Ascendo Biotechnology Completes Oversubscribed Series A Financing to Advance Innate Immune Checkpoint Pipeline

On April 30, 2026 Ascendo Biotechnology reported the completion of its Series A funding round , which was highly supported by institutional investors and oversubscribed. Participating investors included TaiAx Life Science Fund, LP (a fund under Taiwania Capital Management Corporation) , Yuanta Venture Capital Co., Ltd., Maxpro Investment Co. , Ltd. , Chenghan Investment Co., Ltd., Darly2 Venture, Inc., TECO Capital Investment Co. , Ltd. , Industrial Technology Investment Corporation (ITIC), Beiley Biofund Inc. , Chang Hwa Bank Venture Capital Co., Ltd. , and First Venture Capital Co. , Ltd. , demonstrating the capital market’s high confidence in the company’s innovative platform and clinical progress.

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Prophet Biotech is a clinical-stage biotech company focused on developing innovative therapies based on "innate immune checkpoints." By regulating the immune response upstream of the innate immune system, it aims to overcome the current bottleneck of limited response rates in immunotherapy. Last year, the company also won the Best Investment Award at the 22nd National Innovation Award and the Best Investment Award at the NBRP Demo Day Pitch Competition, further affirming its technological innovation and market potential.

Founded by Dr. Lu Yanda, whose clinical background comes from the Mackay Memorial Hospital system, the company’s core technologies originate from clinical and translational medicine research in Taiwan. Based on its independent research and development, it has established an innovative immune regulation platform to promote the clinical translation and application of innate immune checkpoint therapy strategies.

The company’s current product line includes two core assets:
ASD141 is a monoclonal antibody targeting innate immune checkpoints, which reshapes the tumor microenvironment by activating upstream immune pathways, thereby enhancing anti-tumor immune responses and is applied to the treatment of advanced solid tumors ;
ASD001 is an antibody drug that regulates innate immune imbalance, aiming to restore immune balance , with development focused on autoimmune diseases .

The funds raised will be primarily used to advance the Phase I clinical trial of the core product ASD141 to key clinical readouts and initiate the subsequent Phase II clinical trial; at the same time, to promote IND enabling studies for ASD001, build the next stage of clinical assets, and strengthen the product pipeline value and long-term growth momentum.

The clinical trials of ASD141 are progressing smoothly, with pharmacological signals of immune cell activation observed in both low- and medium-dose groups, and many patients exhibiting a stable disease response . As the dosage continues to increase, its clinical efficacy is expected to be further validated, and it holds promise as a significant new therapy that breaks through the limitations of existing immune checkpoint therapies.

The company expects to complete the Phase I clinical trial of ASD141 by the end of this year and advance to Phase II clinical development next year. As key clinical data gradually accumulates, Prophet Biotech will simultaneously promote global strategic collaborations and licensing negotiations, actively expand international market opportunities, and maximize the commercial value of its products.

Dr. Lu Yanda, founder of Prophet Biotech, stated , "The successful completion of this fundraising further strengthens the company’s ability to advance key clinical milestones. Building on the positive signals shown by the preliminary clinical data of ASD141, the company will continue to advance dose escalation and clinical validation, and actively engage in global collaborations and licensing discussions to accelerate product development and unlock long-term value."

(Press release, Ascendo Biotechnology, APR 30, 2026, View Source [SID1234665044])

Corcept Therapeutics Announces First Quarter Financial Results and Provides Corporate Update

On April 30, 2026 Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol, reported its results for the quarter ended March 31, 2026.

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Financial Results

Corcept’s first quarter 2026 revenue was $164.9 million, compared to $157.2 million in the first quarter of 2025. First quarter 2026 operating expenses were $214.5 million, compared to $153.8 million in the same period last year, due to increased spending to prepare for the launch of Lifyorli to treat patients with platinum-resistant ovarian cancer and to invest in growth initiatives in our Cushing’s syndrome business. Net loss per common share (diluted) was $0.30 in the first quarter of 2026, compared to net income per common share (diluted) of $0.17 in the first quarter of 2025. Corcept expects to return to profitability in the second quarter of 2026.

