Latest news with #Drug
Business Wire
2 days ago
- Business
- Business Wire
URGN ALERT: Kirby McInerney LLP Announces the Filing of a Securities Class Action on Behalf of UroGen Pharma Ltd. Investors
NEW YORK--(BUSINESS WIRE)--The law firm of Kirby McInerney LLP announces that a class action lawsuit has been filed in the U.S. District Court for the District of New Jersey on behalf of those who acquired UroGen Pharma Ltd. ('UroGen' or the 'Company') (NASDAQ:URGN) securities during the period from July 27, 2023, through May 15, 2025 ('the Class Period'). Investors have until July 28, 2025 to apply to the Court to be appointed as lead plaintiff in the lawsuit. [LEARN MORE ABOUT THE CLASS ACTION] UroGen is a biopharmaceutical company focused on the development and commercialization of solutions for urothelial and specialty cancers. One of its lead product candidates, UGN-102, is a treatment for low-grade, intermediate-risk invasive bladder cancer. UGN-103 is currently in phase 3 of clinical trials ('ENVISION'). On May 16, 2025, the Federal Drug Administration ('FDA') released a briefing document in advance of an Oncologic Drugs Advisory Committee meeting on May 21 to discuss a New Drug Application ('NDA') for UGN-102. In the briefing, the FDA stated: 'Given that ENVISION lacked a concurrent control arm, the primary endpoints of complete response ('CR') and duration of response ('DOR') are difficult to interpret. While CR indicates drug activity of UGN-102, it is unclear whether the observed DOR can be attributed to the investigational product or instead reflects the natural history of the disease.' Moreover, the FDA questioned the long-term benefits of UGN-102, noting a lack of data on future treatments and its potential to reduce the frequency of transurethral resection of bladder tumor procedures in certain patient populations. The FDA also said it had 'recommended a randomized trial design to the Applicant several times during their product's development due to concerns with interpreting efficacy results' but UroGen 'chose not to conduct a randomized trial with a design and endpoints that the FDA considered appropriate.' On this news, the price of UroGen fell $2.54 per share, or approximately 26%, from $9.85 per share on May 15, 2025, to close at $7.31 on May 16, 2025. Then, on May 21, 2025, before the market opened, the Oncologic Drugs Advisory Committee voted against approving the UGN-102 NDA. The committee found that the overall benefit-risk of the investigational therapy UGN-102 (intravesical mitomycin) is not favorable in patients with recurrent low-grade, intermediate-risk non-muscle invasive bladder cancer. On this news, UroGen's stock price fell $3.37, or 44.7%, to close at $4.17 per share on May 21, 2025, on unusually heavy trading volume. The complaint alleges that defendants, throughout the Class Period, failed to disclose that: (1) the ENVISION clinical study was not designed to demonstrate substantial evidence of effectiveness of UGN-102 because it lacked a concurrent control arm; (2) as a result, the Company would have difficulty demonstrating that the duration of response endpoint was attributable to UGN-102; (3) UroGen failed to heed the FDA's warnings about the study design used to support a drug application for UGN-102; and (4) as a result of the foregoing, there was a substantial risk that the NDA for UGN-102 would not be approved. If you purchased or otherwise acquired UroGen securities, have information, or would like to learn more about this investigation, please contact Thomas W. Elrod of Kirby McInerney LLP by email at investigations@ or fill out the contact form below, to discuss your rights or interests with respect to these matters without any cost to you. Kirby McInerney LLP is a New York-based plaintiffs' law firm concentrating in securities, antitrust, whistleblower, and consumer litigation. The firm's efforts on behalf of shareholders in securities litigation have resulted in recoveries totaling billions of dollars. Additional information about the firm can be found at Kirby McInerney LLP's website. This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.
Business Wire
3 days ago
- Business
- Business Wire
TriSalus Life Sciences Announces Chief Financial Officer Transition With Appointment of David B. Patience
DENVER--(BUSINESS WIRE)--TriSalus Life Sciences, Inc. (Nasdaq: TLSI) (the 'Company'), an oncology company integrating novel delivery technology with standard of care therapies and its investigational immunotherapeutic to transform treatment for patients with solid tumors, today announces the appointment of David B. Patience as Chief Financial Officer, effective July 1, 2025. Mr. Patience succeeds James Young, who stepped down for personal reasons effective May 30, 2025. Dan Giordano, Vice President of Finance for TriSalus, will serve as acting Chief Financial Officer during the transition period. Mr. Young remains available to the Company to support an orderly transition. 'We are thrilled to welcome David to our leadership team,' said Mary Szela, President and CEO of TriSalus Life Sciences. 'David's strong expertise in capital markets and proven track record of financial leadership and operational execution will be invaluable and play a crucial role as we drive our next phase of growth. On behalf of our leadership team, I also thank Jim Young for his service and contributions. We wish him the best in his future endeavors.' Mr. Patience joins TriSalus from Accelerate Diagnostics, where he served as CFO since 2023. He brings extensive experience in leading strategic product portfolio planning, in-depth market analysis of organic and in-organic portfolio opportunities and technical and commercial feasibility analysis of partnerships, mergers and acquisitions. Prior to his time at Accelerate, Mr. Patience held positions with Morgan Stanley's Investment Banking Division, Continental Advisors equity group, and various financial research roles at Nuveen Investments. Mr. Patience holds a Bachelor of Science in Business Administration from the University of Colorado Leeds School of Business and an M.B.A. from the University of Chicago Booth School of Business. About TriSalus TriSalus Life Sciences ® is an oncology focused medical technology company seeking to transform outcomes for patients with solid tumors by integrating its innovative delivery technology with standard-of-care therapies, and with its investigational immunotherapeutic, nelitolimod, a class C Toll-like receptor 9 agonist, for a range of different therapeutic and technology applications. The Company's platform includes devices that utilize a proprietary drug delivery technology and a clinical stage investigational immunotherapy. The Company's two FDA-cleared devices use its proprietary Pressure-Enabled Drug Delivery™ (PEDD) approach to deliver a range of therapeutics: the TriNav ® Infusion System for hepatic arterial infusion of liver tumors and the Pancreatic Retrograde Venous Infusion System for pancreatic tumors. The PEDD technology is