1stOncology™: Cancer Intelligence Service – Page 1136 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Citius Pharmaceuticals, Inc. Announces First Reported Revenue Following Successful Launch of LYMPHIR™

On February 13, 2026 Citius Pharmaceuticals, Inc. ("Citius Pharma" or the "Company") (Nasdaq: CTXR), a biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products reported business and financial results for the fiscal first quarter ended December 31, 2025, and provided a business update, including progress at its majority-owned subsidiary, Citius Oncology, Inc. (Nasdaq: CTOR)..

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!

"I am thrilled to report that we have successfully transitioned to a revenue generating company following Citius Oncology’s December 2025 launch of LYMPHIR. We recorded $3.9 million in revenue during the quarter, reflecting the initial sales at Citius Oncology’s nationwide network of distributors. This milestone is the result of years of focused execution designed to translate innovation into tangible value for the cutaneous T-cell community and Citius stakeholders alike. I congratulate the entire Citius team on an outstanding effort to bring LYMPHIR to market," said Leonard Mazur, Chairman and Chief Executive Officer of Citius Oncology and Citius Pharma.

"While we are still in the early stages of the launch, we expect momentum to build as we continue to stand up the full commercial organization and more fully deploy our technology-driven platform to expand patient access and drive market penetration. Looking ahead, we see multiple avenues for growth, including encouraging early signals from investigator-initiated studies, opportunities to expand access in international markets, and the potential to build a durable oncology franchise. Most importantly, LYMPHIR now offers patients living with cutaneous T-cell lymphoma a meaningful new treatment option and a more hopeful future," added Mazur.

"We remain committed to financial stewardship to sustain this momentum, and focused execution to advance our late-stage pipeline, which includes Mino-Lok and Halo-Lido. Our goal remains to serve our community with first-in-class critical care products, and in so doing maximize long-term shareholder value," concluded Mazur.

Business Highlights and Subsequent Developments

● Commercial inflection achieved through majority-owned subsidiary: Citius Oncology successfully launched LYMPHIR (denileukin diftitox-cxdl) in the U.S. in December 2025 for adult patients with relapsed or refractory Stage I–III cutaneous T-cell lymphoma (CTCL) following at least one prior systemic therapy;

● Early physician adoption underway: Initial specialty distributor sales were completed nationwide, enabling product availability across U.S. treatment centers. Patients have begun receiving LYMPHIR at leading cancer centers;

● Commercial execution supported by technology: Citius Oncology deployed an AI-enabled commercial platform to support targeted physician engagement and efficient penetration of a highly concentrated prescriber base in this rare oncology market;

● International patient access advancing: Agreements have been negotiated with regional partners to enable patient access to LYMPHIR utilizing Named Patient Programs (NPPs) where permitted in territories throughout European and the Middle East;

● Continued support of promising upside opportunities for LYMPHIR: Preliminary topline data from two investigator-initiated Phase I combination studies evaluating the potential to expand clinical utility and future label expansion opportunities. include:

o use in combination with pembrolizumab in patients with recurrent solid tumors;

o incorporation as part of lymphodepletion regimens prior to CAR-T therapy;

● Late-stage pipeline progress maintained: Citius Pharma continues to advance Mino-Lok, an antibiotic lock solution to salvage catheters when treating catheter-related bloodstream infections, and Halo-Lido (CITI-002), a topical prescription formulation for hemorrhoids. The Company remains engaged with the FDA regarding both programs.

First Quarter 2026 Financial Highlights

● Cash and cash equivalents totaled $7.7 million as of December 31, 2025;

● Generated net proceeds of approximately $20.9 million from equity financings during the quarter, including capital raised at both Citius Pharma and Citius Oncology;

● Consolidated revenue was $3.9 million, reflecting initial U.S. sales of LYMPHIR at Citius Oncology;

● Research and development expenses were $1.6 million, compared to $2.1 million in the prior-year period, reflecting reduced clinical development activity;

● General and administrative expenses totaled $5.7 million, compared to $5.4 million in the prior-year period;

● Stock-based compensation expense totaled $4.3 million, compared to $2.5 million in the prior-year period; and,

● Net loss applicable to common stockholders was $8.2 million, or $(0.41) per share, compared to a net loss of $9.8 million, or $(1.30) per share, in the prior-year period.

