On February 17, 2026 Accord BioPharma, the U.S. specialty division of Intas Pharmaceuticals, Ltd., focused on the development of oncology, immunology, and critical care therapies, reported that the U.S. Food and Drug Administration (FDA) has approved FILKRI (filgrastim-laha), a biosimilar to NEUPOGEN (filgrastim), for patients with cancer receiving myelosuppressive chemotherapy; patients with acute myeloid leukemia receiving induction or consolidation chemotherapy; patients with cancer undergoing bone marrow transplantation; patients with severe chronic neutropenia; and patients acutely exposed to myelosuppressive doses of radiation (hematopoietic syndrome of acute radiation syndrome).1

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The approval of FILKRI marks the sixth product in Accord BioPharma’s growing portfolio of FDA-approved biosimilars, following the company’s acquisition last year of UDENYCA (pegfilgrastim-cbqv), a biosimilar to Neulasta (pegfilgrastim),2 as well as the seventh approved product in the overall portfolio. With the addition of FILKRI, Accord BioPharma now offers physicians in the U.S. a comprehensive granulocyte colony-stimulating factor (G-CSF) portfolio with both long-acting (UDENYCA) and short-acting (FILKRI) biosimilar options to meet the needs of patients, providers, and practices.1,2

Accord has applied for and expects to receive a permanent Q-code from the U.S. Centers for Medicare & Medicaid Services (CMS), which will standardize and facilitate the billing and reimbursement process across hospital outpatient, ambulatory surgery center, and physician office settings of care.

Tackling Vital Healthcare Needs
Neutropenia is a common and potentially serious complication of cancer treatment and occurs when white blood cells called neutrophils—which serve as a major line of defense against bacterial and fungal infections—fall below normal levels. This reduction increases a person’s risk of developing an infection. Granulocyte colony-stimulating factor, or G-CSF, is a growth factor that stimulates the production and release of neutrophils in the body. By accelerating neutrophil recovery, G-CSF can help reduce the duration of neutropenia.3,4

FILKRI belongs to the G-CSF class and is a growth factor manufactured by recombinant DNA technology. FILKRI works by regulating the production of neutrophils within the bone marrow.1

"Cancer patients often face significant challenges with treatment-related neutropenia, which can lead to serious infections, treatment delays, and dose reductions that may compromise therapeutic outcomes," said Chrys Kokino, President, Accord North America. "With FILKRI alongside UDENYCA, the provider-preferred option over Neulasta and all other biosimilars,* we now offer healthcare providers a complete G-CSF portfolio with short- and long-acting biosimilar options. This positions Accord BioPharma as a committed partner in oncology supportive care, expanding access to high-quality biologics."

Demonstrated Biosimilarity and Safety Profile
FILKRI was approved based on two randomized studies in healthy adults, with pharmacokinetics (PK)/pharmacodynamics (PD) assessed in one study and safety and immunogenicity evaluated in both, compared with reference product NEUPOGEN. These studies demonstrated the biosimilarity in PD and PK parameters between FILKRI and NEUPOGEN and showed overall safety and immunogenicity similar to NEUPOGEN.5 FILKRI is contraindicated in patients with a history of serious allergic reactions to human granulocyte colony-stimulating factors, such as filgrastim products or pegfilgrastim products.1

Expanding Access: Accord BioPharma’s Biosimilar Vision
Accord BioPharma believes deeply in the power of biosimilars to reshape the future of treatment. With the support of Intas, an established global leader with nearly five decades of experience, Accord BioPharma is transforming the conventional treatment landscape across several priority therapeutic areas by introducing biosimilars to the U.S. market.

As part of this commitment, Accord BioPharma is rapidly expanding its U.S. portfolio with a strategic goal to launch 20 biosimilar products by 2030, solidifying its position as a reliable partner delivering more affordable, high-quality biologic alternatives. In addition to developing and marketing their own biosimilar products, the company is strategically collaborating with select partners around the world to bring more biosimilars to the U.S. market as swiftly as possible.

