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Telix Pharmaceuticals (TLX)

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Recent press releases and 8-K filings for TLX.

Telix Pharmaceuticals' Illuccix NDA Accepted in China, Achieves FY 2025 Revenue Guidance
TLX
New Projects/Investments
Guidance Update
  • Telix Pharmaceuticals Limited announced on January 20, 2026, that the Chinese National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE) has accepted the filing of a New Drug Application (NDA) for TLX591-Px (Illuccix®), its lead prostate cancer imaging agent, in partnership with Grand Pharmaceutical Group Limited.
  • The Illuccix China pivotal Phase 3 study, which reported positive top-line results in December 2025, met its primary endpoint with an overall patient-level positive predictive value (PPV) of 94.8% for tumor detection, and 67.2% of patients experienced a change in their treatment plan as a consequence of the imaging.
  • This NDA submission is considered a major milestone for Telix, as China represents a strategically important market with over 134,000 men diagnosed with prostate cancer in 2022 and a projected 1,600+ PET/CT cameras by the end of 2025.
  • Telix also announced it achieved its FY 2025 guidance with US$804 million (A$1.2 billion) in revenue.
Jan 20, 2026, 9:15 PM
Telix Pharmaceuticals Provides 2026 Outlook and Strategic Priorities
TLX
Guidance Update
Product Launch
New Projects/Investments
  • Telix Pharmaceuticals projects full financial year guidance of $800 million-$820 million and expects to surpass $1 billion in revenue in the coming years. The company's strategy through 2027 is to maximally reinvest revenue into pipeline and infrastructure, prioritizing growth over short-term earnings.
  • The company anticipates launching Pixclara and Zircaix in 2026 following regulatory resubmissions and has three therapeutic programs in Phase 3 pivotal late-stage trials this year, including TLX-591 for prostate cancer.
  • Telix has expanded its lead commercial product, Illuccix, into 17 new countries and is conducting a Phase 3 bypass biopsy study to significantly grow the addressable market for its prostate cancer franchise.
  • Approximately $500 million has been invested in the last two years in manufacturing, supply chain, and distribution capabilities, including a nuclear pharmacy network in the U.S., supporting the delivery of approximately 2.9 million doses to patients last year.
Jan 12, 2026, 5:00 PM
Telix Provides Business Update at J.P. Morgan Healthcare Conference
TLX
Guidance Update
Product Launch
New Projects/Investments
  • Telix is a commercial-stage radiopharma company specializing in oncology, focused on developing both imaging and therapeutic agents. The company's guidance for the full financial year is in the $800 million-$820 million range, with expectations to significantly exceed $1 billion in revenue over the next couple of years.
  • The company successfully launched Illuccix, which received new drug approval in April of last year and pass-through effective October 1st. Illuccix has expanded into 17 countries outside the United States, including Europe and the U.K., and an NDA has been filed in China.
  • Telix expects to launch Pixclara and Zircaix in 2026, subject to regulatory approvals, following resubmissions to the FDA. The company has three therapeutic programs in phase three, pivotal late-stage trials this year.
  • Between now and the end of 2027, Telix plans to maximally reinvest revenue from its commercial business into its pipeline and infrastructure, positioning itself as a self-funded biotech company.
  • Telix has invested approximately $500 million in the last two years in manufacturing, supply chain, and distribution capabilities, including owning a nuclear pharmacy network in the United States. Last year, the group delivered about 2.9 million doses to patients across all operating segments.
Jan 12, 2026, 5:00 PM
Telix Pharmaceuticals Provides Financial Guidance and Pipeline Updates at J.P. Morgan Healthcare Conference
TLX
Guidance Update
Product Launch
New Projects/Investments
  • Telix Pharmaceuticals provided full financial year guidance in the $800 million-$820 million range and aims to significantly exceed $1 billion in revenue over the next couple of years, with a strategic focus on reinvesting revenue into pipeline and infrastructure until the end of 2027 rather than prioritizing earnings per share.
  • The company expects to launch Pixclara and Zircaix in 2026, pending regulatory approvals, and has initiated a phase 3 bypass biopsy study for Illuccix and Gazelix, which could double the market opportunity for prostate cancer imaging.
  • Telix has invested approximately $500 million in the last two years in manufacturing, supply chain, and distribution capabilities, including a US nuclear pharmacy network, and delivered about 2.9 million doses to patients last year.
  • The company has three therapeutic programs in phase three pivotal late-stage trials this year, with updates including the randomized segment of the TLX-591 study recruiting internationally and the TLX-592 alpha program starting clinical trials.
Jan 12, 2026, 5:00 PM
Telix Pharmaceuticals Faces Securities Fraud Class Action Lawsuit
TLX
Legal Proceedings
  • A class action lawsuit has been filed against Telix Pharmaceuticals Limited (NASDAQ: TLX).
  • The complaint alleges that defendants made false and/or misleading statements and/or failed to disclose that they materially overstated the progress with prostate cancer therapeutic candidates and the quality of Telix's supply chain and partners during the Class Period of February 21, 2025 – August 28, 2025.
