ImmunityBio Receives Conditional Marketing Authorization Recommendation from the European Medicines Agency for ANKTIVA® with BCG for Non-Muscle Invasive Bladder Cancer Carcinoma in Situ—A First in Europe




ImmunityBio Receives Conditional Marketing Authorization Recommendation from the European Medicines Agency for ANKTIVA® with BCG for Non-Muscle Invasive Bladder Cancer Carcinoma in Situ—A First in Europe

• ANKTIVA plus BCG is the first immunotherapy for non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors, to receive a positive recommendation for marketing authorization in Europe. For patients whose disease does not respond to BCG, there are currently no authorized treatment options; the primary option is surgical removal of the bladder.
• Unlike the U.S., where only one BCG substrain is approved, Europe recognizes and has approved approximately six major BCG substrains, making standard-of-care therapy broadly available across the region.¹
• The recommendation is based on the EMA’s determination that the benefit of making ANKTIVA available to patients now outweighs the risks associated with earlier access, providing an important option for adults with BCG-unresponsive NMIBC, and builds on existing approvals in the U.S. and United Kingdom.
• Each year, more than 150,000 people in Europe are diagnosed with NMIBC.²

CULVER CITY, Calif.–(BUSINESS WIRE)–ImmunityBio (NASDAQ: IBRX), a leading immunotherapy company, announced today that the European Medicines Agency has recommended granting a conditional marketing authorization in the EU for ANKTIVA^® (nogapendekin alfa inbakicept) in combination with Bacillus Calmette-Guérin (BCG) for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) carcinoma in situ. This recommendation will help facilitate early access to medicines that address conditions where the remaining treatment option is surgery to remove the bladder.

“ANKTIVA represents an important evolution in the treatment of NMIBC CIS, strengthening the immune response and improving the durability of BCG,” said Dr. Patrick Soon-Shiong, Founder, Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio. “Hundreds of patients in the U.S. are already experiencing the benefits of this therapy, and our goal is to make it available to patients in Europe and other parts of the world as quickly and responsibly as possible, to ensure avoidance of a radical cystectomy. We are pleased that the EMA issued this positive recommendation based on our single-arm trial and through a regulatory process that allows earlier access to ANKTIVA, when as stated in the EMA announcement, the benefit of a medicine’s immediate availability to patients outweighs the inherent risks.”

“ANKTIVA offers a new treatment option for patients and addresses an important unmet need,” the EMA noted in an announcement on the recommendation. “There are currently no authorised treatments for NMIBC that does [sic] not respond to BCG.”

Bladder cancer is a serious public health concern in the European Union, ranking as the fifth-most common cancer and the seventh most frequently diagnosed cancer in men.^2,3 The European Association of Urology and World Bladder Cancer Patient Coalition estimate that more than 200,000 patients will be diagnosed with bladder cancer in 2025.⁴ Approximately 75% of these patients (150,000) will have NMIBC, which is cancer that has grown only on the lining of the bladder and not into the muscle layer underneath, and is the most common form of bladder cancer.

“We are looking forward to finalizing plans to bring our innovative treatment to qualified EU patients,” said Richard Adcock, President and CEO of ImmunityBio. “With the United States’ new Most-Favored-Nation Prescription Drug Pricing policy now in effect, we are thoughtfully assessing our approach to launching in Europe to ensure broad, equitable, and sustainable access.”

The decision was based on a review of the results of a single-arm clinical trial in 100 adults with BCG-unresponsive NMIBC who received ANKTIVA in combination with BCG. In 71% of patients, signs of cancer disappeared (complete response rate) with responses ranging up to 54+ months; these responses lasted for approximately 27 months on average. The complete response rate of responders at 12 months was 66% and at 24 months was 42%. As part of the recommendation, ImmunityBio will continue to follow up with trial participants and submit long-term safety and efficacy post-marketing results to the EMA.

“Six BCG strains are available in Europe for use in combination with ANKTIVA, and we are expeditiously developing our recombinant BCG candidate to address ongoing BCG shortages in the U.S. and help ensure that all eligible patients can benefit from this treatment,” said Adcock.

ANKTIVA has been recommended for a conditional marketing authorization, an EU regulatory mechanism designed to facilitate early access to medicines that address an unmet medical need. This pathway allows the EMA to recommend marketing authorization when the benefit of a medicine’s immediate availability to patients outweighs the potential risks associated with the data, in this case, from a single-arm trial. The EMA’s opinion will now be forwarded to the European Commission for final approval of EU-wide marketing authorization.

U.S. IMPORTANT SAFETY INFORMATION

INDICATION AND USAGE: ANKTIVA® is an interleukin-15 (IL-15) receptor agonist indicated with Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.

WARNINGS AND PRECAUTIONS: Risk of Metastatic Bladder Cancer with Delayed Cystectomy. Delaying cystectomy can lead to the development of muscle-invasive or metastatic bladder cancer, which can be lethal. If patients with CIS do not have a complete response to treatment after a second induction course of ANKTIVA® with BCG, reconsider cystectomy.

DOSAGE AND ADMINISTRATION: For Intravesical Use Only. Do not administer by subcutaneous or intravenous routes.

Please see the complete Prescribing Information for ANKTIVA^® at Anktiva.com.

About ImmunityBio

ImmunityBio is a vertically-integrated commercial stage biotechnology company developing next-generation therapies that bolster the natural immune system to defeat cancers and infectious diseases. The Company’s range of immunotherapy and cell therapy platforms, alone and together, act to drive and sustain an immune response with the goal of creating durable and safe protection against disease. Designated an FDA Breakthrough Therapy, ANKTIVA is the first FDA-approved immunotherapy for non-muscle invasive bladder cancer CIS that activates NK cells, T cells, and memory T cells for a long-duration response. The Company is applying its science and platforms to treating cancers, including the development of potential cancer vaccines, as well as developing immunotherapies and cell therapies that we believe sharply reduce or eliminate the need for standard high-dose chemotherapy. These platforms and their associated product candidates are designed to be more effective, accessible, and easily administered than current standards of care in oncology and infectious diseases. For more information, visit ImmunityBio.com (Founder’s Vision) and connect with us on X (Twitter), Facebook, LinkedIn, and Instagram.

1. Guallar-Garrido S. and Julián E. Bacillus Calmette-Guérin (BCG) Therapy for Bladder Cancer: An Update. Immunotargets Ther. 2020 Feb 13;9:1–11. Available at https://pmc.ncbi.nlm.nih.gov/articles/PMC7025668
2. European Association of Urology. EAU Guidelines on Muscle-invasive and Metastatic Bladder Cancer. Limited Update March 2025. Available at https://uroweb.org/guidelines/muscle-invasive-and-metastatic-bladder-cancer/chapter/epidemiology-aetiology-and-pathology
3. European Association of Urology. Bladder Cancer: The Forgotten Cancer. Sep 2022. Available at https://uroweb.org/news/bladder-cancer-the-forgotten-cancer
4. World Bladder Cancer Patient Coalition, EAU. Tackling Bladder Cancer in Europe. February 2025. Available at https://worldbladdercancer.org/wp-content/uploads/2025/03/WBCPC-EAU-Bladder-Cancer-MEP-A4-2025-Digital59.pdf

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, such as statements regarding the European Commission’s recommendation facilitating early access to medicine and the benefits of the immediate availability of ANKTIVA, the development of therapeutics for cancer and infectious diseases, potential benefits to patients, potential treatment outcomes for patients, the described mechanism of action and results and contributions therefrom, the application of the Company’s science and platforms to treat cancers or develop cancer vaccines, immunotherapies and cell therapies that has the potential to change the paradigm in cancer care, the Company’s ability to distribute treatment broadly to patients in the EU, the Company’s follow up with trial participants and the submission of long-term trial results to the EMA, the European Commission’s recommendation of final approval of broader marketing of ANKTIVA^®, the Company’s development of a recombinant Bacillus Calmette-Guérin (BCG) candidate to address BCG shortages to ensure that patients access to treatment, and ImmunityBio’s approved product and investigational agents as compared to existing treatment options, among others. Statements in this press release that are not statements of historical fact are considered forward-looking statements, which are usually identified by the use of words such as “anticipates,” “believes,” “continues,” “goal,” “could,” “estimates,” “scheduled,” “expects,” “intends,” “may,” “plans,” “potential,” “predicts,” “indicate,” “projects,” “is,” “seeks,” “should,” “will,” “strategy,” and variations of such words or similar expressions.

