PYLARIFY ® (piflufolastat F 18) injection (also known as 18 F-DCFPyL or PyL) is a fluorinated small molecule PSMA-targeted PET imaging agent that enables. Full year 2022 results saw a 119. May 26, 2022 at. ”. Article Text. A sample CMS-1500 claim form for billing PYLARIFY® is provided below. See also: rubidium chloride rb-82 side effects in more detail. BEDFORD, Mass. , [18 F]-DCFPyL was approved by the Food and Drug Administration (FDA) in May 2021 and is commercially available as PYLARIFY ® (Piflufolastat F 18 Injection) and sold by Lantheus. We. Follow the PYLARIFY® injection with an intravenous flush of 0. 18F-DCFPyL is now the first commercially available PSMA PET. A generic version of piflufolastat F 18 is not available. I was previously told that Medicare covered the. Follow. On March 23, 2022, the Food and Drug Administration approved Pluvicto (lutetium Lu 177 vipivotide tetraxetan, Advanced Accelerator Applications USA, Inc. 4 million in revenue, up 25% year over year, and a net loss of $11. Last Price Change % Change; LNTH. 63. 00 to $127. (shares outstanding times share price) below $2 to $2. Call 844-339-8514 844-339-8514. Beta particles such as Lu177, as used in the Novartis compound, generally cause only minor salivary gland toxicity. See today’s best. 6505--PET Isotope Pylarify F-18 PSMA Solicitation # 36C24423Q1222. Last Price Change % Change; LNTH. Compare prices and print coupons for Pylarify (Piflufolastat F 18) and other drugs at CVS, Walgreens, and other pharmacies. The recommended PYLARIFY dose is 333 MBq (9 mCi) with an acceptable range of 296 MBq to 370 MBq (8 mCi to 10 mCi), administered as a bolus intravenous injection. 69 towards any auto purchase with disability-friendly driving features. PYLARIFY PSMA - Where and when. PETNET Solutions Inc, A Siemens Healthineers Company, reliably delivers PET radiopharmaceuticals via the largest network of cyclotron-equipped radiopharmacies globally. Review. The rule originally reduced the conversion factor down by $1. 随着Pylarify的批准，某些患有前列腺癌的男性将有更多的机会获得PSMA靶向PET成像， 这可以帮助医疗. Androgen-deprivation therapy (ADT) and other therapies targeting the androgen pathway. This study aimed to. Frederic Pouliot, Hospitalier Universitaire (CHU) de Québec-Université Laval. To treat human African trypanosomiasis caused by the parasite Trypanosoma brucei gambiense. Inject a bolus of 9 mCi (333 MBq) of PYLARIFY® with an acceptable range of 296 MBq to 370 MBq (8 mCi to 10 mCi) administered as a single bolus intravenous injection. Piflufolastat F 18 (PYLARIFY®) is an 18F-labelled diagnostic imaging agent that has been developed by Progenics Pharmaceuticals Inc. 9 mg ethanol in 0. A sample CMS-1500 claim form for billing PYLARIFY® is provided below. 4-9 PYLARIFY ® (piflufolastat F. 3. In May 2021, the U. PDF Version. So, Lantheus isn't officially a small-cap stock. Each milliliter contains 37 to 2,960 MBq (1 to 80 mCi) piflufolastat F 18 with ≤0. Two kinds of PSMA PET indicators are FDA-approved for recurrent patients and high-risk patients: Pylarify and Ga68PSMA11. 61 PYLARIFY AI™ is intended to be used by healthcare professionals and researchers for acceptance, transfer, storage, image display, manipulation, quantification and reporting of digital medical images. Turning now to earnings. Morris, MD, discusses the choice between the 2 FDA-approved PSMA-PET imaging agents—and piflufolastat F 18 (18F-DCFPyL; Pylarify) and Gallium 68 PSMA-11 (Ga 68 PSMA-11)—for managing patients with prostate cancer. Estimated Primary Completion Date : October 2025. In another report released yesterday, JonesTrading also maintained a Buy rating on the stock with a $114. Dispose of any unused PYLARIFY in compliance with applicable. In May 2023 the FDA approved F-18-flotufolastat. The new technology (called piflufolastat F 18 or PYLARIFY®) consists of a radioactive targeting molecule which, upon injection, selectively seeks out and attaches to a protein on the cancer cells’ surface. Food and Drug Administration approved the use of PyL (PYLARIFY®) PET/CT with PyL greatly enhances the specificity and. This handout explains a PET/CT Pylarify PSMA scan. Same pills. The AWP benchmark has been used for over four decades to determine pricing and reimbursement of prescription drugs to third parties. PYLARIFY® CODING AND BILLING GUIDE | PYLARIFY® Reimbursement Hotline: 844-339-8514 PYLARIFY® and the associated services provided in a physician office are billed on the CMS-1500 claim form or its electronic equivalent. 