GHR

Positive topline results from Phase 2a study of MAR001 demonstrate clinically meaningful reductions in remnant cholesterol and triglycerides; Phase 2b study expected to initiate in First Half 2025 Second Lead Program announced, MAR002, a growth hormone receptor (GHR) antagonist for the treatment of acromegaly; Phase 1 study expected to initiate in Second Half 2025 Marea to present at 43rd Annual J.P. Morgan Healthcare Conference on Wednesday, January 15 SAN FRANCISCO, CA, USA I January 09, 2025 I Marea Therapeutics, Inc., a clinical-stage biotechnology company harnessing the latest advances in human genetics to develop first-in-class, next-generation medicines for cardio-endocrine diseases, today provided an update on the company’s recent progress and upcoming milestones for 2025 in advance of the J.P. Morgan 43 rd Annual Healthcare Conference, taking place from January 13-16, 2025 in San Francisco, CA. “Since our launch in June 2024, Marea has made excellent progress across a number of areas,” said Josh Lehrer, M.D., M.Phil., FACC, chief executive officer of Marea. “Based on positive results from our Phase 2a study that demonstrate clinically meaningful reductions in remnant cholesterol and triglycerides, we are preparing to advance MAR001 into Phase 2b clinical development in the first half of 2025. These data demonstrate the potential of MAR001 to address the untreated lipid and metabolic drivers of cardiovascular disease in high-risk patients. In addition, we announced our second lead pipeline program for the treatment of acromegaly with clinical development expected to initiate in the second half of 2025. Our strong pipeline progress, further fueled by the recent expansion of our management team and board of directors, positions us for an important 2025 as we seek to accelerate a new generation of medicines for cardiometabolic and endocrine diseases.” Positive Phase 2a Topline Results for MAR001 “These clinical data, coupled with the remarkable human genetic validation of ANGPTL4, the target for MAR001, establishes MAR001 as one of the most promising candidates advancing into late-stage development for treating residual cardiovascular risk in the patients who remain at highest risk despite aggressive standard of care therapies,” said Ethan Weiss, M.D., chief scientific officer of Marea. Second Lead Pipeline Program Announced: MAR002 for the Treatment of Acromegaly MAR002 is a potential first-in-class anti-growth hormone receptor (GHR) antibody being developed for acromegaly. Acromegaly is a life-shortening disease where much of the morbidity is caused by insulin resistance, lipotoxicity, and cardiovascular events. Current therapies for acromegaly are associated with suboptimal disease control. It is estimated there are more than 30,000 patients with acromegaly in the U.S. Marea expects to initiate a Phase 1 clinical trial with MAR002 in the second half of 2025. Other Corporate Highlights Presentation at the 43 rd Annual J.P. Morgan Healthcare Conference Management will participate in the 43 rd Annual J.P Morgan Healthcare Conference. In addition to hosting meetings, management will present an overview of the Company on Wednesday, January 15, at 11:30 a.m. PT in San Francisco. About Marea Therapeutics Marea Therapeutics is a clinical-stage biotechnology company harnessing the latest advances in human genetics to develop first-in-class, next-generation medicines for cardio-endocrine diseases. The company’s lead program, MAR001, is in Phase 2 clinical development for adults with metabolic dysfunction and high risk for cardiovascular disease. The company is also advancing MAR002 for the treatment of acromegaly. To learn more, please visit www.mareatx.com and follow us on LinkedIn and X . SOURCE: Marea Therapeutics

With this approval, Foundation Medicine has seven companion diagnostic indications for breast cancer, the most of any comprehensive genomic profiling company BOSTON--(BUSINESS WIRE)-- Foundation Medicine, Inc. today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOne®Liquid CDx to be used as a companion diagnostic for Itovebi™ (inavolisib) in combination with palbociclib (Ibrance®) and fulvestrant, a therapy developed by Genentech, a member of the Roche group, which has been contemporaneously approved for the treatment of adult patients with endocrine-resistant, PIK3CA -mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant endocrine therapy. Approximately 70% of all breast cancers are hormone-receptor positive, HER2-negative. 1 PIK3CA is the most commonly mutated gene in hormone-receptor positive, HER2-negative breast cancer, with approximately 40% of patients harboring this mutation. 