On August 17, 2026 AbelZeta Pharma, Inc. ("AbelZeta" or the "Company"), a global clinical-stage biopharmaceutical company focused on the discovery and development of innovative and proprietary cell-based therapeutic products, reported that the Company received the U.S. Food and Drug Administration (FDA) clearance of IND application for C-CAR039, also known as Prizloncabtagene Autoleucel (Prizlon-cel), an anti-CD20/CD19 bispecific CAR-T, for the treatment of relapsed or refractory (r/r) Large B-cell Lymphoma (LBCL).

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In July 2026, AbelZeta regained all development, regulatory, manufacturing, commercialization, out-licensing and other collaboration rights relating to C-CAR039. The Company is currently working with the FDA to finalize the protocols for clinical development in third- or later-line LBCL patients previously treated with CAR-T therapies and second-line LBCL patients that are CAR-T therapy treatment naïve.

The program is supported by encouraging long-term clinical data presented at European Society for Blood and Marrow Transplantation (EBMT) in March 2026. Results from 48 patients with r/r B-cell non-Hodgkin lymphoma (B-NHL) enrolled in the Company’s early clinical trials in China demonstrated a favorable safety profile and deep and durable responses, with an overall response rate (ORR) of 91.5% and complete response (CR) rate of 85.1%. Median PFS was 60.1 months at a median follow-up of 53.9 months.

"We are pleased to welcome C-CAR039 back to our hematology malignancy portfolio," said Tony (Bizuo) Liu, Chairman and Chief Executive Officer of AbelZeta. "Clinical trial results to date have demonstrated the favorable safety and encouraging efficacy of C-CAR039 in r/r LBCL patients. We believe that it has potential to help patients who have been treated and relapsed with commercially approved CAR-T therapies. This population has significant unmet medical needs and C-CAR039 represents a solution. We will also explore the potential of C-CAR039 in early lines of LBCL. We remain confident about the potential of C-CAR039 and are fully committed to accelerating the global development of C-CAR039, leveraging our extensive expertise in cell therapy."

The registrational Phase II clinical trial of C-CAR039 for r/r LBCL in CAR-T therapy naïve patients in China is still ongoing.

(Press release, AbelZeta, AUG 17, 2026, View Source [SID1234670158])

On August 16, 2026 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM; HKEX:13) reported that positive high-level results from the SAFFRON Phase III trial showed ORPATHYS (savolitinib) plus TAGRISSO (osimertinib) demonstrated a statistically significant and clinically meaningful improvement in both progression-free survival ("PFS") and overall survival ("OS") versus doublet platinum-based chemotherapy in patients with epidermal growth factor receptor-mutated ("EGFRm") non-small cell lung cancer ("NSCLC"). Patients in the trial had tumors with high levels of MET overexpression or amplification and had progressed on prior treatment with TAGRISSO.

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Third-generation EGFR-tyrosine kinase inhibitors ("TKIs") have significantly improved outcomes for patients with EGFRm NSCLC.1 However, one in three patients’ tumors will develop MET overexpression or amplification, one of the most common mechanisms of resistance on third-generation EGFR-TKIs.1,2 MET-driven resistance is associated with poor prognosis, and there is a significant unmet need for effective and well-tolerated treatment options in later-line settings.2

Professor Shun Lu, Director of Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, School of Medicine and principal investigator of the trial, said: "These exciting results from SAFFRON represent a critical advance for patients with EGFR-mutated non-small cell lung cancer experiencing MET-driven resistance after osimertinib, a population with poor outcomes and no biomarker-directed treatment options available that are oral and well-tolerated. MET is one of the most common drivers of progression on targeted therapy in this setting, and these data underscore the potential impact of this novel osimertinib plus savolitinib combination and the urgency of MET testing to inform treatment decisions."​

Dr Weiguo Su, Chief Executive Officer* and Chief Scientific Officer of HUTCHMED, said: "Overcoming MET-driven resistance after EGFR TKI therapy has been a long-standing challenge in clinical practice. The SAFFRON global study further reinforces the robust efficacy previously demonstrated in the SACHI Phase III trial that supported approval in China, with the results providing clear evidence to support global registrations of the TAGRISSO and ORPATHYS combination. We are grateful to everyone who supported this trial. Together with AstraZeneca, we look forward to potentially bringing this landmark treatment to patients around the world."