(Press release, Citius Pharmaceuticals, FEB 13, 2026, View Source [SID1234662669])

AMGEN TO PRESENT AT CITI’S 2026 VIRTUAL ONCOLOGY LEADERSHIP SUMMIT

On February 13, 2026 Amgen (NASDAQ:AMGN) reported that it will present at Citi’s 2026 Virtual Oncology Leadership Summit at 12:15 p.m. PT on Wednesday, Feb. 18, 2026. Jean-Charles Soria, senior vice president of oncology within global development at Amgen, will present at the conference. The webcast will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public.

The webcast, as with other selected presentations regarding developments in Amgen’s business given by management at certain investor and medical conferences, can be found on Amgen’s website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen’s Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.

(Press release, Amgen, FEB 13, 2026, View Source [SID1234662668])

Alivexis and OHARA Pharmaceutical Co., Ltd. to Collaborate on Selected Drug Targets

On February 13, 2026 Alivexis, Inc. (Headquartered in Minato-ku, Tokyo; CEO S. Roy Kimura) reported that it has entered into a Research Collaboration Agreement with OHARA Pharmaceutical Co., Ltd. ("OHARA") to identify small‑molecule compounds for multiple targets selected by OHARA, leveraging Alivexis’ drug discovery platform ModBind and related technologies.

Under this collaboration, Alivexis will apply its computational drug discovery platform, including ModBind, to support the discovery of novel small‑molecule candidates for multiple targets in the neuroscience field. In addition to in silico evaluations, Alivexis will provide research support, including structural analysis of compound–target interactions, and will work jointly with OHARA to establish experimental systems and perform compound synthesis, evaluation, and optimization.
In support of this drug discovery program, Alivexis will receive a one‑time fee for the use of its computational drug discovery platform, research funding, and may be eligible to receive financial consideration, subject to the terms and conditions of the collaboration agreement.

About ModBind.
ModBind is a proprietary physics-based simulation technology developed by Alivexis that enables high-speed, highly accurate prediction of absolute binding strength between small molecule compounds and target proteins, without the need for experimentally-derived biological activity data. Leveraging ModBind along with other platform technologies, we have already advanced five compounds to clinical candidate status. One program resulted in a licensing agreement with a Swiss company in June 2024, valued at approximately 42.5 billion yen, demonstrating the practical and commercial utility of our technology. In addition, we have conducted multiple joint research projects with pharmaceutical companies, with ModBind serving as the core technology in these collaborations.

In addition, in August 2025, we were selected for the third round of the "GENIAC (Generative AI Accelerator Challenge)" program, a project led by the Ministry of Economy, Trade and Industry (METI) and the New Energy and Industrial Technology Development Organization (NEDO) which aims to strengthen domestic development capabilities in generative AI. By integrating ModBind with AI training, we aim to build and implement a generative AI foundation model for drug discovery that predicts the biological activity of small-molecule compounds with world-leading accuracy.

【CEO S. Roy Kimura’s Comments】
"I am excited to announce the signing of our drug discovery collaboration with OHARA focused on the use of our proprietary and ground-breaking ModBind simulation technology to accelerate early drug discovery for a selected disease target. Through our collaboration, we look forward to gaining further validation of our technology while contributing to the discovery of novel clinical candidate compounds for diseases with significant unmet medical needs."

(Press release, Alivexis, FEB 13, 2026, View Source [SID1234662667])

HanchorBio Receives FDA Orphan Drug Designation for HCB101 in Gastric Cancer

On February 13, 2026 HanchorBio, Inc. (TPEx: 7827), a global clinical-stage biotechnology company advancing next-generation immunotherapies for oncology and autoimmune diseases, reported that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) to HCB101 for the treatment of gastric cancer. The designation covers gastric cancer broadly, including advanced gastric adenocarcinoma in both HER2-positive and HER2-negative subtypes. This milestone underscores the significant unmet medical need in gastric cancer and provides important regulatory support for the continued clinical development of HCB101 in this patient population.

This designation marks the first FDA Orphan Drug Designation for HanchorBio, representing a significant regulatory milestone for the company and further validating its strategy of advancing differentiated immunotherapies in areas of high unmet medical need.