2 “This approval reinforces the importance of testing for PIK3CA mutations at the time of diagnosis to help guide decision-making in the first-line setting for metastatic breast cancer patients,” said Mia Levy, Ph.D., M.D., chief medical officer at Foundation Medicine. “Our high-quality liquid biopsy companion diagnostic relies on a routine blood draw to identify patients with PIK3CA mutations, enhancing broader access to genomic testing while allowing more patients to benefit from this new best-in-class first-line treatment regimen.” Foundation Medicine is the only company with an FDA-approved portfolio of tissue and blood-based comprehensive genomic profiling tests. From a routine blood sample, FoundationOne Liquid CDx analyzes more than 300 cancer-related genes to provide genomic insights. With this approval, Foundation Medicine has seven companion diagnostic indications for breast cancer, the most of any comprehensive genomic profiling company. 3 Foundation Medicine is the global leader in approved companion diagnostic indications with more than 60% of all approved U.S. companion diagnostic indications for next-generation sequencing (NGS) testing. “Given the high prevalence of PIK3CA mutations in hormone receptor-positive, HER2-negative breast cancer, the introduction of a new targeted treatment regimen in the first-line setting will have a profound impact on this patient population,” said Jean A. Sachs, MSS, MLSP, chief executive officer at Living Beyond Breast Cancer. “Biomarker testing plays an important role in helping patients and their families make personalized treatment decisions based on their individual cancer, and we’re encouraged to see Foundation Medicine continue to expand its approved companion diagnostic indications in breast cancer.” Foundation Medicine and FoundationOne® are registered trademarks of Foundation Medicine, Inc. About Foundation Medicine: Your Essential Partner in Cancer Care Foundation Medicine is a pioneer in molecular profiling for cancer, working to shape the future of clinical care and research. We collaborate with a broad range of partners across the cancer community and strive to set the standard for quality, scientific excellence, and regulatory leadership. Our deep understanding of cancer biology helps physicians make informed treatment decisions for their patients and empowers researchers to develop new medicines. Every day, we are driven to help our partners find answers and take action, enabling more people around the world to benefit from precision cancer care. For more information, please visit us on and follow us on LinkedIn and X . About FoundationOne®Liquid CDx FoundationOne®Liquid CDx is a qualitative next generation sequencing based in vitro diagnostic test for prescription use only that uses targeted high throughput hybridization-based capture technology to analyze 324 genes utilizing circulating cell-free DNA (cfDNA) isolated from plasma derived from anti-coagulated peripheral whole blood of advanced cancer patients. The test is FDA-approved to report short variants in over 300 genes and is a companion diagnostic to identify patients who may benefit from treatment with specific therapies (listed in Table 1 of the Intended Use) in accordance with the approved therapeutic product labeling. Additional genomic findings may be reported and are not prescriptive or conclusive for labeled use of any specific therapeutic product. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. Patients who are negative for companion diagnostic mutations should be reflexed to tumor tissue testing and genomic alteration status confirmed using an FDA-approved tumor tissue test, if feasible. For the complete label, including companion diagnostic indications and complete risk information, please visit . __________________________________ 1 Howlader N, Altekruse SF, Li CI, et al. US incidence of breast cancer subtypes defined by joint hormone receptor and HER2 status. J Natl Cancer Inst 2014;106(5). 2 The Cancer Genome Atlas Network. Comprehensive molecular portraits of human breast tumours. Nature. 2012;490:61–70. 3 Data on File, Foundation Medicine, Inc., 2024 Contacts Media: Foundation Medicine: Holly Campbell, 480.213.8368 newsroom@foundationmedicine.com

