Lantheus Holdings, Inc. (LNTH)

Lantheus Holdings, Inc. is a global pharmaceutical company dedicated to the development, manufacturing, and commercialization of advanced diagnostic and therapeutic agents. Their mission is to empower clinicians worldwide in the accurate diagnosis and effective treatment of a wide spectrum of conditions, particularly heart disease, various cancers, and other serious illnesses. Their current diagnostic portfolio features several key products: DEFINITY, a microbubble ultrasound contrast agent for cardiac evaluations; TechneLite, a technetium generator essential for nuclear medicine; Xenon-133, used to assess pulmonary function; Neurolite, which helps identify stroke-damaged areas in the brain; Cardiolite, an injectable Tc-99m-labeled imaging agent; Thallium-201 for detecting cardiovascular disease; and Gallium-67, utilized in identifying infections and cancerous tumors. They also offer the Automated Bone Scan Index, a tool for quantifying prostate cancer burden from bone scans; PYLARIFY, designed for visualizing lymph nodes, bone, and soft tissue metastases to detect recurrent or metastatic prostate cancer; and Cobalt (Co 57), a non-pharmaceutical radiochemical. In the therapeutic space, Lantheus provides AZEDRA, a radiopharmaceutical treatment for both adult and pediatric patients, and RELISTOR, a medication addressing opioid-induced constipation. The company's robust development pipeline includes promising innovations such as flurpiridaz F 18, an agent for assessing myocardial blood flow; 1095, a PSMA-targeted iodine-131 labeled small molecule; LMI 1195 for neuroblastoma tumors in both children and adults; PYLARIFY AI, an AI-powered medical device software for standardized quantitative analysis of PSMA PET/CT images in prostate cancer; and leronlimab, an investigational humanized monoclonal antibody. Lantheus serves a diverse client base, including radiopharmacies, distributors, integrated delivery networks, hospitals, clinics, and group medical practices. They foster strategic collaborations with notable industry partners such as NanoMab Technology Limited, Bausch Health Companies, Inc., GE Healthcare Limited, Curium, Bayer AG, CytoDyn Inc., ROTOP, FUJIFILM, Regeneron Pharmaceuticals, Inc., and POINT Biopharma US Inc. Established in 1956, Lantheus Holdings, Inc. maintains its corporate headquarters in North Billerica, Massachusetts.

Sector: In Vitro & In Vivo Diagnostic Substances

Industry: Drug Manufacturers - Specialty & Generic

Lantheus Holdings, Inc.

NASDAQ:LNTHHealthcare · Drug Manufacturers - Specialty & Generic

Mkt Cap$6.56B

Float63.82M

Shares O/S65.3M

Inst Own-

SI5.7%

Dilution

+0.14%$100.46

AH$100.46+0.00%vs close

Mkt Cap$6.56B

Float63.82M

O/S65.3M

Vol

$ Vol

RVOL

Inst Own-

SI5.7%

Earnings

Dilution

NASDAQ:LNTH$100.46+0.14%

MCap$6.56B

Float63.82M

O/S65.3M

SI5.7%

Inst Own-

Dilution

Phase Distribution

17 lead-sponsored trials·1 active·14 completed

Phase 110

Phase 1/21

Phase 22

Phase 33

Phase 41

(4 more as collaborator)

Status Overview

Recruiting1

Completed14

Stopped2

Trials need funding. See this company's dilution risk and cash position.

