Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) is ending 2025 in rare biotech air. The RNA interference (RNAi) specialist has secured its first U.S. drug approval, locked in a multibillion‑dollar licensing deal with Novartis, and just dosed the first subjects in a new Alzheimer’s disease trial — all while its share price hovers near record highs. [1]
As of intraday trading on December 9, 2025, Arrowhead Pharmaceuticals stock trades around $69 per share, giving the company a market value in the $9–9.5 billion range. That’s up dramatically from under $10 per share at its 52‑week low, and represents a triple‑digit gain over the past year and roughly 260–270% year‑to‑date, depending on the data source. [2]
Below is a detailed look at the latest news, forecasts and analysis shaping ARWR stock today.
Arrowhead Pharmaceuticals stock today: near 52‑week highs after a blistering rally
Arrowhead shares hit a new 52‑week high of about $71.5 during trading on December 8, following a series of positive catalysts including an Alzheimer’s trial start and a recent FDA Breakthrough Therapy designation. The current 52‑week range is roughly $9.6 to $71.5, highlighting just how far the stock has run in 2025. [3]
Recent trading has been unusually heavy. On December 8, ARWR closed at $68.60, up 11.65% on the day, with about 5 million shares changing hands — more than double typical volume. A short‑term technical service, StockInvest, upgraded ARWR to a “Strong Buy” candidate based on momentum and moving‑average signals, while also flagging the stock as “very high risk” due to wide intraday swings and an overbought RSI. [4]
MarketBeat notes that on December 8, the stock hit $69.50 intraday, up nearly 15% from the prior close of $61.44, with a market cap around $9.6 billion, a beta near 1.3, and a P/E still formally negative given near‑breakeven GAAP earnings. [5]
In short, Arrowhead has moved from beaten‑down RNAi story stock to one of 2025’s standout biotech momentum names, but with volatility to match.
2025 turning point: first FDA approval and a dramatic financial swing
The core of the rerating is straightforward: Arrowhead is now a commercial‑stage company.
On November 18, 2025, the U.S. FDA approved REDEMPLO (plozasiran) as a treatment for familial chylomicronemia syndrome (FCS), a rare genetic disorder characterized by extremely high triglyceride levels and recurrent, sometimes fatal pancreatitis. [6]
Key points from the approval and supporting data:
- REDEMPLO is Arrowhead’s first FDA‑approved medicine and the first approval of a drug based on its TRiM™ RNAi platform. [7]
- In the Phase 3 PALISADE trial, patients on REDEMPLO achieved about an 80% median reduction in triglycerides compared with a modest reduction on placebo, and the risk of acute pancreatitis episodes fell sharply. [8]
- The drug is self‑administered as a subcutaneous injection once every three months, a meaningful convenience advantage versus more frequent injection regimens in the class. [9]
Arrowhead estimates there are around 6,500 people in the U.S. living with genetic or clinical FCS, while FDA and analyst estimates peg the global FCS population at 3,000–5,000 patients — a small but high‑value niche market where effective therapies can command premium pricing. [10]
Analysts cited by Reuters expect Redemplo (plozasiran) to reach around $1.4 billion in annual sales by 2031, although that forecast assumes successful defense of IP and competitive positioning. [11]
The impact on Arrowhead’s financials in fiscal 2025 (year ended September 30) is striking:
- Revenue surged to $829.4 million from just $3.6 million in fiscal 2024, largely driven by milestone payments and deal‑related income, plus the early transition to commercial operations. [12]
- Operating income swung from a $601 million loss to a $98 million profit.
- Net loss attributable to Arrowhead shareholders narrowed to roughly $1.6 million, essentially breakeven on a GAAP basis, versus a $599 million loss a year earlier.
- Total cash and investments (cash, equivalents and marketable securities) climbed to around $782 million, giving the company a healthy war chest heading into 2026. [13]
To support the launch, Arrowhead introduced a “One‑REDEMPLO” pricing model and a patient support program branded Rely On REDEMPLO, which offers access and financial assistance services. [14]
From a business‑model perspective, 2025 marks Arrowhead’s transition from pure development‑stage biotech to a hybrid of royalty/milestone‑driven and direct commercial revenue, with the potential for multiple future launches.
Cardiometabolic franchise: Breakthrough Therapy and a bigger triglyceride opportunity
The FCS approval is only the first step for plozasiran.
On December 2, 2025, the FDA granted Breakthrough Therapy designation to plozasiran as an adjunct to diet for severe hypertriglyceridemia (SHTG), defined as triglycerides ≥500 mg/dL. This setting involves a far larger patient population than ultra‑rare FCS and carries significant risk of pancreatitis and cardiovascular disease. [15]
According to Arrowhead and conference abstracts:
- The ongoing Phase 3 SHASTA‑3 and SHASTA‑4 trials are evaluating plozasiran in SHTG patients, with baseline and rationale data presented at the World Congress of Insulin Resistance, Diabetes and Cardiovascular Disease (WCIRDC) in early December. [16]
- The Breakthrough designation could accelerate development and review, assuming the Phase 3 data confirm strong triglyceride lowering and pancreatitis risk reduction.
