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Company adds two injectable products, Fosaprepitant for Injection and Fulvestrant Injection, to its growing portfolio for the U.S market Latest progress marks continued momentum following October 2023 launch, with four portfolio products and a growing pipeline Management to showcase the Company’s portfolio of critical injectable medications and differentiated business model at DCAT Week 2024 from March 18-21 in New York SCHAUMBURG, Ill.--(BUSINESS WIRE)-- Avenacy, a specialty pharmaceutical company focused on supplying critical injectable medications, today announced it has launched Fosaprepitant for Injection and Fulvestrant Injection in the United States. This press release features multimedia. View the full release here: (Photo: Business Wire) “Avenacy has had a strong start to 2024, with two product launches already executed and two more newly announced additions to our rapidly expanding portfolio. Since the Company’s launch in October, we have invested in bringing high-demand injectable products to market and strengthening our global network of development and manufacturing partners, and we are ready to build upon this important foundation as we prepare for significant growth,” said Jeff Yordon, Co-Founder and CEO of Avenacy. “We are looking forward to participating in DCAT 2024, where we will be discussing how Avenacy is well-positioned to continue addressing key gaps in the U.S. drug supply landscape through its differentiated portfolio, robust pipeline, and unwavering commitment to quality, safety, and patient care.” Fosaprepitant for Injection is a therapeutic equivalent generic for Emend® (fosaprepitant) approved by the U.S. Food and Drug Administration. Fosaprepitant for Injection, in combination with other antiemetic agents, is indicated in adults for the prevention of: Acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin Delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC). Fosaprepitant for Injection had U.S. sales of approximately $35 million for the twelve months ending in June 2023.1 Avenacy’s product contains 150 mg of Fosaprepitant as a lyophilized powder in a single-dose vial for reconstitution. Fulvestrant Injection is a therapeutic equivalent generic for Faslodex® (fulvestrant) approved by the U.S. Food and Drug Administration. Fulvestrant Injection is indicated for: Monotherapy use for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer in postmenopausal women not previously treated with endocrine therapy; or HR-positive advanced breast cancer in postmenopausal women with disease progression following endocrine therapy. Combination therapy use for the treatment of HR-positive, HER2-negative advanced or metastatic breast cancer in postmenopausal women in combination with ribociclib as initial endocrine based therapy or following disease progression on endocrine therapy; or HR-positive, HER2-negative advanced or metastatic breast cancer in combination with palbociclib or abemaciclib in women with disease progression after endocrine therapy. Fulvestrant Injection had U.S. sales of approximately $71 million for the twelve months ending in June 2023.1 Avenacy’s product is supplied as 5 mL pre-filled syringes for injection containing 250 mg per 5 mL Fulvestrant. Please see links for Full Prescribing Information of Fosaprepitant for Injection and Fulvestrant Injection. In line with Avenacy’s mission to champion patient safety and streamline patient care, Fosaprepitant for Injection and Fulvestrant Injection will feature the Company’s highly differentiated packaging and labeling to support accurate medication selection. Avenacy will begin shipping Fosaprepitant for Injection and Fulvestrant Injection to wholesale partners this week. Since launching in October of last year, Avenacy, backed by a robust global network of development and FDA-approved cGMP-certified contract manufacturing partners, has already brought four injectable products to the U.S. market. The company is poised to continue this trajectory with plans to pursue 20+ additional products for launch this year. To learn more about Avenacy’s products or the Company’s exciting growth plans for 2024, please see the Avenacy management team at DCAT Week 2024 taking place in New York City from March 18-21st. To request a meeting with a member of the Avenacy team, please reach out to Avenacy@fticonsulting.com. Emend® is a registered trademark of Merck & Co. Faslodex® is a registered trademark of AstraZeneca. 1Source: IQVIA About Avenacy Avenacy is a U.S.-based specialty pharmaceutical company focused on supplying critical injectable medications used to treat patients in various medically supervised settings, from acute care hospitals to outpatient clinics and physician offices. Through a rigorous and optimized selection process, the Company is building out a pipeline of high-quality FDA approved injectable products in order to ensure a resilient portfolio that can meet the needs of today’s dynamic drug supply chain. With an experienced team, commitment to quality and reliability, and product offerings intended to facilitate safe and efficient patient care, Avenacy strives to be a trusted partner for essential medications. Avenacy was launched in 2023 and is headquartered in Schaumburg, IL. For more information, please visit . View source version on businesswire.com: Contacts Media FTI Consulting Avenacy@fticonsulting.com Source: Avenacy Smart Multimedia Gallery Photo (Photo: Business Wire) Logo View this news release and multimedia online at:

