On July 9, 2026 Freenome, an early cancer detection company developing blood-based screening tests, reported favorable results from its pivotal clinical validation study assessing the performance of assay and algorithm improvements for its updated version of the SimpleScreen CRC blood-based colorectal cancer (CRC) screening test.

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The study successfully met its primary and secondary endpoints. The updated test showed 18.2% sensitivity for detecting advanced precancerous lesions (APLs), 41.9% sensitivity for APLs with high-grade dysplasia (HGD), and 80.4% sensitivity for detecting CRC, including 52% of Stage I cases (Stage I (T1) 39.9% and Stage I (T2) 81.2%), 100% of Stage II, 97.3% of Stage III and 100% of Stage IV. The results were adjusted to the age and sex distribution of the U.S. Census to better reflect the intended use population, and specificity for no findings on colonoscopy was 90%.

CRC remains the second-leading cause of cancer-related death in the United States, yet more than 50 million eligible adults are not up to date on recommended screening. Blood-based screening tests have the potential to reach people who might otherwise remain unscreened.

The clinical validation of the updated SimpleScreen CRC test includes blinded, previously unevaluated samples from participants who enrolled in PREEMPT CRC1 — a prospective, registrational study — as well as previously tested samples. Conducted at more than 200 sites, the PREEMPT CRC study enrolled 48,995 asymptomatic, average-risk adults between the ages of 45 and 85 scheduled to undergo a screening colonoscopy. The analysis included more than 85 individuals with CRC, 1,500 with APLs, and 150 with APLs with HGD.

Endpoint

Updated SimpleScreen CRC
CV study2

(US Census Weighted Endpoints)

SimpleScreen CRC in
PREEMPT CRC study1

(US Census Weighted Endpoints)

N

Value (95% CI)

N

Value (95% CI)

Sensitivity for CRC (Primary)

89

80.4%

(70.2%, 87.7%)

72

81.1%

(71.3%, 88.1%)

Sensitivity for APL (Primary)

1570

18.2%

(16.3%, 20.4%)

2567

13.7%

(12.4%, 15.0%)

Sensitivity for HGD (APL 2.1)

(Secondary)

157

41.9%

(34.0%, 50.3%)

110

30.5%

(22.7%, 39.5%)

Detecting APLs, particularly those with HGD, is important because these lesions are more likely to progress to CRC if left untreated. The sensitivity results for APL and APL with HGD demonstrated in this study are the highest reported to date for any non-invasive screening blood test in a prospective registrational pivotal clinical study.

"The sensitivity for APL and APL with HGD for the updated SimpleScreen CRC test is a marked improvement and gets us closer to matching the performance of certain stool-based CRC screening tests, with potentially higher adherence," noted Aasma Shaukat, M.D., M.P.H., professor of medicine at NYU Grossman School of Medicine and a co-lead principal investigator on the PREEMPT CRC study.

With the improved detection of APLs and HGD, our published model3 suggests that the updated test would result in 7.7% more life-years gained, 9.5% more cases of cancer prevented, and 9.5% more cancer deaths prevented, compared to the first-generation CRC test version.4

"This study marks a major milestone in our mission to advance blood-based colorectal cancer screening," said Aaron Elliott, Ph.D., CEO of Freenome. "The significant improvement in detecting precancerous lesions demonstrates the critical role our SimpleScreen CRC platform can play in early detection and prevention of colon cancer. With millions of eligible Americans still not getting screened, expanding access to accurate, non-invasive screening options that patients are more likely to complete has never been more important."

Freenome submitted its Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA) in August 2025 for the first-generation version of its SimpleScreen CRC test. The FDA is expected to complete its review in mid 2026. Freenome intends to submit a supplemental PMA to the FDA for the next-generation SimpleScreen CRC test.

In August 2025, Freenome and Abbott entered into a commercial collaboration agreement to bring SimpleScreen CRC to market. Upon FDA approval, SimpleScreen CRC will be exclusively commercialized and made available by Abbott. Freenome will be offering a multi-cancer product consisting of SimpleScreen CRC in combination with its SimpleScreen Lung laboratory-developed test solely to patients who are eligible for both screenings.

The commercial collaboration agreement included a milestone payment tied to the outcome of this study. That intended milestone payment will be set at $70 million, pending FDA approval of the next-generation test and the successful technology transfer of the product to Abbott. Freenome and Abbott are collaborating on a multi-year R&D program focused on improving assay performance.