Plozasiran will compete directly with Ionis Pharmaceuticals’ drug Tryngolza (olezarsen), which already holds an FDA label in FCS and has reported robust triglyceride reductions in SHTG as well. Analysts have called olezarsen’s SHTG data a “home run,” setting a high bar for Arrowhead’s entry. [17]
The rivalry is not only commercial but legal. In September, Ionis sued Arrowhead, alleging plozasiran infringes an Ionis patent, while Arrowhead filed a declaratory‑judgment complaint in Delaware seeking to invalidate the patent and assert independent development. [18]
This FCS/SHTG arena is therefore one of Arrowhead’s largest long‑term value drivers and also one of its highest legal and competitive risk areas.
Arrowhead has further extended the cardiometabolic footprint through:
- Zodasiran, now in the YOSEMITE Phase 3 trial for homozygous familial hypercholesterolemia (HoFH), a severe LDL‑cholesterol disorder. [19]
- ARO‑DIMER‑PA, a first‑in‑class dual‑target RNAi “dimer” aimed at both PCSK9 and APOC3, with a Phase 1/2a clearance request filed in 2025. [20]
- A Greater China cardiometabolic partnership, through majority‑owned subsidiary Visirna, which struck a deal giving Sanofi rights to plozasiran in Greater China in exchange for $130 million upfront and up to $265 million in plozasiran‑related milestones. [21]
Together, these assets make Arrowhead one of the more diversified triglyceride and lipid‑focused RNAi platforms in public markets.
CNS expansion: Novartis’ Parkinson’s bet and Arrowhead’s own Alzheimer’s trial
Another pillar of the 2025 bull story is Arrowhead’s push into central nervous system (CNS) diseases, an area long considered challenging for RNA‑based therapeutics.
Novartis deal for ARO‑SNCA (Parkinson’s and synucleinopathies)
In early September, Arrowhead announced a global license and collaboration with Novartis for ARO‑SNCA, a preclinical RNAi therapy targeting alpha‑synuclein, a protein implicated in Parkinson’s disease and related synucleinopathies. [22]
Deal terms:
- $200 million upfront payment to Arrowhead upon closing.
- Up to $2 billion in development, regulatory and sales milestones.
- Tiered royalties that can reach the low double digits on net sales.
- Novartis gains exclusive global rights to ARO‑SNCA and additional TRiM™‑based targets.
Analysts view the deal as a strong external validation of Arrowhead’s TRiM™ platform for CNS delivery, particularly given Novartis’ prior setbacks with alpha‑synuclein approaches. [23]
ARO‑MAPT: Arrowhead’s own Alzheimer’s shot
On December 9, Arrowhead disclosed that it has dosed the first subjects in a Phase 1/2a trial of ARO‑MAPT, an RNAi therapy designed to silence the MAPT gene, which encodes tau protein, in people with early Alzheimer’s disease and other tauopathies. [24]
Key details from the ARO‑MAPT program:
- New CNS delivery system: ARO‑MAPT is the first Arrowhead candidate to use a proprietary systemic delivery technology that has shown the ability in primate studies to cross the blood–brain barrier and achieve deep, sustained target knockdown throughout the CNS after subcutaneous dosing. [25]
- Phase 1/2a design: The AROMAPT‑SC‑1001 study will enroll up to 64 healthy volunteers and 48 patients with early Alzheimer’s disease, testing both weekly and monthly subcutaneous dosing regimens over multiple injections. [26]
- Timeline: Arrowhead has guided that initial human data from early parts of the study are expected in the second half of 2026, meaning this is a multi‑year story rather than an immediate revenue driver. [27]
The company is also presenting its CNS delivery work at the 7th Annual CNS Delivery Summit in December, including a talk titled “TRiM™ platform for subcutaneous delivery of siRNA to CNS,” reinforcing the strategic push beyond liver‑targeted RNAi. [28]
Taken together, the Novartis alliance and the ARO‑MAPT trial position Arrowhead as a serious RNAi player in neurodegeneration, albeit at a very early clinical stage.
Partnerships and pipeline breadth beyond cardiometabolic and CNS
Arrowhead’s 2025 update highlights just how broad its clinical network has become:
- Sarepta collaboration (muscular dystrophy): Arrowhead recorded $300 million in milestones tied to the ARO‑DM1 program for type 1 myotonic dystrophy, with milestone payments partially taken as Arrowhead shares repurchased from Sarepta at $18.79 and placed into treasury, modestly reducing share count. [29]
- Late‑stage partnered hepatic programs:
- Fazirsiran, licensed to Takeda, is in Phase 3 for alpha‑1 antitrypsin‑associated liver disease.
