On November 11, 2025 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported that the company will present five abstracts at the 2025 Society for Neuro-Oncology (SNO) Annual Meeting taking place November 19-23 in Honolulu, Hawaii. The presentations will feature both clinical and preclinical research evaluating Modeyso (dordaviprone), as well as new preclinical data featuring JZP3507 (formerly ONC206) in central nervous system (CNS) tumors, reflecting Jazz’s growing impact and innovation in neuro-oncology.

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Key presentations include:

New translational research characterizing potential molecular pathways associated with sensitivity to dordaviprone and exploring how targeted combination strategies may help to enhance response.
Preclinical data evaluating how dordaviprone may influence the tumor immune environment to inform future research on rational immunotherapy combinations.
"These presentations at SNO represent the collective progress of our dedicated research team within Jazz and our academic collaborators who share a relentless commitment to improving outcomes for patients living with devasting brain tumors," said Joshua E. Allen, Ph.D., chief scientific officer, oncology, Jazz Pharmaceuticals. "The SNO presentations provide new insights into how treatment might be further optimized in the future for patients with brain cancer. The continued advancement of Modeyso and our ongoing research across many areas, including the JZP3507 (ONC206) program, reflect our belief that through scientific innovation and persistence, we will continue to bring new hope to patients and families who urgently need better options."

The full SNO abstracts are available here. The full list of Jazz presentations at SNO 2025 are:

Topic

Author

Presentation Details

EGFR metabolically suppresses differentiation in H3 K27M-mutant diffuse midline glioma

Sunjong Ji, Robert Doherty, Mateus Mota, Siva Kumar Natarajan, Daniel de la Nava, Peter Sajjakulnukit, Erik R. Peterson, Tiffany Adam, Michael Niculcea, Katie Vo, Kelsey Wink, Subramaniam Bavani, Yadavilli Sridevi, Javad Nazarian, Joanna J. Phillips, Sabine Mueller, Mariella Filbin, David A. Solomon, Daniel R. Wahl, Costas Lyssiotis, Tingting Qin, Alexander Beck, Pavithra Viswanath, Nicholas Nuechterlein, Sebastian M. Waszak, Sriram Venneti, Carl Koschmann

Type: Oral Abstract

Session: Pediatric Abstracts
– Session I

Date: Friday, November 21,
10:49-10:54 a.m. HST

Number: TMET-51

Dordaviprone (ONC201) in a pediatric patient with recurrent H3 K27M-mutant diffuse glioma and leptomeningeal disease

Gabriel Batistella, Felipe D’Almeida Costa, Tomás Freddi, Nicholas Wojtynek, David Korones

Type: Poster

Session: Poster and Networking Session

Date: Friday, November 21, 11:30 a.m.-12:45 p.m. HST

Number: CTP-15

Allosteric ClpP agonist ONC206 alters mitochondrial metabolism and stress response to elicit apoptosis in meningioma

Andrew K. Lee, Cristina Maranto, Scott Foster, Varun V. Prabhu, Joshua E. Allen

Type: Poster

Session: Poster and Networking Session

Date: Saturday, November 22, 11:45 a.m.-1:05 p.m. HST

Number: TMET-26

ONC206 inhibits tumor growth and is a potential novel therapeutic strategy for refractory medulloblastoma

Theophilos Tzaridis, Jingbo Liu, Joshua E. Allen, Varun V. Prabhu, Robert J. Wechsler-Reya, Tobey MacDonald

Type: Poster

Session: Poster and Networking Session

Date: Saturday, November 22, 11:45 a.m.-1:05 p.m. HST

Number: EXTH-70

Leveraging the immunomodulatory effects of dordaviprone (ONC201) to induce long-term survival response in diffuse midline glioma patients and models

Clara Savary, Mika L. Persson, Evangeline R. Jackson, Ryan J. Duchatel, Tuan Vo, Izac J. Findlay, Alicia M. Douglas, Liesl Bramberger, Daniel de la Nava, Bryce C. Thomas, Holly P. McEwen, Tyrone S. Beitaki, Laura Rodriguez de la Fuente, Yolanda Colino-Sanguino, Fatima Valdes Mora, Martin R. Larsen, Pouya Faridi, Jeff Holst, Jemma Mayall, Cassie N. Kline, Andrea T. Franson, Sriram Venneti, Hubert Hondermarck, Jay Horvat, Brett Nixon, Rodrigo Cartaxo, Javad Nazarian, Esther Hulleman, Sabine Mueller, Nicholas A. Vitanza, Carl Koschmann, Marta M. Alonso, Tiago Ferreira Carvalheiro, Jasper van der Lugt, Matthew D. Dun