a novel delivery approach designed to address the anatomic limitations of arterial infusion for the pancreas. The PEDD approach modulates pressure and flow in a manner that delivers more therapeutic to the tumor and is designed to reduce undesired delivery to normal tissue, bringing the potential to improve patient outcomes. Nelitolimod, the Company's investigational immunotherapeutic candidate, is designed to improve patient outcomes by treating the immunosuppressive environment created by many tumors and which can make current immunotherapies ineffective in the liver and pancreas. Patient data generated during early Pressure-Enabled Regional Immuno-Oncology™ (PERIO) clinical trials support the hypothesis that nelitolimod delivered via the PEDD technology may have favorable immune effects within the liver and systemically. The target for nelitolimod, TLR9, is expressed across cancer types and the mechanical barriers addressed by the PEDD technology are commonly present as well. The Company is in the final stages of data completion for a number of phase 1 clinical trials and will begin exploring partnership opportunities for development. Forward Looking Statements Statements made in this press release regarding matters that are not historical facts are 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding the benefits and potential benefits of the Company's PEDD drug delivery technology, TriNav ® system and nelitolimod investigational immunotherapy, and the Company's ability to execute on its strategy. Risks that could cause actual results to differ from those expressed in these forward-looking statements include risks associated with clinical development and regulatory approval of drug delivery and pharmaceutical product candidates, including that future clinical results may not be consistent with patient data generated during the Company's clinical trials, the cost and timing of all development activities and clinical trials, unexpected safety and efficacy data observed during clinical studies, the risks associated with the credit facility, including the Company's ability to remain in compliance with all its obligations thereunder to avoid an event of default, the risk that the Company will continue to raise capital through the issuance and sale of its equity securities to fund its operations, the risk that the Company will not be able to achieve the applicable revenue requirements to access additional financing under the credit facility, the risk that the Company will not become profitable on its expected timeline, if at all, the risk that the reported financial results will differ from the estimates provided in this press release, changes in expected or existing competition or market conditions, changes in the regulatory environment, unexpected litigation or other disputes, unexpected expensed costs, and other risks described in the Company's filings with the Securities and Exchange Commission under the heading 'Risk Factors.' All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management's assumptions and estimates as of such date. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made except as required by law.
Business Upturn
4 days ago
- Business
- Business Upturn
Eton Pharmaceuticals Announces U.S. FDA Approval for KHINDIVI™ (hydrocortisone) Oral Solution
• KHINDIVI is the first and only FDA-approved hydrocortisone oral solution • Commercial launch expected the week of June 2nd • Eton expects combined peak sales of KHINDIVI and ALKINDI SPRINKLE® (hydrocortisone) oral granules to exceed $50 million DEER PARK, Ill., May 28, 2025 (GLOBE NEWSWIRE) — Eton Pharmaceuticals, Inc ('Eton' or 'the Company') (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, today announced the U.S. Food and Drug Administration (FDA) approval of a New Drug Application (NDA) for KHINDIVI™ (hydrocortisone) Oral Solution as a replacement therapy in pediatric patients five years of age and older with adrenocortical insufficiency. KHINDIVI is the only FDA-approved oral solution formulation of hydrocortisone. It comes in a 1mg/ml strength designed to eliminate the need to split or crush tablets, and to offer simple and accurate dosing specifically tailored to each patient's needs. It does not require refrigeration, mixing, or shaking – it is a ready-to-use oral liquid solution. KHINDIVI is designed to offer administration simplicity and dosing accuracy, and to provide a therapy option for patients who have difficulty swallowing tablets or with special administration needs, such as patients with a gastric tube. 'The FDA approval of KHINDIVI is a tremendous achievement for Eton and more importantly, a pivotal step forward for pediatric patients with adrenal insufficiency. As a home-grown program, our team expertly navigated the development, clinical and regulatory pathway. In addition, being in a position to commercialize KHINDIVI within days of this approval is a further testament to the executional excellence from our entire company,' said Sean Brynjelsen, CEO of Eton Pharmaceuticals. 'For decades, patients have been seeking an FDA-approved hydrocortisone liquid that allows incremental, accurate dosing in the preferred dosage form for children. We are excited to now make it available to patients. Our commercial team is fully mobilized and ready to hit the ground running within the first week of approval. We're committed to ensuring that pediatric endocrinologists across the country are aware of this important new treatment option,' continued Brynjelsen. 'Managing adrenal insufficiency in pediatric patients requires precise and consistent hydrocortisone dosing that can be carefully titrated to small increments that address the individualized pharmacokinetic needs of each child,' said Dr. Kyriakie Sarafoglou, Professor, Division of Pediatric Endocrinology & Division of Pediatric Genetics & Metabolism, University of Minnesota. 'The availability of an FDA-approved oral hydrocortisone liquid solution offers physicians a new tool to dose patients accurately, which is important to clinical outcomes during this dynamic period of growth and development.' 'For families facing the daily challenges of pediatric congenital adrenal hyperplasia (CAH), timely access to the right treatments is critical,' said Dina Matos, Executive Director of the CARES Foundation—the only U.S. organization solely focused on the CAH community. 