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Associated Press
30 minutes ago
- Business
- Associated Press
Babesiosis Incidence in U.S. 10x Higher Than CDC Estimates, According to Insurance Claims Study Commissioned by 60 Degrees Pharmaceuticals
WASHINGTON, June 03, 2025 (GLOBE NEWSWIRE) -- 60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP; SXTPW) ('60 Degrees' or the 'Company'), a pharmaceutical company focused on developing new medicines for infectious diseases, today announced results of an insurance claims analysis related to babesiosis and chronic fatigue, as conducted by Komodo Health, a healthcare technology company that delivers the evidentiary standard for real-world data and analytics, contracted by the Company. Results showed approximately 25,000 Americans seek reimbursement for babesiosis-related medical costs each year, according to 60 Degrees Pharmaceuticals. In contrast, current estimates published by the Centers for Disease Control and Prevention (CDC) show only 2,000 cases in 2020. Babesia infections last at least 12 months in 14 percent of patients and may relapse up to 27 months later, as documented in the scientific literature. Many physicians treating tick-borne infections speculate the true duration of infection may be much longer. The claims data indicated approximately 31 percent of babesiosis cases persist longer than 30 days, and that nearly half of those are associated with chronic fatigue lasting longer than six months. Fatigue is the last symptom of babesiosis to resolve in acute disease. Chronic fatigue during babesiosis has not been systematically described in the literature. Further, the claims data, which captured approximately 40 percent of U.S. diagnostic data, showed that over three years, more than 12 million U.S. adults experienced chronic fatigue greater than six months in duration. Current Infectious Diseases Society of America advice and other professional guidelines do not mandate babesiosis as a differential diagnosis if a patient self-reports experiencing such fatigue. The Company is testing, through its clinical development program, the medical hypothesis that the true burden of babesiosis is much larger than claims data suggest and is a function of the incidence of chronic fatigue lasting six months or longer, multiplied by the proportion of such individuals with confirmable infections. A molecular incidence study in patients with chronic fatigue commissioned by the Company was recently completed. Once published, the data will allow establishment of a ceiling on the incidence of persistent babesiosis. Clinical Babesiosis Studies Sponsored by 60 Degrees Pharmaceuticals Three 60 Degrees Pharmaceuticals-sponsored clinical trials ( NCT06478641, NCT06207370, NCT06656351 ) are underway or planned to evaluate tafenoquine's safety and efficacy in treating humans diagnosed with babesiosis. Data are expected from one or more of these studies in the first half of 2026 and will be used as part of a planned New Drug Application (NDA) submission to the U.S. Food and Drug Administration for babesiosis, anticipated in 2026. About ARAKODA® (tafenoquine) Tafenoquine was discovered by Walter Reed Army Institute of Research. Tafenoquine was approved for malaria prophylaxis in 2018 in the United States as ARAKODA® and in Australia as KODATEF®. Both were commercially launched in 2019 and are currently distributed through pharmaceutical wholesaler networks in each respective country. They are available at retail pharmacies as a prescription-only malaria prevention drug. According to the Centers for Disease Control and Prevention, the long terminal half-life of tafenoquine, which is approximately 16 days, offers the advantage of less frequent dosing for the prophylaxis of malaria. ARAKODA® is not suitable for everyone, and patients and prescribers should review the Important Safety Information below. Individuals at risk of contracting malaria are prescribed ARAKODA® 2 x 100 mg tablets once per day for three days (the loading phase) prior to travel to an area of the world where malaria is endemic, 2 x 100 mg tablets weekly for up to six months during travel, then 2 x 100 mg in the week following travel. ARAKODA® (tafenoquine) Important Safety Information ARAKODA® is an antimalarial indicated for the prophylaxis of malaria in patients aged 18 years and older. Contraindications ARAKODA® should not be administered to: Warnings and Precautions Hemolytic Anemia: G6PD testing must be performed before prescribing ARAKODA® due to the risk of hemolytic anemia. Monitor patients for signs or symptoms of hemolysis. G6PD Deficiency in Pregnancy or Lactation: ARAKODA® may cause fetal harm when administered to a pregnant woman with a G6PD-deficient fetus. ARAKODA® is not recommended during pregnancy. A G6PD-deficient infant may be at risk for hemolytic anemia from exposure to ARAKODA® through breast milk. Check infant's G6PD status before breastfeeding begins. Methemoglobinemia: Asymptomatic elevations in blood methemoglobin have been observed. Initiate appropriate therapy if signs or symptoms of