Clinical Trials

Sponsor role

Status

Phase

Phase 4
Completed
Impact of FBB PET Amyloid Imaging in Change of Diagnosis in Patients With AD
Neuraceq (florbetaben 18F)
Alzheimer's Disease (AD)
Enrollment
218
Start
Oct 2015
Primary Completion
Sep 2016
Completion
Nov 2016
NCT02681172
Phase 3
Completed
Phase III Study of Florbetaben (BAY94-9172) PET Imaging for Detection/Exclusion of Cerebral β-amyloid Compared to Histopathology
Florbetaben (BAY94-9172)
Alzheimer Disease
Enrollment
218
Start
Nov 2009
Primary Completion
Sep 2011
Completion
Dec 2013
NCT01020838
Phase 3
Completed
Efficacy of [18F]Florbetaben PET for Diagnosis of Cardiac AL Amyloidosis
[18F]florbetaben
Cardiac Amyloidosis, AL Amyloidosis +1
Enrollment
244
Start
Jan 2023
Primary Completion
Apr 2026
Completion
May 2026
NCT05184088
Phase 3
Recruiting
[18F]PI-2620 Phase 3 Histopathological Study
[18F]PI-2620
Alzheimer Disease
Enrollment
200
Start
Dec 2022
Primary Completion
Mar 2028est.
Completion
Sep 2028est.
NCT05641688
Phase 2
Completed
Phase II Study of Florbetaben (BAY 94-9172) PET Imaging for Detection/Exclusion of Cerebral β-amyloid in Patients With Probable Alzheimer's Disease Compared to Healthy Volunteers
Florbetaben (BAY94-9172)
Alzheimer Disease, Amyloid Beta-Protein
Enrollment
422
Start
Aug 2008
Primary Completion
Nov 2010
Completion
Nov 2010
NCT00750282
Phase 2
Completed
Phase II Study of Florbetaben (BAY94-9172) PET Imaging for Detection/Exclusion of Cerebral β-amyloid.
Florbetaben (BAY94-9172)
Down Syndrome, Amyloid Beta-protein
Enrollment
109
Start
Jun 2009
Primary Completion
Jan 2011
Completion
Jan 2011
NCT00928304
Phase 1/2
Terminated
PET/CT Imaging Study of the Safety and Diagnostic Performance of [68Ga]RM2 in Patients With Primary Prostate Cancer
[68Ga]RM2
Prostate Cancer
Enrollment
30
Start
May 2015
Primary Completion
Dec 2016
Completion
Dec 2016
NCT02483884
Phase 1
Completed
PET/CT Imaging for Radiation Dosimetry, Plasma Pharmacokinetics, Safety and Tolerability in Healthy Volunteers and Safety, Tolerability and Diagnostic Performance of BAY86-9596 in Patients With Non-small Cell Lung Cancer, Breast Cancer, Head and Neck Cancer and Patients With Inflammations
BAY86-9596, BAY86-9596
Diagnostic Imaging
Enrollment
35
Start
May 2010
Primary Completion
Sep 2011
Completion
Sep 2011
NCT01089998
Phase 1
Completed
Radiation Dosimetry, Metabolism, Pharmacokinetics, Safety and Tolerability and PET Imaging With BAY94-9392 in Healthy Volunteers and Patients With Cancer or Inflammation
