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Ipsen delivers strong sales in the first nine months of 2025 and further upgrades its full-year guidance

On October 22, 2025 Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-care biopharmaceutical company, reported its sales for the year to date and the third quarter of 2025.

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YTD 2025 YTD 2024 % change Q3 2025 Q3 2024 % change
€m €m Actual CER €m €m Actual CER
Oncology 1,912.0 1,829.8 4.5 % 6.6 % 624.0 604.0 3.3 % 7.0 %
Rare Disease 255.4 129.7 97.0 % 101.0 % 102.0 50.8 100.8 % 109.1 %
Neuroscience 567.3 536.4 5.8 % 9.5 % 188.9 181.9 3.9 % 9.1 %
Total Sales 2,734.8 2,495.9 9.6 % 12.1 % 915.0 836.6 9.4 % 13.7 %

"We have demonstrated strong momentum through the first nine months of 2025, with solid growth across all three therapeutic areas and increasing contributions from our rare liver disease franchise. As a result, we are further upgrading our full-year guidance to reflect this performance." said David Loew, Chief Executive Officer, Ipsen.
"This quarter, we were also pleased with the data from the Phase II LANTIC trial in aesthetics, with a differentiated first-in-class long-acting molecule, IPN10200. With the proposed acquisition of ImCheck Therapeutics announced this morning, we are adding a first-in-class asset to expand our oncology pipeline. Our efforts remain focused on advancing science with purpose to bring the benefits patients are looking for, as we believe everyone deserves a life fully lived."

Full-year 2025 guidance
Based on the strong performance in the third quarter, Ipsen further upgrades its financial guidance for 2025:

Total sales growth of around 10.0%, at CER (prior guidance greater than 7.0%). Based on the average level of exchange rates in September 2025, an adverse impact on total sales of around 3% from currencies is expected
Core operating margin of around 35.0% of total sales (prior guidance greater than 32.0%)
This guidance assumes a limited impact from lanreotide generic on Somatuline sales and an accelerated sales growth from the rest of the portfolio.

Pipeline update for Q3 2025
On 22 September 2025 Ipsen announced that the LANTIC Phase II trial in aesthetics delivered a first-in-class, differentiated long-acting clinical profile for IPN10200, a recombinant, first-in-class molecule uniquely engineered to generate increased receptor affinity and internalization that produces a longer duration of action. Data showed a rapid onset of action, peak effect superior to placebo and a substantial majority of patients experiencing clinically significant longer duration of effect vs placebo and vs Dysport, defined as a score of "none" or "mild" of line severity at Week 24. The data will be presented at an upcoming scientific conference in H1 2026, and Phase III start-up activities have been initiated.

On 19 September 2025 Ipsen announced regulatory approval for Bylvay (odevixibat) for the treatment of pruritus associated with progressive familial intrahepatic cholestasis (PFIC) in Japan, offering a non-surgical treatment option for infants, young children and adults.

On 23 July 2025, Ipsen received European Commission approval for Cabometyx (cabozantinib) in previously treated advanced neuroendocrine tumors (NETs), based on positive outcomes from the Phase III CABINET trial.

Business development
On 22 October 2025 Ipsen announced a definitive share purchase agreement to acquire ImCheck Therapeutics, a private French biotechnology company pioneering next-generation immuno-oncology therapies. The acquisition is focused on the lead Phase I/II program ICT01 in first line unfit acute myeloid leukemia (AML) with a Phase IIb/III to start in 2026. ICT01 is a first-in-class monoclonal antibody targeting BTN3A, a key immune-regulatory molecule broadly expressed across cancer, and which has received Orphan Drug Designation from the U.S. Food and Drug Administration and Orphan designation from the European Medicines Agency in July 2025.

Under the terms of the agreement, shareholders of ImCheck Therapeutics will receive a €350m cash payment at closing of the transaction, and deferred payments contingent upon the achievement of specified regulatory approvals and sales-based milestones. The transaction is expected to close by the end of Q1 2026, subject to fulfilment of customary closing conditions.

Conference call
A conference call and webcast for investors and analysts will begin today at 1pm CET. Participants can access the call and its details by registering here; webcast details can be found here.

