On February 19, 2026 Daiichi Sankyo reported that European Medicines Agency (EMA) has validated the Type II Variation marketing authorization application for ENHERTU (trastuzumab deruxtecan) as a monotherapy for adult patients with HER2 positive (immunohistochemistry [IHC] 3+ or in-situ hybridization [ISH]+) breast cancer who have residual invasive disease after neoadjuvant HER2 targeted treatment.

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ENHERTU is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/NYSE: AZN).

The validation confirms the completion of the application and commences the scientific review process by the EMA’s Committee for Medicinal Products for Human Use (CHMP). The application is based on data from the DESTINY-Breast05 phase 3 trial presented at the 2025 European Society for Medical Oncology (#ESMO25) Congress and subsequently published in The New England Journal of Medicine. In the trial, ENHERTU demonstrated a statistically significant and clinically meaningful improvement in invasive disease-free survival (IDFS) versus trastuzumab emtansine (T-DM1) in patients with HER2 positive breast cancer with residual invasive disease following neoadjuvant therapy.

"Patients who have residual invasive disease despite neoadjuvant therapy face a heightened risk of recurrence and are in need of better options following neoadjuvant treatment and surgery," said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. "This validation in the EU is an important step toward bringing ENHERTU to eligible patients earlier in the treatment journey to help reduce the risk of disease recurrence and progression to metastatic disease."

Additional regulatory submissions for ENHERTU also are underway in the EU, including in combination with pertuzumab for the first-line treatment of adult patients with unresectable or metastatic HER2 positive breast cancer based on data from DESTINY-Breast09 and for previously treated HER2 positive unresectable or metastatic solid tumors based on data from DESTINY-PanTumor02, DESTINY-CRC02 and DESTINY-Lung01.

About DESTINY-Breast05
DESTINY-Breast05 is a global, multicenter, randomized, open-label, phase 3 trial evaluating the efficacy and safety of ENHERTU (5.4 mg/kg) versus T-DM1 in patients with HER2 positive early breast cancer with residual invasive disease in breast or axillary lymph nodes following neoadjuvant therapy and a high risk of recurrence. High risk of recurrence was defined as presentation with inoperable cancer (prior to neoadjuvant therapy) or pathologically positive axillary lymph nodes following neoadjuvant therapy.

The primary endpoint of DESTINY-Breast05 is investigator-assessed IDFS, which is defined as the time from randomization until first invasive local, axillary or distant recurrence or death from any cause. The key secondary endpoint is investigator-assessed disease-free survival. Other secondary endpoints include overall survival, distant recurrence-free interval, brain metastases-free interval and safety.

DESTINY-Breast05 enrolled 1,635 patients in Asia, Europe, North America, Oceania and South America. For more information about the trial, visit ClinicalTrials.gov.

About Post Neoadjuvant Treatment for HER2 Positive Early Breast Cancer
Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide.1 More than two million breast cancer cases were diagnosed in 2022, with more than 665,000 deaths globally.1 In Europe, approximately 557,000 cases of breast cancer are diagnosed annually, with more than 144,000 deaths.1

HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumors including breast cancer.2 HER2 protein overexpression may occur as a result of HER2 gene amplification and is often associated with aggressive disease and poor prognosis in breast cancer.2 Approximately one in five cases of breast cancer is considered HER2 positive.3

For patients with HER2 positive early breast cancer, achieving pathologic complete response (pCR) with neoadjuvant treatment is the earliest indicator of improved long-term survival.4 However, approximately half of patients who receive neoadjuvant treatment do not experience pCR, putting them at increased risk of disease recurrence.5,6,7,8,9

Despite receiving additional treatment for residual disease in the post-neoadjuvant setting, some patients still experience invasive disease or death and current treatment options have shown limited impact on central nervous system recurrence.10 Once patients are diagnosed with metastatic disease, the five-year survival rate drops from nearly 90% to approximately 30%.11

Post-neoadjuvant therapy represents a key opportunity to minimize the risk of recurrence and prevent progression to metastatic disease for patients with residual disease. New treatment options are needed in the early breast cancer setting to help reduce the likelihood of disease progression and improve long-term outcomes for more patients.12,13

About ENHERTU
ENHERTU (trastuzumab deruxtecan; fam-trastuzumab deruxtecan-nxki in the U.S. only) is a HER2 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, ENHERTU is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced program in AstraZeneca’s ADC scientific platform. ENHERTU consists of a HER2 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

ENHERTU (5.4 mg/kg) in combination with pertuzumab is approved in the U.S. as a first-line treatment for adult patients with unresectable or metastatic HER2 positive (IHC 3+ or ISH+) breast cancer, as determined by an FDA-approved test, based on the results from the DESTINY-Breast09 trial.

