On November 10, 2025 Ontada, a leader in real-world oncology data and insights, reported it will present new research findings in an oral presentation at the ISPOR Europe 2025 conference, being held this week in Glasgow, Scotland. ISPOR is the leading professional society for health economics and outcomes research globally. The study, titled, "A Framework for Accelerating Clinical Development with Real-World External Control Arms (ECA) in Phase 2 Trials," addresses a critical gap in early-stage clinical research by offering a scalable approach to contextualizing single-arm trial data.

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This research highlights the potential of ECAs to enhance Phase 2 trials, which often lack traditional control groups and face challenges related to small sample sizes and slow patient accrual, particularly in oncology and rare diseases.

Key Data Findings

Real-world data (RWD) curation: The framework outlines a systematic approach to identifying and curating structured and unstructured RWD sources to build robust ECAs.
Trial emulation: It applies rigorous eligibility criteria from the trial to real-world cohorts, ensuring comparability.
Adaptive matching strategies: To address limited trial sample sizes, the framework uses simulation techniques to create synthetic datasets that support more robust patient matching.
Pilot application: The framework was successfully applied to a Phase 2 single arm trial of Tucatinib and Doxil in HER2+ metastatic breast cancer, demonstrating feasibility and value.
"Phase 2 trials are essential for identifying promising therapies, but their inherent design poses challenges to achieving rapid and robust inferences," said Jessica K. Paulus, ScD, vice president, Real World Research, Ontada. "This framework leverages high-quality real-world data and extends state-of-the-science methods in ECA development to overcome barriers in Phase 2 trial conduct, offering a practical path to accelerate development while maintaining scientific rigor. It’s a meaningful step toward more efficient clinical research."

Study Methodology

The framework was developed through a literature review of best practices in Phase 3 ECA design and adapted for Phase 2 single-arm trials. It incorporates simulation-based matching to address the challenge of limited trial patient data and was piloted using real-world data for a newly launched Phase 2 trial in HER2+ metastatic breast cancer.

Research at ISPOR Europe 2025

Ontada is showcasing its research capabilities at ISPOR with five accepted abstracts on topics such as evolving trends in patient demographics and diagnosis in gastric cancer, improving data quality in oncology electronic health record-derived databases, assessing secular trends in ovarian cancer diagnoses, and real-world associations between smoking status and genetic driver mutations in metastatic lung cancer. For a complete list of Ontada presentations, visit Ontada’s ISPOR Europe 2025 site. Additionally, visit Ontada at booth #616 at the Scottish Event Campus in Glasgow, November 10–12, to explore our latest research and real-world oncology solutions.

"At Ontada, we are committed to advancing oncology research through innovative applications of real-world data," said Christine Davis, president, Ontada. "Our presence at ISPOR Europe reflects the depth and diversity of our real-world research capabilities. From advancing trial design with external control arms to uncovering trends in cancer diagnosis and treatment, our work is helping shape the future of oncology through data-driven insights."

Ontada is a part of McKesson, which has an unmatched portfolio of oncology and multispecialty solutions and partners that provide research, insights, technologies and services that help to address barriers and improve cancer and multispecialty care.

(Press release, Ontada, NOV 10, 2025, View Source [SID1234659748])

On November 10, 2025 Galecto, Inc. ("Galecto") reported the completion of the acquisition of Damora Therapeutics, Inc. ("Damora"), a privately held biotechnology company advancing a pipeline of antibody therapeutics aimed at transforming the treatment of mutant calreticulin- (mutCALR)-driven Myeloproliferative Neoplasms (MPNs), including Essential Thrombocythemia (ET) and Myelofibrosis (MF). The acquisition gives the combined company a pipeline covering a broad spectrum of hematological cancers and leverages the deep expertise of both teams, and positions Galecto to advance Damora’s complementary assets for people living with blood cancers, with the goal of developing safer, more effective, and more convenient disease-modifying therapies.

