Gynecomastia

IRVINE, Calif., March 11, 2025 (GLOBE NEWSWIRE) -- Nymox announces that it dismissed the Delaware matter pending against Ascella on March 7, 2025. A number of factors caused the company to reconsider its strategy to adequately protect its shareholders. Nymox CEO Paul Averback said, "The dismissal at this stage is a legal step after consultation with counsel, with whom we have full confidence. We assure our shareholders that further steps are contemplated and we will report accordingly at the appropriate time." About NYMOX Nymox has submitted applications seeking the approval to, and continues to consider submitting additional applications seeking the approval to market the Company's first in class drug NYMOZARFEX (TM) to treat the symptoms of benign prostatic hyperplasia (BPH). BPH is one of the most common conditions affecting middle aged and elderly men throughout the world. BPH can be devastating to men who suffer from the condition. Current treatments are associated with numerous intolerable side effects including sexual problems, such as impotence and retrograde ejaculation. Medications for BPH have been associated with prostate cancer, depression, gynecomastia and other adverse effects. The majority of men stop taking the available medications due to these and other problems. Surgery is often needed for advanced BPH. Surgery is usually effective but it is not without risks, the discomforts of surgery, and BPH surgery has side effects such as permanent retrograde ejaculation for many patients. Nymox has reported 10-year follow-up new data on all available patients from its U.S. clinical trial of NYMOZARFEX (TM) for the treatment of low grade localized prostate cancer. The available long-term data newly assessed, confirmed that all available data shows that the NYMOZARFEX (TM) treatment had important and statistically significant benefit for reducing the long-term progression of these prostate cancers. About NYMOZARFEX (TM) (Fexapotide) NYMOZARFEX (TM) is given in an in-office procedure that is administered in a few minutes without need of anesthesia or analgesia. The drug has been tested in clinical trials involving overall more than 1750 patients with over 1600 injections administered including over 1200 NYMOZARFEX (TM) administrations. NYMOZARFEX (TM) has led to significant long-term improvements and has shown an excellent safety profile without the side effects normally associated with existing BPH treatments. For more information please contact info@nymox.com or 800-936-9669. Forward Looking Statements To the extent that statements contained in this press release are not descriptions of historical facts regarding Nymox, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including statements regarding the need for new options to treat BPH and prostate cancer, the potential of Fexapotide to treat BPH and prostate cancer and the estimated timing of further developments for Fexapotide. Such forward-looking statements involve substantial risks and uncertainties that could cause our clinical development program, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the clinical drug development process, including the regulatory approval process, the timing of Nymox's regulatory filings, Nymox's substantial dependence on Fexapotide, Nymox's commercialization plans and efforts and other matters that could affect the availability or commercial potential of Fexapotide. Nymox undertakes no obligation to update or revise any forward looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of Nymox in general, see Nymox's current and future reports filed with the U.S. Securities and Exchange Commission, including its Annual Report on Form 20-F for the year ended December 31, 2023.

Closest thing to real steroids to use for cutting and bulking in the bodybuilding industry SAN FRANCISCO, CA / ACCESSWIRE / December 15, 2024 / For many years, professional and amateur bodybuilders have been drawn to the allure of steroids for muscle growth and strength gains, a trend observed by experienced trainers working closely with athletes over decades.But the risks of anabolic androgenic steroids-legal issues, severe side effects, and long-term damage to your health-just aren't worth it. That's why I've turned my attention to legal steroid alternatives.Legal alternatives to Dianabol and Trenbolone, for example, are designed to give you the same benefits as traditional oral and injectable steroids-more muscle, more strength, and more endurance-but without the downsides.The best part? They're legal and available to buy online in the USA.In this guide, I'll take you through the best bodybuilding steroid alternatives that not only deliver amazing results but also support your overall health and performance. Whether you want to bulk up, get lean, or enhance your athleticism, these legal steroid alternatives have you covered.Best Legal Steroids for Sale Online - IntroHere are the most effective and popular muscle building supplements and legal substitutes to traditional anabolic steroids for sale online in the USA.D-Bal Max (Dianabol)Tren-Max (Trenbolone)Crazy Bulk Stacks (4 x combo)Testo Prime (Testosterone)The listed brands and products can be ordered online and have long money back guarantees. Free delivery to the United States, Canada, UK and Australia.Top-Rated Legal Steroids for Bodybuilding:Here is a more in depth explanation of the most effective steroids for sale that are legally available to buy in the USA. Each product is from a reputable manufacturer and can be ordered directly, which passes on savings and ease of communication with customer service.