Lantheus Announces Presentations Featuring PYLARIFY (Piflufolastat F 18) Data at the ASCO GU Meeting

On February 5, 2025 Lantheus Holdings, Inc. (the Company) (NASDAQ: LNTH), the leading radiopharmaceutical-focused company committed to enabling clinicians to Find, Fight and Follow disease to deliver better patient outcomes, reported piflufolastat F 18 data will be presented at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Cancers Symposium, taking place February 13-15, 2025, in San Francisco, CA.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Presentation details are as follows:

Date & Time: Thursday, February 13, 2025, 11:25 am – 12:45 pm PT and 5:45 PM-6:45 PM PT
Session Number: Poster Session A
Session Title: Prostate Cancer
Title: Early Detection of Recurrent Prostate Cancer Using 18F-DCFPyL PET/CT in Patients with Minimal PSA Levels
Presenter: Ida Sonni, University of California, Department of Radiation Oncology
Poster Number: J8

Date & Time: Thursday, February 13, 2025, 11:25 am – 12:45 pm PT and 5:45 PM-6:45 PM PT
Session Number: Poster Session A
Session Title: Prostate Cancer
Title: The Role of Conventional Imaging and Piflufolastat F18 in Newly-Diagnosed and Recurrent Prostate Cancer Patients: Preliminary Observations from the PYLARIFY Registry
Presenter: Neal Shore, Carolina Urologic Research Center
Poster Number: A19

About PYLARIFY (piflufolastat F 18) Injection
PYLARIFY (piflufolastat F 18) injection (also known as 18F-DCFPyL or PyL) is a fluorinated small molecule PSMA-targeted PET imaging agent that enables visualization of lymph nodes, bone and soft tissue metastases to determine the presence or absence of recurrent and/or metastatic prostate cancer. For men with prostate cancer, PYLARIFY PET combines the accuracy of PET imaging, the precision of PSMA targeting and the clarity of an F 18 radioisotope for superior diagnostic performance. 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.1-6

PYLARIFY has made a profound impact on the lives of patients battling prostate cancer. It is the number one ordered PSMA PET imaging agent in the U.S., and is a proven diagnostic backed by real-world experience, including in over 400,000 scans across 48 states.

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 definitive therapy.
with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.
Important Safety Information

Contraindications

None.

Warnings and Precautions

Risk of Image Misinterpretation
Imaging interpretation errors can occur with PYLARIFY imaging. A negative image does not rule out the presence of prostate cancer and a positive image does not confirm the presence of prostate cancer. The performance of PYLARIFY for imaging of patients with biochemical evidence of recurrence of prostate cancer seems to be affected by serum PSA levels. The performance of PYLARIFY for imaging of metastatic pelvic lymph nodes prior to initial definitive therapy seems to be affected by risk factors such as Gleason score and tumor stage. PYLARIFY uptake is not specific for prostate cancer and may occur with other types of cancer as well as non-malignant processes and in normal tissues. Clinical correlation, which may include histopathological evaluation of the suspected prostate cancer site, is recommended.

Hypersensitivity Reactions
Monitor patients for hypersensitivity reactions, particularly patients with a history of allergy to other drugs and foods. Reactions may be delayed. Always have trained staff and resuscitation equipment available.

Radiation Risks
Diagnostic radiopharmaceuticals, including PYLARIFY, expose patients to radiation. Radiation exposure is associated with a dose-dependent increased risk of cancer. Ensure safe handling and preparation procedures to protect patients and health care workers from unintentional radiation exposure. Advise patients to hydrate before and after administration and to void frequently after administration.

Adverse Reactions
The most frequently reported adverse reactions were headaches, dysgeusia and fatigue, occurring at rate of ≤2% during clinical studies with PYLARIFY. In addition, a delayed hypersensitivity reaction was reported in one patient (0.2%) with a history of allergic reactions.

Drug interactions

Androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, may result in changes in uptake of PYLARIFY in prostate cancer. The effect of these therapies on performance of PYLARIFY PET has not been established.

To report suspected adverse reactions for PYLARIFY, call 1-800-362-2668 or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please read the accompanying full Prescribing Information also available at PYLARIFY.com.