BAY94-9392
Diagnostic Imaging, Neoplasms
Enrollment
46
Start
Apr 2010
Primary Completion
Aug 2011
Completion
Aug 2011
NCT01103310
Phase 1
Completed
Florbetaben (BAY94-9172) PET (Positron Emission Tomography) Imaging in MCI (Mild Cognitive Impairment) Patients
Florbetaben (BAY94-9172)
Alzheimer Disease, Amyloid Beta-Protein
Enrollment
45
Start
Jun 2008
Primary Completion
Dec 2011
Completion
Dec 2011
NCT01138111
Phase 1
Completed
Evaluation of the Diagnostic Potential of BAY1006578 in Probable Alzheimers Disease Patients Versus Healthy Volunteers and Radiation Dosimetry of BAY1006578 in Healthy Volunteers
BAY1006578, BAY1006578
Diagnostic Imaging
Enrollment
24
Start
Jun 2010
Primary Completion
Oct 2011
Completion
Oct 2011
NCT01153607
Phase 1
Completed
Exploration of Tumor Accumulation of BAY94-9392 in Patients With Cancer
PET tracer (BAY94-9392)
Neoplasms
Enrollment
30
Start
Dec 2010
Primary Completion
Oct 2011
Completion
Oct 2011
NCT01186601
Phase 1
Completed
PET/CT Imaging for Radiation Dosimetry, Plasma Pharmacokinetics, Biodistribution, Safety and Tolerability and Diagnostic Performance of BAY86-7548 in Patients With Prostate Cancer and Healthy Volunteers
Bombesin (68Ga) labeled (BAY86-7548), Bombesin (68Ga) labeled (BAY86-7548)
Diagnostic Imaging
Enrollment
19
Start
Nov 2010
Primary Completion
Nov 2011
Completion
Dec 2011
NCT01205321
Phase 1
Completed
PET/CT (Positron Emission Tomography/Computed Tomography) Imaging for Safety and Tolerability and Diagnostic Performance of BAY1075553 in Patients With Prostate Cancer and Healthy Volunteers
BAY1075553, BAY1075553
Diagnostic Imaging
Enrollment
14
Start
Feb 2011
Primary Completion
Oct 2011
Completion
Nov 2011
NCT01287845
Phase 1
Completed
PET/CT (Positron Emission Tomography / Computed Tomography) Investigations With BAY86-9596 (18F) (300 MBq) Following Single Intravenous Administration in Patients With Cancer or Inflammations.
BAY86-9596
Diagnostic Imaging
Enrollment
24
Start
May 2011
Primary Completion
Dec 2011
Completion
Dec 2011
NCT01297088
Phase 1
Terminated
PET Imaging of Intracranial Cancers With 18F-FSPG
18F-FSPG
Brain Cancer
Enrollment
26
Start
Nov 2014
Primary Completion
Mar 2016
Completion
Mar 2016
NCT02370563
Phase 1
Completed
Test-retest Study With [18F]FBB in Cardiac Amyloidosis
Florbetaben F18
Cardiac Amyloidosis
Enrollment
15
Start
Oct 2025
Primary Completion
Oct 2026
Completion
Oct 2026
NCT06790394

