Telix Pharmaceuticals Limited (ASX:TLX, Nasdaq:TLX) entered the spotlight again on December 17, 2025, as TLX stock extended its December sell-off amid a fast-moving mix of clinical-trial updates, regulatory overhang, and investor litigation headlines. [1]
On the ASX, Telix shares closed at A$11.73, down 6.61% on the session, with a wide intraday range from A$11.535 to A$12.730 and volume of roughly 6.36 million shares—a notably volatile day by recent standards. [2]
In the U.S., Telix’s Nasdaq-listed shares/ADS were also under pressure, with U.S. market coverage noting a gap-down move and a roughly 6%–7% decline in early trading action on Dec. 17. [3]
What’s driving the renewed volatility—and what are analysts forecasting from here?
TLX share price today: what happened on December 17, 2025
Telix’s ASX-listed shares posted a sharp one-day decline:
- Close (Dec. 17): A$11.73 (-6.61%)
- Open: A$12.62 | High: A$12.73 | Low: A$11.535
- Volume: ~6.36M [4]
Zooming out slightly, the last three sessions show how quickly sentiment has deteriorated:
- Dec. 15: A$13.17
- Dec. 16: A$12.56
- Dec. 17: A$11.73 [5]
That’s roughly a 10.9% drop across three sessions (Dec. 15 close to Dec. 17 close), based on the historical prices above. [6]
The move also leaves TLX near the bottom of its disclosed 52-week range (as shown on market data pages that list A$11.535–A$31.970), placing the stock down roughly 63% from the 52-week high—a dramatic reversal for a name that had previously been one of Australia’s standout healthcare momentum stories. [7]
Key news from Dec. 17: Telix issues a ProstACT Global “status” update after market chatter
The most important company-originated development dated December 17, 2025 was Telix’s statement on the ProstACT Global Phase 3 study for its lead prostate cancer therapeutic candidate TLX591 (lutetium-177 rosopatamab tetraxetan).
Telix said the announcement was released in response to “inaccurate information in market circulation.” [8]
What Telix confirmed about ProstACT Global (TLX591)
According to the company’s Dec. 17 update:
- Part 1 enrollment is complete (the safety and dosimetry lead-in), per protocol. [9]
- Telix is preparing for data lock and read-out, including the docetaxel cohort, which it describes as the final cohort to complete enrollment. [10]
- Part 1 data will be presented to the FDA to determine eligibility for U.S. patients to join Part 2 (randomized treatment expansion). [11]
- An Independent Data Monitoring Committee (IDMC) reviewed available Part 1 data and recommended proceeding to Part 2; Telix said it has advanced the study into Part 2 in jurisdictions where approvals have been obtained. [12]
- Telix added a reminder that TLX591 has not received marketing authorization in any jurisdiction. [13]
Why this matters for TLX stock
For investors, TLX591 is central to the “next chapter” narrative: Telix is already commercial in imaging, but meaningful upside expectations often hinge on whether its therapeutics can progress cleanly through Phase 3 and into regulatory filings.
The catch: in biotech, “clarifying” statements can cut both ways. They may reassure long-term holders about fundamentals—yet also highlight that information flow and market interpretation are actively influencing near-term trading.
For additional context, Telix issued a related update on December 8, 2025, stating that the first patient had been dosed in Part 2 of the ProstACT Global Phase 3 study and describing global expansion plans for Part 2. [14]
Lawsuit and “shareholder alert” headlines remain a heavy overhang
Alongside today’s company update, Telix continues to face a drumbeat of investor-law-firm announcements tied to a U.S. securities class action theme.
What these releases claim (and what they don’t)
Multiple press releases circulating in mid-December point to allegations that Telix and certain executives overstated progress on prostate cancer therapeutic candidates and misrepresented aspects of supply chain/manufacturing readiness. These are allegations, not court findings. [15]
Key details repeatedly cited in the releases include:
- A stated lead plaintiff deadline of Jan. 9, 2026 (in some announcements). [16]
- A referenced “class period” of Feb. 21, 2025 to Aug. 28, 2025 for purchasers of Telix ADS (per one major release). [17]
- References to two major “regulatory” moments: an SEC subpoena disclosure (July 2025) and an FDA Complete Response Letter (Aug. 2025). [18]
From a market-structure standpoint, these headlines can matter even when investors expect limited fundamental impact, because they can:
- Increase perceived risk,
- Keep new buyers on the sidelines, and
- Add incremental selling pressure from holders with low tolerance for uncertainty.
