These two top healthcare stocks are on the rise, carving a potentially higher growth path.
Clarity Pharmaceuticals (ASX: CU6)
Clarity Pharmaceuticals (ASX: CU6) has secured a major milestone with the U.S. FDA granting Fast Track Designation (FTD) for 64Cu-SAR-bisPSMA, its novel PET imaging agent for PSMA-positive prostate cancer lesions in patients with biochemical recurrence (BCR) following definitive therapy. This builds on an earlier FTD for the same agent in patients with suspected prostate cancer metastasis prior to initial definitive therapy. These dual FTDs enable Clarity to streamline regulatory processes and accelerate the development of a potentially best-in-class diagnostic for prostate cancer. The market for PSMA PET imaging in the U.S. is valued at ~US$2 billion (AU$3.2 billion) and is expected to grow to ~US$3 billion (AU$4.75 billion) by 2029. Current products offer little differentiation, and some new entrants are relying on unpatented agents like 68GaPSMA-11. Clarity’s proprietary SAR Technology delivers distinct advantages, including superior precision, tumour retention, and logistical efficiencies. The company is also preparing to initiate recruitment for its second registrational trial, AMPLIFY, in the coming months, further cementing its commitment to advancing diagnostic solutions.
Clarity’s pipeline extends beyond prostate cancer diagnostics. Its Discovery Program is developing innovative radiopharmaceuticals, including SAR-bisFAP, a product targeting fibroblast activation protein (FAP). FAP is widely expressed across many malignancies, creating a significant opportunity for pan-cancer imaging and therapies. Preclinical data for SAR-bisFAP have shown strong tumour targeting, retention, and pharmacokinetic profiles, underscoring its potential to address high unmet needs across oncology. The company’s SAR Technology platform is a key differentiator. Unlike conventional chelators, SAR Technology securely binds copper isotopes, enabling copper-64 for imaging and copper-67 for therapy. This “perfect pairing” enhances diagnostic accuracy while providing critical supply chain, environmental, and logistical benefits. With over 28 patent families protecting its platform and products, Clarity is uniquely positioned to develop next-generation radiopharmaceuticals. Clarity’s commitment to innovation, supported by strong intellectual property and differentiated technology, is driving progress in the rapidly growing radiopharmaceuticals market. By addressing unmet medical needs with precision-engineered solutions, Clarity aims to create significant clinical and commercial impact across oncology diagnostics and therapies.
TELIX Pharmaceuticals Limited (ASX: TLX)
TELIX Pharmaceuticals Limited (ASX: TLX) achieved significant milestones in January 2025, starting with the approval of its prostate cancer imaging agent, Illuccix®, in Europe. The product received Marketing Authorization through a decentralized procedure, paving the way for its commercial launch across the European Economic Area. Illuccix® is a breakthrough diagnostic tool in prostate cancer, recommended by key clinical guidelines for its superior accuracy in disease staging and biochemical recurrence evaluation. This approval follows strong revenue performance in Q4 2024, with the company reporting US$142 million in revenue for the quarter, reflecting a 46% year-on-year increase. Full-year revenue for 2024 exceeded guidance, reaching US$517 million, a 55% increase over the previous year, driven primarily by Illuccix® sales.
Telix’s ongoing expansion of its product portfolio is evident through its strategic acquisition of promising therapeutic and diagnostic assets. These include a major acquisition of Fibroblast Activation Protein (FAP)-targeting therapy candidates, which has high potential for treating multiple cancers, including bladder cancer. The company is also advancing its therapeutic pipeline, with pivotal trials for its prostate cancer therapy candidate, TLX591, and its kidney cancer therapy candidate, TLX250, progressing well. Additionally, Telix made strides in its neuro-oncology pipeline with the brain cancer imaging agent, TLX101, now under FDA review for approval. These efforts are expected to significantly bolster Telix’s market position in the coming years.
Telix is well-positioned for substantial growth with several important launches planned for 2025. This includes the submission of Biologics License Applications (BLAs) for its kidney cancer imaging agent Zircaix® and brain cancer imaging agent Pixclara®, both of which are expected to receive regulatory decisions in 2025. The company is also advancing its pipeline of next-generation radiopharmaceuticals, including therapies targeting CAIX in kidney cancer and alpha-emitting isotopes. This robust pipeline, combined with strong commercial performance and strategic manufacturing capabilities, positions Telix for a transformative 2025.
Source: Company's Report
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