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Jazz Pharmaceuticals Announces FDA Acceptance and Priority Review of Supplemental Biologics License Application for Ziihera® (zanidatamab-hrii) Combinations in First-Line HER2+ Locally Advanced or Metastatic GEA

On April 27, 2026 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported that the U.S. Food and Drug Administration (FDA) accepted for filing with Priority Review the supplemental Biologics License Application (sBLA) for Ziihera (zanidatamab-hrii) containing combinations for the first-line treatment of adult patients with HER2-positive (HER2+) unresectable locally advanced or metastatic gastric, gastroesophageal junction (GEJ), or gastroesophageal adenocarcinoma (GEA). The FDA has set a PDUFA target action date of August 25, 2026.

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The sBLA is supported by data from the pivotal HERIZON-GEA-01 trial to investigate the efficacy and safety of zanidatamab in combination with standard-of-care chemotherapy with or without the PD-1 inhibitor Tevimbra (tislelizumab) in patients with advanced or metastatic GEA, including gastric, GEJ and esophageal adenocarcinomas. The submission is under review via the Real-Time Oncology Review (RTOR) program, an initiative of FDA’s Oncology Center of Excellence designed to provide a more efficient review process to ensure that safe and effective treatments are available to patients as early as possible.

"The HERIZON-GEA-01 trial results are practice changing, supporting the potential of zanidatamab as the HER2-targeted agent-of-choice in HER2+ first-line locally advanced or metastatic GEA. Importantly, the results demonstrated adding tislelizumab to zanidatamab plus chemotherapy further enhanced clinical benefit and marked the first immuno-oncology combination to show efficacy across both PD-L1–positive and PD-L1–negative tumors in this clinical setting," said Rob Iannone, M.D., M.S.C.E., executive vice president, global head of R&D, and chief medical officer of Jazz Pharmaceuticals. "We look forward to continuing to work closely with FDA to obtain approval and quickly bring zanidatamab to market for GEA patients in need of new options."

The FDA granted Breakthrough Therapy designation to zanidatamab in combination with fluoropyrimidine- and platinum-containing chemotherapy, with or without tislelizumab, for the first-line treatment of patients with HER2+ unresectable locally advanced or metastatic gastric, GEJ, or esophageal adenocarcinoma. Breakthrough Therapy designation is intended to expedite the development and review of therapies that, based on preliminary clinical evidence, may offer substantial improvement over available therapies on one or more clinically significant endpoints, reflecting both the seriousness of the disease and the unmet medical need in this setting.

About the Phase 3 HERIZON-GEA-01 Trial
HERIZON-GEA-01 (NCT05152147) is a global, randomized, open-label Phase 3 trial, conducted jointly with BeOne Medicines, to evaluate and compare the efficacy and safety of zanidatamab plus chemotherapy, with or without tislelizumab, to trastuzumab plus chemotherapy as first-line treatment for adult patients with advanced/metastatic HER2+ GEA. The trial randomized 914 patients from approximately 300 trial sites in more than 30 countries. Appropriate patients for this trial had unresectable locally advanced, recurrent or metastatic HER2+ GEA (adenocarcinomas of the stomach or esophagus, including the gastroesophageal junction), defined as 3+ HER2 expression by IHC or 2+ HER2 expression by IHC with ISH positivity per central assessment. Patients were randomized to the three trial arms: zanidatamab in combination with chemotherapy and tislelizumab; zanidatamab in combination with chemotherapy; and trastuzumab plus chemotherapy. The trial is evaluating dual primary endpoints, PFS per blinded independent central review (BICR) and OS. Results from the trial were presented in January 2026 at the 2026 ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium.

About Gastroesophageal Adenocarcinoma
GEA, including cancers of the stomach, gastroesophageal junction, and esophagus, is the fifth most common cancer worldwide, and approximately 20% of patients have HER2+ disease.1,2,3 HER2+ GEA has high morbidity and mortality, and patients are urgently in need of new treatment options. The overall prognosis for patients with GEA remains poor, with a global five-year survival rate of less than 30% for gastric cancer and about 19% for GEA.4

