On July 31, 2026 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a clinical-stage biotechnology company targeting cancer and autoimmune diseases, reported an update on its activities for the quarter ended 30 June 2026 (Q4 FY26).

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EFTILAGIMOD ALFA SYSTEMATIC EVALUATION

In May 2026, Immutep announced results from a systematic evaluation of five clinical trials of eftilagimod alfa (efti) in combination with standard-of-care (SOC) therapies in cancer patients, presented at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting1.

The analysis included 592 patients across five independent studies (TACTI-mel, TACTI-002, TACTI-003, AIPAC, and AIPAC-003) spanning four cancer indications (NSCLC, HNSCC, metastatic breast cancer, and melanoma).

Treatment with 30 mg subcutaneous efti plus SOC in these trials resulted in a significant increase in circulating absolute lymphocyte count (ALC), a blood-based measure of immune activity, which was not seen with SOC alone.

Increased ALC was significantly associated with improved clinical outcomes, with ALC responders in the efti plus SOC group showing a clinically meaningful median overall survival (OS) improvement of 7.7 months compared to non-responders (p=0.0017). These effects were observed across tumour types and were independent of the combination partner.

The analysis did not include data from the TACTI-004 study, as immune data collection for that trial had not been completed at the time of the analysis.

LUNG CANCER

TACTI-004 (KEYNOTE-F91) – Phase III Trial in 1L NSCLC

In March 2026, Immutep announced that the Independent Data Monitoring Committee (IDMC) for the TACTI-004 Phase III study evaluating efti in patients in 1st line non-small cell lung cancer (1L NSCLC) had recommended the discontinuation of the trial following a planned interim futility analysis in accordance with the study protocol.

In response to the IDMC’s recommendation, enrolment in TACTI-004 was halted and Immutep is continuing an orderly wind-down of the study, including appropriate patient follow-up and site close-out.

Immutep is also continuing its thorough review of available data to understand the factors behind the futility outcome, including manufacturing aspects. This root cause analysis is ongoing in Q3 CY 26, as it is dependent on data availability and logistics, and covers TACTI-004 database lock, statistical analysis, and laboratory data review.

Dr. Reddy’s Laboratories Ltd. ("Dr. Reddy’s"), a licensing partner for efti, continues to demonstrate support and provide technical expertise to assist with the completion of the root cause analysis.

Subsequent to quarter end, Immutep provided an update on aspects of the root cause analysis. In the interim futility analysis (N=173), the objective response rate was 42.9% in the efti arm compared with 55.1% in the control arm, with no superiority observed in any PD-L1 subgroup. Pending final analysis, no new safety signals have been observed. Preliminary immune-monitoring data indicated that patients treated with efti in TACTI-004 showed a different immune-activation profile, with lower circulating lymphocyte and monocyte counts, compared with prior efti studies. While no conclusive causal factor has been established to date, the ongoing analysis is expected to provide further insights, with additional results anticipated in Q3 CY26.

INSIGHT-003 – Phase I Trial in Non-Squamous 1L NSCLC

Patients in the investigator-initiated INSIGHT-003 Phase I trial, in which dosing is now complete, continue to be followed up.

In this study, the combination of efti with KEYTRUDA and chemotherapy has generated strong objective response rates (ORR) and disease control rates (DCR) in 51 evaluable patients with advanced or metastatic non-squamous 1L NSCLC across all PD-L1 expression levels2.

Subsequent to the end of the quarter, Immutep announced mature overall survival (OS) results from INSIGHT-003 (data cut-off 27 March 2026). Median OS was 30.9 months in the overall population (N=51) and in patients with PD-L1 TPS <50% (N=47). Approximately 92% of patients had no or low PD-L1 expression (PD-L1 TPS <1 or PD-L1 TPS 1-49).

These single-arm Phase I results compare favourably with historical benchmarks.

SOFT TISSUE SARCOMA

EFTISARC-NEO – Phase II Trial in Soft Tissue Sarcoma

The investigator-initiated EFTISARC-NEO Phase II trial evaluating efti with radiotherapy plus KEYTRUDA in the neoadjuvant setting for resectable soft tissue sarcoma (STS) has met its primary objective, with patients showing strong immune system activation in line with efti’s mode of action, including statistically significant increases in the expression of key cytokines and chemokines in peripheral blood. Patients are continuing to be followed up for disease-free survival.

In April 2026, Immutep announced that it had been granted orphan drug designation for efti in this setting from the FDA.

An abstract containing health-related quality of life (HRQoL) data from the EFTISARC-NEO trial has been accepted for presentation at the ESMO (Free ESMO Whitepaper) Congress 2026 in October 2026. Consistent with the congress’ embargo policy, the data will be made available by the investigator at the time of presentation.

BREAST CANCER

AIPAC-003 – Phase II Trial in Metastatic Breast Cancer

The AIPAC-003 Phase II trial, evaluating efti in combination with chemotherapy in hormone receptor positive (HR+), HER2 negative/low metastatic breast cancer that is resistant to endocrine-based therapy, as well as in metastatic triple-negative breast cancer not eligible for PD-(L)1-based therapy, has been completed. The last patient follow-up visit occurred during the quarter and the trial was accordingly closed effective 30 June 2026.