'The introduction of KHINDIVI is a significant advancement, particularly because accurately splitting pills to achieve proper dosing for children has long been a struggle. The ability to dose patients more accurately is critical for treatment outcomes. We commend Eton for working to make this therapy accessible through specialty channels. This marks meaningful progress for our community and a vital step toward easing the daily burden on parents and caregivers.' KHINDIVI will be promoted by Eton's existing team of pediatric endocrinology rare disease specialists. Eton currently commercializes ALKINDI SPRINKLE (hydrocortisone) Oral Granules, which is FDA-approved for pediatric patients with adrenocortical insufficiency. The addition of KHINDIVI will provide adrenal insufficiency patients and caregivers with an additional option when choosing the treatment that best meets their individual needs. Adrenocortical insufficiency is a rare, but serious condition in which the adrenal glands do not produce sufficient cortisol. Eton estimates that there are more than 5,000 adrenal insufficiency patients in the U.S. between the ages of 5 and 17, and expects peak sales of KHINDIVI, combined with ALKINDI SPRINKLE, will exceed $50 million per year. KHINDIVI will be available in the coming days in the United States exclusively through Anovo, a specialty pharmacy dedicated to serving patients with rare and chronic conditions. Anovo will administer the Eton Cares Program in partnership with Eton Pharmaceuticals. The program provides prescription fulfillment, insurance benefits investigation, educational support, financial assistance for qualified patients, and other services designed to help patients access treatment. Eton Cares will offer co-pay assistance to allow for $0 co-pays for qualifying patients. Clinicians seeking to prescribe KHINDIVI can e-prescribe by selecting Anovo #5 or fax in a patient referral form to 855-813-2039. Additional product details can be found on the product website, INDICATION KHINDIVI is a corticosteroid indicated as replacement therapy in pediatric patients 5 years of age and older with adrenocortical insufficiency. Limitation of Use KHINDIVI is not approved for increased dosing during periods of stress or acute events. Use a different hydrocortisone-containing drug product for stress dosing. IMPORTANT SAFETY INFORMATION Contraindication Hypersensitivity to hydrocortisone or any of the other ingredients in KHINDIVI oral solution. Warnings and Precautions Adrenal Crisis: Undertreatment or sudden discontinuation of therapy with KHINDIVI may lead to symptoms of adrenal insufficiency, adrenal crisis, and death. Adrenal crisis may also be induced by stress events, such as infections or surgery when patients require higher doses of corticosteroids. During periods of stress (e.g., infections, surgery), switch to another oral hydrocortisone product and increase the dose if oral medications are tolerated. Monitor patients when switching to KHINDIVI to ensure KHINDIVI is providing the same level of hydrocortisone exposure as the previously used oral hydrocortisone formulation. If symptoms of adrenal insufficiency occur, increase the total daily dosage of KHINDIVI. Systemic Adverse Reactions Due to Inactive Ingredients: Hyperosmolarity KHINDIVI is not approved in pediatric patients less than 5 years of age. The inactive ingredients polyethylene glycol 400, propylene glycol, and glycerin undergo substantial systemic absorption, individually or in combination, resulting in increased plasma osmolarity in all pediatric patients, especially in pediatric patients less than 5 years of age. Monitor pediatric patients using KHINDIVI for signs and symptoms consistent with hyperosmolarity. Metabolic Acidosis and Other Adverse Reactions The inactive ingredient polyethylene glycol 400 and propylene glycol that may result in metabolic acidosis, hypoglycemia, hepato-renal injury, and central nervous system toxicity (e.g., seizure and coma), may increase the risk of adrenal crisis. Monitor laboratory values and for physical signs and symptoms of these adverse reactions. Laxative Effects Due to Inactive Ingredients The inactive ingredients polyethylene glycol 400 and glycerin, whether alone or in combination, may cause gastrointestinal irritation resulting in vomiting and/or diarrhea. These gastrointestinal reactions may increase the risk of adrenal crisis. Monitor for signs or symptoms of gastrointestinal irritation and associated fluid and electrolyte abnormalities. Immunosuppression and Increased Risk of infection with Use of a Dosage Greater Than Replacement: The use of a greater than replacement dosage can suppress the immune system and increase the risk of infection with any pathogen, including viral, bacterial, fungal, protozoan, or helminthic pathogens. Monitor for the development of infection and consider dosage reduction as needed. Growth Retardation: Long-term use in excessive doses may cause growth retardation. Use the minimum dosage of KHINDIVI to achieve desired clinical response and monitor the patient's growth. Cushing's Syndrome Due to Use of Excessive Doses of Corticosteroids: Prolonged use with supraphysiologic doses may cause Cushing's syndrome. Monitor patients for signs and symptoms of Cushing's syndrome every 6 months. Decrease in Bone Mineral Density: Corticosteroids decrease bone formation and increase bone resorption which may lead to the development of osteoporosis. Use the minimum dosage of KHINDIVI to achieve desired clinical response. Psychiatric Adverse Reactions: Use may be associated with severe psychiatric adverse reactions, such as euphoria, mania, psychosis with hallucinations and delirium, or depression. Symptoms typically emerge within a few days or weeks of starting the treatment. Most reactions resolve after either dose reduction or withdrawal, although specific treatment may be necessary. Monitor patients for behavioral and mood disturbances during treatment. Instruct caregivers and/or patients to seek medical advice if psychiatric symptoms develop. Ophthalmic Adverse Reactions: Cataracts, glaucoma, and central serous chorioretinopathy have been reported with prolonged use of high doses. Monitor patients for blurred vision or other visual disturbances, and if they occur, refer them to an ophthalmologist. Gastrointestinal Adverse Reactions: There is an increased risk of gastrointestinal perforation in patients with certain gastrointestinal disorders. Signs of gastrointestinal perforation, such as peritoneal irritation, may be masked in patients receiving corticosteroids. Corticosteroids should be used with caution if there is a probability of impending perforation, abscess, or other pyogenic infections; diverticulitis, fresh intestinal anastomoses, and active or latent peptic ulcer. Concurrent administration of corticosteroids with nonsteroidal anti-inflammatory drugs (NSAIDs) may increase the risk of gastrointestinal adverse reactions. Monitor patients receiving corticosteroids and concomitant NSAIDs for gastrointestinal adverse reactions. Risk of Kaposi's Sarcoma with Use of a Dosage Greater Than Replacement: Kaposi's sarcoma has been reported to occur in patients receiving corticosteroid therapy, most often for chronic conditions at a dosage greater than replacement (supraphysiologic dosage). If patients take a supraphysiologic chronic dosage of KHINDIVI, they are at increased risk of developing Kaposi's sarcoma. Vaccination: Administration of live vaccines may be acceptable in KHINDIVI-treated pediatric patients with adrenocortical insufficiency who receive replacement corticosteroids. Adverse Reactions The serious adverse reactions