Dr Susan Galbraith, Executive Vice President, Oncology Hematology R&D, AstraZeneca, said: "These data demonstrate the clear benefit of adding ORPATHYS to backbone therapy TAGRISSO to address MET overexpression or amplification while maintaining EGFR suppression. By combining ORPATHYS and TAGRISSO, with its established efficacy, safety profile and central nervous system protection, we aim to deliver the first biomarker-directed, all-oral option in this setting to patients across the globe. This further strengthens our leadership in EGFR-mutated lung cancer, reinforcing our strategy to improve patient outcomes across stages and through lines of therapy with novel combinations."

The safety profile for ORPATHYS plus TAGRISSO was consistent with the known profiles of each medicine, and there were no new safety findings. These data will be presented at a forthcoming medical meeting and shared with global regulatory authorities.

ORPATHYS plus TAGRISSO is approved in China for patients with locally advanced or metastatic EGFRm NSCLC with MET amplification after disease progression on EGFR-TKI therapy based on the SACHI Phase III trial.

ORPATHYS is being jointly developed by AstraZeneca and HUTCHMED and commercialized by AstraZeneca.

About NSCLC and MET aberrations

Lung cancer is the leading cause of cancer death globally, accounting for almost one in four (23%) cancer deaths.3 Lung cancer is broadly split into NSCLC and small cell lung cancer, with 80-85% of patients diagnosed with NSCLC.4 Approximately 75% of NSCLC patients are diagnosed with advanced disease.5 Additionally, about 10-15% of NSCLC patients in the US and Europe, and 30-40% of patients in Asia, have EGFRm NSCLC.​6,7,8

MET is a tyrosine kinase receptor that has an essential role in normal cell development.9 MET overexpression or amplification can lead to tumor growth and the metastatic progression of cancer cells.9,10 An estimated 34% of tumors will develop high levels of MET overexpression or amplification after progression on a third-generation EGFR TKI.1

About SAFFRON

SAFFRON is a randomized, open-label, multi-center, global Phase III trial studying the efficacy of ORPATHYS (300mg twice daily) added to TAGRISSO (80mg once daily) versus doublet platinum-based chemotherapy in 338 patients with EGFRm, locally advanced or metastatic NSCLC with MET overexpression or amplification whose disease progressed following first- or second-line treatment with TAGRISSO. The trial enrolled patients in 230 centers across 29 countries, including in North America, Europe, South America and Asia. The primary endpoint is PFS and key secondary endpoints include OS and objective response rate (ORR).

Patients were prospectively selected for SAFFRON using the high MET level cut-offs identified in the SAVANNAH Phase II trial. ​In SAVANNAH, MET overexpression or amplification levels were determined by two tests: immunohistochemistry (IHC), which detects if cancer cells have a particular protein or marker on their surface, and fluorescence in situ hybridization (FISH), which detects a specific DNA sequence from cancer cells.

About ORPATHYS

ORPATHYS (savolitinib) is an oral, potent and highly selective MET TKI that has demonstrated clinical activity in advanced solid tumors. It blocks atypical activation of the MET receptor tyrosine kinase pathway that occurs because of mutations (such as exon 14 skipping alterations or other point mutations), gene amplification or protein overexpression.

ORPATHYS is approved in China for the treatment of adult patients with locally advanced or metastatic NSCLC with MET exon 14 skipping alteration, representing the first selective MET inhibitor approved in China. ORPATHYS also received a conditional approval in China for the treatment of patients with locally advanced or metastatic gastric cancer or gastroesophageal junction (GC/GEJ) adenocarcinoma patients with MET amplification who have failed at least two prior systemic treatments. ORPATHYS in combination with TAGRISSO is approved in China for patients with locally advanced or metastatic EGFR mutation-positive non-squamous NSCLC with MET amplification after disease progression on EGFR TKI therapy based on the SACHI Phase III trial. The combination was also granted a temporary authorization in Switzerland for the treatment of patients with locally advanced or metastatic EGFRm NSCLC and high levels of MET overexpression or amplification who progressed on prior treatment with TAGRISSO. This was based on results from the global SAVANNAH Phase II trial.