Statements of past performance, efforts, or results of our preclinical and clinical trials, about which inferences or assumptions may be made, can also be forward-looking statements and are not indicative of future performance or results. Forward-looking statements are neither forecasts, promises nor guarantees, and are based on the current beliefs of ImmunityBio’s management as well as assumptions made by and information currently available to ImmunityBio. Such information may be limited or incomplete, and ImmunityBio’s statements should not be read to indicate that it has conducted a thorough inquiry into, or review of, all potentially available relevant information. Such statements reflect the current views of ImmunityBio with respect to future events and are subject to known and unknown risks, including business, regulatory, economic and competitive risks, uncertainties, contingencies and assumptions about ImmunityBio, including, without limitation, (i) risks and uncertainties regarding participation and enrollment and potential results from the clinical trial described herein, (ii) whether clinical trials will result in registrational pathways, (iii) whether clinical trial data will be accepted by regulatory agencies, (iv) the ability of ImmunityBio to fund its ongoing and anticipated clinical trials, (v) the ability of ImmunityBio to continue its planned preclinical and clinical development of its development programs through itself and/or its investigators, and the timing and success of any such continued preclinical and clinical development, patient enrollment and planned regulatory submissions, (vi) potential delays in product availability and regulatory approvals, (vii) ImmunityBio’s ability to retain and hire key personnel, (viii) ImmunityBio’s ability to obtain additional financing to fund its operations and complete the development and commercialization of its various product candidates, (ix) potential product shortages or manufacturing disruptions that may impact the availability and timing of product, (x) ImmunityBio’s ability to successfully commercialize its approved product and product candidates, (xi) ImmunityBio’s ability to scale its manufacturing and commercial supply operations for its approved product and future approved products, and (xii) ImmunityBio’s ability to obtain, maintain, protect, and enforce patent protection and other proprietary rights for its product candidates and technologies. More details about these and other risks that may impact ImmunityBio’s business are described under the heading “Risk Factors” in the Company’s Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on March 3, 2025, and the Company’s Form 10-Q filed with the SEC on November 5, 2025 and in subsequent filings made by ImmunityBio with the SEC, which are available on the SEC’s website at www.sec.gov. ImmunityBio cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date hereof. ImmunityBio does not undertake any duty to update any forward-looking statement or other information in this press release, except to the extent required by law.

Contacts

ImmunityBio Contacts:

Investors
Hemanth Ramaprakash, PhD, MBA
ImmunityBio, Inc.
+1 858-746-9289

Hemanth.Ramaprakash@ImmunityBio.com

Media
Sarah Singleton
ImmunityBio, Inc.
+1 415-290-8045

Sarah.Singleton@ImmunityBio.com

Exact Sciences, the NSABP Foundation, and the German Breast Group Present Results for the Oncodetect® MRD Test in Early Triple-Negative Breast Cancer at SABCS




Exact Sciences, the NSABP Foundation, and the German Breast Group Present Results for the Oncodetect® MRD Test in Early Triple-Negative Breast Cancer at SABCS

New data reveals Oncodetect’s powerful prognostic performance in one of the largest TNBC MRD studies to date¹

MADISON, Wis.–(BUSINESS WIRE)–Exact Sciences Corp. (NASDAQ: EXAS), a leading provider of cancer screening and diagnostic tests, today announced the first clinical study results from its Oncodetect^® molecular residual disease (MRD) test in breast cancer. Findings from the NSABP B-59 substudy, conducted in collaboration with the NSABP Foundation and the German Breast Group (GBG), demonstrated that the Oncodetect test strongly predicts distant recurrence following surgery in patients with early triple-negative breast cancer (TNBC)², one of the most aggressive and difficult-to-treat breast cancer subtypes.³

These data, representing one of the largest TNBC MRD datasets analyzed to date,¹ were presented by Dr. Marija Balic, MD, PhD, scientific director of the NSABP Translational Research Program, at the San Antonio Breast Cancer Symposium (SABCS). The results demonstrate Oncodetect’s ability to help identify patients at higher risk of recurrence and strengthen the growing clinical evidence supporting the test’s role in guiding post-surgical treatment decisions.

The entities intend to submit these data to a peer-reviewed journal for publication, and Exact Sciences will submit the data to MolDx in support of Medicare coverage.

Prognostic performance of the Oncodetect test in early triple-negative breast cancer

In an analysis of 147 patients from the B-59 substudy, post-surgical detection of circulating tumor DNA (ctDNA) was strongly associated with risk of distant recurrence.² Patients who remained ctDNA-positive after neoadjuvant therapy and surgery had substantially higher recurrence risk compared to ctDNA-negative patients.² The key findings include:

• Post-surgery MRD-positive status was associated with a ~30-fold higher risk of distant recurrence compared to those who were MRD-negative.²
• 95% of patients who were MRD negative after surgery remained free of distant recurrence at 3 years.²
• Neo-adjuvant therapy given before surgical resection, which is the standard of care in patients with TNBC, reduced ctDNA positivity in patients from 95% before the start of treatment to 9% after treatment. ²

These data demonstrate that ctDNA detection after surgery is a powerful prognostic indicator of recurrence risk in TNBC and may help identify patients who could benefit from additional adjuvant therapy.

“The NSABP Foundation is proud to collaborate on this impactful study,” said Dr. Norman Wolmark, chairman, NSABP Foundation. “The strength of these data, particularly the clear separation in distant recurrence curves, highlight the prognostic power of ctDNA and its potential to guide post-surgical management strategies for high-risk breast cancer.”

Inside the NSABP B-59 study

In partnership with the NSABP Foundation, the Oncodetect substudy was conducted within the NSABP-B-59/GBG-96-GeparDouze trial, which enrolled patients with TNBC receiving neoadjuvant therapy with or without atezolizumab. Blood samples were collected before treatment and after surgery to evaluate whether ctDNA positivity at the post-surgery timepoint was associated with distant recurrence-free interval, with a median follow-up of 37 months. Exact Sciences is also collaborating with the NSABP Foundation on NSABP B-64, a large prospective registry trial enrolling 1,800 participants across all breast cancer subtypes.

“This is an important milestone for our Oncodetect program and for patients facing aggressive breast cancers like TNBC,” said Dr. Rick Baehner, senior vice president, chief medical officer, Precision Oncology at Exact Sciences. “These data demonstrate how ctDNA testing can provide critical insights into recurrence risk and more precisely help inform treatment decisions.”

References

1. Data source on file. Accessed November 25, 2025.
2. Balic, Marija, Geyer, Charles Jr. et. al. Evaluation of a whole-exome sequencing tumor-informed circulating tumor DNA MRD assay in patients with early triple-negative breast cancer receiving neoadjuvant chemotherapy with or without atezolizumab: A substudy of the NSABP-B-59/GBG-96-GeparDouze Trial. Presented at: San Antonio Breast Cancer Symposium (SABCS): December 11, 2025; San Antonio, TX.
3. Obidiro O, Battogtokh G, Akala EO. Triple Negative Breast Cancer Treatment Options and Limitations: Future Outlook. Pharmaceutics. 2023 Jun 23;15(7):1796. doi: 10.3390/pharmaceutics15071796. PMID: 37513983; PMCID: PMC10384267.

About Exact Sciences

A leading provider of cancer screening and diagnostic tests, Exact Sciences (Nasdaq: EXAS) helps patients and health care providers make timely, informed decisions before, during, and after a cancer diagnosis. The company’s growing portfolio includes well-established brands such as Cologuard^® and Oncotype DX^®, along with innovative solutions like the Cancerguard^® test for multi-cancer early detection and the Oncodetect^® test for molecular residual disease and recurrence monitoring. Exact Sciences continues to invest in a robust pipeline of advanced cancer diagnostics aimed at improving outcomes. For more information, visit ExactSciences.com, follow @ExactSciences on X, or connect on LinkedIn and Facebook.

Oncodetect and Oncotype DX are trademarks of Genomic Health, Inc., a wholly owned subsidiary of Exact Sciences. Cologuard and Exact Sciences are trademarks of Exact Sciences Corporation. Oncodetect is only available in the United States.