(Press release, Ipsen, OCT 22, 2025, View Source [SID1234656869])

Ipsen to acquire ImCheck Therapeutics, expanding its leadership in oncology, strengthening its pipeline

On October 22, 2025 Ipsen (Euronext: IPN; ADR: IPSEY) and ImCheck Therapeutics reported they have entered into a definitive share purchase agreement in which Ipsen will acquire all issued and outstanding shares of ImCheck Therapeutics, a private French biotechnology company pioneering next-generation immuno-oncology therapies. The anticipated acquisition is focused on the lead Phase I/II program ICT01 in first line acute myeloid leukemia (AML)3 patients who are ineligible for intensive chemotherapy. ICT01 is a first-in-class monoclonal antibody targeting BTN3A, a key immune-regulatory molecule broadly expressed across cancer, and received Orphan Drug Designations from the U.S. Food and Drug Administration and European Medicines Agency in July 2025.

Many AML patients are unable to tolerate intensive chemotherapy and must rely on lower-intensity options, which often deliver limited and short-lived benefit.2 This high-risk, unfit population continues to face a significant unmet medical need, highlighting the urgency for new therapies that can improve survival and quality of life.

"At completion, the acquisition of ImCheck Therapeutics presents an opportunity for us to expand our pipeline in oncology and reinforces our commitment to deliver transformative therapies to the people who need them most," said David Loew, CEO, Ipsen. "We feel confident that with the ICT01 promising data combined with Ipsen’s global development and commercialization expertise, we are well positioned to start a Phase IIb/III trial in 2026."

Interim data (n=45) orally presented at the annual American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 20251 from the Phase I/II EVICTION trial showed treatment with ICT01 in combination with venetoclax and azacitidine (Ven-Aza) achieved very encouraging high responses. In this single-arm trial, treatment response nearly doubled relative to those seen in historical standard of care data across all molecular subtypes in newly diagnosed patients including sub-types typically less responsive to standard of care (Ven-Aza).2 ICT01 in combination with Ven-Aza was also shown to be well tolerated, underscoring ICT01’s potential as a novel immunotherapy to improve outcomes for patients with AML.

"We are thrilled to become part of Ipsen, a company whose ambition for transformative care matches our commitment to bringing innovative treatments to patients. This transaction recognizes groundbreaking science originating from French academia," said Pierre d’Epenoux, CEO, ImCheck Therapeutics. "It also highlights the exceptional work the ImCheck team and our partners have achieved to advance the understanding of butyrophilns and gamma delta T cells. Joining Ipsen will help us accelerate ICT01 toward registrational studies and commercialization. I remain grateful to the patients and investors for their contributions to furthering ImCheck’s pioneering science."

Transaction details
Under the terms of the agreement, through a wholly owned affiliate of Ipsen SAS, shareholders of ImCheck Therapeutics will receive a 350 million euros payment on a cash-free and debt-free basis at closing of the transaction, and deferred payments contingent upon the achievement of specified regulatory approvals and sales-based milestones, for a total potential consideration up to 1 billion euros.

The transaction is expected to close by the end of Q1 2026, subject to fulfilment of customary closing conditions including the expiration or termination of any required regulatory and governmental approvals under French and U.S. regulations.

Advisors
Allen & Overy Shearman (Paris) is acting as legal counsel to Ipsen. Centerview Partners is acting as exclusive financial advisor to ImCheck Therapeutics with Goodwin (London) and Dentons (Paris) acting as legal counsel.

About the EVICTION trial
EVICTION is a first-in-human, dose-escalation (Part 1) and cohort-expansion (Part 2) clinical trial of ICT01 in patients with various advanced relapsed or refractory solid or hematologic cancers that have exhausted standard-of-care treatment options, as well as newly-diagnosed AML. More information on the EVICTION trial can be found at clinicaltrials.gov (NCT04243499).

