On April 20, 2026 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported will webcast management participation as follows:

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!

• BofA Securities Health Care Conference 2026 at 10:00 a.m. PT (1:00 p.m. ET) on Tuesday, May 12, 2026

• Goldman Sachs 47th Annual Global Healthcare Conference at 2:00 p.m. ET on Monday, June 8, 2026

The sessions may be accessed from the "Investors & Media" page of Regeneron’s website at View Source Replays and transcripts of the webcasts will be archived on the Company’s website for at least 30 days.

(Press release, Regeneron, APR 20, 2026, View Source [SID1234664552])

On April 20, 2026 Independent biopharmaceutical company Specialised Therapeutics (ST) reported the approval of ZEPZELCA (lurbinectedin), in combination with atezolizumab (Tecentriq), as a new first-line maintenance treatment option for adult patients in Australia and Singapore, who have been diagnosed with extensive-stage small cell lung cancer (ES-SCLC), an aggressive form of lung cancer.[1],[2] This follows the recent decision by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) to issue a positive opinion recommending the approval of ZEPZELCA in Europe.[10]

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!

In combination with atezolizumab, ZEPZELCA has been approved for use in Australia and Singapore as a maintenance treatment for extensive-stage small cell lung cancer (ES-SCLC) in adult patients whose disease has not progressed after first-line induction therapy with atezolizumab, carboplatin and etoposide.[1],[2]

Both approvals for ZEPZELCA in ES-SCLC were obtained under Project Orbis — an initiative of the United States Food and Drug Administration’s (US FDA’s) Oncology Center of Excellence. These ZEPZELCA approvals represent the eighth time ST has successfully navigated the Project Orbis process since 2021.

Lung cancer remains a significant health challenge in the region, with an estimated 15,000 diagnoses and 9,000 deaths from the disease each year in Australia.[7],[8] In Singapore, lung cancer is the third most common cancer, with 9,732 new cases diagnosed between 2019-2023.[11] Small cell lung cancer (SCLC) is a highly aggressive cancer that has often already spread to other organs when first diagnosed.[6] It accounts for approximately 10-15% of all lung cancer cases and has a low 5-year survival rate of under 7%.[6]

Professor Nick Pavlakis, Medical Oncologist from Royal North Shore Hospital in Sydney, acknowledged the approval of the new combination therapy as an important step in helping to improve outcomes for patients with ES-SCLC.

"Most patients with small cell lung cancer typically present with extensive-stage disease at diagnosis, meaning they are often faced with experiencing high rates of relapse or recurrence, limited treatment options and a poor prognosis," said Professor Pavlakis.

"While outcomes for patients have improved over the past five years with the addition of immunotherapy to chemotherapy, there continues to be a significant clinical need to improve on first-line therapies used to treat extensive-stage small cell lung cancer to prolong disease control and enhance survival. Today’s announcement is welcome news for the medical and patient community."

ZEPZELCA is being made available in Australia, New Zealand, Singapore, Malaysia, Thailand and Vietnam by Specialised Therapeutics (ST), under exclusive license from European biopharmaceutical company PharmaMar, which has pioneered the development of marine-based oncology medicines.

ST Chief Executive Officer, Mr Carlo Montagner, said the approval of ZEPZELCA for ES-SCLC in the first-line setting would provide clinicians and patients with an important new therapeutic option for this difficult to treat cancer.

"We are delighted to have secured regulatory approvals for ZEPZELCA in combination with atezolizumab as a first-line maintenance therapy for adults diagnosed with ES-SCLC in Australia and Singapore," said Mr Montagner.

"Despite the improved efficacy of first-line therapies for ES-SCLC that have been available since 2019, survival outcomes remain suboptimal, with an estimated 40% of patients experiencing a relapse and requiring second-line treatment. The availability of additional first-line treatment options will enable eligible patients and their clinicians to find the therapy that is right for them, can help to improve their quality of life and importantly, give them more time to spend with their families and loved ones."

Chief Medical Officer for PharmaMar, Javier Jimenez, welcomed the regulatory approval for ZEPZELCA, saying: "We are very pleased that patients in Australia and Singapore can have access to this new therapy, as it marks an important milestone in the management of this disease, where a significant unmet medical need persists. Building on more than 40 years of commitment to research in diseases with limited treatment options, we will continue to collaborate with our partner in Australia to enable timely and equitable access to this new treatment."