- Olpasiran, licensed to Amgen, is in Phase 3 for elevated lipoprotein(a), a major residual cardiovascular risk factor. [30]
- A suite of pulmonary and liver programs (e.g., ARO‑RAGE, ARO‑MUC5AC, ARO‑MMP7, ARO‑PNPLA3, ARO‑C3) remain in Phase 1/2 development for asthma, idiopathic pulmonary fibrosis, NASH and complement‑mediated diseases, among others. [31]
Management’s earlier “20 in 25” goal — 20 clinical‑stage or marketed TRiM‑based products by 2025 — is close to becoming reality, underpinning the bull case that Arrowhead is more a platform story than a single‑asset bet. [32]
Wall Street view: strong‑buy ratings, but price targets lag the stock
Analyst sentiment has turned decisively positive in recent months.
According to StockAnalysis and QuiverQuant:
- 10 analysts currently cover ARWR with a consensus rating of “Strong Buy.”
- The average 12‑month price target is $56, with a range from $17 (low) to $85 (high); median is around $60. [33]
- The most recent updates include:
- HC Wainwright: target raised from $80 to $85 (Strong Buy, Dec 2).
- BofA Securities: target raised from $42 to $62 (Strong Buy, Dec 1).
- Chardan:$60 (Strong Buy, Dec 1).
- Piper Sandler:$70 (Overweight, Nov 19).
- RBC Capital:$52 (Outperform, Nov 19).
- Goldman Sachs and Morgan Stanley: both at $48, with neutral/hold stances. [34]
MarketBeat’s aggregation gives ARWR a “Moderate Buy” label with an average target of about $53.33, while GuruFocus and other services cluster targets in the mid‑$50s to high‑$50s. [35]
That is where valuation tension shows up:
- At roughly $69, ARWR trades around 20–25% above the average analyst target and only modestly below the most bullish $85 scenario.
- Several valuation‑focused services (e.g., Simply Wall St and Trefis‑linked analysis) have flagged ARWR as somewhat overvalued versus their discounted‑cash‑flow models, even before the most recent leg higher. [36]
In effect, the stock price appears to be front‑running the Street, pricing in more optimistic assumptions about plozasiran’s broader indications, REDEMPLO’s launch curve, and the CNS pipeline than the average model currently does.
Earnings and revenue outlook: big 2025, then a reset
Consensus forecasts show that 2025’s explosive revenue is unlikely to be repeated immediately.
According to StockAnalysis:
- Revenue is projected to drop from about $829 million in fiscal 2025 to roughly $398 million in 2026, a decline of just over 50%, primarily because milestone and upfront payments are inherently lumpy.
- Analysts then expect a further step down to around $292 million in 2027, before any potential re‑acceleration from new indications or launches. [37]
- Consensus EPS is forecast to move back into deeper negative territory (around ‑$3.29 in 2026 and ‑$4.00 in 2027), reflecting heavy reinvestment in R&D and launch activities. [38]
With no dividend and a forward PE that remains not meaningful while earnings are negative, Arrowhead is still a growth‑stage biotech whose valuation rests on future cash flows rather than current profitability. [39]
Investors should treat 2025’s near‑breakeven year as a milestone, not the new baseline.
Ownership, insider activity and market sentiment
MarketBeat estimates that around 62–63% of Arrowhead’s shares are held by institutional investors, while insiders own about 4.3%. [40]
Data from QuiverQuant and insider‑trading trackers show:
- No insider purchases reported in the last several months.
- A series of insider sales, including:
- James Hamilton, Chief Medical Officer, selling 60,000 shares over the last six months for roughly $1.7 million.
- Director Mauro Ferrari selling 8,750 shares around $56.39, reducing his stake by about 11%. [41]
- Over the most recent quarter, insiders in total sold roughly 43,750 shares worth about $1.6 million. [42]
External commentators have noted that while insider ownership is reasonably high for a biotech of this size, the pattern of net selling and absence of buying is a mild caution flag at current prices.
On the institutional side, QuiverQuant highlights significant new positions from funds such as Driehaus Capital, Arrowstreet Capital, Deerfield and Janus Henderson in Q3 2025, while T. Rowe Price exited its position, illustrating the mixed but generally constructive professional sentiment around the stock. [43]
Short‑term technical and trading services (including StockInvest and other momentum trackers) currently score Arrowhead as a high‑risk, high‑reward momentum play, with high volatility and a strong uptrend. [44]
Key risks: litigation, competition, clinical uncertainty and volatility
Despite the powerful bull narrative, several risks stand out:
- Patent litigation with Ionis
- The dueling lawsuits over plozasiran’s FCS use could, in a downside scenario, result in damages, royalty obligations, or constraints on commercialization if Ionis prevails.