Type: Oral Abstract

Session: CNS Rare Tumor Abstracts – Session II

Date: Sunday, November 23, 11:34-11:39 a.m. HST

Number: DDDR-38

About H3 K27M-Mutant Diffuse Midline Glioma
H3 K27M-mutant diffuse midline glioma is a rare and highly aggressive brain tumor that primarily affects the midline structures of the brain and spinal cord.1,2 It is characterized by a specific genetic mutation (H3 K27M) that disrupts epigenetic regulation and drives tumor growth.4 Most commonly diagnosed in children and young adults, patients with this type of glioma often face an extremely poor prognosis, with limited therapeutic options and very low survival rates following recurrence.3 Median survival is approximately one year from diagnosis and 5.1 months after progressing following frontline therapy.7

About Modeyso (dordaviprone)
Modeyso (dordaviprone) (formerly known as ONC201) is approved by the U.S. Food and Drug Administration (FDA) for the treatment of H3 K27M-mutant diffuse midline glioma in adult and pediatric patients one year of age and older with progressive disease following prior therapy.4 Modeyso is an oral small molecule administered once weekly. Modeyso is a mitochondrial caseinolytic protease P (ClpP) agonist and also inhibits the dopamine-2 (D2) receptor. In vitro, dordaviprone activated the integrated stress response, induced apoptosis, and altered mitochondrial metabolism, leading to restored histone H3 K27 trimethylation in H3 K27M-mutant diffuse glioma.4

Modeyso received accelerated approval in August 2025 based on a pre-specified integrated efficacy analysis of 50 adult and pediatric patients with recurrent H3 K27M-mutant diffuse midline glioma enrolled across five open-label clinical studies (ONC006, ONC013, ONC014, ONC016, and ONC018). Continued approval may be contingent upon verification and description of clinical benefit, including in the ongoing Phase 3 ACTION trial (NCT05580562), which is evaluating the safety and clinical benefit of dordaviprone 5 in newly diagnosed patients with H3 K27M-mutant diffuse glioma following radiotherapy. Modeyso was developed by Chimerix prior to its acquisition by Jazz Pharmaceuticals in April 2025.

Modeyso (dordaviprone) is only approved in the United States.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS
Hypersensitivity
MODEYSO can cause severe hypersensitivity reactions.

In the pooled safety population, Grade 3 hypersensitivity reactions occurred in 0.3% of patients receiving MODEYSO. Signs and symptoms of hypersensitivity may include rash, hives, fever, low blood pressure, wheezing, or swelling of the face or throat.

Inform patients about the signs and symptoms of hypersensitivity reactions and instruct them to seek immediate medical attention if symptoms occur.

If clinically significant hypersensitivity or anaphylaxis occur, immediately interrupt MODEYSO and initiate appropriate medical treatment and supportive care. Based on the severity of the adverse reaction, temporarily interrupt or permanently discontinue MODEYSO.

QTc Interval Prolongation
MODEYSO causes concentration-dependent QTc interval prolongation, which can increase the risk for ventricular tachyarrhythmias (e.g. torsades de pointes) or sudden death.

In patients who received MODEYSO and underwent at least one post baseline ECG, QTcF increase of >60 msec compared to baseline and QTcF >500 msec occurred in 6% and 1.2% of patients, respectively.

Monitor ECGs and electrolytes prior to initiation and periodically during treatment, as clinically indicated. Increase the frequency of monitoring in patients with congenital long QT syndrome, existing QTc prolongation, a history of ventricular arrhythmias, electrolyte abnormalities, heart failure, or who are taking strong or moderate CYP3A4 inhibitors.

Avoid concomitant use with other agents known to prolong the QT interval. If concomitant use cannot be avoided, increase the frequency of monitoring and separate administration of MODEYSO and QT-prolonging product.