Investigator-Initiated Phase II Trial for Neoadjuvant Efti in HR+/HER2-negative Breast Cancer

As previously announced, a proposed investigator-initiated Phase II trial evaluating neoadjuvant efti as monotherapy and in combination with chemotherapy prior to surgery in early-stage HR+/HER2-negative breast cancer remains on hold pending completion of the root cause analysis related to TACTI-004.

IMP761 DEVELOPMENT PROGRAM FOR AUTOIMMUNE DISEASE

IMP761 – Phase I Trial

In June 2026, Immutep presented positive interim data from its placebo-controlled, double-blind, randomized, first-in-human Phase I study evaluating IMP761, a first-in-class LAG-3 agonist antibody, at the EULAR 2026 Congress in London.

The single ascending dose part of the study met its primary endpoint, demonstrating favourable safety and tolerability in healthy volunteers, with IMP761 well tolerated across all dose levels tested.

The data also showed statistically significant pharmacodynamic activity, including reduced local inflammatory responses and attenuated T-cell activity compared to placebo, with the 7 mg/kg dose achieving a statistically significant inhibition in skin blood perfusion (p = 0.029).

The pharmacokinetic profile supports once-every-four-weeks dosing. These encouraging results support further clinical evaluation of IMP761 in autoimmune diseases driven by T-cell-mediated inflammation, such as rheumatoid arthritis, with additional trial updates expected in H2 CY26.

INTELLECTUAL PROPERTY

During the quarter, Immutep was granted seven patents.

Four patents were granted directed to an assay for use in measuring the potency of IMP761 as part of a quality control step in production of the agonist LAG-3 antibody. The patents were granted in China, Hong Kong, South Korea, and Canada. A new patent was also granted in Indonesia directed to IMP761.

New patents were also granted during the quarter in the United States and Israel directed to LAG525 (ieramilimab), jointly owned by Immutep S.A.S. and Novartis AG. Subsequent to quarter end, Novartis gave notice terminating the out-license agreement relating to ieramilimab after years of clinical inactivity, effective 9 August 2026. The license is not generating revenue for Immutep and no further milestone or royalty payments are anticipated. Under the terms of the agreement, following termination Novartis is required to assign its ownership interest in the jointly owned LAG-3 patents arising under the collaboration to Immutep S.A.S.

LEGAL PROCEEDINGS

Following the announcement on 13 March 2026 regarding the discontinuation of the TACTI-004 Phase III trial, one putative securities class action was filed in the United States but not served. After the Company sent a Rule 11 letter to the plaintiff, the suit was dismissed voluntarily.

FINANCIAL SUMMARY

During the quarter, Immutep continued to exercise prudent cash management, particularly in light of the TACTI-004 Phase III discontinuation.

The Company is well funded with cash and cash equivalents, and term deposit balance as at 30 June 2026 of approximately A$68.87 million, which is A$29.2 million greater than the FY2026 budget.

The total balance consists of 1) a cash and cash equivalent balance of A$63.67 million and 2) bank term deposits totaling A$5.20 million, which have been recognised as short-term investments due to having maturities of more than 3 months and less than 12 months.

In Q4 FY26, cash receipts from customers were A$13K, which is mainly due to research material sales. For the very first time the Company also received A$218K (EUR 133K) under Germany’s R&D tax incentive program (Forschungszulage) in relation to eligible R&D activities undertaken in FY22.

The Forschungszulage is Germany’s statutory research tax incentive under the Forschungszulagengesetz (FZulG). Under the current regime, eligible companies may claim a tax credit of up to 35% (25% before 28 March 2024) of qualifying internal R&D personnel costs. The timing of receipt of Forschungszulage payments may differ significantly from the period in which the related R&D expenditure is incurred due to the statutory application, assessment and review process. The FY2022 claim was the Company’s first claim under the program and was subject to a detailed review. The allowance is a non-dilutive source of funding for the Company’s German R&D operations (conducted through Immutep GmbH).

The net cash used in G&A activities in the quarter was A$1.5 million compared to A$0.9 million in Q3 FY26. In respect of the US$20 million upfront eftilagimod license fee received from Dr. Reddy’s in January 2026, US$2.7 million (A$4.1 million3) was recognised as revenue and US$17.3 million (A$25.8 million4) as unearned revenue in the Company’s Half Year Financial Report for the period ended 31 December 2025. Following discontinuation of TACTI-004, Immutep repaid US$10 million to Dr. Reddy’s in June 2026, reducing unearned revenue accordingly, with the remaining US$7.3 million fully recognised as revenue for the financial year ended 30 June 2026. As previously disclosed, Dr. Reddy’s holds exclusive rights to develop and commercialise efti in the licensed territories, while Immutep retains all rights to the product in the key pharmaceutical markets, including North America, Europe, and Japan. Immutep also remains eligible for up to US$349.5 million in potential milestones along with royalties on commercial sales, and retains global manufacturing rights.

Net cash used in R&D activities was A$22.0 million for the quarter, compared with A$11.8 million in Q3 FY26, with the increase primarily reflecting higher payments relating to TACTI-004. Although the Company took immediate action following the discontinuation of TACTI-004 in March 2026, trial activity only began to slow from May 2026, with close-out and root cause analysis activities continuing through the quarter. As invoices are generally payable approximately one month after issue, TACTI-004 payments in Q4 FY26 were approximately A$8 million higher than in Q3 FY26. These payments are expected to decline significantly in subsequent quarters.