9% Sodium Chloride Injection USP. Subsequently, in May 2021, the FDA approved piflufolastat F 18 (Pylarify) for identifying suspected metastasis or recurrence of prostate cancer. • Assay the dose in a suitable dose calibrator prior to administration. PYLARIFY (piflufolastat F18) injection . FDA-Approved Drugs in 2020. Post Administration Instructions • Follow the PYLARIFY injection with an intravenous flush of 0. The cash price charged by various facilities ranged from $6000 to close to $20,000, and MDA was near the high end. Lantheus describes its PYLARIFY AI product, on the other hand, as “the only FDA-cleared medical device to offer standardized quantitative and accurate reporting” of PSMA PET/CT images, including those achieved using PYLARIFY PET/CT. 00 thru 2/28/21. (RTTNews) - Lantheus Holdings Inc. Each milliliter contains 37 to 2,960 MBq (1 to 80 mCi) piflufolastat F 18 with ≤0. PYLARIFY is the clear market leader in PSMA PET imaging. . O’Fallon (618) 416-7970. More than 90% of. The men were negative on conventional. , Nov. Effect of these therapies on performance has not been established. , Nov. Market Summary > Current Price . SPX. 01 µg/mCi of piflufolastat at calibration time and date, and ≤ 78. DJIA. 10 PYLARIFY ® (piflufolastat F 18) Injection Indication PYLARIFY ® (piflufolastat F 18) Injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer: with suspected metastasis who are candidates for initial. [1] [4] [5] It is given by intravenous injection. Lantheus Announces CMS Grants Transitional Pass-Through Payment for PYLARIFY® (piflufolastat F 18) Injection, Effective January 1, 2022. PyL PET imaging is approved for two types of patients with. PYLARIFY ® (piflufolastat F 18) injection (also known as 18 F-DCFPyL or PyL) is a fluorinated small molecule PSMA-targeted PET imaging agent that enables. Each milliliter contains 37 to 2,960 MBq (1 to 80 mCi) piflufolastat F 18 with ≤0. The approval covers the. U. 01 μg/mCi of. 0. com is $4,420. This is the first and only commercially. • Dispose of any unused PYLARIFY in compliance with applicable regulations. 45 and $0. U. Only the tracers that do have pass thru status will be noted in each specified group of DX codes below. 044 hours and its elimination half-life is 3. S. Medicare allowed $1800+ for the PET/CT but zero for the Pylarify. com. In 2020, the FDA approved 53 new molecular entities, including 34 small molecules and 4 diagnostic agents [ 49 ]. 22, 2021 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. Customer Support at 1-800-964-0446 M-F 8:30 am-8:00 pm EST, or email [email protected]% Sodium Chloride Injection, USP. While the company generated $527M in revenue from Pylarify, revenue from its other radiopharmaceutical oncology products reached $4. 4 million. Michael J. “The data we presented at ASCO GU emphasize the clinical utility of piflufolastat F 18 to. PSMA has become an important development in prostate cancer diagnostics. 10 PYLARIFY ® (piflufolastat F 18) Injection Indication PYLARIFY ® (piflufolastat F 18) Injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer: with suspected metastasis who are candidates for initial. Lantheus Announces Presentations Featuring PYLARIFY AI™ at the 2023 Society for Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting. Lantheus Announces Presentation Featuring PYLARIFY® (Piflufolastat F18) at the 2022 ASCO GU Meeting. The PYLARIFY® Patient Support Program can help streamline the use of PYLARIFY® and assist with insurance assessment. Prostate specific membrane antigen (PSMA) is an attractive target for molecular imaging of prostate cancer and several other solid tumors because of its overexpression in prostate carcinoma and tumor neovasculature, respectively. Get an estimate from a Price Specialist. Furthermore, a theranostic agent named Pluvicto, a PSMA-targeted radionuclide from Novartis for men with metastatic castrate-resistant prostate cancer, was approved by the FDA in March 2022. The mean of analysts' price targets for CRISPR Therapeutics AG (CRSP) points to a 33. To reduce the risk of kidney and. 1M in 2022, following a 25% YoY decline, according to the. Compare prices and print coupons for Piflufolastat F 18 (Pylarify) and other drugs at CVS, Walgreens, and other pharmacies. 