About NSABP Foundation

The NSABP Foundation designs and conducts clinical trials to improve the care of people with breast or colorectal cancer. The Foundation manages more than 700 sites that enroll patients into clinical trials. Founded in 1958 as the legacy National Surgical Adjuvant Breast and Bowel Project (NSABP), the goal is to identify and achieve opportunities for enhanced diagnostics, more precise and less debilitating treatments, and develop clinical strategies for the prevention of cancer for those who are at risk. To learn more and to support the mission, please visit www.NSABP.org.

Forward-Looking Statement

This news release contains forward-looking statements concerning our expectations, anticipations, intentions, beliefs, or strategies regarding the future. These forward-looking statements are based on assumptions that we have made as of the date hereof and are subject to known and unknown risks and uncertainties that could cause actual results, conditions, and events to differ materially from those anticipated. Therefore, you should not place undue reliance on forward-looking statements. Risks and uncertainties that may affect our forward-looking statements are described in the Risk Factors sections of our most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q, and in our other reports filed with the Securities and Exchange Commission. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments, or otherwise.

Contacts

Media Contact
Lisa Warshaw

+1 323-360-8778

lwarshaw@exactsciences.com

Investor Contact
Derek Leckow

+1 608-893-0009

investorrelations@exactsciences.com

Phase III PALLAS Study Shows Signatera™ MRD Testing Provides Powerful Post‑Surgical Prognostic Information in Patients with High and Intermediate Risk HR+/HER2‑ Breast Cancer




Phase III PALLAS Study Shows Signatera™ MRD Testing Provides Powerful Post‑Surgical Prognostic Information in Patients with High and Intermediate Risk HR+/HER2‑ Breast Cancer

MRD status after surgery stratifies patients beyond established clinical and genomic risk tools

AUSTIN, Texas–(BUSINESS WIRE)–Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, together with Alliance Foundation Trials, LLC (AFT) and the Austrian Breast and Colorectal Cancer Study Group (ABCSG), today announced initial translational research results from the international randomized Phase III PALLAS study.

Presented today at the San Antonio Breast Cancer Symposium (SABCS), these first data, generated from a U.S. biomarker cohort of 420 patients, show that molecular residual disease (MRD) status, measured by the Signatera Genome test after surgery (and adjuvant chemotherapy +/- radiation if administered), is a highly prognostic biomarker for distant recurrence risk in stage II–III, HR+/HER2- breast cancer. The findings support Natera’s strategy to integrate MRD testing into routine post‑surgical risk assessment, enabling a more personalized approach to managing early-stage HR+ breast cancer. Data from a parallel ex-US cohort will be presented in conjunction with a treatment subgroup analysis at a later date.

In PALLAS, patients with stage II–III HR+/HER2- breast cancer were randomized to receive two years of palbociclib, a CDK4/6 inhibitor, in combination with endocrine therapy. Signatera MRD assessments were performed after surgery at three key postoperative timepoints: on the first day of protocol-directed experimental therapy (baseline), on-treatment at approximately 6 months (C6D1), and at the end of the 2-year interventional treatment period (EOT). Key findings from this initial analysis include:

Signatera correctly identified patients with low risk of recurrence.

• At baseline, approximately 92% of patients were MRD-negative and had excellent outcomes, with 5-year distant recurrence-free interval (DRFI) of 93%. Measured starting at EOT, MRD-negative patients had a 5-year DRFI of 95%. This underscored that MRD-negativity after surgery and adjuvant endocrine therapy is associated with an exceptionally low risk of distant recurrence.

MRD-positive patients had very poor outcomes with current therapy.

• Baseline MRD positivity was observed in roughly 8% of this stage II–III HR+/HER2- population. These patients had 5-year DRFI of 28%, corresponding to a markedly elevated hazard of distant recurrence compared with MRD-negative patients (hazard ratio [HR] ~15). At the end of protocol-directed therapy, MRD-positive patients had a 5-year DRFI of 32%, with hazard ratios exceeding 20 versus MRD-negative patients.

There was strong prognostic value across all postoperative timepoints tested in the analysis.

• Signatera ctDNA status at baseline, C6D1 and EOT was consistently and strongly associated with distant recurrence risk, even when accounting for clinical and pathologic features. Across these timepoints, MRD-positive patients had hazard ratios well into the double digits (13.4-21.5) compared with MRD-negative patients, demonstrating much larger risk separation than is typically seen with individual clinicopathologic factors alone.

“ctDNA has emerged as one of the most promising biomarkers in early-stage breast cancer, and the TransPALLAS collaboration gives us a uniquely powerful opportunity to study ctDNA in the adjuvant setting,” said Heather Parsons, M.D., MPH, first author, Trans-PALLAS member, and associate professor of the clinical research division and program head of the breast oncology program at Fred Hutch Cancer Center. “We are excited to share these findings with the breast oncology community and advance a better understanding of recurrence risk for patients with HR+/HER2- disease.”

“The results from this preplanned analysis of the PALLAS trial support Natera’s vision for individualizing the management of early-stage HR+/HER2- breast cancer,” said Minetta Liu, M.D., chief medical officer of oncology and early cancer detection at Natera. “Implementation of longitudinal post-surgical ctDNA testing with Signatera advances us beyond a one‑size‑fits‑all management approach based solely on initial tumor characteristics. Instead, we can start to imagine treatment algorithms where ctDNA-negative patients are spared unnecessary treatment with related toxicity, and ctDNA-positive patients are prioritized for more intensive or novel therapies. It’s a fundamental shift toward truly MRD‑informed care.”

About the PALLAS Trial

PALbociclib CoLlaborative Adjuvant Study (PALLAS) (NCT02513394) is a randomized (1:1), prospective, international, multicenter, open-label Phase 3 study comparing the combination of palbociclib in combination with endocrine therapy (ET) versus ET alone for adults with HR+, HER2- Stage II and Stage III EBC, including those at moderate to high risk of recurrence. MRD detection via ctDNA testing was a predefined biomarker analysis to identify patients at highest risk of recurrence. The previously reported trial which did not include MRD analysis, co-sponsored by the ABCSG and the AFT as part of a clinical research collaboration with Pfizer, Breast International Group (BIG), German Breast Group (GBG), National Surgical Adjuvant Breast and Bowel Project (NSABP), and PrECOG, LLC (PrECOG), did not meet its primary endpoint, showing no benefit of palbociclib plus endocrine therapy in the adjuvant setting in patients with histologically confirmed HR+/HER2- invasive EBC. Palbociclib is not approved in EBC.

About Natera

Natera™ is a global leader in cell-free DNA and precision medicine, dedicated to oncology, women’s health, and organ health. We aim to make personalized genetic testing and diagnostics part of the standard-of-care to protect health and inform earlier, more targeted interventions that help lead to longer, healthier lives. Natera’s tests are supported by more than 325 peer-reviewed publications that demonstrate excellent performance. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas, and San Carlos, California, and through Foresight Diagnostics, its subsidiary, operates an ISO 27001-certified and CAP-accredited laboratory certified under CLIA in Boulder, Colorado. For more information, visit www.natera.com.

Forward-Looking Statements

All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that Natera’s plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera’s expectations as of the date of this press release, and Natera disclaims any obligation to update the forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to whether the results of clinical or other studies will support the use of our product offerings, the impact of results of such studies, our expectations of the reliability, accuracy and performance of our tests, or of the benefits of our tests and product offerings to patients, providers and payers. Additional risks and uncertainties are discussed in greater detail in “Risk Factors” in Natera’s recent filings on Forms 10-K and 10-Q and in other filings Natera makes with the SEC from time to time. These documents are available at www.natera.com/investors and www.sec.gov.

Contacts

Investor Relations: Mike Brophy, CFO, Natera, Inc., investor@natera.com
Media: Lesley Bogdanow, VP of Corporate Communications, Natera, Inc., pr@natera.com

Bristol Myers Squibb Announces Dividend Increase




Bristol Myers Squibb Announces Dividend Increase

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol Myers Squibb (NYSE: BMY) today announced that its Board of Directors has declared a quarterly dividend of sixty-three cents ($0.63) per share on the $0.10 par value common stock of the company. The dividend is payable on February 2, 2026, to stockholders of record at the close of business on January 2, 2026.