Cash and investments were $515.4 million at March 31, 2026, compared to $532.4 million at December 31, 2025.

"This quarter’s results include a significant milestone: With the FDA’s approval of Lifyorli (relacorilant) to treat women with platinum-resistant ovarian cancer more than three months before its PDUFA date, this is the last quarter for which our financial results will reflect the sales of just one medication. In April, Lifyorli, in combination with nab-paclitaxel, was added to NCCN Guidelines as a preferred regimen and uptake has been vigorous.

In February, our Cushing’s syndrome business completed its transition to our new pharmacy vendor, which is successfully fulfilling the increasing demand for Korlym and our authorized generic. March and April marked all-time highs in the number of patients starting treatment.

We have increased our 2026 revenue guidance to $950 – $1,050 million," said Joseph K. Belanoff, M.D., Corcept’s Chief Executive Officer.

Clinical Development

"The FDA’s approval of Lifyorli in platinum-resistant ovarian cancer is welcome news for women with this difficult-to-treat disease. It also underscores the potential of our oncology program, which we believe will produce medications to treat many tumor types and a broad array of combination therapies. We expect results from our BELLA trial combining relacorilant with nab-paclitaxel and bevacizumab in patients with platinum-resistant ovarian cancer by the end of this year, with results from our studies of relacorilant in patients with platinum-sensitive ovarian, endometrial, cervical and pancreatic cancers available by the end of next year. Our Phase 1b SYNERGY study combining our proprietary, selective glucocorticoid receptor antagonist, nenocorilant, with the PD-1 checkpoint inhibitor nivolumab will also produce results next year," said Dr. Belanoff.

"We are engaged with the FDA to determine the best path forward for our New Drug Application (NDA) for relacorilant in Cushing’s syndrome and are confident that the ultimate outcome will be approval.

In addition, results from MONARCH, our Phase 2b trial in patients with metabolic dysfunction-associated steatohepatitis (MASH), are expected by the end of this year. We also plan to start a Phase 3 trial of dazucorilant in patients with ALS later this year. The goal of this trial will be simple – replicate the significant survival benefits observed in our Phase 2 DAZALS study," added Dr. Belanoff.

Hypercortisolism (Cushing’s Syndrome)

New Drug Application – Engaged with FDA to determine best path forward for relacorilant to treat patients with Cushing’s syndrome
GRACE – Pivotal Phase 3 trial of relacorilant in 152 patients with Cushing’s syndrome – Results published in The Lancet Diabetes & Endocrinology (Pivonello et al, February 2026)
CATALYST – Findings referenced in the March 2026 update of the American Association of Clinical Endocrinology (AACE) Consensus Statement Algorithm for Management of Adults with Type 2 Diabetes
MOMENTUM – Prevalence of hypercortisolism was 27.3 percent in 1,086 patients with resistant hypertension – Results presented at the American College of Cardiology (ACC) in March
"Our studies have shown that patients with hypercortisolism who receive relacorilant experience clinically and statistically significant improvements in multiple signs and symptoms of the disease, without the off-target effects and adverse reactions associated with currently available treatments," said Bill Guyer, PharmD, Corcept’s Chief Development Officer. "Relacorilant has the potential to become the new standard of care."

"The need for better treatments for patients with hypercortisolism is urgent. Our CATALYST and MOMENTUM studies demonstrate that hypercortisolism is an underlying driver of disease for many patients with diabetes and hypertension, whose disease doesn’t respond to standard-of-care treatments. These findings will lead to increased screening and improved treatment," added Dr. Guyer.

