LNTH Lantheus Holdings Inc.
Upcoming Catalysts
| Drug | Stage | Catalyst Date |
|---|---|---|
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PyL
Prostate cancer
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NDA Filing
NDA Filing
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flurpiridaz F 18
Coronary artery disease (CAD)
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Phase 3
Phase 3
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Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
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1095
Prostate Cancer
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Phase 2
Phase 2
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Phase 2 enrolment has paused due to COVID-19.
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Subcutaneous RELISTOR
Chronic pain
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Approved
Approved
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Approved September 29, 2014.
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Oral RELISTOR
Chronic pain
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Approved
Approved
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Approved July 19 2016.
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1404
Help visualize prostate cancer by targeting prostate specific membrane antigen (PSMA)
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Phase 3
Phase 3
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Phase 3 trial met one of two co-primary endpoints.
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Azedra
Pheochromocytoma
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Approved
Approved
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FDA approval announced July 30, 2018.
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DEFINITY (BENEFIT 1)
Left Ventricular Ejection Fraction
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Phase 3
Phase 3
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Phase 3 trial did not meet primary endpoint - February 3, 2020.
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Latest News
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Lantheus Holdings, Inc. (the "Company") (NASDAQ:LNTH), the parent company of Lantheus Medical Imaging, Inc. and Progenics Pharmaceuticals, Inc., and a global leader in the development, manufacture and commercialization of innovative diagnostic and therapeutic agents and products, today announced that 17 abstracts highlighting PyL™ (18F-DCFPyL) have been selected for presentation at the virtual Society of Nuclear Medicine and Molecular Imaging (SNMMI) 2020 Annual Meeting taking place July 11-14, 2020. PyL is the PSMA-targeted small molecule positron emission tomography (PET) imaging investigational agent designed to visualize prostate cancer, which the Company recently purchased as part of the oncology business of Progenics.
The abstracts to be presented at the meeting will feature data on PyL from two presentations based on Company-sponsored studies, including the positive results from the Phase 3 CONDOR trial evaluating the diagnostic performance and clinical impact of PyL in patients with biochemical recurrence of prostate cancer. A third abstract focuses on the digital solution the Company is developing in parallel with PyL to potentially support prostate cancer staging using an automated miPSMA Index of the PET/CT PyL-PSMA images.
"Physicians and patients continue to experience an unmet need for diagnostic imaging that could assist in staging high risk prostate cancer and reliably detect recurrent or metastatic disease. The unmet need is particularly important among patients with low PSA values," said Istvan Molnar, M.D., the Company's Chief Medical Officer. "We believe that the demonstrated strong diagnostic performance of our PSMA-targeted PET imaging investigational agent, PyL, could provide clinicians with actionable information. In addition, the use of the widely available isotope fluorine-18 may result in broad patient accessibility. Data to be presented at SNMMI this year further highlights PyL's clinical potential, including the positive Phase 3 results of the CONDOR study, which achieved its primary endpoint with a correct localization rate of 84.8% to 87.0% among the three blinded independent readers. We remain on track to submit a New Drug Application ("NDA") with the U.S. Food and Drug Administration ("FDA") for PyL in the third quarter of 2020."
SNMMI presentations will be made available on July 11, 2020 and can be found in the virtual Science Pavilion.
Details for the SNMMI 2020 presentations based on Company-sponsored studies and Company-led digital solution development are as follows:
Title: Diagnostic Performance of PSMA-Targeted 18F-DCFPyL PET/CT in Men with Biochemically Recurrent Prostate Cancer: Results from the Phase 3, Multicenter CONDOR Study
Lead Author: Steven Rowe, Johns Hopkins UniversityTitle: miPSMA Index: Comprehensive and Automated Quantification of 18F-DCFPyL (PyL-PSMA) PET/CT for Prostate Cancer Staging
Lead Author: Kerstin Johnsson, Progenics PharmaceuticalsTitle: Measuring bias in quantitative PET biomarkers in-vivo
Lead Author: Martin Lodge, Johns Hopkins UniversityAbout PyL™ for PET Imaging of Prostate Cancer
PyL (also known as 18F-DCFPyL) is a fluorinated PSMA-targeted positron emission tomography (PET) imaging agent that enables visualization of both bone and soft tissue metastases to determine the presence or absence of recurrent and/or metastatic prostate cancer.