Payment for staff costs was A$2.5 million in the quarter, compared to A$2.6 million in Q3 FY26. Total net cash outflows used in operating activities in the quarter were A$38.9 million compared to net cash inflow from operating activities of A$13.5 million in Q3 FY26.

Payments to Related Parties (detailed in item 6.1 of the Appendix 4C) comprises Non-Executive Directors’ fees and Executive Directors’ remuneration of A$336K.

Total net cash inflow received in investing activities for the quarter was A$21.1 million, which is mainly due to the net decrease of short-term investments. The short-term investments are comprised of term deposits with maturities of greater than 3 months and less than 12 months. During the quarter, the Company transferred back A$21.1 million from short-term investments that had matured to cash at bank.

After the TACTI-004 Phase III futility outcome, the Company has initiated cost reduction measures to preserve capital and extend its cash runway. These measures include a targeted reduction in headcount and other operating expense reductions, most of which will become effective following the end of FY26. The discontinuation of TACTI-004 also precipitates a reduction in cash outlays due to the trial activity being wound down. At the time of preparing this report, the Company expects its cash runway to extend well into H1 of CY28.

(Press release, Immutep, JUL 31, 2026, View Source [SID1234669608])

On July 31, 2026 CellOrigin, a biotechnology company focused on next-generation in vivo and in vitro cell therapy technologies, reported two major progresses in both research and strategic partnership.

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At the 2026 ASCO (Free ASCO Whitepaper) Annual Meeting, CellOrigin’s scientific co-founder’s team presented two new studies on solid tumor cell therapy. The first, CAR-Mix multicellular synergistic therapy, combines engineered macrophages with polyclonal T cells and has demonstrated synergistic antitumor activity in a mesothelin-positive ovarian cancer preclinical model, offering a potential polytypic immune cell approach to overcoming antigen heterogeneity in solid tumors. An IIT clinical study based on this product has been launched, and the first patient was dosed in early 2026. The initial findings indicate a generally well-tolerated safety profile and promising signs of clinical activity. The second, TMT Engager, an LNP-mRNA-based in vivo T-cell engager, enables in situ formation of T-cell–macrophage–tumor cell tripartite conjugates, a strategy designed to engage both innate and adaptive immunity against diverse tumor antigens — addressing a key limitation of current solid-tumor therapies, where tumor heterogeneity often leads to treatment resistance. This approach has demonstrated robust antitumor efficacy in preclinical models of both liver cancer and ovarian cancer.

In parallel, CellOrigin has entered into a co-development agreement with Walvax Biotechnology to jointly conduct an Investigator-Initiated Trial (IIT) for a hepatocellular carcinoma indication using mRNA-LNP-based in vivo GPC3-CAR therapy. This study is based on a preclinical study reported by the same team in the 2025 ASCO (Free ASCO Whitepaper) meeting. This partnership leverages CellOrigin’s expertise in precision CAR design, early pharmacodynamic evaluation, clinical protocol development, and full-cycle IIT execution, alongside Walvax’s industrial strengths in process quality systems, clinical-grade large-scale manufacturing, and product registration. By combining their respective technological and industrial capabilities, the two companies aim to accelerate the clinical translation of novel therapies for solid tumors.

Through sustained R&D investment, CellOrigin has established a comprehensive in vivo CAR technology platform addressing solid tumors, autoimmune diseases and organ fibrosis. Core capabilities include:

mRNA-LNP delivery technology enabling controlled organ and cell type-specific in vivo CAR expression that balances efficacy and safety;

Differentiated CAR molecule design tackling key challenges of solid tumors, such as precise lesion targeting, physical tumor barrier penetration, and promotion of polyclonal and memory T-cell formation for enhanced durability;

Full-chain translational capability, covering product design, preclinical efficacy and safety evaluation, clinical trial implementation, and regulatory filing.

CellOrigin continues to strengthen its leading position in the in vivo CAR therapy space for solid tumors. The company has built a proprietary platform portfolio—including iMAC, CAR-Vac, CAR-Mix, and TMT Engager—for immunocellular therapies targeting solid tumors, autoimmune diseases and organ fibrosis. Looking ahead, CellOrigin remains committed to scientific innovation and open collaboration, working with industry partners to advance frontier immunotherapies into the clinic and address unmet medical needs for patients.

(Press release, CellOrigin Biotech, JUL 31, 2026, View Source [SID1234669588])

On July 31, 2026 AbbVie (NYSE:ABBV) reported financial results for the second quarter ended June 30, 2026.

"AbbVie delivered another excellent quarter, marked by outstanding execution and pipeline advancement. We also announced the proposed acquisition of Apogee Therapeutics, which strengthens our ability to deliver innovative medicines to patients, bolsters our immunology leadership and creates significant shareholder value," said Robert A. Michael, chairman and chief executive officer, AbbVie. "Based on our substantial momentum, AbbVie’s long-term outlook remains very strong."

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Second-Quarter Results

•Worldwide net revenues were $16.990 billion, an increase of 10.2 percent on a reported basis, or 9.5 percent on an operational basis.