ENHERTU (5.4 mg/kg) is approved in more than 90 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2 positive (IHC 3+ or ISH+) breast cancer who have received a prior anti-HER2-based regimen, either in the metastatic setting or in the neoadjuvant or adjuvant setting, and have developed disease recurrence during or within six months of completing therapy based on the results from the DESTINY-Breast03 trial.

ENHERTU (5.4 mg/kg) is approved in more than 90 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2 low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy based on the results from the DESTINY-Breast04 trial.

ENHERTU (5.4 mg/kg) is approved in more than 60 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic hormone receptor (HR) positive, HER2 low (IHC 1+ or IHC 2+/ ISH-) or HER2 ultralow (IHC 0 with membrane staining) breast cancer, as determined by a locally or regionally approved test, that have progressed on one or more endocrine therapies in the metastatic setting based on the results from the DESTINY-Breast06 trial.

ENHERTU (5.4 mg/kg) is approved in more than 70 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic NSCLC whose tumors have activating HER2 (ERBB2) mutations, as detected by a locally or regionally approved test, and who have received a prior systemic therapy based on the results from the DESTINY-Lung02 and/or DESTINY-Lung05 trials. Continued approval in China and the U.S. for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

ENHERTU (6.4 mg/kg) is approved in more than 80 countries/regions worldwide for the treatment of adult patients with locally advanced or metastatic HER2 positive (IHC 3+ or IHC 2+/ISH+) gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen based on the results from the DESTINY-Gastric01, DESTINY-Gastric02 and/or DESTINY-Gastric04 trials.

ENHERTU (5.4 mg/kg) is approved in more than 10 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2 positive (IHC 3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options based on efficacy results from the DESTINY-PanTumor02, DESTINY-Lung01 and DESTINY-CRC02 trials. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

About the ENHERTU Clinical Development Program
A comprehensive global clinical development program is underway evaluating the efficacy and safety of ENHERTU as a monotherapy or in combination or sequentially with other cancer medicines across multiple HER2 targetable cancers.

(Press release, Daiichi Sankyo, FEB 19, 2026, View Source [SID1234662809])

On February 19, 2026 Brenus Pharma, a clinical-stage biotechnology company pioneering in vivo "off-the-shelf" immunotherapies, reported the selection of an abstract for a poster presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Immuno-Oncology (AACRIO) annual conference (February 18-21, 2026), in Los Angeles. The poster showcases new preclinical data and early clinical insights from the company’s lead candidate, STC-1010, supporting it as a promising therapeutic option for MSS, immune-cold colorectal cancer (CRC)—a major unmet clinical need.

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In a syngeneic CT26 model, murine STC-1010 significantly inhibits tumor growth and extends survival by 40%. New mechanistic datas reveal expansion of CD4⁺ and CD8⁺ T cells in draining lymph nodes alongside a significant humoral response compared to control, demonstrating coordinated cellular and humoral immune activation in vivo.

Other findings show that dendritic cells efficiently capture STC-1010, leading to their activation as demonstrated by transcriptomic analysis revealing significant upregulation of key immune pathways in an ex vivo model compared to controls. These activated dendritic cells process and present STC-1010 antigens, as demonstrated by detection of STC-1010’s peptides at both intracellular (processed antigen) and surface (presented antigen) levels. They then prime autologous CD8⁺ T cells that mediate robust, reproducible cytotoxicity (tumor killing) against colorectal cancer cells, with consistent apoptosis rates across pilot and GMP production batches.

The first-in-human BreAK CRC 001 phase I/IIa trial (NCT06934538) was launched in patients with unresectable, metastatic, or locally advanced CRC to assess the safety and efficacy of STC-1010 in first-line combined with standard-of-care. Preliminary data from MSS + KRAS-mutant CRC patients indicated a good safety profile, with no dose-limiting toxicities. Phase Ia complete safety data and exploratory efficacy across dose cohorts expected in Q2 2026. Link to abstract: here, Poster #A061.

Thanks to : Pr François GHIRINGHELLI (MD, PhD), CGFL Cancer Center, Dijon ; Pr Antoine ITALIANO (M.D, PhD), Bergonié Institute, Bordeaux, and Gustave Roussy Institute, Villejuif ; Dr Diego TOSI (M.D, PhD), ICM, Montpellier, and Pr Benoit YOU, HCL, Lyon, (MD, PhD) in France.

(Press release, Brenus Pharma, FEB 19, 2026, View Source [SID1234662808])

On February 19, 2026 Pilatus Biosciences Inc., a biopharmaceutical company developing novel metabolic checkpoint immunotherapies for liver and gastrointestinal cancers, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for PLT012, the company’s first-in-class anti-CD36 monoclonal antibody for the treatment of hepatocellular carcinoma (HCC). Pilatus is also developing PLT012 in additional solid tumor indications.