Oncology

Relacorilant in Combination with Chemotherapy

FDA approved Lifyorli (relacorilant) plus nab-paclitaxel for the treatment of patients with platinum-resistant ovarian cancer in March 2026
Lifyorli plus nab-paclitaxel added to the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology (NCCN Guidelines) as a preferred regimen in April 2026
Marketing Authorization Application (MAA) – European Medicines Agency reviewing MAA for relacorilant plus nab-paclitaxel to treat patients with platinum-resistant ovarian cancer – Approval expected by the end of this year
ROSELLA – Both dual primary endpoints (progression-free and overall survival) met – Complete results presented at the Society of Gynecologic Oncology (SGO) meeting in April and published in The Lancet (Lorusso et al, April 2026)
BELLA Part A – Enrollment completed in Phase 2 trial of relacorilant plus nab-paclitaxel and bevacizumab in 95 patients with platinum-resistant ovarian cancer – Results expected by the end of this year
BELLA Part B – Enrollment continues in Phase 2 trial of relacorilant plus nab-paclitaxel and bevacizumab in 90 patients with platinum-sensitive ovarian cancer whose disease progressed while on a PARP inhibitor
BELLA Part C – Enrollment continues in Phase 2 trial of relacorilant plus nab-paclitaxel in 90 patients with endometrial cancer (who have received one or two prior lines of therapy)
STELLA – Initiated Phase 2 trial of relacorilant plus nab-paclitaxel in 50 patients with cervical cancer (received one or two prior lines of therapy), conducted in collaboration with ARCAGY-GINECO
TRIDENT – Enrollment continues in Phase 2 trial of relacorilant plus nab-paclitaxel and gemcitabine as first-line therapy in 60 patients with pancreatic cancer
Nenocorilant in Combination with Immunotherapy

SYNERGY – Enrollment continues in Phase 1b dose-finding trial of nenocorilant plus nivolumab in 30 patients with a variety of solid tumors
Relacorilant in Combination with Androgen Deprivation Therapy

Prostate cancer – Enrollment continues in randomized, placebo-controlled Phase 2 trial of relacorilant plus enzalutamide in 90 patients with early-stage prostate cancer, conducted in collaboration with the University of Chicago
"The FDA approved Lifyorli because the addition of Lifyorli to nab-paclitaxel in our Phase 3 ROSELLA trial reduced the risk of death in patients with platinum-resistant ovarian cancer by 35 percent, with no need for a biomarker selection. These outstanding results, along with pre-clinical and clinical data that we and our academic collaborators have generated, validate the thesis that glucocorticoid receptor antagonism may help patients with a wide variety of tumor types and may be useful in combination with a wide variety of chemo- or immuno-therapies. Our development program is dedicated to proving this idea," added Dr. Guyer.

Metabolic Dysfunction-Associated Steatohepatitis (MASH)

MONARCH – Enrollment completed in randomized, double-blind, placebo-controlled, Phase 2b trial of miricorilant in 175 patients with biopsy-confirmed or presumed MASH – Results expected by the end of this year
"In our Phase 1b study, miricorilant rapidly reduced liver fat while improving fibrosis, liver enzymes and other markers of liver health, including key metabolic and lipid measures. We look forward to building on these promising findings in our Phase 2b MONARCH study, with results expected by the end of this year," said Dr. Guyer.

Amyotrophic Lateral Sclerosis (ALS)

DAZALS – Exploratory analyses showed that patients who received dazucorilant 300 mg exhibited an 84 percent reduction in risk of death during the study’s first year compared to patients who received placebo (hazard ratio: 0.16, p-value: 0.0009) – This benefit persisted into the study’s second year with an 87 percent reduction in risk of death (hazard ratio: 0.13, p-value: < 0.0001)
Phase 3 trial – Planned to begin later this year
"Elevated cortisol activity is associated with ALS. In our Phase 2 DAZALS study, patients who received dazucorilant exhibited a profound reduction in early mortality, at a stage when many patients with ALS still retain significant function and quality of life," said Dr. Guyer. "Our ongoing dose-titration study aims to improve gastrointestinal tolerability to inform the path forward in this program."

Conference Call

We will hold a conference call on April 30, 2026, at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time). Participants must register in advance of the conference call by clicking here. Upon registering, each participant will receive a dial-in number and a unique access PIN. Each access PIN will accommodate one caller. A listen-only webcast will be available by clicking here. A replay of the call will be available on the Investors / Events tab of Corcept.com.

