On April 23, 2026 Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-care biopharmaceutical company, reported its sales for the first quarter of 2026.

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Q1 2026 % change % change
€m Actual CER
Oncology 707.5 8.0 % 13.0 %
Rare Disease 147.1 109.1 % 125.4 %
Neuroscience 220.3 13.8 % 18.5 %
Total Sales 1,074.9 17.0% 22.6%

"Ipsen has delivered a strong start to 2026," said David Loew, Chief Executive Officer, Ipsen. "We advanced our strategic priorities across the business, combining strong top‑line performance with continued pipeline progress. I am very pleased with the growth of our rare liver disease franchise with the performance of Iqirvo and Bylvay. Additionally, with three Phase III readouts expected this year and three new late-stage programs starting, Ipsen is well-positioned to drive sustainable growth and deliver meaningful value for patients."

Full-year guidance 2026
Ipsen is confirming its financial guidance3 for full-year 2026:

Total sales growth greater than 13.0%, at constant currency, assuming accelerated sales growth of the portfolio excluding Somatuline and the growth of Somatuline sales due to generic lanreotide challenges. Based on the average level of exchange rates in March 2026, an adverse effect on total sales of around 1% of currencies is expected
Core operating margin greater than 35.0% of total sales
Upcoming 2026 milestones

Ipsen anticipates several key milestones across its portfolio in 2026, including:

Iqirvo (ELSPIRE trial) – Readout of pivotal Phase III in primary biliary cholangitis
Bylvay (BOLD trial) – Readout of pivotal Phase III in biliary atresia
Dysport (BEOND trials) – Readout of pivotal Phase III trials in chronic and episodic migraine
Corabotase (IPN10200, LANTIC trial) – Readout of Phase II in lateral canthal lines and forehead lines
Data from stage 1 of the Phase II LANTIC trial of corabotase (IPN10200) will be presented at the Music City SCALE (Symposium for Cosmetic Advances and Laser Education) 2026 symposium in May.

Pipeline update
On 30 January 2026, Ipsen expanded its pre‑clinical pipeline in rare neurodegenerative diseases through a global collaboration and exclusive option agreement with Origami Therapeutics. The partnership focuses on a research‑stage protein‑degrader program targeting genetic neurodegenerative diseases. Should Ipsen exercise its option following successful drug‑candidate nomination, the Company would assume full responsibility for global development and commercialization, reinforcing its strategy in rare neuroscience and first‑in‑class innovation.

On 9 March 2026, Ipsen announced the voluntary withdrawal of Tazverik (tazemetostat) from all indications and all Ipsen markets, effective immediately, following emerging safety data from the ongoing Phase Ib/III SYMPHONY‑1 trial in follicular lymphoma.

On 22 April 2026, following the positive European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) opinion, Ipsen was granted conditional marketing authorization by the European Commission (EC) for Ojemda (tovorafenib) as monotherapy for the treatment of patients 6 months of age and older with pediatric low-grade glioma (pLGG) harboring a BRAF fusion or rearrangement or BRAF V600 mutation, who have progressed after one or more prior systemic therapies. Approval is based on the pivotal Phase II FIREFLY-1 data demonstrating meaningful and durable tumor responses.

Conference call

A conference call and webcast for investors and analysts will begin today at 2pm CET. Participants can access the call and its details by registering here; webcast details can be found here.

Calendar

Ipsen intends to publish its half-year results on 30 July 2026.

Notes

All financial figures are in € millions (€m). The performance shown in this announcement covers the three-month period to 31 March 2026 (Q1 2026, the quarter), compared to the three-month period to 31 March 2025 (Q1 2025) unless stated otherwise.

(Press release, Ipsen, APR 23, 2026, View Source [SID1234664722])

On April 23, 2026 Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating Fast Track designated GLSI-100, an immunotherapy to prevent breast cancer recurrences, reported that an abstract has been accepted for publication at the upcoming 2026 ASCO (Free ASCO Whitepaper) Annual Meeting along with a corresponding poster presentation.