Interrupt or reduce the dose of MODEYSO in patients who develop QT prolongation; permanently discontinue in patients with signs of life-threatening arrhythmias.

Embryo-Fetal Toxicity
MODEYSO can cause fetal harm when administered to a pregnant woman.

Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with MODEYSO and for 1 month after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with MODEYSO and for 1 month after the last dose.

ADVERSE REACTIONS

Serious adverse reactions occurred in 33% of the 376 patients who received MODEYSO. Serious adverse reactions in >2% of patients included hydrocephalus (5%), vomiting (4.3%), headache (3.2%), seizure (2.4%), and muscular weakness (2.1%). Fatal adverse reactions occurred in 1% of patients who received MODEYSO, including cardiac arrest (0.5%), intracranial hemorrhage (0.3%), and encephalopathy (0.3%).

The most common adverse reactions (≥20%) reported in clinical trials with MODEYSO were fatigue (34%), headache (32%), vomiting (24%), nausea (24%), and musculoskeletal pain (20%). The most common (≥2%) Grade 3 or 4 laboratory abnormalities were decreased lymphocytes (7%), decreased calcium (2.7%), and increased alanine aminotransferase (2.4%).

DRUG INTERACTIONS
Strong and Moderate CYP3A4 Inhibitors
Avoid concomitant use of MODEYSO with strong and moderate CYP3A4 inhibitors. If concomitant use cannot be avoided, reduce the MODEYSO dose as recommended and monitor for toxicity.

Strong and Moderate CYP3A4 Inducers
Avoid concomitant use of strong and moderate CYP3A4 inducers with MODEYSO.

USE IN SPECIFIC POPULATIONS
Lactation
There are no data on the presence of MODEYSO in human milk because of the potential for serious adverse reactions from MODEYSO in breastfed children, advise women not to breastfeed during treatment with MODEYSO and for 1 week after the last dose.

Pediatric Use
The safety and effectiveness of MODEYSO have not been established in patients less than 1 year of age. Dosing has not been established for patients weighing less than 22 pounds (10 kg).

Please refer to the full Prescribing Information, available here, including both Patient Information and Instructions for Use, for complete safety and administration information.

(Press release, Jazz Pharmaceuticals, NOV 11, 2025, View Source [SID1234659762])

On November 11, 2025 Whitehawk Therapeutics, Inc. (Nasdaq: WHWK), an oncology therapeutics company applying advanced technologies to established tumor biology to efficiently deliver improved antibody drug conjugate (ADC) cancer treatments, reported that Dave Lennon, PhD, President and CEO, will present at the Jefferies Global Healthcare Conference in London on November 18, 2025, at 11:30 AM GMT.

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A live webcast of the presentation can be accessed by visiting the Whitehawk Therapeutics IR website and will be available for replay for approximately 30 days following the event.

(Press release, Whitehawk Therapeutics, NOV 11, 2025, View Source [SID1234659761])

On November 11, 2025 Oncotelic Therapeutics Inc. (OTLC) and JV partner Sapu Bioscience reported the publication of their landmark review article, "Sub-15 nm Nanoparticles for Drug Delivery: Emerging Frontiers and Therapeutic Potential," in the International Journal of Molecular Sciences (IJMS 2025, 26, 10842; View Source) .

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Authored by Dr. Tapas De, Vuong Trieu, Scott Myers, Sanjive Qazi, Saran Saund, and Cynthia Lee, the paper is the first comprehensive review to systematically examine nanoparticles strictly within the 5-15 nm size domain-a scale that is now emerging as the most transformative scale in nanomedicine.

Defining a New Size Regime in Nanomedicine

While most clinical nanodrugs today rely on carriers between 50 nm and 200 nm, this review highlights how ultrasmall nanoparticles below 15 nm demonstrate fundamentally distinct biological behavior.

These sub-15 nm systems exhibit:

Deeper tissue and tumor penetration, reaching desmoplastic or poorly vascularized regions that larger nanocarriers cannot access;
Reduced reticuloendothelial accumulation and rapid renal clearance, minimizing long-term organ toxicity;
Enhanced diffusion across biological barriers, including the blood-brain barrier; and
Quantum-scale surface properties enabling multifunctional imaging and therapeutic applications.
This nanoscale window represents a new pharmacological paradigm where therapeutic delivery, tissue penetration, and clearance kinetics can be simultaneously optimized-offering the potential to overcome limitations of both small molecules and traditional nanocarriers.