Aligns with Eton’s Mission to Develop and Distribute Medicines that Have a Life Changing Impact for Patients with Ultra-rare Conditions Acquisition to Bolster Eton’s Commercial Pediatric Endocrinology Portfolio DEER PARK, IL, USA I October 03, 2024 I Eton Pharmaceuticals, Inc (“Eton” or “the Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, today announced that it has entered into an asset purchase agreement to acquire Increlex® (mecasermin injection) from Ipsen S.A. (“Ipsen”). The acquisition is expected to close near year-end 2024. “Eton’s mission is to develop and distribute medicines that make a life changing impact for patients with the rarest of conditions. Increlex, a critical medication for patients with the ultra-rare condition of severe IGF-1 deficiency, aligns perfectly with our mission and our significant expertise in serving extremely rare patient populations,” said Sean Brynjelsen, CEO of Eton Pharmaceuticals. “Leveraging our strong presence in the pediatric endocrinology community, we aim to raise awareness of this underdiagnosed and undertreated condition. We look forward to collaborating with Ipsen to ensure continuity of care and long-term supply for patients globally.” Increlex is a biologic product used to treat children and adolescents from 2- to 18-years-old who suffer from severe primary insulin-like growth factor 1 deficiency (SPIGFD) because their bodies do not make enough insulin-like growth factor 1 (IGF-1). The medicine is approved in 40 territories, including the United States (U.S.) and the European Union (EU). It is estimated that approximately 200 patients in the United States and 900-1,000 patients in Europe live with SPIGFD. Increlex is the only treatment approved by the U.S. Food and Drug Administration (FDA) or European Medicines Agency (EMA) for SPIGFD. Post closing, Eton will immediately commercialize the product in the U.S. without disruption to patient supply. Outside the U.S., Ipsen will continue distributing the product during a six-month transition period to ensure no disruption to patient supply, after which the commercialization will be continued by Eton. The transaction will be financed by Eton’s cash on hand and an expansion of the Company’s existing credit facility with SWK Holdings. Ipsen reported global sales for Increlex of €17.3 million in 2023. Important Safety Information Contraindications Warnings and Precautions Adverse Reactions Common adverse reactions include hypoglycemia, local and systemic hypersensitivity, and tonsillar hypertrophy. U.S. Indication INCRELEX ® (mecasermin) is indicated for the treatment of growth failure in pediatric patients aged 2 years and older with severe primary IGF-1 deficiency* (IGFD), or with hormone (GH) gene deletion who have developed neutralizing antibodies to GH. Limitations of use: INCRELEX ® is not a substitute to GH for approved GH indications. INCRELEX ® is not indicated for use in patients with secondary forms of IGFD, such as GH deficiency, malnutrition, hypothyroidism, or chronic treatment with pharmacologic doses of anti-inflammatory steroids. *Severe primary IGF-1 deficiency (IGFD) is defined by height standard deviation score ≤ -3.0 and basal IGF-1 standard deviation score ≤ -3.0 and normal or elevated GH. Full U.S. Prescribing Information for Increlex ® is available at: http://increlex.com/pdf/hcp-full-prescribing-information.pdf You are encouraged to report negative effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch , or call 1-800-FDA-1088. EU Indication In the European Union, INCRELEX is indicated for the long-term treatment of growth failure in children and adolescents from 2 to 18 years with confirmed severe primary insulin-like growth factor 1 deficiency (Primary IGFD). Severe Primary IGFD is defined by: height standard deviation score <–3.0 and basal IGF-1 levels below the 2.5th percentile for age and gender and GH sufficiency. Exclusion of secondary forms of IGF 1 deficiency, such as malnutrition, hypopituitarism, hypothyroidism, or chronic treatment with pharmacologic doses of anti-inflammatory steroids. Severe Primary IGFD includes patients with mutations in the GH receptor (GHR), post-GHR signaling pathway, and IGF 1 gene defects; they are not GH deficient, and therefore, they cannot be expected to respond adequately to exogenous GH treatment. In some cases, when deemed necessary, the physician may decide to assist in the diagnosis by performing an IGF-I generation test. Detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu About Eton Eton is an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases. The Company currently has five commercial rare disease products: ALKINDI SPRINKLE®, PKU GOLIKE®, Carglumic Acid, Betaine Anhydrous, and Nitisinone. The Company has three additional product candidates in late-stage development: ET-400, ET-600, and ZENEO® hydrocortisone autoinjector. For more information, please visit our website at www.etonpharma.com . SOURCE : Eton