(Press release, Corcept Therapeutics, APR 30, 2026, https://ir.corcept.com/news-releases/news-release-details/corcept-therapeutics-announces-first-quarter-financial-results-3 [SID1234664963])

IDEAYA Biosciences to Initiate New Drug Application Submission from the Darovasertib OptimUM-02 Trial under the Oncology Center of Excellence Real-time Oncology Review (RTOR) Program

On April 30, 2026 IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a precision medicine oncology company, reported that the U.S. Food and Drug Administration (FDA) has agreed to review its New Drug Application (NDA) for darovasertib in combination with crizotinib (darovasertib combination) for patients with first line (1L) HLA*A2-negative metastatic uveal melanoma (mUM) under the Oncology Center of Excellence (OCE) Real-Time Oncology Review (RTOR) program.

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"We are grateful for the continued partnership with the FDA and being accepted in the Oncology Center of Excellence Real-Time Oncology Review program based on the topline results from the OptimUM-02 trial. This is an important achievement for IDEAYA and the people living with mUM who today have very few treatment options. We believe the topline results from OptimUM-02 provide further evidence to support the potential benefit of the darovasertib combination in patients with first-line HLA*A2-negative mUM, and we look forward to working closely with the FDA through the RTOR process to make this promising new potential treatment available to patients as quickly as possible," said Yujiro S. Hata, President and Chief Executive Officer of IDEAYA Biosciences.

On April 13th, IDEAYA reported positive topline data from the Phase 2/3 OptimUM-02 trial of darovasertib in combination with crizotinib in 1L HLA*A2-negative mUM. The trial met its primary endpoint, with the combination reducing the risk of disease progression by 58% (Hazard Ratio of 0.42; 95% CI: 0.30, 0.59; p-value: <0.0001) and achieving a statistically significant improvement in median progression-free survival (PFS) of 6.9 months versus 3.1 months in the investigator choice of therapy (ICT) arm as assessed by blinded independent central review (BICR). On secondary endpoints, an overall response rate (ORR) of 37.1%, including 5 complete responses, was observed in patients treated with the darovasertib combination versus 5.8% in the ICT arm (p-value: <0.0001) with a median duration of response (DOR) of 6.8 months. Overall survival (OS) data were not yet mature, however the darovasertib combination did show an early trend in OS improvement versus the ICT arm. The combination was generally well-tolerated with a manageable safety profile consistent with previously reported results and known side-effects of each drug.

The FDA’s OCE RTOR program allows an applicant to pre-submit components of its NDA to allow the FDA to review clinical trial data before the complete filing is submitted and aims to provide a more efficient review process to ensure safe and effective treatments are available to patients as early as possible. IDEAYA plans to initiate the RTOR submission process with the first pre-submission targeted for May, with completion of the NDA filing expected in the second half of 2026.

Full results from the OptimUM-02 trial will be presented in a late-breaking oral presentation at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting, taking place in Chicago, Illinois. IDEAYA is also conducting clinical trials of darovasertib in HLA*A2-positive mUM as well as in the neoadjuvant and adjuvant settings of primary uveal melanoma.

(Press release, Ideaya Biosciences, APR 30, 2026, View Source [SID1234664981])

Update on FDA Advisory Committee vote on camizestrant in combination with a CDK4/6 inhibitor for advanced HR-positive breast cancer

On April 30, 2026 AstraZeneca reported that The US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) did not reach a majority vote in favor of the benefit risk profile of AstraZeneca’s camizestrant in combination with a cyclin-dependent kinase (CDK) 4/6 inhibitor (palbociclib, ribociclib or abemaciclib) for the 1st-line treatment of patients with hormone receptor (HR)-positive, HER2-negative advanced breast cancer whose tumours have an emergent ESR1 mutation, based on the SERENA-6 Phase III trial. The Committee voted 3 to 6.

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In July 2025, the FDA accepted the New Drug Application (NDA) for camizestrant in combination with a CDK4/6 inhibitor based on positive results from the pivotal SERENA-6 Phase III trial presented at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and simultaneously published in The New England Journal of Medicine.1 The FDA granted Breakthrough Therapy Designation (BTD) for the camizestrant combination in this setting in May 2025.