About ICT01
ICT01 is a humanized, anti-BTN3A (also known as CD277) monoclonal antibody that promotes the recognition and elimination of tumor cells by γ9δ2 T cells, which are responsible for immunosurveillance of malignancy and infections. The three isoforms of BTN3A targeted by ICT01 are overexpressed on many solid tumors (e.g., melanoma, urothelial cell, colorectal, ovarian, pancreatic, and lung cancer) and hematologic malignancies (e.g., leukemia and lymphomas) and are also expressed on the surface of innate (e.g., γδ T cells and NK cells) and adaptive immune cells (T cells and B cells). Binding to BTN3A is essential for the activation of the anti-tumor immune response of γ9δ2 T cells. By altering the conformation of BTN3A, ICT01 promotes this binding, thereby selectively activating circulating γ9δ2 T cells. This leads to migration of γ9δ2 T cells out of the circulation and into the tumor tissue, and triggers a downstream immunological cascade through secretion of pro-inflammatory cytokines, including but not limited to IFNγ and TNFα, further augmenting the anti-tumor immune response. Anti-tumor activity and efficacy of ICT01 have been shown in patients across several cancer indications.

(Press release, Ipsen, OCT 22, 2025, View Source [SID1234656868])

HanchorBio Secures US Patent for Innovative SIRPα/CD47 Fusion Protein HCB101

On October 21, 2025 HanchorBio reported that its proprietary HCB101, a SIRPα/CD47 fusion protein candidate, has been officially granted a US patent (Patent No. 12,447,195) by the United States Patent and Trademark Office (USPTO). Titled "ENGINEERED SIRPα VARIANTS AND METHODS OF USE THEREOF", the patent represents major international recognition for the company’s innovative technology for immuno-oncology.

Mechanism of Action and Novelty of HCB101: An Innovative Fusion Protein Design

Developed using HanchorBio’s proprietary FBDB (Fc-Based Designed Biologics) platform, HCB101 is an engineered SIRPα/CD47 fusion protein designed to precisely modulate the immune system’s recognition and phagocytic functions, effectively overcoming the challenge of tumor immune evasion and enhancing the clearance of cancer cells.

The molecule employs an engineered variant strategy, featuring novel amino acid substitutions at previously unclaimed and undisclosed SIRPα sites.
These innovative structural mutations significantly enhance the binding affinity and functional potency of HCB101 toward CD47 expressed on tumor cells, thereby reactivating macrophage-mediated cancer cell killing while minimizing the hematologic toxicities commonly associated with traditional CD47 monoclonal antibody therapies.

The USPTO recognized HCB101’s original mutation design and unprecedented potency as clear evidence of novelty and inventive step, distinguishing it from prior technologies and enabling the molecule to successfully pass the rigorous US patent examination process.

In addition to robust intellectual property protection, the patent also strengthens HanchorBio’s position for licensing negotiations and strategic collaborations, further enhancing its global partnership and value creation potential.

Dr. Scott Liu, Chairman of HanchorBio, commented: "The US patent grant for HCB101 is a testament to HanchorBio’s robust R&D capabilities in immunotherapy, while also illustrating the heights of innovation that Taiwan’s biotech industry is capable of reaching. Backed by a solid IP position, we are committed to further expanding global collaboration."

Why the United States: A Strategic and Symbolic First Step

HanchorBio strategically selected the United States as the first jurisdiction for patent filing and issuance, recognizing it as the world’s most influential and standard-bearing market for biopharmaceutical innovation and licensing. US patent approval often serves as a benchmark for patent examiners in other countries, amplifying both credibility and momentum for subsequent filings.

For the filing, HanchorBio worked with Fish & Richardson, one of the largest and most respected intellectual property law firms in the US. The successful approval of HCB101’s US patent demonstrates the molecule’s technical originality and therapeutic advancement, paving the way for accelerated future examinations in Europe and multiple Asian territories.

Dr. Wenwu Zhai, Chief Scientific Officer of HanchorBio, remarked:
"We prioritized the US market as the foundation of our IP strategy, as its market scale and influence align closely with our long-term growth objectives. Building on this milestone, we will further build a comprehensive global IP protection network."

Global Patent Strategy: Strengthening Licensing and Partnerships

Following this US patent grant, HanchorBio will advance patent filings across Europe, Taiwan, and other Asian countries as part of its broader global IP roadmap.
This strategy aims to consolidate the company’s leadership in immuno-oncology and fusion protein drug development, while significantly enhancing its negotiating power for international licensing and co-development opportunities.