About Prostate Cancer
Prostate cancer is the second most common form of cancer affecting men in the United States: an estimated one in nine men will be diagnosed with prostate cancer in his lifetime. The American Cancer Society estimates that each year approximately 174,650 new cases of prostate cancer will be diagnosed and about 31,620 men will die of the disease. Approximately 2.9 million men in the U.S. currently count themselves among prostate cancer survivors.
About Lantheus Holdings, Inc.
Lantheus Holdings, Inc. is the parent company of Lantheus Medical Imaging, Inc. and Progenics Pharmaceuticals, Inc., and a global leader in the development, manufacture and commercialization of innovative diagnostic and therapeutic agents and products. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; TechneLite® (Technetium Tc99m Generator), a technetium-based generator that provides the essential medical isotope used in nuclear medicine procedures; RELISTOR® for the treatment of opioid-induced constipation, which is partnered with Bausch Health Companies, Inc.; and AZEDRA® for the treatment of certain rare neurological cancers. The Company is headquartered in North Billerica, Massachusetts with offices in New York, New Jersey, Puerto Rico, Canada and Sweden. For more information, visit www.lantheus.com.
Safe Harbor for Forward-Looking and Cautionary Statements
This document contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks and uncertainties and are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Such statements are based upon current plans, estimates and expectations that are subject to various risks and uncertainties. The inclusion of forward-looking statements should not be regarded as a representation that such plans, estimates and expectations will be achieved. Words such as "anticipate," "expect," "project," "intend," "believe," "may," "will," "should," "plan," "could," "target," "contemplate," "estimate," "predict," "potential," "opportunity," "creates" and words and terms of similar substance used in connection with any discussion of future plans, actions or events identify forward-looking statements. All statements, other than historical facts, are forward-looking statements. Important factors that could cause actual results to differ materially from Lantheus' plans, estimates or expectations could include, but are not limited to: (i) the timing of the filing of the Company's PyL NDA with the FDA; (ii) a delay in obtaining, or failure to obtain, a positive regulatory outcome from the FDA and other regulatory authorities; (iii) the Company's ability to successfully launch PyL as a commercial product; (iv) the market receptivity to PyL as a new diagnostic agent; (v) the safety and efficacy of PyL; and (vi) the intellectual property protection of PyL. Additional factors that may affect the future results of Lantheus are set forth in Lantheus' filings with the SEC, including Lantheus' most recently filed Annual Report on Form 10-K, subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the SEC, which are available on the SEC's website at www.sec.gov. Readers are urged to consider these factors carefully in evaluating these forward-looking statements, and not to place undue reliance on any forward-looking statements. Readers should also carefully review the risk factors described in other documents that Lantheus file from time to time with the SEC. The forward-looking statements in this document speak only as of the date of these materials. Except as required by law, Lantheus assumes no obligation to update or revise these forward-looking statements for any reason, even if new information becomes available in the future.
View source version on businesswire.com: https://www.businesswire.com/news/home/20200701005282/en/
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Lantheus Holdings, Inc. (the "Company") (NASDAQ:LNTH), the parent company of Lantheus Medical Imaging, Inc. ("LMI"), a global leader in the development, manufacture and commercialization of innovative diagnostic imaging agents and products, today announced that it has completed its previously announced merger with Progenics Pharmaceuticals, Inc. ("Progenics") (NASDAQ:PGNX), an oncology company developing innovative medicines and artificial intelligence to find, fight and follow cancer. The merger agreement was first announced on October 2, 2019.
"Today marks an important day for Lantheus and Progenics. This combination forms an innovative company with a diversified diagnostics and therapeutics portfolio," said Mary Anne Heino, Lantheus President and Chief Executive Officer. "The transaction leverages Lantheus' long-standing expertise in complex manufacturing, supply chain and commercial excellence, with Progenics' three leading FDA approved products, clinical pipeline and development capabilities. We're excited to welcome the talented Progenics employees to the Lantheus organization to help build upon our solid foundation."