25 to $1. Manufacturing, Supply Chain and Distribution Capabilities Deep experience dealing with complex radiopharmaceuticals: Both imaging and therapy radioligands –short-lived and long-lived. See also: rubidium chloride rb-82 side effects in more detail. $26,699. PYLARIFY® is an advanced diagnostic imaging agent used with PET/CT scans to find tumors in the prostate, lymph nodes, bones, and other organs, typically better than other types of imaging scans. Abstract. BEDFORD, Mass. In patients with. PYLARIFY may be diluted with 0. Call 866. Food and Drug Administration (FDA) for Pylarify (F-18 DCFPyL), a PET radiopharmaceutical designed to target prostate-specific membrane antigen (PSMA). 9% sodium chloride injection USP. (NASDAQ: LNTH) (Lantheus), an established leader and fully integrated provider. Adjusted EPS should be in a range of $1. Information on submitting SPL files using eLIST may be found in the guidance for industry . A series of interviews was recently conducted with a panel of experts on prostate cancer imaging modalities that included Steven Rowe, MD, PhD, Associate Professor of Radiology and Radiological Science, Johns Hopkins University School of Medicine, Baltimore, MD, and Neal D. $250. Any excess purchase price over the fair value of the net. Session Title: Clinical Oncology Track - TROP Session. Trial 1 included two groups of. Prices for popular Radiopharmaceutical Viewing 15 of 15 medications Popularity arrow_drop_down Azedra as low as $9,234 IOBENGUANE I-131 is a. If the invoice lists a dose price, you must indicate the number of mCi’s in the dose. NORTH BILLERICA, Mass. 33 for the second quarter. PYLARIFY is a sterile, non-pyrogenic, clear, colorless solution for intravenous injection. Lantheus has offices in Massachusetts, New Jersey, Canada and Sweden. com. 9% sodium chloride injection USP. chevron_right. Abstract. 17 ± 0. Spread / Average Target +98. PYLARIFY® uses a radioactive tracer called fluorine-18, or 18. prostate cancer survivors. For a whole-body PET-CT scan, the price can jump well above $6,000. Introduction. , a Lantheus company, for positron emission tomography (PET) that targets prostate-specific membrane antigen (PSMA). Email: [email protected] Coupon & Prices - Cost $49 per month Pylarify Coupon & Prices Is your Pylarify medication too expensive? Get notified when Pylarify medication is added to NiceRx. The FDA approved PYLARIFY based on evidence from two clinical trials (Trial 1/NCT02981368 and Trial 2/NCT03739684) of 593 male patients with prostate cancer. Positron emission tomography (PET) is a type of nuclear medicine procedure that measures metabolic activity of the cells of body tissues. Billerica, MA), for. , Nov. In some cases, depending on the clinical scenario, the same diagnosis code describes a. Learn about prostate cancer and how it’s monitored. Difficulty with breathing or swallowing. • Dispose of any unused PYLARIFY in compliance with applicable. IndicationWe would like to show you a description here but the site won’t allow us. Mass General Brigham Health Plan 2 3. 2-7. Androgen-deprivation therapy (ADT) and other therapies targeting the androgen pathway. Each milliliter contains 37 to 2,960 MBq (1 to 80 mCi) piflufolastat F. Medicare allowed $1800+ for the PET/CT but zero for the Pylarify. Subsequently, in May 2021, the FDA approved piflufolastat F 18 (Pylarify) for identifying suspected metastasis or recurrence of prostate cancer. PYLARIFY® FOR PCa IMAGING; EFFICACY AND SAFETY. Post Administration Instructions • Follow the PYLARIFY injection with an intravenous flush of 0. Phone: 1-800-964-0446. Consistency: Enhance the reproducibility and reliability among the readers. PYLARIFY® CODING AND BILLING GUIDE | PYLARIFY® Reimbursement Hotline: 844-339-8514 PYLARIFY® and the associated services provided in a physician office are billed on the CMS-1500 claim form or its electronic equivalent. PYLARIFY AI™ (aPROMISE) is the only deep learning enabled FDA-cleared medical device software to offer standardized PSMA PET reporting with PYLARIFY AI on PSMA PET/CT images, including those. I think it will be quite expensive. 9% sodium chloride injection USP. S. Trade Name Pylarify Name of Applicant Progenics Pharmaceuticals, Inc. Worldwide revenue of $102. The June 2021 release of Pylarify set in motion a new series of price increases. Frederic Pouliot, Hospitalier Universitaire (CHU) de Québec-Université Laval. 