About Ziihera (zanidatamab-hrii)
Ziihera (zanidatamab-hrii) is a bispecific HER2-directed antibody that binds to two extracellular sites on HER2. Binding of zanidatamab-hrii with HER2 results in internalization leading to a reduction in HER2 expression of the receptor on the tumor cell surface. Zanidatamab-hrii induces complement-dependent cytotoxicity (CDC), antibody-dependent cellular cytotoxicity (ADCC), and antibody-dependent cellular phagocytosis (ADCP). These mechanisms result in tumor growth inhibition and cell death in vitro and in vivo.5 In the United States, Ziihera is indicated for the treatment of adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer (BTC), as detected by an FDA-approved test.1 The FDA granted accelerated approval for this indication based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).1

Zanidatamab is being developed in multiple clinical trials as a targeted treatment option for patients with solid tumors that express HER2. Zanidatamab is being developed by Jazz Pharmaceuticals and BeOne under license agreements from Zymeworks, which first developed the molecule.

An sBLA for zanidatamab is being reviewed by the FDA under RTOR in first-line HER2+ locally advanced or metastatic GEA. The FDA granted two Breakthrough Therapy designations for zanidatamab’s development: one as a single agent for previously treated HER2 gene-amplified BTC, and one in combination with fluoropyrimidine- and platinum-containing chemotherapy, with or without tislelizumab for first-line HER2+ unresectable locally advanced or metastatic gastric, GEJ or esophageal adenocarcinoma. The FDA also granted two Fast Track designations for zanidatamab: one as a single agent for refractory BTC and one in combination with standard-of-care chemotherapy for first-line GEA. Additionally, zanidatamab has received Orphan Drug designations from the FDA for the treatment of BTC, gastric (including GEJ) cancer, and esophageal cancer, as well as Orphan Drug designations from the European Medicines Agency for the treatment of BTC, gastric/GEJ cancer and oesophageal cancer.

Important Safety Information for ZIIHERA

WARNING: EMBRYO-FETAL TOXICITY
Exposure to ZIIHERA during pregnancy can cause embryo-fetal harm. Advise patients
of the risk and need for effective contraception.

WARNINGS AND PRECAUTIONS

Embryo-Fetal Toxicity
ZIIHERA can cause fetal harm when administered to a pregnant woman. In literature reports, use of a HER2-directed antibody during pregnancy resulted in cases of oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death.

Verify the pregnancy status of females of reproductive potential prior to the initiation of ZIIHERA. Advise pregnant women and females of reproductive potential that exposure to ZIIHERA during pregnancy or within 4 months prior to conception can result in fetal harm. Advise females of reproductive potential to use effective contraception during treatment with ZIIHERA and for 4 months following the last dose of ZIIHERA.

Left Ventricular Dysfunction
ZIIHERA can cause decreases in left ventricular ejection fraction (LVEF). LVEF declined by >10% and decreased to <50% in 4.3% of 233 patients. Left ventricular dysfunction (LVD) leading to permanent discontinuation of ZIIHERA was reported in 0.9% of patients. The median time to first occurrence of LVD was 5.6 months (range: 1.6 to 18.7). LVD resolved in 70% of patients.

Assess LVEF prior to initiation of ZIIHERA and at regular intervals during treatment. Withhold dose or permanently discontinue ZIIHERA based on severity of adverse reactions.

The safety of ZIIHERA has not been established in patients with a baseline ejection fraction that is below 50%.

Infusion-Related Reactions
ZIIHERA can cause infusion-related reactions (IRRs). An IRR was reported in 31% of 233 patients treated with ZIIHERA as a single agent in clinical studies, including Grade 3 (0.4%), and Grade 2 (25%). IRRs leading to permanent discontinuation of ZIIHERA were reported in 0.4% of patients. IRRs occurred on the first day of dosing in 28% of patients; 97% of IRRs resolved within one day.

Prior to each dose of ZIIHERA, administer premedications to prevent potential IRRs. Monitor patients for signs and symptoms of IRR during ZIIHERA administration and as clinically indicated after completion of infusion. Have medications and emergency equipment to treat IRRs available for immediate use.

If an IRR occurs, slow, or stop the infusion, and administer appropriate medical management. Monitor patients until complete resolution of signs and symptoms before resuming. Permanently discontinue ZIIHERA in patients with recurrent severe or life-threatening IRRs.

Diarrhea
ZIIHERA can cause severe diarrhea.

Diarrhea was reported in 48% of 233 patients treated in clinical studies, including Grade 3 (6%) and Grade 2 (17%). If diarrhea occurs, administer antidiarrheal treatment as clinically indicated. Perform diagnostic tests as clinically indicated to exclude other causes of diarrhea. Withhold or permanently discontinue ZIIHERA based on severity.