•Global net revenues from the immunology portfolio were $8.786 billion, an increase of 15.1 percent on a reported basis, or 14.6 percent on an operational basis.
◦Global Skyrizi net revenues were $5.505 billion, an increase of 24.4 percent on a reported basis, or 24.0 percent on an operational basis.
◦Global Rinvoq net revenues were $2.525 billion, an increase of 24.5 percent on a reported basis, or 23.7 percent on an operational basis.
◦Global Humira net revenues were $756 million, a decrease of 35.9 percent on a reported basis, or 36.1 percent on an operational basis.

•Global net revenues from the neuroscience portfolio were $3.228 billion, an increase of 20.3 percent on a reported basis, or 19.8 percent on an operational basis.
◦Global Vraylar net revenues were $1.071 billion, an increase of 18.9 percent.
◦Global Botox Therapeutic net revenues were $1.042 billion, an increase of 12.2 percent on a reported basis, or 11.6 percent on an operational basis.
◦Global Ubrelvy net revenues were $392 million, an increase of 16.0 percent on a reported basis, or 15.9 percent on an operational basis.
◦Global Qulipta net revenues were $350 million, an increase of 30.9 percent on a reported basis, or 30.3 percent on an operational basis.
◦Global Vyalev net revenues were $256 million.

•Global net revenues from the oncology portfolio were $1.650 billion, a decrease of 1.5 percent on a reported basis, or 2.4 percent on an operational basis.
◦Global Venclexta net revenues were $771 million, an increase of 11.6 percent on a reported basis, or 9.6 percent on an operational basis.
◦Global Imbruvica net revenues were $532 million, a decrease of 29.4 percent.
◦Global Elahere net revenues were $211 million, an increase of 33.1 percent on a reported basis, or 31.8 percent on an operational basis.

•Global net revenues from the aesthetics portfolio were $1.282 billion, an increase of 0.3 percent on a reported basis, or a decrease of 0.9 percent on an operational basis.
◦Global Botox Cosmetic net revenues were $728 million, an increase of 5.2 percent on a reported basis, or 3.4 percent on an operational basis.
◦Global Juvederm net revenues were $245 million, a decrease of 6.0 percent on a reported basis, or 6.6 percent on an operational basis.

•On a GAAP basis, the gross margin ratio in the second quarter was 74.7 percent. The adjusted gross margin ratio was 84.7 percent.

•On a GAAP basis, selling, general and administrative (SG&A) expense was 21.4 percent of net revenues. The adjusted SG&A expense was 21.0 percent of net revenues.

•On a GAAP basis, research and development (R&D) expense was 13.8 percent of net revenues. The adjusted R&D expense was 13.6 percent of net revenues.

•Acquired IPR&D and milestones expense was 1.7 percent of net revenues.

•On a GAAP basis, the operating margin ratio in the second quarter was 37.9 percent. The adjusted operating margin ratio was 48.3 percent.

•Net interest expense was $679 million.

•On a GAAP basis, the tax rate in the quarter was 15.5 percent. The adjusted tax rate was 14.7 percent.

•Diluted earnings per share (EPS) in the second quarter was $2.03 on a GAAP basis. Adjusted diluted EPS, excluding specified items, was $3.65. These results include an unfavorable impact of $0.17 per share related to acquired IPR&D and milestones expense.

Recent Events

•AbbVie and Apogee Therapeutics announced a definitive agreement under which AbbVie will acquire Apogee and its diverse pipeline of clinical-stage candidates in development across inflammatory and immunological diseases. The proposed acquisition includes zumilokibart (APG777), a late-stage, half-life extended monoclonal antibody targeting IL-13 for atopic dermatitis (AD), as well as APG273, a potential best-in-category long-acting combination targeting IL-13 and thymic stromal lymphopoietin (TSLP) in asthma. The acquisition holds potential for substantial shareholder value creation, with mega-blockbuster peak sales potential across Apogee’s pipeline of assets, and is expected to close in the third quarter of 2026. The transaction values Apogee at a total equity value of approximately $10.9 billion. Additional information on the transaction can be found at investors.abbvie.com.

•AbbVie announced the U.S. Food and Drug Administration (FDA) and the European Commission (EC) approved Skyrizi (risankizumab) for the treatment of children six years of age and older with moderate to severe plaque psoriasis. The FDA also approved Skyrizi for pediatric use in psoriatic arthritis. These approvals were supported by data from Phase 3 OptIMMize clinical trial program.

•AbbVie announced the EC approved Rinvoq (upadacitinib) for the treatment of adult and adolescent patients with non-segmental vitiligo. With this approval, Rinvoq is the first systemic medication approved in the European Union (EU) for patients with non-segmental vitiligo. This approval is supported by data from the Phase 3 Viti-Up clinical program, in which Rinvoq met both co-primary endpoints, with statistically significant and clinically meaningful improvements in total body and facial repigmentation at week 48, as well as key ranked secondary endpoints.

•AbbVie announced the EC approved Rinvoq for the treatment of adult and adolescent patients with severe alopecia areata. This approval is supported by data from the Phase 3 UP-AA clinical program, in which Rinvoq met the primary endpoint of severity of alopecia tool score ≤ 20 as well as key secondary endpoints, including improvements in eyebrows and eyelashes, at week 24.