methemoglobinemia occur. Psychiatric Effects: Serious psychotic adverse reactions have been observed in patients with a history of psychosis or schizophrenia, at doses different from the approved dose. If psychotic symptoms (hallucinations, delusions, or grossly disorganized thinking or behavior) occur, consider discontinuation of ARAKODA® therapy and evaluation by a mental health professional as soon as possible. Hypersensitivity Reactions: Serious hypersensitivity reactions have been observed with administration of ARAKODA®. If hypersensitivity reactions occur, institute appropriate therapy. Delayed Adverse Reactions: Due to the long half-life of ARAKODA® (approximately 16 days), psychiatric effects, hemolytic anemia, methemoglobinemia, and hypersensitivity reactions may be delayed in onset and/or duration. Adverse Reactions: The most common adverse reactions (incidence greater than or equal to 1 percent) were: headache, dizziness, back pain, diarrhea, nausea, vomiting, increased alanine aminotransferase (ALT), motion sickness, insomnia, depression, abnormal dreams, and anxiety. Drug Interactions Avoid co-administration with drugs that are substrates of organic cation transporter-2 or multidrug and toxin extrusion transporters. Use in Specific Populations Lactation: Advise women not to breastfeed a G6PD-deficient infant or infant with unknown G6PD status during treatment and for 3 months after the last dose of ARAKODA®. To report SUSPECTED ADVERSE REACTIONS, contact 60 Degrees Pharmaceuticals, Inc. at 1- 888-834-0225 or the FDA at 1-800-FDA-1088 or The full prescribing information of ARAKODA® is located here. About 60 Degrees Pharmaceuticals, Inc. 60 Degrees Pharmaceuticals, Inc., founded in 2010, specializes in developing and marketing new medicines for the treatment and prevention of infectious diseases that affect the lives of millions of people. 60 Degrees Pharmaceuticals, Inc. achieved FDA approval of its lead product, ARAKODA® (tafenoquine), for malaria prevention, in 2018. 60 Degrees Pharmaceuticals, Inc. also collaborates with prominent research organizations in the U.S., Australia, and Singapore. The 60 Degrees Pharmaceuticals, Inc. mission has been supported through in-kind funding from the U.S. Department of Defense and private institutional investors including Knight Therapeutics Inc., a Canadian-based Pan-American specialty pharmaceutical company. 60 Degrees Pharmaceuticals, Inc. is headquartered in Washington D.C., with a majority-owned subsidiary in Australia. Learn more at The statements contained herein may include prospects, statements of future expectations and other forward-looking statements that are based on management's current views and assumptions and involve known and unknown risks and uncertainties. Actual results, performance or events may differ materially from those expressed or implied in such forward-looking statements. Cautionary Note Regarding Forward-Looking Statements This press release may contain 'forward-looking statements' within the meaning of the safeharbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward‐looking statements reflect the current view about future events. When used in this press release, the words 'anticipate,' 'believe,' 'estimate,' 'expect,' 'future,' 'intend,' 'plan,' or the negative of these terms and similar expressions, as they relate to us or our management, identify forward‐looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and trends, the economy, activities of regulators and future regulations and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results and financial condition may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause our actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the following: there is substantial doubt as to our ability to continue on a going-concern basis; we might not be eligible for Australian government research and development tax rebates; if we are not able to successfully develop, obtain FDA approval for, and provide for the commercialization of non-malaria prevention indications for tafenoquine (ARAKODA® or other regimen) or Celgosivir in a timely manner, we may not be able to expand our business operations; we may not be able to successfully conduct planned clinical trials or patient recruitment in our trials might be slow or negligible; and we have no manufacturing capacity which puts us at risk of lengthy and costly delays of bringing our products to market. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission ('SEC'), including the information contained in our Annual Report on Form 10-K filed with the SEC on April 1, 2024, and our subsequent SEC filings. Investors and security holders are urged to read these documents free of charge on the SEC's website at As a result of these matters, changes in facts, assumptions not being realized or other circumstances, the Company's actual results may differ materially from the expected results discussed in the forward-looking statements contained in this press release. Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise. Media Contacts: Sheila A. Burke [email protected] (484) 667-6330 Investor Contact: Patrick Gaynes [email protected]