ADVERSE REACTIONS
Serious adverse reactions occurred in 53% of 80 patients with unresectable or metastatic HER2-positive BTC who received ZIIHERA. Serious adverse reactions in >2% of patients included biliary obstruction (15%), biliary tract infection (8%), sepsis (8%), pneumonia (5%), diarrhea (3.8%), gastric obstruction (3.8%), and fatigue (2.5%). A fatal adverse reaction of hepatic failure occurred in one patient who received ZIIHERA.

The most common adverse reactions in 80 patients with unresectable or metastatic HER2-positive BTC who received ZIIHERA (≥20%) were diarrhea (50%), infusion-related reaction (35%), abdominal pain (29%), and fatigue (24%).

USE IN SPECIFIC POPULATIONS

Pediatric Use
Safety and efficacy of ZIIHERA have not been established in pediatric patients.

Geriatric Use
Of the 80 patients who received ZIIHERA for unresectable or metastatic HER2-positive BTC, there were 39 (49%) patients 65 years of age and older. Thirty-seven (46%) were aged 65-74 years old and 2 (3%) were aged 75 years or older.

No overall differences in safety or efficacy were observed between these patients and younger adult patients.

The full U.S. Prescribing Information for ZIIHERA, including BOXED Warning, is available at: View Source

TEVIMBRA (tislelizumab) is a registered trademark of BeOne Medicines.

(Press release, Jazz Pharmaceuticals, APR 27, 2026, View Source [SID1234664814])

Xcovery Partners with EVERSANA to Commercialize Lung Cancer Drug Ensacove in the U.S.

On April 27, 2026 Xcovery Holdings, Inc., (Xcovery) an evidence-based, innovation-driven pharmaceutical company, reported an agreement with EVERSANA, a leading provider of commercialization services to the global life sciences industry, to support and expand the U.S. commercial launch of ENSACOVE (ensartinib), the company’s novel therapy for adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC).

Ensacove (ensartinib) is a next generation ALK inhibitor jointly developed by Xcovery and Betta Pharmaceuticals, Co. Ltd. (Betta). It is indicated for the treatment of adult patients with ALK-positive locally advanced or metastatic NSCLC as detected by an FDA-approved test who have not previously received an ALK inhibitor and is now available in the United States as a treatment for these patients (www.ensacove.com).

Under the agreement, EVERSANA will provide comprehensive end‑to‑end commercialization services for Xcovery, including but not limited to agency of record, market access, commercial and medical teams to support the company’s strategy to make Ensacove available to more patients across the U.S.

"The approval of Ensartinib was a major milestone in our mission to advance precision oncology," said Giovanni Selvaggi, M.D., Chief Medical Officer of Xcovery Holdings, Inc. "As we expand the U.S. launch of ENSACOVE, we are focused on ensuring that patients and providers have the support they need. EVERSANA brings highly experienced, scalable commercialization capabilities, and we’re pleased to partner with them to broaden patient access."

"EVERSANA was built to help companies just like Xcovery implement more impactful commercial strategies which will allow more patients to benefit from therapies like Ensartinib," said Gregory Skalicky, President, EVERSANA.

About ENSACOVE

ENSACOVE (ensartinib) is a kinase inhibitor indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK) positive locally advanced or metastatic non-small cell lung cancer (NSCLC) who have not previously received an ALK inhibitor.

ENSACOVE is contraindicated in patients who have experienced a severe hypersensitivity reaction to ENSACOVE, FD&C Yellow No. 5 (tartrazine), or to any of its components.
ENSACOVE can cause the following serious adverse reactions. Withhold, reduce the dose, or permanently discontinue ENSACOVE based on severity.

Interstitial Lung Disease (ILD)/Pneumonitis occurred in 5% of patients, including 1.3% Grade 3 and 0.4% Grade 4. Monitor patients for new or worsening symptoms indicative of ILD/pneumonitis and immediately withhold ENSACOVE if suspected. Permanently discontinue in patients with ILD/pneumonitis.