•At the 2026 Digestive Disease Week (DDW) Annual Meeting, AbbVie presented new data across its gastroenterology portfolio, including 18 abstracts in Crohn’s disease (CD) and ulcerative colitis (UC). Presentations included real-world evidence and long-term findings that reinforced the efficacy, safety profile and durability of Skyrizi and Rinvoq in inflammatory bowel diseases (IBD).

•AbbVie announced the EC approved Aquipta (atogepant) for the acute treatment of migraine in adults with or without aura. This approval marks the second indication for Aquipta in the EU, where it is now approved as both an acute treatment option for migraine attacks and as a preventive treatment option for adults with chronic or episodic migraine who experience at least four migraine days per month. The approval is supported by data from the Phase 3 ECLIPSE trial, which showed that Aquipta resulted in statistically significant pain freedom at two hours versus placebo during the first migraine attack, with sustained pain freedom from 2 to 48 hours and a clinically meaningful and consistent effect across multiple migraine attacks.

•AbbVie announced the FDA approved Decnupaz (pivekimab sunirine) for the treatment of adult patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN), an ultra-rare and aggressive hematologic malignancy. Decnupaz is the first antibody-drug conjugate (ADC) approved for BPDCN that is initiated in an outpatient setting and marks AbbVie’s first ADC approved for blood cancer. The approval is supported by data from the Phase 1/2 CADENZA trial, in which newly diagnosed patients with BPDCN treated with Decnupaz demonstrated clinically meaningful and durable responses.

•AbbVie announced the EC authorized an expanded label for Venclyxto (venetoclax) to include use in combination with acalabrutinib and use in combination with Imbruvica (ibrutinib) for the treatment of adult patients with previously untreated chronic lymphocytic leukemia (CLL). The authorization provides an all-oral, fixed-duration, chemotherapy-free treatment option for patients with CLL and supports the potential for time off treatment. The expanded label is supported by data from the Phase 3 AMPLIFY trial, Phase 3 GLOW trial and Phase 2 CAPTIVATE trial.

Recent Events (Continued)

•AbbVie announced the EC granted marketing authorization for Tepkinly (epcoritamab) in combination with lenalidomide and rituximab (R2) for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL). The approval is based on results from the pivotal Phase 3 EPCORE FL-1 trial, in which fixed-duration Tepkinly plus R2 achieved statistically significant improvement of progression-free survival (PFS) and overall response rates (ORR) compared to R2, with approximately three out of four patients achieving a complete response (CR). This approval marks the first bispecific-based therapy approved in Europe for the treatment of R/R FL in the second-line setting, offering patients a chemotherapy-free option. Tepkinly/Epkinly is being co-developed by AbbVie and Genmab.

•AbbVie announced topline results from the Phase 3 EPCORE DLBCL-4 trial evaluating the combination of Epkinly (epcoritamab) and lenalidomide, compared to rituximab plus gemcitabine plus oxaliplatin in adult patients with R/R diffuse large B-cell lymphoma (DLBCL) who received at least one prior line of therapy. In the trial, the chemotherapy-free combination of Epkinly plus lenalidomide demonstrated statistically significant and clinically meaningful improvement in PFS. The safety profile of Epkinly when administered in combination with lenalidomide was consistent with the known safety profiles of the individual agents.

•At the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, AbbVie announced new data demonstrating the breadth and momentum of its next-generation oncology pipeline. Presentations highlighted the potential of AbbVie’s novel topoisomerase 1 inhibitor–based ADC and T‑cell engager platforms within solid tumors and blood cancers, including oral presentations in prostate cancer, small cell lung cancer (SCLC), platinum-resistant ovarian cancer (PROC) and multiple myeloma (MM).

•At the European Hematology Association (EHA) (Free EHA Whitepaper) 2026 Congress, AbbVie presented data that reinforced its leadership and commitment to ongoing research to improve outcomes for people living with blood cancers. Featured data from AbbVie’s blood cancer portfolio and pipeline included 21 oral and poster presentations, which highlighted etentamig (ABBV-383), Epkinly and Decnupaz. The presentations also showcased Venclexta (venetoclax) data, including a final analysis of the Phase 3 CLL14 trial which demonstrated that after a median follow-up of 9.2 years, treatment with Venclexta plus obinutuzumab resulted in superior PFS compared to treatment with obinutuzumab plus chlorambucil in previously untreated CLL.

•Allergan Aesthetics announced the FDA approved Skinvive by Juvederm as the first hyaluronic acid injectable indicated to reduce neck lines for the improvement of neck appearance in adults over the age of 21. This approval is supported by a randomized, multicenter, evaluator-blinded, controlled pivotal clinical study in which participants treated with Skinvive by Juvederm saw a clinically significant improvement in neck lines at one month. This approval represents the second FDA-approved indication for Skinvive by Juvederm, which is also approved to improve skin smoothness of the cheeks in adults.

•Allergan Aesthetics announced the EC and Health Canada approved Boey (trenibotulinumtoxinE) as the first rapid-onset, short-duration neurotoxin for the temporary improvement of moderate to severe glabellar lines in adults. These approvals are supported by data from two Phase 3 clinical trials, in which Boey demonstrated rapid onset of action as early as eight hours after administration and observed efficacy duration of two to three weeks, with treatment-emergent adverse events similar to placebo.