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A concurrent private placement of Series C non-voting convertible preferred stock was led by Fairmount with participation from the following institutional investors: Viking Global Investors, Venrock Healthcare Capital Partners, Commodore Capital, Janus Henderson Investors, Wellington Management, RA Capital Management, TCGX, Forbion, BB Biotech, Blackstone Multi-Asset Investing, Perceptive Advisors, Vestal Point Capital, Balyasny Asset Management, Andreessen Horowitz (a16z Bio + Health), and a leading life sciences investment firm. The private placement resulted in gross proceeds to Galecto of approximately $284.9 million and is expected to fund operations into 2029, enabling advancement of Damora’s lead program, DMR-001, through key Phase 1 proof-of-concept data expected in 2027, as well as pipeline programs, DMR-002 and DMR-003, into Phase 1 studies.

MPNs are a group of rare, chronic blood cancers characterized by the abnormal production of blood cells in the bone marrow. MutCALRs drive uncontrolled proliferation and disease progression in 25% of ET and 35% of MF cases. There are approximately 42,000 patients in the United States living with mutCALR-driven MPNs.

Damora is the sixth company launched based on assets developed by Paragon Therapeutics. DMR-001 is a potentially best-in-class anti-mutCALR monoclonal antibody demonstrated to have enhanced activity in Type 1 and Type 2 mutCALR-driven preclinical models, with approximately 10-fold greater potency against Type 2 mutCALR-driven cell proliferation, as compared to internal data generated using a reference molecule in clinical development, supporting its potential to address the full spectrum of mutCALR mutations in both ET and MF. DMR-001 is engineered with validated half-life extension technology to enable infrequent low-volume, subcutaneous dosing. An IND submission for DMR-001, with anticipated first-in-human administration via subcutaneous administration, is expected to occur in mid-2026.

"The acquisition of Damora marks a pivotal milestone for Galecto as we evolve our focus toward advancing Damora’s highly differentiated mutCALR portfolio, which addresses significant unmet need across the full spectrum of blood cancers driven by mutCALR," said Dr. Hans Schambye, President and CEO of Galecto. "This pipeline, led by DMR-001, is designed to overcome the limitations of current candidates in early clinical development and has the potential to establish a new standard of care in the treatment of ET and MF. With a strong balance sheet, we believe we are well-positioned to drive these programs rapidly into the clinic and ultimately deliver meaningful benefit to patients."

"The immediate access to public capital markets and the strengthened financial position achieved through this acquisition and concurrent private placement provides momentum to accelerate the development of our highly specialized portfolio," added Peter Harwin, incoming Galecto Board Member and Managing Member at Fairmount. "Our team is eager to leverage Galecto’s infrastructure to rapidly transition DMR-001 from IND-enabling studies to first-in-human trials by mid-2026, ensuring these assets, focused on superior efficacy and convenience, reach patients as quickly as possible."

In addition, Galecto is excited to combine these newly acquired complementary pipeline assets with its investigational candidate GB3226, a dual ENL-YEATS and FLT3 inhibitor for multiple genetic subsets of acute myeloid leukemia (AML). As previously disclosed, GB3226 will be featured in two poster presentations at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, taking place December 6 – 9, 2025, in Orlando, Florida. Galecto also announced that it received constructive feedback from the U.S. Food and Drug Administration (FDA) in response to its pre-Investigational New Drug (pre-IND) submission and plans to submit an IND application in the first quarter of 2026 to enable future clinical evaluation of GB3226 in AML.

Management & Organization

In conjunction with the transaction, Galecto Board Members will include:

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Carl Goldfischer, MD (current Chair)

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Jayson Dalls, MD (current)

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Amit Munshi (current)

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Hans Schambye, MD, PhD (current)

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Peter Harwin, Managing Member, Fairmount

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Chris Cain, PhD, Director of Research, Fairmount

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Julianne Bruno, Growth Partner, Fairmount

About the Acquisition and Financing Transaction

The acquisition was approved by the Board of Directors of Galecto and the Board of Directors and stockholders of Damora. The closings of the transactions are not subject to the approval of Galecto’s stockholders. On an as-converted basis and after accounting for these transactions (and without giving effect to any beneficial ownership limitations), the total number of shares of Galecto common stock will be 61,998,882.

