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.

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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])

On October 21, 2025 Atossa Therapeutics, Inc. (Nasdaq: ATOS) ("Atossa" or the "Company"), a clinical-stage biopharmaceutical company developing innovative medicines in oncology, reported that Laura J. Esserman, MD, MBA, Professor of Surgery and Radiology at the University of California, San Francisco and Principal Investigator of RECAST, will speak at the Early Detection Research Conference in Portland, OR, about the Company’s collaborative work in the RECAST platform trial for ductal carcinoma in situ (DCIS), a biologically heterogeneous, non-invasive breast condition that can progress to invasive breast cancer in a subset of patients.

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RECAST is a multi-arm, Phase 2, randomized, neoadjuvant platform trial designed to identify which patients with hormone receptor–positive DCIS are best suited for active surveillance and to determine whether novel endocrine therapies can expand the population that can safely avoid surgery. The trial includes arms evaluating standard therapy (tamoxifen or aromatase inhibitor) as well as novel agents: (Z)-Endoxifen, elacestrant, and Hav-088. Efficacy is assessed with mammography and breast MRI, alongside biomarker discovery and quality-of-life endpoints. Enrollment began in January 2024; 50 patients have been enrolled toward a target of 400 across 17 activated clinical sites, with additional sites planned.

Why this matters for investors

Large, under-served market: DCIS is commonly treated like invasive cancer (surgery ± radiation ± endocrine therapy). Demonstrating that a biomarker-guided, non-surgical approach is safe and effective could reshape standard of care and expand use of oral endocrine agents in early-stage disease management.
Efficient signal-finding: The platform design enables parallel testing of multiple agents, including Atossa’s (Z)-Endoxifen, with common imaging and biomarker endpoints to generate comparative signals that can inform registration strategies.
Multiple potential catalysts: Early imaging response, biomarker correlation, and active-surveillance suitability rates by arm create interim readout opportunities that can de-risk later-stage programs and guide payer-relevant health-economic modeling.
Strategic collaborations: RECAST is sponsored by Quantum Leap Healthcare Collaborative with research support from NIH and industry partners. This shared-infrastructure model can accelerate enrollment, broaden site access, and optimize capital efficiency.
"RECAST is purpose-built to answer the question that payers, physicians, and patients care most about: who truly needs surgery and who does not," said Steven Quay, MD, PhD, Chairman and CEO of Atossa Therapeutics. "For Atossa, the trial offers a capital-efficient path to demonstrate the potential of (Z)-Endoxifen in a large early-disease setting, generate decision-grade biomarkers, and position us for value-creating milestones over the coming quarters."

RECAST Trial Objectives

Increase the fraction of DCIS patients suitable for long-term active surveillance using novel endocrine therapy.
Correlate risk of progression to invasive ductal carcinoma with risk categorization after six months of therapy.
Identify biomarkers that predict response and elucidate mechanisms of imaging response and resistance.
Assess quality of life compared with standard endocrine therapy.
Current Trial Status

Phase: 2 (platform)
Population: HR-positive DCIS (any grade)
Arms: Tamoxifen/AI (control), (Z)-Endoxifen, elacestrant, Hav-088
Assessments: Mammogram, MRI, biomarker panels, QoL
Enrollment: 50/400; 17 active U.S. sites; additional site activations planned.

(Press release, Atossa Therapeutics, OCT 21, 2025, View Source [SID1234656881])

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").

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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])

On October 21, 2025 HanchorBio reported that its proprietary HCB101, a SIRPα/CD47 fusion protein candidate, has been officially granted a US patent (Patent No. 12,447,195) by the United States Patent and Trademark Office (USPTO). Titled "ENGINEERED SIRPα VARIANTS AND METHODS OF USE THEREOF", the patent represents major international recognition for the company’s innovative technology for immuno-oncology.

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Mechanism of Action and Novelty of HCB101: An Innovative Fusion Protein Design

Developed using HanchorBio’s proprietary FBDB (Fc-Based Designed Biologics) platform, HCB101 is an engineered SIRPα/CD47 fusion protein designed to precisely modulate the immune system’s recognition and phagocytic functions, effectively overcoming the challenge of tumor immune evasion and enhancing the clearance of cancer cells.

The molecule employs an engineered variant strategy, featuring novel amino acid substitutions at previously unclaimed and undisclosed SIRPα sites.
These innovative structural mutations significantly enhance the binding affinity and functional potency of HCB101 toward CD47 expressed on tumor cells, thereby reactivating macrophage-mediated cancer cell killing while minimizing the hematologic toxicities commonly associated with traditional CD47 monoclonal antibody therapies.

The USPTO recognized HCB101’s original mutation design and unprecedented potency as clear evidence of novelty and inventive step, distinguishing it from prior technologies and enabling the molecule to successfully pass the rigorous US patent examination process.