(Press release, Lantheus, FEB 5, 2025, View Source [SID1234662961])

Bicycle Therapeutics to Participate in the Oppenheimer 35th Annual Healthcare Life Sciences Conference

On February 5, 2025 Bicycle Therapeutics plc (NASDAQ: BCYC), a pharmaceutical company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology, reported that management will participate in a fireside chat at the Oppenheimer 35th Annual Healthcare Life Sciences Conference on Wednesday, Feb. 12, at 10 a.m. ET (Press release, Bicycle Therapeutics, FEB 5, 2025, View Source [SID1234650050]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

A live webcast of the fireside chat will be accessible from the Investor section of the company’s website at www.bicycletherapeutics.com. A replay of the webcast will be archived and available following the event.

Boston Scientific announces results for fourth quarter and full year 2024

On February 5, 2025 Boston Scientific Corporation (NYSE: BSX) reported net sales of $4.561 billion during the fourth quarter of 2024, growing 22.4 percent on a reported basis, 23.1 percent on an operational1 basis and 19.5 percent on an organic2 basis, all compared to the prior year period (Press release, Boston Scientific, FEB 5, 2025, View Source [SID1234650066]). The company reported GAAP net income attributable to Boston Scientific common stockholders of $566 million or $0.38 per share (EPS), compared to $504 million or $0.34 per share a year ago and achieved adjusted3 EPS of $0.70 for the period, compared to $0.55 a year ago.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

For the full year 2024, the company generated net sales of $16.747 billion, growing 17.6 percent on a reported basis, 18.5 percent on an operational1 basis and 16.4 percent on an organic2 basis. The company reported GAAP net income attributable to Boston Scientific common stockholders of $1.853 billion or $1.25 per share, compared to $1.570 billion or $1.07 per share a year ago, and delivered full year adjusted3 EPS of $2.51, compared to $2.05 a year ago.

"2024 was one of the best years in the history of Boston Scientific, fueled by our innovative portfolio, the launch of our FARAPULSE Pulsed Field Ablation System as well as significant clinical achievements and commercial excellence across businesses and regions," said Mike Mahoney, chairman and chief executive officer, Boston Scientific. "We have a strong foundation for growth, and I am incredibly grateful for our talented global team and the opportunity to continue transforming the lives of millions of patients around the world."

Fourth quarter financial results and recent developments:

Reported net sales of $4.561 billion, representing an increase of 22.4 percent on a reported basis, compared to the company’s guidance range of 16.5 to 18.5 percent; 23.1 percent on an operational basis; and 19.5 percent on an organic basis, compared to the company’s guidance range of 14 to 16 percent, all compared to the prior year period.

Reported GAAP net income attributable to Boston Scientific common stockholders of $0.38 per share, compared to the company’s guidance range of $0.41 to $0.43 per share, and achieved adjusted EPS of $0.70 per share, compared to the guidance range of $0.64 to $0.66 per share.

Achieved the following net sales growth in each reportable segment, compared to the prior year period:
MedSurg: 12.4 percent reported, 13.0 percent operational and 7.0 percent organic
Cardiovascular: 28.8 percent reported, 29.5 percent operational and 27.4 percent organic

Achieved the following net sales growth in each region, compared to the prior year period:
United States (U.S.): 30.7 percent reported and operational
Europe, Middle East and Africa (EMEA): 10.8 percent reported and 11.6 percent operational
Asia-Pacific (APAC): 11.1 percent reported and 12.4 percent operational
Latin America and Canada (LACA): 4.6 percent reported and 12.6 percent operational
Emerging Markets4: 12.4 percent reported and 15.2 percent operational

Presented positive 36-month primary endpoint findings from the OPTION clinical trial at the American Heart Association Scientific Sessions demonstrating superior bleeding risk reduction and similar efficacy with the WATCHMAN FLX Left Atrial Appendage Closure Device compared to oral anticoagulation in high-risk patients with atrial fibrillation (AF) post ablation, followed by a late-breaking sub-analysis at AF Symposium 2025 reaffirming positive outcomes with the device in both concomitant and sequential procedures.

Presented positive 12-month primary endpoint findings from phase one of the ADVANTAGE AF clinical trial at AF Symposium 2025 that achieved the safety and effectiveness endpoints for the treatment of patients with persistent AF with the FARAPULSE Pulsed Field Ablation System.

Received U.S. Centers for Medicare & Medicaid Services approval of a new transitional pass-through payment for the AGENT Drug-Coated Balloon effective Jan. 1, 2025, which offers facilities additional reimbursement for outpatient procedures.