57 USD. 5). “PYLARIFY has the potential to contribute meaningful and actionable information that can be used to personalize treatment plans in men with low PSA levels,” said Dr. 61 to $33. For example, shares gapped up 11% in November of last year following the company’s quarterly report. Use in men who might have prostate cancer. PYLARIFY is a sterile, non-pyrogenic, clear, colorless solution for intravenous injection. This grant pays $21,058. While the company generated $527M in revenue from Pylarify, revenue from its other radiopharmaceutical oncology products reached $4. 9% Sodium Chloride Injection USP. Medicare did not pay for the Pylarify used in PSMA PET/CT Scan. Corrected files may be viewed in the OALC FOIA library. In patients with biochemically recurrent PCa, (131/205) of patients with noninformative standard imaging † had a change in intended management plan 3‡. The collaboration with Novartis directly. 5% of patients within the studies are shown in Table 2. Radiopharmaceuticals are decaying radioisotopes with half-lives ranging from a few hours to several days. Trademark Application Number is a unique ID to identify the PYLARIFY mark in CIPO. PYLARIFY® (piflufolastat F 18) Injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer: with suspected metastasis who are candidates for initial definitive therapy. • Assay the dose in a suitable dose calibrator prior to administration. Helping to improve those odds is Johns Hopkins radiologist Martin Pomper, who recently culminated a 25-year quest to develop better prostate cancer imaging with PET/CT. Novartis plans to expand Pluvicto and its companion imaging agent into even larger indications and has Phase III trials underway for prostate cancer patients who are hormone-sensitive as well as those not previously. 9% sodium chloride injection USP. PYLARIFY revenues in 1H23 were $405m - up 82% year-on-year - so it seems clear that PYLARIFY revenues have substantially more growth potential - Lantheus' guidance for total revenues in 2023. Lantheus has multiple products on the market with two standouts driving the most growth with Pylarify and Definity. 71e2149657a0653da6dd8e244c72a94b. Patients will need a signed order from their treating physician prior to. PYLARIFY ® (piflufolastat F 18) Injection In the U. 6 based on expected EPS of $6. eviCore healthcare by Evernorth leverages our clinical expertise, evidence-based guidelines and innovative technologies to deliver best-in-class medical benefit management solutions that inform more effective, affordable treatment and site of care decisions for each patient’s needs. Assay the dose in a suitable dose calibrator prior to administration. Indication. PK ! ¾ˆ H [Content_Types]. It’s rare among young men, but the chance of having prostate cancer rises rapidly after age 50. • Assay the dose in a suitable dose calibrator prior to administration. CC-BY-4. 54 surpassed the. Adriano Dias told attendees. On May 27, the U. The collaboration with Novartis directly. • PYLARIFY seems to be affected by the amount (level) of PSA in your blood. S. Last Price Change % Change; LNTH. BEVERLY TOWER ADVANCED IMAGING CENTER 8750 Wilshire Blvd. Estimated. INDICATION. PYLARIFY® (piflufolastat F 18) Injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer: with suspected metastasis who are candidates for initial definitive therapy. • Dispose of any unused PYLARIFY in compliance with applicable regulations. Shore, MD, FACS, CMO, Surgical Oncology/Urology Genesis Care, US;. The incidence of prostate cancer increases with patient age, with an incidence rate of 1 in 350 men for those under 50 years of age, climbing to an incidence of 60% in men over the age of 65. 4-9 PYLARIFY ® (piflufolastat F. 9% Sodium Chloride Injection, USP. Choyke et al (Journal of Nuclear Medicine, June 2020) addressed this in a prospective study of 18F-DCFPyL PET/CT in 90 men with biochemical recurrence with a median PSA of 2. This suggests a possible upside of 68. An improved PET/CT scan could mean an improved prostate cancer treatment plan. Pylarify. skin itching, rash, or redness. May 26, 2022 at. Inject a bolus of 9 mCi (333 MBq) of PYLARIFY® with an acceptable range of 296 MBq to 370 MBq (8 mCi to 10 mCi) administered as a single bolus intravenous injection. Lantheus has multiple products on the market with two standouts driving the most growth with Pylarify and Definity. It seems that the approved Medicare payment will be $ 5,224. PYLARIFY AI™ Indications for Use PYLARIFY AI is intended to be used by healthcare professionals and researchers for acceptance, transfer, storage, image display, manipulation, quantification and reporting of digital medical images. 