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The 2026 ASCO (Free ASCO Whitepaper) Annual Meeting will be held from May 28 to June 2, 2026. The full text of the abstract and poster will be available on June 1, 2026, the day of the presentation.

CEO Snehal Patel commented, " We look forward to meeting many of our principal investigators at the conference. Our abstract will be the second abstract co-authored by the Company and the full Steering Committee of FLAMINGO-01 presenting preliminary injection site reaction immune response data from the non-HLA-A*02 open-label arm."

In addition to ASCO (Free ASCO Whitepaper), the Company plans to attend ESMO (Free ESMO Whitepaper) Breast, BIO partnering, and investor conferences in the coming months.

About the 2026 ASCO (Free ASCO Whitepaper) Annual Meeting

ASCO is the world’s leading professional organization for physicians and oncology professionals caring for people with cancer. ASCO (Free ASCO Whitepaper) offers premier scientific events for oncology professionals, patient advocates, industry representatives, and major media outlets worldwide. The ASCO (Free ASCO Whitepaper) Annual Meeting program features poster presentations, poster discussion sessions, clinical science symposia, and dynamic education sessions about recent advancements in cancer research, treatment, and patient care. For more information, please visit the conference website at: View Source

About FLAMINGO-01 Open Label Phase III Data

More than 1,300 patients have been screened with a current screen rate of approximately 800 patients per year. The 250 patient non-HLA-A*02 arm is now fully enrolled, where all patients received GLSI-100, which is 5 times more treated patients and recurrence rate data than the approximately 50 patients treated in the Phase IIb trial. The Primary Immunization Series (PIS), which includes the first 6 GLSI-100 injections over the first 6 months and is required to reach peak protection, is followed by 5 booster injections given every 6 months to prolong the immune response, thereby providing longer-term protection.

In the non-HLA-A*02 arm, a preliminary analysis of recurrence rates after the PIS is completed shows an approximately 70-80% reduction in recurrence rate.
This observation is trending similarly to the Phase IIb trial results and hazard ratio where HLA-A*02 patients were treated and where breast cancer recurrences were reduced up to 80% compared to a 20-50% reduction in recurrence rate by other approved products.
The immune response at baseline prior to any GLSI-100 treatment, the increasing immune response during the PIS, and the safety profile of non-HLA-A*02 patients is trending similarly to the HLA-A*02 arms of FLAMINGO-01 and to the Phase IIb study.
The AACR (Free AACR Whitepaper) Meeting 2026 delayed-type-hypersensitivity (DTH) poster can be downloaded here.
The frequency of DTH reactions increased by approximately 4x (290%) in the total open-label non-HLA-A*02 population, increasing from 5.2% of the patients experiencing a DTH reaction at baseline, prior to any GLSI-100 administration, to 20.4% of the patients experiencing a DTH reaction in month 4 or month 6 (McNemar, p < 0.001).
As reported in Table 1 of the poster, each HLA-A type exhibited more frequent immune reactivity after treatment with GLSI-100 than at baseline with frequency increasing from 100% to 700%.
Baseline DTH reaction prior to any treatment suggests that GP2 may be a natural antigen and that GP2 specific T cells may exist in some patients prior to any treatment with GLSI-100. Baseline immune response to GP2 prior to any vaccination with GP2 was also observed in the Phase IIb trial and is being observed in the blinded randomized arms of FLAMINGO-01, where HLA-A*02 only patients are being vaccinated.
Analysis of the open label data from FLAMINGO-01 has been conducted in a manner that maintains the study blind. The open label recurrence rate, immune response, and safety data is based on the patients enrolled to date in FLAMINGO-01 and the data provided by the clinical sites so far, which is not completed or fully reviewed, and is thus preliminary. While comparing any preliminary FLAMINGO-01 data to the Phase IIb clinical trial data may be possible, these preliminary results are not a prediction of future results, and the results at the end of the study may differ.