This quarterly dividend represents a 1.6% increase over last year’s quarterly rate of sixty-two cents ($0.62) per share. At this quarterly dividend rate, subject to the normal quarterly review by the Board of Directors, the annual dividend rate for the fiscal year 2026 is $2.52 per share. This marks the 17^th consecutive year that the company has increased its dividend and the 94^th consecutive year that the company has paid a dividend.

In addition, the Board of Directors has declared a quarterly dividend of fifty cents ($0.50) per share on the company’s $2.00 convertible preferred stock, payable on March 2, 2026, to stockholders of record at the close of business on February 3, 2026.

About Bristol Myers Squibb: Transforming Patients’ Lives Through Science

At Bristol Myers Squibb, our mission is to discover, develop, and deliver innovative medicines that help patients prevail over serious diseases. We are pursuing bold science to define what’s possible for the future of medicine and the patients we serve. For more information about Bristol Myers Squibb, visit us at BMS.com and follow us on LinkedIn, X, YouTube, Facebook, and Instagram.

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Contacts

Media Relations:
media@bms.com

Investor Relations:
investor.relations@bms.com

Quince Therapeutics Announces Publication of Use of eDSP in Early-Stage Clinical Studies in Pulmonary and Inflammatory Bowel Disorders




Quince Therapeutics Announces Publication of Use of eDSP in Early-Stage Clinical Studies in Pulmonary and Inflammatory Bowel Disorders

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–$QNCX #biotech–Quince Therapeutics, Inc. (Nasdaq: QNCX), a late-stage biotechnology company dedicated to unlocking the power of a patient’s own biology for the treatment of rare diseases, announced the publication of a summary of early-stage clinical studies of its Phase 3 lead asset, eDSP (dexamethasone sodium phosphate [DSP] encapsulated in a patient’s own red blood cells), in pulmonary and inflammatory bowel disorders (IBD) in the scientific journal Frontiers in Drug Delivery.

Dirk Thye, M.D., Quince’s Chief Executive Officer and Chief Medical Officer, said, “This new Frontiers in Drug Delivery publication highlights the potential for clinical utility of our lead asset, eDSP, across pulmonary and IBD indications. The purpose of these prior studies was to demonstrate that eDSP can be delivered at efficacious doses while avoiding the frequent and debilitating common toxicities associated with chronic corticosteroid therapy. Importantly, it also speaks to the potential of eDSP to transform treatment paradigms across multiple diseases where chronic corticosteroid treatment is – or has the potential to become – the standard of care. As we rapidly approach topline results in the middle of the first quarter of 2026 for our Phase 3 NEAT study of eDSP in Ataxia-Telangiectasia (A-T), we believe these data further underscore not only the ability of eDSP to deliver corticosteroid efficacy without toxicities, but also highlight the significant pipeline expansion opportunities that lie ahead of Quince, assuming positive NEAT results.”

Frontiers in Drug Delivery Publication Highlights

The Frontiers in Drug Delivery publication entitled Use of Encapsulated Dexamethasone Sodium Phosphate (eDSP) in Chronic Obstructive Pulmonary Disease, Cystic Fibrosis, and Inflammatory Bowel Disorders summarizes early-stage studies of eDSP conducted across eight clinical trials in patients with pulmonary and IBD.

Highlights include:

• Broad application of eDSP across multiple disease indications: Early-stage clinical studies investigated eDSP in patients, whose age ranged from five to 83 years, with chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF), Crohn’s disease (CD), and ulcerative colitis (UC). DSP was loaded into autologous erythrocytes ex vivo and reinfused every two weeks or monthly with follow-ups that ranged from one to 24 months.
• Encouraging results in pulmonary and IBD: eDSP resulted in improved FEV1 and reduced infections in CF patients and improved symptoms in COPD with markedly reduced corticosteroid doses. In IBD, eDSP at low doses enabled corticosteroid withdrawal in 60% to 78% of patients and achieved remission in pediatric and adult CD and UC. Importantly, adverse toxicity effects typical of corticosteroids were notably absent while pharmacokinetic studies documented persistence of DSP levels up to 28 days post-infusion. Notably, the mean dose used in these early trials did not exceed 10 mg of eDSP per infusion suggesting that glucocorticoid receptor occupation could be achieved with a low eDSP dose.
• eDSP feasibility and tolerability across wide age range: Early studies demonstrate that eDSP is a feasible and well-tolerated treatment in children and older patients, delivering low-dose corticosteroids with prolonged therapeutic levels. These findings support further development of erythrocyte-based drug delivery for chronic inflammatory diseases in patients with corticosteroid-sensitive or corticosteroid-dependent disease.

About eDSP

eDSP is comprised of dexamethasone sodium phosphate (DSP) encapsulated in a patient’s own red blood cells (autologous erythrocytes). DSP is a corticosteroid well known for its anti-inflammatory properties as well as its dose-limiting toxicity due to adrenal suppression. The eDSP System is designed to provide the efficacy of corticosteroids and to reduce or eliminate the significant adverse effects that accompany chronic use of corticosteroid treatment.

eDSP leverages Quince’s proprietary Autologous Intracellular Drug Encapsulation, or AIDE, technology platform, which is a novel drug/device combination that uses an automated process designed to encapsulate a drug into the patient’s own red blood cells. Red blood cells have several characteristics that make them a potentially effective vehicle for drug delivery, including potentially better tolerability, enhanced tissue distribution, reduced immunogenicity, and prolongation of circulating half-life. Quince’s AIDE technology is designed to harness these benefits to allow for the chronic administration of drugs that have limitations due to toxicity, poor biodistribution, suboptimal pharmacokinetics, or immune response.

Currently, Quince is advancing its pivotal Phase 3 NEAT (Neurological Effects of eDSP in Subjects with A–T; NCT06193200/IEDAT-04-2022) clinical trial of eDSP in patients with Ataxia-Telangiectasia (A-T). a rare inherited autosomal recessive neurodegenerative and immunodeficiency disorder. The NEAT study is an international, multicenter, randomized, double-blind, placebo-controlled clinical trial to evaluate the neurological effects of eDSP in patients with A-T. This study consists of two cohorts randomized (1:1) between eDSP or placebo and treatment includes six infusions scheduled once every 21 to 30 days. The primary efficacy endpoint will be measured by the change from baseline to last efficacy visit using the Rescored modified International Cooperative Ataxia Rating Scale (RmICARS) compared to placebo.

The company expects to report topline results from its Phase 3 NEAT clinical trial in the middle of the first quarter of 2026.

About Quince Therapeutics

Quince Therapeutics, Inc. (Nasdaq: QNCX) is a late-stage biotechnology company dedicated to unlocking the power of a patient’s own biology for the treatment of rare diseases. For more information on the company and its latest news, visit www.quincetx.com and follow Quince on social media platforms LinkedIn, Facebook, X, and YouTube.

Forward-looking Statements

Statements in this news release contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 as contained in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to the “safe harbor” created by those sections. All statements, other than statements of historical facts, may be forward-looking statements. Forward-looking statements contained in this news release may be identified by the use of words such as “believe,” “may,” “should,” “expect,” “anticipate,” “plan,” “believe,” “estimated,” “potential,” “intend,” “will,” “can,” “seek,” or other similar words. Examples of forward-looking statements include, among others, statements relating to the timing, success, and reporting of results of the clinical trials and related data, including expected timing and outcome of Phase 3 NEAT topline results; ; current and future clinical development of eDSP, including for the potential treatment of Ataxia-Telangiectasia (A-T), Duchenne muscular dystrophy (DMD), pulmonary and inflammatory bowel disorders, and other potential indications; planned regulatory agency submissions and clinical trials and timeline, prospects, and milestone expectations; and potential benefits of eDSP and the company’s market opportunity. Forward-looking statements are based on Quince’s current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict and could cause actual results to differ materially from what the company expects. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Factors that could cause actual results to differ include, but are not limited to, the risks and uncertainties described in the section titled “Risk Factors” in the company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 24, 2025, Quarterly Report on Form 10-Q filed with the SEC on November 12, 2025, and other reports as filed with the SEC. Forward-looking statements contained in this news release are made as of this date, and Quince undertakes no duty to update such information except as required under applicable law.

Contacts

Media & Investor Contact:
Stacy Roughan

Quince Therapeutics, Inc.