associated with KHINDIVI are adrenal crisis, systemic adverse reactions due to inactive ingredients, immunosuppression and increased risk of infection with dosage greater than replacement, Cushing's Syndrome, growth retardation, Kaposi's Sarcoma risk, psychiatric, ophthalmic and gastrointestinal adverse reactions. To report a suspected adverse event related to KHINDIVI, contact Eton Pharmaceuticals, Inc. at 1-855-224-0233 or the U.S. Food and Drug Administration (FDA) at or call 1-800-FDA-1088. Please see full Prescribing Information for more information. INDICATION AND IMPORTANT SAFETY INFORMATION Contraindication Hypersensitivity to hydrocortisone or any of the ingredients in ALKINDI SPRINKLE. Warnings and Precautions Adrenal Crisis: Undertreatment or sudden discontinuation of therapy may lead to symptoms of adrenal insufficiency, adrenal crisis, and death. Adrenal crisis may also be induced by stressor events, such as infections or surgery. Monitor patients closely when switching from other forms of hydrocortisone to ALKINDI SPRINKLE. Instruct patients and/or caregivers to contact their healthcare provider if the full dose of ALKINDI SPRINKLE is not administered, as a repeat dose may be required. Increase the dose during periods of stress. Switch patients who are vomiting, severely ill, or unable to take oral medications to parenteral corticosteroid formulations. Immunosuppression and Increased Risk of Infection with Use of a Dosage Greater Than Replacement: Use of a greater than replacement dosage can suppress the immune system and increase the risks of new infections or exacerbation of latent infections with any pathogen, including viral, bacterial, fungal, protozoan, or helminthic infections. Monitor patients for signs and symptoms of infections. Growth Retardation: Long-term use in excessive doses may cause growth retardation. Use the minimum dosage of ALKINDI SPRINKLE to achieve desired clinical response and monitor the patient's growth. Cushing's Syndrome Due to Use of Excessive Doses of Corticosteroids: Prolonged use with supraphysiologic doses may cause Cushing's syndrome. Monitor patients for signs and symptoms of Cushing's syndrome every 6 months; pediatric patients under one year of age may require more frequent monitoring. Decrease in Bone Mineral Density: Corticosteroids decrease bone formation and increase bone resorption, which may lead to inhibition of bone growth and development of osteoporosis. Use the minimum dosage of ALKINDI SPRINKLE to achieve desired clinical response. Psychiatric Adverse Reactions: Use may be associated with severe psychiatric adverse reactions, such as euphoria, mania, psychosis with hallucinations and delirium, or depression. Symptoms typically emerge within a few days or weeks of starting the treatment. Most reactions resolve after either dose reduction or withdrawal, although specific treatment may be necessary. Monitor patients for behavioral and mood disturbances during treatment. Instruct caregivers and/or patients to seek medical advice if psychiatric symptoms develop. Ophthalmic Adverse Reactions: Cataracts, glaucoma, and central serous chorioretinopathy have been reported with prolonged use of high doses. Monitor patients for blurred vision or other visual disturbances, and if they occur, refer them to an ophthalmologist. Gastrointestinal Adverse Reactions: There is an increased risk of gastrointestinal perforation in patients with certain gastrointestinal disorders. Signs of gastrointestinal perforation, such as peritoneal irritation, may be masked in patients receiving corticosteroids. Corticosteroids should be used with caution if there is a probability of impending perforation, abscess, or other pyogenic infections; diverticulitis; fresh intestinal anastomoses; and active or latent peptic ulcer. Concurrent administration of corticosteroids with nonsteroidal anti-inflammatory drugs (NSAIDs) may increase the risk of gastrointestinal adverse reactions. Monitor patients receiving corticosteroids and concomitant NSAIDs for gastrointestinal adverse reactions. Risk of Kaposi's Sarcoma with Use of a Dosage Greater Than Replacement: Kaposi's sarcoma has been reported to occur in patients receiving corticosteroid therapy, most often for chronic conditions at a dosage greater than replacement (supraphysiologic dosage). If patients take a supraphysiologic chronic dosage of ALKINDI SPRINKLE, they are at increased risk of developing Kaposi's sarcoma. Vaccination: Administration of live vaccines may be acceptable in ALKINDI SPRINKLE-treated pediatric patients with adrenocortical insufficiency who receive replacement corticosteroids. Adverse Reactions Common adverse reactions for corticosteroids include fluid retention, alteration in glucose tolerance, elevation in blood pressure, behavioral and mood changes, increased appetite, and weight gain. To report a suspected adverse event related to ALKINDI SPRINKLE, contact Eton Pharmaceuticals, Inc. at 1-855-224-0233 or the U.S. Food and Drug Administration (FDA) at or call 1-800-FDA-1088. INDICATION ALKINDI SPRINKLE is a corticosteroid indicated for replacement therapy in pediatric patients with adrenocortical insufficiency. Please see full Prescribing Information for more information. About Eton Pharmaceuticals Eton is an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases. The Company currently has eight commercial rare disease products: KHINDIVI®, INCRELEX®, ALKINDI SPRINKLE®, GALZIN®, PKU GOLIKE®, Carglumic Acid, Betaine Anhydrous, and Nitisinone. The Company has five additional product candidates in late-stage development: ET-600, Amglidia®, ET-700, ET-800 and ZENEO® hydrocortisone autoinjector. For more information, please visit our website at Forward-Looking Statements Statements contained in this press release regarding matters that are not historical facts are 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995, including statements associated with the expected ability of Eton to undertake certain activities and accomplish certain goals and objectives. These statements include but are not limited to statements regarding Eton's business strategy, Eton's plans to develop and commercialize its product candidates, the safety and efficacy of Eton's product candidates, Eton's plans and expected timing with respect to regulatory filings and approvals, and the size and growth potential of the markets for Eton's product candidates. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as 'believes,' 'anticipates,' 'plans,' 'expects,' 'intends,' 'will,' 'goal,' 'potential' and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Eton's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. These and other risks concerning Eton's development programs and financial position are described in additional detail in Eton's filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Eton undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. Investor Relations: InvestorsLisa M. Wilson, In-Site Communications, Inc.T: 212-452-2793 E: [email protected]