About GLSI-100 Phase IIb Study

In the prospective, randomized, single-blinded, placebo-controlled, multi-center (16 sites led by MD Anderson Cancer Center) Phase IIb clinical trial of HLA-A*02 breast cancer patients, 46 HER2/neu 3+ over-expressor patients were treated with GLSI-100, and 50 placebo patients were treated with GM-CSF alone. After 5 years of follow-up, there was an 80% or greater reduction in cancer recurrences in the HER2/neu 3+ patients who were treated with GLSI-100, followed, and remained disease free over the first 6 months, which we believe is the time required to reach peak immunity and thus maximum efficacy and protection. The Phase IIb results can be summarized as follows:

80% or greater reduction in metastatic breast cancer recurrence rate over 5 years of follow-up with a peak immune response at 6 months and well-tolerated safety profile.
The PIS elicited a potent immune response as measured by local skin tests and immunological assays.
About FLAMINGO-01 and GLSI-100

FLAMINGO-01 (NCT05232916) is a Phase III clinical trial designed to evaluate the safety and efficacy of Fast Track designated GLSI-100 (GP2 + GM-CSF) in HER2 positive breast cancer patients who had residual disease or high-risk pathologic complete response at surgery and who have completed both neoadjuvant and postoperative adjuvant trastuzumab based treatment. The trial is led by Baylor College of Medicine and currently includes US and European clinical sites from university-based hospitals and academic and cooperative networks with plans to open up to 150 sites globally. In the double-blinded arms of the Phase III trial, approximately 500 HLA-A*02 patients are planned to be randomized to GLSI-100 or placebo, and up to 250 patients of other HLA types are planned to be treated with GLSI-100 in a third arm. The trial has been designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, where 28 events will be required. An interim analysis for superiority and futility will be conducted when at least half of those events, 14, have occurred. This sample size provides 80% power if the annual rate of events in placebo-treated subjects is 2.4% or greater.

For more information on FLAMINGO-01, please visit the Company’s website here and clinicaltrials.gov here. Contact information and an interactive map of the majority of participating clinical sites can be viewed under the "Contacts and Locations" section. Please note that the interactive map is not viewable on mobile screens. Related questions and participation interest can be emailed to: [email protected]

About Breast Cancer and HER2/neu Positivity

One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 300,000 new breast cancer patients and 4 million breast cancer survivors. HER2 (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.

(Press release, Greenwich LifeSciences, APR 23, 2026, View Source [SID1234664721])

On April 23, 2026 Epitopea, a transatlantic biotech developing off-the-shelf, durable, RNA-based cancer immunotherapies, reported that it has received approval from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and the Regional Ethics Committee (REC) for its clinical trial application (CTA) for its first-in-human clinical trial (OVACT) of its lead program, CryptiVax-1001, targeting advanced high-grade serous ovarian cancer.

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Epitopea also announces the appointment of Professor Susana Banerjee (MBBS MA PhD FRCP), a Consultant Medical Oncologist and Research Lead for the Gynaecology Unit at The Royal Marsden NHS Foundation Trust and Professor in Women’s Cancers at the Institute of Cancer Research, as Chief Investigator of the OVACT trial.

Dr. Klaus Edvardsen, MD, Chief Medical Officer of Epitopea, commented, "We are excited by the achievement of this significant regulatory milestone, which is a credit to our dedicated clinical and wider Epitopea team. We also welcome Professor Banerjee to her role as Chief Investigator of our first clinical trial. Her world-class expertise in ovarian cancer and leadership in global clinical development will bring invaluable insights as we transition to a clinical-stage company."

OVACT is a Phase 1/1b dose escalation and expansion trial designed to evaluate the safety, tolerability, immunogenicity, and early clinical activity of CryptiVax-1001 in HRP+/BRCA-wildtype high-grade serous ovarian cancer patients.

