Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) is seeing a sharp pullback in Tuesday trading (Dec. 16, 2025), with shares recently changing hands around $62—down roughly 9% from the prior close—after hitting an intraday low near $59.76.
That drop may look dramatic in isolation, but it’s landing on top of an unusually eventful stretch for the RNA interference (RNAi) biotech: Arrowhead just transitioned into a commercial-stage story after its first FDA approval, picked up an FDA Breakthrough Therapy designation for a follow-on indication, and kicked off a new Alzheimer’s-related clinical program—three ingredients that tend to increase both upside narratives and day-to-day volatility in biotech stocks. [1]
Below is a full rundown of the current news flow as of 16.12.2025, the most-cited forecasts and price targets, and the next catalysts that could matter most for ARWR stock.
Why Arrowhead Pharmaceuticals stock is sliding today
As of the latest available tape, ARWR’s move is being framed by market outlets as a high-volatility retracement rather than a single, clearly identified negative catalyst. [2]
What is in the immediate company news cycle is relatively routine: Arrowhead disclosed inducement equity grants (restricted stock units) for 78 new employees, approved by the board on Dec. 12 and announced Dec. 15 under Nasdaq’s Listing Rule 5635(c)(4). These are standard hiring-related disclosures and typically aren’t considered fundamental catalysts by themselves—though they can remind traders that fast-scaling biotechs often use equity heavily to recruit. [3]
The more realistic driver of Tuesday’s downside is the market’s favorite non-mystical explanation: profit-taking and positioning after a powerful run tied to late-2025 regulatory and pipeline headlines. Earlier in December, Arrowhead shares touched a 52-week high of $71.62, after a surge that some services flagged as “overbought” on momentum indicators. [4]
The big fundamental story behind ARWR in late 2025
1) FDA approval: REDEMPLO (plozasiran) brings Arrowhead into the commercial club
Arrowhead’s defining 2025 milestone is the U.S. FDA approval of REDEMPLO (plozasiran) for familial chylomicronemia syndrome (FCS)—its first marketed product and a major validation event for its RNAi platform. [5]
Reuters reported that in clinical testing, Redemplo reduced triglycerides by ~80% and lowered pancreatitis risk by 83% versus placebo in a late-stage study, and noted that it became only the second drug approved in the U.S. for FCS (after Ionis’ Tryngolza). [6]
That sets up two realities for ARWR investors:
- Commercial execution now matters. The stock is no longer valued purely as “pipeline optionality.”
- Competition and legal risk matter more. Reuters also highlighted dueling patent litigation between Arrowhead and Ionis around RNA-targeting IP claims. [7]
Industry coverage emphasized the same inflection point: after two decades, Arrowhead is now a commercial-stage company—and the Redemplo clearance puts it into direct competition with Ionis in a rare-disease triglyceride market. [8]
2) FDA Breakthrough Therapy designation: expansion path for plozasiran in severe hypertriglyceridemia
On Dec. 2, 2025, Arrowhead said the FDA granted Breakthrough Therapy designation to investigational plozasiran for severe hypertriglyceridemia (SHTG) (TG ≥ 500 mg/dL) as an adjunct to diet. [9]
In the same release, the company said it expects to complete Phase 3 studies SHASTA-3, SHASTA-4, and MUIR-3 in mid-2026 and aims to submit a supplemental NDA by year-end 2026. [10]
This matters for valuation because SHTG is much larger than FCS—so the “real” revenue debate for many analysts isn’t whether Redemplo sells into a tiny ultra-rare population, but whether plozasiran expands into broader high-triglyceride segments on a timeline the market can underwrite.
3) New CNS swing: ARO-MAPT begins human dosing in Alzheimer’s-related tauopathies
On Dec. 8, 2025, Arrowhead announced it dosed the first subjects in a Phase 1/2a study of ARO-MAPT for tauopathies including Alzheimer’s disease, using a delivery system designed to cross the blood-brain barrier with subcutaneous dosing (based on preclinical work). [11]
Crucially for near-term expectations, the company said it anticipates initial data for early parts of the study in the second half of 2026. [12]
CNS programs can add huge upside or huge uncertainty. Markets tend to price that as volatility.
4) Sarepta milestone payment adds non-dilutive cash narrative (but it’s still milestone-driven)
Arrowhead also announced on Nov. 24, 2025 that it earned a $200 million milestone payment from Sarepta Therapeutics tied to progress in a Phase 1/2 study of ARO-DM1 / SRP-1003 for type 1 myotonic dystrophy. The company said it expected payment within 60 days, and noted plans to initiate enrollment in a higher-dose cohort in Q1 2026. [13]
For investors, this reinforces a key feature of Arrowhead’s financial profile: partnership economics can meaningfully impact cash flow, but milestone timing is inherently lumpy.
The numbers: Arrowhead’s fiscal 2025 results and cash position
In its fiscal year-end report (for the year ended Sept. 30, 2025), Arrowhead reported:
- Revenue:$829.448 million (vs. $3.551 million in fiscal 2024) [14]
- R&D expense:$607.159 million [15]
- Operating income:$98.346 million [16]
- Net loss attributable to Arrowhead:$(1.631) million (the press release also shows net income including noncontrolling interest) [17]
- Total cash resources (cash + restricted cash + available-for-sale securities):$781.524 million [18]
- Shares outstanding:135.702 million [19]
Translation: the 2025 revenue spike is real, but it’s heavily tied to collaboration and milestone economics, not yet recurring product sales at scale—exactly the kind of setup where Wall Street spends a year (or three) arguing about what the “true” earnings power should be.
