December 11, 2025
Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX) is ending 2025 in a paradoxical position: commercially successful, rich in late‑stage oncology assets, but trading near its 12‑month lows amid SEC scrutiny, an FDA setback and a growing stack of class‑action lawsuits. At the same time, new clinical milestones and a fresh collaboration with Varian are reinforcing the long‑term radiopharmaceutical growth story.
This overview pulls together today’s news, the latest clinical and legal developments, and current analyst forecasts as of 11 December 2025.
Telix share price today: depressed after a volatile year
By midday in New York on 11 December, Telix’s Nasdaq‑listed American Depositary Shares (ADSs) were trading around US$9.33, down about 6% on the day and sitting not far above their 52‑week low of US$8.76, compared with a 52‑week high of US$30.36. That implies a market capitalisation of roughly US$3.1 billion, with trailing twelve‑month revenue of about US$664 million and net income of roughly US$11 million. [1]
On the Australian market, Telix’s ordinary shares are changing hands near A$14.00, with daily volume in the 1.7 million range. [2] Several independent analyses note that, at these levels, Telix trades on a price‑to‑sales multiple around the mid‑single digits, materially below many domestic and global biotech peers that command double‑digit sales multiples. [3]
The result is a stock that screens expensive on traditional earnings metrics – Telix’s trailing P/E ratio is above 200x – but cheap relative to its current revenue base and long‑term growth forecasts, a common profile for commercial‑stage, high‑growth biotech names. [4]
New strategic collaboration with Varian puts theranostics inside the radiotherapy workflow
The headline corporate development on 11 December 2025 is Telix’s newly announced partnership with Varian, a Siemens Healthineers company and one of the dominant players in external beam radiation therapy (EBRT). [5]
Under the strategic clinical collaboration:
- Telix and Varian will co‑develop clinical applications that combine Telix’s radiopharmaceutical “theranostic” products with EBRT, aiming to make molecular imaging and targeted radiation a more integrated part of the radiation oncology toolkit. [6]
- The initial focus is PSMA‑PET imaging in prostate cancer radiotherapy, using Telix’s PSMA imaging agents Gozellix® and Illuccix® to help select patients, plan therapy (including in Varian’s Ethos adaptive radiotherapy environment), and monitor treatment response. [7]
- The framework is designed to be expandable to other Telix imaging assets such as TLX250‑CDx (Zircaix®) for kidney cancer and TLX101‑CDx (Pixclara®) for brain tumours, as well as future therapeutic radiopharmaceuticals. [8]
For Telix, the Varian alliance is strategically important on several fronts:
- It anchors Telix’s products inside the day‑to‑day workflow of radiation oncologists, who are central decision‑makers across many cancer types.
- It creates a global clinical study platform with a partner that already has deep relationships with cancer centres and hospital systems.
- It reinforces Telix’s positioning as a theranostics specialist, where the same biological targets are used for both imaging and therapy – a theme increasingly recognised in oncology pipelines.
While the collaboration does not come with explicit revenue guidance, it strengthens the narrative that Telix is building an ecosystem around its imaging agents rather than selling standalone diagnostic products.
ProstACT Global Phase 3: first Part 2 patient dosed, pipeline story matures
On 8 December 2025, Telix announced that the first patient has been dosed in Part 2 (the randomized treatment expansion) of its ProstACT Global Phase 3 trial of TLX591, the company’s lead therapeutic candidate for metastatic castration‑resistant prostate cancer (mCRPC). [9]
Key points from the ProstACT update:
- ProstACT Global is an international Phase 3 trial testing TLX591 plus standard of care (such as AR pathway inhibitors or docetaxel) versus standard of care alone in mCRPC. [10]
- Part 1 – a smaller safety and dosimetry “lead‑in” – has completed target enrolment; Part 2 aims to recruit about 490 patients across sites in Australia, New Zealand, Canada and, pending regulatory steps, the U.S., Europe and several Asian markets. [11]
- Telix expects to present preliminary Part 1 data to the U.S. FDA and the EMA in the coming months, which will shape the expansion of trial sites and eventual registration strategy. [12]
TLX591 is a lutetium‑labelled radio antibody‑drug conjugate (rADC) that targets prostate‑specific membrane antigen (PSMA). Telix emphasises that, in long‑term follow‑up to date, TLX591 has shown a different safety profile from smaller PSMA‑targeted peptide radioligand therapies, with low kidney uptake and minimal salivary gland involvement, potentially reducing some common side effects of existing PSMA therapies. [13]
Independent coverage has framed the ProstACT Part 2 transition as a value‑defining inflection point:
- A December 11 analysis by Simply Wall St notes that Telix has reached this milestone after a “tough stretch” for shareholders, with the stock sharply lower year‑to‑date despite a three‑year total shareholder return near 97%, suggesting sentiment is resetting rather than the story being broken. [14]
- The same piece highlights a price‑to‑sales ratio around 4.7x, well below both Australian biotech peers and global comparables, and a discounted cash‑flow (DCF) fair value estimate near A$28.77 per share, implying the market may be under‑pricing ProstACT’s contribution if the trial delivers. [15]
A separate feature from Kalkine Media today, “ASX 200 Biotech Watch: Telix’s ProstACT Trial and Valuation,” similarly stresses that Telix’s revenue growth and pipeline progress contrast with a softer share price, painting the current valuation as a tug‑of‑war between maturing radiopharma potential and familiar late‑stage clinical risks. [16]
Q3 results and guidance: strong commercial engine behind the pipeline
Beneath the clinical headlines, Telix’s commercial business continues to grow rapidly.