The HCB101 patent represents not only a technological milestone but also a pivotal step in HanchorBio’s journey toward global market expansion.

(Press release, Hanchor Bio, OCT 21, 2025, View Source [SID1234656882])

Atossa Therapeutics Highlights Progress in RECAST™ DCIS Platform Trial at Early Detection Research Conference; Laura Esserman, MD, MBA, to Discuss Active-Surveillance Strategy and Novel Endocrine Agents

On October 21, 2025 Atossa Therapeutics, Inc. (Nasdaq: ATOS) ("Atossa" or the "Company"), a clinical-stage biopharmaceutical company developing innovative medicines in oncology, reported that Laura J. Esserman, MD, MBA, Professor of Surgery and Radiology at the University of California, San Francisco and Principal Investigator of RECAST, will speak at the Early Detection Research Conference in Portland, OR, about the Company’s collaborative work in the RECAST platform trial for ductal carcinoma in situ (DCIS), a biologically heterogeneous, non-invasive breast condition that can progress to invasive breast cancer in a subset of patients.

RECAST is a multi-arm, Phase 2, randomized, neoadjuvant platform trial designed to identify which patients with hormone receptor–positive DCIS are best suited for active surveillance and to determine whether novel endocrine therapies can expand the population that can safely avoid surgery. The trial includes arms evaluating standard therapy (tamoxifen or aromatase inhibitor) as well as novel agents: (Z)-Endoxifen, elacestrant, and Hav-088. Efficacy is assessed with mammography and breast MRI, alongside biomarker discovery and quality-of-life endpoints. Enrollment began in January 2024; 50 patients have been enrolled toward a target of 400 across 17 activated clinical sites, with additional sites planned.

Why this matters for investors

Large, under-served market: DCIS is commonly treated like invasive cancer (surgery ± radiation ± endocrine therapy). Demonstrating that a biomarker-guided, non-surgical approach is safe and effective could reshape standard of care and expand use of oral endocrine agents in early-stage disease management.
Efficient signal-finding: The platform design enables parallel testing of multiple agents, including Atossa’s (Z)-Endoxifen, with common imaging and biomarker endpoints to generate comparative signals that can inform registration strategies.
Multiple potential catalysts: Early imaging response, biomarker correlation, and active-surveillance suitability rates by arm create interim readout opportunities that can de-risk later-stage programs and guide payer-relevant health-economic modeling.
Strategic collaborations: RECAST is sponsored by Quantum Leap Healthcare Collaborative with research support from NIH and industry partners. This shared-infrastructure model can accelerate enrollment, broaden site access, and optimize capital efficiency.
"RECAST is purpose-built to answer the question that payers, physicians, and patients care most about: who truly needs surgery and who does not," said Steven Quay, MD, PhD, Chairman and CEO of Atossa Therapeutics. "For Atossa, the trial offers a capital-efficient path to demonstrate the potential of (Z)-Endoxifen in a large early-disease setting, generate decision-grade biomarkers, and position us for value-creating milestones over the coming quarters."

RECAST Trial Objectives

Increase the fraction of DCIS patients suitable for long-term active surveillance using novel endocrine therapy.
Correlate risk of progression to invasive ductal carcinoma with risk categorization after six months of therapy.
Identify biomarkers that predict response and elucidate mechanisms of imaging response and resistance.
Assess quality of life compared with standard endocrine therapy.
Current Trial Status

Phase: 2 (platform)
Population: HR-positive DCIS (any grade)
Arms: Tamoxifen/AI (control), (Z)-Endoxifen, elacestrant, Hav-088
Assessments: Mammogram, MRI, biomarker panels, QoL
Enrollment: 50/400; 17 active U.S. sites; additional site activations planned.

(Press release, Atossa Therapeutics, OCT 21, 2025, View Source [SID1234656881])

Breakthrough clinical trial confirms that GammaTile delivers superior tumor control compared to standard of care for patients with newly diagnosed operable brain metastases

On October 21, 2025 GT Medical Technologies, a company focused on improving the lives of patients with brain tumors, reported the interim results from its ROADS clinical trial (Randomized Controlled Trial of Resection [Surgery] and GammaTile versus Standard of Care) in patients with operable, newly diagnosed brain metastases.1

The trial, which completed randomization of 230 patients over 30 leading cancer centers in the United States in August 2025, evaluated whether implanting GammaTile – a form of brain tumor radiation that begins immediately at the time of surgery, with no waiting or time lost – could improve outcomes compared with the current standard of care (surgery followed by postoperative external beam stereotactic radiation therapy [SRT]). The standard approach requires a recovery period before radiation can begin, during which remaining microscopic tumor cells may regrow.