21, 2022, the NC Medicaid and NC Health Choice programs covers piflufolastat F18 injection, for intravenous use (Pylarify) for use in the Physician’s Administered Drug Program (PADP) when billed with HCPCS code A9595 - Piflufolastat f-18, diagnostic, 1 millicurie. 9 mg ethanol in 0. Both Pylarify and 8 Ga-PSMA-11 scanning tools will improve prostate cancer detection. To qualify for Pluvicto, one needs a positive PSMA PET scan, but. In the U. November 29, 2021 08:30 ET | Source: Lantheus Holdings, Inc. In most cases, a PET scan is considered to be a diagnostic non-laboratory test, and like other imaging covered by Medicare, the cost to the patient will be 20% after the plan’s deductible has been met. The product's dosage form is injection and is administered via intravenous form. If you need help understanding your options, enrolling, or managing your plan, a Florida Blue agent is here for you. 4 PYLARIFY binds to the target, enabling the. 7% year-over-year, and progressed our. These side effects may go away during treatment as your body adjusts to the medicine. An infusion is when medication is put into your bloodstream through a vein over a period of time. Removed the agents listed under #9 A. 5 to 7. I think Kaiser will allow you to also get an mpMRI, which may prove to be useful if your recurrence is intra-prostatic. NORTH BILLERICA, Mass. NORTH BILLERICA, Mass. More Info See Prices. PYLARIFY is a product in our radiopharmaceutical oncology product category. Piflufolastat F 18 Used for Diagnosis Pylarify (piflufolastat F 18) is a radioactive tracer that's used in positron emission tomography (PET) scans for males with certain types of prostate cancer. Piflufolastat F-18. For men with prostate cancer, PYLARIFY PET. 8 billion market cap still falls on the lower end of the scale. On May 26, 2021, the FDA approved Pylarify. Thirty-one out of thirty-four molecules contain at least one heterocyclic ring, and eleven out of thirty-four molecules contain at least one fluorine atom. We offer high-quality, cost-efficient pharmaceuticals. , Lantheus received approval for [18 F]-DCFPyL, now PYLARIFY® (Piflufolastat F 18 Injection) from the Food and Drug Administration (FDA) in May 2021. NORTH BILLERICA, Mass. 4. The PYLARIFY mark is filed in the category of Class 042 Computer and scientific , Class 044 Medical and veterinary,. ATLANTA, March 31, 2022 /PRNewswire-PRWeb/ -- Syntermed is proud. VERNON, IL - SSM Health Illinois is now offering a cutting-edge imaging service that helps better detect prostate cancer in men. The national average according to MDSave. Welcome to the Lantheus Third Quarter 2023 Financial Results. 01 µg/mCi of piflufolastat at calibration time and date, and ≤ 78. This article describes the least restrictive coverage possible. Please talk with your doctor about whether a PSA. The PSMA ligand is similar to the one used for therapy but uses a different type of radioactive material that provides an image (PET/CT) to show where the tumor is and how well the ligand attaches to it. Post Administration Instructions • Follow the PYLARIFY injection with an intravenous flush of 0. 2021-06-02 15:48. This agent shows promise as a targeted treatment for patients with PSMA-positive metastatic castration-resistant prostate cancer. The wholesale acquisition cost for the maximum dose of Locametz is $5,600, while Pluvicto's maximum list price is $255,000. It has 2 main parts, targeted and radioactive. PYLARIFY was developed to target PSMA, a protein that is overexpressed on the surface of more than 90% of primary and metastatic prostate cancer cells. Patient mail is delivered M-F (please include return address): Northside Hospital Atlanta. 9% vs 65. S. Pyl is proprietary, whereas Ga-68-PSMA-11 was donated as patent-free. ADT and other therapies targeting the androgen pathway (eg, androgen receptor antagonists) may result in changes in uptake of piflufolastat F18 in prostate cancer. All Drugs; Human Drugs; Animal Drugs. PYLARIFY AI is intended to be used by healthcare professionals and researchers for acceptance, transfer, storage, image display, manipulation, quantification and reporting of digital medical images. Trial 1 included two groups of. PYLARIFY is the clear market leader in PSMA PET imaging. Received the EOB for my Pylarify PSMA scan. Piflufolastat F 18 injection is a radioactive diagnostic agent indicated for PET of PSMA positive lesions in men with prostate cancer. (Pylarify™) to section E. Additionally, your doctor may monitor your blood. 