Yahoo
4 hours ago
- Business
- Yahoo
CORCEPT THERAPEUTICS ANNOUNCES FIRST QUARTER FINANCIAL RESULTS AND PROVIDES CORPORATE UPDATE
Revenue of $157.2 million, compared to $146.8 million in first quarter 2024 Reiterated 2025 revenue guidance of $900 – $950 million Net income per common share (diluted) of $0.17, compared to $0.25 in first quarter 2024 Cash and investments of $570.8 million as of March 31, 2025 REDWOOD CITY, Calif., May 05, 2025--(BUSINESS WIRE)--Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat serious endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol, today reported its results for the quarter ended March 31, 2025. Financial Results "In the first quarter, we had another record number of prescriptions from new and existing prescribers, broadly distributed throughout the country. Growing physician awareness of hypercortisolism has resulted in increased screening and treatment of patients with this devastating disease. Our specialty pharmacy vendor began the quarter unable to fulfill this surge in demand, which negatively affected our first quarter financial results. Pharmacy operations improved substantially in March and April, with each month setting a record for tablets dispensed. We are reiterating our 2025 revenue guidance of $900 – $950 million," said Joseph K. Belanoff, M.D., Corcept's Chief Executive Officer. Corcept's first quarter 2025 revenue was $157.2 million, compared to $146.8 million in the first quarter of 2024. First quarter 2025 operating expenses were $153.8 million, compared to $117.3 million in the same period last year. Net income was $20.5 million in the first quarter of 2025, compared to $27.8 million in the first quarter of 2024. Cash and investments were $570.8 million at March 31, 2025, compared to $603.2 million at December 31, 2024. The balance at March 31, 2025 reflects the acquisition of $43.3 million of common stock in the first quarter pursuant to the company's stock repurchase program, net exercise of employee stock options and net vesting of restricted stock grants. Clinical Development "Our New Drug Application (NDA) for relacorilant in hypercortisolism is progressing towards approval by the end of this year. We will submit our NDA next quarter for relacorilant in platinum-resistant ovarian cancer. We expect that relacorilant will have a role in helping treat earlier stages of ovarian cancer and other tumors that express the glucocorticoid receptor and have already begun our next clinical trial, BELLA. Meanwhile, we are making progress in understanding the role of cortisol modulation to treat a broad range of other serious disorders, including ALS and Metabolic Dysfunction-Associated Steatohepatitis (MASH)," added Dr. Belanoff. Hypercortisolism (Cushing's Syndrome) Relacorilant for patients with hypercortisolism – U.S. Food and Drug Administration (FDA) accepted NDA for filing; Prescription Drug User Fee Act (PDUFA) target action date of December 30, 2025 GRACE – Pivotal Phase 3 trial of relacorilant in 152 patients with all etiologies of hypercortisolism – Results presented at Endocrine Society (ENDO) annual meeting and Heart in Diabetes (HiD) conference in June 2024 GRADIENT – Randomized, double-blind, placebo-controlled, Phase 3 trial of relacorilant in 137 patients with hypercortisolism caused by adrenal gland pathology – Results will be presented at American Association of Clinical Endocrinology (AACE) annual meeting in May 2025 Phase 3 long-term extension study of 116 patients who completed the GRACE, GRADIENT or Phase 2 relacorilant studies – Results presented at World Congress on Insulin Resistance, Diabetes and Cardiovascular Disease (WCIRDC) in December 2024 CATALYST Part 1 – Prevalence of hypercortisolism in patients with difficult-to-control type 2 diabetes – Results published in Diabetes Care in April 2025 CATALYST Part 2 – Randomized, double-blind, placebo-controlled study of Korlym® in 136 patients with hypercortisolism – Results to be presented at the American Diabetes Association's 85th Scientific Sessions (ADA) in June 2025 MOMENTUM – Enrollment continues in 1,000-patient trial examining the prevalence of hypercortisolism in patients with resistant hypertension – Results expected by year-end "The positive results from our pivotal GRACE, GRADIENT, long-term extension and Phase 2 studies provide powerful support for the NDA for relacorilant in hypercortisolism. Patients in these studies experienced clinically significant improvements in a wide array of the signs and symptoms of hypercortisolism, without the off-target effects and toxicities that accompany currently available treatments. Relacorilant has the potential to become the new standard of care for patients with hypercortisolism," said Bill Guyer, PharmD, Corcept's Chief Development Officer. "CATALYST is a landmark study that will change the way physicians treat some of their sickest patients. Its findings are striking: One in four patients whose diabetes resists treatment with the best available