HCB101 is a next-generation CD47–SIRPα pathway inhibitor, engineered as an affinity-optimized and toxicity-mitigated SIRPα-IgG4 Fc fusion protein. The molecule is designed to restore macrophage-mediated phagocytosis and enhance antigen presentation while minimizing the hematologic toxicities that have historically limited earlier CD47-targeting approaches, enabling rational combination with established standards of care.

"Receiving our first FDA Orphan Drug Designation is a major milestone for HanchorBio and important validation of our scientific, regulatory, and development strategy," said Scott Liu, PhD, Founder, Chairman, and CEO of HanchorBio. "Gastric cancer remains an area of profound unmet medical need, and this designation reinforces our commitment to developing differentiated immunotherapies that can meaningfully improve outcomes for patients. This designation strengthens HCB101’s profile as a globally relevant asset and represents a strategically important step as we advance the program toward U.S. and international development. It further supports our ongoing engagement with multinational partners as we explore collaboration and licensing opportunities for HCB101 and our broader immunotherapy pipeline."

Gastric cancer is a rare disease in the United States, with prevalence well below the FDA’s statutory threshold for orphan designation. Despite advances in targeted therapy and immune checkpoint inhibition, outcomes, particularly in the second-line setting, remain poor, with limited durability of response and substantial treatment-related toxicity.

HCB101 is currently being evaluated in multiple ongoing clinical studies, including a Phase 1b/2a trial (NCT06771622) assessing HCB101 in combination with ramucirumab and paclitaxel in second-line advanced gastric cancer. Early clinical findings have demonstrated promising antitumor activity with a safety profile consistent with the molecule’s differentiated design.

Alvin Luk, PhD, MBA, CCRA, President & Chief Medical Officer (Group) and Chief Executive Officer (U.S.A.) of HanchorBio, added, "The FDA’s decision reflects the seriousness of gastric cancer and the clinical rationale underlying HCB101’s development. HCB101’s IgG4-based SIRPα-Fc design was intentionally selected to support repeated dosing and combination strategies as an innate immune checkpoint backbone in solid tumors. In a second-line gastric cancer setting, where standard regimens offer limited durability, the depth of tumor shrinkage and consistency of response observed to date, while remaining compatible with standard ramucirumab-paclitaxel administration, support the continued global advancement of HCB101 for patients with significant unmet need."

Orphan Drug Designation provides certain development incentives, including eligibility for tax credits on qualified clinical trial expenses, exemption from FDA user fees, and the potential for seven years of market exclusivity upon approval in the United States.

HanchorBio plans to continue advancing HCB101 through global clinical development while exploring its potential as a backbone immunotherapy across multiple solid tumor indications.

About HCB101
HCB101 is a rationally engineered SIRPα–IgG4 Fc fusion protein developed on HanchorBio’s FBDB platform to selectively block the CD47–SIRPα innate immune checkpoint while minimizing hematologic toxicity. Unlike earlier anti-CD47 approaches, HCB101 is designed to preserve macrophage-mediated antitumor activity while reducing binding to red blood cells, a limitation that historically constrained the clinical utility of CD47-directed therapies.

HCB101 was engineered using AI-assisted structural modeling to achieve differentiated binding to CD47 on cancer cells while maintaining low affinity for CD47 on red blood cells. Its safety profile, receptor occupancy characteristics, and pharmacologic properties are designed to support integration with established oncology regimens without disrupting standard dosing, safety expectations, or clinical workflows. Across ongoing clinical and translational evaluation, HCB101 has demonstrated consistent target engagement and early antitumor activity as both monotherapy and in combination settings, including tumor types historically considered challenging for CD47-directed therapies.

Together, these attributes position HCB101 as a differentiated innate immune checkpoint backbone with broad potential for a wide variety of combination strategies across solid tumors and hematologic malignancies.

(Press release, Hanchor Bio, FEB 13, 2026, View Source [SID1234662652])

Vertex Reports Fourth Quarter and Full Year 2025 Financial Results

On February 12, 2026 Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) reported consolidated financial results for the fourth quarter and full year ended December 31, 2025, and provided its full year 2026 financial guidance.