"This approval of FILKRI demonstrates our steadfast dedication to expanding access to cost-effective biologic treatments in the critically important field of oncology," said Binish Chudgar, Chairman and Managing Director of Intas Pharmaceuticals. "We’re proud to have one of the largest biosimilar pipelines within the industry. With Accord BioPharma, we’re positioning ourselves as a dependable partner in the United States—one that’s deeply committed to understanding stakeholder priorities and revolutionizing patient access."

(Press release, Accord BioPharma, FEB 17, 2026, View Source [SID1234662732])

On February 17, 2026 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), reported that the Japan Patent Office (JPO) has issued a notice of allowance for Patent Application No. 2021-577862 titled, "METHOD OF RECONSTITUTING LIPOSOMAL ANNAMYCIN." A patent from the application is expected to be issued in the coming months.

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The allowed claims cover proprietary methods for reconstituting and preparing liposomal Annamycin from a preliposomal lyophilizate under controlled temperature conditions to achieve precise concentrations suitable for intravenous administration. These methods are designed to ensure consistent dosing, stability, and handling during preparation and delivery, including maintaining the formulation at physiologic temperatures throughout reconstitution and dilution. Annamycin, Moleculin’s novel, lipid-based anthracycline drug candidate, is being developed for the treatment of acute myeloid leukemia (AML) and other hematologic malignancies and is positioned to potentially become the first non-cardiotoxic anthracycline approved for clinical use. Additional preclinical studies conducted at leading cancer centers suggest Annamycin may have broader applicability across multiple cancer types. This Japanese patent allowance complements Moleculin’s existing U.S. and European patent coverage, with additional Annamycin-related patent applications pending in major jurisdictions worldwide.

"Securing strong patent protection across key global markets remains a core strategic priority as we advance our non-cardiotoxic therapy for relapsed or refractory acute myeloid leukemia through pivotal Phase 3 development," commented Walter Klemp, Chairman and CEO of Moleculin. "This newly allowed Japanese patent further strengthens our international intellectual property position by protecting critical methods supporting the preparation and clinical use of our therapy, reinforcing our confidence in its long-term value as we work toward potential regulatory approval and commercialization in key territories worldwide."

Annamycin, also known by its non-proprietary name of naxtarubicin, currently has Fast Track Status and Orphan Drug Designation from the FDA for the treatment of relapsed or refractory AML, in addition to Orphan Drug Designation for the treatment of STS lung mets. Furthermore, Annamycin has Orphan Drug Designation for the treatment of relapsed or refractory AML from the EMA.

(Press release, Moleculin, FEB 17, 2026, https://moleculin.com/moleculin-announces-notice-of-allowance-for-japanese-patent-covering-annamycin/ [SID1234662715])

On February 17, 2026 Diakonos Oncology Corp., a clinical-stage biotechnology company developing a new generation of immunotherapies to treat challenging and aggressive cancers, reported that the independent Data Safety Monitoring Board (DSMB) overseeing its ongoing Phase 2 DOC-GBM2 clinical trial of DOC1021 in patients with newly diagnosed glioblastoma (GBM) has completed a scheduled safety review and recommended that the study continue as planned.

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The DSMB’s recommendation followed a review of available safety data from patients randomized in the DOC-GBM2 study. Approximately six months after the first patient was treated, the committee reported that no safety concerns have been identified to date and that no changes to the study design are warranted.

"Ensuring patient safety remains central to our clinical development efforts, particularly in serious and hard-to-treat cancers such as glioblastoma," said Laura Aguilar, M.D., Ph.D., Chief Medical Officer at Diakonos Oncology. "It is reassuring to see a safety profile for DOC1021 in this study that is consistent with prior Phase 1 data, and the independent committee’s recommendation to continue this Phase 2 trial without modification provides added confidence as we progress the development of DOC1021 for patients with glioblastoma."

About DOC1021

DOC1021 is a first-in-class, patient-derived double-loaded dendritic cell therapy that uniquely combines tumor lysate and amplified tumor-derived mRNA. The immunotherapy is made with a patient’s dendritic cells combined with mRNA and proteins prepared from freshly obtained patient tumor specimens.

