1stOncology™: Cancer Intelligence Service – Page 418 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Genmab Commences Tender Offer for All Issued and Outstanding Common Shares of Merus N.V.

On October 21, 2025 Genmab A/S (Nasdaq: GMAB) ("Genmab") reported that it is commencing, through a wholly owned subsidiary, Genmab Holding II B.V. ("Purchaser"), a cash tender offer (the "Offer") to purchase all of the issued and outstanding common shares ("Common Shares") of Merus N.V. (Nasdaq: MRUS) ("Merus") for $97.00 per Common Share in cash (the "Offer Consideration"), less any applicable withholding taxes and without interest. The Offer is being made pursuant to the previously announced transaction agreement, dated as of September 29, 2025, by and among Genmab, Purchaser and Merus (the "Transaction Agreement").

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

Purchaser has filed today with the U.S. Securities and Exchange Commission (the "SEC") a tender offer statement on Schedule TO, which includes the terms of the Offer. Additionally, Merus has filed a Schedule 14D-9 with the SEC, which includes the recommendation of its Board of Directors that Merus shareholders accept the Offer and tender their Common Shares into the Offer.

Unless the Offer is earlier terminated, the Offer will expire at 5:00 p.m., New York City time, on December 11, 2025 (the "Initial Expiration Time") or, if the Offer is extended pursuant to and in accordance with the terms of the Transaction Agreement, the date and time to which the Offer has been so extended (the Initial Expiration Time, or such later expiration date and time to which the Offer has been so extended, the "Expiration Time"). If the conditions to the consummation of the Offer are satisfied, Purchaser will commence a subsequent offering period (the "Subsequent Offering Period") on the first business day following the Expiration Time. During the Subsequent Offering Period, Purchaser will offer to purchase additional Common Shares at the Offer Consideration, less any applicable withholding taxes and without interest, for a period of not less than 10 business days.

The Offer is not subject to a financing condition but is subject to other conditions as described in the Schedule TO and related tender offer documents, including satisfaction of a minimum tender condition.

Merus shareholders should read the Schedule TO, Schedule 14D-9, letter of transmittal and other tender offer documents, together with any amendments or supplements thereto, before making a decision as to whether to tender their Common Shares into the Offer. These documents can be obtained free of charge at the website maintained by the SEC at www.sec.gov or by contacting the information agent for the tender offer, Innisfree M&A Incorporated, as described in the Schedule TO and other tender offer documents.

(Press release, Genmab, OCT 21, 2025, View Source [SID1234656866])

Galapagos Announces Intention to Wind Down Cell Therapy Business as Part of the Company’s Ongoing Transformation

On October 21, 2025 Galapagos NV (Euronext & NASDAQ: GLPG) reported its intention to wind down its cell therapy business and pursue new transformational business development transactions with its available cash resources. The intention to wind down follows a comprehensive review of strategic alternatives, including a potential divestiture.

The plan would enable the Company to enhance operational efficiencies and focus on utilizing its available cash to execute its strategy of building a pipeline of novel therapeutics through strategic business development transactions under the leadership of its new management team.

"We have undertaken a thorough strategic review and sale process to identify potential buyers or investors with the expertise and resources to take the cell therapy business forward," said Henry Gosebruch, Chief Executive Officer of Galapagos. "Following a limited number of non-binding offers, ultimately no viable proposals were received with terms or financing that would reasonably support the business’ future. After a comprehensive review of all strategic alternatives, given the ongoing investment requirements, coupled with evolving market dynamics and taking into account the interest of all relevant stakeholders, we believe that allocating our capital to other areas of unmet need would be a more attractive use of our resources. Now that this comprehensive strategic review process has concluded, we look forward to continuing to pursue transformative business development opportunities."

Based on this assessment and extensive input from its advisors, Galapagos intends to wind down its cell therapy business. This intention to wind down the cell therapy business aims to support a stronger and more sustainable future for Galapagos. We are deeply grateful to our dedicated employees, investigators, patients, shareholders, and partners for their continued commitment and support.

The intention to wind down the cell therapy business was unanimously approved by the Board of Galapagos NV other than the two Directors appointed by Gilead, both of whom recused themselves from the vote. This intention is subject to the conclusion of consultations with works councils in Belgium and the Netherlands, during which Galapagos will continue to operate the business. Galapagos would consider any viable proposal to acquire all, or part of the cell therapy business, if such a proposal emerges during the wind down process.

The intention to wind down, if ultimately implemented, is anticipated to impact approximately 365 employees across Europe, the U.S. and China, as well as the closure of the sites in Leiden (the Netherlands), Basel (Switzerland), Princeton and Pittsburgh (U.S.), and Shanghai (China). The remaining Galapagos NV organization would be repositioned for long-term growth through transformational business development, and would keep a dedicated presence at its headquarters in Mechelen, Belgium. The non-cell therapy activities would continue to be managed by Galapagos.