#1 - D-Bal Max - Legal Dianabol SteroidCLICK to view D-Bal Max price, special offers and availabilityAs someone with years of experience in bodybuilding and training both men and women to achieve massive muscle gains, I've used and experimented with countless steroids and supplements.But when it comes to legal alternatives that can produce similar results to anabolic steroids, D-Bal Max is the most effective.D-Bal Max is designed to replicate the muscle-building power of Dianabol, one of the most famous anabolic steroids.Like other legal steroid alternatives, D-Bal Max falls under the category of dietary supplements and is subject to different regulatory standards compared to anabolic steroids.What makes it the top choice is its ability to deliver massive lean muscle growth without the dangerous side effects associated with steroids.I've had clients who wanted to bulk up quickly but were hesitant to use illegal anabolic steroids, and D-Bal Max has consistently provided them with the results they were looking for.What sets D-Bal Max apart is its powerful blend of ingredients that work synergistically to boost muscle size, strength, and endurance.It contains a combination of natural compounds like Pro BCAA Complex, 20-Hydroxyecdysterone, and a Whey Protein Complex, which together enhance protein synthesis, increase nitrogen retention, and improve energy levels.These are the same mechanisms through which Dianabol works, but D-Bal Max does it safely and legally.I've personally seen the transformation in individuals who've used D-Bal Max as part of their training regimen.Their muscles become fuller and stronger, their recovery times are shortened, and they're able to push harder in the gym.The results are not just superficial; they're substantial and sustainable, making D-Bal Max an ideal choice for anyone serious about increased muscle and bodybuilding.If you're looking to get big quickly and want a legal, safe alternative to Dianabol, D-Bal Max is the best option on the market. It delivers powerful results without the risks, and that's why I recommend it to all my clients.#2 - Tren-Max - Legal TrenboloneCLICK for promotions and price on legal Trenbolone - Tren-MaxTrenbolone is another steroid that I've used, and it's similar to Dianabol in that both are incredibly effective for rapid muscle growth and strength gains. However, Trenbolone takes it a step further by offering lean muscle gains without the water retention that often comes with Dbol.When I was looking for a legal alternative that could deliver similar results to Trenbolone, I came across Tren-Max from CrazyBulk, and I have to say, it's the best Trenbolone substitute legally available to buy in the USA.Tren-Max is designed to replicate the powerful anabolic effects of Trenbolone, but without the harsh side effects. Tren-Max is a legal alternative to performance enhancing drugs like Trenbolone, providing similar benefits without the legal and health risks. What makes Tren-Max so effective is its ability to boost muscle mass, strength, and conditioning all at once.It works by increasing nitrogen retention and red blood cell production, which are the same pathways that make Trenbolone so potent. The difference is, Tren-Max does this naturally and legally.Some of the guys I have trained who wanted the muscle density and vascularity that Trenbolone provides, didn't want to risk the severe side effects like "Tren cough," night sweats, or cardiovascular strain. Tren max has been the perfect solution for them.It's packed with natural ingredients like Beta-Sitosterol, Samento Inner Bark, Nettle Leaf Extract, and Pepsin, which together promote serious muscle growth, enhanced fat loss, and improved physical conditioning.The results I've seen with Tren-Max are impressive. My clients have experienced significant gains in muscle hardness and strength, similar to what you'd expect from a Trenbolone cycle, but without the risks associated with steroids.The strength gains are real, and the muscle definition is far more pronounced, giving that chiseled, gym-hardened look.If you're aiming to get ripped and build solid, lean muscle mass while staying on the right side of the law, Tren-Max from CrazyBulk is the way to go.It's a must have for anyone serious about achieving a powerful, shredded physique without compromising their health.