Analyst forecasts for ARWR stock: price targets are rising, but dispersion is huge
If you want one word to describe ARWR’s “forecast” landscape right now, it’s dispersion—targets are all over the map, and they’ve been moving quickly after the FDA approval.
Recent notable target moves (late Nov–early Dec 2025)
- Piper Sandler raised its price target to $70 from $45 (Nov. 19) [20]
- BofA Securities raised its price target to $62 from $42 (Dec. 1) [21]
- H.C. Wainwright raised its price target to $85 from $80 (Dec. 3) [22]
- A later The Fly note reported BofA raising its price target again to $81 from $62 while keeping a Buy rating (early Dec.) [23]
Meanwhile, a Nasdaq/Fintel-style snapshot (as of Nov. 17, 2025) showed an average one-year price target of $50.53, with forecasts ranging from $17.17 to $84.00—a range that basically screams “biotech uncertainty.” [24]
A valuation-style forecast: Zacks Small-Cap Research’s $76 view
Zacks Small-Cap Research published notes in late 2025 that valued ARWR at $76/share using a probability-adjusted DCF framework, while emphasizing that the model depends heavily on ongoing clinical success. [25]
That same Zacks note laid out a catalyst roadmap for 2026 (including obesity program readouts, ARO-MAPT biomarker timing, SHASTA topline expectations, and other pipeline checkpoints). [26]
Sales outlook: Redemplo could become a meaningful product—if expansion lands
Reuters cited LSEG-compiled expectations that Redemplo could reach about $1.4 billion in sales by 2031 (consensus-style forecasting, not guidance). [27]
That number is a reminder of what the market is really trading: not just FCS, but the idea that Arrowhead can use FCS as a wedge into a broader triglyceride franchise, while advancing a pipeline that spans cardiometabolic disease, neurology, and rare genetic conditions.
What ARWR investors are watching next
Here’s what appears most “price-relevant” from the currently known pipeline and regulatory calendar:
REDEMPLO launch traction (2026):
Investors will watch for early signals on payer coverage, patient onboarding, and persistence—especially because Arrowhead’s own year-end commentary highlighted the transition into commercial-stage operations. [28]
SHTG Phase 3 completion and sNDA timing:
Arrowhead says it is on schedule to complete key Phase 3 studies in mid-2026 and target a supplemental NDA by year-end 2026. [29]
ARO-MAPT early human data (2H 2026):
The company expects initial Phase 1/2a data availability in the second half of 2026—a potential sentiment catalyst because CNS delivery is a major technical hurdle in RNAi. [30]
Sarepta-partnered ARO-DM1 / SRP-1003 progress (Q1 2026 and beyond):
Arrowhead said it intends to initiate enrollment in a higher-dose cohort in Q1 2026, and it expects the $200M milestone payment within 60 days of the Nov. 24 announcement. [31]
Key risks that still hang over Arrowhead stock
Even after the FDA approval, ARWR remains a classic “high beta biotech” in several ways:
- Commercial uncertainty: launch execution can disappoint even when the science is solid.
- Clinical readout risk: much of the valuation still rests on future data (SHTG expansion and broader pipeline).
- Competitive and legal risk: Ionis has an approved competitor product and an ongoing patent fight with Arrowhead. [32]
- Volatility risk: the stock’s recent 52-week-high sprint and sharp pullbacks underscore how quickly sentiment can reverse. [33]
Bottom line on ARWR stock on Dec. 16, 2025
Arrowhead Pharmaceuticals stock is down sharply today, but the bigger story is that ARWR is in the middle of a business-model transition: from “pipeline-only RNAi developer” to “commercial-stage biotech with a launch, expansion plans, and a deep (and risky) clinical slate.”
That transition often comes with violent market mood swings—especially when analyst targets are being revised upward in real time and the next major data points are still quarters away. [34]
References
1. www.reuters.com, 2. www.marketbeat.com, 3. arrowheadpharma.com, 4. ng.investing.com, 5. www.reuters.com, 6. www.reuters.com, 7. www.reuters.com, 8. www.biopharmadive.com, 9. arrowheadpharma.com, 10. arrowheadpharma.com, 11. arrowheadpharma.com, 12. arrowheadpharma.com, 13. arrowheadpharma.com, 14. arrowheadpharma.com, 15. arrowheadpharma.com, 16. arrowheadpharma.com, 17. arrowheadpharma.com, 18. arrowheadpharma.com, 19. arrowheadpharma.com, 20. www.investing.com, 21. www.investing.com, 22. www.investing.com, 23. www.tipranks.com, 24. www.nasdaq.com, 25. s27.q4cdn.com, 26. s27.q4cdn.com, 27. www.reuters.com, 28. arrowheadpharma.com, 29. arrowheadpharma.com, 30. arrowheadpharma.com, 31. arrowheadpharma.com, 32. www.reuters.com, 33. ng.investing.com, 34. www.investing.com