medications have hypercortisolism; hyperglycemia in these patients responds powerfully to treatment with a cortisol modulator. We reached an important milestone with the publication of CATALYST's prevalence phase results in Diabetes Care and look forward to presenting the full results of the study's treatment phase at ADA next month," added Dr. Guyer. "Building on the insights from CATALYST, our MOMENTUM study will deepen physicians' understanding of hypercortisolism as a cause of resistant hypertension." Oncology Relacorilant for patients with platinum-resistant ovarian cancer – NDA submission expected in the third quarter with submission of Marketing Authorization Application (MAA) in Europe shortly thereafter ROSELLA – Primary endpoint of improved progression-free survival (PFS) met in pivotal Phase 3 trial of relacorilant plus nab-paclitaxel in 381 patients with platinum-resistant ovarian cancer (hazard ratio: 0.70; p-value: 0.008; median PFS of 6.5 versus 5.5 months); interim evaluation of overall survival (OS) (hazard ratio: 0.69; p-value: 0.01; median OS of 16.0 versus 11.5 months), with no increase in side effect burden – Results to be presented at the American Society of Clinical Oncology (ASCO) annual meeting in June 2025 BELLA – Enrollment underway in Phase 2 trial of relacorilant plus nab-paclitaxel and bevacizumab in 90 patients with platinum-resistant ovarian cancer Early-stage prostate cancer – Enrollment continues in randomized, placebo-controlled, Phase 2 trial of relacorilant plus enzalutamide in patients with early-stage prostate cancer, conducted in collaboration with the University of Chicago "The ROSELLA results are an important advance for patients with platinum-resistant ovarian cancer, a disease with few treatment options. The PFS and OS improvements demonstrated in ROSELLA, with no increase in safety burden, bring us closer to delivering a new standard of care for these patients. We look forward to presenting the full results from ROSELLA in a late-breaker session at ASCO and submitting our NDA next quarter," said Dr. Guyer. "We are building on the findings from ROSELLA with our BELLA study, which will examine whether combining relacorilant with two medications – nab-paclitaxel and bevacizumab – will offer patients with platinum-resistant ovarian cancer another potent treatment option." Amyotrophic Lateral Sclerosis (ALS) DAZALS – In a randomized, double-blind, placebo-controlled Phase 2 study in 249 patients with ALS, dazucorilant did not meet the primary endpoint of improvement in the ALS Functional Rating Scale-Revised (ALSFRS-R) DAZALS – An exploratory analysis at the one-year mark shows that patients who received 300 mg of dazucorilant at baseline demonstrate significantly improved overall survival, compared to patients who received placebo and did not switch to dazucorilant in the long-term extension study (hazard ratio of 0.16, p-value: 0.0009) DAZALS – Results to be presented at European Network to Cure ALS (ENCALS) annual meeting in June 2025 "ALS is a devastating disease. Patients who received dazucorilant did not show improvement in the ALS Functional Rating Scale-Revised (ALSFRS-R), which was DAZALS' primary endpoint. An improvement in overall survival, first seen at the six-month mark, was also observed at year one of the study. An exploratory analysis determined that patients who received 300 mg of dazucorilant at the start of the study lived significantly longer than patients who received placebo and did not switch to dazucorilant in the long-term extension study, with a hazard ratio of 0.16 (p-value: 0.0009). This long-term extension study is on-going. We will immediately seek input from U.S. and European regulatory authorities on the next steps with dazucorilant," said Dr. Guyer. Metabolic Dysfunction-Associated Steatohepatitis (MASH) MONARCH – Enrollment continues in randomized, double-blind, placebo-controlled, Phase 2b trial of miricorilant in patients with biopsy-confirmed or presumed MASH "In our Phase 1b study, miricorilant reduced liver fat very rapidly, improved liver health and key metabolic and lipid measures and was well-tolerated. We look forward to building on these promising results in our MONARCH study. First results are expected by the end of next year," said Dr. Guyer. Conference Call We will hold a conference call on May 5, 2025, at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time). Participants must register in advance of the conference call by clicking here. Upon registering, each participant will receive a dial-in number and a unique access PIN. Each access PIN will accommodate one caller. A listen-only webcast will be available by clicking here. A replay of the call will be available on the Investors / Events tab of About Corcept Therapeutics For over 25 years, Corcept has focused on cortisol modulation and its potential to treat patients with a wide variety of serious disorders, leading to the discovery of more than 1,000 proprietary selective cortisol modulators and glucocorticoid receptor antagonists. Corcept is conducting advanced clinical trials