#3 - Bulking Stack - Steroid Stack ComboCLICK for details and availability on CRAZY BULK Bulking StackIf you're training someone who's looking for quick and rapid muscle gains, the CrazyBulk Bulking Stack is a combination I strongly recommend.This stack contains the top legal alternatives to some of the most powerful and popular anabolic steroids: Dianabol (Dbol), Trenbolone (Tren), Deca-Durabolin (Deca), and Testosterone. Together, these legal supplements create the ultimate combination for anyone serious about packing on muscle mass fast.The CrazyBulk Bulking Stack is designed to mimic the effects of traditional bulking steroids without the dangerous side effects. The stack includes:D-Bal (Dianabol alternative): Known for rapid muscle and strength gains, D-Bal boosts protein synthesis and nitrogen retention, which are crucial for building muscle mass.Tren-Max (Trenbolone alternative): Tren-Max promotes lean muscle gains, enhanced fat loss, and increased vascularity, giving you that hard, defined look while still packing on size.Deca-max (Deca-Durabolin alternative): Deca-Max supports joint health and boosts collagen synthesis, which is essential for heavy lifting. It also enhances muscle endurance and recovery, allowing for more intense, longer workouts.Testo-Max (Testosterone alternative): Testo-Max powers the entire stack by naturally increasing testosterone levels, which is the key hormone for muscle growth, strength, and overall performance.While the stack does not include human growth hormone, it provides a comprehensive approach to muscle building and performance enhancement.When combined, these four supplements work synergistically to create an anabolic environment in your body that promotes rapid muscle growth, increased strength, and faster recovery times.The stack is perfect for pushing past plateaus and achieving the kind of muscle mass that's typically only possible with steroids, but without the legal risks or harmful side effects.If you're training someone who wants to see dramatic results quickly, the CrazyBulk Bulking Stack is an unbeatable option. It's a safe, legal, and highly effective way to achieve massive muscle gains in a short amount of time, making it the ultimate choice for serious bodybuilders and athletes.#4 - Testo Prime - Legit Testosterone BoosterCLICK to get pricing and discount deals on TestoPrime - Legal TestosteroneIf you're aiming to get ripped and build solid, lean muscle mass while staying on the right side of the law, Tren Max from CrazyBulk is the way to go.It's a game-changer for anyone serious about achieving a powerful, shredded physique without compromising their health.But let me tell you, no matter how effective your stack is, it's going to fall short if your testosterone levels aren't where they need to be. That's where TestoPrime comes into play.This is hands down the best natural testosterone booster I've come across, and it's something I recommend to everyone, whether they're just starting out or they're seasoned lifters looking to break through a plateau.TestoPrime is packed with proven ingredients that naturally elevate your testosterone levels, which is crucial for muscle growth, fat loss, and overall performance.As someone who has experimented with various T-boosters over the years, I can honestly say that TestoPrime delivers results you can feel. The increased energy, improved mood, and enhanced strength are all game-changers in the gym.There were men and women who I have worked with who were struggling with low energy, slow recovery, and just not seeing the muscle gains they were working so hard for.After adding TestoPrime to their regimen, the difference was night and day. Their strength shot up, their recovery times shortened, and they started packing on lean muscle much faster.It's also great for keeping your natural testosterone levels high when you're cycling off other supplements, ensuring that you maintain the gains you've worked so hard for.TestoPrime isn't just about boosting testosterone; it's about optimizing your entire performance. It helps burn stubborn fat, enhances mental clarity, and gives you the edge you need to dominate every workout.If you're serious about taking your training to the next level, TestoPrime is an absolute must-have in your supplement arsenal.#5 - Testol 140 - Legally Available Rad 140RAD 140, also known as Testolone, isn't an anabolic steroid, but it's a powerful SARM (Selective Androgen Receptor Modulator) that's gained a lot of attention in the bodybuilding community for its ability to mimic the effects of traditional steroids without some of the harsh side effects.It's known for delivering impressive muscle gains, enhanced strength, and improved physical conditioning. But if you're looking for a legal and safe alternative that gives you similar results, Testol 140 from CrazyBulk is the way to go.Testol 140 is designed to replicate the incredible muscle-building and fat-burning effects of RAD 140, but with a formula that's 100% natural and legal.One of the things I love about Testol 140 is that it provides the same kind of lean, hard muscle gains that you'd expect from a SARM like RAD 140, but without the risks associated with SARMs, such as potential liver toxicity or hormonal imbalances.I've had clients who were skeptical about legal alternatives, especially when they'd heard so much hype around RAD 140.But after incorporating Testol 140 into their training program, they quickly saw why this SARM is one the most effective legal steroid alternatives for targeted muscle