About TAGRISSO

TAGRISSO (osimertinib) is a third-generation, irreversible EGFR-TKI with proven clinical activity in NSCLC, including the treatment of central nervous system metastases. TAGRISSO (40mg and 80mg QD oral tablets) has been used to treat more than one million patients across its indications worldwide and AstraZeneca continues to explore TAGRISSO as a treatment for patients across multiple stages of EGFRm NSCLC.

TAGRISSO is approved as monotherapy in more than 120 countries including the US, EU, China and Japan. Approved indications include for first-line treatment of patients with locally advanced or metastatic EGFRm NSCLC, locally advanced or metastatic EGFR T790M mutation-positive NSCLC, adjuvant treatment of early-stage EGFRm NSCLC and locally advanced, unresectable NSCLC following platinum-based chemoradiation therapy. TAGRISSO is also approved in combination with chemotherapy in more than 80 countries, including the US, EU, China and Japan, for first-line treatment of patients with locally advanced or metastatic EGFRm NSCLC.

There is an extensive body of evidence supporting the use of TAGRISSO in EGFRm NSCLC, and it is the only targeted therapy shown to improve patient outcomes across all stages of the disease.

In late-stage disease, TAGRISSO demonstrated improved outcomes as monotherapy in the FLAURA Phase III trial and in combination with chemotherapy in the FLAURA2 Phase III trial. TAGRISSO is also being investigated in this setting in combination with DATROWAY (datopotamab deruxtecan or Dato-DXd) in the TROPION-Lung14 and TROPION-Lung15 Phase III trials.

TAGRISSO also showed improved outcomes in early-stage disease in the NeoADAURA and ADAURA Phase III trials and in locally advanced stages in the LAURA Phase III trial. As part of AstraZeneca’s ongoing commitment to treating patients as early as possible in lung cancer, TAGRISSO is also being investigated in the early-stage adjuvant resectable setting in the ADAURA2 Phase III trial.

(Press release, Hutchison China MediTech, AUG 16, 2026, View Source [SID1234670162])

On August 14, 2026 (the "Closing"), Werewolf Therapeutics, Inc. (the "Company") reported to have entered into an asset purchase agreement (the "Purchase Agreement") with EMD Serono Research & Development Institute Inc. ("EMD"), pursuant to which, and subject to the terms and conditions thereof, the Company sold to EMD (the "Asset Sale") technology comprising (i) its pre-clinical INDUCER platform, including all patents and know-how related thereto, pre-clinical compounds and related intangible assets, and (ii) its INDUKINE platform, including certain patents, certain know-how related thereto, and pre-clinical compounds, excluding the clinical development programs for WTX-124 and WTX-330 (collectively, the "Transferred Assets"). The Company retains all rights necessary for the continued development of its WTX-124 and WTX-330 clinical programs.

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Pursuant to the Purchase Agreement and related ancillary agreements, in consideration for the Transferred Assets, EMD agreed to pay to the Company upfront consideration of $28.0 million and an additional $5.0 million upon the completion of the transfer of the Transferred Assets technology.

The Purchase Agreement contains customary representations, warranties and covenants of each of the Company and EMD. The Purchase Agreement further provides that, subject to certain limitations, the Company and EMD will each indemnify the other for certain losses arising from such breaches of representations, warranties and covenants and liabilities allocated to such party pursuant to the terms of the Purchase Agreement.

In addition, the Purchase Agreement contains a non-competition covenant pursuant to which the Company agreed not to exploit certain compounds, products or programs claimed in the Transferred Intellectual Property (as defined in the Purchase Agreement) that are directed to the same tumor target as any Transferred Compound (as defined in the Purchase Agreement) for a period of twenty-four (24) months after the Closing, subject to customary exceptions for change of control transactions.