Lucid Capital Markets is serving as financial advisor to the Board of Directors of Galecto. Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C., is serving as legal counsel to Galecto. Wedbush PacGrow is serving as financial advisor to Damora. Jefferies, Leerink Partners, UBS, and LifeSci are serving as the placement agents to Damora, and Gibson, Dunn & Crutcher LLP is serving as legal counsel to Damora.

Webcast Details

The company will host a webcast on November 10, at 8:00 a.m. ET to discuss the transaction as well as Damora’s approach and pipeline assets. To access the call, please dial 1-646-357-8766 (International) or 1-888-880-3330 (toll-free). To access the live webcast, please go to View Source A replay of the webcast presentation will be temporarily archived on the Investors section of Galecto’s website following the presentation.

(Press release, Galecto Biotech, NOV 10, 2025, View Source [SID1234659713])

On November 10, 2025 Terns Pharmaceuticals, Inc. ("Terns" or the "Company") (Nasdaq: TERN), a clinical-stage oncology company, reported financial results for the third quarter ended September 30, 2025, and provided corporate updates.

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"We’re thrilled with the positive momentum of the CARDINAL program generated by the unprecedented Phase 1 MMR achievement rate and encouraging safety/tolerability profile published in the recent ASH (Free ASH Whitepaper) abstract. These data continue to reinforce our view of the potential of TERN-701 to become a best-in-disease treatment for patients with chronic myeloid leukemia (CML)," said Amy Burroughs, chief executive officer of Terns Pharmaceuticals. "Our team continues to execute with precision and focus towards an updated and expanded CARDINAL readout at ASH (Free ASH Whitepaper), with an ultimate goal of bringing this important new therapy to CML patients."

Recent Pipeline Developments and Anticipated Milestones

TERN-701: Novel investigational allosteric BCR::ABL1 inhibitor for chronic myeloid leukemia (CML)

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In November 2025, Terns announced that an abstract with updated data from the ongoing Phase 1 CARDINAL trial evaluating TERN-701 in patients with relapsed/refractory CML had been selected for oral presentation at the 67th ASH (Free ASH Whitepaper) Annual Meeting and Exposition
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The abstract reported data from the ongoing dose escalation and dose expansion parts of the CARDINAL trial. Highlights include from the abstract include:
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Overall (cumulative) major molecular response (MMR) rate of 75% by 24 weeks, with 64% achieving MMR and 100% maintaining MMR
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Overall (cumulative) MMR by 24 weeks in difficult to treat patient subgroups
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69% in patients with lack of efficacy to last tyrosine kinase inhibitor (TKI)
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60% in patients who had prior asciminib
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67% in patients with prior asciminib / ponatinib / investigational TKI
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No patients had lost MMR at the time of data cutoff
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Encouraging safety and tolerability profile at all doses evaluated
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A more expansive and updated dataset from the CARDINAL trial will be presented at the ASH (Free ASH Whitepaper) Annual Meeting:
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Session Name: 632. Chronic Myeloid Leukemia: Clinical and Epidemiological: Therapeutic agents to enhance patient outcomes
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Session Date: December 8, 2025
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Session Time: 2:45 – 4:15pm ET
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Presentation Time: 2:45 – 3:00pm ET
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The Company will host a conference call to review the data on December 8, 2025 at 4:30pm ET. The event can be accessed live on the investor relations section of Terns’ website, where it will also be archived

TERN-601: Oral, small-molecule glucagon-like peptide-1 receptor agonist (GLP1-RA) for obesity