in patients with hypercortisolism, solid tumors, ALS and liver disease. In February 2012, the company introduced Korlym, the first medication approved by the U.S. Food and Drug Administration for the treatment of patients with endogenous hypercortisolism. Corcept is headquartered in Redwood City, California. For more information, visit Forward-Looking Statements Statements in this press release, other than statements of historical fact, are forward-looking statements based on our current plans and expectations and are subject to risks and uncertainties that might cause our actual results to differ materially from those such statements express or imply. These risks and uncertainties include, but are not limited to, those related to our ability to: operate our business; study and develop Korlym, relacorilant, miricorilant, dazucorilant and our other product candidates; our investigational compounds' clinical attributes, regulatory approvals, mandates, oversight and other requirements; and the scope and protective power of our intellectual property. These risks and uncertainties are set forth in our SEC filings, which are available at our website and the SEC's website. In this press release, forward-looking statements include those concerning: trends in medical practice, including trends regarding the identification and treatment of patients with hypercortisolism; our 2025 revenue guidance and factors that may affect our revenue and continued revenue growth, such as increased uptake or price reductions in competing medications, including generic versions of Korlym, and the performance of our third-party pharmacy and other vendors; relacorilant as a treatment for patients with hypercortisolism and ovarian and other cancers, dazucorilant as a treatment for patients with ALS, miricorilant as a treatment for patients with MASH; the timing and outcome of relacorilant's NDAs and planned MAA in hypercortisolism and ovarian cancer; the timing and outcome of our CATALYST, MOMENTUM, ROSELLA, BELLA, DAZALS and MONARCH trials and their impact on patient care and Corcept's commercial prospects; and the accrual and attributes of our clinical data. We disclaim any intention or duty to update forward-looking statements made in this press release. CORCEPT THERAPEUTICS INCORPORATED CONDENSED CONSOLIDATED BALANCE SHEETS (In thousands) March 31, 2025 December 31, 2024(1) (Unaudited) Assets Cash and investments $ 570,804 $ 603,165 Trade receivables, net of allowances 61,819 53,976 Inventory 15,534 15,995 Operating lease right-of-use asset 5,147 5,324 Deferred tax assets, net 144,445 130,914 Other assets 48,706 31,179 Total assets $ 846,455 $ 840,553 Liabilities and Stockholders' Equity Accounts payable $ 27,947 $ 15,376 Operating lease liabilities 6,835 6,936 Other liabilities 128,388 138,652 Stockholders' equity 683,285 679,589 Total liabilities and stockholders' equity $ 846,455 $ 840,553 (1) Derived from audited financial statements at that date CORCEPT THERAPEUTICS INCORPORATED CONDENSED CONSOLIDATED STATEMENTS OF INCOME (In thousands, except per share data) Three Months Ended March 31, 2025 2024 Revenues Product revenue, net $ 157,214 $ 146,808 Operating expenses Cost of sales 2,403 2,535 Research and development 60,735 58,505 Selling, general and administrative 90,660 56,268 Total operating expenses 153,798 117,308 Income from operations 3,416 29,500 Interest and other income 6,202 5,493 Income before income taxes 9,618 34,993 Income tax benefit (expense) 10,929 (7,231 ) Net income $ 20,547 $ 27,762 Net income attributable to common stockholders $ 20,288 $ 27,514 Basic net income per common share $ 0.19 $ 0.27 Diluted net income per common share $ 0.17 $ 0.25 Weighted-average shares outstanding used in computing net income per common share Basic 104,106 102,791 Diluted 119,819 109,915 View source version on Contacts Investor inquiries:ir@ Media inquiries:communications@
Associated Press
a day ago
- Business
- Associated Press
FDA expands XENOVIEW® indication to include children from six years of age
DURHAM, NC and LONDON, June 02, 2025 (GLOBE NEWSWIRE) -- Polarean Imaging plc (AIM: POLX) ('Polarean' or the 'Company'), a commercial-stage medical imaging technology leader in functional Magnetic Resonance Imaging ('MRI') of the lungs, announces that the US Food and Drug Administration ('FDA') has approved the Company's Supplemental New Drug Application ('NDA') to expand the indication of XENOVIEW®. This approval immediately lowers the minimum patient age from 12 to six years old, significantly broadening access to this technology and expanding Polarean's total addressable market. The approval means that XENOVIEW can now be used with MRI for evaluation of lung ventilation in adults and pediatric patients aged six years and older, representing an increase in the number of eligible patients by approximately one million. The FDA supplement approval also includes the introduction of new XENOVIEW Dose Delivery Bag sizes tailored for smaller lungs of younger patients and corresponding updates to the HPX Polarization Measurement Station to measure