Global Head, Oncology Development, Novartis. "As the field moves toward more precision-based approaches and earlier treatment intensification in mHSPC, we are encouraged by the potential for Pluvicto to redefine the standard of care across metastatic prostate cancer."

Novartis has filed regulatory submissions in the United States, China and Japan, with first decisions expected in H2 2026.

PSA progression signals disease resistance
PSA progression can be an early indicator of emerging disease resistance, and approximately one-third of patients do not achieve undetectable PSA levels with SOC alone3. Progression to mCRPC, which typically happens within 20 months of diagnosis, is associated with significantly worse outcomes and a life expectancy less than two years4-7. Approximately 186,000 men are diagnosed with mHSPC each year across the US, China, Japan, France, Germany, Italy, Spain and the United Kingdom1.

About Pluvicto (lutetium (177Lu) vipivotide tetraxetan)
Pluvicto is an intravenous RLT that combines a targeting compound (a ligand) with a therapeutic radionuclide (a radioactive particle, in this case lutetium-177). After administration into the bloodstream, Pluvicto binds to PSMA-expressing target cells, including prostate cancer cells that express PSMA, a transmembrane protein. Once bound, energy emissions from the radioisotope damage the target cells and nearby cells, disrupting their ability to replicate and/or triggering cell death.

Pluvicto is the only PSMA-targeted agent approved for PSMA+ mCRPC and is the first RLT to demonstrate a clinical benefit for patients with PSMA+ mHSPC in a Phase III trial. Novartis is investigating Pluvicto in oligometastatic prostate cancer, an earlier stage of disease, in the PSMA-DC trial (NCT05939414).

Educational Resources for RLT
To support the integration and safe administration of Novartis RLT products across urology and oncology, Novartis created the RLT Institute. The Institute provides educational resources on theranostics, safety and licensing, facilities and equipment, and clinical workflows to support urologists, oncologists and multidisciplinary teams as they prepare for and integrate RLT into patient care.

(Press release, Novartis, MAY 17, 2026, View Source [SID1234665811])