growth. The muscle gains are substantial, and the fat loss is real, helping them achieve that shredded, lean look that's so hard to get naturally. Plus, Testol 140 also boosts energy levels and stamina, allowing you to push harder in your workouts and recover faster afterward.What really sets Testol 140 apart is that it's safe, effective, and doesn't mess with your hormones like some of the harsher substances out there.It's ideal for anyone who wants to experience the benefits of RAD 140-such as increased muscle mass, strength, and endurance-without the legal risks or side effects.If you're serious about building a lean, strong physique naturally, Testol 140 is a smart choice that delivers on its promises.What are Legal Steroids and How Do They Work as Performance Enhancing Drugs?Legal steroids (also known as steroid alternatives) are supplements that mimic the muscle building effects of anabolic steroids but without the side effects.Unlike taking anabolic steroids, which can lead to severe health risks, legal steroids offer a safer alternative for muscle growth and performance enhancement.They work by boosting the body's natural functions such as protein synthesis and nitrogen retention which are needed for muscle growth and strength.Unlike regular anabolic steroids, legal steroids do not have synthetic hormones or harmful substances so it's a safer steroid option for anyone who wants to build muscle and perform better.Benefits of Legal Steroids for Muscle MassLegal steroids is a safer and faster way to build muscle and strength without the risks of anabolic steroids.They help in building lean muscle while losing fat so you get a more defined and athletic body. These supplements also boost athletic performance and endurance so it's a favorite among bodybuilders and athletes.Plus legal steroids don't need post-cycle therapy (PCT) and are generally easier to use than regular anabolic steroids.How to Choose the Legal Steroid Alternative for YouWhen choosing a legal steroid alternative for your needs you need to consider a few things to make sure you get it right.First identify your goals-muscle mass, endurance or fat loss-and choose a product that fits. Look for products with natural ingredients and from companies that have a good safety and effectiveness record.Also read reviews and stay up to date with the latest science. As of 2024 several studies have proven certain natural ingredients in legal steroids and you can make a more educated decision. Always do your research to make sure the product you choose is safe and effective. And always consult with a doctor before starting any new supplement regimen to tailor the product to your needs and health.Safety and Side Effects of Anabolic Steroid UseLegal steroids are generally safe and don't have the same severe side effects as anabolic steroids but you can still experience mild side effects.These can be stomach upset, headaches or allergic reactions depending on your individual sensitivity to certain ingredients. The latest 2024 research confirms that these side effects are rare and mild especially when you follow the recommended dosage.To minimize the risk you need to follow the recommended dosage and consult with a doctor if you experience any adverse effects.Natural Ingredients and Their BenefitsD-Aspartic Acid: A natural amino acid that increases testosterone production which is needed for muscle growth and strength. 2024 research confirms it helps with muscle mass in athletes.Panax Ginseng: A natural herb that improves athletic performance and endurance. 2024 research shows it increases energy and reduces fatigue during intense workouts.L-Carnitine: An amino acid involved in fat metabolism and muscle growth. 2024 science proves it helps with fat loss and preserves lean muscle mass.Tyrosine: An amino acid that helps with muscle growth and recovery. It increases mental focus and reduces stress which can impact workout performance and recovery time.Can Women Use Legal Steroid Alternatives?Yes, women can use steroid alternatives to build muscle, lose fat and support overall fitness goals. But you must use steroids like Anavar for example, that are specifically designed for women to avoid virilization (development of male characteristics).Many legal steroid alternatives on the market are designed for women, powerful but balanced formulas that support lean muscle growth and fat loss without hormonal imbalance. Always follow the recommended dosage and consult with a doctor before starting any supplement to make sure it's aligned with your health and fitness goals.Are Steroid Substitutes Legal in the USA?Yes, steroid substitutes are 100% legal in the United States and available to buy online and in stores. These alternatives are made from natural ingredients and do not contain synthetic compounds found in androgenic anabolic steroids, so they are safe and legal to use.But you must choose products from reputable companies that are transparent with their ingredients and manufacturing process. Follow the recommended dosage to ensure safety and effectiveness.Before-After Results of the Best Steroid SubstitutesD-Bal MAX: Users get massive muscle gain and