•AbbVie announced the EC approved Maviret (glecaprevir/pibrentasvir) for the treatment of acute hepatitis C virus (HCV) infection in adults and children aged 3 years and older. This approval gives clinicians an option to initiate treatment as soon as acute infection is confirmed and makes Maviret the only treatment approved in the EU for both acute and chronic HCV infection.

Full-Year 2026 Outlook

AbbVie is updating its adjusted diluted EPS guidance to include the impact of the proposed Apogee Therapeutics acquisition, which is expected to be $0.14 dilutive in 2026, based upon an anticipated close in the third quarter of this year. This dilution is partially offset by $0.10 of overperformance. As a result, AbbVie is updating its adjusted diluted EPS guidance range for the full year 2026 from $13.91 – $14.11 to $13.87 – $14.07, reflecting a change of $0.04 at the midpoint.

The company’s 2026 adjusted diluted EPS guidance includes an unfavorable impact of $0.58 per share related to acquired IPR&D and milestones expense incurred year-to-date through the second quarter 2026. This guidance excludes any impact from acquired IPR&D and milestones that may be incurred beyond the second quarter of 2026, as both cannot be reliably forecasted.

(Press release, AbbVie, JUL 31, 2026, View Source [SID1234669572])

On July 31, 2026 Daiichi Sankyo (TSE: 4568) reported financial results for the first quarter of fiscal year 2026, ending June 30, 2026.

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"Daiichi Sankyo delivered strong revenue growth in the first quarter of fiscal year 2026 as we began execution of our new Five-Year Business Plan," said Hiroyuki Okuzawa, President and CEO of Daiichi Sankyo. "Three new U.S. approvals for Enhertu and Datroway were received in a single week in May, underscoring the continued strength of our portfolio where we anticipate delivering more than 20 new indications across five medicines by 2030. These results reinforce the durability of our growth trajectory and support our outlook for fiscal 2026 and beyond."

Q1 FY2026 Results
Global revenue increased 21.1% year-over-year to 574.7 billion yen, driven by the company’s global oncology products. Operating profit decreased 12.0% year-over-year to 85.1 billion yen, primarily due to EU Specialty Business restructuring expenses.

Global revenue from oncology products was driven by Enhertu and Datroway, the company’s flagship antibody drug conjugates (ADCs). Enhertu revenue, including milestone payments, was 239.8 billion yen, a 48.9% increase. Datroway revenue, including milestone payments, was 23.9 billion yen, a 176.4% increase.

Revenue from the Japan Business was 120.0 billion yen, driven by Lixiana and Tarlige. ASCA (Asia, South and Central America) Business revenue was 68.7 billion yen, driven by Enhertu. EU Specialty Business revenue was 74.7 billion yen, driven by Lixiana and Nilemdo/Nustendi.

Full fiscal year 2026 guidance has been revised upward from the forecast issued in May 2026. Global revenue is anticipated to increase from 2.28 to 2.34 trillion yen, driven by stronger sales anticipated in the U.S. and favorable foreign exchange rates. Operating profit is anticipated to increase from 315.0 to 320.0 billion yen.

Further details on financial performance can be found in the Financial Results Presentation Material. Daiichi Sankyo will host an investor and media conference call and webcast to discuss Q1 FY2026 results on Friday, July 31 at 5:30 pm Japan Standard Time.

Q4 FY2025 Results Revision
Operating profit has increased from 229.1 billion yen to 258.0 billion yen. Following the announcement of the Q4 FY2025 financial results on May 11, 2026, the Company identified an error in the aggregation process for selling, general and administrative (SG&A) expenses. As a result of the decrease in SG&A expenses, operating profit has been revised upward.

Portfolio and Pipeline Highlights
Daiichi Sankyo continued to advance its portfolio and pipeline with several milestones across its oncology portfolio, demonstrating momentum towards its goal of launching 20 new indications across five medicines by 2030.

Three new breast cancer indications were approved within one week in the U.S. for Enhertu and Datroway in May 2026, including simultaneous approval of two new indications for Enhertu in the neoadjuvant and adjuvant HER2 positive early breast cancer setting based on the DESTINY-Breast11 and DESTINY-Breast05 phase 3 trials, followed by one new indication for Datroway in the first-line metastatic triple negative breast cancer (TNBC) setting for patients not candidates for immunotherapy based on the TROPION-Breast02 phase 3 trial. Datroway received approval in the EU for the same TNBC indication and Enhertu received a positive CHMP opinion for the first-line treatment of HER2 positive metastatic breast cancer based on the DESTINY-Breast09 phase 3 trial in July 2026.

A Biologics License Application (BLA) was accepted and granted priority review in the U.S. in April 2026 for ifinatamab deruxtecan (I-DXd) for the treatment of adult patients with extensive-stage small cell lung cancer with disease progression on or after platinum-based chemotherapy, with a Prescription Drug User Fee Act (PDUFA) date of October 10, 2026.

Additional regulatory approvals were received in June 2026 for medicines in other major countries/regions. Enhertu received approval in the EU for a HER2 positive metastatic tumor agnostic indication and Vanflyta was approved in China in the newly diagnosed setting of FLT3-ITD positive acute myeloid leukemia (AML).