High-Grade Serous Ovarian Cancer(HGSOC) remains one of the most difficult-to-treat solid tumors, with most patients (~80%) presenting with advanced or metastatic disease. While most women respond to first-line platinum chemotherapy, nearly all ultimately relapse and progress to platinum-resistant disease. Existing maintenance options leave a major therapeutic gap among HRP+/BRCA-wildtype patients, who represent roughly half of the ovarian cancer population.

Professor Banerjee added: "There is a substantial unmet need in homologous recombination proficient (HRP) ovarian cancer, where available maintenance therapies deliver limited durable benefit. Epitopea’s CryptiVax-1001 vaccine, which targets a novel repertoire of tumor-specific antigens, has the potential to meaningfully extend remission for patients with few effective treatment options."

Epitopea’s pipeline is enabled by CryptoMapTM, a proprietary discovery engine that identifies tumor-presented antigens arising from the dark genome, a previously inaccessible source of novel, tumor-specific targets. These antigens, known as CryptigensTM, demonstrate high inter-patient sharing, enabling development of true off-the-shelf mRNA immunotherapies.

(Press release, Epitopea, APR 23, 2026, View Source [SID1234664720])

On April 23, 2026 CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a clinical-stage oncology company advancing leronlimab, a first-in-class humanized monoclonal antibody targeting the CCR5 receptor with therapeutic potential across multiple indications, including metastatic triple-negative breast cancer ("mTNBC") and colorectal cancer ("mCRC"), reported it will host an investor webcast on April 30, 2026, at 1 p.m. PT, to provide a corporate and clinical update.

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The investor webcast will highlight CytoDyn’s latest scientific, clinical, operational, and financial progress, as well as calendar 2026 priorities and upcoming milestones. Dr. Jacob P. Lalezari, CEO of CytoDyn, will be joined by Pashtoon M. Kasi, M.D., M.S., Medical Director of GI Oncology, City of Hope Orange County, Irvine, California, and Robert E. Hoffman, Chief Financial Officer of CytoDyn.

Date: Thursday, April 30, 2026

Time: 1 p.m. PT

Registration and Access Link

This is a livestream presentation. Attendees are advised to log in ahead of the start time. The Company will host a live Q&A session during the webcast; questions may be submitted in advance to [email protected].

Following the conclusion of the webcast, a replay will be available for approximately 30 days on the investor relations section of the Company’s website.

(Press release, CytoDyn, APR 23, 2026, View Source [SID1234664719])

On April 23, 2026 Alpha Tau Medical Ltd. (Nasdaq: DRTS, DRTSW) ("Alpha Tau"), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT, reported the successful treatment of the first patient in ACAPELLA (Alpha DaRT for CAncer of the PancrEas in Locally advanced Adenocarcinoma), the Company’s European multicenter clinical trial evaluating Alpha DaRT combined with capecitabine for patients with inoperable locally advanced pancreatic ductal adenocarcinoma (LAPC) who have completed first-line mFOLFIRINOX chemotherapy. The procedure was performed at CHU Grenoble Alpes by Pr. Gaël Roth, Lead Investigator of ACAPELLA, and his team, marking the first use of Alpha DaRT for pancreatic cancer in Europe.

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Pancreatic ductal adenocarcinoma is among the most lethal malignancies worldwide. Across Europe, approximately 140,000 new cases are diagnosed annually and nearly 132,000 deaths are recorded each year.¹ Approximately 30% of patients present with locally advanced disease – tumors that have infiltrated critical vascular structures but remain confined without distant metastases, rendering surgery impossible.²ʾ³ This translates to an estimated 42,000 patients in Europe and approximately 4,500 patients in France alone each year, facing a poor survival outlook. While first-line mFOLFIRINOX has extended survival for patients who tolerate it, there is no established standard of care once induction is complete. Intensive chemotherapy cannot be sustained indefinitely, and conversion towards surgical resection with systemic therapy alone remains rare, leaving most patients without a treatment path forward.