"These results strengthen our confidence in the role blood-based colorectal cancer screening can play in expanding screening," said Jake Orville, senior vice president of Abbott’s cancer diagnostics business. "Combined with Abbott’s preferred, guideline-supported screening option, we’re uniquely positioned to offer healthcare providers and patients a differentiated colorectal cancer screening portfolio built on innovation, performance and choice—with one goal in mind: helping more people get screened."

While the foundational SimpleScreen CRC test will provide a robust, clinically validated screening option for patients, Freenome continues to advance its next-generation pipeline of single- and multi-cancer tests. Through its pioneering Personalized Cancer Detection approach to screening, Freenome will be matching blood-based screening tests to the cancers most relevant to individuals based on their health profile, while leveraging its multiomics platform to optimize test performance for additional validated indications.

(Press release, Freenome, JUL 9, 2026, View Source [SID1234669129])

On July 9, 2026 Blue Earth Therapeutics, a clinical-stage radiopharmaceutical company and University College London (UCL) reported initiation of a Phase 1 clinical trial (NCT07414940) evaluating Actinium (225Ac) rhPSMA-10.1 Injection, an investigational alpha‑emitting PSMA‑targeted radiopharmaceutical for the treatment of patients within clinical trials in metastatic castrate‑resistant prostate cancer (mCRPC). The study is sponsored by UCL and is being conducted at UCL Hospital, London. Blue Earth Therapeutics is providing funding and supply of investigational drug product.

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This Phase 1 study is designed to evaluate the safety and anti-tumour activity of Actinium (225Ac) rhPSMA-10.1 Injection in participants with PSMA‑positive mCRPC whose disease has progressed following prior therapy. Results from the study are expected to characterise the side effects of Actinium (225Ac) rhPSMA-10.1 Injection and to inform dose selection for subsequent research.

Alpha-emitting radionuclides such as actinium-225 (225Ac) deliver a high amount of energy over a short distance in tissue, causing irreparable DNA damage to targeted cancer cells whilst aiming to limit exposure to surrounding healthy tissue. When incorporated into a PSMA-targeting molecule such as rhPSMA-10.1, this approach is designed to deliver localised radiation directly to prostate cancer lesions, potentially offering a targeted treatment strategy for patients with advanced cancer.

Actinium (225Ac) rhPSMA-10.1 Injection is the second clinical candidate in Blue Earth Therapeutics’ oncology pipeline, building on the company’s ongoing Lutetium (¹⁷⁷Lu) rhPSMA‑10.1 Injection clinical programme, which is currently in a Phase 2 clinical trial. Together, these programmes reflect the company’s work across both alpha‑ and beta‑emitting radiopharmaceutical therapies using its radiohybrid PSMA platform.

UCL Cancer Institute director Professor Gert Attard said: "This study is an important step in advancing more precise treatment options for men with metastatic castrate-resistant prostate cancer. The combination of a highly targeted PSMA approach with the potent, short-range effects of an alpha-emitting radionuclide offers a promising strategy to deliver meaningful anti-tumour activity while limiting toxicity. Early-phase trials such as this are essential for determining safety, refining dose and guiding how these therapies can be integrated into personalised treatment pathways to improve outcomes for patients."

"Initiation of this collaborative Phase 1 study represents an important milestone for Blue Earth Therapeutics and our investigational radiopharmaceutical therapy pipeline," said Dr David Gauden, Chief Executive Officer of Blue Earth Therapeutics. "Building on our clinical experience in both alpha‑ and beta‑emitting radiopharmaceutical therapies, we are combining the targeting precision of rhPSMA with the alpha‑emitting properties of actinium‑225 to explore a potential treatment approach for patients with advanced prostate cancer. We are very grateful to the team at UCL and to their patients for undertaking this study."

About metastatic prostate cancer

It has been forecast that in 2025 there would be 50,055 new cases of metastatic prostate cancer in the United States (de novo diagnoses plus recurrence from earlier stage diagnoses).1 Five-year survival for newly diagnosed metastatic prostate cancer is low, 40.1%.2 While death rates from prostate cancer have declined over the past three decades2, there is still considerable room to improve patient outcomes.