Yahoo
4 days ago
- Business
- Yahoo
Eton Pharmaceuticals Announces U.S. FDA Approval for KHINDIVI™ (hydrocortisone) Oral Solution
• KHINDIVI is the first and only FDA-approved hydrocortisone oral solution• Commercial launch expected the week of June 2nd• Eton expects combined peak sales of KHINDIVI and ALKINDI SPRINKLE® (hydrocortisone) oral granules to exceed $50 million DEER PARK, Ill., May 28, 2025 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc ('Eton' or 'the Company') (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, today announced the U.S. Food and Drug Administration (FDA) approval of a New Drug Application (NDA) for KHINDIVI™ (hydrocortisone) Oral Solution as a replacement therapy in pediatric patients five years of age and older with adrenocortical insufficiency. KHINDIVI is the only FDA-approved oral solution formulation of hydrocortisone. It comes in a 1mg/ml strength designed to eliminate the need to split or crush tablets, and to offer simple and accurate dosing specifically tailored to each patient's needs. It does not require refrigeration, mixing, or shaking – it is a ready-to-use oral liquid solution. KHINDIVI is designed to offer administration simplicity and dosing accuracy, and to provide a therapy option for patients who have difficulty swallowing tablets or with special administration needs, such as patients with a gastric tube. 'The FDA approval of KHINDIVI is a tremendous achievement for Eton and more importantly, a pivotal step forward for pediatric patients with adrenal insufficiency. As a home-grown program, our team expertly navigated the development, clinical and regulatory pathway. In addition, being in a position to commercialize KHINDIVI within days of this approval is a further testament to the executional excellence from our entire company,' said Sean Brynjelsen, CEO of Eton Pharmaceuticals. 'For decades, patients have been seeking an FDA-approved hydrocortisone liquid that allows incremental, accurate dosing in the preferred dosage form for children. We are excited to now make it available to patients. Our commercial team is fully mobilized and ready to hit the ground running within the first week of approval. We're committed to ensuring that pediatric endocrinologists across the country are aware of this important new treatment option,' continued Brynjelsen. 'Managing adrenal insufficiency in pediatric patients requires precise and consistent hydrocortisone dosing that can be carefully titrated to small increments that address the individualized pharmacokinetic needs of each child,' said Dr. Kyriakie Sarafoglou, Professor, Division of Pediatric Endocrinology & Division of Pediatric Genetics & Metabolism, University of Minnesota. 'The availability of an FDA-approved oral hydrocortisone liquid solution offers physicians a new tool to dose patients accurately, which is important to clinical outcomes during this dynamic period of growth and development.' 'For families facing the daily challenges of pediatric congenital adrenal hyperplasia (CAH), timely access to the right treatments is critical,' said Dina Matos, Executive Director of the CARES Foundation—the only U.S. organization solely focused on the CAH community. 'The introduction of KHINDIVI is a significant advancement, particularly because accurately splitting pills to achieve proper dosing for children has long been a struggle. The ability to dose patients more accurately is critical for treatment outcomes. We commend Eton for working to make this therapy accessible through specialty channels. This marks meaningful progress for our community and a vital step toward easing the daily burden on parents and caregivers.' KHINDIVI will be promoted by Eton's existing team of pediatric endocrinology rare disease specialists. Eton currently commercializes ALKINDI SPRINKLE (hydrocortisone) Oral Granules, which is FDA-approved for pediatric patients with adrenocortical insufficiency. The addition of KHINDIVI will provide adrenal insufficiency patients and caregivers with an additional option when choosing the treatment that best meets their individual needs. Adrenocortical insufficiency is a rare, but serious condition in which the adrenal glands do not produce sufficient cortisol. Eton estimates that there are more than 5,000 adrenal insufficiency patients in the U.S. between the ages of 5 and 17, and expects peak sales of KHINDIVI, combined with ALKINDI SPRINKLE, will exceed $50 million per year. KHINDIVI will be available in the coming days in the United States exclusively through Anovo, a specialty pharmacy dedicated to serving patients with rare and chronic conditions. Anovo will administer the Eton Cares Program in partnership with Eton Pharmaceuticals. The program provides prescription fulfillment, insurance benefits investigation, educational support, financial assistance for qualified patients, and other services designed to help patients access treatment. Eton Cares will offer co-pay assistance to allow for $0 co-pays for qualifying patients. Clinicians seeking to prescribe KHINDIVI can e-prescribe by selecting Anovo #5 or fax in a patient referral form to 855-813-2039. Additional product details can be found on the product website, INDICATION KHINDIVI is a corticosteroid indicated as replacement therapy in pediatric patients 5 years of age and older with adrenocortical insufficiency. Limitation of Use KHINDIVI is not approved for increased dosing during periods of stress or acute events. Use a different hydrocortisone-containing drug product for stress dosing. IMPORTANT SAFETY INFORMATION Contraindication Hypersensitivity to hydrocortisone or any of the other ingredients in KHINDIVI oral solution. Warnings and Precautions Adrenal Crisis: Undertreatment or sudden discontinuation of therapy with KHINDIVI may lead to symptoms of adrenal insufficiency, adrenal crisis, and death. Adrenal crisis may also be induced by stress events, such as infections or surgery when patients require higher doses of corticosteroids. During periods of stress (e.g., infections, surgery), switch to another oral hydrocortisone product and increase the dose if oral medications are tolerated. Monitor patients when switching to KHINDIVI to ensure KHINDIVI is providing the same level of hydrocortisone exposure as the previously used oral hydrocortisone formulation. If symptoms of adrenal insufficiency occur, increase the total daily dosage of KHINDIVI. Systemic Adverse Reactions Due to Inactive Ingredients: Hyperosmolarity KHINDIVI is not approved in pediatric patients less than 5 years of age. The inactive ingredients polyethylene glycol 400, propylene glycol, and glycerin undergo substantial systemic absorption, individually or in combination, resulting in increased plasma osmolarity in all pediatric patients, especially in pediatric patients less than 5 years of age. Monitor pediatric patients using KHINDIVI for signs and symptoms consistent with hyperosmolarity. Metabolic Acidosis and Other Adverse Reactions The inactive ingredient polyethylene glycol 