Data from more than 25 abstracts across multiple cancers were presented at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) (#ASCO26) in June 2026.

Medicine

Indication

Q1 FY2026 Update

Enhertu

Breast

Enhertu Approved in the U.S. for Two New Indications for Patients with HER2 Positive Early Breast Cancer (May 2026)
Enhertu Plus Pertuzumab Recommended for Approval in the EU by CHMP as First-Line Treatment for Patients with HER2 Positive Metastatic Breast Cancer (July 2026)
Tumor

Agnostic

Enhertu Approved in the EU as First Tumor Agnostic HER2 Directed Therapy and Antibody Drug Conjugate for Patients with Previously Treated HER2 Positive Metastatic Solid Tumors (June 2026)

Datroway

Breast

Datroway Approved in the U.S. as First TROP2 Directed Antibody Drug Conjugate for First-Line Treatment of Patients with Metastatic Triple Negative Breast Cancer Who Are Not PD-1/PD-L1 Inhibitor Candidates (May 2026)
Datroway Approved in the EU as Only TROP2 Directed Medicine with Overall Survival Benefit for the First-Line Treatment of Patients with Metastatic TNBC Who Are Not Candidates for Immunotherapy (July 2026)

I-DXd

Lung

Ifinatamab Deruxtecan Granted Priority Review in the U.S. for Adult Patients with Previously Treated Extensive-Stage Small Cell Lung Cancer who Experienced Disease Progression on or After Platinum-Based Chemotherapy (April 2026)

Vanflyta

AML

Vanflyta Approved in China as First and Only FLT3 Inhibitor for Patients with Newly Diagnosed FLT3-ITD Positive AML (June 2026)

Pipeline

Various

Daiichi Sankyo Showcases Progress Across Industry-Leading Oncology Portfolio with Latest Research Updates at ASCO (Free ASCO Whitepaper) (May 2026)
Corporate Highlights
Daiichi Sankyo announced its next Five-Year Business Plan (FY2026 – FY2030) in May 2026 outlining how the company plans to deliver more than 2.3 trillion yen in oncology revenue by 2030 and be a global top five oncology company by 2035 as part of its larger 2035 Vision to be recognized as a "trusted healthcare innovator transforming the lives of people through our science and technology."

As part of the company’s continued transformation into a global oncology company, Daiichi Sankyo announced in April 2026 that it will transfer in stages all of its shares of Daiichi Sankyo Healthcare Co., Ltd, its over-the-counter drug business in Japan, to Suntory Holdings Limited. The deal is estimated to be completed by June 2029.

(Press release, Daiichi Sankyo, JUL 31, 2026, https://www.businesswire.com/news/home/20260730555689/en/Daiichi-Sankyo-Reports-First-Quarter-Fiscal-Year-2026-Financial-Results [SID1234669589])

On July 31, 2026 AstraZeneca and Daiichi Sankyo’s Datroway (datopotamab deruxtecan) reported that it has been approved in the European Union (EU) as monotherapy for the 1st-line treatment of adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy.

The approval by the European Commission follows the positive opinion of the Committee for Medicinal Products for Human Use of the European Medicines Agency and is based on results from the TROPION-Breast02 Phase III trial which were presented at the 2025 European Society for Medical Oncology Congress and subsequently published in Annals of Oncology.

Giuseppe Curigliano, MD, PhD, Director of the Early Drug Development Division, European Institute of Oncology, Professor of Medical Oncology, University of Milan, Italy and investigator for the TROPION-Breast02 trial, said: "For people living with metastatic triple-negative breast cancer, every new treatment option matters. Despite recent advances, more than two thirds of patients are not candidates for immunotherapy and have had limited options beyond chemotherapy. In my practice, I see firsthand the devastating impact this aggressive disease has on patients and their families. This approval of datopotamab deruxtecan provides a new treatment option for eligible patients and represents meaningful progress."

Dave Fredrickson, Executive Vice President, Oncology Haematology Business Unit, AstraZeneca, said: "Every year, more than 80,000 people in Europe are diagnosed with triple-negative breast cancer, a disease that often affects younger women and has limited treatment options in the metastatic setting. Today’s approval of Datroway brings an antibody drug conjugate with a differentiated clinical profile underpinned by a strong survival benefit to people with this aggressive disease."

Ken Keller, Global Head of Oncology Business, and President and CEO, Daiichi Sankyo, Inc, said: "With this approval, Datroway is the only TROP2-directed antibody drug conjugate approved in the EU that has demonstrated an overall survival benefit in the 1st-line setting for the treatment of patients with metastatic triple-negative breast cancer. We look forward to bringing Datroway to patients in the EU as an additional treatment option with the potential to extend survival, reflecting our commitment to advancing innovative medicines that address unmet needs for people living with cancer."