About Radiohybrid Prostate‐Specific Membrane Antigen (rhPSMA)

rhPSMA compounds are referred to as radiohybrid ("rh"), as each molecule possesses four distinct domains. The first consists of a Prostate‐Specific Membrane Antigen‐targeted receptor ligand. It is attached to two labelling moieties which may be radiolabelled with diagnostic isotopes such as 18F or 68Ga for PET imaging, or with therapeutic isotopes such as 177Lu or 225Ac for radioligand therapy, all of which are joined together by a modifiable linker which can be used to modulate important pharmacokinetic characteristics. Radiohybrid PSMA offers the potential for targeted treatment for men with prostate cancer and originated at the Technical University of Munich, Germany. Blue Earth Diagnostics acquired exclusive worldwide rights to rhPSMA diagnostic imaging technology from Scintomics GmbH in 2018, and therapeutic rights in 2020, and has sublicensed the therapeutic application to its sister company Blue Earth Therapeutics.

(Press release, Blue Earth Therapeutics, JUL 9, 2026, View Source [SID1234669128])

On July 9, 2026 Accord BioPharma, the U.S. specialty division of Intas Pharmaceuticals, Ltd., focused on the development of oncology, immunology, and central nervous system (CNS) therapies, reported that the U.S. Food and Drug Administration (FDA) has approved ENNUMO (pegfilgrastim-pccg), a biosimilar to NEULASTA (pegfilgrastim). ENNUMO is indicated in adults and pediatric patients aged newborn and older to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia, and to increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome).1 ENNUMO is approved by the FDA for the same indications as its reference product, NEULASTA.

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With this approval, Accord BioPharma is now the only company in the U.S. offering two distinct pegfilgrastim biosimilars — ENNUMO and UDENYCA (pegfilgrastim-cbqv) — alongside FILKRI (filgrastim-laha), its short-acting granulocyte colony-stimulating factor (G-CSF) biosimilar approved in February 2026. Together, these three products form a G-CSF portfolio designed to meet the diverse clinical and operational needs of oncology practices, hospitals, and the patients they serve.

"Every FDA approval marks a step forward in our mission to expand patient access to high-quality, affordable biologic therapies," said Chrys Kokino, President, Accord North America. "With ENNUMO, we now offer healthcare providers the largest G-CSF portfolio in the world from a single biosimilar company. We are on track to deliver 20 biosimilars by 2030. We recognize that both patients and oncology practices are counting on us for the long term as we expand our oncology product offerings. Most importantly we are proud that we have and will continue to increase patient access to these critically important medicines."

Expanding Access Through Portfolio Breadth
Febrile neutropenia is one of the most serious and frequently occurring complications of myelosuppressive chemotherapy, contributing to treatment delays, dose reductions, hospitalizations, and increased mortality risk in patients with cancer.2 Granulocyte colony-stimulating factors have become a cornerstone of oncology supportive care, and biosimilars are playing an increasingly critical role in expanding access to these therapies across a range of clinical settings.

"From speaking with our customers, we know the needs of oncology practices are not one-size-fits-all, and we’ve built our portfolio to address this reality," said Nuvan Dassanaike, Senior Vice President, Digital and Marketing Strategy & Operations, Accord BioPharma. "With ENNUMO and UDENYCA, we have pegfilgrastim biosimilar options to offer—alongside FILKRI for short-acting G-CSF—so we can meet physicians and their patients where they are."

Part of a Broader Biosimilar Growth Story
The approval of ENNUMO marks the latest milestone in Accord BioPharma’s rapid portfolio expansion. The company has set a strategic goal to launch 20 biosimilar products in the U.S. by 2030, building on a growing commercial portfolio that now spans oncology and immunology, with an aim to further expand into central nervous system therapies. Backed by Intas Pharmaceuticals, Ltd., one of the world’s largest and most experienced biosimilar developers with nearly five decades of global pharmaceutical expertise, Accord BioPharma is uniquely positioned to deliver on this ambition.

"ENNUMO’s approval is another proof point that what we’re building at Accord BioPharma can genuinely change the treatment landscape for patients in the U.S.," said Binish Chudgar, Chairman and Managing Director, Intas Pharmaceuticals, Ltd. "Our goal of 20 biosimilars by 2030 is not just a number. It reflects the depth of our pipeline and our determination to deliver."