Hepatotoxicity, including drug-induced liver injury can occur. 59% of patients had increased alanine aminotransferase (ALT), including 5% Grade 3. Increased aspartate aminotransferase (AST) occurred in 58% of patients, including 1.8% Grade 3. Increased bilirubin occurred in 12% of patients, including 2.3% Grade 3 and 0.2% Grade 4. There was one case of drug-induced liver injury. Monitor liver function tests at baseline and every 2 weeks during the first cycle of treatment, and then monthly or as clinically indicated.

Dermatologic Adverse Reactions can occur, including drug reaction with eosinophilia and systemic symptoms (DRESS), rash, pruritus, and photosensitivity. Dermatologic adverse reactions occurred in 80% of patients, including Grade 3 in 14% of patients. Rash occurred in 72% of patients, including Grade 3 in 12% of patients. Pruritus occurred in 32% of patients, including 2.4% Grade 3. There was one Grade 3 case (0.2%) of DRESS. Advise patients to limit direct sun exposure during treatment and for at least 1 week after discontinuation. Monitor for dermatologic adverse reactions during treatment.
Bradycardia occurred in 6% of patients. All bradycardia events were Grade 1 or 2. Monitor heart rate regularly during treatment.

Hyperglycemia. Increased blood glucose occurred in 44% of patients, including Grade 3 in 2.5% (based on laboratory data). Monitor serum glucose periodically during treatment.
Visual Disturbances occurred in 8% of patients (0.2% Grade 3) and included blurred vision, diplopia, photopsia, vitreous floaters, visual impairment, visual field defect, and reduced visual acuity. Advise patients to report visual symptoms during treatment and obtain ophthalmologic evaluation in patients with visual disturbances.

Increased Creatine Phosphokinase (CPK) occurred in 43% of patients who had CPK laboratory data available, with Grade 3 in 1.5% and 0.5% Grade 4. Advise patients to report any unexplained muscle pain, tenderness, or weakness. Monitor CPK periodically during treatment.

Hyperuricemia occurred in 6% of patients, with 0.4% Grade 3 and 0.7% Grade 4. Monitor uric acid periodically during treatment and initiate urate-lowering medications as clinically indicated.
ENSACOVE can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception during treatment and for 1 week after the last dose.

ENSACOVE contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons.

The most common adverse reactions (incidence ≥20%) were rash, musculoskeletal pain, constipation, pruritus, cough, nausea, edema, vomiting, fatigue, and pyrexia.

Drug Interactions: Avoid concomitant use of P-gp inhibitors and moderate or strong CYP3A inhibitors or inducers.

Lactation: Advise women not to breastfeed during treatment and for 1 week after the last dose.
Use in Specific Populations: Avoid use of ENSACOVE in patients with severe hepatic impairment (total bilirubin >3 times ULN and any AST).

(Press release, Xcovery, APR 27, 2026, View Source [SID1234664813])

Amsulostat poised for late-stage clinical development following positive FDA feedback

On April 27, 2026 Syntara Limited (ASX: SNT), a clinical-stage drug development company, reported that it has received positive feedback from the U.S. Food and Drug Administration (FDA) following a constructive in person Type C meeting regarding the planned Phase 2b clinical trial of its lead candidate, amsulostat, for the treatment of patients with myelofibrosis (MF) who have had an inadequate response to standard of care.

Following a review of amsulostat’s development to date, the FDA supported the proposed Phase 2b study design and provided guidance on the detail of the study and overall development pathway for amsulostat. This feedback represents a major milestone for the company, enabling progression into late-stage clinical development and creating opportunity for further engagement with potential commercial partners.

The Phase 2b study will be a double blind, placebo-controlled study of amsulostat added to standard of care (JAK inhibition) for patients who have had an inadequate response. The primary endpoint will be achievement of 50% reduction in total symptom score (TSS50) after 9 months of treatment. Subject to final protocol review, the number of patients to be studied is expected to be approximately 100.

Syntara Chief Executive Officer Gary Phillips said: "We are delighted to have received a positive FDA review of the trial protocol for the planned Phase 2b study. Amsulostat has a differentiated and competitive safety and efficacy profile, with strong potential as a breakthrough therapy for MF patients with an inadequate response to standard of care. We are also advancing amsulostat’s development into myelodysplastic syndrome (MDS), where two clinical studies are currently ongoing.