Received both U.S. Food and Drug Administration (FDA) approval and CE mark for the Vercise Cartesia X and HX Directional Leads, the first and only 16-contact directional leads designed for more precise targeting for enhanced clinical outcomes using the Vercise Genus Deep Brain Stimulation System.

Completed the acquisition of Axonics, Inc., an innovative medical technology company focused on the development and commercialization of differentiated devices for the treatment of urinary and bowel dysfunction.

Announced and completed the acquisition of Cortex, Inc., a privately held medical technology company focused on the development of a diagnostic mapping solution which aims to identify triggers and drivers outside of the pulmonary veins that are foundational to AF.

Announced agreements to acquire the following companies, subject to customary closing conditions:
Bolt Medical, Inc., a developer of an intravascular lithotripsy advanced laser-based platform for the treatment of coronary and peripheral artery disease which is pending U.S. FDA approval.
Intera Oncology Inc., a medical device company that provides the Intera 3000 Hepatic Artery Infusion Pump and floxuridine, a chemotherapy drug.
1 Operational net sales growth excludes the impact of foreign currency fluctuations.

2 Organic net sales growth excludes the impact of foreign currency fluctuations and net sales attributable to acquisitions and divestitures for which there are less than a full period of comparable net sales.

3 Adjusted EPS excludes the impacts of certain charges (credits) which may include amortization expense, goodwill and other intangible asset impairment charges, acquisition/divestiture-related net charges (credits), investment portfolio net losses (gains) and impairments, restructuring and restructuring-related net charges (credits), certain litigation-related net charges (credits), European Union Medical Device Regulation (EU MDR) implementation costs, debt extinguishment net charges, deferred tax expenses (benefits) and certain discrete tax items.

4 Periodically, we assess our list of Emerging Markets countries, and effective January 1, 2023, modified our list to include all countries except the United States, Western and Central Europe, Japan, Australia, New Zealand and Canada.

Fourth quarter net sales by business and region:

Increase/(Decrease)

Three Months Ended
December 31,

Reported
Basis

Impact of
Foreign
Currency
Fluctuations

Operational
Basis

Impact of
Recent
Acquisitions/
Divestitures

Organic
Basis

(in millions)

2024

2023

Endoscopy

$ 690

$ 645

7.0 %

0.6 %

7.6 %

(0.7) %

7.0 %

Urology

630

527

19.5 %

0.5 %

20.1 %

(12.2) %

7.9 %

Neuromodulation

299

269

11.4 %

0.5 %

11.9 %

(6.4) %

5.5 %

MedSurg

1,619

1,441

12.4 %

0.6 %

13.0 %

(6.0) %

7.0 %

Cardiology

2,297

1,751

31.1 %

0.8 %

31.9 %

— %

31.9 %

Peripheral Interventions

645

533

21.0 %

0.8 %

21.7 %

(9.2) %

12.5 %

Cardiovascular

2,942

2,285

28.8 %

0.8 %

29.5 %

(2.2) %

27.4 %

Net Sales

$ 4,561

$ 3,725

22.4 %

0.7 %

23.1 %

(3.6) %

19.5 %

Increase/(Decrease)

Three Months Ended
December 31,

Reported
Basis

Impact of
Foreign
Currency
Fluctuations

Operational
Basis

(in millions)

2024

2023

U.S.

$ 2,893

$ 2,213

30.7 %

— %

30.7 %

EMEA

830

749

10.8 %

0.9 %

11.6 %

APAC

684

616

11.1 %

1.2 %

12.4 %

LACA

155

148

4.6 %

8.0 %

12.6 %

Net Sales

$ 4,561

$ 3,725

22.4 %

0.7 %

23.1 %

Emerging Markets4

$ 668

$ 595

12.4 %

2.8 %

15.2 %

Amounts may not foot due to rounding. Growth rates are based on actual, non-rounded amounts and may not recalculate precisely.

Net sales growth rates that exclude the impact of foreign currency fluctuations and/or the impact of acquisitions/divestitures are not prepared in
accordance with GAAP.