Contact: [email protected]

IMPORTANT SAFETY INFORMATION

Contraindications: ENNUMO is contraindicated in patients with a history of a serious hypersensitivity reaction to pegfilgrastim products or filgrastim products. Reactions have included anaphylaxis.

Splenic Rupture: Splenic rupture, including fatal cases, can occur following the administration of pegfilgrastim products. Patients who report left upper abdominal or shoulder pain after receiving ENNUMO should be evaluated for an enlarged spleen or splenic rupture.

Acute Respiratory Distress Syndrome: Acute respiratory distress syndrome (ARDS) can occur in patients receiving pegfilgrastim products. Evaluate patients for ARDS who develop fever, lung infiltrates or respiratory distress after receiving ENNUMO. Discontinue ENNUMO in patients with ARDS.

Serious Hypersensitivity Reactions: Serious hypersensitivity reactions, including anaphylaxis, can occur in patients receiving pegfilgrastim products. The majority of reported events occurred upon initial exposure and can recur within days after the discontinuation of initial therapies to manage the reaction. Permanently discontinue ENNUMO in patients with serious hypersensitivity reactions.

Use in Patients with Sickle Cell Disorders: Severe and sometimes fatal sickle cell crises can occur in patients with sickle cell disorders receiving pegfilgrastim products. Discontinue ENNUMO if sickle cell crisis occurs.

Glomerulonephritis: Glomerulonephritis has occurred in patients receiving pegfilgrastim products. The diagnoses were based upon azotemia, hematuria (microscopic and macroscopic), proteinuria, and renal biopsy. Generally, events of glomerulonephritis resolved after dose-reduction or discontinuation of pegfilgrastim products. If glomerulonephritis is suspected, evaluate for cause and if likely, consider dose-reduction or interruption of ENNUMO.

Leukocytosis: White blood cell (WBC) counts of 100 x 109/L or greater have been observed in patients receiving pegfilgrastim products. Monitoring of complete blood count (CBC) during ENNUMO therapy is recommended.

Thrombocytopenia: Pegfilgrastim products can cause thrombocytopenia. Monitor platelet counts during ENNUMO therapy.

Capillary Leak Syndrome: Capillary leak syndrome has been reported after granulocyte colony-stimulating factor (G-CSF) administration, including pegfilgrastim products, and is characterized by hypotension, hypoalbuminemia, edema and hemoconcentration. Episodes vary in frequency, severity and may be life-threatening if treatment is delayed. Closely monitor patients who develop symptoms of capillary leak syndrome and provide standard symptomatic treatment, which may include a need for intensive care.

Potential for Tumor Growth Stimulatory Effects on Malignant Cells: The G-CSF receptor through which pegfilgrastim products and filgrastim products act has been found on tumor cell lines. The possibility that pegfilgrastim products act as a growth factor for any tumor type, including myeloid malignancies and myelodysplasia, diseases for which pegfilgrastim products are not approved, cannot be excluded.

Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML) in Patients with Breast and Lung Cancer: MDS and AML have been associated with the use of pegfilgrastim products in conjunction with chemotherapy and/or radiotherapy in patients with breast and lung cancer. Monitor patients for signs and symptoms of MDS/AML in these settings.

Aortitis: Aortitis has been reported in patients receiving pegfilgrastim products and may occur as early as the first week after start of therapy. Manifestations may include generalized signs and symptoms such as fever, abdominal pain, malaise, back pain, and increased inflammatory markers (e.g., c-reactive protein and white blood cell count). Consider aortitis in patients who develop these signs and symptoms without known etiology. Discontinue ENNUMO if aortitis is suspected.

Nuclear Imaging: Increased hematopoietic activity of the bone marrow in response to growth factor therapy, including pegfilgrastim products, has been associated with transient positive bone imaging changes and should be considered when interpreting bone imaging results.

Most Common Adverse Reactions:

Most common adverse reactions (≥ 5% higher difference in incidence compared to placebo) are bone pain and pain in extremity.

INDICATIONS

ENNUMO is a leukocyte growth factor indicated in adults and pediatric patients aged newborn and older to:

Decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.
Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome).
Limitations of Use:

ENNUMO is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.

To report SUSPECTED ADVERSE REACTIONS, contact Accord BioPharma Inc at 1-866-941-7875 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

ENNUMO (pegfilgrastim-pccg) injection for manual use is supplied in a 6 mg/0.6 mL single-dose prefilled syringe.