In its Q3 2025 trading update released in October, Telix reported:
- Unaudited group revenue of approximately US$206 million for Q3 2025, up 53% year‑on‑year, and slightly ahead of Q2’s US$204 million. [17]
- A full‑year 2025 revenue guidance increase to US$800–820 million. [18]
- Expanded global roll‑out of Illuccix®, now approved in 19 European markets plus the UK, with commercial launches underway in key EU territories. [19]
- Confirmation that Gozellix®, its second PSMA imaging agent, is now fully reimbursed by U.S. Medicare (CMS) via a dedicated billing code and transitional pass‑through payment, effective from 1 October 2025. [20]
On a trailing twelve‑month basis, third‑party data show Telix generating around US$664 million in revenue with positive net income, marking a clear transition from pure development‑stage biotech to commercial‑stage radiopharma platform. [21]
Forecast data compiled by valueinvesting.io suggest that:
- Revenue for the current year is expected to be about US$824 million, rising to roughly US$974 million next year, an estimated 18% year‑on‑year increase.
- Earnings per share are projected to more than double in 2026 from a low base, underscoring the operating leverage investors hope to see as the product suite scales. [22]
Legal and regulatory overhang: SEC subpoena, FDA CRL and a wave of class actions
The primary drag on Telix’s share price in the second half of 2025 has been regulatory friction and litigation risk.
SEC subpoena on prostate cancer disclosures
On 22 July 2025, Telix disclosed that it had received a subpoena from the U.S. Securities and Exchange Commission (SEC) seeking documents and information “primarily relating to the company’s disclosures regarding the development of [its] prostate cancer therapeutic candidates,” including TLX591 and TLX592. Telix’s ASX announcement described the subpoena as part of a fact‑finding investigation, noting that the company is cooperating fully. [23]
Law‑firm summaries report that Telix’s ADSs fell by around 10% in the trading sessions immediately following the disclosure, with further declines later in the summer. [24]
FDA Complete Response Letter for TLX250‑CDx (Zircaix®)
On 28 August 2025, Telix announced that the U.S. FDA had issued a Complete Response Letter (CRL) for its Biologics License Application (BLA) for TLX250‑CDx (Zircaix®), a zirconium‑89‑labelled antibody imaging agent intended to differentiate clear cell renal cell carcinoma (ccRCC) from benign kidney masses. [25]
According to Telix and independent coverage, the CRL:
- Highlighted deficiencies in chemistry, manufacturing and controls (CMC), including the need to demonstrate that commercial‑scale product is comparable to material used in the Phase 3 ZIRCON trial. [26]
- Included notices of deficiencies to certain third‑party manufacturing and supply‑chain partners. [27]
Telix has said it believes the CMC issues are “readily addressable” and plans to work with the FDA, including through a Type A meeting, to clarify the resubmission path. [28] Nonetheless, the CRL triggered a one‑day share‑price fall of more than 20% on the ASX and remains central to investors’ risk assessment. [29]
Securities class actions and investor lawsuits
These regulatory events have now escalated into multiple securities class‑action filings in U.S. courts:
- A complaint led by firms including Hagens Berman and Glancy Prongay & Murray alleges that between 21 February 2025 and 28 August 2025, Telix and certain executives overstated the progress of its prostate cancer therapeutic candidates and the robustness of its supply chain and partners, rendering some public statements misleading. [30]
- On 11 December 2025, The Gross Law Firm issued a fresh notice reminding Telix shareholders of a 9 January 2026 lead‑plaintiff deadline, repeating the core allegations of overstated clinical progress and supply‑chain quality. [31]
The cases remain at an early stage. The allegations have not been proven in court, and Telix has indicated it is cooperating with regulators and intends to address manufacturing issues identified in the CRL. [32]
For investors, however, the legal overhang introduces:
- Potential financial liabilities if settlements or judgments occur.
- Reputational and execution risk, as management time is diverted and partners and regulators may take a more cautious stance.
- A layer of uncertainty over disclosures related to pipeline milestones, particularly in prostate cancer and kidney imaging.
Analyst forecasts: deep upside on paper, tempered by execution risk
Despite the regulatory noise, most equity research coverage still frames Telix as a high‑growth radiopharmaceutical name with material upside potential – at least on a 12‑month view.