ZEPZELCA belongs to a class of medicines known as alkylating agents, which work by damaging the DNA of cancer cells, helping to slow or stop their growth.[12] The regulatory approvals for ES-SCLC in Australia and Singapore were based on results from the Phase 3 IMforte clinical trial. The study enrolled 660 treatment-naïve patients with ES-SCLC across 13 countries in the induction phase. Following this, 483 patients who responded to induction treatment were randomised to receive either ZEPZELCA with atezolizumab (LU-AT) or atezolizumab monotherapy (AT) as first-line maintenance therapy.[13] The trial results supported the use of LU-AT as a new first-line maintenance treatment option over AT alone in patients with this aggressive cancer, with improvements recorded in both median progression free survival (PFS; 5.4 months vs. 2.1 months) and median overall survival (OS; 13.2 months vs.10.6 months).[13]

Significant variations in treatment-related adverse events (AEs) were noted in the two trial groups (83.5% in patients receiving LU-AT vs. 40% among patients receiving AT monotherapy).[13] Treatment with LU-AT was considered to be generally well tolerated, with no new or unexpected safety signals.[13] The most common adverse reactions (≥ 30%), including laboratory abnormalities, in patients who received ZEPZELCA with atezolizumab were decreased lymphocytes, decreased platelets, decreased haemoglobin, decreased leukocytes, decreased neutrophils, nausea, and fatigue/asthenia.

For further details on ZEPZELCA, contact your healthcare professional and refer to the approved Australian Consumer Medicine Information, available from the TGA’s website.*

PBS Information: ZEPZELCA is not listed on the Pharmaceutical Benefits Scheme (PBS).

(Press release, Specialised Therapeutics Australia, APR 20, 2026, View Source [SID1234664569])

On April 20, 2026 Radiopharm Theranostics (ASX: RAD, Nasdaq: RADX, "Radiopharm" or the "Company"), a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for areas of high unmet medical need, reported that new data from the ongoing Phase 0/1 HEAT trial (NCT06824155), evaluating 177Lu-RAD202, a first-in-class HER2-targeted radiopharmaceutical therapy, will be presented as a poster at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026, being held April 17–22, 2026 in San Diego, California.

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 first-in-human results represent an important early milestone for our HER2-targeted radiopharmaceutical program," said Dr. Dimitris Voliotis, Chief Medical Officer of Radiopharm Theranostics. "In a heavily pre-treated patient population with significant unmet need, 177Lu-RAD202 demonstrated encouraging tumor uptake and a favorable safety profile at the lowest dose level. Importantly, the observed dosimetry supports continued dose escalation, which was recently approved by the Data Safety and Monitoring Committee (DSMC) to advance to the third cohort at 130 mCi dosing. We look forward to further evaluating the therapeutic potential of this novel approach and expect to see signs of antitumor activity at higher, more therapeutic dose levels."

The AACR (Free AACR Whitepaper) poster highlights first-in-human safety, biodistribution, dosimetry and tumor uptake clinical findings from the initial lowest dose cohort of three patients with advanced HER2-positive breast and urothelial cancers who had received multiple prior metastatic therapies and were dosed at 30 mCi.

Key Findings from the AACR (Free AACR Whitepaper) Abstract and Poster

Meaningful tumor uptake of 177Lu-RAD202 was observed at the initial and lowest dose level of 30 mCi, particularly in breast cancer lesions
177Lu-RAD202 was generally well tolerated in the first three treated patients, with predominantly Grade 1–2 treatment-emergent adverse events
No dose-limiting toxicities or treatment discontinuations due to adverse events were observed
Organ-level absorbed radiation doses were within expected and clinically acceptable ranges, supporting continued dose escalation
Poster Presentation Details

Title: A First-in-Class HER2-Targeted Radiopharmaceutical Therapy: Initial Findings from the Phase 0/1 HEAT Trial of 177Lu-RAD202 in HER2+ Advanced Solid Tumors
Abstract Number: CT046
Presenter: Dimitris Voliotis, M.D., Chief Medical Officer of Radiopharm Theranostics
Session: Poster Session
Dates: April 20, 2026 at 9:00 AM PT
The complete poster can be found on the Company’s website here.