various bag sizes. This approval reinforces Polarean's dedication to advancing functional lung imaging and increasing access to its technology, enabling enhanced care for a broader patient population. Christopher von Jako, Ph.D., Chief Executive Officer of Polarean, said: 'We are delighted that the FDA has approved our Supplemental NDA, allowing XENOVIEW to be used in younger pediatric patients, increasing the number of patients eligible to use our technology by approximately one million. This expanded indication further enhances our technology's clinical utility, offering clinicians an advanced tool to assess the lungs in children with chronic respiratory conditions, and strengthens its return on investment for hospitals. We look forward to launching a controlled US market release of the pediatric Dose Delivery Bags later this year, starting with Cincinnati Children's.' Erik Hysinger, MD, Pediatric Pulmonologist from Cincinnati Children's, said: 'This approval is an exciting step for children with chronic lung diseases, such as cystic fibrosis, asthma, bronchopulmonary dysplasia, and inflammation following bone-marrow transplant. For years, I've studied Xenon MRI in children ages 6 to 12, and expanding access to younger patients offers clinicians a powerful tool to characterize disease progression, monitor response to therapy, and guide interventions like airway dilation or tissue removal. This imaging platform enhances our ability to deliver more personalized, precise care for children with complex respiratory conditions.' For more information, visit About Polarean Polarean is a revenue-generating medical imaging technology company revolutionizing pulmonary medicine through direct visualization of lung function by introducing the power and safety of MRI to the respiratory healthcare community. This community is in desperate need of modern solutions to accurately assess lung function. The Company strives to optimize lung health and prevent avoidable loss by illuminating hidden disease, addressing the global unmet medical needs of more than 500 million patients worldwide suffering from chronic respiratory disease. Polarean is a leader in the field of hyperpolarization science and has successfully developed the first and only hyperpolarized Xenon MRI inhaled contrast agent, XENOVIEW®, which is now FDA-approved in the United States. Polarean is dedicated to researching, developing, and commercializing innovative imaging solutions with its non-invasive and radiation-free pulmonary functional MRI platform. This comprehensive drug-device platform encompasses the proprietary Xenon gas blend, gas hyperpolarization system, as well as software and accessories, facilitating fully integrated modern respiratory imaging operations. Founded in 2012, with offices in Durham, NC, and London, United Kingdom, Polarean is committed to increasing global awareness of and broad access to its XENOVIEW MRI technology platform. For the latest news and information about Polarean, please visit XENOVIEW IMPORTANT SAFETY INFORMATION Indication XENOVIEW™, prepared from the Xenon Xe 129 Gas Blend, is a hyperpolarized contrast agent indicated for use with magnetic resonance imaging (MRI) for evaluation of lung ventilation in adults and pediatric patients aged 6 years and older. Limitations of Use XENOVIEW has not been evaluated for use with lung perfusion imaging. CONTRAINDICATIONS None. Warnings and Precautions Risk of Decreased Image Quality from Supplemental Oxygen: Supplemental oxygen administered simultaneously with XENOVIEW inhalation can cause degradation of image quality. For patients on supplemental oxygen, withhold oxygen inhalation for two breaths prior to XENOVIEW inhalation, and resume oxygen inhalation immediately following the imaging breath hold. Risk of Transient Hypoxia: Inhalation of an anoxic gas such as XENOVIEW may cause transient hypoxemia in susceptible patients. Monitor all patients for oxygen desaturation and symptoms of hypoxemia and treat as clinically indicated. Adverse Reactions Adverse Reactions in Adult Patients: The adverse reactions (> one patient) in efficacy trials were oropharyngeal pain, headache, and dizziness. Adverse Reactions in Pediatric and Adolescent Patients: In published literature in pediatric patients aged 6 to 18, transient adverse reactions were reported: blood oxygen desaturation, heart rate elevation, numbness, tingling, dizziness, and euphoria. In at least one published study of pediatric patients aged 6 to 18 years, transient decrease in SpO2% and transient increase in heart rate was reported following hyperpolarized xenon Xe 129 administration. Please see full prescribing information at Contact Information: Polarean: Chuck Osborne Chief Financial Officer +1 (919) 206-7900, ext. 117 [email protected] [email protected] [email protected] General inquiries: [email protected] Follow Polarean on LinkedIn here Polarean: Chuck Osborne Chief Financial Officer +1 (919) 206-7900, ext. 117 [email protected] Polarean Investors: Anna Dunphy / Phillip Marriage +44 (0)20 7933 8780 [email protected] Polarean Media Contact: Alexis Opp +1 (919) 206-7900, ext. 145 [email protected] General inquiries: [email protected]