A Platform for the Next Generation of Precision Therapies

"Sub-15 nm nanoparticles are not just smaller versions of conventional nanomedicines-they behave as an entirely new class of therapeutic entities," said Saran Saund, CBO of Oncotelic Therapeutics. "They open the door to safer, smarter, and more selective cancer treatments capable of crossing biological barriers that have limited drug delivery for decades."

Dr. Tapas De, Director of NanoFormulation at Oncotelic and lead author, added:

"Our analysis reveals that this ultrasmall size range achieves an optimal balance between deep tumor diffusion and systemic safety.

It’s the same size regime where nature’s own biomolecules-like antibodies and enzymes-operate most effectively."

Impact on Sapu’s Nanomedicine Pipeline

The findings directly inform the Sapu Deciparticle platform, including Sapu-003, an intravenous everolimus nanomedicine currently preparing for first-in-human evaluation.

"Publishing this comprehensive review validates the foundation of our Deciparticle technology," said Saran Saund, CBO of Oncotelic.

"Our ability to manufacture highly stable nanoparticles below 15 nm will be key to unlocking new therapeutic frontiers-from oncology to neurological and immune disorders."

About the Publication

Sub-15 nm Nanoparticles for Drug Delivery: Emerging Frontiers and Therapeutic Potential
Authors: Tapas De, Vuong Trieu, Scott Myers, Sanjive Qazi (Oncotelic Therapeutics); Saran Saund, Cynthia Lee (Sapu Bioscience)
Journal: International Journal of Molecular Sciences (ISSN 1422-0067)
DOI: 10.3390/ijms262210842
Published: November 8, 2025

(Press release, Oncotelic, NOV 11, 2025, View Source [SID1234659760])

On November 11, 2025 AC Immune SA (NASDAQ: ACIU), a clinical-stage biopharmaceutical company pioneering precision therapeutics for neurodegenerative diseases, reported that Company Management will participate in a fireside chat and one-on-one investor meetings during the Jefferies Global Healthcare Conference in London, taking place November 17-20, 2025.

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The fireside chat will take place on November 18, 2025, at 4:30 AM (ET) / 9:30 AM (GMT). A webcast of the fireside chat will be available on the Events Page of AC Immune’s website. A replay will be archived in the same location.

Please contact your Jefferies representative to request a meeting with AC Immune’s management team at the conference.

(Press release, AC Immune, NOV 11, 2025, View Source [SID1234659759])

On November 11, 2025 The Board of Directors of Recordati S.p.A. reported the Group’s Interim results on 30th September 2025, representing additional voluntary financial reporting. The Report was prepared using the assessment, measurement and recognition criteria prescribed by international accounting standards (IFRS). The Group’s Interim Report dated 30th September 2025 will be available on November 14th at the company’s offices and on the company’s website (www.recordati.com) and can also be viewed on the authorized storage system 1Info (www.1Info.it).

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Rob Koremans, Chief Executive Officer of Recordati, commented: "We are very pleased with the excellent progress we have achieved in the first nine months across the business, especially in Rare Diseases and the strong traction of Isturisa with the expanded label. After a thorough analysis of the Cushing’s syndrome market, we are now confident to double our peak year sales expectations for Isturisa to greater than € 1.2 billion as we invest in and target the non-overt patient population, unlocking tremendous additional potential. We are excited about the opportunities ahead and assured in our ability to continue executing on our strategy and creating incremental value for all our stakeholders."

Financial highlights

Consolidated net revenue for the first nine months of 2025 was € 1,956.2 million, up 12.2% versus the first nine months of 2024 or 8.1% on a like-for-like(3) basis at CER, driven by strong business momentum across both Specialty & Primary Care and Rare Diseases. The adverse FX impact for the first nine months of 2025 was € 35.5 million (-2.0%).

RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA S.p.A.