The FDA is not bound by the Committee’s guidance but takes its advice into consideration. AstraZeneca will continue to work with the FDA as it completes its review of the application.

Kevin Kalinsky, MD, MS, FASCO, Division Director of Medical Oncology, Winship Cancer Institute of Emory University and investigator for the trial, said: "Patients with this specific form of breast cancer are in urgent need of new treatments that delay disease progression. Today’s recommendation by the ODAC is disappointing, as new options and innovative treatment strategies which address emerging resistance ahead of disease progression and deterioration in quality of life are needed in the 1st-line setting."

Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: "New innovations and novel treatment strategies that provide benefit to patients are required to drive advances in this 1st-line setting, and so we are disappointed with the mixed outcome of today’s ODAC meeting. We strongly believe in the results of the SERENA-6 trial, and are encouraged that the Committee saw camizestrant as a safe and effective potential new medicine. We remain confident in the clinical benefit the combination can bring to patients by changing therapeutic strategy at the earliest opportunity, and are committed to challenging the status quo in the pursuit of innovation that optimises outcomes for patients."

Results from a planned interim analysis of the SERENA-6 Phase III trial showed a highly statistically significant and clinically meaningful 56% reduction in the risk of disease progression or death with the camizestrant combination versus standard-of-care treatment with an aromatase inhibitor (AI) (anastrozole or letrozole) in combination with a CDK4/6 inhibitor (based on a hazard ratio [HR] of 0.44; 95% confidence interval [CI] 0.31–0.60; p<0.00001).1 Median PFS was 16.0 months for patients who switched to the camizestrant combination versus 9.2 months for the comparator arm, and nearly one third (29.7%) of patients in the camizestrant arm showed sustained disease control at 24 months of treatment, versus 5.4% patients in the AI arm.1

Data for the key secondary endpoints of time to second disease progression (PFS2) and overall survival (OS) were immature at the time of the interim analysis, however a subsequent pre-planned analysis demonstrated a statistically significant and clinically meaningful PFS2 benefit of 25.7 months versus 19.1 months in favour of the camizestrant combination (HR: 0.63; 95% CI: 0.46, 0.86; p = 0.00373) and OS continued to mature in favour of the camizestrant combination (HR: 0.87, CI: 0.57-1.30). The trial will continue to assess OS as a key secondary endpoint. Additional analyses of patient reported outcome (PRO) measures published in Annals of Oncology showed that the camizestrant combination demonstrated consistent benefit in delaying time to deterioration (TTD) in quality of life and reduced the risk of deterioration in patient-reported cancer symptoms and functioning, where the camizestrant combination reduced the risk of deterioration in global health status and quality of life by 46% compared with the AI combination (HR 0.54; 95% CI, 0.34-0.84; nominal p<0.001).2

The safety profile of camizestrant in combination with palbociclib, ribociclib or abemaciclib in the SERENA-6 trial was consistent with the known safety profile of each medicine. No new safety concerns were identified and discontinuations were very low and similar in both arms.

SERENA-6 is the first global, double-blind, registrational Phase III trial to use a circulating tumour DNA (ctDNA)-guided approach to detect the emergence of endocrine resistance and inform a switch in therapy before disease progression. The innovative trial design used ctDNA monitoring via a blood test at the time of routine tumour scans every two to three months to identify patients for early signs of endocrine resistance via the emergence of ESR1 mutations. Following detection of an ESR1 mutation without disease progression, the endocrine therapy of patients was switched to camizestrant from ongoing treatment with an AI, while continuing combination with the same CDK4/6 inhibitor.

Regulatory applications for camizestrant in this setting are also under review in the EU, Japan and several other countries.