Upon completion of the merger, Progenics stockholders received, for each share of Progenics common stock, 0.31 of a share of Lantheus common stock and one non-tradeable contingent value right, which is payable in two contingent payments, subject to a cap, upon the achievement of certain milestones related to the financial performance of PyLTM (18F-DCFPyL), Progenics' prostate-specific membrane antigen targeted imaging agent designed to visualize prostate cancer.
The Company will continue to trade on Nasdaq under the ticker symbol LNTH. Progenics is being delisted.
About Lantheus Holdings, Inc. and Lantheus Medical Imaging, Inc.
Lantheus Holdings, Inc. is the parent company of LMI, a global leader in the development, manufacture and commercialization of innovative diagnostic imaging agents and products. LMI provides a broad portfolio of products, including the echocardiography contrast agent DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable Suspension and TechneLite® (Technetium Tc99m Generator), a technetium-based generator that provides the essential medical isotope used in nuclear medicine procedures. The Company is headquartered in North Billerica, Massachusetts with offices in Puerto Rico and Canada. For more information, visit www.lantheus.com.
About Progenics
Progenics is an oncology company focused on the development and commercialization of innovative targeted medicines and artificial intelligence to find, fight and follow cancer, including: therapeutic agents designed to treat cancer (AZEDRA®, 1095, and PSMA TTC); prostate-specific membrane antigen ("PSMA") targeted imaging agents for prostate cancer (PyL™ and 1404); and imaging analysis technology (aBSI and PSMA AI). Progenics has three commercial products, AZEDRA, for the treatment of patients with unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma (rare neuroendocrine tumors of neural crest origin) who require systemic anticancer therapy; and oral and subcutaneous formulations of RELISTOR® (methylnaltrexone bromide) for the treatment of opioid-induced constipation, which are partnered with Bausch Health Companies Inc. Progenics is headquartered in New York, New York with manufacturing facilities in Somerset, New Jersey. Additional information about Progenics is available at www.progenics.com.
Safe Harbor for Forward-Looking and Cautionary Statements
This document contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks and uncertainties and are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Such statements are based upon current plans, estimates and expectations that are subject to various risks and uncertainties. The inclusion of forward-looking statements should not be regarded as a representation that such plans, estimates and expectations will be achieved. Words such as "anticipate," "expect," "project," "intend," "believe," "may," "will," "should," "plan," "could," "target," "contemplate," "estimate," "predict," "potential," "opportunity," "creates" and words and terms of similar substance used in connection with any discussion of future plans, actions or events identify forward-looking statements. All statements, other than historical facts, including the expected benefits of the merger, such as efficiencies, cost savings, synergies, revenue growth, creating shareholder value, growth potential, market profile, enhanced competitive position, and financial strength and flexibility; the competitive ability and position of the combined company; and any assumptions underlying any of the foregoing, are forward-looking statements. Important factors that could cause actual results to differ materially from Lantheus' plans, estimates or expectations could include, but are not limited to: (i) the merger may involve unexpected costs or liabilities; (ii) the effect of the merger on the ability of Lantheus to maintain relationships with customers, suppliers and others with whom Lantheus does business, or on Lantheus' operating results and business generally; (iii) Lantheus' business may suffer as a result of disruption of management's attention due to the merger; (iv) the outcome of any legal proceedings related to the merger; (v) Lantheus may be adversely affected by other economic, business, and/or competitive factors, including the ongoing COVID-19 pandemic; (vi) risks that the merger disrupts current plans and operations and the potential difficulties in employee retention as a result of the merger; (vii) risks that the anticipated benefits of the merger or other commercial opportunities may otherwise not be fully realized or may take longer to realize than expected; (viii) the impact of legislative, regulatory, competitive and technological changes; and (ix) expectations for future clinical trials, the timing and potential outcomes of clinical studies and interactions with regulatory authorities. Additional factors that may affect the future results of Lantheus are set forth in Lantheus' filings with the SEC, including Lantheus' most recently filed Annual Report on Form 10-K, subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the SEC, which are available on the SEC's website at www.sec.gov. Readers are urged to consider these factors carefully in evaluating these forward-looking statements, and not to place undue reliance on any forward-looking statements. Readers should also carefully review the risk factors described in other documents that Lantheus files from time to time with the SEC. The forward-looking statements in this document speak only as of the date of these materials. Except as required by law, Lantheus assumes no obligation to update or revise these forward-looking statements for any reason, even if new information becomes available in the future.
