PharmaMar Group Announces Financial Results as of September 30th, 2025

On October 30, 2025 PharmaMar Group (MSE: PHM) reported a 3% increase in total revenue during the first nine months of this year, reaching €130.9 million. Recurring revenue, resulting from the sum of net sales plus royalties received from our partners, grew by 6% to €105.6 million as of September 30th, 2025.

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As of September 30th this year, total sales in oncology amounted to €62.4 million, representing a 9% increase over the same period last year. These sales include commercial sales of Yondelis (trabectedin) in Europe, sales of raw materials to our partners, both trabectedin and lurbinectedin, and the positive performance of Zepzelca (lurbinectedin) in Europe, whose revenues increased by 34.7% in the first nine months of this year, reaching €31.4 million. Of particular note are revenues from lurbinectedin under the compassionate use program—mainly in France—which increased by 22% to €21.8 million, and commercial sales of Zepzelca in Switzerland, which amounted to €9.6 million, representing growth of 76% compared to the same period in 2024.

As of September 30th, 2025, oncology royalty income grew by 2% to €43.2 million. This amount corresponds mainly to royalties received from sales of lurbinectedin by our partners Jazz Pharmaceuticals and Luye Pharma, which together amounted to €35.0 million[1].. Added to this amount are royalties from sales of trabectedin by our partners in the US and Japan, totaling €8.2 million.

Non-recurring income from licensing agreements amounted to €25.3 million at the end of the first nine months of 2025, compared to €26.9 million in the same period last year. Noteworthy is the lurbinectedin licensing agreement for Japan signed with Merck for €21.0 million in April 2025, together with €3.0 million in deferred revenue from the 2019 agreement signed with Jazz Pharmaceuticals in relation to lurbinectedin. In the current fiscal year, the annual revenue recognition for the latter agreement is estimated at €4 million, while the total amount to be recognized in the previous fiscal year was approximately €23 million. Of the total €300 million in revenue received in 2020 in relation to the agreement signed with Jazz Pharmaceuticals, 94% of the total has been recognized in the income statement.

PharmaMar group’s investment in R&D stood at €69.6 million as of September 30, compared to €75.98 million for the first nine months of the previous year.

Of the total R&D investment for the period, the oncology segment recorded €66.0 million, compared to €70.0 million as of September 30, 2024. This variation is mainly due to the completion, in December 2024, of recruitment for the LAGOON Phase III clinical trial with lurbinectedin in small cell lung cancer.

The Company continues to invest in the clinical development of other molecules in earlier Phase I stages with PM534 and PM54, all for the treatment of solid tumors.

The RNAi segment recorded €3.6 million in R&D as of September 30, 2025, compared to €6.0 million in the same period of the previous year. This variation is due to the completion in the first months of 2024 of the PIVO1 Phase III clinical trial with tivanisiran for dry eye.

As of September 30th, 2025, the Group’s EBITDA reached €23.1 million, compared to €6.3 million in the same period of the previous year.

As a result of all the above, the PharmaMar Group doubled its net profit compared to the same period last year, reaching €15.3 million vs. €7.4 million.

(Press release, PharmaMar, OCT 30, 2025, View Source [SID1234657164])

Forlong Biotechology to Present Clinical Data from FL115, a novel interleukin-15 (IL-15) superagonist, in Late-breaking Session at 40th SITC Annual Meeting

On October 30, 2025 Forlong Biotechnology, a clinical-stage biotech company focusing on developing transformative cytokine therapies for patients with severe unmet needs, reported that a late-breaking abstract featuring interim safety and efficacy data from a Phase 1 study evaluating the Company’s novel IL-15 superagonist, FL115, has been selected for poster presentation at the 40th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (SITC 2025) being held November 5-9, 2025, in National Harbour, Maryland.