Notes

HR-positive breast cancer
Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide.3 More than two million patients were diagnosed with breast cancer in 2022, with more than 665,000 deaths globally.3 In the US, breast cancer is the most common cancer in women, with more than 300,000 new cases of the disease diagnosed annually, and more than 42,000 deaths.4 While survival rates are high for those diagnosed with early breast cancer, only about 30% of patients diagnosed with or who progress to metastatic disease are expected to live five years following diagnosis.5

HR-positive breast cancer, characterised by the expression of estrogen or progesterone receptors, or both, is the most common subtype of breast cancer with 70% of tumours considered HR-positive and HER2-negative.5 Estrogen receptor (ERs) often drive the growth of HR-positive breast cancer cells.6

Globally, approximately 200,000 patients with HR-positive breast cancer are treated with a medicine in the 1st-line setting; most frequently with endocrine therapies that target ER-driven disease, which are often paired with CDK4/6 inhibitors.7-9 In the US, approximately 37,000 patients with HR-positive metastatic breast cancer are treated with these therapies in the 1st-line setting.7-9 However, resistance to these therapies develops in many patients.9 Once this occurs, treatment options are limited and survival rates are low with approximately 36% of patients anticipated to live beyond five years after diagnosis.5,9

Mutations in the ESR1 gene are a key driver of endocrine resistance and are associated with poor outcomes, emerging during treatment of the disease and becoming more prevalent as the disease progresses.10,11 Approximately 30% of patients with endocrine sensitive HR-positive disease develop ESR1 mutations during 1st-line treatment before disease progression.7

The optimisation of endocrine therapy and overcoming resistance to enable patients to continue benefiting from these treatments, as well as identifying new therapies for those who are less likely to benefit, are active areas of focus for breast cancer research.

SERENA-6
SERENA-6 is a Phase III, double-blind, randomised trial evaluating the efficacy and safety of camizestrant in combination with a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib) versus treatment with an AI (anastrozole or letrozole) in combination with a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib) in patients with HR-positive, HER2-negative advanced breast cancer (patients with either locally advanced disease, or metastatic disease) whose tumours have an emergent ESR1 mutation.

The global trial enrolled 315 adult patients with histologically confirmed HR-positive, HER2-negative advanced breast cancer, undergoing treatment with an AI in combination with a CDK4/6 inhibitor as 1st-line treatment. The primary endpoint of the SERENA-6 trial is PFS as assessed by investigator, with secondary endpoints including OS, and PFS2 by investigator assessment.

Camizestrant
Camizestrant is an investigational, potent, next-generation oral selective estrogen receptor degrader (SERD) and complete ER antagonist that is currently in Phase III trials for the treatment of HR-positive breast cancer.

AstraZeneca’s broad, robust and innovative clinical development programme, including the SERENA-6, SERENA-4, CAMBRIA-1 and CAMBRIA-2 trials, is evaluating the safety and efficacy of camizestrant when used as a monotherapy or in combination with CDK4/6 inhibitors to address a number of areas of unmet need in HR-positive, HER2-negative breast cancer.

Camizestrant has demonstrated anti-cancer activity across a range of preclinical models, including those with ER-activating mutations. In the SERENA-2 Phase II trial, camizestrant demonstrated a statistically significant and clinically meaningful improvement in PFS versus Faslodex (fulvestrant) in the overall trial population, including in patients with ESR1 tumour mutations irrespective of prior treatment with CDK4/6 inhibitors in patients with ER-positive locally advanced or metastatic breast cancer, previously treated with endocrine therapy. The SERENA-1 Phase I trial demonstrated that camizestrant is well tolerated and has a promising anti-tumour profile when administered alone or in combination with palbociclib, ribociclib and abemaciclib; three widely used CDK4/6 inhibitors.

AstraZeneca in breast cancer
Driven by a growing understanding of breast cancer biology, AstraZeneca is challenging, and redefining, the current clinical paradigm for how breast cancer is classified and treated to deliver even more effective treatments to patients in need – with the bold ambition to one day eliminate breast cancer as a cause of death.

AstraZeneca has a comprehensive portfolio of approved and promising compounds in development that leverage different mechanisms of action to address the biologically diverse breast cancer tumour environment.