Vice President, Corporate Communications & Investor Relations

ir@quincetx.com

Curebound Awards $8.5 Million for 23 Cancer Research Studies, Including $1 Million Cure Prize




Curebound Awards $8.5 Million for 23 Cancer Research Studies, Including $1 Million Cure Prize

Philanthropic organization has awarded $51.5 million in cancer research grants to date with one vision: cures in our lifetime.

SAN DIEGO–(BUSINESS WIRE)–#AI—Curebound, a philanthropic organization that fundraises for and invests in innovative cancer research, today announced it has awarded 23 new grants totaling $8.5 million, including a $1 million Cure Prize, to advance promising cancer research programs.

Curebound’s Scientific Advisory Board, together with more than 100 scientific peer reviewers across the nation, evaluated hundreds of applications for Curebound grant programs – Catalyst, Discovery, Equity, Targeted Grants and Cure Prize – across key research pillars, including:

• Cancer Risk Detection
• Novel Approaches + Therapeutics
• Personalized Immunotherapy
• Cancer Community Equities
• Childhood Cancers

“Curebound identified these recipients based on their scientific strengths and ability to translate research breakthroughs into life-saving treatments quickly. We are grateful to the scientists nationwide who volunteered to evaluate hundreds of grant applications to select these 23 exciting cancer studies,” said Curebound Chief Science Advisor Ezra Cohen, MD, FRCPSC, FASCO.

2025 Curebound $1 Million Cure Prize

The Curebound Cure Prize is awarded for groundbreaking, collaborative and translational cancer research with near-term clinical application.

• Ludmil Alexandrov, PhD, UC San Diego; Diane Simeone, MD, UC San Diego; Adam Yala, PhD, UC Berkely; Karandeep Singh, MD, UC San Diego – Multi-modal artificial intelligence framework for early detection of pancreatic cancer

2025 Targeted Grant Recipients

Curebound Targeted Grants provide $500,000 each to research projects that are closer to clinical stages. Interdisciplinary collaboration is required to qualify and to ensure each project is geared toward translational application.

• David Cheresh, PhD, UC San Diego; Andrew Lowy, MD, UC San Diego – A human bispecific antibody to target pancreatic cancer stroma
• Steven Olson, Sanford Burnham Prebys; Dan Theodorescu, MD, PhD, University of Arizona – Discovery of NPEPPS inhibitors for the treatment of muscle-invasive bladder cancer
• Ronald Evans, PhD, The Salk Institute; Herve Tiriac, PhD, UC San Diego; Jonathan Weitz, PhD, UC San Diego; Scott Kopetz, MD, PhD, University of Texas MD Anderson – Intercepting colorectal cancer growth and therapeutic resistance through inhibition of protein fatty acid diacylation
• Rebecca Rakow-Penner, MD, PhD, UC San Diego; Christopher Millan, PhD, Beken Bio; Jingjing Zou, PhD, UC San Diego; Michael McHale, MD, UC San Diego – Ovarian cancer comprehensive screening and risk assessment with extracellular vesicle circulating blood tumor marker and MRI
• Fleur Ferguson, PhD, UC San Diego; Andrew Lowy, MD, UC San Diego; Anne Bang, PhD, Sanford Burnham Prebys; Eric Wang, PhD, Sanford Burnham Prebys; Jeremiah Momper, PhD, UC San Diego; Uri Manor, PhD, UC San Diego – Overcoming K-ras inhibitor resistance in PDAC
• Andrew Lowy, MD, UC San Diego; Yuan Chen, PhD, UC San Diego – SUMO Inhibition and Irinotecan: A Novel Synergistic Combination for Pancreatic Cancer Therapy
• Sumit K. Chanda, PhD, Scripps Research; Nikunj Shukla, UC San Diego; Sunnie Yoh, PhD, Scripps Research – Targeted immunopotentiation of neoantigen vaccines using innate immune agonists
• Charles Spruck, PhD, Sanford Burnham Prebys; Angela Liou, MD, Sanford Burnham Prebys; Eduard Sergienko, Sanford Burnham Prebys; Jon Covel, PhD, Sanford Burnham Prebys – Therapeutic targeting of immunomodulator FBXO44 in cancer

2025 Discovery Grant Recipients

Curebound Discovery Grants are one-time seed grants of $250,000 for early-phase studies that require interinstitutional collaboration and have the potential to open new frontiers in cancer science.

• Kelly Kersten, PhD, Sanford Burnham Prebys; Christina Towers, PhD, The Salk Institute – Elucidating how tumor mitochondrial transfer affects macrophage function in cancer
• Mitchell Kronenberg, PhD, La Jolla Institute for Immunology; Anusha Ganesan, MD, PhD, Rady Children’s Hospital; Hilde Cheroutre, PhD, La Jolla Institute for Immunology; Kyu Hye Chun, PhD, UC San Diego and La Jolla Institute for Immunology; Nicolas Thiault, PhD, La Jolla Institute for Immunology – Enlisting cytotoxic CD4+ T cells to fight childhood cancers
• Maximiliano A. D’Angelo, PhD, Sanford Burnham Prebys; Hatim Husain, MD, UC San Diego; Susanne Heyen-Genel, PhD, Sanford Burnham Prebys – Modulating Nup37 for novel cancer therapies
• Ronald Evans, PhD, The Salk Institute, Dannielle Engle, PhD, The Salk Institute; Herve Tiriac, PhD, UC San Diego – Overcoming stromal barriers to KRAS inhibition in pancreatic cancer with VDR agonist therapy
• Tony Hunter, PhD, The Salk Institute; Herve Tiriac, PhD, UC San Diego; Jonathan Weitz, PhD, UC San Diego; Yuan Sui, PhD, The Salk Institute – Perturbing the OSM-OSMR signaling axis in pancreatic ductal adenocarcinoma (PDA)
• Xueqin Sun, PhD, Sanford Burnham Prebys; Eduard Sergienko, PhD, Sanford Burnham Prebys; Frank Furnari, PhD, UC San Diego – Targeting a novel epigenetic vulnerability in glioblastoma
• Frank Furnari, PhD, UC San Diego; Raghavendra Vadla, PhD, UC San Diego; Susan Kaech, PhD, The Salk Institute – Targeting BRD2 to block therapy-induced reprogramming and immune evasion in glioblastoma
• Lukas Chavez, PhD, Sanford Burnham Prebys; Megan Paul, MD, Rady Children’s Hospital; Susanne Heyen-Genel, PhD, Sanford Burnham Prebys – Targeting ecDNA in high-risk medulloblastoma: A high-throughput assay to discover novel therapeutic probes
• Andrew Lowy, MD, UC San Diego; Herve Tiriac, PhD, UC San Diego; Ian Pass, PhD, Sanford Burnham Prebys – Targeting MICAL2 for pancreatic cancer therapy
• Robert Signer, PhD, UC San Diego; Helena Yu, MD, UC San Diego – The role of proteostasis pathways in pediatric leukemia

2025 Catalyst Grant Recipient

Curebound Catalyst Grants provide $250,000 of non-dilutive funding for early-stage companies to conduct research that addresses critical challenges in cancer prevention, detection or treatment and demonstrates opportunity to advance swiftly to the clinic.

• Michael Kelner, MD, Illudent, Inc.; Sean Uryu, Illudent; Venkata Kotaraju, Illudent – Illudent Therapeutics: Precision small-molecule targeting cancers deficient in nucleotide-excision repair

2025 Equity Grant Recipients

Curebound Equity Grants of $250,000 fund a broad range of research focused on advancing cancer care in medically underrepresented and underserved communities, with the goal of improving access, outcomes and equity.

• Brent Rose, MD, UC San Diego; Corinne McDaniels-Davidson, PhD, San Diego State; Edmund Qiao, MD, UC San Diego; Matthew Banegas, PhD; UC San Diego; Michelle Johnson, MD; UC San Diego – Addressing cancer disparities through pre-diagnostic care: A SEER-Medicare analysis of prostate, breast, and colorectal cancer
• Joshua Demb, PhD, UC San Diego; Linda Lara-Jacobo, PhD, San Diego State; Nicolas Lopez-Galvez, PhD, San Diego State – Promotora-led cancer prevention in the fields: Linking environmental pollutants and GI cancer risk in Imperial Valley
• Sharon Choi, MD, PhD, UC San Diego; Humberto Prada, PhD, San Diego State; Noe Crespo, PhD, San Diego State; Rana McKay, MD, UC San Diego – Structured exercise and nutritional guidance in Hispanic/Latino men with prostate cancer: A pilot study of SALUD-PC

“This $8.5 million in funding will support diverse, innovative and highly promising cancer research efforts,” said Curebound CEO Anne Marbarger. “None of this would be possible without our committed donors and the incredible scientific advisors who volunteer their time to rigorously review and select the studies Curebound funds. We’re proud to support these talented scientists and research teams and look forward to the progress their work will bring for people living with cancer.”