The foregoing description of the terms of the Purchase Agreement does not purport to be complete and is qualified in its entirety by reference to the terms and conditions of the Purchase Agreement, a copy of which the Company intends to file with a subsequent Securities and Exchange Commission report.

Simultaneously with the execution of the Purchase Agreement, on August 14, 2026 the Company entered into a license agreement (the "License Agreement") with EMD pursuant to which EMD granted the Company an exclusive license to certain patents included in the Transferred Assets that enable the Company to exploit and perform clinical development programs for WTX-124 and WTX-330.

Additionally, under the License Agreement, EMD granted to the Company certain licenses to enable the Company to grant certain licenses to (i) Harpoon Therapeutics, Inc. ("Harpoon") under that certain Second Amended and Restated Assignment and License Agreement between the Company and Harpoon dated December 20, 2019 (the "Harpoon License") and (ii) Jazz Pharmaceuticals Ireland Limited ("Jazz") under the Company’s existing license agreement with Jazz that was entered into in connection with that certain Asset Purchase Agreement dated as of May 7, 2026 by and between the Company and Jazz, under which the Company has granted a non-exclusive license to certain technology originally licensed to the Company under the Harpoon License.

The foregoing description of the terms of the License Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the License Agreement, a copy of which the Company intends to file with a subsequent Securities and Exchange Commission report.

(Filing, Werewolf Therapeutics, AUG 14, 2026, View Source [SID1234670253])

On August 14, 2026 Tvardi Therapeutics, Inc. ("Tvardi" or the "Company") (NASDAQ: TVRD), a clinical-stage biopharmaceutical company focused on the development of novel, oral, small molecule therapies targeting STAT3 to treat inflammatory and proliferative diseases, reported its financial and operating results for the second quarter ended June 30, 2026, and provided a business update.

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Recent Developments

Reported topline results from the healthy volunteer study of its next-generation STAT3 inhibitor, TTI-109, confirming prodrug design, improved tolerability and pharmacodynamic evidence of STAT3 target engagement.
TTI-109 delivered TTI-101-equivalent exposure with improved tolerability and, across the active dose range, reductions in cellular and humoral immune populations known to correlate with UC disease severity.
Selected UC as the initial disease indication for TTI-109, based on its ability to modulate multiple pathogenic pathways downstream of STAT3 simultaneously.
In UC, STAT3 acts as a single convergent node downstream of multiple signaling pathways implicated in disease progression, integrating immune dysregulation, inflammation and tissue remodeling.
These findings are further supported by published clinical studies linking reductions in activated STAT3 with higher rates of clinical remission across multiple UC therapeutic classes.
UC represents a large, underserved market, with more than 1.25 million patients diagnosed in the U.S. and an addressable market of approximately $3 billion in the U.S. and $9 billion globally.
Announced that the Company will host a KOL webinar on the clinical potential of TTI-109 in UC featuring Randy Longman, MD, PhD (Weill Cornell Medicine) on August 19, 2026, at 11:00 a.m. ET.
Imran Alibhai, Ph.D., Chief Executive Officer of Tvardi, stated, "Since our last quarterly report, we have made significant progress in the clinical development of our STAT3 inhibitors. Regarding our next-generation STAT3 inhibitor, TTI-109, we were enthusiastic to see modulation of disease-relevant immune cell population even in healthy volunteers. We believe this bodes well for the development of TTI-109 in inflammatory and proliferative diseases, like UC."

Key Upcoming Milestones

August 19, 2026: KOL webinar with Randy Longman, M.D., Ph.D., on the UC treatment landscape and TTI-109. To register, please click here
4Q 2026: TTI-101 Phase 1b/2 HCC topline data
2027: Initiation of clinical trial of TTI-109 in UC, subject to clearance of Investigational New Drug (IND) application and additional funding
Second Quarter 2026 Financial Results

Research and development expenses for the three months ended June 30, 2026, were $4.0 million as compared to $5.8 million for the comparable period in 2025. The decrease was primarily driven by lower clinical costs associated with TTI-101, partially offset by higher development costs associated with TTI-109.