The unique double-loading approach, which mimics a viral infection, unlocks a synergistic and exponentially more powerful tumor killing TH1 response driven by dual protein and RNA antigen sourcing, and it allows targeting of the complete cancer antigen pool. Moreover, the approach does not require any molecular modification of the patient’s immune cells for manufacturing and does not require preconditioning chemotherapy or high dose IL-2 for administration. DOC1021 allows for simple administration in the outpatient setting and broad reach via community cancer centers.

Diakonos currently has two active clinical trials with DOC1021, a Phase 1 pancreatic cancer study (NCT04157127) and a Phase 2 glioblastoma (GBM) study (NCT06805305). Diakonos has received Fast Track designations from the FDA for both the GBM and pancreatic cancer programs, in October 2023 and May 2024, respectively. The company also received Orphan Drug Designation for the GBM program in January 2024. A refractory melanoma Phase 1/2 study with DOC1021 (NCT07288112) will be initiated early this year with the facilitation and support of the Cancer Prevention and Research Institute of Texas (CPRIT).

(Press release, Diakonos Oncology, FEB 17, 2026, View Source [SID1234662733])

On February 17, 2026 ViroMissile, Inc., a cancer immunotherapy company pioneering the IDOV (Intravenously Deliverable Oncolytic Virus) platform, reported the expansion of its ongoing Phase I clinical trial of IDOV-Immune into the United States.

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IDOV-Immune is ViroMissile’s leading oncolytic virus therapy candidate built on the company’s proprietary IDOV platform, the first technology designed to reliably deliver oncolytic viruses systemically and reach tumors throughout the body. The expansion follows clearance of the company’s Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA), building on the study’s initial launch in Australia and allowing leading U.S. cancer centers to begin enrolling patients with advanced solid tumors.

"Expanding our Phase I program into U.S. clinical sites marks an important step in the development of IDOV-Immune and reflects the growing momentum of our systemically deliverable oncolytic virus platform," said Nanhai George Chen, PhD, Founder and Chief Executive Officer of ViroMissile. "As we advance, our focus remains on translating years of scientific innovation into a therapeutic approach with the potential to expand what is possible for patients with advanced cancers."

The Phase I clinical trial (NCT06910657) is evaluating IDOV-Immune in adults with advanced solid tumors. The first patient was dosed at The Alfred Hospital in Melbourne, Victoria, Australia, marking the initiation of clinical evaluation. With U.S. IND acceptance, the trial will soon enroll participants at U.S. sites, including MD Anderson Cancer Center (Houston, TX), START (San Antonio, TX), and Washington University School of Medicine (St. Louis, MO).

Shah Rahimian, MD, Chief Medical Officer of ViroMissile, added, "As the Phase I study expands into U.S. sites, our priority is to generate high-quality clinical data on the safety and immune activity of IDOV-Immune as a systemically administered oncolytic therapy in patients with advanced cancers. By carefully evaluating how this therapy engages the immune system throughout the body, we aim to better understand its potential to reach metastatic disease and ultimately expand treatment options for patients with significant unmet need. These early findings will be critical in shaping the program’s future development."

(Press release, ViroMissile, FEB 17, 2026, View Source [SID1234662692])

On February 17, 2026 Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on enhancing the standard of care for bevacizumab for the treatment of retina diseases, reported financial results for the first quarter fiscal year 2026 and provided a corporate update.

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"LYTENAVA (bevacizumab gamma) is demonstrating increasing adoption in Europe following our initial launches, with growing demand and quarter-over-quarter unit sales growth," said Bob Jahr, Chief Executive Officer of Outlook Therapeutics. "Building on this momentum, we are actively working towards launching into additional EU markets in the near term, following our January launch into Austria, as part of a broader regional expansion strategy."

In addition to the planned launches of LYTENAVA in Ireland and the Netherlands in 2026, followed by France, Italy and Spain in 2027, Outlook Therapeutics also continues with its efforts to potentially partner with established companies in other countries in Europe, Latin America and Asia.

Financial Highlights for the Fiscal First Quarter Ended December 31, 2025

For the fiscal first quarter ended December 31, 2025, Outlook Therapeutics reported net loss attributable to common stockholders of $23.1 million, or $ 0.38 per basic and diluted share. This compares with net income attributable to common stockholders of $17.4 million, or $0.72 per basic and diluted share for the same period last year.