Yahoo
a day ago
- Business
- Yahoo
FDA expands XENOVIEW® indication to include children from six years of age
Increases number of eligible patients by approximately one million DURHAM, NC and LONDON, June 02, 2025 (GLOBE NEWSWIRE) -- Polarean Imaging plc (AIM: POLX) ('Polarean' or the 'Company'), a commercial-stage medical imaging technology leader in functional Magnetic Resonance Imaging ("MRI") of the lungs, announces that the US Food and Drug Administration ('FDA') has approved the Company's Supplemental New Drug Application ('NDA') to expand the indication of XENOVIEW®. This approval immediately lowers the minimum patient age from 12 to six years old, significantly broadening access to this technology and expanding Polarean's total addressable market. The approval means that XENOVIEW can now be used with MRI for evaluation of lung ventilation in adults and pediatric patients aged six years and older, representing an increase in the number of eligible patients by approximately one million. The FDA supplement approval also includes the introduction of new XENOVIEW Dose Delivery Bag sizes tailored for smaller lungs of younger patients and corresponding updates to the HPX Polarization Measurement Station to measure various bag sizes. This approval reinforces Polarean's dedication to advancing functional lung imaging and increasing access to its technology, enabling enhanced care for a broader patient population. Christopher von Jako, Ph.D., Chief Executive Officer of Polarean, said: "We are delighted that the FDA has approved our Supplemental NDA, allowing XENOVIEW to be used in younger pediatric patients, increasing the number of patients eligible to use our technology by approximately one million. This expanded indication further enhances our technology's clinical utility, offering clinicians an advanced tool to assess the lungs in children with chronic respiratory conditions, and strengthens its return on investment for hospitals. We look forward to launching a controlled US market release of the pediatric Dose Delivery Bags later this year, starting with Cincinnati Children's.' Erik Hysinger, MD, Pediatric Pulmonologist from Cincinnati Children's, said: 'This approval is an exciting step for children with chronic lung diseases, such as cystic fibrosis, asthma, bronchopulmonary dysplasia, and inflammation following bone-marrow transplant. For years, I've studied Xenon MRI in children ages 6 to 12, and expanding access to younger patients offers clinicians a powerful tool to characterize disease progression, monitor response to therapy, and guide interventions like airway dilation or tissue removal. This imaging platform enhances our ability to deliver more personalized, precise care for children with complex respiratory conditions.' For more information, visit PolareanPolarean is a revenue-generating medical imaging technology company revolutionizing pulmonary medicine through direct visualization of lung function by introducing the power and safety of MRI to the respiratory healthcare community. This community is in desperate need of modern solutions to accurately assess lung function. The Company strives to optimize lung health and prevent avoidable loss by illuminating hidden disease, addressing the global unmet medical needs of more than 500 million patients worldwide suffering from chronic respiratory disease. Polarean is a leader in the field of hyperpolarization science and has successfully developed the first and only hyperpolarized Xenon MRI inhaled contrast agent, XENOVIEW®, which is now FDA-approved in the United States. Polarean is dedicated to researching, developing, and commercializing innovative imaging solutions with its non-invasive and radiation-free pulmonary functional MRI platform. This comprehensive drug-device platform encompasses the proprietary Xenon gas blend, gas hyperpolarization system, as well as software and accessories, facilitating fully integrated modern respiratory imaging operations. Founded in 2012, with offices in Durham, NC, and London, United Kingdom, Polarean is committed to increasing global awareness of and broad access to its XENOVIEW MRI technology platform. For the latest news and information about Polarean, please visit IMPORTANT SAFETY INFORMATION IndicationXENOVIEW™, prepared from the Xenon Xe 129 Gas Blend, is a hyperpolarized contrast agent indicated for use with magnetic resonance imaging (MRI) for evaluation of lung ventilation in adults and pediatric patients aged 6 years and older. Limitations of UseXENOVIEW has not been evaluated for use with lung perfusion imaging. CONTRAINDICATIONSNone. Warnings and PrecautionsRisk of Decreased Image Quality from Supplemental Oxygen: Supplemental oxygen administered simultaneously with XENOVIEW inhalation can cause degradation of image quality. For patients on supplemental oxygen, withhold oxygen inhalation for two breaths prior to XENOVIEW inhalation, and resume oxygen inhalation immediately following the imaging breath hold. Risk