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In October 2025, Terns announced top-line 12-week data from the Phase 2 study of TERN-601 for the treatment of obesity, which showed maximum placebo-adjusted weight loss of 4.6% with 12% treatment discontinuation due to adverse events
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Asymptomatic, reversible grade 3 liver enzyme elevations occurred in three participants during post-treatment follow-up period, two of which were deemed drug related
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The results of the Phase 2 study did not support the Company’s further development of TERN-601 in obesity
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Terns had previously announced its decision to no longer invest in metabolic disease

Pipeline and Partnering Programs

"As we continue to sharpen our strategic focus in oncology, earlier this year we decided we would discontinue internal clinical development of our metabolic programs. While these metabolic assets have shown promise, we believe their full potential can best be realized through external partnerships," noted Andrew Gengos, chief financial officer of Terns.

TERN-501: Oral, thyroid hormone receptor-beta (THR-β) agonist

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Based on non-clinical studies, THR-β is a complementary mechanism to GLP-1, potentially providing broader metabolic and liver benefits in addition to increased weight loss
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Terns is seeking a strategic partner to advance this program

TERN-801: Oral, small-molecule glucose-dependent insulinotropic polypeptide receptor (GIPR) antagonist

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In the third quarter of 2025, Terns nominated TERN-801, an oral small-molecule GIPR antagonist as a development candidate from the TERN-800 series discovery effort
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Terns is seeking a strategic partner to advance this program

Third Quarter 2025 Financial Results

Cash Position: As of September 30, 2025, cash, cash equivalents and marketable securities were $295.6 million, as compared with $358.2 million as of December 31, 2024. Based on its current operating plan, Terns expects these funds will be sufficient to support its planned operating expenses into 2028.

Research and Development (R&D) Expenses: R&D expenses were $19.9 million for the quarter ended September 30, 2025, as compared with $15.2 million for the quarter ended September 30, 2024.

General and Administrative (G&A) Expenses: G&A expenses were $7.8 million for the quarter ended September 30, 2025, as compared with $9.8 million for the quarter ended September 30, 2024.

Net Loss: Net loss was $24.6 million for the quarter ended September 30, 2025, as compared with $21.9 million for the quarter ended September 30, 2024.

(Press release, Terns Pharmaceuticals, NOV 10, 2025, View Source [SID1234659729])

On November 10, 2025 Purdue Pharma L.P. ("Purdue") reported that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to its pipeline drug tinostamustine for the treatment of malignant gliomas, a broad category of brain and spinal cord cancers that affect both adults and children and includes rapidly growing, invasive tumors like glioblastoma. As many as 22,000 people are diagnosed with malignant gliomas annually in the United States1. FDA grants ODD status to encourage development of promising medicines intended for the treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the United States.

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Purdue is currently investigating tinostamustine in patients with glioblastoma, the most common malignant glioma, that is aggressive, very challenging to treat and for which there is no cure.2 Most patients do not survive more than 15 months with current treatment approaches.3 The ODD request for tinostamustine was supported by robust epidemiologic, clinical and pre-clinical evidence, as well as mechanistic rationale supporting its potential to address a critical unmet medical need for glioblastoma.

"As many as 15,000 people in the U.S. are diagnosed with glioblastoma each year.3 Unfortunately, there is limited survival benefit with existing treatment options," said Julie Ducharme, Vice President and Chief Scientific Officer, Purdue. "This recognition from FDA is an important milestone in our mission of advancing innovative science in areas of serious, unmet medical need. We look forward to further investigating tinostamustine, which has shown promise in early trials."

Orphan drug designation is intended to facilitate drug development for rare diseases and may provide certain incentives to drug developers.4,5 These benefits include tax credits for qualified clinical trials, exemption from user fees including New Drug Application (NDA), and a potential for seven years of market exclusivity following approval.

Tinostamustine is a potential first-in-class, new chemical entity that combines two potentially synergistic mechanisms of action, bifunctional alkylating activity and pan histone deacetylase inhibition (or HDAC inhibition). Tinostamustine has the potential to be a first-line treatment for glioblastoma.