Registered Office

Via Matteo Civitali, 1 20148 Milano, Italy
Tel. +39 02 487871
Fax +39 02 40073747
www.recordati.com

Share Capital € 26.140.644,50 fully paid-up
Milano, Monza, Brianza and Lodi Comp. Reg. No. 00748210150 Tax Code/VAT No. 00748210150
Milano R.E.A. No. 401832

Company subject to the Management and Coordination Activity of Rossini Luxembourg S.àr.l

Specialty & Primary Care revenue was € 1,129.9 million for the first nine months of 2025, up 3.2% or 5.0% on a like-for-like basis(3) at CER (+2.5% excluding Türkiye). This reflects continued strong performance of all core therapeutic areas (promoted product evolution index of 104), despite slight slowdown in relevant market growth (Italy, Cough & Cold and lack of a price increase in Türkiye to date). In particular, the Urology and Cardiovascular franchises grew by mid-single digit rates, while the Gastrointestinal franchise grew at high-single digit rates driven by the strong in-market performance of several products in the portfolio, both prescription and OTC.

Rare Diseases revenue was € 782.2 million for the first nine months of 2025, up 29.2% as compared to the first nine months of 2024, or 14.1% on a like-for-like(3) basis at CER, driven by strong volume growth across all three franchises. The Endocrinology franchise achieved net revenue of € 283.6 million, an increase of 18.4%, reflecting strong new patient uptake of Isturisa in the U.S. with over 1,200 net active patients and double-digit growth of Signifor. The Hema-Oncology franchise achieved net revenue of € 301.3 million, growing by 71.4%, reflecting the contribution of Enjaymo of € 104 million (+24.7% vs the first nine months of 2024 pro-forma(8)), and driven by strong growth of Sylvant and Qarziba. The Metabolic franchise achieved net revenue of €

197.3 million, growing by 3.7%, driven by Carbaglu and Panhematin.

Adjusted operating income(9) was € 591.1 million for the first nine months of 2025, up 9.6% as compared to the first nine months of 2024 and 30.2% of net revenue. Operating income was €

496.7 million in the first nine months of 2025, down 1.5% over the first nine months of 2024, absorbing gross margin-related non-cash charges of € 62.5 million versus € 28.1 million in the first nine months of 2024, arising mostly from the unwind of the fair value step up of the acquired Enjaymo inventory and additional amortization. Non-recurring costs were € 32.0 million versus €
7.3 million in the first nine months of 2024 and include, beside the costs for further optimization of the Specialty and Primary Care commercial organization in Italy and Spain, also a one-off provision in the third quarter of 2025 of € 14.1 million for a litigation settlement with AIFA (Italian health authorities) related to prior years’ payback for Urorec.

EBITDA(1) was € 743.9 million for the first nine months of 2025, up 11.8% compared to the first nine months of 2024, with margin of 38.0% of net revenue. Strong revenue performance was partially offset by a higher level of investments to support the launches of the Isturisa expanded label in the U.S. and Enjaymo, and to support continued geographic expansion.

Financial expenses were € 67.4 million, up 8.1% as compared to the same period of the previous year. New loans taken out during 2024 to fund the acquisition of Enjaymo and in 2025 resulted in an increase in interest expense of € 14.1 million, while net exchange gains over the period amounted to € 10.9 million (mainly unrealized and driven by the devaluation of the U.S. dollar), against net FX losses of € 2.8 million in the first nine months of 2024.

Adjusted net income(2) was € 493.1 million, 25.2% of revenue, up by 10.7% compared to the same period of 2024, with higher operating performance partially offset by the increase in financial expenses and the tax rate. Net income was € 326.3 million, 16.7% of net revenue, down 3.6% versus the prior year, reflecting non-cash charges arising from the acquisition of Enjaymo, higher non-recurring cost and higher tax rate.

Free cash flow(4) was € 396.8 million for the first nine months of 2025, a decrease of € 37.5 million versus the first nine months of 2024, with higher EBITDA more than offset by higher working capital absorption (mainly driven by higher U.S. stock levels) and higher interests and income tax paid.
Net debt(5) as of September 30, 2025 was € 2,032.2 million, or leverage of 2.1x EBITDA pro-forma(6),
compared to net debt of € 2,154.3 million on December 31, 2024, following dividend payment of €
138.5 million, treasury shares purchased for € 101.4 million (net of proceeds from exercising stock
options) and the upfront payment for Vazkepa rights of USD$ 25 million.

Shareholders’ equity was € 1,927.8 million.