UPPSALA, SWEDEN / ACCESSWIRE / March 13, 2024 / Biovica International (STO:BIOVIC-B)(STO:BIOVIC.B)(FRA:9II) Biovica, active in blood-based cancer monitoring, today announces that a clinical trial, BettER, is being launched at Washington University School of Medicine in St. Louis. The study is aimed at evaluating whether patients with HR+ HER2- metastatic or unresectable breast cancer benefit from DiviTum® TKa "We are thrilled to once again collaborate with Washington University on another trial. This time it is a translational trial, which if successful would pave the way for increased uptake of DiviTum TKa, for the benefit of breast cancer patients," said Anders Rylander, CEO of Biovica. "We are excited to offer patients with ER+ HER2- advanced breast cancer the opportunity to incorporate TK testing with the goal of further tailoring treatment, reducing unnecessary toxicity and improving patient outcomes," says Katherine Clifton, M.D who is a breast medical oncologist and the lead investigator of the trial at Washington University School of Medicine in St. Louis. The BettER study seeks to evaluate the impact of early therapeutic switching based on biomarker-driven insights, utilizing DiviTum TKa to guide treatment decisions. The study will enroll 50 patients, assessing the effectiveness of modifying treatment based on TKa levels measured at baseline and shortly after treatment initiation. Patients demonstrating insufficient TKa suppression will be recommended for an alternative therapy, potentially enhancing treatment outcomes. Contact Anders Rylander, CEO Phone: +46 76 666 16 47 E-mail: anders.rylander@biovica.com Anders Morén, CFO Phone: +46 73 125 92 46 E-mail: anders.moren@biovica.com Biovica - Treatment decisions with greater confidence Biovica develops and commercializes blood-based biomarker assays that help oncologists monitor cancer progression. Biovica's assay, DiviTum® TKa, measures cell proliferation by detecting the TKa biomarker in the bloodstream. The assay has demonstrated its ability to provide insight to therapy effectiveness in several clinical trials. The first application for the DiviTum® TKa test is treatment monitoring of patients with metastatic breast cancer. Biovica's vision is: "Improved care for cancer patients." Biovica collaborates with world-leading cancer institutes and pharmaceutical companies. DiviTum® TKa has received FDA 510(k) clearance in the US and is CE-marked in the EU. Biovica's shares are traded on the Nasdaq First North Premier Growth Market (BIOVIC B). FNCA Sweden AB is the company's Certified Adviser. For more information, please visit: Attachments Interventional DiviTum® TKa trial launches at Washington University SOURCE: Biovica International View the original press release on accesswire.com

IRVINE, Calif. & AMSTERDAM--( BUSINESS WIRE )-- Agendia ® , Inc. , announced today it will share new data from the ongoing prospective, observational FLEX Trial ( NCT03053193 ) in two poster presentations at the 41 st Annual Miami Breast Cancer Conference (MBCC), taking place March 7 – 10 th , 2024. The first poster, titled MammaPrint ® and BluePrint ® predict anthracycline chemosensitivity in patients with HR+HER2-early-stage breast cancer enrolled in FLEX, (Audeh, W., et al.), investigates the associations between MammaPrint and BluePrint classifications, therapy regimen, and the likelihood of achieving a pathologic Complete Response (pCR). Researchers looked at patients who had hormone receptor-positive (HR+), Human Epidermal Growth Factor Receptor (HER) 2-negative early-stage breast cancer – categorized as MammaPrint High Risk – who had been treated with either a combination of two (taxane and cyclophosphamide, TC) or three (TC with anthracycline, AC-T) types of neoadjuvant chemotherapy. Patients were then further stratified into MP High 1 and High 2 categories, and further stratified by BluePrint subtype of Luminal and Basal. Results showed that patients with MP High 2 tumors, including Luminal B and Basal subtypes, are more likely to achieve a pCR in response to AC-T, while the addition of anthracycline to the therapy regimen does not appear to improve pCR rates for patients with MP High 1, Luminal B-type tumors. The second poster, titled Prediction of chemotherapy benefit by MammaPrint ® in patients with HR+HER2-early-stage breast cancer from real-world evidence studies (Audeh, W., et al.), used data from patients with HR+ HER2-negative early-stage breast cancer enrolled in the FLEX