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FL115 is an engineered IL-15/IL15Rα-Fbody fusion protein, aiming to enhance anti-tumor immunity via IL-15-mediated signaling on NK and CD8+ T cells while minimizing complexity from Fc. Fbody is a single-chain Fc designed to eliminate classical Fc effects including ADCC/CDC/ADCP while retaining FcRn engagement. Multiple Phase 1 clinical studies for FL115 as a monotherapy are being completed. FL115 is currently being investigated in combination with Bacillus Calmette-Guérin (BCG) in a Phase 2 clinical trial to evaluate safety and preliminary efficacy in patients with nonmuscle invasive bladder cancer (NMIBC) and in combination with an anti-PD1 monoclonal antibody in a Phase 1b/2 clinical trial to evaluate safety and preliminary efficacy in patients with advanced solid tumors.

"Our mission is to leverage our synthetic immunology platforms to engineer cytokines to fine tune the immune system, providing cancer patients with novel treatment options," said Dong Wei, Ph.D., Chief Executive Officer of Forlong Biotechnology, "IL-15 has long been believed to be an attractive cytokine for cancer immunotherapy, and fusing Fbody to IL-15/IL15Rα complex presents a differentiated IL-15 superagonist profile for the treatment of solid tumors. We appreciate the opportunity to present initial data from our Phase 1 study of FL115 to leading immuno-oncology experts in this prestigious late-breaking forum."

Poster Details:

Program: FL115
Poster Title: Preliminary safety, pharmacokinetics, pharmacodynamics and efficacy of FL115, a novel IL-15 superagonist, from a Phase 1 study in patients with advanced solid tumors
Abstract Number: 1334
Presenter: Dong Wei, Ph.D., CEO, Forlong Biotechnology
Date & Time: Saturday, November 8, 2025

About FL115

FL115 is an engineered IL-15/IL15Rα-Fbody fusion protein, aiming to enhance anti-tumor immunity via IL-15-mediated signaling on NK and CD8+ T cells while minimizing complexity from Fc. FL115 has demonstrated significant anti-tumor activities as a monotherapy or as part of combination therapy in vivo, and can be manufactured by a robust and efficient process with excellent product stability. Clinically, FL115 has demonstrated favorable safety profile and preliminary clinical responses as a monotherapy, and has the best-in-class potential to synergize with current and emerging T cell-targeting immunotherapies through combination therapy to significantly improve the treatment outcome for patients. It is currently being investigated in combination with Bacillus Calmette-Guérin (BCG) in a Phase 2 clinical trial to evaluate safety and preliminary efficacy in patients with nonmuscle invasive bladder cancer (NMIBC) and in combination with an anti-PD1 monoclonal antibody in a Phase 1b/2 clinical trial to evaluate safety and preliminary efficacy in patients with advanced solid tumors.

(Press release, Forlong Biotechnology, OCT 30, 2025, View Source [SID1234657182])

Consolidated Financial Results for the Second Quarter of Fiscal Year Ending March 31, 2026

On October 30, 2025 Ono reported Consolidated Financial Results for the Second Quarter of Fiscal Year Ending March 31, 2026.

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(Filing, 3 mnth, SEP 30, Ono, 2025, OCT 30, 2025, View Source [SID1234661688])

Photocure ASA: Results for the third quarter of 2025

On October 29, 2025 Photocure ASA (OSE:PHO) reported Hexvix/Cysview revenues of NOK 134.1 million in the third quarter of 2025 (Q3 2024: NOK 120.1 million), and an EBITDA of NOK 10.2 million (Q3 2024: NOK 5.0 million) for the company. Looking ahead, Photocure expects product revenue growth in the range of 8% to 10% on a constant currency basis (compared to 7 to 11% previously) and an EBITDA improvement in 2025. While the company is not providing a specific EBITDA guidance range, Photocure expects continued operating leverage flow-through in its core commercial business and significant potential growth in milestones this year.

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"Photocure delivered another strong quarter, extending our track record of double-digit topline revenue growth with positive EBITDA. We continued to execute with discipline this quarter while in parallel advancing new growth initiatives that further amplify our central role in precision diagnostics for bladder cancer," said Dan Schneider, President & Chief Executive Officer of Photocure.