strength after using D-Bal MAX. It's praised for mimicking the effects of Dianabol without the side effects, so it's a top choice for those who want to bulk up fast and safely.CrazyBulk Bulking Stack: This stack combines several legal steroid substitutes and users get impressive muscle gain, strength and overall athletic performance. It's perfect for those who are under intense training and want to maximize their muscle building potential.TestoPrime: TestoPrime is highly recommended for its ability to boost testosterone levels naturally and users get massive muscle gain, strength and fat loss. Users also get more energy and faster recovery, so it's a top choice for those who want to transform their body.How to Choose the Best Over the Counter Steroid SubstitutesWhen choosing the best over the counter steroid substitutes, prioritize products made from natural ingredients and from reputable companies. Start by reading reviews and research the product to make sure it has a good safety and effectiveness record.Look for legal steroids online that are tested and backed by science or positive user reviews. And always consult with a doctor before starting any new supplement to ensure you're healthy and not taking any medications. This way you can choose the right and effective steroid alternative for your needs.Summary - Legal Steroid Alternatives and Dietary Supplements for SaleSo there you have it, legal steroid alternatives are a powerful and safe way to increase muscle growth, strength and athletic performance without the risks of anabolic steroids. These products like D-Bal MAX, CrazyBulk Bulking Stack and TestoPrime deliver impressive results by using natural ingredients that are scientifically backed and tailored to your goals.Whether you want to bulk up, lose fat or just overall physical conditioning these legal steroid alternatives are the solution. They are legal, available and designed to help you peak performance safely. Just remember, the key to success with any supplement is to choose products from reputable companies, follow the dosage and consult with a doctor to make sure they are suitable for your individual health and fitness goals.FAQWhere to buy steroids online?You can buy steroids online but in many countries including the US it's illegal to buy without a prescription. However you can buy legal steroid alternatives which are safe and work from reputable websites like CrazyBulk which specializes in natural supplements that mimic the effects of anabolic steroids.What's the best natural steroid for lean mass?The best natural supplement for lean mass is often considered to be a product like TestoPrime which boosts testosterone levels naturally and supports muscle growth and fat loss. Another popular one is Trenorol from CrazyBulk which mimics the effects of Trenbolone and gives lean muscle gains without water retention.Is buying steroids online legal?In many countries including the US it's illegal to buy anabolic steroids online without a prescription. However buying legal steroid alternatives which are made from natural ingredients and don't contain synthetic hormones is legal and can be done through online retailers.What are the safest steroid alternatives online?The safest steroid alternatives are those made from natural ingredients and sold by reputable companies. Products like D-Bal MAX, Trenorol and TestoPrime are popular ones that mimic the effects of anabolic steroids but are legal and safe to use. They are available to buy online.Can women use legal steroid alternatives?Yes women can use legal steroid alternatives but make sure to choose products designed for women to avoid side effects. Products like CrazyBulk's Anvarol and Winsol are popular for women who want to build lean muscle and burn fat safely.How do I know I'm buying safe and legal steroid alternatives online?To make sure you're buying safe and legal steroid alternatives, buy from well known companies with good reviews and transparent ingredient lists. Look for products made from natural ingredients and tested for safety and effectiveness. Consult with a healthcare professional before starting any new supplement.Top Natural Steroids for Muscle GrowthFor those seeking muscle growth without the risks associated with anabolic steroids, natural alternatives are a safer and effective option. Here are some of the top natural steroids for muscle growth:Creatine: Found naturally in foods like fish and meat, creatine helps increase muscle strength and endurance, making it a popular choice among athletes.Ashwagandha: This herb, used in Ayurvedic medicine, is known for its ability to promote muscle growth and enhance strength.Tribulus Terrestris: A plant extract that boosts testosterone levels, Tribulus Terrestris supports muscle growth and overall physical performance.D-Aspartic Acid (DAA): An amino acid that increases testosterone levels, DAA is essential for promoting muscle growth and strength.Vitamin D: An essential nutrient, Vitamin D plays a crucial role in muscle growth and strength, supporting overall health and performance.These natural supplements provide a safer alternative to anabolic steroids, helping to build muscle