and NBRST trials to generate a prediction of the magnitude of chemotherapy benefit based upon a patient’s genomic risk, looking at the MammaPrint index more closely as a continuous variable. Researchers examined the association of the MammaPrint index with benefit from chemotherapy by evaluating two clinical endpoints, the likelihood of pCR in response to neoadjuvant chemotherapy, and the five-year outcome among patients who received chemotherapy and endocrine therapy or endocrine therapy alone. Consistent with results found in the landmark MINDACT trial, this study showed that the MammaPrint index demonstrates strong efficacy in predicting low chemosensitivity in Low Risk and Ultra Low Risk tumors, reinforcing that these groups do not derive significant chemotherapy benefit. However, it was also observed that chemotherapy effectiveness increased as MammaPrint risk increased in High 1 and High 2 tumors, as evidenced by both pCR rates and 5-year outcomes, demonstrating that the overall benefit of chemotherapy increases as MammaPrint risk increases. Taken together, these findings indicate the utility of MammaPrint to predict neoadjuvant and adjuvant chemotherapy benefit in this patient population. “In this unique real world evidence FLEX study, we were able to look at chemosensitivity for patients who had received neoadjuvant treatment and the chemo benefit for patients who are treated with systemic therapy after surgery, showing that MammaPrint is predictive of chemotherapy benefit in both cases. The FLEX Trial, with over 16,000 women enrolled, is now allowing us to look at clinical outcomes as well as analyzing whole transcriptome data,” said William Audeh, MD, MS, Chief Medical Officer of Agendia. “The data we’re sharing at the Miami Breast Cancer Conference confirms that gene expression profiling with these assays identify who may benefit from chemotherapy, and may prove helpful in regimen selection as well. We look forward to further exploring the capabilities of MammaPrint and BluePrint for women across the entire spectrum of breast cancer risk and subtype.” The goal of Agendia’s research is to increase the likelihood of managing each individual’s cancer diagnosis by delivering a customized treatment plan to the patients most likely to benefit based on the unique features of their tumor. About Agendia Agendia is a leading provider of innovative solutions in the field of precision oncology. With a focus on early-stage breast cancer, Agendia offers reliable biological insights that inform personalized treatment decisions for patients and their care teams. Their advanced genomic assays, MammaPrint ® + BluePrint ® , enable clinicians to quickly identify the most effective treatment plan, minimizing the risk of both under- and over-treatment. Founded in 2003 in Amsterdam, Agendia is headquartered in Irvine, California with a state-of-the-art laboratory facility. Led by world-renowned scientists and oncologists, Agendia is committed to advancing genomic insights through ongoing research. This includes the notable FLEX Study– the world's largest whole transcriptome Real-World Evidence-based Breast Cancer database which aims to revolutionize precision in breast cancer management. With cutting-edge technology, research and innovation, Agendia strives to shape the future of precision oncology and make a significant impact in the fight against breast cancer. About MammaPrint MammaPrint ® is a gene expression profiling test that reveals the distinct underlying biology of an early-stage tumor to determine its risk of spreading. As the only FDA-cleared gene expression profiling test to assess a woman's risk of distant metastasis, MammaPrint ® provides critical answers that help inform the future of her treatment plan at the point of diagnosis, including the timing and benefit to chemotherapy and endocrine therapy. MammaPrint® listens to the signals from 70 key genes in a woman’s tumor to stratify her risk within four distinct categories - ranging from UltraLow, Low, High 1, and High 2– to fuel a right-sized care plan tailored to her biology and her life's plans. About BluePrint BluePrint ® is a gene expression profiling test that reveals the driving forces behind a tumor’s growth at the earliest stage possible in a woman’s breast cancer care journey to help optimize and personalize treatment planning. As the only molecular subtyping test available in the U.S., BluePrint® goes where pathology cannot, offers critical insights that providers may otherwise have not known to act on, and gives women the best chance to return to a life not defined by cancer. BluePrint® measures the activity of 80 key genes that are involved in a tumor's growth to classify a tumor as Luminal-type, HER2-type, or Basal-type, each of which warrant distinct treatment pathways. By revealing the distinct underlying biology of a woman's tumor, BluePrint® can catch often misclassified, yet highly aggressive, Basal tumors, so women can be prescribed the most appropriate treatment from the start.