General and administrative expenses were $2.6 million for the three months ended June 30, 2026, as compared to $3.1 million for the three months ended June 30, 2025. The decrease was primarily driven by lower professional fees, reflecting higher accounting and consulting costs in the comparable 2025 period associated with the Company’s April 2025 merger, partially offset by higher legal and investor relations costs associated with operating as a public company.

Net loss for the three months ended June 30, 2026, was $6.5 million, compared to net income of $4.2 million for the three months ended June 30, 2025. Net income in the prior-year period reflected a $12.7 million non-cash gain from the change in fair value of the Company’s convertible notes, which converted into common stock in connection with the Company’s merger with Cara Therapeutics in April 2025.

Basic and diluted net loss per share attributable to common shareholders for the three months ended June 30, 2026, were both $(0.69). Basic net income per share attributable to common shareholders for the three months ended June 30, 2025 was $0.51, and diluted net loss per share for the same period was $(1.00), reflecting the dilutive impact of the Company’s convertible notes prior to their conversion into common stock in April 2025.

Cash, cash equivalents and short-term investments as of June 30, 2026, were $15.8 million, as compared to $30.8 million as of December 31, 2025. Tvardi anticipates that its existing cash, cash equivalents and short-term investments will be sufficient to fund operations, as currently planned, through the HCC topline readout into the third quarter of 2027. Advancing TTI-109 into UC and additional indications will require additional funding and IND clearance.

(Press release, Tvardi Therapeutics, AUG 14, 2026, View Source [SID1234670151])

On August 14, 2026 Adlai Nortye Ltd. (NASDAQ: ANL) (the "Company" or "Adlai Nortye"), a clinical-stage biotechnology company focused on the development of innovative cancer therapies, reported its business highlights and its first half financial results for the period ended June 30, 2026.

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"We continue to execute well across our pipeline, with initial clinical data on track for both of our pan-RAS(ON) inhibitor-based assets in 2027," said Yang Lu, CEO and Chairman of Adlai Nortye. "In alignment with our goal of rapidly bringing a solution to cancer patients in the U.S. and globally, we are advancing our globalization strategy by expanding our clinical development, strategic, and operational capabilities in the United States and Singapore. This expansion will help to accelerate our clinical pipeline progress and strengthen our clinical operations to support our RAS program development. We believe these efforts will support the efficient global development of our pipeline and position the Company for long-term growth."

Research & Development (R&D) Highlights

AN9025

AN9025, an oral small molecule pan-RAS(ON) inhibitor with best-in-class potential, continues to be evaluated in a global Phase I clinical trial of patients with advanced or metastatic solid tumors harboring RAS mutations.

In February 2026, the first patient was dosed in the once-daily (QD) arm in the U.S.

In July 2026, the first patient was dosed in the intermittent once-weekly (QW) arm in the U.S.

Both the QD and QW dosing arms are enrolling concurrently in the U.S. and China.

Additional clinical trial sites in the U.S. will be activated in second half of 2026, in preparation for expansion cohorts.

The Company remains on track to share initial Phase Ia dose escalation data in the first half of 2027 from the QD arm, with a potential early look at the QW arm.
AN4035

AN4035 is a first-in-class RAS-inhibitor antibody drug conjugate (ADC) targeting CEACAM5, with a highly potent pan-RAS(ON) inhibitor payload.

In July 2026, the Company received Human Research Ethics Committee (HREC) approval in Australia for the Phase I clinical trial of AN4035 as monotherapy and in combination with cetuximab, in patients with CEACAM5-enriched, RAS-addicted solid tumors.

Investigational New Drug (IND) submissions to the U.S. FDA and China NMPA are expected to follow.

The Company is on track to dose the first patient with AN4035 in the second half of 2026, and initial clinical data is expected to be available in the second half of 2027.
AN8025

AN8025 is a next-generation tri-specific antibody fusion protein derived from an approved αPD-L1 antibody and fused with functionally optimized CD86 variant and LAG3 variant.