On April 8, 2026, Radiopharm Theranostics announced the positive recommendation from the Data Safety and Monitoring Committee (DSMC) to advance 177Lu-RAD202 to the third cohort at a dose level of 130mCi in the Phase 1 ‘HEAT’ clinical trial in patients with HER2-positive advanced solid tumors1. The DSMC is a multidisciplinary committee that conducts detailed reviews of study data, discusses potential safety events and provides recommendations regarding trial continuation.

About the HEAT Trial

177Lu-RAD202 is a Lutetium-177–labeled single-domain antibody (sdAb) designed to target HER2-expressing tumors. The sdAb format enables deep tumor penetration and rapid systemic clearance, while the beta-emitting isotope 177Lu delivers cytotoxic radiation with potential bystander effects independent of HER2 receptor density.

The HEAT trial (HER2-Antibody Therapy with Lutetium-177; (NCT06824155) is a first-in-human, open-label, multicenter integrated Phase 0/1 study evaluating 177Lu-RAD202 in patients with HER2-positive locally-advanced or metastatic solid tumors.

Phase 0 evaluates biodistribution, pharmacokinetics, and radiation dosimetry using an imaging dose
Phase 1 consists of multiple-dose escalation to assess safety, tolerability, tumor targeting, and to determine the recommended Phase 2 dose
About RAD202:

RAD202 is a proprietary single-domain monoclonal antibody (sdAb) that targets the Human Epidermal Growth Factor Receptor 2 (HER2)-positive expression in advanced solid tumors. HER2 is overexpressed in breast cancer and several other solid tumors and represents a validated target in oncology. In a previous diagnostic study of ten HER2-positive breast cancer patients, RAD202 demonstrated clinical proof-of-concept and had positive safety and biodistribution.

(Press release, Radiopharm Theranostics, APR 20, 2026, View Source [SID1234664586])

On April 20, 2026 Eli Lilly and Company (NYSE: LLY) and Kelonia Therapeutics, Inc. ("Kelonia"), a clinical-stage biotechnology company pioneering in vivo gene delivery, reported a definitive agreement for Lilly to acquire Kelonia.

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!

Kelonia has developed a proprietary in vivo gene placement system (iGPS ) that uses specially engineered lentiviral-based particles designed to efficiently and selectively enter T-cells inside the body, allowing the patient’s own body to generate chimeric antigen receptor T-cell (CAR-T) therapies that can treat underlying disease. Kelonia’s lead program, KLN-1010, is an investigational, one-time intravenous gene therapy that generates anti-B-cell maturation antigen (BCMA) CAR-T cells, targeting the BCMA protein expressed on the surface of multiple myeloma cells. Encouraging early clinical results were presented in the plenary session of the 2025 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, providing initial clinical validation and demonstrated promising tolerability. KLN-1010 could represent a transformative advance in the treatment of multiple myeloma by eliminating the complexities of ex vivo patient-specific cell therapy manufacturing, and pre-administration chemotherapy.

"Autologous CAR-T therapies have meaningfully improved outcomes for patients with various cancers, but significant manufacturing, safety, and access barriers mean that only a fraction of eligible patients actually receive them. Kelonia’s in vivo platform has the potential to change that by delivering rapid, durable responses in a far simpler, off-the-shelf format," said Jacob Van Naarden, executive vice president and president of Lilly Oncology and head of corporate business development. "The early clinical data for KLN-1010 are highly encouraging, both as a potential step forward for patients with multiple myeloma and as proof of concept for Kelonia’s platform. We look forward to working together with the Kelonia team to rapidly advance KLN-1010 to address patient need and recognize the full potential of their platform in other conditions where patients may benefit."

"Kelonia’s leadership in advancing the immense promise of in vivo cell therapy is unmatched, extending its reach and impact beyond the traditional boundaries of personalized medicine," said Kevin Friedman, Ph.D., chief executive officer of Kelonia. "We have demonstrated the ability to achieve deep multiple myeloma remissions with significantly reduced complexity and cost relative to ex vivo CAR T-cell approaches. In combination with Lilly’s strengths, our in vivo iGPS platform is positioned to broaden the reach of cell therapy beyond the current CAR-T landscape in hematologic malignancies and to transform treatment across a far wider range of cancers and other serious diseases. It’s been a privilege continuing the journey started by Michael Birnbaum and the Venrock team. I am deeply grateful to our employees, partners, and investigators, and most importantly, the patients who make this progress possible."

Under the terms of the agreement, Lilly will acquire Kelonia, and Kelonia shareholders will receive up to $7.00 billion in cash, inclusive of an upfront payment of $3.25 billion, and subsequent payments upon achievement of certain clinical, regulatory and commercial milestones.