Across the Australian and U.S. listings:
- On the ASX, valueinvesting.io aggregates 16 analysts with an average 12‑month price target of about A$28.34 per share, versus a spot price around A$14.00 – suggesting roughly 94% upside. The target range runs from A$22.83 to A$36.75, with an overall “Buy” consensus (10 Buy, 5 Strong Buy, 1 Hold). [33]
- TipRanks, tracking 10 analysts, reports a similar average target of A$27.84, with the same approximate 94% implied upside using a last price near A$14.32. [34]
- TradingView’s forecast dataset is broadly in line, with an average price target just above A$28, and a range in the low‑20s to mid‑30s. [35]
On the U.S. Nasdaq‑listed TLX ADSs:
- StockAnalysis notes that four analysts currently rate Telix a “Strong Buy”, with an average 12‑month price target of US$21.00, or roughly 125% upside from today’s US$9.33 quote. [36]
- Public.com’s forecast snapshot is consistent, also highlighting a Strong Buy consensus and a 2025 price prediction around US$21 for TLX. [37]
- An analyst note from H.C. Wainwright in September reduced its target from US$23 to US$20 but maintained a Buy rating, arguing that expanding diagnostic indications, particularly via the BiPASS trial for Illuccix and Gozellix in prostate cancer diagnosis, could materially enlarge Telix’s U.S. scan market. [38]
Beyond price targets, Simply Wall St’s forward‑looking model estimates that Telix’s earnings could grow at over 40% per year and revenue at around 17% per year, with return on equity potentially reaching about 20% within three years. [39]
At the same time, valuation tools across these platforms consistently flag that Telix’s apparent discount to their fair‑value estimates is not a free lunch: it reflects market concern about:
- The timeline and certainty of resolving the TLX250‑CDx CRL and re‑engaging with the FDA. [40]
- The outcome and duration of SEC and class‑action proceedings, which could weigh on multiples for an extended period. [41]
- Execution risk across multiple late‑stage programs competing in crowded fields (PSMA therapies and imaging, kidney cancer, glioblastoma). [42]
Key factors to watch going into 2026
For readers tracking Telix Pharmaceuticals stock from today’s levels, the balance of catalysts and risks over the next 12–18 months looks something like this:
- Radiation‑oncology adoption curve
How quickly Telix and Varian can translate their collaboration into concrete clinical protocols, trial readouts and – eventually – routine use of Telix’s agents in EBRT planning and follow‑up. [43] - ProstACT Global data and regulatory interactions
Preliminary Part 1 data shared with the FDA and EMA, recruitment pace in Part 2, and any early efficacy or safety signals that clarify TLX591’s competitive position in mCRPC. [44] - Resolution of the Zircaix® CRL
The timing and content of Telix’s re‑engagement with the FDA on TLX250‑CDx, remediation progress at manufacturing partners, and the extent to which the ccRCC imaging opportunity is delayed versus structurally impaired. [45] - Legal trajectory
Early court rulings, any motions to dismiss in the securities suits, and updates on the SEC’s investigation will heavily influence how much discount investors assign to Telix’s narrative. [46] - Commercial execution and margins
Whether Telix can sustain high double‑digit revenue growth while improving profitability, especially as Gozellix and Illuccix expand geographically and new indications are pursued. [47]
Bottom line
As of 11 December 2025, Telix Pharmaceuticals sits at a crossroads:
- On one side, it has two FDA‑approved PSMA imaging agents, fast‑growing revenue, an expanding European footprint, a late‑stage prostate cancer therapy trial in full swing and now a strategic collaboration with Varian that could embed its theranostics deeper into cancer care. [48]
- On the other, it faces an SEC investigation, an FDA CRL for a key kidney‑cancer imaging asset and several securities class‑action lawsuits, all of which cloud the visibility of future cash flows and may keep some institutional investors on the sidelines until there is more clarity. [49]
Analyst models currently imply substantial upside versus both the ASX and Nasdaq trading prices, but those targets rest on the assumption that Telix can navigate its regulatory and legal challenges while continuing to execute commercially and clinically.
References
1. stockanalysis.com, 2. valueinvesting.io, 3. simplywall.st, 4. stockanalysis.com, 5. www.prnewswire.com, 6. www.prnewswire.com, 7. www.prnewswire.com, 8. www.prnewswire.com, 9. www.prnewswire.com, 10. www.prnewswire.com, 11. www.prnewswire.com, 12. www.prnewswire.com, 13. www.prnewswire.com, 14. simplywall.st, 15. simplywall.st, 16. kalkinemedia.com, 17. www.prnewswire.com, 18. www.prnewswire.com, 19. www.prnewswire.com, 20. www.prnewswire.com, 21. stockanalysis.com, 22. valueinvesting.io, 23. announcements.asx.com.au, 24. zlk.com, 25. www.sec.gov, 26. www.globenewswire.com, 27. www.globenewswire.com, 28. www.reuters.com, 29. www.reuters.com, 30. www.gurufocus.com, 31. www.prnewswire.com, 32. announcements.asx.com.au, 33. valueinvesting.io, 34. www.tipranks.com, 35. www.tradingview.com, 36. stockanalysis.com, 37. public.com, 38. www.investing.com, 39. simplywall.st, 40. www.reuters.com, 41. www.globenewswire.com, 42. www.prnewswire.com, 43. www.prnewswire.com, 44. www.prnewswire.com, 45. ir.telixpharma.com, 46. www.prnewswire.com, 47. www.prnewswire.com, 48. www.prnewswire.com, 49. announcements.asx.com.au