of Transient Hypoxia: Inhalation of an anoxic gas such as XENOVIEW may cause transient hypoxemia in susceptible patients. Monitor all patients for oxygen desaturation and symptoms of hypoxemia and treat as clinically indicated. Adverse Reactions Adverse Reactions in Adult Patients: The adverse reactions (> one patient) in efficacy trials were oropharyngeal pain, headache, and dizziness. Adverse Reactions in Pediatric and Adolescent Patients: In published literature in pediatric patients aged 6 to 18, transient adverse reactions were reported: blood oxygen desaturation, heart rate elevation, numbness, tingling, dizziness, and euphoria. In at least one published study of pediatric patients aged 6 to 18 years, transient decrease in SpO2% and transient increase in heart rate was reported following hyperpolarized xenon Xe 129 administration. Please see full prescribing information at Contact Information:Polarean: Chuck Osborne Chief Financial Officer +1 (919) 206-7900, ext. 117 cosborne@ Polarean Investors: Anna Dunphy / Phillip Marriage +44 (0)20 7933 8780 polarean@ Media Contact: Alexis Opp +1 (919) 206-7900, ext. 145 aopp@ General inquiries: info@ Follow Polarean on LinkedIn here CONTACT: Polarean: Chuck Osborne Chief Financial Officer +1 (919) 206-7900, ext. 117 cosborne@ Polarean Investors: Anna Dunphy / Phillip Marriage +44 (0)20 7933 8780 polarean@ Polarean Media Contact: Alexis Opp +1 (919) 206-7900, ext. 145 aopp@ General inquiries: info@
Time of India
3 days ago
- Health
- Time of India
US government pulls plug on programs critical to HIV vaccine studies: What does that mean
In a move that's raising a lot of eyebrows in the health world, the Trump administration just pulled the plug on a major HIV vaccine research program. We're talking about a $258 million initiative that played a key role in finding a potential vaccine for HIV—gone. And it doesn't stop there. This is just the latest in a string of cuts that have hit HIV prevention and treatment efforts pretty hard, both in the U.S. and around the world. Public health experts aren't holding back—they're calling this a big step backward in the decades-long fight against HIV, the NY Times reported. So, what exactly happened? For starters, the National Institutes of Health (NIH) also hit the pause button on a clinical trial of an HIV vaccine developed by Moderna. Yep, that Moderna—the same company that helped bring us a COVID-19 vaccine in record time. "The cuts will shutter two major HIV vaccine research efforts that were first funded by the NIH in 2012 at the Duke Human Vaccine Institute and the Scripps Research Institute, multiple scientists said. A spokesperson for Moderna said the vaccine manufacturer's clinical trials through the NIH's HIV Vaccine Trials Network have also been put on pause," CBS News reported. Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like 5 Books Warren Buffett Wants You to Read In 2025 Blinkist: Warren Buffett's Reading List Undo And that's not all. The CDC's HIV prevention division? Shut down. This was the department that gave states and territories funding to help stop outbreaks and educate communities. Without it, many local programs are scrambling to figure out how to keep going. The timing of this decision The cancellation of the HIV funds comes weeks ahead of the US Food and Drug Administration's deadline (June 19) for deciding on approval of Gilead's lenacapavir, a twice-yearly injectable drug to prevent HIV. Recent clinical trials have demonstrated lenacapavir's remarkable efficacy. In the PURPOSE 1 trial involving cisgender women in sub-Saharan Africa, the drug achieved 100% efficacy in preventing HIV infections. Similarly, the PURPOSE 2 trial, which included cisgender men, transgender individuals, and gender-diverse people across multiple countries, reported a 96% reduction in HIV incidence compared to background rates. "The U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) submissions for lenacapavir—the company's twice-yearly injectable HIV-1 capsid inhibitor—for the prevention of HIV as pre-exposure prophylaxis (PrEP)," the pharma company had said in February 2025. So why does this matter? Because even though a lot of progress has been made, HIV is still a big issue in the U.S. According to the CDC's April 2024 report, the number of new HIV infections did go down by about 12% between 2018 and 2022—which is good news! But it is still seeing 31,800 new cases a year. That's not nothing. And here's a breakdown of where and who it's hitting the hardest: About 67% of those new infections were among gay, bisexual, and other men who have sex with men. Around 22% of infections happened through heterosexual contact. The South is taking the biggest hit—nearly half (49%) of all new HIV cases in 2022 came from Southern states. So yes, it's still a serious public health issue, especially in communities that already struggle with access to health care. What worries experts most is that these cuts could completely unravel years—decades, even—of progress. One step to a healthier you—join Times Health+ Yoga and feel the change