To see the completed list of 2025 Curebound research grant recipients click here. To learn more about donating, visit www.curebound.org/get-involved. To apply for Curebound funding, visit www.curebound.org/what-we-do.

About Curebound

Curebound fundraises for and invests in cancer research with the power to save lives. Through collaborative grants, corporate partnerships, and strategic investments, Curebound accelerates better prevention, detection, and treatments for cancer. Headquartered in the major U.S. biotech hub of San Diego, amid 3,000+ life sciences companies, leading health systems, and world-class research institutions, Curebound partners with these organizations to forge interdisciplinary collaboration, foster knowledge sharing, and fund pioneering cancer research. So far, Curebound has funded $51.5 million in cancer research, awarding 170 study grants for 23 types of pediatric and adult cancers. This work has resulted in 30 expanded clinical trials reaching 1,864 patients and has spurred $161 million in follow-on funding for Curebound-supported investigators. Cancer is relentless – so is Curebound. Join us at www.curebound.org.

Contacts

Media Contact:

Hilary McCarthy

774.364.1440

Hilary@clearpointagency.com

IVD Raw Materials Industry Presents $35.8 Billion Valuation by 2030 – Expansion of POC and Home Diagnostics Strengthens Need for High-Quality Antibodies, Antigens, and Buffers – ResearchAndMarkets.com




IVD Raw Materials Industry Presents $35.8 Billion Valuation by 2030 – Expansion of POC and Home Diagnostics Strengthens Need for High-Quality Antibodies, Antigens, and Buffers – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “IVD Raw Materials – Global Strategic Business Report” has been added to ResearchAndMarkets.com’s offering.

The global market for IVD Raw Materials was valued at US$27.7 Billion in 2024 and is projected to reach US$35.8 Billion by 2030, growing at a CAGR of 4.3% from 2024 to 2030. This comprehensive report provides an in-depth analysis of market trends, drivers, and forecasts, helping you make informed business decisions.

Growth in the IVD raw materials market is driven by several factors including rising global demand for diagnostic testing, increasing complexity of assay formats, and heightened regulatory scrutiny of material quality. Advances in recombinant production, synthetic chemistry, and expression systems are enabling reliable, scalable supply of high-performance components.

End-use expansion in molecular diagnostics, infectious disease testing, and personalized medicine is creating recurring demand for highly specific and stable raw materials. Emergence of new pathogens, focus on decentralized testing, and growing investment in lab infrastructure are further boosting usage. As diagnostics become central to preventive and precision medicine, the need for high-quality IVD raw materials continues to grow in both established and emerging healthcare markets.

Scope of the Report

The report analyzes the IVD Raw Materials market, presented in terms of market value (USD). The analysis covers the key segments and geographic regions outlined below:

• Segments: Product (IVD Antibody & Antigens, IVD Enzymes, IVD Proteins, IVD Biological Buffers, Other Products); Technology (Clinical Chemistry Technology, Immunochemistry Technology, Molecular Diagnostics Technology, Other Technologies); End-Use (Pharma & Biotech Companies End-Use, Diagnostic Laboratories End-Use, Other End-Uses).
• Geographic Regions/Countries: World; United States; Canada; Japan; China; Europe (France; Germany; Italy; United Kingdom; Spain; Russia; and Rest of Europe); Asia-Pacific (Australia; India; South Korea; and Rest of Asia-Pacific); Latin America (Argentina; Brazil; Mexico; and Rest of Latin America); Middle East (Iran; Israel; Saudi Arabia; United Arab Emirates; and Rest of Middle East); and Africa.

Key Insights:

• Market Growth: Understand the significant growth trajectory of the IVD Antibody & Antigens segment, which is expected to reach US$13.0 Billion by 2030 with a CAGR of a 3.8%. The IVD Enzymes segment is also set to grow at 5.0% CAGR over the analysis period.
• Regional Analysis: Gain insights into the U.S. market, valued at $7.6 Billion in 2024, and China, forecasted to grow at an impressive 7.8% CAGR to reach $7.3 Billion by 2030. Discover growth trends in other key regions, including Japan, Canada, Germany, and the Asia-Pacific.

Key Questions Answered:

• How is the Global IVD Raw Materials Market expected to evolve by 2030?
• What are the main drivers and restraints affecting the market?
• Which market segments will grow the most over the forecast period?
• How will market shares for different regions and segments change by 2030?
• Who are the leading players in the market, and what are their prospects?

Report Features:

• Comprehensive Market Data: Independent analysis of annual sales and market forecasts in US$ Million from 2024 to 2030.
• In-Depth Regional Analysis: Detailed insights into key markets, including the U.S., China, Japan, Canada, Europe, Asia-Pacific, Latin America, Middle East, and Africa.
• Company Profiles: Coverage of players such as Aalto Bio Reagents Ltd., AMSBIO (AMS Biotechnology), BBI Solutions, Bio-Rad Laboratories, Inc., Bio-Check (UK) Ltd and more.
• Complimentary Updates: Receive free report updates for one year to keep you informed of the latest market developments.

Some of the 39 companies featured in this IVD Raw Materials market report include:

• Aalto Bio Reagents Ltd.
• AMSBIO (AMS Biotechnology)
• BBI Solutions
• Bio-Rad Laboratories, Inc.
• Bio-Check (UK) Ltd
• Bioporto Diagnostics
• Diarect AG
• EastCoast Bio
• Fitzgerald Industries Intl.
• Fujirebio
• HyTest Ltd
• Jena Bioscience GmbH
• Medix Biochemica
• Meridian Bioscience, Inc.
• MyBiosource, Inc.
• QuidelOrtho Corporation
• RayBiotech, Inc.
• Rockland Immunochemicals, Inc.
• Scripps Laboratories, Inc.
• Sekisui Diagnostics

Key Attributes

Market Overview

• Influencer Market Insights
• World Market Trajectories
• Tariff Impact on Global Supply Chain Patterns
• IVD Raw Materials – Global Key Competitors Percentage Market Share in 2025 (E)
• Competitive Market Presence – Strong/Active/Niche/Trivial for Players Worldwide in 2025 (E)

Market Trends & Drivers

• Rising Demand for In Vitro Diagnostics Across Infectious Disease, Cancer, and Genetic Testing Drives Consumption of Raw Materials
• Expansion of Point-of-Care and Home Diagnostics Strengthens Need for High-Quality Antibodies, Antigens, and Buffers
• OEM Focus on Recombinant Protein Engineering and Monoclonal Antibody Production Enhances Specificity and Stability
• Growth in Molecular Diagnostics and PCR-Based Assays Throws Spotlight on High-Fidelity Enzymes and Primers
• Increasing Emphasis on Supply Chain Resilience and Material Traceability Supports Strategic Sourcing of IVD Inputs
• OEM Investment in GMP-Compliant Raw Material Manufacturing Improves Quality Assurance for Diagnostic Kit Producers
• Rising Adoption of Multiplex Assays and Rapid Diagnostic Tests Fuels Need for Custom Coating and Blocking Reagents
• OEM Development of Bulk Supply Agreements With Test Kit Manufacturers Enhances Scalability and Delivery Reliability
• Growth in Companion Diagnostics and Personalized Medicine Expands Use of Specialized Biomarker Reagents
• OEM Innovation in Lyophilized and Room-Temperature Stable Raw Materials Supports Distribution in Low-Resource Settings

For more information about this report visit https://www.researchandmarkets.com/r/uevenz

About ResearchAndMarkets.com

ResearchAndMarkets.com is the world’s leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

Contacts

ResearchAndMarkets.com

Laura Wood, Senior Press Manager

press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470

For U.S./ CAN Toll Free Call 1-800-526-8630

For GMT Office Hours Call +353-1-416-8900

Cocaine Use Disorder Market Analysis, Trends and Outlook 2025-2032 by Treatment Modality, Treatment Setting, Indication, Diagnostic Tests and Region – ResearchAndMarkets.com




Cocaine Use Disorder Market Analysis, Trends and Outlook 2025-2032 by Treatment Modality, Treatment Setting, Indication, Diagnostic Tests and Region – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “Cocaine Use Disorder Market – Global Forecast 2025-2032” has been added to ResearchAndMarkets.com’s offering.

