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])

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.

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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])

On October 21, 2025 Xspray Pharma AB (publ) (Nasdaq Stockholm: XSPRAY) reported that the U.S. Food and Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) for XS003 (nilotinib) for review under the 505(b)(2) regulatory pathway. The FDA has set a PDUFA date to June 18, 2026, which is the date by when the agency is expected to announce a decision on the application.

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XS003 is an improved formulation of nilotinib (Tasigna) for the treatment of chronic myeloid leukemia (CML), developed using Xspray’s proprietary HyNap technology. Data demonstrate bioequivalence to the reference product at less than half the dose, as well as a significantly reduced food effect (29% compared to 82% for Tasigna). The food effect associated with the reference product complicates patient adherence and is related to the requirement that the patient must be in a fasting state, which is included in its so-called "boxed warning" regarding QTc prolongation and the risk of sudden death. The significantly reduced food effect with XS003 means it is expected that it may be taken with or without food and thereby avoid warning text regarding food interaction. Any final labeling and related warnings will be determined by the FDA during the review process.

"The FDA’s decision to accept our NDA for review marks an important milestone," says Per Andersson, CEO of Xspray Pharma. "With two product candidates under FDA review, we are demonstrating that the HyNap platform has broad applicability and the potential to deliver more improved TKIs to the market."

Together with the company’s first product candidate Dasynoc, XS003 addresses a U.S. market of approximately USD 2.7 billion. The FDA’s notification confirms that the application is complete and that a full review is now underway. XS003 is manufactured at the same external facility as Dasynoc.

"Since the FDA now has a solid understanding of our manufacturing process, I am confident that the upcoming Pre-Approval Inspection will be completed without observations. It is essentially the same process that has previously been inspected. Furthermore, we are working closely with the manufacturer to ensure that all planned improvements to the other parts of the facility that previously received observations are completed well ahead of the PDUFA date," comments CEO Per Andersson.

(Press release, Xspray, OCT 21, 2025, View Source [SID1234666042])

On October 21, 2025 Hanmi reported third quarter financial results for the year 2025 (Press release, Hanmi, OCT 21, 2025, View Source [SID1234661651]).

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On October 21, 2025 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW, BCTXZ), (TSX: BCT) (" BriaCell " or the " Company "), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, reported a collaboration with Memorial Sloan Kettering Cancer Center’s (MSK’s) Therapeutics Accelerator Cohort program to accelerate the clinical development of Bria-OTS+, BriaCell’s next generation personalized off-the-shelf immunotherapy, for multiple cancer indications including metastatic breast cancer, prostate cancer, and other cancers.

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The collaboration starts with manufacturing, IND development and clinical protocol support for a Phase 1 clinical trial with Bria-BRES+, BriaCell’s next generation personalized immunotherapy for patients with breast cancer under the Bria-OTS+ platform. The partnership expands on BriaCell’s previously-announced selection into MSK’s accelerator program .

As one of the world’s foremost cancer research and treatment institutions, MSK has more than 135 years of leadership in patient care, education and discovery. Through the MSK Therapeutics Accelerator, MSK’s therapeutic-based strategic collaboration program, BriaCell will obtain access to MSK’s clinical and institutional expertise, including cell therapy manufacturing, Investigational New Drug (IND) preparation and submission and clinical development to expedite development of the Bria-OTS+ platform.

"We are thrilled to collaborate with MSK’s scientific and clinical experts to address the urgent unmet medical need of many thousands of metastatic breast cancer patients," stated Dr. William V. Williams, BriaCell’s President and CEO.

"We are honored to be working with the team of cancer specialists at MSK," noted Miguel Lopez-Lago, PhD, BriaCell’s Chief Scientific Officer. "This collaboration with MSK will accelerate the development of our advanced personalized off-the-shelf immunotherapy platform, Bria-OTS+, which we believe has the potential to transform cancer care and significantly improve patients’ lives through its unique mechanism of action."

"We look forward to working with BriaCell through MSK’s Therapeutics Accelerator to help advance this next-generation personalized immunotherapy into the clinic. Collaborations like this are essential to translating promising scientific innovations into potential new treatment options for patients," commented Shanu Modi, MD, Breast Medical Oncologist and Attending Physician at MSK.

(Press release, BriaCell Therapeutics, OCT 21, 2025, View Source [SID1234656937])