In the event that the board would effectively proceed with a full wind down decision (i.e. when the intention would be confirmed after works council procedures), the Company would expect to incur the following spend related to the cell therapy business: €100 million to €125 million of operating costs from Q4 2025 through 2026 and €150 million to €200 million of one-time restructuring costs in 2026. An updated 2025 cash outlook will be provided with the Company’s third-quarter earnings in early November.

In connection with this process, Paul Weiss, Linklaters and Rutgers & Posch are serving as legal advisors and Morgan Stanley & Co. International plc is acting as financial advisor.

This press release contains inside information within the meaning of Regulation (EU) No 596/2014 of the European Parliament and of the Council of 16 April 2014 on market abuse (market abuse regulation).

(Press release, Galapagos, OCT 21, 2025, View Source [SID1234656865])

Citius Pharmaceuticals Announces a Registered Direct Offering of $6.0 Million Priced At-The-Market Under Nasdaq Rules

On October 21, 2025 Citius Pharmaceuticals Inc. (Nasdaq: CTXR) ("Citius Pharma" or the "Company"), a biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products, reported that it has entered into definitive agreement for the purchase of an aggregate of 3,973,510 shares of its common stock (or pre-funded warrants in lieu thereof) and accompanying common warrants to purchase up to an aggregate of 3,973,510 shares of its common stock, at a purchase price of $1.51 per share (or pre-funded warrant in lieu thereof) and accompanying common warrant in a registered direct offering priced at-the-market under Nasdaq rules. The common warrants will have an exercise price of $1.40 per share, will be exercisable immediately upon issuance, and will expire five years from the initial exercise date. The closing of the offering is expected to occur on or about October 21, 2025, subject to the satisfaction of customary closing conditions.

H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The aggregate gross proceeds to the Company from the offering are expected to be approximately $6.0 million, before deducting the placement agent fees and other offering expenses payable by the Company. The Company currently intends to use the net proceeds from the offering to support the commercial launch of LYMPHIR, including milestone, regulatory and other payments, development initiatives for all of our product candidates, as well as for general corporate purposes.

The securities described above are being offered pursuant to a "shelf" registration statement (File No. 333-277319) filed with the Securities and Exchange Commission ("SEC") on February 23, 2024 and declared effective on March 1, 2024. The offering is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. The prospectus supplement and the accompanying prospectus relating to the securities being offered will be filed with the SEC and be available at the SEC’s website at www.sec.gov. Electronic copies of the prospectus supplement and the accompanying prospectus relating to the securities being offered may also be obtained, when available, by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by telephone at (212) 856-5711 or e-mail at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.

(Press release, Citius Pharmaceuticals, OCT 21, 2025, View Source [SID1234656863])

Alecensa Extends Median Overall Survival to Over 80 Months in ALK-Positive Metastatic Non-Small Cell Lung Cancer

On October 21, 2025 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that the final data from the global Phase III ALEX study (NCT02075840) and the latest results from the global Phase III ALINA study (NCT03456076) of its anti-cancer agent/ALK inhibitor Alecensa (generic name: alectinib) for anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) were presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2025 Annual Congress.

In the final analysis of overall survival (OS), a secondary endpoint of the ALEX study, the median survival time for Alecensa was 81.1 months compared to 54.2 months for crizotinib (hazard ratio[HR]=0.78, 95% CI: 0.56-1.08).1
This survival advantage was consistent across all subgroups, including those with central nervous system metastases. The median duration of response was approximately four times longer with Alecensa compared to crizotinib (42.3 months vs 11.1 months, HR=0.41, 95% CI: 0.30-0.56), and the safety profile was consistent with the known profile of Alecensa. The main adverse event (≥30%) was constipation (40.1%), and despite a longer median treatment duration with Alecensa compared to crizotinib (28.1 months vs. 10.8 months), no new or unexpected safety signals were observed.1

Updated results from the ALINA study (NCT03456076) were also presented at ESMO (Free ESMO Whitepaper) 2025. ALINA is the Phase III trial of an ALK inhibitor with demonstrated efficacy in resectable stage IB-IIIA (UICC/AJCC 7th edition) ALK-positive NSCLC. In the primary analysis, Alecensa showed a significant disease-free survival (DFS) benefit compared to chemotherapy (HR=0.24, 95% CI: 0.13-0.43, p<0.001).2

After a median follow-up of four years, Alecensa continued to show improved DFS compared to chemotherapy in stage II-IIIA and stage IB-IIIA (ITT: intent-to-treat) patient populations. Alecensa reduced the risk of recurrence or death by 64% compared to platinum-based chemotherapy in completely resected stage II-IIIA ALK-positive NSCLC (HR=0.36, 95% CI: 0.23-0.56) and by 65% in the ITT population with completely resected stage IB-IIIA ALK-positive NSCLC (HR=0.35, 95% CI: 0.23-0.54). This DFS improvement was consistently demonstrated across subgroups, and a clinically meaningful improvement in CNS DFS was also maintained. Regarding safety, results were consistent with the primary analysis, with no new safety concerns or unexpected issues identified.2