The Cocaine Use Disorder Market is experiencing substantial growth, expanding from USD 1.29 billion in 2024 to USD 1.36 billion in 2025, with projections indicating a CAGR of 5.82% reaching USD 2.03 billion by 2032. This comprehensive market research study sheds light on the evolving dynamics and strategic imperatives within the cocaine use disorder treatment landscape. The report provides essential insights for stakeholders navigating the complexities of treatment modalities, regulatory shifts, and external forces affecting patient outcomes since the late twentieth century.

Transformative Shifts in Treatment Innovation

Recent advances in neurobiological research and digital therapeutics have catalyzed a paradigm shift in treating cocaine use disorder, emphasizing personalized medicine and innovative care models. Regulatory agencies have adopted more adaptive frameworks, enabling expedited implementation of novel therapies. For decision-makers, these advancements present opportunities for strategic planning and capturing competitive advantages through emerging technologies.

Telehealth platforms and mobile solutions have further expanded the reach of behavioral therapies, generating real-world data to refine treatment algorithms. Such integrative approaches underscore the market’s progression toward sustainable outcomes.

Key Takeaways from This Report

• Identifies high-impact opportunities for decision-makers within the cocaine use disorder treatment market.
• Offers insights into emerging trends and innovative care models driving sustainable patient outcomes.
• Highlights the importance of strategic partnerships and regional diversification in mitigating tariff impacts.
• Provides direction for leveraging supply chain resilience and data-driven execution in market strategies.

Market Segmentation & Coverage

The report forecasts revenues and analyzes trends in segmentation by treatment modality, setting, indication, diagnostic testing, payer type, provider network, and regional dynamics. The following detailed breakdowns are examined:

• Treatment Modality
  • Behavioral Therapy
    • Cognitive Behavioral Therapy
    • Contingency Management
    • Motivational Interviewing
  • Combined Therapy
    • Integrated Programs
    • Sequential Programs
  • Pharmacotherapy
    • Antidepressants
      • Selective Serotonin Reuptake Inhibitors
      • Serotonin-Norepinephrine Reuptake Inhibitors
    • Psychostimulants
• Treatment Setting
  • Inpatient
    • Detoxification
    • Residential Rehabilitation
  • Outpatient
• Indication
  • Acute
  • Chronic
• Diagnostic Tests
  • Cardiovascular Examination
  • Neurologic Examination
  • Urine Toxicology Examination

Key Attributes

The companies profiled in this Cocaine Use Disorder market report include:

• Alkermes PLC
• Alnylam Pharmaceuticals, Inc.
• Camurus AB
• Embera NeuroTherapeutics, Inc.
• Indivior PLC
• Johnson & Johnson Services, Inc.
• KemPharm, Inc.
• Kinoxis Therapeutics
• Novartis International AG
• Orexo AB
• Otsuka Pharmaceutical Co., Ltd.
• Pfizer Inc.
• Polpharma SA
• Revive Therapeutics Ltd.
• Sage Therapeutics, Inc.
• Saniona AB
• Shionogi & Co., Ltd.
• Sigmapharm Laboratories, LLC
• STALICLA SA
• Teva Pharmaceuticals USA, Inc.
• Viatris Inc.
• Mylan Pharmaceuticals Inc.

For more information about this report visit https://www.researchandmarkets.com/r/mg5h70

About ResearchAndMarkets.com

ResearchAndMarkets.com is the world’s leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

Contacts

ResearchAndMarkets.com

Laura Wood, Senior Press Manager

press@researchandmarkets.com

For E.S.T Office Hours Call 1-917-300-0470

For U.S./ CAN Toll Free Call 1-800-526-8630

For GMT Office Hours Call +353-1-416-8900

FDA Grants Breakthrough Therapy Designation to Investigational Drug Adrabetadex for Individuals with Infantile-Onset Niemann-Pick Disease Type C




FDA Grants Breakthrough Therapy Designation to Investigational Drug Adrabetadex for Individuals with Infantile-Onset Niemann-Pick Disease Type C

• Breakthrough Therapy Designation is based on FDA’s review of survival analyses comparing adrabetadex-treated patients with external controls and marks a significant regulatory milestone ahead of an NDA submission.

THOUSAND OAKS, Calif.–(BUSINESS WIRE)–Beren Therapeutics P.B.C.®, a Public Benefit Corporation and parent company of Mandos LLC®, today announced that Mandos received Breakthrough Therapy Designation (BTD) from the U.S. Food and Drug Administration (FDA) for adrabetadex, an investigational drug for infantile-onset Niemann-Pick disease type C (NPC).

BTD is granted by the FDA to expedite the development of drugs for serious or life-threatening conditions when preliminary clinical evidence may indicate a substantial improvement over existing therapy. The FDA decision was informed by an externally controlled survival analysis that showed adrabetadex improves survival in individuals with infantile-onset NPC and was reviewed alongside supportive biomarker and nonclinical data.

Adrabetadex previously received BTD in 2016 under a prior sponsor, and the FDA rescinded the designation based on data from a 12-month Phase 2b/3 clinical trial. Beren, through its subsidiary Mandos, acquired the adrabetadex program from Mallinckrodt in 2021 and has worked closely with the FDA and NPC community to advance adrabetadex’s development and generate the data and analyses that supported the new BTD designation.

“This newly granted designation represents an important milestone in the evaluation of adrabetadex for people living with infantile-onset NPC,” said Jason Camm, Chief Executive Officer of Beren Therapeutics P.B.C. “We are grateful to the people living with NPC and their caregivers, clinicians, and advocates who have worked with us through a long development path.”

Dr. Elizabeth Berry-Kravis, Professor of Pediatrics at Rush University Medical Center and principal EAP investigator, noted: “Infantile-onset NPC is a devastating, rapidly fatal diagnosis. Seeing statistically significant improvements in survival signals a meaningful shift in what is achievable for these patients.”

Adrabetadex also has Orphan Drug and Rare Pediatric Disease designations. Beren plans to submit an NDA in the near future and expects adrabetadex to be eligible for Priority Review.

About Niemann-Pick Disease Type C

Niemann-Pick disease type C (NPC) is a rare, autosomal-recessive, severe, neurodegenerative disorder caused by pathologic variants in the NPC1 (~95% of cases) or NPC2 genes, leading to impaired cholesterol trafficking resulting in progressive neurological decline and premature death. Infantile-onset NPC refers to NPC in individuals who first experience neurological symptoms between 0 and 6 years of age. Earlier neurological onset is associated with more rapid progression and poorer prognosis, with mean survival of ~5.6 years for early-infantile-onset (age of neurological onset <2 years) and ~13.4 years for late-infantile-onset (2 to <6 years). Individuals with early- and late-infantile-onset NPC typically present with manifestations affecting multiple organs, with the most severe and debilitating effects occurring in the brain.

About Adrabetadex (VTS-270)

Adrabetadex (VTS-270) is a proprietary mixture of 2-hydroxypropyl-β-cyclodextrin isomers under investigation as a treatment for Niemann-Pick disease type C (NPC). By re-establishing intracellular cholesterol trafficking, adrabetadex directly addresses the underlying pathology of NPC. Adrabetadex is generally well tolerated. The main adverse events associated with adrabetadex include hearing impairment that can be managed with hearing aids when necessary, and post-dose fatigue and/or ataxia.

Adrabetadex has not been approved by the FDA or any other health authority at this time.

About Beren Therapeutics P.B.C. and Mandos

Beren Therapeutics P.B.C. is a founder-led, clinical-stage biotechnology company pioneering the discovery, development, and commercialization of cyclodextrin-based therapeutics for conditions characterized by defective cholesterol trafficking.

Beren and its subsidiary, Mandos, are committed to the development of adrabetadex for individuals living with Niemann-Pick disease type C (NPC), a condition characterized by defects in intracellular cholesterol trafficking. Beren and Mandos have supported the NPC community by providing access to adrabetadex* through an Expanded Access Program (EAP). Beren will continue working closely with patients, families, researchers, regulators and others on a path to bring forth this potentially transformative, investigational therapy for NPC.