1M, lead largely by the success of PYLARIFY - their PSMA PET imaging agent - and the expansion of their Radiopharmaceutical Oncology pipeline. -1. PYLARIFY may be diluted with 0. Efficacy: High-risk PCa: OSPREY COHORT A; Efficacy: Biochemically Recurrent PCa: CONDOR;. Turning now to earnings. ac61418. 5 billion. (RTTNews) - Lantheus Holdings Inc. (the Company) (NASDAQ: LNTH), a company committed to improving patient outcomes through diagnostics, radiotherapeutics and artificial intelligence solutions that enable clinicians to Find, Fight and Follow disease, announced PYLARIFY AI data will be presented at the. In some cases, depending on the clinical scenario, the same diagnosis code describes a. 00. RADIUM-223 DICHLORIDE is a. It helps your. 4 million. 6 brokerages have issued 1 year price objectives for Lantheus' stock. prostate cancer survivors. 7 mCi). Received the EOB for my Pylarify PSMA scan. PET scans. • Assay the dose in a suitable dose calibrator prior to administration. N/A. Food and Drug Administration approved the use of PyL (PYLARIFY ®) — also known as 18 F-DCFPyL — a positron-emitting imaging agent that. Lantheus Holdings, Inc. Medicare Supplement Insurance can help cover your out-of-pocket PET scan costs. PYLARIFY Indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer: • With suspected metastasis who are candidates for initial definitive therapy • With suspected recurrence based on elevated serum prostate-specific antigen (PSA) level 9 Fluorine-18The Department of Health Care Access and Information (HCAI) has released to the public the mandatory reporting of information related to increases to the Wholesale Acquisition Cost (WAC) of prescription drugs by drug product as identified by the drug product’s National Drug Code (NDC). Mary Anne Heino: Thank you, Mark, and good morning to everyone. In the United States, the average wholesale price (AWP) is a pharmaceutical term that describes the average price paid by a retailer to buy a drug from the wholesaler. In May 2021, the U. Pronunciation of pylarify with 2 audio pronunciations, 1 meaning and more for pylarify. As the levels of PSAINDICATION. PROVIDENCE ST JOSEPH HOSPITAL - ORANGE 1140 W LA VETA AVE ORANGE CA 92868. 9 mg ethanol in 0. The recommended PYLARIFY dose is 333 MBq (9 mCi) with an acceptable range of 296 MBq to 370 MBq (8 mCi to 10 mCi), administered as a bolus intravenous injection. (NASDAQ:LNTH) Q3 2023 Earnings Call Transcript November 3, 2023 Operator: Good morning. The FDA approved PYLARIFY based on evidence from two clinical trials (Trial 1/NCT02981368 and Trial 2/NCT03739684) of 593 male patients with prostate cancer. May 27, 2021 — Today, the FDA approved the 18F-DCFPyL PSMA PET imaging agent (also known as “PyL” for short or by its trade name “PYLARIFY”). 9% Sodium Chloride . PYLARIFY AI™, FDA-cleared artificial intelligence platform developed to assist in standardized quantification of PSMA PET/CT scans Oral Presentation: Date & Time:. 6 based on expected EPS of $6. 49 hours. , May 28, 2021 /PRNewswire/ -- SOFIE, an established Radiopharmaceutical Contract Manufacturing Organization and GMP radiopharmacy network, will be commercially. The device provides general. 5 to 7. (the Company) (NASDAQ: LNTH), a company committed to improving patient outcomes through diagnostics, radiotherapeutics and artificial intelligence solutions that enable clinicians to Find, Fight and Follow disease, announced it will present the following presentations at. is the parent company of Lantheus Medical Imaging, Inc. In addition to clinical drug information, FDB publishes several drug pricing data fields, including: FDB discontinued the publication of Blue Book Average Wholesale Price (AWP) on September. What is the average wholesale price (AWP)? In the United States, the average wholesale price (AWP) is a pharmaceutical term that describes the average price paid by a retailer to buy a drug from the wholesaler. As the levels of PSAWhat You Need To Know. So, we'll have to see how Lantheus prices it. 1-800-995-4219.