The trial was led by Dr. Thomas Beckham, Assistant Professor, Department of Radiation Oncology, Division of Radiation Oncology, and Dr. Jeffrey Weinberg, Professor of Neurosurgery, Deputy Chair and Vice-Chair of Clinical Operations in The Department of Neurosurgery at The University of Texas MD Anderson Cancer Center. The interim data, presented at the 2025 Congress of Neurological Surgeons by Dr. Weinberg, shows significant and durable improvements in reducing tumor recurrence and increasing surgical bed recurrence-free survival (time to tumor recurrence or death) with GammaTile.

Key Interim Findings

A pre-planned interim analysis was conducted with 168 enrolled patients:1*

GammaTile showed superiority in the primary endpoint of the study. Patients who received GammaTile lived longer without tumor regrowth, and there was a greater than 50% reduction in risk of either tumor recurrence or death compared to standard of care [SRT] (hazard ratio 0.42, p=0.0024).
GammaTile showed superiority in overall protection from worrisome radiographic brain changes (either tumor recurrence or radiation-related tissue damage). At the time of analysis, more than half of GammaTile patients remained free from both tumor regrowth and radiation-related tissue damage, while in the SRT group, more than half of patients had already experienced one of these events by 16 months (hazard ratio of 0.32, p=0.018).
GammaTile demonstrated significant gains in efficacy with no increase in safety concerns. Rates of treatment-related side effects remained low and comparable between both groups proving GammaTile delivers superior outcomes without added risk.
"The interim data from the ROADS trial is the first randomized, multicenter evidence showing the superiority of starting radiation immediately at the time of tumor removal with GammaTile for operable brain metastases," says Michael Garcia, MD, MS, Chief Medical Officer at GT Medical Technologies. "These results highlight the importance of immediate, targeted radiation therapy."

"Although the ROADS trial focused on patients with operable brain metastases, the study reflects real-world treatment patterns, where many patients have a large metastasis that needs surgery and small brain metastases that can be well managed with stereotactic radiation without removal," said Weinberg. "In such cases, patients randomized to the GammaTile arm received GammaTile radiation for the operable tumor and stereotactic radiation for the small metastases. These interim results suggest that this approach not only achieves local control but does so with superiority over the existing standard of care. My colleague, Dr. Beckham, and I agree this evidence may redefine how we treat this disease."

The Brain Metastases Challenge

Brain metastases affect up to 40% of all cancer patients and significantly impact survival and quality of life.2 For patients with operable tumors, surgery followed by external beam stereotactic radiation has been the standard of care, yet its limitations are well recognized, with a 1-year tumor recurrence rate of 28%.3 In addition, up to one third of patients miss or delay postoperative radiation due to access barriers, fragmented care pathways, or logistical challenges.4 These treatment gaps leave patients vulnerable to recurrence, decline in brain function, and added burden for families.

GammaTile is designed to overcome these shortcomings by delivering immediate, targeted, and continuous radiation directly into the surgical cavity at the time of tumor removal.5 This ensures that radiation therapy begins when microscopic cancer cells are the most vulnerable—immediately after surgery, at the lowest point of tumor burden—and guarantees that every patient receives radiation treatment. By closing the treatment gap, GammaTile provides more durable tumor control, reduces recurrence risk, and streamlines the care journey for patients.1 Importantly, GammaTile also gives patients and clinicians peace of mind that treatment has started right at tumor removal.

"We are deeply encouraged by these results," said Per Langoe, Chief Executive Officer of GT Medical Technologies. "By providing immediate radiation when and where it is needed most, GammaTile is showing the potential to transform outcomes for patients with operable brain tumors."

(Press release, GT Medical Technologies, OCT 21, 2025, View Source [SID1234656880])