The FDA Zircaix (TLX250-CDx) Complete Response Letter is still shaping sentiment
A second major force behind TLX’s choppy tape is regulatory: Telix’s kidney cancer imaging candidate TLX250-CDx (Zircaix) received an FDA Complete Response Letter (CRL) earlier this year.
In a Telix regulatory update (published via SEC filing), the company said the CRL:
- Identified deficiencies relating to Chemistry, Manufacturing, and Controls (CMC)
- Requested additional data to establish comparability between the clinical-trial product and scaled commercial manufacturing
- Noted Form 483 issues issued to two third-party manufacturing/supply chain partners requiring remediation before resubmission [19]
Telix stated it believed the issues were “readily addressable” and planned to request a Type A meeting with the FDA. [20]
Independent coverage around the CRL has emphasized the same theme: manufacturing and supply chain execution is often the hidden make-or-break factor in radiopharmaceutical approvals, especially as programs scale. [21]
Notably, a urology trade outlet resurfaced the topic on Dec. 17, 2025, summarizing the CRL and highlighting that TLX250-CDx posted strong diagnostic performance in the Phase 3 ZIRCON study while still being held up by the CMC/regulatory process. [22]
Why TLX250 matters even though it’s “just” imaging
Telix’s near-term revenue base is anchored by prostate cancer imaging products, but TLX250-CDx is viewed as a potential expansion lever into kidney cancer imaging—another high-value area where “first-to-market” status could have meaningful commercial implications.
So, even as Telix has stressed that 2025 guidance excludes revenue from unapproved products, markets still price the option value of future approvals—and discount it sharply when timelines become uncertain. [23]
What’s going right: commercial momentum and new partnerships
Despite the volatility, Telix is not trading like a pre-revenue biotech. It has an established commercial business in radiopharmaceutical diagnostics.
Revenue and guidance: Telix lifted FY2025 revenue expectations
In an October 2025 update, Telix reported US$206 million in quarterly revenue and upgraded FY2025 revenue guidance to US$800–US$820 million, driven primarily by PSMA imaging product sales (Illuccix and Gozellix) and contribution from its RLS business. [24]
That matters in today’s tape because investors are trying to distinguish between:
- Near-term cash generation from approved imaging products, and
- Longer-duration upside from pipeline approvals (and the risks that come with them).
December partnership headline: Telix and Varian (Siemens Healthineers) collaboration
On Dec. 10, 2025, Telix announced a strategic clinical collaboration with Varian (a Siemens Healthineers company) to explore clinical applications combining Telix theranostics with external beam radiation therapy (EBRT)—with initial focus on PSMA-PET imaging in prostate cancer radiotherapy patients. [25]
The release specifically referenced using Illuccix and Gozellix in EBRT patient selection and treatment planning workflows, and noted the collaboration framework could later extend to pipeline candidates such as Zircaix (TLX250-CDx) and Pixclara (TLX101-CDx). [26]
For investors, this type of partnership headline can help reinforce Telix’s “platform” narrative—though markets typically demand follow-through in the form of study starts, endpoints, and timelines.
Analyst forecasts and price targets: wide dispersion after the sell-off
With TLX stock now trading far below earlier highs, forecast ranges have become a prominent part of the debate.