The company continued to execute on its plan to expand blue light cystoscopy (BLC) use in Q3 2025 with the installation of 14 new Saphira towers in the U.S. — 7 new accounts and 7 blue light tower upgrades. In addition, due to increasing demand, ForTec has acquired and deployed 6 additional BLC towers, bringing the total number of mobile BLC towers to 24. With the increasing momentum provided by ForTec’s mobile solution, Photocure had 373 active accounts in the U.S. at the end of the quarter, an increase of 23% versus the second quarter of 2024. Across Europe, a total of 49 Olympus Visera Elite III blue light cystoscopy (BLC) capable systems were installed since the launch in Q1 2025.

Total revenues ended at NOK 135.0 million in the third quarter of 2025, up from NOK 120.2 million, with an EBIT of NOK 2.9 million (-2.2). Cash and cash equivalents were NOK 247.8 million at the end of the period.

After the closing of the quarter, Photocure announced a partnership with Intelligent Scopes Corporation (ISC), a U.S. subsidiary of Claritas HealthTech, to develop AI software to support physicians in real-time during BLC, improving early-stage bladder cancer detection, diagnosis and resection completeness.

"Together, Photocure and ISC intend to pursue FDA clearance for the AI software compatible with any BLC system. Based on the terms of the agreement, Photocure will have exclusive, perpetual rights to commercialize the new solution via its direct sales force, distributors or partners, as well as license the software to device manufacturers in any given country upon regulatory clearance. Our partnership with ISC, along with other strategic initiatives underway, represents a step toward expanding clinical adoption, driving operating leverage, and building long-term intrinsic value for shareholders," Schneider added.

Photocure believes that the benefits of BLC with Hexvix/Cysview offer superior detection and management of bladder cancer..

"Looking ahead, we anticipate sustained revenue growth, fueled by rigid kit adoption, expansion of mobile BLC, and HD upgrades that enhance utilization and sales. The tailwinds from a wave of recently approved NMIBC therapeutics are raising awareness around early detection and personalized disease management, validating Photocure’s position at the center of this rapidly evolving ecosystem. In addition to our commercial progress, we are encouraged by potential catalysts that could further strengthen our growth trajectory. These include CMS reimbursement developments, reintroduction of flexible BLC solutions to the market, entrance of additional equipment manufacturers and a potential FDA reclassification in favor of BLC from a citizen’s petition — each representing an opportunity to broaden patient access and accelerate adoption. Lastly, our license agreement with Asieris for Cevira has potential to trigger a significant milestone payment when it receives regulatory approval in China," Schneider concluded.

(Press release, PhotoCure, OCT 29, 2025, View Source [SID1234657077])

Aclaris Therapeutics to Participate in Three November Healthcare Conferences

On October 29, 2025 Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel product candidates for immuno-inflammatory diseases, reported that the Company will participate in three upcoming healthcare conferences in November.

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On Wednesday November 12, 2025, at 11:00 AM EST, Aclaris’ Chief Executive Officer Dr. Neal Walker and other members of Aclaris’ senior leadership team will participate in a fireside chat during the Guggenheim 2nd Annual Healthcare Conference in Boston, MA.
On Wednesday November 12, 2025, at 1:20 PM EST, Aclaris’ President and Chief Operating Officer Dr. Hugh Davis and other members of Aclaris’ senior leadership team will participate in a fireside chat during the Stifel 2025 Healthcare Conference in New York, NY.
On Monday November 17, 2025, at 2:00 PM GMT (9:00 AM EST), Dr. Walker will participate in a fireside chat during the Jefferies Global Healthcare Conference in London, UK.

Live and archived webcasts of these events will be accessible on the Events page of View Source The webcasts will be available on the Aclaris website for at least 30 days.

(Press release, Aclaris Therapeutics, OCT 29, 2025, View Source [SID1234657098])