		Drug / Therapy	Title	Conditions	Enrollment				Link
Phase 4	Completed	Neuraceq (florbetaben 18F)	Impact of FBB PET Amyloid Imaging in Change of Diagnosis in Patients With AD	Alzheimer's Disease (AD)	218	Oct 2015	Sep 2016	Nov 2016	NCT02681172
Phase 3	Completed	Florbetaben (BAY94-9172)	Phase III Study of Florbetaben (BAY94-9172) PET Imaging for Detection/Exclusion of Cerebral β-amyloid Compared to Histopathology	Alzheimer Disease	218	Nov 2009	Sep 2011	Dec 2013	NCT01020838
Phase 3	Completed	[18F]florbetaben	Efficacy of [18F]Florbetaben PET for Diagnosis of Cardiac AL Amyloidosis	Cardiac Amyloidosis, AL Amyloidosis	244	Jan 2023	Apr 2026	May 2026	NCT05184088
Phase 3	Recruiting	[18F]PI-2620	[18F]PI-2620 Phase 3 Histopathological Study	Alzheimer Disease	200	Dec 2022	Mar 2028est.	Sep 2028est.	NCT05641688
Phase 2	Completed	Florbetaben (BAY94-9172)	Phase II Study of Florbetaben (BAY 94-9172) PET Imaging for Detection/Exclusion of Cerebral β-amyloid in Patients With Probable Alzheimer's Disease Compared to Healthy Volunteers	Alzheimer Disease, Amyloid Beta-Protein	422	Aug 2008	Nov 2010	Nov 2010	NCT00750282
Phase 2	Completed	Florbetaben (BAY94-9172)	Phase II Study of Florbetaben (BAY94-9172) PET Imaging for Detection/Exclusion of Cerebral β-amyloid.	Down Syndrome, Amyloid Beta-protein	109	Jun 2009	Jan 2011	Jan 2011	NCT00928304
Phase 1/2	Terminated	[68Ga]RM2	PET/CT Imaging Study of the Safety and Diagnostic Performance of [68Ga]RM2 in Patients With Primary Prostate Cancer	Prostate Cancer	30	May 2015	Dec 2016	Dec 2016	NCT02483884
Phase 1	Completed	BAY86-9596, BAY86-9596	PET/CT Imaging for Radiation Dosimetry, Plasma Pharmacokinetics, Safety and Tolerability in Healthy Volunteers and Safety, Tolerability and Diagnostic Performance of BAY86-9596 in Patients With Non-small Cell Lung Cancer, Breast Cancer, Head and Neck Cancer and Patients With Inflammations	Diagnostic Imaging	35	May 2010	Sep 2011	Sep 2011	NCT01089998
Phase 1	Completed	BAY94-9392	Radiation Dosimetry, Metabolism, Pharmacokinetics, Safety and Tolerability and PET Imaging With BAY94-9392 in Healthy Volunteers and Patients With Cancer or Inflammation	Diagnostic Imaging, Neoplasms	46	Apr 2010	Aug 2011	Aug 2011	NCT01103310
Phase 1	Completed	Florbetaben (BAY94-9172)	Florbetaben (BAY94-9172) PET (Positron Emission Tomography) Imaging in MCI (Mild Cognitive Impairment) Patients	Alzheimer Disease, Amyloid Beta-Protein	45	Jun 2008	Dec 2011	Dec 2011	NCT01138111
Phase 1	Completed	BAY1006578, BAY1006578	Evaluation of the Diagnostic Potential of BAY1006578 in Probable Alzheimers Disease Patients Versus Healthy Volunteers and Radiation Dosimetry of BAY1006578 in Healthy Volunteers	Diagnostic Imaging	24	Jun 2010	Oct 2011	Oct 2011	NCT01153607
Phase 1	Completed	PET tracer (BAY94-9392)	Exploration of Tumor Accumulation of BAY94-9392 in Patients With Cancer	Neoplasms	30	Dec 2010	Oct 2011	Oct 2011	NCT01186601
Phase 1	Completed	Bombesin (68Ga) labeled (BAY86-7548), Bombesin (68Ga) labeled (BAY86-7548)	PET/CT Imaging for Radiation Dosimetry, Plasma Pharmacokinetics, Biodistribution, Safety and Tolerability and Diagnostic Performance of BAY86-7548 in Patients With Prostate Cancer and Healthy Volunteers	Diagnostic Imaging	19	Nov 2010	Nov 2011	Dec 2011	NCT01205321
Phase 1	Completed	BAY1075553, BAY1075553	PET/CT (Positron Emission Tomography/Computed Tomography) Imaging for Safety and Tolerability and Diagnostic Performance of BAY1075553 in Patients With Prostate Cancer and Healthy Volunteers	Diagnostic Imaging	14	Feb 2011	Oct 2011	Nov 2011	NCT01287845
Phase 1	Completed	BAY86-9596	PET/CT (Positron Emission Tomography / Computed Tomography) Investigations With BAY86-9596 (18F) (300 MBq) Following Single Intravenous Administration in Patients With Cancer or Inflammations.	Diagnostic Imaging	24	May 2011	Dec 2011	Dec 2011	NCT01297088
Phase 1	Terminated	18F-FSPG	PET Imaging of Intracranial Cancers With 18F-FSPG	Brain Cancer	26	Nov 2014	Mar 2016	Mar 2016	NCT02370563
Phase 1	Completed	Florbetaben F18	Test-retest Study With [18F]FBB in Cardiac Amyloidosis	Cardiac Amyloidosis	15	Oct 2025	Oct 2026	Oct 2026	NCT06790394

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