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FDA Fast Track designation is intended to facilitate the development and expedite the review of therapies that treat serious conditions and address unmet medical needs. The designation enables more frequent interactions with the FDA and potential eligibility for rolling review, priority review, and accelerated approval pathways.

PLT012 is a first-in-class metabolic checkpoint antibody designed to block CD36-mediated lipid uptake and immune suppression within the tumor microenvironment. CD36 is an immune-metabolic regulator highly expressed on exhausted T cells, NK cells, regulatory T cells, and tumor-associated macrophages, but far less prevalent in healthy tissues. By targeting CD36, PLT012 is engineered to invigorate innate and adaptive effector cells, reduce immunosuppressive cell populations, and promote stronger anti-tumor immune responses.

"Receiving FDA Fast Track designation for PLT012 is an important milestone that reinforces the potential of our checkpoint therapy approach to transform the treatment of HCC," said Raven Lin, Ph.D., Co-Founder and CEO, Pilatus Biosciences. "PLT012 was designed to address the metabolic adaptations that drive immune evasion in cancer. With IND clearance already secured and our Phase 1 trial open for patient enrollment, this designation will help accelerate clinical development and advance towards delivering a novel therapeutic option for patients, both in HCC and other solid tumors where patients do not benefit from existing immunotherapies."

The Phase 1 study (NCT07337525) is currently open for patient enrollment at clinical sites in Dallas and Houston, Texas. The study will evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary signs of clinical activity, with expansion cohorts planned for tumor types strongly influenced by CD36-mediated metabolic dysregulation. In preclinical models, PLT012 demonstrated monotherapy activity across both immune-inflamed and immune-excluded tumors and showed potential synergy with PD-1/PD-L1 inhibitors, supporting development as both a single agent and a combination therapy.

"Targeting CD36 represents a promising new way to reshape the tumor microenvironment. Importantly, we also start to reveal its superior activity on treating metabolic disorders. The fast track represents the beginning of an exciting chapter for Pilatus Biosciences," said Prof. Ping-Chih Ho, Chair of Scientific Advisory Board and Co-founder at Pilatus Biosciences. "Importantly, PLT012 has the potential to redefine how we approach the MASH-to-HCC continuum by intervening at the metabolic root of disease to treat and prevent progression."

Pilatus has also received FDA Orphan Drug Designation for PLT012 for the treatment of liver and intrahepatic bile duct cancers.

Beyond oncology, PLT012’s mechanism of action may also address upstream drivers of liver disease progression. By targeting CD36-mediated lipid uptake, PLT012 has demonstrated promising preclinical activity in metabolic dysfunction-associated steatohepatitis (MASH), including reductions in inflammation and fibrosis. By addressing the full disease continuum, from early hepatic dysfunction to advanced malignancy, PLT012 is well-positioned to intervene at the metabolic root of disease and potentially slow or halt progression.

About PLT012

PLT012 is a humanized monoclonal antibody designed to selectively block CD36-mediated lipid uptake, a key mechanism driving immunosuppression and immune exclusion within the tumor microenvironment. By targeting lipid metabolism, PLT012 exerts a unique mechanism of action: it reduces immunosuppressive cell populations, including Tregs and pro-tumor macrophages, while simultaneously enhancing anti-tumor activities of intratumoral NK cell and cytotoxic CD8+ T cell that are otherwise susceptible to lipid-induced exhaustion. In preclinical studies, PLT012 has demonstrated potent monotherapy efficacy in models of liver malignancies, with a favorable safety profile across species. Leveraging its distinct mechanism of action, PLT012 further acts as a potent sensitizer in combination with anti–PD-L1 therapies, effectively overcoming drug resistance in immune "cold" tumors and liver metastases.

(Press release, Pilatus Biosciences, FEB 19, 2026, View Source [SID1234662807])

On February 19, 2026 TriSalus Life Sciences, Inc. (Nasdaq: TLSI) ("TriSalus" or the "Company"), an oncology focused medical technology company advancing novel drug delivery technologies alongside standard-of-care therapies to improve outcomes for patients with solid tumors, reported that it intends to offer to sell shares of its common stock in an underwritten public offering. All of the shares to be sold in the offering are to be sold by TriSalus. In addition, TriSalus intends to grant the underwriters a 30-day option to purchase up to 15% of the total number of shares of common stock sold in the offering, on the same terms and conditions. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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Lake Street Capital Markets is acting as the sole book-runner for the proposed offering.