About ALEX study

The ALEX study (NCT02075840/B028984) is a randomized, multicenter, open-label Phase III study evaluating the efficacy and safety of Alecensa (alectinib) versus crizotinib in treatment-naïve ALK-positive NSCLC. Patients were randomly assigned in a 1:1 ratio to receive either Alecensa or crizotinib. Crossover between treatment groups before disease progression was not permitted. In the ALEX study, alectinib was administered orally at 600 mg twice daily, which differs from the approved dosage and administration in Japan.
The primary endpoint of the ALEX study is progression-free survival (PFS) as assessed by the investigator. Secondary endpoints include PFS as assessed by an Independent Review Committee, time to central nervous system progression, objective response rate (as defined by RECIST criteria), duration of response, overall survival, health-related quality of life, and safety. This multicenter study was conducted in 303 patients across 161 sites in 31 countries.

About ALINA study
The ALINA study (NCT03456076) is a randomized, active-controlled, multicenter, open-label Phase III study evaluating the efficacy and safety of adjuvant Alecensa compared with platinum-based chemotherapy in resected Stage IB (tumor ≥4 cm) to IIIA (UICC/AJCC 7th edition) ALK-positive NSCLC. The study enrolled 257 patients who were randomly assigned to either the Alecensa or chemotherapy treatment arm. The primary endpoint is disease-free survival. Secondary endpoints include overall survival and the percentage of patients experiencing adverse events.

About Alecensa
Alecensa is a highly selective, central nervous system-active, oral medicine created at Chugai Pharmaceutical Co., Ltd. for people with non-small cell lung cancer (NSCLC) whose tumors are identified as anaplastic lymphoma kinase (ALK) positive. ALK fusion / rearrangement gene-positive lung cancer is found in approximately 3-5% of NSCLC cases.5 Alecensa is already approved in over 100 countries as an initial (first-line) and second-line treatment for ALK fusion / rearrangement gene-positive metastatic NSCLC, including in the United States, Europe, Japan, China, and Taiwan. For adjuvant therapy of ALK fusion / rearrangement gene-positive NSCLC, Alecensa received approval in the United States in April 2024, followed by Europe in June 2024, and Japan in August 2024. In Japan, Alecensa has been approved for "ALK fusion gene-positive unresectable, advanced or recurrent non-small cell lung cancer," "adjuvant therapy of ALK fusion-positive non-small cell lung cancer," and "recurrent or refractory ALK fusion gene-positive anaplastic large cell lymphoma."

Trademarks used or mentioned in this release are protected by law.

(Press release, Chugai, OCT 21, 2025, View Source [SID1234656862])

Alligator Bioscience granted US patent covering ATOR-4066 bispecific antibody

On October 21, 2025 Alligator Bioscience (Nasdaq Stockholm: ATORX), a clinical-stage biotechnology company developing tumor-directed immuno-oncology antibody drugs, reported that the United States Patent and Trademark Office (USPTO) has granted US Patent No. 12,448,465, covering the composition of matter of ATOR-4066, the company’s bispecific antibody targeting CD40 and CEACAM5. The patent will formally issue on 21 October 2025.

The granted patent provides broad protection for ATOR-4066, including the bispecific antibody itself and its unique binding regions targeting CD40 and CEACAM5, and is expected to remain in force until 2043, excluding any potential patent term extensions.

ATOR-4066 is a novel bispecific antibody designed to activate CD40 on antigen-presenting cells while simultaneously targeting CEACAM5 on tumor cells. By bridging immune activation and tumor recognition, ATOR-4066 has demonstrated potent preclinical anti-tumor activity. The candidate is advancing toward clinical development as part of Alligator’s next-generation immuno-oncology pipeline. The program builds on Alligator’s extensive experience with mitazalimab, its lead CD40 agonist currently advancing toward pivotal development in pancreatic cancer.

"This patent grant marks an important milestone in strengthening the intellectual property protection around ATOR-4066," said Søren Bregenholt, CEO of Alligator Bioscience. "It underscores the innovation behind our bispecific antibody platform and reinforces the long-term value of our pipeline as we continue to advance novel immunotherapies toward the clinic."
Alligator has an additional continuation application pending in this patent family in the United States, further expanding the scope of protection around ATOR-4066.

(Press release, Alligator Bioscience, OCT 21, 2025, https://mfn.se/a/alligator-bioscience/alligator-bioscience-granted-us-patent-covering-ator-4066-bispecific-antibody [SID1234656861])