400 and propylene glycol that may result in metabolic acidosis, hypoglycemia, hepato-renal injury, and central nervous system toxicity (e.g., seizure and coma), may increase the risk of adrenal crisis. Monitor laboratory values and for physical signs and symptoms of these adverse reactions. Laxative Effects Due to Inactive Ingredients The inactive ingredients polyethylene glycol 400 and glycerin, whether alone or in combination, may cause gastrointestinal irritation resulting in vomiting and/or diarrhea. These gastrointestinal reactions may increase the risk of adrenal crisis. Monitor for signs or symptoms of gastrointestinal irritation and associated fluid and electrolyte abnormalities. Immunosuppression and Increased Risk of infection with Use of a Dosage Greater Than Replacement: The use of a greater than replacement dosage can suppress the immune system and increase the risk of infection with any pathogen, including viral, bacterial, fungal, protozoan, or helminthic pathogens. Monitor for the development of infection and consider dosage reduction as needed. Growth Retardation: Long-term use in excessive doses may cause growth retardation. Use the minimum dosage of KHINDIVI to achieve desired clinical response and monitor the patient's growth. Cushing's Syndrome Due to Use of Excessive Doses of Corticosteroids: Prolonged use with supraphysiologic doses may cause Cushing's syndrome. Monitor patients for signs and symptoms of Cushing's syndrome every 6 months. Decrease in Bone Mineral Density: Corticosteroids decrease bone formation and increase bone resorption which may lead to the development of osteoporosis. Use the minimum dosage of KHINDIVI to achieve desired clinical response. Psychiatric Adverse Reactions: Use may be associated with severe psychiatric adverse reactions, such as euphoria, mania, psychosis with hallucinations and delirium, or depression. Symptoms typically emerge within a few days or weeks of starting the treatment. Most reactions resolve after either dose reduction or withdrawal, although specific treatment may be necessary. Monitor patients for behavioral and mood disturbances during treatment. Instruct caregivers and/or patients to seek medical advice if psychiatric symptoms develop. Ophthalmic Adverse Reactions: Cataracts, glaucoma, and central serous chorioretinopathy have been reported with prolonged use of high doses. Monitor patients for blurred vision or other visual disturbances, and if they occur, refer them to an ophthalmologist. Gastrointestinal Adverse Reactions: There is an increased risk of gastrointestinal perforation in patients with certain gastrointestinal disorders. Signs of gastrointestinal perforation, such as peritoneal irritation, may be masked in patients receiving corticosteroids. Corticosteroids should be used with caution if there is a probability of impending perforation, abscess, or other pyogenic infections; diverticulitis, fresh intestinal anastomoses, and active or latent peptic ulcer. Concurrent administration of corticosteroids with nonsteroidal anti-inflammatory drugs (NSAIDs) may increase the risk of gastrointestinal adverse reactions. Monitor patients receiving corticosteroids and concomitant NSAIDs for gastrointestinal adverse reactions. Risk of Kaposi's Sarcoma with Use of a Dosage Greater Than Replacement: Kaposi's sarcoma has been reported to occur in patients receiving corticosteroid therapy, most often for chronic conditions at a dosage greater than replacement (supraphysiologic dosage). If patients take a supraphysiologic chronic dosage of KHINDIVI, they are at increased risk of developing Kaposi's sarcoma. Vaccination: Administration of live vaccines may be acceptable in KHINDIVI-treated pediatric patients with adrenocortical insufficiency who receive replacement corticosteroids. Adverse Reactions The serious adverse reactions associated with KHINDIVI are adrenal crisis, systemic adverse reactions due to inactive ingredients, immunosuppression and increased risk of infection with dosage greater than replacement, Cushing's Syndrome, growth retardation, Kaposi's Sarcoma risk, psychiatric, ophthalmic and gastrointestinal adverse reactions. To report a suspected adverse event related to KHINDIVI, contact Eton Pharmaceuticals, Inc. at 1-855-224-0233 or the U.S. Food and Drug Administration (FDA) at or call 1-800-FDA-1088. Please see full Prescribing Information for more information. INDICATION AND IMPORTANT SAFETY INFORMATION Contraindication Hypersensitivity to hydrocortisone or any of the ingredients in ALKINDI SPRINKLE. Warnings and Precautions Adrenal Crisis: Undertreatment or sudden discontinuation of therapy may lead to symptoms of adrenal insufficiency, adrenal crisis, and death. Adrenal crisis may also be induced by stressor events, such as infections or surgery. Monitor patients closely when switching from other forms of hydrocortisone to ALKINDI SPRINKLE. Instruct patients and/or caregivers to contact their healthcare provider if the full dose of ALKINDI SPRINKLE is not administered, as a repeat dose may be required. Increase the dose during periods of stress. Switch patients who are vomiting, severely ill, or unable to take oral medications to parenteral corticosteroid formulations. Immunosuppression and Increased Risk of Infection with Use of a Dosage Greater Than Replacement: Use of a greater than replacement dosage can suppress the immune system and increase the risks of new infections or exacerbation of latent infections with any pathogen, including viral, bacterial, fungal, protozoan, or helminthic infections. Monitor patients for signs and symptoms of infections. Growth Retardation: Long-term use in excessive doses may cause growth retardation. Use the minimum dosage of ALKINDI SPRINKLE to achieve desired clinical response and monitor the patient's growth. Cushing's Syndrome Due to Use of Excessive Doses of Corticosteroids: Prolonged use with supraphysiologic doses may cause Cushing's syndrome. Monitor patients for signs and symptoms of Cushing's syndrome every 6 months; pediatric patients under one year of age may require more frequent monitoring. Decrease in Bone Mineral Density: Corticosteroids decrease bone formation and increase bone resorption, which may lead to inhibition of bone growth and development of osteoporosis. Use the minimum dosage of ALKINDI SPRINKLE to achieve desired clinical response. Psychiatric Adverse Reactions: Use may be associated with severe psychiatric adverse reactions, such as euphoria, mania, psychosis with hallucinations and delirium, or depression. Symptoms typically emerge within a few days or weeks of starting the treatment. Most reactions resolve after either dose reduction or withdrawal, although specific treatment may be necessary. Monitor patients for behavioral and mood disturbances during treatment. Instruct caregivers and/or patients to seek medical advice if psychiatric symptoms develop. Ophthalmic Adverse Reactions: Cataracts, glaucoma, and central serous chorioretinopathy have been reported with prolonged