"2025 marked a year of strong revenue growth, commercial diversification, and pipeline advancement," said Reshma Kewalramani, M.D., Chief Executive Officer and President of Vertex. "Our focus in 2026 remains on executing across the CF franchise, bringing CASGEVY to more patients around the globe and continuing to launch JOURNAVX, as we also prepare for the anticipated near‑term commercialization of povetacicept in IgAN. With expanding leadership in CF, exciting commercial momentum, and multiple mid- and late-stage programs advancing, Vertex is well positioned to deliver long‑term value for patients and shareholders."

Fourth Quarter 2025 Results

Total revenue increased 10% to $3.19 billion compared to the fourth quarter of 2024, primarily driven by the continued performance of cystic fibrosis (CF) therapies and additional growth from diversification into additional disease areas. In the U.S., total revenue increased 12% to $2.06 billion due to continued strong CF patient demand, including for ALYFTREK; a modest benefit from CF channel inventory; higher realized net prices in CF versus the prior year; and contributions from CASGEVY and JOURNAVX. Outside the U.S., total revenue increased 5% to $1.13 billion due to solid CF performance across multiple geographies and increased CASGEVY revenue.

Combined GAAP and non-GAAP R&D, Acquired IPR&D and SG&A expenses were $1.52 billion and $1.36 billion, respectively, in the fourth quarter of 2025, compared to $1.46 billion and $1.30 billion, respectively, for the fourth quarter of 2024. These increases were primarily due to commercial investment to support the launch of JOURNAVX in acute pain.

GAAP and non-GAAP effective tax rates were 10.5% and 13.5%, respectively, compared to 19.7% and 21.3%, respectively, for the fourth quarter of 2024. In the fourth quarter of 2025, the tax rates incorporated a one-time benefit from recognition of previously deferred tax credits and a change in estimated prior-year liabilities.

GAAP and non-GAAP net income were $1.2 billion and $1.3 billion, respectively, compared to $913 million and $1.0 billion, respectively, for the fourth quarter of 2024, primarily driven by increased product revenue.

Full Year 2025 Results

Total revenue of $12.0 billion increased 9% compared to 2024, primarily driven by the continued performance of CF therapies and early contributions from the three ongoing launches. In the U.S., total revenue increased 13% to $7.55 billion due to continued strong CF patient demand, including for ALYFTREK, and higher realized net prices in CF versus the prior year; as well as contributions from CASGEVY and JOURNAVX. Outside the U.S., total revenue increased 3% to $4.45 billion due to solid CF performance across multiple geographies and contributions from CASGEVY.

Combined GAAP and non-GAAP R&D, Acquired IPR&D and SG&A expenses were $5.8 billion and $5.1 billion, respectively, compared to $9.7 billion and $8.8 billion, respectively, in 2024. The decreases were primarily due to $4.4 billion of AIPR&D expenses associated with Vertex’s acquisition of Alpine Immune Sciences incurred in the second quarter of 2024, partially offset by increased R&D investment in support of multiple mid- and late-stage clinical development programs and increased commercial investment to support the launch of JOURNAVX.

GAAP and non-GAAP effective tax rates were 14.9% and 17.3%, respectively, compared to 315.5% and 91.0%, respectively, in 2024. In 2025, the effective tax rates were lower than U.S. statutory rates primarily due to one-time benefits from recognition of previously deferred tax credits and Alpine-related R&D tax credits. The GAAP effective tax rate also included excess tax benefits related to stock-based compensation.

GAAP and Non-GAAP net income were $4.0 billion and $4.7 billion, respectively, compared to a GAAP net loss of $(536) million and non-GAAP net income of $111 million, respectively, for 2024, reflecting the Alpine AIPR&D in 2024 and increased product revenue partially offset by increased operating expenses.

Cash, cash equivalents, and total marketable securities as of December 31, 2025, were $12.3 billion, compared to $11.2 billion as of December 31, 2024. The increase was primarily due to cash flows from operating activities, partially offset by repurchases of Vertex’s common stock pursuant to its share repurchase programs.

(Press release, Vertex Pharmaceuticals, FEB 12, 2026, View Source [SID1234666032])