Full year net sales by business and region:

Increase/(Decrease)

Year Ended

December 31,

Reported
Basis

Impact of
Foreign
Currency
Fluctuations

Operational
Basis

Impact of
Recent
Acquisitions /
Divestitures

Organic
Basis

(in millions)

2024

2023

Endoscopy

$ 2,687

$ 2,482

8.3 %

0.6 %

8.9 %

(1.0) %

8.0 %

Urology

2,200

1,964

12.0 %

0.5 %

12.5 %

(3.3) %

9.3 %

Neuromodulation

1,106

976

13.3 %

0.4 %

13.7 %

(11.0) %

2.7 %

MedSurg

5,993

5,422

10.5 %

0.6 %

11.1 %

(3.6) %

7.5 %

Cardiology

8,344

6,709

24.4 %

1.0 %

25.4 %

— %

25.4 %

Peripheral Interventions

2,410

2,110

14.2 %

1.2 %

15.5 %

(4.6) %

10.9 %

Cardiovascular

10,755

8,819

22.0 %

1.1 %

23.0 %

(1.1) %

21.9 %

Net Sales

$ 16,747

$ 14,240

17.6 %

0.9 %

18.5 %

(2.1) %

16.4 %

Increase/(Decrease)

Year Ended

December 31,

Reported
Basis

Impact of
Foreign
Currency
Fluctuations

Operational
Basis

(in millions)

2024

2023

U.S.

$ 10,210

$ 8,425

21.2 %

— %

21.2 %

EMEA

3,228

2,856

13.0 %

0.8 %

13.8 %

APAC

2,686

2,400

11.9 %

3.7 %

15.7 %

LACA

624

560

11.4 %

2.6 %

14.1 %

Net Sales

$ 16,747

$ 14,240

17.6 %

0.9 %

18.5 %

Emerging Markets4

$ 2,680

$ 2,310

16.1 %

3.6 %

19.6 %

Amounts may not foot due to rounding. Growth rates are based on actual, non-rounded amounts and may not recalculate precisely.

Net sales growth rates that exclude the impact of foreign currency fluctuations and/or the impact of acquisitions/divestitures are not prepared in
accordance with U.S. GAAP.

Guidance for Full Year and First Quarter 2025

The company estimates net sales growth for the full year 2025, versus the prior year period, to be in a range of approximately 12.5 to 14.5 percent on a reported basis, and approximately 10 to 12 percent on an organic basis. Full year organic net sales guidance excludes the impact of foreign currency fluctuations and net sales attributable to acquisitions and divestitures for which there are less than a full period of comparable net sales. The company estimates EPS on a GAAP basis in a range of $1.86 to $1.93 and estimates adjusted EPS, excluding certain charges (credits), of $2.80 to $2.87.

The company estimates net sales growth for the first quarter of 2025, versus the prior year period, to be in a range of approximately 17 to 19 percent on a reported basis, and approximately 14 to 16 percent on an organic basis. First quarter organic net sales guidance excludes the impact of foreign currency fluctuations and net sales attributable to acquisitions and divestitures for which there are less than a full period of comparable net sales. The company estimates EPS on a GAAP basis in a range of $0.43 to $0.45 and estimates adjusted EPS, excluding certain charges (credits), of $0.66 to $0.68.

Conference Call Information

Boston Scientific management will be discussing these results with analysts on a conference call today at 8:00 a.m. ET. The company will webcast the call to interested parties through its website: investors.bostonscientific.com. Please see the website for details on how to access the webcast. The webcast will be available for approximately one year on the Boston Scientific website.

Cellectar Biosciences to Present at the Oppenheimer 35th Annual Healthcare Life Sciences Conference

On February 5, 2025 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, reported that members of its management team will present an overview of the company at the upcoming Oppenheimer 35th Annual Healthcare Life Sciences Conference being held virtually (Press release, Cellectar Biosciences, FEB 5, 2025, View Source [SID1234650051]). Details are as follows:

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Date: Wednesday, February 12, 2025
Time: 12:00 PM Eastern Time
Webcast: Click HERE

A replay of the corporate presentation will be available on the Events section of the company’s investor relations website.

Carisma Therapeutics to Participate in Oppenheimer 35th Annual Healthcare Life Sciences Conference

On February 5, 2025 Carisma Therapeutics Inc. (Nasdaq: CARM) ("Carisma" or the "Company"), a leader in macrophage-focused therapeutics, reported that Steven Kelly, President and Chief Executive Officer, will participate in the Oppenheimer 35th Annual Healthcare Life Sciences Conference on Tuesday, February 11 at 4:40 pm ET (Press release, Carisma Therapeutics, FEB 5, 2025, View Source [SID1234650067]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

An audio webcast of the event will be available on the Company’s Investor Events section of the Investor Relations webpage and will be archived for a limited time following the event.