"Behind every designation like this are real people, patients and families, facing the devastating reality of malignant gliomas, especially glioblastoma," said Craig Landau, MD, President and CEO, Purdue Pharma. "We are deeply committed to pursuing this medicine that has the potential to bring hope where few options exist today. Tinostamustine represents a step forward in our efforts to help address the urgent and unmet needs of those affected by these aggressive cancers."

The Company also recently entered into an agreement with the Global Coalition for Adaptive Research (GCAR) to pursue the Phase 2/3 clinical development of tinostamustine in GBM AGILE (Glioblastoma Adaptive Global Innovative Learning Environment – NCT03970447), a global adaptive platform trial for glioblastoma.

This press release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that tinostamustine will successfully complete development or gain FDA approval.

(Press release, Purdue Pharma, NOV 10, 2025, View Source [SID1234659749])

On November 10, 2025 Genmab A/S (Nasdaq: GMAB) ("Genmab") reported that it and its wholly owned subsidiary Genmab Finance LLC ("Genmab Finance") intend to offer, subject to market and other conditions, $1.5 billion of senior secured notes due 2032 (the "Secured Notes") and $1.0 billion of senior unsecured notes due 2033 (the "Unsecured Notes," and together with the Secured Notes, the "Notes").

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Genmab also launched the syndication of a new $2.0 billion senior secured term loan "B" facility, which term loan "B" facility is in addition to a $1.0 billion senior secured term loan "A" facility and $500 million senior secured revolving credit facility (collectively, the "New Credit Facilities") that Genmab previously syndicated to certain lenders as part of the financing for the pending acquisition (the "Acquisition") of Merus N.V. ("Merus").

Genmab intends to use the net proceeds from this offering of the Notes, together with borrowings under the New Credit Facilities and cash on hand, to fund the consideration payable in connection with the Acquisition of Merus and related fees and expenses in connection with the Acquisition, the borrowings under the New Credit Facilities and the issuance of the Notes.

Prior to the Acquisition closing, the Notes and the related guarantees from Genmab subsidiaries will be secured solely by segregated securities accounts of Genmab in which the gross proceeds of the Notes will be held. Following the purchase of all Merus common shares tendered in the previously announced tender offer by Genmab, the Secured Notes will be secured by a first priority security interest in certain assets of Genmab and its subsidiaries that will guarantee the obligations under the New Credit Facilities, in accordance with certain customary practices in the relevant jurisdictions, and subject to certain thresholds, exceptions and permitted liens. The Secured Notes will be unconditionally guaranteed on a senior secured basis and the Unsecured Notes will be unconditionally guaranteed on a senior unsecured basis by certain subsidiaries of Genmab that will guarantee the obligations under the New Credit Facilities.

The indentures governing the Notes are expected to contain customary covenants that, among other things, restrict, with certain exceptions, the ability of each of Genmab and its subsidiaries to incur additional debt, pay dividends, make certain other restricted payments, incur debt secured by liens, dispose of assets, engage in consolidations and mergers or sell or transfer all or substantially all of its assets.

The Notes will not be registered under the Securities Act of 1933, as amended (the "Securities Act"), or any state or other securities laws and may not be offered or sold in the United States absent an effective registration statement or an applicable exemption from the registration requirements of or in a transaction not subject to the Securities Act and any state or other applicable securities laws. Accordingly, the offering of the Notes is available only to persons who are either (1) reasonably believed to be "qualified institutional buyers" as defined in Rule 144A under the Securities Act or (2) non-U.S. persons outside the United States pursuant to Regulation S under the Securities Act. The Notes will be subject to restrictions on transferability and resale and may not be transferred or resold except in compliance with the registration requirements of the Securities Act or pursuant to an exemption therefrom and in compliance with any state or other applicable securities laws.

This announcement shall not constitute an offer to sell or a solicitation of an offer to purchase any securities and shall not constitute an offer, solicitation or sale in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful. The offering of the Notes may be made only by means of an offering memorandum.

(Press release, Genmab, NOV 10, 2025, View Source [SID1234659714])