With additional clinical milestones expected over the next 12 months, including top-line data from the Phase 2 study of SNT-4728 for isolated REM sleep behaviour disorder (iRBD), a prodromal feature of Parkinson’s disease, and results from a placebo-controlled study of SNT-9465, a topical pan-LOX inhibitor for hypertrophic scarring; 2026 is shaping up to be a landmark year for Syntara."

(Press release, Syntara, APR 27, 2026, https://mcusercontent.com/add2e2fa70ec3d0eeaf2a93cc/files/2cc7439a-7a49-d9c3-e873-9f0527792fed/Positive_FDA_feedback_for_Amsulostat_P2b_trial.pdf [SID1234664812])

Altimmune Announces Closing of $225 Million Oversubscribed Public Offering of Securities

On April 27, 2026 Altimmune, Inc. (Nasdaq: ALT), a late clinical-stage biopharmaceutical company developing pemvidutide to address serious liver diseases, reported the closing of its previously announced underwritten public offering consisting of (i) 64,250,000 shares of its common stock and 64,250,000 accompanying common stock warrants to purchase shares of common stock or pre-funded warrants in lieu thereof and (ii) in lieu of common stock, to certain investors that so choose, pre-funded warrants to purchase an aggregate of up to 10,750,000 shares of its common stock and 10,750,000 accompanying common stock warrants to purchase shares of common stock or pre-funded warrants in lieu thereof, each at an exercise price of $0.001 per pre-funded warrant. The common stock and pre-funded warrants are being sold in combination with an accompanying common stock warrant to purchase one share of common stock (or pre-funded warrant in lieu thereof) issued for each share of common stock or pre-funded warrant sold. The accompanying common stock warrant is immediately exercisable from the date of issuance and will expire upon the earlier of (i) the fifth anniversary of the original issuance date and (ii) forty-five days following the Company’s public announcement of a successful data readout of its Phase 3 trial of pemvidutide in metabolic dysfunction-associated steatohepatitis ("MASH"). The combined offering price of each share of common stock and accompanying common stock warrant is $3.00. The combined offering price of each pre-funded warrant and accompanying common stock warrant is $2.999.

All of the shares, pre-funded warrants and accompanying common stock warrants in the offering were sold by Altimmune. The gross proceeds from the offering before deducting underwriting discounts and commissions and other offering expenses, were approximately $225 million.

"This financing provides the resources to initiate and execute the pemvidutide Phase 3 trial in MASH and provides cash runway through our anticipated 52-week data readout of the trial," said Jerry Durso, President and Chief Executive Officer of Altimmune. "Despite the availability of approved therapies, there remains significant unmet need for patients with MASH. We believe pemvidutide has the potential to offer a differentiated profile with meaningful benefits for patients. We are grateful for the conviction and confidence shown by these top-tier investors, as we execute on our goal to bring pemvidutide to patients with serious liver diseases and create long-term value for our shareholders."

Altimmune intends to use the net proceeds to fund its upcoming Phase 3 trial in MASH, as well as for working capital and general corporate purposes. Altimmune expects to initiate its Phase 3 trial in MASH in the second half of 2026.

Leerink Partners and Barclays acted as joint bookrunning managers for the offering. Titan Partners acted as co-bookrunning manager for the offering.

The shares of common stock, pre-funded warrants, common stock warrants and shares of common stock issuable upon the exercise of the pre-funded warrants and common stock warrants were offered by Altimmune pursuant to two effective shelf registration statements on Form S-3 that were previously filed with the U.S. Securities and Exchange Commission (SEC) and declared effective by the SEC on December 5, 2025 and March 13, 2025, respectively, and a related registration statement that was filed with the SEC on April 22, 2026 pursuant to Rule 462(b) under the Securities Act of 1933, as amended (and became automatically effective upon filing). The preliminary prospectus supplement and accompanying prospectuses relating to and describing the terms of the offering were filed with the SEC on April 22, 2026 and are available on the SEC’s website located at www.sec.gov. Electronic copies of the final prospectus supplement may be obtained, when available, by contacting Leerink Partners LLC, Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, or by telephone at (800) 808-7525 ext. 6105, or by email at [email protected]; Barclays Capital Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at (888) 603-5847, or by email at [email protected]; or by accessing the SEC’s website at www.sec.gov.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

(Press release, Altimmune, APR 27, 2026, View Source [SID1234664810])

Allarity Therapeutics Announces that the Stenoparib DRP® Test Has Received a Notice of Allowance from the US Patent and Trademark Office

On April 27, 2026 Allarity Therapeutics, Inc. ("Allarity" or the "Company") (NASDAQ: ALLR), a Phase 2 clinical-stage pharmaceutical company dedicated to developing stenoparib (2X-121)—a differentiated, dual PARP and WNT pathway inhibitor reported that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for its patent application covering the Company’s DRP companion diagnostic specific to stenoparib.