The shares are being offered and sold by the Company pursuant to an effective shelf registration statement on Form S-3 (File No. 333-291509) previously filed with the U.S. Securities and Exchange Commission (the "SEC") on November 13, 2025 and declared effective by the SEC on December 4, 2025. The offering of such shares is being made only by means of a prospectus supplement that forms a part of the registration statement. A preliminary prospectus supplement and accompanying base prospectus relating to the offering has been or will be filed with the SEC and will be available for free on the SEC’s website at View Source When available, copies of the preliminary prospectus supplement and the accompanying base prospectus relating to the offering may be obtained from Lake Street Capital Markets, LLC at 121 South Eighth Street, Suite 1000, Minneapolis, MN 55402, or e-mail at [email protected]. The final terms of the proposed offering will be disclosed in a final prospectus supplement to be filed with the SEC.

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 other jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.

(Press release, TriSalus Life Sciences, FEB 19, 2026, View Source [SID1234662806])

On February 19, 2026 Ten63 Therapeutics, an advanced AI drug-discovery company, reported that it added strategic investment from new investors Chugai Venture Fund and the Gates Foundation, bringing the Company’s total funding to over $45M.

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"We are very impressed with Ten63’s AI drug discovery platform and its ability to quickly and accurately simulate trillions of potential drugs," said John Gustofson, President and Head of Chugai Venture Fund. "However, this is not just about making drug discovery faster. It’s about creating medicines for targets no one else can and designing better alternatives where existing drugs deliver inadequate results."

The increased funding will fuel the advancement of Ten63’s proprietary computational drug discovery platform, BEYOND. BEYOND is the world’s first Large Quantum Chemistry Model (LQCM), delivering precise quantum-mechanics level simulations that are orders of magnitude faster than other cutting-edge computational approaches. The company says BEYOND enables the pursuit of previously undruggable targets, which correspond to 80% of all proteins in the human body. Ten63 has multiple programs showing its platform can overcome previously intractable problems. One such program focuses on Myc, one of the most-studied oncogenes, which has long been considered undruggable and is believed to drive 70% of all cancers. Despite hundreds of attempts spanning 40 years, it remains elusive. With the mathematical breakthroughs behind BEYOND, Ten63 has Myc-targeting therapeutics in active development that surpass all previous attempts at Myc inhibition.

"AI not only accelerates drug discovery; it enables us to pursue high-impact targets in ways that were previously impossible. Many of the most important targets across multiple diseases are considered undruggable. These critical targets are data-poor and difficult to reach experimentally. Making them exceptionally difficult for traditional experimental screening and current AI techniques. They require a new approach," said Marcel Frenkel, PhD, CEO of Ten63 Therapeutics.

Powered by BEYOND, the company is pursuing a pipeline of first- and best-in-class small molecules against some of the most impactful oncology targets. The company is focused on high-impact, but thus far undruggable or underdrugged disease targets.

Frenkel continued, "By perfecting a simulation environment that enables AI to explore and learn from trillions of molecular possibilities, millions of times faster than physical methods, while retaining experimental-level accuracy, we are advancing towards superintelligence for drug discovery. At that point, we believe little will remain undruggable."

New investors, the Gates Foundation and Chugai Venture Fund, RYSE, K5 Global, SF Holdings, Duke Capital Partners, Cape Fear BioCapital, Black Opal Ventures, and Panorama, joined Ten63’s existing syndicate, including Hatteras Venture Partners, Yosemite, Morpheus Ventures, Alexandria Venture Investments, and Draper Associates, in the latest funding round.

In connection with the financing, Mike Dial, Ph.D., Managing Director of Chugai Venture Fund, joined Ten63’s board of directors.

Coordinated Global Effort
In connection with the investment, Ten63 also received a grant from the Gates Foundation to support a global strategy to address one of the deadliest cancers worldwide: cervical cancer.

Human papillomavirus (HPV) is the most common sexually transmitted infection in the world. Some strains of HPV are high-risk and can lead to cancers, like cervical, vulvar, and vaginal cancers. Each year, HPV causes cancer in more than 650,000 women and men. Early detection and treatment of precancerous cells can prevent this from happening. Ten63’s BEYOND platform is being used to develop cost-effective and safe treatments for HPV lesions worldwide by tackling the viral proteins that lead to cancer and have so far been undruggable.

"The enthusiasm and momentum behind this new funding validates what we’ve believed from the beginning," says Clay Thorp, Ten63 Chairman of the Board and General Partner at Hatteras Venture Partners "Ten63’s approach has the potential to transform not just cancer treatment, but the entire spectrum of drug discovery."

(Press release, Ten63 Therapeutics, FEB 19, 2026, View Source [SID1234662805])