With Enhertu (trastuzumab deruxtecan), a HER2-directed antibody drug conjugate (ADC), AstraZeneca and Daiichi Sankyo are aiming to improve outcomes in previously treated HER2-positive, HER2-low and HER2-ultralow metastatic breast cancer and are exploring its potential in earlier lines of treatment and in new breast cancer settings.

In HR-positive breast cancer, AstraZeneca continues to improve outcomes with foundational medicines Faslodex and Zoladex (goserelin) and aims to reshape the HR-positive space with first-in-class AKT inhibitor, Truqap, the TROP-2-directed ADC, Datroway (datopotamab deruxtecan) and next-generation oral SERD and potential new medicine camizestrant.

PARP inhibitor Lynparza (olaparib) is a targeted treatment option that has been studied in early and metastatic breast cancer patients with an inherited BRCA mutation. AstraZeneca with MSD (Merck & Co., Inc. in the US and Canada) continue to research Lynparza in these settings. AstraZeneca is also exploring the potential of saruparib, a potent and selective inhibitor of PARP1, in combination with camizestrant in BRCA-mutated, HR-positive, HER2-negative advanced breast cancer.

To bring much-needed treatment options to patients with triple-negative breast cancer, an aggressive form of breast cancer, AstraZeneca is collaborating with Daiichi Sankyo to evaluate the potential of Datroway alone and in combination with immunotherapy Imfinzi (durvalumab).

AstraZeneca in oncology
AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients.

The Company’s focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyse changes in the practice of medicine and transform the patient experience.

AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death.

(Press release, AstraZeneca, APR 30, 2026, View Source [SID1234664997])

Prescient Therapeutics advances PTX-100 trial and cell therapy platforms

On April 30, 2026 Prescient Therapeutics Ltd (ASX:PTX) reported continued progress across its oncology development pipeline during the March 2026 quarter, led by expanding enrolment and site activation in its PTX-100 Phase 2a clinical program.

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The company’s global Phase 2a study of PTX-100 in Cutaneous T-cell Lymphoma (CTCL) continued to build momentum, with two new Italian sites activated during the quarter, taking the total number of active sites to 11 at March 31.

A further Italian site was activated after quarter-end, lifting the active global site count to 12, with European expansion expected to increase the total to up to 16 sites.

Enrolment advancing
Patient enrolment also advanced, with six patients enrolled during the quarter for a total of 12 at quarter-end. A further 6 patients were enrolled across the US, Australia and Italy by April 24, increasing total enrolment to 18 patients. The Phase 2a protocol allows enrolment of up to 40 patients.

Prescient also reported progress in understanding PTX-100’s mode of action through its collaboration with CSIRO. Using artificial intelligence and advanced computational modelling, scientists constructed a 3D model of PTX-100’s interaction with its target protein.

The modelling showed PTX-100 binds tightly to its target and blocks the active site with high selectivity, a profile the company said may support efficacy across target protein conformations and reduce the likelihood of resistance emerging in cancer cells.

Prescient’s earlier Phase 1b study has now fully closed following completion of the clinical study report. One patient remains on PTX-100 through compassionate access after 2.5 years, reflecting durable clinical benefit in that individual.

Data generation
The company continues to assess opportunities to generate additional clinical data for PTX-100 in Peripheral T-cell Lymphoma, with further studies to be considered after selection of the recommended Phase 2 dose for CTCL.

Across its cell therapy platforms, business development discussions continued during the quarter for both OmniCAR and CellPryme, with further updates to be provided as material developments occur.

Prescient ended the quarter with cash and term deposits of $11.93 million, following receipt of a $4.3 million R&D tax refund in January 2026. Net operating cash outflows totalled $2.21 million, including $1.17 million invested in research and development and clinical activities.

CEO James McDonnell will host an online investor briefing on Tuesday, May 5, 2026, at 12pm AEST. Registration is available here: View Source

(Press release, Prescient Therapeutics, APR 30, 2026, View Source;utm_medium=rss&utm_campaign=prescient-therapeutics-advances-ptx-100-trial-and-cell-therapy-platforms [SID1234668718])