RBC initiates coverage: “Sector Perform,” A$17 price target
On Dec. 15, 2025, Investing.com reported that RBC Capital initiated Telix with a Sector Perform rating and a price target of A$17.00, citing Telix’s commercialized prostate cancer diagnostic assets while forecasting earnings and free cash flow to remain broadly flat through FY2027 as the company invests in its pipeline. [27]
MarketBeat (U.S. listing): “Moderate Buy,” average price target $21.00
A MarketBeat note dated Dec. 17, 2025 described Telix as having a “Moderate Buy” consensus and an average price target of $21.00 (for the Nasdaq-traded shares), while also listing a mix of Buy/Hold/Sell ratings across covering analysts. [28]
TipRanks and TradingView: “Strong Buy” consensus (AU:TLX) with higher targets
Other forecast aggregators show higher 12-month targets for the ASX listing:
- TipRanks (AU:TLX): consensus Strong Buy, average target ~A$27.91 (range cited around A$22.61–A$35.02, per the page snapshot). [29]
- TradingView (ASX:TLX): target ~A$27.28, with a wide range of estimates on the page. [30]
Fintel / Jefferies recap: compiled target range and fundamentals snapshot
A Fintel item dated Dec. 6, 2025 also summarized compiled targets and forward estimates (as displayed on that platform), including an average one-year price target and a forecast range, plus projections for revenue and non-GAAP EPS. [31]
How to read these forecasts: the dispersion itself is the message. Telix sits at the crossroads of (1) real commercial traction in imaging and (2) binary-ish regulatory execution risk, which tends to blow out forecast ranges.
Technical picture on Dec. 17: “Strong Sell” signals, deeply oversold RSI
From a pure technical-indicator perspective, Investing.com’s technical summary for Telix showed:
- A “Strong Sell” technical summary across multiple time frames
- RSI(14) around 15.6, flagged as oversold [32]
Oversold readings don’t predict a rebound by themselves, but they do illustrate how one-sided the selling became into Dec. 17—often a setup for heightened volatility in either direction as traders react to any incremental catalyst.
What to watch next for Telix (TLX) stock
With TLX now trading in a headline-sensitive zone, the next decisive moves are likely to come from specific milestones, not broad narratives:
- ProstACT Global Part 1 readout timing and FDA engagement to expand Part 2 into U.S. sites (as Telix flagged in today’s status update). [33]
- Zircaix / TLX250-CDx resubmission path after the FDA CRL—particularly any updates on manufacturing comparability data and remediation of third-party findings. [34]
- Progress on Pixclara (TLX101-CDx) resubmission planning (Telix has previously described an FDA pathway involving additional analysis of existing data). [35]
- Any new clinical data or expanded collaborations stemming from the Varian partnership and its PSMA/EBRT focus. [36]
- Developments in the shareholder litigation process, including the approach of referenced deadlines and any court milestones (noting again that press releases reflect allegations and legal positioning). [37]
Bottom line
As of December 17, 2025, Telix Pharmaceuticals (TLX) stock is being pulled by opposing forces:
- Bull case anchors: strong commercial imaging revenues, raised FY2025 guidance, and continued pipeline progression (including today’s ProstACT clarification and the Varian collaboration). [38]
- Bear case pressure points: regulatory execution risk (CMC/supply chain scrutiny for Zircaix), plus legal/SEC-related headline risk that can keep multiples compressed even when core sales stay resilient. [39]
The market’s next big decision on TLX may hinge less on broad “biotech sentiment” and more on whether Telix can deliver clean, confidence-building milestones—especially around trial readouts and FDA interactions—while keeping its commercial engine compounding in the background. [40]
References
1. telixpharma.com, 2. www.investing.com, 3. www.marketbeat.com, 4. www.investing.com, 5. www.investing.com, 6. www.investing.com, 7. au.investing.com, 8. telixpharma.com, 9. telixpharma.com, 10. telixpharma.com, 11. telixpharma.com, 12. telixpharma.com, 13. telixpharma.com, 14. telixpharma.com, 15. www.prnewswire.com, 16. www.prnewswire.com, 17. www.prnewswire.com, 18. www.prnewswire.com, 19. www.sec.gov, 20. www.sec.gov, 21. www.fiercebiotech.com, 22. www.urologytimes.com, 23. www.sec.gov, 24. telixpharma.com, 25. www.globenewswire.com, 26. www.globenewswire.com, 27. www.investing.com, 28. www.marketbeat.com, 29. www.tipranks.com, 30. www.tradingview.com, 31. fintel.io, 32. au.investing.com, 33. telixpharma.com, 34. www.sec.gov, 35. telixpharma.com, 36. www.globenewswire.com, 37. www.prnewswire.com, 38. telixpharma.com, 39. www.sec.gov, 40. telixpharma.com