For the fiscal first quarter ended December 31, 2025, Outlook Therapeutics reported an adjusted net loss attributable to common stockholders of $13.5 million, or $0.22 per basic and diluted share, as compared to an adjusted net loss attributable to common stockholders of $21.6 million, or $0.89 per basic and diluted share for the first fiscal quarter of 2025.

Adjusted net loss attributable to common stockholders for the fiscal quarter ended December 31, 2025 excludes $6.7 million of loss from change in fair value of promissory notes and $2.8 million of loss from change in fair value of warrant liability. Adjusted net loss attributable to common stockholders for the fiscal quarter ended December 31, 2024 excludes $40.3 million of gain from change in fair value of warrant liability and $1.3 million of loss from change in fair value of promissory notes.

Revenue in the fiscal quarter ended December 31, 2025 was negatively impacted by an increase in the returns reserve for estimated product returns from the UK distributor resulting from short dated product used for the initial shipments into the distribution channel in June 2025 to support the launch of LYTENAVA in Europe. No further adjustments for these batches are anticipated for the remainder of fiscal year 2026. Overall, unit sales of LYTENAVA in Europe more than doubled in the quarter ended December 31, 2025, as compared to the previous three months.

As of December 31, 2025, Outlook Therapeutics had cash and cash equivalents of $8.7 million, which does not include $2.4 million of net proceeds from sales under its at-the-market offering program after December 31, 2025.

ONS-5010 U.S. Regulatory Update

Outlook Therapeutics has requested a Type A meeting with the U.S. Food and Drug Administration to discuss the Complete Response Letter (CRL) dated December 30, 2025, regarding the Company’s Biologics License Application (BLA) for ONS-5010, an investigational ophthalmic bevacizumab formulation for the treatment of wet age-related macular degeneration (wet AMD). The Company submitted the Type A meeting request to work with the FDA on a path forward to resolving the FDA’s request for additional confirmatory evidence. The timing of the Type A meeting is subject to FDA scheduling, and further updates will be provided as appropriate.

"Outlook Therapeutics remains fully committed to advancing ONS-5010 in the United States," Mr. Jahr continued. "Our ongoing discussions with the FDA beginning in September 2025 have confirmed alignment on CMC, safety, and the positive results from NORSE TWO, and we look forward to constructive discussions with the FDA as we seek guidance on confirmatory evidence that will withstand current dynamics."

The CRL identified a single deficiency based on a purported lack of substantial evidence of effectiveness, and recommended submission of additional confirmatory evidence. Outlook Therapeutics believes this determination is inconsistent with the totality of evidence submitted in the BLA, including data from an adequate and well-controlled study and confirmatory evidence of effectiveness. Prior to submitting the Type A meeting request, Outlook Therapeutics conducted informal meetings with the FDA to discuss the CRL.

About ONS-5010 / LYTENAVA (bevacizumab-vikg, bevacizumab gamma)

ONS-5010/LYTENAVA is an ophthalmic formulation of bevacizumab produced in the United States for the treatment of wet AMD. LYTENAVA (bevacizumab gamma) is the subject of a centralized Marketing Authorization granted by the European Commission in the EU and Marketing Authorization granted by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK for the treatment of wet AMD.

In the United States, ONS-5010/LYTENAVA (bevacizumab-vikg) is investigational. In certain European Union Member States ONS-5010/LYTENAVA must receive pricing and reimbursement approval before it can be sold.

Bevacizumab-vikg (bevacizumab gamma in the EU and UK) is a recombinant humanized monoclonal antibody (mAb) that selectively binds with high affinity to all isoforms of human vascular endothelial growth factor (VEGF) and neutralizes VEGF’s biologic activity through a steric blocking of the binding of VEGF to its receptors Flt-1 (VEGFR-1) and KDR (VEGFR-2) on the surface of endothelial cells. Following intravitreal injection, the binding of bevacizumab to VEGF prevents the interaction of VEGF with its receptors on the surface of endothelial cells, reducing endothelial cell proliferation, vascular leakage, and new blood vessel formation in the retina.

(Press release, Outlook Therapeutics, FEB 17, 2026, View Source [SID1234662716])