Isturisa Update

On April 15, 2025, the U.S. Food and Drug Administration (FDA) approved the supplemental new drug application (sNDA) for Isturisa (osilodrostat) for the treatment of endogenous hypercortisolemia in adults with Cushing’s syndrome for whom surgery is not an option or has not been curative. This was an expansion of the previous indication for the treatment of patients with Cushing’s disease, which is a sub-type of Cushing’s syndrome. The Isturisa indication expansion was supported by the extensive Isturisa clinical development program, which included over 350 patients. In addition, during the second quarter of 2025, Isturisa was granted regulatory approval in both Canada and Russia.

The Company today upgraded its peak year sales estimate for Isturisa to greater than € 1.2 billion (from a previous range of € 550 – € 650 million) based on a decision to actively pursue the non-overt Cushing’s syndrome market which is included in the current expanded U.S. label. The non-overt Cushing’s syndrome patient population typically does not present clinical characteristics, but an unmet medical need remains with cardiometabolic co-morbidities such as hypertension or diabetes. These patients are treated by community endocrinologists, selected primary care physicians and cardiologists. At peak, the total opportunity is potentially over four-fold the number of eligible patients for treatment from approximately 7,000 patients today to approximately 30,000 patients, driven by better diagnosis and treatment of the non-overt Cushing’s syndrome patient population.

On the basis of the expanded label, the Company is increasing commercial and medical activities, headcount and real-world evidence studies. In addition, the Company will initiate a Phase IV randomized controlled study in 2026 to assess the efficacy and safety of osilodrostat in adults with mild hypercortisolemia and uncontrolled hypertension due to Cushing’s syndrome. Additional investments behind Isturisa in the U.S. will ramp up to a total of approximately € 40 million – € 50 million per year.

Pipeline Update

During the second quarter of 2025, an investigator-sponsored clinical trial (IST) was initiated to investigate the safety, dose and early signs of effect for dinutuximab beta (Qarziba) in combination with chemotherapy for the treatment of patients with GD2-positive Ewing sarcoma.

Following the Committee for Medicinal Products for Human Use (CHMP) positive opinion earlier this year, on July 28, 2025, the European Commission issued a positive decision and granted marketing authorization, under exceptional circumstances, for Maapliv, a solution of amino acids intended for the treatment of maple syrup urine disease (MSUD) presenting with an acute decompensation episode in patients from birth who are not eligible for an oral and enteral branched-chain amino acids (BCAA)-free formulation.

The Company completed enrollment of the pasireotide Phase 2 trial for the treatment of post-bariatric hypoglycemia in August 2025. Top-line results are expected in the second quarter of 2026.

Following the meeting with the U.S. Food and Drug Administration (FDA) in early September, a potential
U.S. biologics license application (BLA) pathway was established with the FDA for Qarziba requiring an additional set of clinical data from the ongoing BEACON-2 trial. Results of the interim analysis are expected in the first half of 2028 and are expected to form the basis, together with existing clinical data, for a potential regulatory filing.

The other lifecycle management programs are progressing in line with plans.

Corporate Development

On June 24, 2025, Recordati announced a licensing and supply agreement with Amarin to commercialize the marketed cardiovascular medicine, Vazkepa (icosapent ethyl) across 59 countries, focused in Europe. Vazkepa is indicated to reduce the risk of cardiovascular events in statin-treated adult patients at high cardiovascular risk with elevated triglycerides and either established cardiovascular disease or diabetes with at least one other cardiovascular risk factor. Vazkepa was approved in 2021 in the EU and UK and in 2022 in Switzerland based on the REDUCE-IT study, a Phase 3 Cardiovascular Outcomes Trial (CVOT) performed in over 8,000 patients with statistically significant and clinically meaningful results in Major Adverse Cardiovascular Events (MACE).

Vazkepa is currently commercialized in 11 European countries, generated net sales of € 12 million in 2024 and is expected to achieve over € 40 million in revenues in 2027 and to be EBITDA positive from 2026. The expected revenue in 2025 is less than € 10 million with a slightly negative impact at the EBITDA level, reflecting the commercial investments required to sustain the expected future growth. Under the terms of the agreement, Recordati paid Amarin an upfront cash payment of US$ 25 million.