In addition to robust intellectual property protection, the patent also strengthens HanchorBio’s position for licensing negotiations and strategic collaborations, further enhancing its global partnership and value creation potential.

Dr. Scott Liu, Chairman of HanchorBio, commented: "The US patent grant for HCB101 is a testament to HanchorBio’s robust R&D capabilities in immunotherapy, while also illustrating the heights of innovation that Taiwan’s biotech industry is capable of reaching. Backed by a solid IP position, we are committed to further expanding global collaboration."

Why the United States: A Strategic and Symbolic First Step

HanchorBio strategically selected the United States as the first jurisdiction for patent filing and issuance, recognizing it as the world’s most influential and standard-bearing market for biopharmaceutical innovation and licensing. US patent approval often serves as a benchmark for patent examiners in other countries, amplifying both credibility and momentum for subsequent filings.

For the filing, HanchorBio worked with Fish & Richardson, one of the largest and most respected intellectual property law firms in the US. The successful approval of HCB101’s US patent demonstrates the molecule’s technical originality and therapeutic advancement, paving the way for accelerated future examinations in Europe and multiple Asian territories.

Dr. Wenwu Zhai, Chief Scientific Officer of HanchorBio, remarked:
"We prioritized the US market as the foundation of our IP strategy, as its market scale and influence align closely with our long-term growth objectives. Building on this milestone, we will further build a comprehensive global IP protection network."

Global Patent Strategy: Strengthening Licensing and Partnerships

Following this US patent grant, HanchorBio will advance patent filings across Europe, Taiwan, and other Asian countries as part of its broader global IP roadmap.
This strategy aims to consolidate the company’s leadership in immuno-oncology and fusion protein drug development, while significantly enhancing its negotiating power for international licensing and co-development opportunities.

The HCB101 patent represents not only a technological milestone but also a pivotal step in HanchorBio’s journey toward global market expansion.

(Press release, Hanchor Bio, OCT 21, 2025, View Source [SID1234656882])

On October 21, 2025 Hoth Therapeutics, Inc. (NASDAQ: HOTH) reported FDA Orphan Drug Designation for HT-KIT and new preclinical data demonstrating >80% suppression of KIT expression and significant tumor-volume reduction by Day 8 in systemic mastocytosis and GIST models. HT-KIT, a precision antisense oligonucleotide (ASO) targeting KIT mRNA, also completed GLP-validated bioanalytical methods supporting IND-enabling studies; Japan Patent No. 7677628 extends platform protection to 2039.

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Preclinical Summary (2025):

Potent gene-level target suppression: HT-KIT achieved >80% reduction of KIT mRNA/protein across in-vitro systems and in vivo models of systemic mastocytosis and GIST.

Rapid anti-tumor activity: In xenograft models, statistically significant tumor-volume reduction by Day 8 was observed, accompanied by apoptotic signaling consistent with KIT pathway knock-down.

Favorable tolerability in early studies: No dose-limiting toxicities observed in the reported preclinical work to date.

Bioanalytical readiness: GLP-validated bioanalytical methods completed to support pharmacokinetic, biodistribution, and exposure-response analyses for IND.
Mechanistic Rationale:

Unlike small-molecule TKIs that inhibit kinase activity, HT-KIT operates upstream at the transcript level, silencing both mutant and wild-type KIT. This mechanism is designed to bypass resistance pathways (secondary mutations, compensatory signaling) and reduce off-target liabilities, potentially improving durability and tolerability in KIT-driven diseases such as aggressive systemic mastocytosis (ASM), SM-AHN, mast cell leukemia (MCL), GIST, and select leukemias.

Orphan Drug Designation (U.S.) supports development in a rare disease with incentives including potential exclusivity upon approval, tax credits, and fee waivers.
Planned Next Steps (Near-Term):

Complete GLP toxicology and CMC packages; submit IND.

Initiate Phase 1/2 dose-escalation/expansion study in advanced systemic mastocytosis and other KIT-driven tumors with translational biomarkers of target engagement (KIT knock-down, tryptase/MRK signaling) and early efficacy readouts (ORR, DCR, PFS signals).

Continue regional IP expansion and evaluate strategic partnerships for development and commercialization.
"HT-KIT’s transcript-level suppression of KIT has now produced consistent anti-tumor performance across models, with a clean preclinical tolerability profile and GLP-ready analytics," said Robb Knie, Chief Executive Officer. "With Orphan Drug Designation secured and an IND-enabling package progressing, we are preparing for a disciplined entry into first-in-human evaluation."

About HT-KIT:

HT-KIT is a precision ASO designed to silence KIT at the mRNA level, aiming to overcome resistance and off-target toxicity seen with kinase inhibitors in systemic mastocytosis, GIST, and select leukemias.

(Press release, Hoth Therapeutics, OCT 21, 2025, View Source [SID1234656883])