Beren is headquartered in Thousand Oaks, CA, and will launch its website out of stealth mode in Q1 2026. For more information, please visit our public-facing subsidiary Mandos.

* Adrabetadex is an investigational drug that has not been approved by the U.S. Food and Drug Administration and has not been found safe and effective to treat NPC or any other condition.

Contacts

Amanda Eckel

BGB Group

Aeckel@bgbgroup.com

Plant Breeding and CRISPR Plants Industry Trends and Market Outlook 2025-2030 – Increasing Regulatory Support for Gene-Edited Crops Spurs Adoption of CRISPR in Mainstream Plant Breeding Programs – ResearchAndMarkets.com




Plant Breeding and CRISPR Plants Industry Trends and Market Outlook 2025-2030 – Increasing Regulatory Support for Gene-Edited Crops Spurs Adoption of CRISPR in Mainstream Plant Breeding Programs – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “Plant Breeding and CRISPR Plants – Global Strategic Business Report” has been added to ResearchAndMarkets.com’s offering.

The global market for Plant Breeding and CRISPR Plants was valued at US$21.7 Billion in 2024 and is projected to reach US$50.1 Billion by 2030, growing at a CAGR of 15% from 2024 to 2030. This comprehensive report provides an in-depth analysis of market trends, drivers, and forecasts, helping you make informed business decisions. The report includes the most recent global tariff developments and how they impact the Plant Breeding and CRISPR Plants market.

The growth in the plant breeding and CRISPR plants market is driven by several critical factors that are transforming the agriculture and biotech industries. First, the increasing demand for food security in a world facing population growth and resource constraints is a major driver. CRISPR technology enables the development of crops that can deliver higher yields and resist environmental stressors, helping to meet the rising food demand. Advances in genetic research and biotechnology have made CRISPR more accessible and efficient, reducing the time and cost associated with developing new crop varieties.

Another factor is the growing focus on sustainable agriculture, as both consumers and governments demand more environmentally friendly farming practices. CRISPR allows for the creation of crops that require fewer inputs, such as water and fertilizers, reducing the environmental footprint of farming. Furthermore, regulatory support is playing a crucial role in the market’s expansion, as several countries are moving towards less stringent regulations for CRISPR-edited plants compared to traditional GMOs, which helps to accelerate the adoption of CRISPR technologies.

The increasing investment in agricultural biotechnology, driven by both public and private sectors, is further fueling the market’s growth. Major agricultural biotech companies, research institutions, and startups are heavily investing in CRISPR-based research to create new crop varieties with desirable traits.

Additionally, consumer preferences for healthier, non-GMO food products are influencing market dynamics, as CRISPR plants are often viewed more favorably by consumers compared to traditional GM crops. Together, these factors are creating a strong growth environment for the plant breeding and CRISPR plants market, positioning it as a key component of the future of agriculture.

Report Scope

The report analyzes the Plant Breeding and CRISPR Plants market, presented in terms of market value (US$ Thousand). The analysis covers the key segments and geographic regions outlined below.

• Segments: Type (Conventional Breeding, Biotechnological Method); Trait (Herbicide Tolerance, Disease Resistance, Yield Improvement, Other Traits); Application (Cereals & Grains, Oilseeds & Pulses, Fruits & Vegetables, Other Applications).
• Geographic Regions/Countries: World; United States; Canada; Japan; China; Europe (France; Germany; Italy; United Kingdom; and Rest of Europe); Asia-Pacific; Rest of World.

Regional Analysis

Gain insights into the U.S. market, valued at $5.9 Billion in 2024, and China, forecasted to grow at an impressive 14.4% CAGR to reach $7.8 Billion by 2030. Discover growth trends in other key regions, including Japan, Canada, Germany, and the Asia-Pacific.

Key Questions Answered:

• How is the Global Plant Breeding and CRISPR Plants Market expected to evolve by 2030?
• What are the main drivers and restraints affecting the market?
• Which market segments will grow the most over the forecast period?
• How will market shares for different regions and segments change by 2030?
• Who are the leading players in the market, and what are their prospects?

Report Features:

• Comprehensive Market Data: Independent analysis of annual sales and market forecasts in US$ Million from 2024 to 2030.
• In-Depth Regional Analysis: Detailed insights into key markets, including the U.S., China, Japan, Canada, Europe, Asia-Pacific, Latin America, Middle East, and Africa.
• Company Profiles: Coverage of players such as Advanta Seeds, Bayer, Benson Hill Biosystems, Bioconsortia, DLF and more.
• Complimentary Updates: Receive free report updates for one year to keep you informed of the latest market developments.

Some of the 23 companies featured in this Plant Breeding and CRISPR Plants market report include:

• Advanta Seeds
• Bayer
• Benson Hill Biosystems
• Bioconsortia
• DLF
• Dow, Inc.
• DuPont de Nemours, Inc.
• Equinom
• Eurofins
• Evogene
• Groupe Limagrain
• Hudson River Biotechnology
• KWS
• Land O’lakes
• Pacific Biosciences
• SGS
• Syngenta

This edition integrates the latest global trade and economic shifts into comprehensive market analysis. Key updates include:

• Tariff and Trade Impact: Insights into global tariff negotiations across 180+ countries, with analysis of supply chain turbulence, sourcing disruptions, and geographic realignment. Special focus on 2025 as a pivotal year for trade tensions, including updated perspectives on the Trump-era tariffs.
• Adjusted Forecasts and Analytics: Revised global and regional market forecasts through 2030, incorporating tariff effects, economic uncertainty, and structural changes in globalization. Includes historical analysis from 2015 to 2023.
• Strategic Market Dynamics: Evaluation of revised market prospects, regional outlooks, and key economic indicators such as population and urbanization trends.
• Innovation & Technology Trends: Latest developments in product and process innovation, emerging technologies, and key industry drivers shaping the competitive landscape.
• Competitive Intelligence: Updated global market share estimates for 2025, competitive positioning of major players (Strong/Active/Niche/Trivial), and refined focus on leading global brands and core players.
• Expert Insight & Commentary: Strategic analysis from economists, trade experts, and domain specialists to contextualize market shifts and identify emerging opportunities.

Key Attributes

Market Overview

• Trade Shocks, Uncertainty, and the Structural Rewiring of the Global Economy
• How Trump’s Tariffs Impact the Market? The Big Question on Everyone’s Mind
• Global Economic Update
• Plant Breeding and CRISPR Plants – Global Key Competitors Percentage Market Share in 2025 (E)
• Competitive Market Presence – Strong/Active/Niche/Trivial for Players Worldwide in 2025 (E)

Market Trends and Drivers

• Rising Demand for High-Yield, Climate-Resilient Crops Drives Adoption of CRISPR and Gene-Editing Technologies in Plant Breeding
• Growing Global Focus on Food Security and Crop Optimization Expands Market for Advanced Plant Breeding Tools and CRISPR Technologies
• Increasing Regulatory Support for Gene-Edited Crops Spurs Adoption of CRISPR in Mainstream Plant Breeding Programs
• Emergence of CRISPR as a Game-Changer in Precision Plant Breeding Propels Demand for Gene-Editing Solutions
• Growing Demand for Pest-Resistant and Disease-Resilient Crops Expands Market for CRISPR Applications in Plant Breeding
• Technological Advancements in Genomics and DNA Sequencing Drive Growth in Precision Plant Breeding Using CRISPR
• Increasing Focus on Reducing Pesticide and Herbicide Use Drives Market for Gene-Edited Crops with Built-In Pest Resistance
• Rising Demand for Biofortified Crops to Address Nutritional Deficiencies Expands Market for CRISPR-Enhanced Plant Breeding
• Increasing Interest in Developing Drought-Resistant and Climate-Adapted Crops Drives Growth of CRISPR Applications in Plant Breeding
• Growing Investment in Agricultural Biotechnology and Gene Editing Expands Opportunities for CRISPR Technology in Commercial Plant Breeding
• Increasing Consumer Demand for Non-GMO, Gene-Edited Crops Spurs Growth of CRISPR Plant Breeding Solutions
• Advances in Molecular Breeding Techniques and Marker-Assisted Selection Expand Applications of CRISPR in Plant Genetics

For more information about this report visit https://www.researchandmarkets.com/r/vg1d9p

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