mass and improve strength without the associated health risks.Herbal Supplements for Muscle GrowthIn addition to natural steroids, several herbal supplements can aid in muscle growth and overall fitness. Here are some effective options:Ginseng: Known for its energy-boosting properties, ginseng helps increase endurance and enhance athletic performance.Fenugreek: This herb is known to increase testosterone levels, promoting muscle growth and strength.Safed Musli: Used in traditional Indian medicine, Safed Musli supports muscle growth and enhances physical strength.5-Alpha-Hydroxy-Laxogenin: A plant extract that promotes muscle growth and strength, 5-alpha-hydroxy-laxogenin is a popular choice among bodybuilders.While these herbal supplements can significantly aid muscle growth, they should be used alongside a healthy diet and regular exercise for the best results. Always consult with a healthcare professional before starting any new supplement to ensure it aligns with your health and fitness goals.Understanding Anabolic SteroidsAnabolic steroids are synthetic hormones designed to mimic the effects of the male sex hormone testosterone. These substances are widely used to promote muscle growth, increase strength, and enhance athletic performance. Available in various forms such as oral tablets, injectable solutions, and creams, anabolic steroids work by increasing protein synthesis, which helps build muscle mass and repair damaged tissues.However, anabolic steroids are classified as controlled substances due to their high potential for misuse and abuse. Using anabolic steroids without a medical prescription is illegal and can lead to severe health consequences. Many athletes and bodybuilders misuse anabolic steroids to gain a competitive edge, but this practice can result in significant health problems, including liver damage, high blood pressure, and cardiovascular disease. The risks associated with anabolic androgenic steroid use far outweigh the benefits, making it crucial to consider safer alternatives.Risks of Anabolic Steroid MisuseMisusing anabolic steroids can lead to a range of serious health problems, including:Liver Damage and Liver Cancer: Anabolic steroids can cause severe liver damage, leading to conditions such as liver cancer.High Blood Pressure and Cardiovascular Disease: Steroid use can raise blood pressure, increasing the risk of cardiovascular diseases, including heart attacks and strokes.Aggressive Behavior and Mood Swings: Known as "roid rage," anabolic steroids can cause significant changes in mood and behavior.Acne and Skin Problems: Steroid use can exacerbate skin conditions, leading to severe acne and other skin issues.Hair Loss and Male Pattern Baldness: Anabolic steroids can accelerate hair loss and contribute to male pattern baldness.Gynecomastia: The development of breast tissue in men, a condition known as gynecomastia, can occur with steroid misuse.Infertility and Sexual Dysfunction: Long-term use of anabolic steroids can lead to infertility and other sexual health issues.Additionally, long-term use of anabolic steroids can lead to dependence and addiction. When individuals stop using anabolic steroids, they may experience withdrawal symptoms such as depression, anxiety, and insomnia. The potential for these severe health risks underscores the importance of avoiding anabolic steroid misuse.Contact InformationTony StevensLabmeeting[email protected]4152229090SOURCE: Labmeeting

DEERFIELD, Ill.--( BUSINESS WIRE )--TerSera Therapeutics LLC announced the presentation of new real-world analyses on the use of goserelin 3.6 mg and goserelin 10.8 mg in premenopausal women with breast cancer. These data were presented in a poster session at the 2024 San Antonio Breast Cancer Symposium, held December 10-13 in San Antonio, TX. 1 A copy of the poster is available here . This was a retrospective, observational, non-inferiority study using structured, de-identified, patient-level data and curated progress notes from U.S. electronic medical record (EMR) data from the ConcertAI Patient360™ Breast Cancer Dataset. The objective of this study was to compare real-world treatment outcomes among breast cancer patients treated with goserelin 3.6 mg and 10.8 mg. The primary outcome was the real-world event-free survival (rwEFS) rate at 12 months to assess the non-inferiority of the goserelin 10.8 mg dose given every 12 weeks vs. the 3.6 mg dose given every 4 weeks. The 12-month rwEFS rates for goserelin 3.6 mg and goserelin 10.8 mg, respectively, were 76.6% vs. 79.2% (treatment difference: 2.7% [95% CI: -1.8%, 7.0%]) which supports the non-inferiority of goserelin 10.8 mg to goserelin 3.6 mg at the prespecified -15% margin based on previously published oncology trials. In evaluating time to discontinuation, this study also found that more patients remained on goserelin 10.8 mg than 3.6 mg at years 1 and 2 post treatment initiation (51.2% vs. 39.6% and 32.4% vs. 23.1%, respectively), supporting previously published data in a separate real-world evidence analysis of breast cancer patients receiving goserelin 10.8 mg. 2 “Ovarian function suppression (OFS) with gonadotropin-releasing hormone