Importantly, this Notice of Allowance covers multiple claims and represents a major step in Allarity’s global strategy to expand and protect the commercial potential of stenoparib when selecting patients using its proprietary stenoparib DRP test. The patent is expected to be formally granted within three months, subject to standard administrative procedures and would provide exclusivity at least into 2039 for stenoparib when used in concert with the DRP as a companion diagnostic.

Thomas Jensen, CEO of Allarity Therapeutics, commented: "This Notice of Allowance from the USPTO represents another successful milestone in our efforts to secure intellectual property protection for our DRP technology in the US, the world’s most important pharmaceutical market. Critically, this patent maximizes the marketing exclusivity in the US for stenoparib in patients selected using the stenoparib DRP test, which is especially important as we seek to accelerate stenoparib toward approval for Ovarian and other cancers."

The allowed claims include methods for predicting clinical benefit based on gene expression profiles derived from tumor samples and for selecting those patients most likely to benefit from stenoparib treatment.

Allarity previously secured a European and Australian patent for the Stenoparib DRP and holds 18 granted patents for other drug-specific DRPs, including eight in the United States. Patent applications for the Stenoparib DRP remain pending in Canada, Japan, China, and India.

About Stenoparib/2X-121
Stenoparib is an orally available, small-molecule dual-targeted inhibitor of PARP1/2 and tankyrase 1/2. At present, tankyrases are attracting significant attention as emerging therapeutic targets for cancer, principally due to their role in regulating the WNT signaling pathway. Aberrant WNT/β-catenin signaling has been implicated in the development and progression of numerous cancers. By inhibiting PARP and blocking WNT pathway activation, stenoparib’s unique therapeutic action shows potential as a promising therapeutic for many cancer types, including ovarian cancer, Small Cell Lung Cancer and colorectal cancer. Allarity has secured exclusive global rights for the development and commercialization of stenoparib, which was originally developed by Eisai Co. Ltd. and was formerly known under the names E7449 and 2X-121. Allarity has two ongoing Phase 2 trial protocols for stenoparib in Ovarian Cancer patients. In the first, patients who had had 2+ lines of therapy were enrolled on stenoparib and given drug twice daily. This protocol has been closed to further enrollment but continues for the enrolled patients who are still receiving benefit from stenoparib administration. The updated data from this study were presented at the AACR (Free AACR Whitepaper) special conference on advances in Ovarian Cancer in September 2025. Note that, as these data are from an ongoing trial, analyses may change as the study fully matures. An amended protocol designed expressly to capitalize on the emerging clinical experience with stenoparib in platinum resistant patients began enrolling patients in the summer of 2025. This amended protocol enrolls only platinum resistant or platinum-ineligible patients and is designed to accelerate the clinical development of stenoparib toward FDA approval. In parallel, a separate Phase 2 trial evaluating stenoparib in combination with temozolomide for relapsed small cell lung cancer (SCLC) began enrolling patients in early 2026 and is currently enrolling patients across multiple U.S. Veterans Administration (VA) sites.

About the Drug Response Predictor – DRP Companion Diagnostic
Allarity uses its drug-specific DRP to select those patients who, by the gene expression signature of their cancer, may have a high likelihood of benefiting from a specific drug. By screening patients before treatment, and only treating those patients with a sufficiently high, drug-specific DRP score, the therapeutic benefit rate may be enhanced. The DRP method builds on the comparison of sensitive vs. resistant human cancer cell lines, including transcriptomic information from cell lines, combined with clinical tumor biology filters and prior clinical trial outcomes. DRP is based on messenger RNA expression profiles from patient biopsies. The DRP platform has shown an ability to provide a statistically significant prediction of the clinical outcome from drug treatment in cancer patients across dozens of clinical studies (both retrospective and prospective). The DRP platform, which may be useful in all cancer types and is patented for dozens of anti-cancer drugs, has been extensively published in the peer-reviewed literature.

(Press release, Allarity Therapeutics, APR 27, 2026, View Source [SID1234664809])