The transaction is subject to customary closing conditions, including customary regulatory approvals, and is expected to close in the second half of 2026. Lilly will determine the accounting treatment of this transaction in accordance with Generally Accepted Accounting Principles (GAAP) upon closing. This transaction will thereafter be reflected in Lilly’s financial results and financial guidance.

For Lilly, Kirkland & Ellis LLP is acting as legal counsel. For Kelonia, Jefferies LLC is acting as financial advisor, and Goodwin Procter LLP is acting as legal counsel.

(Press release, Eli Lilly, APR 20, 2026, View Source [SID1234664537])

On April 20, 2026 Verismo Therapeutics, a clinical-stage CAR T cell therapy company pioneering a novel multichain KIR-CAR platform technology, reported the first clinical results from its ongoing Phase 1 STAR-101 clinical trial (NCT05568680) evaluating SynKIR-110 KIR-CAR living medicine in patients with advanced mesothelin-expressing solid tumors, including ovarian cancer, mesothelioma, and cholangiocarcinoma. These late-breaking data were presented during the Clinical Trial Plenary session 3 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026 in San Diego, CA (Abstract CT 104).

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!

"We are excited to share Verismo’s first presentation of clinical data evaluating our multi-chain SynKIR-110 KIR-CAR candidate, showing a positive safety profile, dose-dependent efficacy signals, and no dose-limiting toxicities," said Laura Johnson, Ph.D., Chief Operating Officer and Chief Scientific Officer of Verismo Therapeutics. "These data represent an important milestone for Verismo’s KIR-CAR platform, which is designed to combine the best of natural killer and T cells to fight cancer and may provide a more durable response than current single-chain CAR T therapies that are prone to exhaustion in difficult-to-treat solid tumor microenvironments."

Janos L. Tanyi, M.D., Ph.D., Principal Investigator for STAR-101 and Professor at the Perelman School of Medicine at the University of Pennsylvania (Penn), presented the data from nine patients treated across three dose-escalation cohorts. SynKIR-110 in dose level cohorts 1 through 3 showed a favorable safety profile, with no dose-limiting toxicities, no high-grade (Gr3+) cytokine release syndrome (CRS), and no immune effector cell-associated neurotoxicity syndrome (ICANS) events observed.

The initial data showed on-target biologic activity based on KIR-CAR T cell expansion and persistence in patients and serum cytokine changes after SynKIR-110 infusion. Anti-tumor activity was observed at increased dose levels, with 1 of 3 patients at dose level 3 achieving a partial response per RECIST criteria that was ongoing after 3+ months at the interim data cut-off for this dataset, which was September 2025. The trial remains ongoing, with continued enrollment to evaluate safety and determine the recommended Phase 2 dose.

"These data are significant because patients with mesothelin-expressing solid tumors continue to face significant and urgent needs for better treatments," said Dr. Tanyi, who is an associate professor of Obstetrics and Gynecology at Penn. "The safety profile we have observed, including low grade (Gr 1-2) CRS in only 3 of 9 patients, and no neurotoxicity, combined with early signs of clinical activity, support continued investigation of this novel approach in patients with solid tumors."

About SynKIR-110 KIR-CAR and the STAR-101 Clinical Trial

SynKIR-110 KIR-CAR is an investigational autologous engineered cell therapy developed using Verismo’s KIR-CAR platform. This approach utilizes a multi-chain, split-signaling architecture derived from natural killer cells, designed to drive long-term anti-tumor T cell function without T cell exhaustion. By keeping antigen recognition separate from T cell activation, the multi-chain architecture is intended to sustain T cell activity even in challenging solid-tumor microenvironments.

The STAR-101 clinical trial is a first-in-human, multicenter, open-label Phase 1 study in the U.S., designed to evaluate the safety, feasibility, and preliminary efficacy of SynKIR-110 in patients with advanced mesothelin-expressing solid tumors, including ovarian cancer, mesothelioma, and cholangiocarcinoma. These target indications are associated with poor prognosis and remain areas of high unmet medical need. The STAR-101 trial follows a dose-escalation design with an expansion cohort at the recommended Phase 2 dose. Patient recruitment and dose escalation in the trial is ongoing.

(Press release, Verismo Therapeutics, APR 20, 2026, View Source [SID1234664570])