- The legal process is likely to be protracted and binary, introducing headline risk for ARWR. [45]
- Competitive pressure in FCS and SHTG
- Ionis’ Tryngolza is already on the market in FCS and has strong late‑stage data in SHTG.
- Arrowhead leans on dosing‑schedule and efficacy advantages, but formulary decisions, real‑world safety and payer negotiations will be crucial in determining market share splits. [46]
- Clinical‑stage pipeline risk
- Many of Arrowhead’s high‑value assets — especially ARO‑MAPT and ARO‑SNCA — are pre‑revenue and early stage; failure in neurodegenerative disease trials is historically common.
- Even successful RNAi knockdown does not guarantee meaningful clinical benefit in complex CNS disorders.
- Revenue volatility and funding needs
- Analyst models imply significant revenue compression in 2026–27 as milestone income normalizes.
- While Arrowhead has over $780 million in cash and investments, sustained negative EPS could eventually require additional capital or debt, especially if multiple late‑stage trials expand in parallel. [47]
- Stock‑price volatility and valuation risk
- With the share price already ahead of average Street targets and short‑term RSI in overbought territory, ARWR is vulnerable to sharp pullbacks on any disappointing data, slower‑than‑expected launch metrics, or adverse court rulings. [48]
What to watch in 2026 and beyond
For investors and observers tracking Arrowhead Pharmaceuticals stock, several catalysts and milestones are likely to drive sentiment over the next 12–24 months:
- Early launch metrics for REDEMPLO in FCS – patient uptake, payer coverage, persistence and real‑world pancreatitis outcomes. [49]
- Phase 3 readouts for plozasiran in SHTG (SHASTA‑3/4) and any regulatory interactions enabled by Breakthrough Therapy status. [50]
- Progress in the Ionis litigation and clarity on the FCS/SHTG intellectual‑property landscape. [51]
- Novartis’ advancement of ARO‑SNCA into human trials, with associated milestone payments and eventual early‑stage readouts in Parkinson’s. [52]
- Initial human data from ARO‑MAPT in Alzheimer’s disease, expected in the second half of 2026. [53]
- Zodasiran’s YOSEMITE Phase 3 program in HoFH and any updates on the dual‑target ARO‑DIMER‑PA program. [54]
How these threads resolve will determine whether Arrowhead’s 2025 surge proves to be the beginning of a durable rerating or a moment in time when expectations sprinted ahead of fundamentals.
Bottom line
Arrowhead Pharmaceuticals stock currently sits at the intersection of genuine scientific progress and elevated investor expectations.
- The company now has a first‑in‑class siRNA drug on the market, a Breakthrough‑designated triglyceride franchise, major partners like Novartis, Amgen, Takeda, Sanofi and Sarepta, and a validated RNAi platform pushing into the CNS. [55]
- At the same time, analyst targets lag the share price, insiders have been net sellers, and upcoming litigation, competitive battles and high‑risk CNS trials could inject substantial volatility.
References
1. arrowheadpharma.com, 2. finance.yahoo.com, 3. finance.yahoo.com, 4. stockinvest.us, 5. www.marketbeat.com, 6. arrowheadpharma.com, 7. arrowheadpharma.com, 8. arrowheadpharma.com, 9. arrowheadpharma.com, 10. arrowheadpharma.com, 11. www.reuters.com, 12. arrowheadpharma.com, 13. arrowheadpharma.com, 14. arrowheadpharma.com, 15. www.businesswire.com, 16. www.businesswire.com, 17. www.investors.com, 18. www.reuters.com, 19. arrowheadpharma.com, 20. arrowheadpharma.com, 21. arrowheadpharma.com, 22. arrowheadpharma.com, 23. www.genengnews.com, 24. www.biospace.com, 25. www.biospace.com, 26. www.biospace.com, 27. www.biospace.com, 28. www.businesswire.com, 29. arrowheadpharma.com, 30. arrowheadpharma.com, 31. arrowheadpharma.com, 32. arrowheadpharma.com, 33. stockanalysis.com, 34. stockanalysis.com, 35. www.marketbeat.com, 36. simplywall.st, 37. stockanalysis.com, 38. stockanalysis.com, 39. stockanalysis.com, 40. www.marketbeat.com, 41. www.quiverquant.com, 42. www.marketbeat.com, 43. www.quiverquant.com, 44. stockinvest.us, 45. www.reuters.com, 46. www.biopharmadive.com, 47. arrowheadpharma.com, 48. stockinvest.us, 49. arrowheadpharma.com, 50. www.businesswire.com, 51. www.reuters.com, 52. www.reuters.com, 53. www.biospace.com, 54. arrowheadpharma.com, 55. arrowheadpharma.com
