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Lantheus to Present Additional Clinical Data from Phase 3 Pivotal SPLASH Trial in PSMA-Positive Metastatic Castration-Resistant Prostate Cancer During ESMO Congress 2024

Key Takeaway: Lantheus Holdings, Inc. will present new clinical data from the Phase 3 SPLASH trial on September 15, 2024, at the ESMO Annual Meeting in Barcelona. The trial focuses on the efficacy of 177Lu-PNT2002, a radioligand therapy for patients with PSMA-positive metastatic castration-resistant prostate cancer. This therapy previously received Fast Track designation from the FDA, indicating its potential significance in addressing unmet needs in cancer treatment. However, the final outcomes of the trial and subsequent regulatory approvals remain uncertain.
Price reaction · baseline $97.86 (2024-08-19 close) · hit after-hours · clean, no other LNTH news in the window
day 0 close · peak
+0.6%

Market Sentiment Analysis

POSITIVE FACTORS

  • Lantheus will present additional clinical data at ESMO Congress 2024, indicating progress in their research.
  • The presentation will provide insights into the efficacy of 177Lu-PNT2002 in treating mCRPC patients.
  • Fast Track designation by FDA suggests expedited development of PNT2002.
  • 177Lu-PNT2002 aims to meet unmet medical needs in prostate cancer therapy.

CONCERNS & RISKS

  • The outcome of the SPLASH trial is uncertain until full data is available.
  • There is the risk of delays or negative regulatory outcome from the FDA.
  • Launching PNT2002 commercially poses additional costs and risks.
  • PNT2002 faces competition which may affect market acceptance.

BiopharmaWatch Analysis

From our catalyst data and publicly available data · not financial advice
Best trade, last catalyst
+48%
120-day peak, hindsight
Typical move
2%
average across 7 past catalysts
Lead asset
18F-DCFPyL
Phase 3 · Prostate Cancer

Full Press Release Details

BEDFORD, Mass., Aug. 20, 2024 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. (“Lantheus”) (NASDAQ: LNTH), the leading radiopharmaceutical-focused company committed to enabling clinicians to Find, Fight and Follow disease to deliver better patient outcomes, today announced that Oliver Sartor, MD, Director of Radiopharmaceutical Trials and Professor of Medical Oncology at the Mayo Clinic in Rochester, Minnesota, will deliver an oral presentation, including additional clinical data from PNT2002’s initial December 2023 readout, during the European Society of Medical Oncology (ESMO) Annual Meeting in Barcelona on Sunday, September 15, 2024.
Title: Efficacy of 177Lu-PNT2002 in PSMA-positive mCRPC following progression on an androgen-receptor pathway inhibitor (ARPI) (SPLASH)
Presentation Number: LBA65
Lecture Date and Time: Sunday, September 15, 2024, 14:45 (CEST), 8:45 a.m. (EDT)
Room: Valencia Auditorium – Hall 5
Presenter: Oliver Sartor, MD, Director of Radiopharmaceutical Trials and Professor of Medical Oncology at the Mayo Clinic in Rochester, Minnesota
177Lu-PNT2002 is a PSMA-targeted, lutetium 177-based radioligand therapy candidate that combines a PSMA-targeted ligand, PSMA-I&T, with the beta-emitting radioisotope no-carrier-added lutetium-177. Lantheus in-licensed exclusive worldwide commercialization rights (excluding certain Asian territories) to 177Lu-PNT2002 from POINT Biopharma (a Lilly company) in December of 2022. In April of 2023, the FDA granted Fast Track designation for 177Lu-PNT2002 for the treatment of mCRPC. Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and address unmet medical needs.
Lantheus is the leading radiopharmaceutical-focused company, delivering life-changing science to enable clinicians to Find, Fight and Follow disease to deliver better patient outcomes. Headquartered in Massachusetts with offices in Canada and Sweden, Lantheus has been providing radiopharmaceutical solutions for more than 65 years. For more information, visit www.lantheus.com.
Safe Harbor for Forward-Looking and Cautionary Statements
This press release contains “forward-looking statements” that are subject to risks and uncertainties. Forward-looking statements include, but are not limited to, statements relating to the potential of PNT2002 and statements regarding Lantheus’ expectations, hopes, beliefs, intentions or strategies regarding the future. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. Forward-looking statements may be identified by their use of terms such as "development,” “expedited,” “will,” and other similar terms. Such forward-looking statements are based upon current plans, estimates and expectations that are subject to risks and uncertainties that could cause actual results to materially differ from those described in the forward-looking statements. Risks and uncertainties that could cause our actual results to materially differ from those described in the forward-looking statements include (i) the outcome of the SPLASH trial after full data is available; (ii) a delay in obtaining, or failure to obtain, a positive regulatory outcome from the FDA and regulatory authorities for PNT2002; (iii) the additional costs and risks associated with Lantheus’ ability to successfully launch PNT2002 as a commercial product; (iv) the market and patient receptivity to PNT2002 as a radiopharmaceutical therapy; (v) the existence, availability and profile of competing products and therapies; (vi) Lantheus’ ability to obtain and maintain adequate coding, coverage and payment for PNT2002; (vii) the intellectual property protection of PNT2002; (viii) POINT’s ability to successfully develop and scale the manufacturing capabilities to support the launch of PNT2002; and (ix) the risks and uncertainties discussed in Lantheus’ filings with the Securities and Exchange Commission (including those described in the Risk Factors section in its Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q). The inclusion of forward-looking statements should not be regarded as a representation that such plans, estimates and expectations will be achieved. Readers are cautioned not to place undue reliance on the forward-looking statements contained herein, which speak only as of the date hereof. Lantheus undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.

Frequently Asked Questions

What is 177Lu-PNT2002?

177Lu-PNT2002 is a PSMA-targeted radioligand therapy developed for mCRPC.

When will the oral presentation on PNT2002 take place?

The presentation is scheduled for September 15, 2024, at 14:45 CEST.

Who will present the clinical data on PNT2002?

Dr. Oliver Sartor from the Mayo Clinic will deliver the presentation.

What designation did the FDA grant to PNT2002?

The FDA granted Fast Track designation for PNT2002 in April 2023.

Where is Lantheus headquartered?

Lantheus is headquartered in Bedford, Massachusetts.

Last updated: Aug 20, 2024