Uzi Sofer, CEO of Alpha Tau, remarked: "Over forty thousand Europeans each year are diagnosed with inoperable locally advanced pancreatic cancer, and even if there are some patients who have managed to complete first-line chemotherapy, there remains no established next step, no standard treatment path, and an inevitable progression for the great majority. That is the great unmet need ACAPELLA was designed to address. Together with the ongoing IMPACT multicenter pancreatic cancer trial in the United States, the ACAPELLA trial represents Alpha Tau’s commitment to building a rigorous, global clinical evidence base for intrapancreatic alpha-emitter radiotherapeutics to treat this terrible disease. The timing of this first patient treatment, just ahead of Digestive Disease Week 2026 in Chicago, offers a welcome opportunity to engage with the global GI oncology community about our exciting clinical progress."

Pr. Gaël Roth, MD PhD, Principal Investigator and Professor of Gastrointestinal Oncology, expert in pancreatic cancer at CHU Grenoble Alpes, stated: "Being the first center in Europe offering access to pancreatic cancer treatment with Alpha DaRT, a new innovative device aiming to improve patients’ outcome in such a severe disease, is both a professional honor and a scientific responsibility. The procedure itself is straightforward – Alpha DaRT sources are delivered directly into the pancreatic tumor under real-time endoscopic ultrasound guidance, in a single session, which for patients who have already completed months of intensive chemotherapy is a meaningful advantage. CHU Grenoble Alpes brings together the expertise in endoscopy and GI Oncology with strong activity in clinical and translational research that a study of this kind requires. I am proud that this European effort begins here."

Robert Den, MD, Chief Medical Officer of Alpha Tau, commented: "With the first ACAPELLA treatment, two multicenter trials – one in the US and now one across Europe – are now advancing simultaneously, marking a meaningful inflection point for Alpha DaRT in pancreatic cancer. ACAPELLA targets a precisely defined patient population that has exhausted the maximum benefit available from current systemic options yet remains inoperable, and its embedded immune biomarker program will help us understand how intrapancreatic alpha-emitter therapy potentially reshapes the tumor immune microenvironment – a question with significant implications for the next generation of combination strategies."

About ACAPELLA

ACAPELLA (Alpha DaRT for CAncer of the PancrEas in Locally advanced Adenocarcinoma, Protocol CTP-PANC-04) is a prospective, interventional, open label, single-arm multicenter clinical trial enrolling up to 40 patients with histologically confirmed inoperable locally advanced pancreatic ductal adenocarcinoma. Eligible patients must have received 8 to 12 cycles of first-line mFOLFIRINOX and demonstrated stable disease or tumor response per RECIST v1.1, with a target lesion of 5 cm or less in longest diameter amenable to Alpha DaRT source implantation and an ECOG performance status of 0 to 1.

In the trial, Alpha DaRT sources are delivered directly into the tumor under real-time endoscopic ultrasound guidance. Three days following Alpha DaRT insertion, patients initiate oral capecitabine for two months. Tumor resectability is assessed every two months, and follow-up extends to 12 months after the Alpha DaRT procedure. The trial is to be conducted across multiple centers in France.

The primary objective is to evaluate the safety of Alpha DaRT in combination with capecitabine, with the primary endpoint being the incidence of device-related serious adverse events graded per CTCAE v5.0 criteria. Secondary endpoints include objective tumor response rate (per RECIST v1.1 criteria) at 2, 4, and 6 months; overall survival and progression free survival at 12 months; and the rate of conversion to surgical resectability, including the percentage of patients achieving R0/R1 resection. Exploratory objectives include changes in SUVmax and CA 19-9, patient reported quality of life, and evaluation of treatment-associated changes in the tumor immune microenvironment.

Additional information about the trial can be found at: View Source

(Press release, Alpha Tau Medical, APR 23, 2026, View Source [SID1234664718])