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.

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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])

On October 21, 2025 GT Medical Technologies, a company focused on improving the lives of patients with brain tumors, reported the interim results from its ROADS clinical trial (Randomized Controlled Trial of Resection [Surgery] and GammaTile versus Standard of Care) in patients with operable, newly diagnosed brain metastases.1

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The trial, which completed randomization of 230 patients over 30 leading cancer centers in the United States in August 2025, evaluated whether implanting GammaTile – a form of brain tumor radiation that begins immediately at the time of surgery, with no waiting or time lost – could improve outcomes compared with the current standard of care (surgery followed by postoperative external beam stereotactic radiation therapy [SRT]). The standard approach requires a recovery period before radiation can begin, during which remaining microscopic tumor cells may regrow.

The trial was led by Dr. Thomas Beckham, Assistant Professor, Department of Radiation Oncology, Division of Radiation Oncology, and Dr. Jeffrey Weinberg, Professor of Neurosurgery, Deputy Chair and Vice-Chair of Clinical Operations in The Department of Neurosurgery at The University of Texas MD Anderson Cancer Center. The interim data, presented at the 2025 Congress of Neurological Surgeons by Dr. Weinberg, shows significant and durable improvements in reducing tumor recurrence and increasing surgical bed recurrence-free survival (time to tumor recurrence or death) with GammaTile.

Key Interim Findings

A pre-planned interim analysis was conducted with 168 enrolled patients:1*

GammaTile showed superiority in the primary endpoint of the study. Patients who received GammaTile lived longer without tumor regrowth, and there was a greater than 50% reduction in risk of either tumor recurrence or death compared to standard of care [SRT] (hazard ratio 0.42, p=0.0024).
GammaTile showed superiority in overall protection from worrisome radiographic brain changes (either tumor recurrence or radiation-related tissue damage). At the time of analysis, more than half of GammaTile patients remained free from both tumor regrowth and radiation-related tissue damage, while in the SRT group, more than half of patients had already experienced one of these events by 16 months (hazard ratio of 0.32, p=0.018).
GammaTile demonstrated significant gains in efficacy with no increase in safety concerns. Rates of treatment-related side effects remained low and comparable between both groups proving GammaTile delivers superior outcomes without added risk.
"The interim data from the ROADS trial is the first randomized, multicenter evidence showing the superiority of starting radiation immediately at the time of tumor removal with GammaTile for operable brain metastases," says Michael Garcia, MD, MS, Chief Medical Officer at GT Medical Technologies. "These results highlight the importance of immediate, targeted radiation therapy."

"Although the ROADS trial focused on patients with operable brain metastases, the study reflects real-world treatment patterns, where many patients have a large metastasis that needs surgery and small brain metastases that can be well managed with stereotactic radiation without removal," said Weinberg. "In such cases, patients randomized to the GammaTile arm received GammaTile radiation for the operable tumor and stereotactic radiation for the small metastases. These interim results suggest that this approach not only achieves local control but does so with superiority over the existing standard of care. My colleague, Dr. Beckham, and I agree this evidence may redefine how we treat this disease."

The Brain Metastases Challenge

Brain metastases affect up to 40% of all cancer patients and significantly impact survival and quality of life.2 For patients with operable tumors, surgery followed by external beam stereotactic radiation has been the standard of care, yet its limitations are well recognized, with a 1-year tumor recurrence rate of 28%.3 In addition, up to one third of patients miss or delay postoperative radiation due to access barriers, fragmented care pathways, or logistical challenges.4 These treatment gaps leave patients vulnerable to recurrence, decline in brain function, and added burden for families.

GammaTile is designed to overcome these shortcomings by delivering immediate, targeted, and continuous radiation directly into the surgical cavity at the time of tumor removal.5 This ensures that radiation therapy begins when microscopic cancer cells are the most vulnerable—immediately after surgery, at the lowest point of tumor burden—and guarantees that every patient receives radiation treatment. By closing the treatment gap, GammaTile provides more durable tumor control, reduces recurrence risk, and streamlines the care journey for patients.1 Importantly, GammaTile also gives patients and clinicians peace of mind that treatment has started right at tumor removal.

"We are deeply encouraged by these results," said Per Langoe, Chief Executive Officer of GT Medical Technologies. "By providing immediate radiation when and where it is needed most, GammaTile is showing the potential to transform outcomes for patients with operable brain tumors."

(Press release, GT Medical Technologies, OCT 21, 2025, View Source [SID1234656880])

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])