agonists (GnRHas) is an essential component of therapy for a large proportion of pre- or perimenopausal women with hormone-sensitive breast cancer,” said Kelly E. McCann, M.D., Ph.D., assistant clinical professor of medicine at the UCLA Health David Geffen School of Medicine. “ZOLADEX 3.6 mg given every 4 weeks is the only FDA-approved GnRHa for women with breast cancer. Our data suggests that the 10.8 mg dose given every 12 weeks may also be an effective option.” U.S. INDICATIONS ZOLADEX 3.6 mg and ZOLADEX 10.8 mg are indicated for: Management of locally confined Stage T2b-T4 (Stage B2-C) carcinoma of the prostate in combination with flutamide. Treatment with ZOLADEX and flutamide should start 8 weeks prior to initiating radiation therapy and continue during radiation therapy. Palliative treatment of advanced carcinoma of the prostate. ZOLADEX 3.6 mg is also indicated for: Management of endometriosis, including pain relief and reduction of endometriotic lesions for the duration of therapy. Experience with ZOLADEX for the management of endometriosis has been limited to women 18 years of age and older treated for 6 months. Use as an endometrial-thinning agent prior to endometrial ablation for dysfunctional uterine bleeding. Palliative treatment of advanced breast cancer in pre- and perimenopausal women. IMPORTANT SAFETY INFORMATION Anaphylactic reactions to ZOLADEX have been reported in the medical literature. ZOLADEX is contraindicated in patients with a known hypersensitivity to GnRH, GnRH agonist analogues, or any of the components in ZOLADEX. ZOLADEX is contraindicated during pregnancy unless used for palliative treatment of advanced breast cancer. ZOLADEX can cause fetal harm when administered to a pregnant woman. If used during pregnancy, the patient should be apprised of the potential hazard to the fetus. There is an increased risk for pregnancy loss due to expected hormonal changes that occur with ZOLADEX treatment. ZOLADEX should not be given to women with undiagnosed abnormal vaginal bleeding. Pregnancy must be excluded for use in benign gynecological conditions. Women should be advised against becoming pregnant while taking ZOLADEX. Effective nonhormonal contraception must be used by all premenopausal women during ZOLADEX therapy and for 12 weeks following discontinuation of therapy. Transient worsening of tumor symptoms, or the occurrence of additional signs and symptoms of breast cancer, may occasionally develop during the first few weeks of treatment. Some patients may experience a temporary increase in bone pain. Monitor patients at risk for complications of tumor flare. Hyperglycemia and an increased risk of developing diabetes or worsening of glycemic control in patients with diabetes have been reported in men receiving GnRH agonists like ZOLADEX. Monitor blood glucose levels and glycosylated hemoglobin (HbA1c) periodically and manage according to current clinical practice. Increased risk of developing myocardial infarction, sudden cardiac death and stroke has been reported in association with use of GnRH agonists like ZOLADEX in men. Patients receiving a GnRH agonist should be monitored for symptoms and signs suggestive of development of cardiovascular disease and be managed according to current clinical practice. Hypercalcemia has been reported in some breast cancer patients with bone metastases after starting treatment with ZOLADEX. If hypercalcemia does occur, appropriate treatment measures should be initiated. Hypersensitivity, antibody formation and acute anaphylactic reactions have been reported with GnRH agonist analogues. ZOLADEX may cause an increase in cervical resistance. Therefore, caution is recommended when dilating the cervix for endometrial ablation. GnRH agonists may prolong the QT/QTc interval. Providers should consider whether the benefits of androgen deprivation therapy outweigh the potential risks in patients with congenital long QT syndrome, congestive heart failure, frequent electrolyte abnormalities, and in patients taking drugs known to prolong the QT interval. Electrolyte abnormalities should be corrected. Consider periodic monitoring of electrocardiograms and electrolytes. Injection site injury and vascular injury including pain, hematoma, hemorrhage and hemorrhagic shock, requiring blood transfusions and surgical intervention, have been reported with ZOLADEX. Extra care should be taken when administering ZOLADEX to patients with low BMI and/or to patients receiving full dose anticoagulation. Depression may occur or worsen in women receiving GnRH agonists. Treatment with ZOLADEX may be associated with a reduction in bone mineral density over the course of treatment. Data suggest a possibility of partial reversibility. In women, current available data suggest that recovery of bone loss occurs on cessation of therapy in the majority of patients. In women, the most frequently reported adverse reactions were related to hypoestrogenism. The adverse reaction profile was similar for women treated for breast cancer, dysfunctional uterine bleeding, and endometriosis. The most commonly reported adverse reactions with ZOLADEX in clinical trials for endometriosis were: hot flashes (96%), vaginitis (75%), headache (75%), decreased libido (61%), emotional lability (60%), depression (54%), sweating (45%), acne (42%), breast atrophy (33%), seborrhea (26%), and peripheral edema (21%). The most commonly reported adverse reactions with ZOLADEX in clinical trials for endometrial thinning were: vasodilation/hot flashes (57%), headache (32%), sweating (16%), and abdominal pain (11%). The most commonly reported adverse reactions with ZOLADEX in breast cancer clinical trials were hot flashes (70%), decreased libido (47.7%), tumor flare (23%), nausea (11%), edema (5%), and malaise/fatigue/lethargy (5%). Injection site reactions were reported in less than 1% of patients. For ZOLADEX 3.6 mg: Hot flashes (62%), sexual dysfunction (21%), decreased erections (18%), lower urinary tract symptoms (13%), lethargy (8%), pain (worsened in the first 30 days) (8%), edema (7%), upper respiratory infection (7%), rash (6%), and sweating (6%). For ZOLADEX 10.8 mg: Hot flashes (64%), pain (general) (14%), gynecomastia (8%), pelvic pain (6%), and bone pain (6%). In the locally advanced carcinoma of the prostate clinical trial, additional adverse event data were collected for the combination therapy with radiation group during both the hormonal treatment and hormonal treatment plus radiation phases of this study. Adverse experiences (incidence >5%) in both phases of this study were hot flashes (46%), diarrhea (40%), nausea (9%), and skin rash (8%). Treatment with ZOLADEX and flutamide did not add substantially to the toxicity of radiation treatment alone. Please see Full Prescribing Information for ZOLADEX 3.6 mg and ZOLADEX 10.8 mg . You are encouraged to report negative side effects of prescription drugs to the FDA. Visit fda.gov/safety/medwatch or call 1-800-FDA-1088. You can also contact TerSera Therapeutics at 1-844-334-4035 or medicalInformation@tersera.com . About HR-positive breast cancer Breast cancer is the second most commonly diagnosed cancer and one of the leading causes of cancer-related deaths worldwide. 3 In the United States, over 310,000 women will be diagnosed with breast cancer this year; 40,000 will be under the age of 50. 4 Approximately 75% of diagnosed cases in women under age 50 are considered to be hormone positive (HR+) breast cancer. Compared to older women, young women generally face more aggressive cancers and lower survival rates. 5-7 Recent studies have shown that breast cancer before age 40 differs biologically from the cancer faced by older women. 6,7 About ZOLADEX® (goserelin implant) ZOLADEX is an injectable luteinizing hormone-releasing hormone agonist (LHRHa) used to treat prostate cancer, breast cancer, and certain benign gynecological disorders. First approved in the U.S. in 1989, ZOLADEX is available as a 3.6 mg implant dosed every 28 days or as a 10.8 mg implant dosed every 12 weeks. Worldwide, ZOLADEX 3.6 mg is approved for use in breast cancer in 125 countries. ZOLADEX 10.8 mg is approved for use in breast cancer in over 60 countries. About TerSera Therapeutics TerSera Therapeutics is a biopharmaceutical company with a focus in oncology and non-opioid pain management. Founded in 2016, TerSera is building new cornerstones of care through its portfolio of unique therapeutics, amplifying their ability to deliver meaningful outcomes for patients. TerSera has been recognized as a 2024 Top Workplace. For additional information, please visit TerSera.com and follow us on LinkedIn . References McCann KE, Osman N, Cannon, J, et al. Real-world outcomes comparing 3-monthly with monthly goserelin implant in premenopausal women with breast cancer. Poster presented at: San Antonio Breast Cancer Symposium (SABCS); December 10-13, 2024; San Antonio, TX. Abstract #SESS-672; Poster ID: P1-08-09. McCann KE, Kaklamani V, Osman N, et al. Treatment patterns of goserelin 3.6 mg once monthly and 10.8 mg every three months in women with breast cancer: a real-world analysis. Poster presented at: American Society of Clinical Oncology (ASCO) Quality Care Symposium; September 27-28, 2024; San Francisco, CA. Abstract #391; Poster Session B Poster F19. Bray F, Laversanne M, Sung H, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin . 2024;74(3):222-263. doi: 10.3322/caac.21834. National Cancer Institute. Surveillance, Epidemiology and End Results Program. Cancer stat facts: female breast cancer subtypes. https://seer.cancer.gov/statfacts/html/breast-subtypes.html . Accessed December 5, 2024. Varella L, Rosenberg S. Breast cancer disparities related to young age at diagnosis. Curr Breast Cancer Rep. 2022;14(3):174-179. doi:10.1007/s12609-022-00459-x. Tesch ME, Partridge AH. Treatment of breast cancer in young adults. Am Soc Clin Oncol Educ Book. 2022;42:795-803. doi:10.1200/EDBK_360970. Guzmán-Arocho YD, Rosenberg SM, Garber JE, et al. Clinicopathological features and BRCA1 and BRCA2 mutation status in a prospective cohort of young women with breast cancer. Br J Cancer . 2022;126(2):302-309. doi:10.1038/s41416-021-01597-2 . ZOLADEX® is a registered trademark of AstraZeneca or its affiliates and is used herein under license. ©2024 TerSera Therapeutics LLC. All rights reserved.