View source version on businesswire.com: https://www.businesswire.com/news/home/20200622005171/en/
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NEW YORK, June 17, 2020 /PRNewswire/ -- Independent Bank Group Inc. (NASD: IBTX) will replace Progenics Pharmaceuticals Inc. (NASD: PGNX) in the S&P SmallCap 600 effective prior to the opening of trading on Monday, June 22. S&P Small-Cap 600 constituent Lantheus Holdings Inc. (NASD: LNTH) is acquiring Progenics Pharmaceuticals in a deal expected to be completed on or about June 19 pending final conditions. Post-acquisition, Lantheus Holdings will remain in S&P SmallCap 600.
Independent Bank Group provides various commercial banking products and services. Headquartered in McKinney, TX the company will be added to the S&P SmallCap 600 GICS (Global Industry Classification Standard) Regional Banks Sub-Industry index.
Following is a summary of the change:
S&P SMALLCAP 600 INDEX – JUNE 22, 2020
COMPANY
GICS ECONOMIC SECTOR
GICS SUB-INDUSTRY
ADDED
Independent Bank Group
Financials
Regional Banks
DELETED
Progenics Pharmaceuticals
Health Care
Biotechnology
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Lantheus Holdings, Inc. (NASDAQ:LNTH) ("Lantheus" or the "Company"), parent company of Lantheus Medical Imaging, Inc. ("LMI"), a leader in the development, manufacture and commercialization of innovative diagnostic imaging agents announced that at a special meeting held earlier today, Lantheus' stockholders voted to approve the issuance of common stock related to the Company's proposed merger with Progenics Pharmaceuticals, Inc. (NASDAQ:PGNX) ("Progenics"), an oncology company developing innovative medicines and artificial intelligence to find, fight and follow cancer.
Lantheus and Progenics previously entered into an Amended and Restated Agreement and Plan of Merger, dated as of February 20, 2020 (the "Merger Agreement"), by and among Progenics, Lantheus and Plato Merger Sub, Inc., a wholly-owned subsidiary of Lantheus ("Merger Sub"). Pursuant to the Merger Agreement, Merger Sub will be merged with and into Progenics (the "merger"), with Progenics surviving the merger as a wholly-owned subsidiary of Lantheus.
Approximately 99% of the total votes cast by holders of Lantheus common stock were voted in favor of the share issuance proposal (excluding abstentions), representing approximately 87% of Lantheus' shares issued and outstanding as of the close of business on May 12, 2020, the record date.
Mary Anne Heino, President and Chief Executive Officer of the Company, said, "We are very excited that our stockholders have approved the share issuance in connection with the Progenics merger and that the Progenics stockholders also approved the transaction earlier today. We believe that the combined company will offer a diversified portfolio of precision diagnostics, radiopharmaceutical therapeutics, digital solutions and pharma service offerings, delivering value across the patient health care continuum."
The merger remains subject to customary closing conditions. The parties expect to close the merger on or about June 19, 2020.
About Lantheus Holdings, Inc. and Lantheus Medical Imaging, Inc.
Lantheus Holdings, Inc. is the parent company of LMI, a global leader in the development, manufacture and commercialization of innovative diagnostic imaging agents and products. LMI provides a broad portfolio of products, including the echocardiography contrast agent DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable Suspension and TechneLite® (Technetium Tc99m Generator), a technetium-based generator that provides the essential medical isotope used in nuclear medicine procedures. The Company is headquartered in North Billerica, Massachusetts with offices in Puerto Rico and Canada. For more information, visit www.lantheus.com.