Business outlook

Strong performance across the business expected to deliver FY 2025 results in line with original guidance(10) (lower half of range) despite challenging macro environment (FX of approx. -3%, expected to continue into 2026)

In FY 2026, Rare Diseases are expected to approach 50% of Total Revenues:

Rare Diseases: high double-digit growth at CER, with accelerating Isturisa uptake (behind broader label and activities to target non-overt patient population) and strong momentum of other key growth assets
Specialty & Primary Care: low single-digit growth at CER (returning to mid- single digit in 2027), reflecting also loss of Cardicor license (~ € 35 million/ year)
FY 2026 margins to reflect additional investments behind Isturisa and adverse FX.

The FY 2027 targets(11) remain unchanged, with strong organic growth complemented by bolt-on BD and M&A.

Updated peak year sales expectations for Isturisa doubled to over € 1.2 billion (from € 550 – 650 million).

Interim dividend 2025

The Board of Directors has resolved to distribute an interim dividend for 2025 of € 0.63 per share (gross of applicable withholding taxes), payable to shareholders holding shares on the ex-dividend date. Treasury shares held by the Company on that date are excluded.

The interim dividend will be paid starting 26 November 2025, with record date 25 November 2025, and coupon no. 36. Shareholders must be registered by 24 November 2025 to be eligible.

The Independent Auditor, EY S.p.A., has issued the opinion required under Art. 2433-bis, paragraph 5 of
the Italian Civil Code, which is available at the Company’s registered office.

The Directors’ Report and the financial statements of Recordati S.p.A. as of 30 June 2025, which form the basis for the Board’s decision to distribute the interim dividend, are available at the Company’s registered office and website (www.recordati.com), and can also be accessed via the authorized storage system 1Info (www.1Info.it).

(1) Net income before income taxes, financial income and expenses, depreciation, amortization and write-downs of property, plant and equipment, intangible assets and goodwill, non-recurring items and non-cash charges arising from the allocation of the purchase price of acquisitions to the gross margin of acquired inventory as foreseen by IFRS
(2) Net income excluding amortization and write-downs of intangible assets (except software) and goodwill, non-recurring items, non-cash charges arising from the allocation of the purchase price of acquisitions to the gross margin of acquired inventory as foreseen by IFRS 3, monetary net gains/losses from hyperinflation (IAS 29), net of tax effects.
(3) Pro-forma growth calculated excluding revenue of Enjaymoand Vazkepa for 9M 2025
(4) Total cash flow excluding financing items, milestones, dividends, purchases of treasury shares net of proceeds from exercise of stock options.
(5) Cash and cash equivalents, less bank debts and loans, which include the measurement at fair value of hedging derivatives.
(6) Pro-forma calculated by adding Enjaymo’s estimated contribution from October to November 2024 (when it still was propriety of Sanofi) to EBITDA
(7) Please note that Italian Legislative Decree 25/2016, which implements Directive 2013/50/EU, no longer stipulates the submission of an interim management report, which was previously required in terms of paragraph 5 of Art. 154-ter of Italian Legislative Decree 58/1998.
(8) Comparing the first nine months 2025 revenue (which considers also the margin retained by Sanofi’s on in market sales for those countries where it was still holding the MA) with the first nine months 2024 revenue totally realized by Sanofi.
(9) Net income before income taxes, financial income and expenses and non-recurring items, non-cash charges arising from the allocation of the purchase price of acquisitions to the gross margin of acquired inventory as foreseen by IFRS 3.
(10) FY 2025 original guidance range announced on February 13, 2025: Net Revenue € 2,600 – € 2,670 million; EBITDA
€ 970 – €1,000 million; Adjusted Net Income € 640 – €670 million
(11) FY 2027 targets: Net Revenue €3,000 – €3,200 million, EBITDA €1,140 – €1,225 million, Adjusted Net Income €770
– €820 million, excluding potential impact from tariffs and/or most favoured nation pricing policies in the U.S.

Conference Call

Recordati will host a conference call tomorrow, November 12th, at 2:00 p.m. CET (1:00 p.m. GMT) to present the results for the first nine months of 2025. Please find the pre-registration link here with all the dial-in details and a calendar invitation to follow.

(Press release, Recordati, NOV 11, 2025, View Source [SID1234659757])