use of high doses. Monitor patients for blurred vision or other visual disturbances, and if they occur, refer them to an ophthalmologist. Gastrointestinal Adverse Reactions: There is an increased risk of gastrointestinal perforation in patients with certain gastrointestinal disorders. Signs of gastrointestinal perforation, such as peritoneal irritation, may be masked in patients receiving corticosteroids. Corticosteroids should be used with caution if there is a probability of impending perforation, abscess, or other pyogenic infections; diverticulitis; fresh intestinal anastomoses; and active or latent peptic ulcer. Concurrent administration of corticosteroids with nonsteroidal anti-inflammatory drugs (NSAIDs) may increase the risk of gastrointestinal adverse reactions. Monitor patients receiving corticosteroids and concomitant NSAIDs for gastrointestinal adverse reactions. Risk of Kaposi's Sarcoma with Use of a Dosage Greater Than Replacement: Kaposi's sarcoma has been reported to occur in patients receiving corticosteroid therapy, most often for chronic conditions at a dosage greater than replacement (supraphysiologic dosage). If patients take a supraphysiologic chronic dosage of ALKINDI SPRINKLE, they are at increased risk of developing Kaposi's sarcoma. Vaccination: Administration of live vaccines may be acceptable in ALKINDI SPRINKLE-treated pediatric patients with adrenocortical insufficiency who receive replacement corticosteroids. Adverse Reactions Common adverse reactions for corticosteroids include fluid retention, alteration in glucose tolerance, elevation in blood pressure, behavioral and mood changes, increased appetite, and weight gain. To report a suspected adverse event related to ALKINDI SPRINKLE, contact Eton Pharmaceuticals, Inc. at 1-855-224-0233 or the U.S. Food and Drug Administration (FDA) at or call 1-800-FDA-1088. INDICATION ALKINDI SPRINKLE is a corticosteroid indicated for replacement therapy in pediatric patients with adrenocortical insufficiency. Please see full Prescribing Information for more information. About Eton Pharmaceuticals Eton is an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases. The Company currently has eight commercial rare disease products: KHINDIVI®, INCRELEX®, ALKINDI SPRINKLE®, GALZIN®, PKU GOLIKE®, Carglumic Acid, Betaine Anhydrous, and Nitisinone. The Company has five additional product candidates in late-stage development: ET-600, Amglidia®, ET-700, ET-800 and ZENEO® hydrocortisone autoinjector. For more information, please visit our website at Forward-Looking Statements Statements contained in this press release regarding matters that are not historical facts are 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995, including statements associated with the expected ability of Eton to undertake certain activities and accomplish certain goals and objectives. These statements include but are not limited to statements regarding Eton's business strategy, Eton's plans to develop and commercialize its product candidates, the safety and efficacy of Eton's product candidates, Eton's plans and expected timing with respect to regulatory filings and approvals, and the size and growth potential of the markets for Eton's product candidates. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as 'believes,' 'anticipates,' 'plans,' 'expects,' 'intends,' 'will,' 'goal,' 'potential' and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Eton's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. These and other risks concerning Eton's development programs and financial position are described in additional detail in Eton's filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Eton undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. Investor Relations:InvestorsLisa M. Wilson, In-Site Communications, Inc.T: 212-452-2793E: lwilson@ MediaEliza Schleifstein, ES MediaT: 917-763-8106E: eliza@ in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
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Targeted Drug Delivery Research Business Analysis Report 2024-2030 with Focus on 30+ Key Players Such as AbbVie, Amgen, AstraZeneca, Becton Dickinson and Co, & Bristol-Myers Squibb
This report offers detailed insights into market trends and drivers, highlighting the latest tariff developments affecting the sector. It accentuates the transformative role of targeted drug delivery in enhancing therapeutic precision and systemic safety, particularly in oncology, neurology, and immunology. The advancements in nanotechnology and biomaterials are pivotal in driving this market. The report guides on market growth areas, including cardiovascular diseases and regional prospects for the USA and China. Targeted Drug Delivery Market Dublin, May 28, 2025 (GLOBE NEWSWIRE) -- The "Targeted Drug Delivery - Global Strategic Business Report" report has been added to global market for Targeted Drug Delivery was valued at US$10.0 Billion in 2024 and is projected to reach US$24.9 Billion by 2030, growing at a CAGR of 16.5% from 2024 to 2030. This comprehensive report provides an in-depth analysis of market trends, drivers, and forecasts, helping you make informed business decisions. Targeted drug delivery systems are revolutionizing the way therapeutic agents are administered by directing drugs specifically to diseased tissues or cells, thereby minimizing systemic exposure and associated side effects. Unlike conventional systemic therapies, which often impact healthy tissues, targeted approaches improve drug concentration at the site of action, enhance therapeutic efficacy, and reduce off-target toxicity. This shift is particularly crucial in oncology, neurology, and immunology, where treatment specificity can significantly influence patient outcomes. What Are the Factors Driving Growth in the Targeted Drug Delivery Market?The targeted drug delivery market is growing rapidly as pharmaceutical innovation pivots toward precision medicine, and as healthcare systems seek therapies that maximize efficacy while minimizing systemic burden. Advances in nanocarrier engineering, biomolecular targeting, and drug conjugation technologies are expanding therapeutic potential across multiple disease categories. Simultaneously, the promise of personalized, tissue-specific treatments is aligning with regulatory incentives, academic research, and commercial ahead, market momentum will depend on how effectively developers can integrate delivery innovations with therapeutic pipelines, meet evolving regulatory standards, and demonstrate clinical and economic value. As treatment paradigms shift toward more individualized, mechanism-based interventions, targeted drug delivery is poised to become a foundational enabler of next-generation medicine - driving growth at the nexus of technology, biology, and patient-centered care. How Are Nanotechnology, Biomaterials, and Smart Carriers Enhancing Targeted Drug Delivery Platforms?Advancements in nanotechnology and biomaterials are enabling the development of highly engineered carriers - such as liposomes, dendrimers, polymeric nanoparticles, and antibody-drug conjugates - that improve drug stability, control release kinetics, and facilitate selective targeting. These systems can be surface-functionalized with ligands, antibodies, or peptides to bind specifically to receptors expressed on diseased cells, enabling receptor-mediated uptake and intracellular delivery of payloads with high delivery systems are also being developed to respond to physiological stimuli - such as pH, enzymes, or temperature - ensuring drug activation only under specific conditions within diseased tissue. Such stimulus-responsive platforms enhance drug control, reduce premature degradation, and support localized therapeutic actions. Emerging innovations, including exosome-based delivery and CRISPR-loaded nanoparticles, are pushing the frontiers of targeted delivery by combining biological compatibility with molecular-level control, opening new pathways for treating previously inaccessible Therapeutic Areas and Delivery Routes Are Driving Demand for Targeted Drug Delivery Solutions?Oncology remains the largest application area for targeted drug delivery due to the need for site-specific chemotherapy, immunotherapy, and radiopharmaceuticals. Technologies such as antibody-drug conjugates and nanoparticle-based formulations are enabling selective tumor targeting, improving treatment response rates and reducing systemic side effects. Similarly, targeted delivery is gaining traction in central nervous system (CNS) disorders, where crossing the blood-brain barrier remains a significant challenge for conventional oncology and neurology, autoimmune diseases, infectious diseases, and rare genetic disorders are emerging as high-growth segments. Intravenous administration remains dominant for systemic targeting, but oral, intranasal, transdermal, and implantable routes are being developed for localized or sustained release applications. The expansion of delivery modalities tailored to disease-specific needs is increasing the versatility of targeted systems, making them viable across a broader spectrum of indications and patient Are Regulatory Pathways, Market Access, and Clinical Translation Influencing Commercialization?Targeted drug delivery products must navigate complex regulatory pathways due to their novel mechanisms, composite structures, and potential safety concerns. Agencies such as the FDA and EMA are refining guidance for nanomedicine and combination products, focusing on aspects like pharmacokinetics, toxicity profiling, and product characterization. Early engagement with regulators, robust clinical evidence, and quality-by-design (QbD) approaches are becoming critical for accelerating approval and ensuring reproducibility at access is equally dependent on cost-effectiveness, manufacturing scalability, and clinical adoption. While targeted therapies often carry high development costs, their ability to improve outcomes and reduce downstream treatment burdens can support favorable health economics. Collaborations between drug developers, device companies, and delivery technology providers are becoming more common to bridge scientific innovation and commercial viability. As real-world data and personalized diagnostics expand, payer and clinician acceptance of targeted drug delivery solutions is gaining traction across global healthcare 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 AbbVie Inc., Amgen Inc., AstraZeneca PLC, Becton Dickinson and Company, Bristol-Myers Squibb and more. Complimentary Updates: Receive free report updates for one year to keep you informed of the latest market developments. Key Insights: Market Growth: Understand the significant growth trajectory of the Cardiovascular Diseases segment, which is expected to reach US$8.6 Billion by 2030 with a CAGR of a 14.5%. The Pulmonary Diseases segment is also set to grow at 16.9% CAGR over the analysis period. Regional Analysis: Gain insights into the U.S. market, valued at $2.6 Billion in 2024, and China, forecasted to grow at an impressive 15.6% CAGR to reach $3.9 Billion by 2030. Discover growth trends in other key regions, including Japan, Canada, Germany, and the Asia-Pacific. Segments Disease Type (Cardiovascular Diseases, Pulmonary Diseases, Infectious Diseases, Endocrine Diseases, Oncological Disorders) Application (First Order Targeting, Second Order Targeting, Third Order Targeting) End-User (Hospitals, Clinics, Other End-Users) Tariff Impact Analysis: Key Insights for 2025What's Included in This Edition: Tariff-adjusted market forecasts by region and segment Analysis of cost and supply chain implications by sourcing and trade exposure Strategic insights into geographic shifts Buyers receive a free July 2025 update with: Finalized tariff impacts and new trade agreement effects Updated projections reflecting global sourcing and cost shifts Expanded country-specific coverage across the industry Key Attributes: Report Attribute Details No. of Pages 168 Forecast Period 2024 - 2030 Estimated Market Value (USD) in 2024 $10 Billion Forecasted Market Value (USD) by 2030 $24.9 Billion Compound Annual Growth Rate 16.5% Regions Covered Global Key Topics Covered: MARKET OVERVIEW Influencer Market Insights World Market Trajectories Targeted Drug Delivery - 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 Precision Medicine and Oncology Drive Rapid Innovation in Targeted Drug Delivery Technologies Nanocarriers, Liposomes, and Antibody-Drug Conjugates Enable Site-Specific Therapeutic Delivery Regulatory Approvals of mRNA and Lipid Nanoparticle Platforms Accelerate Adoption in Non-Viral Modalities Reduced Off-Target Effects and Enhanced Bioavailability Strengthen Use in Rare and Chronic Conditions Integration of Imaging-Guided and pH-Sensitive Delivery Systems Enhances Tumor Selectivity Biotech Startups Focus on Ligand-Targeted and Receptor-Specific Drug Delivery Innovations Inhalable, Transdermal, and Injectable Formats Expand Application in Pain, CNS, and Autoimmune Disorders Controlled Release Technologies Improve Dosing Compliance and Patient Outcomes R&D in RNA, CRISPR, and Gene Therapy Expands Scope for Targeted Nucleic Acid Delivery Smart Polymers and External Stimuli (e.g., magnetic, ultrasonic) Open New Frontiers in Precision Delivery FOCUS ON SELECT PLAYERS:Some of the 32 companies featured in this report AbbVie Inc. Amgen Inc. AstraZeneca PLC Becton Dickinson and Company Bristol-Myers Squibb Camurus AB Confo Therapeutics Daiichi Sankyo Co., Ltd. Eli Lilly and Company Evox Therapeutics Ltd Genmab A/S GlaxoSmithKline plc ImmunoGen, Inc. Ionis Pharmaceuticals, Inc. Johnson & Johnson Merck & Co., Inc. Novartis AG Pfizer Inc. Precision NanoSystems Inc. Seagen Inc. For more information about this report visit About 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. Attachment Targeted Drug Delivery Market CONTACT: CONTACT: Laura Wood,Senior Press Manager press@ 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 +353-1-416-8900Sign in to access your portfolio