The global Phase I clinical study of AN8025 is currently ongoing in Australia and China.

The Company remains on track to complete dose escalation by the end of 2026.
AN0025

AN0025 is a small molecule EP4 antagonist designed to modulate the tumor microenvironment.

The randomized Phase II ARTEMIS (Augmenting RadioTherapy in REctal Cancer to Minimise Invasive Surgery) study of preoperative AN0025 and chemoradiotherapy combination in rectal cancer has completed enrollment and patient follow-up is ongoing.

The futility analysis of this Phase II study was successfully passed in March 2026, and the topline results are expected in the first half of 2027.
AN4005

AN4005 is an orally available, small-molecule PD-L1 inhibitor that demonstrates antitumor activity by the blockade of PD-1/PD-L1 interaction.

Despite encouraging preliminary results of favorable safety and tolerability in patients with advanced tumors, and preliminary efficacy in a tumor type known to respond to anti-PD-(L)1 therapy, moving forward as part of our strategic pipeline prioritization, we will de-prioritize the development of AN4005 as a monotherapy and remain open for collaboration to explore its potential as a combination partner.

A clinical update from the ongoing expansion cohorts is expected to be presented at the 2026 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) meeting.
Corporate Highlights

In February 2026, the Company completed an oversubscribed private placement equity financing, raising $140 million, before deducting placement agent fees and other private placement expenses.

In April 2026, the Company completed an oversubscribed private placement equity financing, raising $150 million, before deducting placement agent fees and other expenses.

The Company recently expanded its Scientific Advisory Board with the appointment of two leading medical oncologists, Dr. David Hong of MD Anderson Cancer Center, and Dr. Piro Lito of Memorial Sloan Kettering Cancer Center.
Key Upcoming Milestones

AN9025: Initial Phase Ia clinical data from the QD arm, and possible early look at QW arm, are expected in 1H27

AN4035: Dosing of first patient in global Phase I trial is expected in 2H26, with initial clinical data in 2H27

AN8025: Phase I dose escalation completion expected by YE 2026
First Half Unaudited Financial Results

The consolidated financial statements of the Company are prepared in accordance with IFRS as issued by the International Accounting Standards Board (IASB). The consolidated financial statements are presented in US dollars, the Company’s functional and presentation currency.

As of June 30, 2026, cash and cash equivalents, together with short-term investments at amortized cost, amounted to US$231.9 million, compared with US$8.1 million as of December 31, 2025.

Net cash used in operating activities was US$15.4 million for the six months ended June 30, 2026, compared with US$15.1 million for the six months ended June 30, 2025.

Revenue increased to US$13.1 million for the six months ended June 30, 2026, from nil for the six months ended June 30, 2025, and was entirely attributable to revenue recognized under the Company’s exclusive license agreement with Jiangsu Aosaikang Pharmaceutical Co., Ltd. relating to AN9025, primarily in connection with upfront payments and development milestone achievements.

Research and development expenses decreased by 4% from US$15.2 million for the six months ended June 30, 2025 to US$14.6 million for the six months ended June 30, 2026, primarily due to lower preclinical development costs, as most of the Company’s major research and development programs remained in early-stage development and had not yet advanced into later-stage clinical trials.

General and administrative expenses increased by 43.1% from US$4.1 million for the six months ended June 30, 2025 to US$5.8 million for the six months ended June 30, 2026. The increase was primarily attributable to higher share-based compensation expense associated with the vesting of certain stock options.

Other gains and expenses, net, decreased by 37.1% from US$1.5 million for the six months ended June 30, 2025 to US$0.9 million for the six months ended June 30, 2026, primarily due to a reduction in government grants recognized during the period.

For the reasons described above, the Company’s net loss decreased by 70.9% to US$5.3 million for the six months ended June 30, 2026, from US$18.3 million for the six months ended June 30, 2025.

(Press release, Adlai Nortye Biopharma, AUG 14, 2026, View Source [SID1234670150])