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])

On October 30, 2025 Olema Pharmaceuticals, Inc. ("Olema" or "Olema Oncology", Nasdaq: OLMA), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted therapies for breast cancer and beyond, reported it will present a trial-in-progress poster for the Phase 3 OPERA-02 trial at the 2025 San Antonio Breast Cancer Symposium (SABCS 2025) taking place December 9-12, 2025 in San Antonio, TX. The trial is evaluating palazestrant in combination with ribociclib in frontline estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer.

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Poster Presentation Details
Title: OPERA-02: a phase 3 randomized, double-blind, active-controlled study of palazestrant with ribociclib versus letrozole with ribociclib for the first-line treatment of ER+, HER2- advanced breast cancer
Abstract Number: 264
Presentation Number: PS5-12-18
Date/Time: Friday, December 12, 2025 from 12:30pm–2:00pm CT / 1:30pm–3:00pm ET

Additional information can be found on the SABCS website. A copy of the poster will be made available on the Publications page of Olema’s website in alignment with the SABCS 2025 embargo policy.

(Press release, Olema Oncology, OCT 30, 2025, View Source [SID1234657163])

On October 30, 2025 Nuvalent, Inc.(Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, reported pipeline progress, reiterated key anticipated milestones, and announced third quarter 2025 financial results.

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"The third quarter of 2025 marked the achievement of a significant milestone with the completion of our NDA submission for zidesamtinib in TKI pre-treated advanced ROS1-positive NSCLC. We look forward to working closely with the FDA throughout the review process, as well as continuing to engage with the agency on potential opportunities for line-agnostic expansion," said Darlene Noci, A.L.M., Chief Development Officer of Nuvalent. "We remain on track to share topline pivotal data this quarter from our ALKOVE-1 trial of neladalkib in TKI pre-treated advanced ALK-positive NSCLC, and continue to progress ALKAZAR, our global Phase 3 randomized, controlled trial of neladalkib for TKI-naïve patients with advanced ALK-positive NSCLC."

"Our commercial preparedness activities are well underway as we carry forward the momentum from these exciting development milestones and continue our efforts to transition toward becoming a fully integrated commercial-stage biopharmaceutical company," said Alex Balcom, Chief Financial Officer of Nuvalent. "Combined with a strong financial position with cash runway anticipated into 2028, we believe we are well positioned to achieve our goal of delivering a new and potential best-in-class option for all patients with ROS1 or ALK-positive NSCLC."

"We are also pleased to have recently shared the first report of preliminary clinical data demonstrating the potential for neladalkib to address medical needs for patients with ALK-positive solid tumors beyond NSCLC, and new preclinical data further demonstrating the potential for NVL-330 to offer a differentiated profile for HER2-altered NSCLC," said James Porter, Ph.D., Chief Executive Officer of Nuvalent. "With a portfolio anchored by complementary indications in biomarker-driven NSCLC and supported by a robust development and discovery pipeline, we continue to build towards our long-term vision of Nuvalent as a sustainable company capable of designing, developing and delivering precisely targeted therapies for patients with cancer."

Recent Pipeline Achievements and Anticipated Milestones

ROS1 Program

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The company has completed its rolling NDA submission for zidesamtinib in tyrosine kinase inhibitor (TKI) pre-treated patients with advanced ROS1-positive non-small cell lung cancer (NSCLC).

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Data supporting the NDA submission were presented in September as part of the Presidential Symposium at the IASLC 2025 World Conference on Lung Cancer.
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The company continues to engage with the FDA on potential opportunities for line-agnostic expansion.
ALK Program

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Evaluation of neladalkib is ongoing in the ALKOVE-1 Phase 1/2 trial for patients with advanced ALK-positive NSCLC and other solid tumors:
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The company presented preliminary data from the ongoing ALKOVE-1 Phase 1/2 clinical trial of neladalkib in patients with advanced ALK-positive solid tumors outside of NSCLC during a poster presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025. Neladalkib demonstrated encouraging preliminary activity across a diverse set of advanced ALK-positive solid tumors, and was generally well-tolerated with a preliminary overall safety profile consistent with its ALK-selective, TRK sparing design, and with previously reported data.
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The company is on track to report topline pivotal data for TKI pre-treated patients with advanced ALK-positive NSCLC by year-end 2025.
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Enrollment is ongoing in ALKAZAR, the company’s global Phase 3 randomized, controlled trial designed to evaluate neladalkib for the treatment of patients with TKI-naïve ALK-positive NSCLC. Patients are randomized 1:1 to receive neladalkib or alectinib, a front-line standard of care, reflecting input from collaborating physician-scientists and alignment with global regulatory agencies.
HER2 Program

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Nuvalent presented new preclinical data for its novel HER2-selective inhibitor, NVL-330, at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper), further supporting its potentially differentiated brain-penetrant profile. Compared to several currently available and investigational HER2 TKIs in the same preclinical assays, NVL-330 demonstrated a favorable efflux ratio and brain partitioning, metrics that are potentially positive predictors of brain exposure in humans. In preclinical models of intracranial activity, NVL-330 induced deep intracranial regression in mice. In the same models, the approved therapies T-DXd and zongertinib did not induce intracranial regression at their clinically relevant doses. Additionally, NVL-330 induced intracranial tumor regression in mice that had progressed in the CNS on zongertinib. These data add to the preclinical characterization of NVL-330 as a brain penetrant TKI that is broadly active against HER2 oncogenic alterations and selective over wild-type EGFR, and the company believes the data support its investigation in patients with advanced HER2-altered NSCLC.
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Enrollment is ongoing in the HEROEX-1 Phase 1a/1b clinical trial evaluating the overall safety and tolerability of NVL-330 for pre-treated patients with HER2-altered NSCLC. Additional objectives include determination of the recommended Phase 2 dose, characterization of NVL-330’s pharmacokinetic profile, and preliminary evaluation of anti-tumor activity. The company expects to continue to progress the HEROEX-1 trial throughout 2025.