Click here for full Prescribing Information.

NEULASTA (pegfilgrastim) is a registered trademark of Amgen Inc.

(Press release, Accord BioPharma, JUL 9, 2026, View Source [SID1234669127])

On July 9, 2026 Cue Biopharma, Inc. (Nasdaq: CUE), a clinical stage biopharmaceutical company focused on developing transformative therapies targeting functional cures for immunological disorders, reported that it has entered into a securities purchase agreement with a group of accredited investors for the private placement of (i) 1,418,071 shares of common stock at a purchase price of $33.21 per share and (ii) to certain investors, in lieu of shares of common stock, pre-funded warrants to purchase up to 87,500 shares of common stock at a price per pre-funded warrant of $33.209, for gross proceeds of approximately $50.0 million.

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The private placement is expected to close on or about July 13, 2026, subject to the satisfaction of customary closing conditions. The pre-funded warrants will have an exercise price of $0.001 per share, be immediately exercisable, and remain exercisable until exercised in full.

The private placement was led by Cormorant Asset Management, with participation from additional new investment funds including Columbia Threadneedle Investments.

The Company intends to use the net proceeds from the private placement to further fund clinical development and for other general corporate purposes.

"We are pleased to have such a high-quality group of biotech investors committing to the long-term support of Cue as we build our company and advance our portfolio targeting functional cures across immunological disorders," said Shao-Lee Lin, M.D., Ph.D., chief executive officer, president and board director of Cue Biopharma. "We look forward to our upcoming clinical milestones, including data from Ascendant Health’s ongoing Phase 2 CSU study in China, which is expected by the end of the third quarter of 2026."

The securities being issued and sold in the private placement, including the shares of common stock underlying the pre-funded warrants, have not been registered under the Securities Act of 1933, as amended (the "Securities Act"). Accordingly, these securities may not be offered or sold in the United States, except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act. Concurrently with the execution of the securities purchase agreement, the Company and the investors entered into a registration rights agreement pursuant to which the Company has agreed to file a registration statement with the Securities and Exchange Commission registering the resale of the shares of common stock sold in the private placement and the shares of common stock underlying the pre-funded warrants sold in the private placement.

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

(Press release, Cue Biopharma, JUL 9, 2026, View Source [SID1234669125])

On July 9, 2026 Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic liver cancers, reported that the first patient has been dosed at the European Institute of Oncology (IEO) in Milan, Italy in its global Phase 2 clinical trial evaluating HEPZATO in combination with standard of care (SOC) treatment for liver-dominant metastatic breast cancer (mBC).

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The Phase 2 trial (DELUMA; NCT06875128) will evaluate the safety and efficacy of HEPZATO in combination with standard of care (SOC) versus SOC alone in patients with liver-dominant HER2-negative mBC following the failure of previous treatments. The SOC options will be physician’s choice of eribulin, vinorelbine or capecitabine. Approximately 90 patients will be enrolled in this randomized, controlled trial, which is expected to be conducted at more than 20 sites across the United States and Europe. The trial’s primary endpoint is hepatic progression-free survival, with several secondary endpoints, including progression-free survival, overall response rate, disease control rate and overall survival.

Company management estimates that approximately 7,000 patients annually in the United States are affected by HER2-negative metastatic breast cancer with liver metastases and are candidates for third-line treatment. This population includes patients with a significant burden of liver metastases, which are likely to be the primary cause of mortality. Delcath aims to provide a novel treatment option for these patients, who have limited therapeutic alternatives.

"Dosing the first patient in this Phase 2 trial at the IEO in Milan, Italy is an important milestone in our effort to expand the clinical investigation of HEPZATO into liver-dominant metastatic breast cancer," said Gerard Michel, Chief Executive Officer of Delcath Systems, Inc. "Building on encouraging efficacy signals in real-world evidence presented at ESMO (Free ESMO Whitepaper) Breast Cancer 2026 and our commercial success in metastatic uveal melanoma, we’re strengthening how we engage sites, educate physicians on liver-directed therapy, and identify appropriate patients. We are encouraged by the momentum we are seeing and look forward to advancing our evaluation of HEPZATO’s potential to address significant unmet needs in oncology beyond metastatic uveal melanoma."

(Press release, Delcath Systems, JUL 9, 2026, View Source [SID1234669124])