Cautionary Statement Regarding Forward-Looking Statements
This document contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks and uncertainties and are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Such statements are based upon current plans, estimates and expectations that are subject to various risks and uncertainties. The inclusion of forward-looking statements should not be regarded as a representation that such plans, estimates and expectations will be achieved. Words such as "anticipate," "expect," "project," "intend," "believe," "may," "will," "should," "plan," "could," "target," "contemplate," "estimate," "predict," "potential," "opportunity," "creates" and words and terms of similar substance used in connection with any discussion of future plans, actions or events identify forward-looking statements. All statements, other than historical facts, including the expected timing of the closing of the merger; the ability of the parties to complete the merger considering the various closing conditions; the expected benefits of the merger, such as efficiencies, cost savings, synergies, revenue growth, creating shareholder value, growth potential, market profile, enhanced competitive position, and financial strength and flexibility; the competitive ability and position of the combined company; and any assumptions underlying any of the foregoing, are forward-looking statements. Important factors that could cause actual results to differ materially from Progenics' and Lantheus' plans, estimates or expectations could include, but are not limited to: (i) conditions to the closing of the merger may not be satisfied; (ii) the merger may involve unexpected costs, liabilities or delays; (iii) the effect of the announcement of the merger on the ability of Progenics or Lantheus to retain and hire key personnel and maintain relationships with customers, suppliers and others with whom Progenics or Lantheus does business, or on Progenics' or Lantheus' operating results and business generally; (iv) Progenics' or Lantheus' respective businesses may suffer as a result of uncertainty surrounding the merger and disruption of management's attention due to the merger; (v) the outcome of any legal proceedings related to the merger; (vi) Progenics or Lantheus may be adversely affected by other economic, business, and/or competitive factors, including the ongoing COVID-19 pandemic; (vii) the occurrence of any event, change or other circumstances that could give rise to the termination of the merger agreement; (viii) risks that the merger disrupts current plans and operations and the potential difficulties in employee retention as a result of the merger; (ix) risks that the anticipated benefits of the merger or other commercial opportunities may otherwise not be fully realized or may take longer to realize than expected; (x) the impact of legislative, regulatory, competitive and technological changes; (xi) expectations for future clinical trials, the timing and potential outcomes of clinical studies and interactions with regulatory authorities; and (xiii) other risks to the consummation of the merger, including the risk that the merger will not be consummated within the expected time period or at all. Additional factors that may affect the future results of Progenics and Lantheus are set forth in their respective filings with the SEC, including each of Progenics' and Lantheus' most recently filed Annual Report on Form 10-K, subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the SEC, which are available on the SEC's website at www.sec.gov. Readers are urged to consider these factors carefully in evaluating these forward-looking statements, and not to place undue reliance on any forward-looking statements. Readers should also carefully review the risk factors described in other documents that Progenics and Lantheus file from time to time with the SEC. The forward-looking statements in this document speak only as of the date of these materials. Except as required by law, Progenics and Lantheus assume no obligation to update or revise these forward-looking statements for any reason, even if new information becomes available in the future.
View source version on businesswire.com: https://www.businesswire.com/news/home/20200616005935/en/
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Lantheus Holdings to Present at the BMO 2020 Prescriptions for Success Virtual Healthcare ConferenceView Full Article Hide Full Article
Lantheus Holdings, Inc. (the "Company") (NASDAQ:LNTH), the parent company of Lantheus Medical Imaging, Inc. ("LMI"), a global leader in the development, manufacture and commercialization of innovative diagnostic imaging agents and products, today announced Mary Anne Heino, President and Chief Executive Officer, will present at the BMO 2020 Prescriptions for Success Virtual Healthcare Conference at 3:30 p.m. ET on Tuesday, June 23.
To access a live webcast of the presentation, please visit the Investors section of the Company's website at www.lantheus.com. A replay of the webcast will be available on the Company's website for 30 days following the live presentation.
About Lantheus Holdings, Inc. and Lantheus Medical Imaging, Inc.
Lantheus Holdings, Inc. is the parent company of LMI, a global leader in the development, manufacture and commercialization of innovative diagnostic imaging agents and products. LMI provides a broad portfolio of products, including the echocardiography contrast agent DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable Suspension and TechneLite® (Technetium Tc99m Generator), a technetium-based generator that provides the essential medical isotope used in nuclear medicine procedures. The Company is headquartered in North Billerica, Massachusetts with offices in Puerto Rico and Canada. For more information, visit www.lantheus.com.
View source version on businesswire.com: https://www.businesswire.com/news/home/20200616005336/en/