Upcoming Events

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Jefferies 2025 Global Healthcare Conference in London: Management will be participating in a fireside chat on Wednesday, November 19, 2025, at 5:00 p.m. GMT. A live webcast will be available in the Investors section of Nuvalent’s website at www.nuvalent.com, and will be archived for 30 days following the conference.

Third Quarter 2025 Financial Results

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Cash Position: Cash, cash equivalents and marketable securities were $943.1 million as of September 30, 2025. Nuvalent continues to believe its existing cash, cash equivalents and marketable securities will be sufficient to fund its current operating plan into 2028.
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R&D Expenses: Research and development (R&D) expenses were $83.8 million for the third quarter of 2025.
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G&A Expenses: General and administrative (G&A) expenses were $28.9 million for the third quarter of 2025.
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Net Loss: Net loss was $122.4 million for the third quarter of 2025.

(Press release, Nuvalent, OCT 30, 2025, View Source [SID1234657162])

On October 30, 2025 Nouscom, a clinical-stage biotech company developing next-generation neoantigen-targeted off-the-shelf and personalized cancer immunotherapies, reported it will give an oral late-breaker as well as a poster presentation of additional results from a Phase 1b/2 trial evaluating NOUS-209 in Lynch Syndrome (LS) carriers at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 40th Anniversary Annual Meeting being held in National Harbor, MD, USA on November 5-9, 2025. The company will also present further data validating NOUS-209 mechanism of action (MoA) in LS carriers at the SITC (Free SITC Whitepaper) meeting.

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Oral Presentation Details:

Title: Final Ph1b/2 Results for NOUS-209 Monotherapy in Lynch Syndrome Carriers: Annual Revaccination Boosts T Cell Immunity Informing Future Cancer Interception Strategies

Session: Clinical Oral Abstract Session 2
Date & Time: Saturday, November 8, 2025, 1:45 PM – 3:00 PM ET
Location: Gaylord National Resort & Convention Center, Potomac Ballroom

Poster Presentations Details:

Poster #118 – NOUS-209 Mechanism of Action Validation
Title: NOUS-209 Enables Broad Targeting of Primary and Metachronous Tumors in Lynch Syndrome

Session: Poster Hall
Time: Saturday, November 8, 2025, 9:00 AM – 6:35 PM ET
Location: Prince George’s ABC

Poster #1336 – NOUS-209 Clinical Data
Title: Final Ph1b/2 Results for NOUS-209 Monotherapy in Lynch Syndrome Carriers

Session: Poster Hall
Time: Saturday, November 8, 2025, 9:00 AM – 6:35 PM ET
Location: Prince George’s ABC

All abstracts are available on the SITC (Free SITC Whitepaper) website View Source

LS is a common inherited condition caused by DNA repair gene mutations. It affects approximately 1 in 300 people, leading to a significantly increased lifetime cancer risk of up to 80%. While current LS disease management relies on frequent screenings or preventive surgery, cancer interception with NOUS-209 aims to train the immune system to recognize and eliminate cancerous cells before they fully develop, grow and spread.

NOUS-209 is an off-the-shelf immunotherapy designed to target tumors with specific genetic deficiencies known as mismatch repair deficiency (dMMR) and/or microsatellite instability (MSI). These tumors produce unique markers known as frameshift peptide (FSP) neoantigens, which serve as tumor-specific neoantigens. Because these FSPs are exclusively found in cancerous cells, they are readily recognizable by the immune system and therefore are ideal targets for immunotherapy. NOUS-209 encodes 209 unique FSP neoantigens shared across multiple MSI tumor types, enabling its potential to treat a broad range of MSI-associated cancers.

Following positive Type B and C meetings with the US Food and Drug Administration (FDA), Nouscom has a clear path forward for the advancement of NOUS-209 into a registration-enabling Phase 2/3 clinical study for cancer interception in LS carriers.

The clinical trial NCT05078866 was led by researchers at The University of Texas MD Anderson Cancer Center, in collaboration with the Cancer Prevention Clinical Trials Network (CP-CTNet) and sponsored by the National Cancer Institute (grant # UG1CA242609). The activities are coordinated by the iCAN-PREVENT consortium of MD Anderson Cancer Center.

(Press release, NousCom, OCT 30, 2025, View Source;utm_medium=rss&utm_campaign=nouscom-to-present-new-positive-phase-1b-2-clinical-and-translational-data-on-nous-209-immunogenicity-and-cancer-interception-potential-in-lynch-syndrome-carriers-at-sitc-2025 [SID1234657161])

On October 30, 2025 Nkarta, Inc. (Nasdaq: NKTX), a clinical-stage biopharmaceutical company developing engineered natural killer (NK) cell therapies, reported its participation in the following investor conferences next month:

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Stifel 2025 Healthcare Conference
November 12, 2025
10:40 a.m. ET – fireside chat

TD Cowen’s Immunology & Inflammation Summit
November 13, 2025
5 p.m. ET – fireside chat

A simultaneous webcast of the event will be available on the Investors section of Nkarta’s website, www.nkartatx.com, and a replay will be archived on the website for approximately 90 days.

(Press release, Nkarta, OCT 30, 2025, View Source [SID1234657160])