In the trial, which included patients with metastatic TNBC who experienced early relapse following prior treatment, Datroway demonstrated a statistically significant and clinically meaningful 5.0-month improvement in median overall survival (OS) (hazard ratio [HR] 0.79; 95% confidence interval [CI] 0.64-0.98; p=0.0291) compared to chemotherapy as 1st-line treatment in this patient population. Median OS was 23.7 months for patients treated with Datroway versus 18.7 months for those treated with chemotherapy. Datroway reduced the risk of disease progression or death by 43% compared to chemotherapy (HR 0.57; 95% CI 0.47-0.69; p<0.0001) as assessed by blinded independent central review (BICR). Datroway was also associated with more robust treatment responses, including an objective response rate (ORR) of 62.5% compared to an ORR of 29.3% with chemotherapy.1

The safety profile of Datroway in TROPION-Breast02 was consistent with previous clinical trials of Datroway in breast cancer.

Based on the results of TROPION-Breast02, Datroway has been included in the ESMO (Free ESMO Whitepaper) Clinical Practice Guidelines as a Category IA 1st-line treatment option for patients with metastatic TNBC who are not candidates for immunotherapy, and it is the preferred option for patients who have relapsed within six months of completing adjuvant therapy.2 In addition, Datroway received a score of 4 out of 5 on the ESMO (Free ESMO Whitepaper) Magnitude of Clinical Benefit Scale (ESMO-MCBS), recognising the clinically meaningful benefit demonstrated in TROPION-Breast02.3

Datroway was approved in the US in May 2026 for the same indication. Additional reviews are underway in China and Japan, as well as Australia, Canada, Singapore and Switzerland as part of Project Orbis.

Datroway is a specifically engineered TROP2-directed DXd antibody drug conjugate discovered by Daiichi Sankyo and being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.

Notes

Triple-negative breast cancer
TNBC accounts for approximately 15% of all breast cancer cases, with an estimated 365,000 diagnoses globally each year.4,5 In Europe, there are an estimated 81,000 diagnoses of TNBC each year.4,6 TNBC is diagnosed more frequently in younger and premenopausal women, and is more prevalent in Black and Hispanic women.7-9 Metastatic TNBC is the most aggressive type of breast cancer and has one of the worst prognoses, with median OS of just 12 to 18 months and only about 15% of patients living five years following diagnosis.7,10,11

While some breast cancers may test positive for oestrogen receptors, progesterone receptors or overexpression of HER2, TNBC tests negative for all three.7 Due to its aggressive nature and absence of common breast cancer receptors, TNBC is characteristically difficult to treat.7 For patients with metastatic disease with PD-L1 expressing tumours, the addition of immunotherapy to chemotherapy has improved outcomes in the 1st-line setting.12,13 However, for approximately 70% of patients with metastatic TNBC who are not candidates for immunotherapy, chemotherapy was the standard 1st-line treatment.14

TROP2 is a protein broadly expressed in several solid tumours, including TNBC.15 TROP2 is associated with increased tumour progression and poor survival in patients with breast cancer.16,17

TROPION-Breast02
TROPION-Breast02 is a global, multicentre, randomised, open-label Phase III trial evaluating the efficacy and safety of Datroway versus investigator’s choice of chemotherapy (paclitaxel, nab-paclitaxel, capecitabine, carboplatin or eribulin) in patients with previously untreated locally recurrent inoperable or metastatic TNBC for whom immunotherapy was not an option. This included patients whose tumours did not express PD-L1 as well as patients with PD-L1 expressing tumours who could not receive immunotherapy due to prior exposure in early-stage disease, comorbidities or immunotherapy not being accessible in their geography. Enrolment included patients with de novo or recurrent disease, regardless of disease-free interval, and those with poor prognostic factors such as stable brain metastases.

The dual primary endpoints of TROPION-Breast02 are OS and progression-free survival (PFS) as assessed by blinded independent central review. Secondary endpoints include PFS as assessed by investigator, ORR, duration of response, disease control rate, pharmacokinetics and safety.

TROPION-Breast02 enrolled 644 patients at sites in Africa, Asia, Europe, North America and South America. For more information, visit ClinicalTrials.gov.

Datroway
Datroway (datopotamab deruxtecan; datopotamab deruxtecan-dlnk in the US only) is a TROP2-directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, Datroway is one of seven DXd ADCs in the oncology pipeline of Daiichi Sankyo, and one of the most advanced programmes in AstraZeneca’s ADC scientific platform. Datroway is comprised of a humanised anti-TROP2 IgG1 monoclonal antibody, developed in collaboration with Sapporo Medical University, attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

Datroway is approved in more than 45 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HR-positive, HER2-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease based on results from the TROPION-Breast01 trial.

Datroway is approved in more than 30 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic TNBC who are not candidates for PD-1/PD-L1 inhibitor therapy based on the results from the TROPION-Breast02 trial.

Datroway is available in the US under accelerated approval for the treatment of adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy based on results from the TROPION-Lung05 and TROPION-Lung01 trials. Continued approval for this indication in the US may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Datroway clinical development programme
A comprehensive global clinical development programme is underway with more than 20 trials evaluating the efficacy and safety of Datroway across multiple cancers, including NSCLC, TNBC and urothelial cancer. The programme includes eight Phase III trials in lung cancer, five Phase III trials in breast cancer, and one Phase II/III trial in urothelial cancer evaluating Datroway as a monotherapy and in combination with other cancer treatments in various settings.

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(Press release, AstraZeneca, JUL 31, 2026, View Source [SID1234669573])