  • The Lead Plaintiff Deadline for investors is January 9, 2026.
Jan 5, 2026, 8:35 PM
Telix Pharmaceuticals Faces Class Action Lawsuit Over Alleged Misstatements and Regulatory Failures
TLX
Legal Proceedings
  • Hagens Berman is reminding investors that the deadline to move for appointment as lead plaintiff in a securities class action lawsuit against Telix Pharmaceuticals (TLX) is January 9, 2026.
  • The lawsuit alleges that Telix and its executives materially overstated the developmental progress of therapeutic candidates, including TLX591/TLX592, and misrepresented the reliability and regulatory compliance of its third-party supply chain and manufacturing partners.
  • These allegations follow an SEC subpoena related to drug development disclosures and an FDA Complete Response Letter (CRL) for the Zircaix application, citing severe Chemistry, Manufacturing, and Controls (CMC) and Form 483 deficiencies at third-party manufacturers.
  • The cumulative effect of these disclosures allegedly caused Telix ADSs to fall sharply, including a 21% drop, leading to damages for investors who purchased ADSs during the Class Period of February 21, 2025 – August 28, 2025.
Jan 1, 2026, 2:00 PM
Telix Pharmaceuticals Faces Class Action Lawsuit Over Regulatory Setbacks
TLX
Legal Proceedings
  • Hagens Berman is reminding investors of the January 9, 2026, deadline to act as lead plaintiff in a securities class action lawsuit against Telix Pharmaceuticals Ltd. (TLX).
  • The lawsuit alleges Telix overstated the developmental progress of its therapeutic candidates and misrepresented its third-party manufacturing reliability and regulatory compliance.
  • Key regulatory setbacks cited include an SEC subpoena concerning disclosures on prostate cancer therapeutic candidates (TLX591/TLX592) and an FDA Complete Response Letter (CRL) for the Zircaix application due to CMC and Form 483 deficiencies.
  • These disclosures led to a 21% drop in Telix ADSs, affecting investors who purchased during the Class Period of Feb. 21, 2025 – Aug. 28, 2025.
Dec 30, 2025, 2:30 PM
Telix Pharmaceuticals faces securities class action lawsuit over alleged misstatements and regulatory setbacks
TLX
Legal Proceedings
  • Hagens Berman is reminding investors of a January 9, 2026, deadline to act as lead plaintiff in a securities class action lawsuit against Telix Pharmaceuticals (TLX).
  • The lawsuit alleges that Telix and its executives overstated the developmental progress of therapeutic candidates and misrepresented the reliability of its third-party supply chain and manufacturing partners.
  • Regulatory setbacks include an SEC subpoena regarding disclosures on prostate cancer drug progress (TLX591/TLX592) and an FDA Complete Response Letter (CRL) for Zircaix due to CMC and Form 483 deficiencies at third-party manufacturers.
  • These disclosures allegedly caused Telix ADSs to fall sharply, including a 21% drop, leading to investor damages during the Class Period of February 21, 2025, to August 28, 2025.
Dec 27, 2025, 8:55 PM
Telix Pharmaceuticals faces class action lawsuit over alleged misstatements and regulatory failures
TLX
Legal Proceedings
Product Launch
  • Hagens Berman is reminding investors in Telix Pharmaceuticals (NASDAQ: TLX) that the deadline to move for lead plaintiff in a securities class action lawsuit is January 9, 2026.
  • The lawsuit alleges Telix and its executives materially overstated the developmental progress of its prostate cancer therapeutic candidates (TLX591/TLX592) and misrepresented the reliability and regulatory compliance of its third-party supply chain and manufacturing partners.
  • These allegations follow an SEC subpoena related to drug development disclosures and an FDA Complete Response Letter (CRL) for the Zircaix application, citing severe Chemistry, Manufacturing, and Controls (CMC) deficiencies.
  • The cumulative effect of these disclosures allegedly caused Telix ADSs to fall sharply, including a 21% drop following the final regulatory news.
Dec 24, 2025, 7:50 PM
Telix Pharmaceuticals Faces Securities Class Action Lawsuit Over Regulatory Setbacks
TLX
Legal Proceedings
Product Launch
  • Hagens Berman is reminding investors of the January 9, 2026, deadline to move the Court for appointment as lead plaintiff in a securities class action lawsuit against Telix Pharmaceuticals Ltd. (TLX).
  • The lawsuit alleges that Telix and its executives overstated the developmental progress of its therapeutic candidates and misrepresented the reliability and regulatory compliance of its third-party supply chain and manufacturing partners.
  • This follows an SEC subpoena related to disclosures on prostate cancer drug development (TLX591/TLX592) and an FDA Complete Response Letter (CRL) citing Chemistry, Manufacturing, and Controls (CMC) deficiencies and Form 483 notices at third-party manufacturers.
  • These regulatory setbacks led to a sharp stock decline, including a 21% drop following the final news, impacting investors who purchased TLX ADSs during the Class Period of Feb. 21, 2025 – Aug. 28, 2025.
Dec 22, 2025, 1:51 PM