ARWR Stock: Arrowhead Pharmaceuticals Hits New High as FDA Approval and Q4 Earnings Converge

Arrowhead Pharmaceuticals’ stock (NASDAQ: ARWR) is entering Tuesday, November 25, 2025 on a hot streak, buoyed by its first FDA‑approved drug, fresh milestone payments, and a big‑ticket partnership with Novartis. Together, these catalysts have turned ARWR into one of the most closely watched biotech tickers heading into today’s fiscal Q4 2025 earnings report.

ARWR stock price and performance heading into November 25, 2025

As of late trading on Monday, November 24, Arrowhead shares changed hands around $44.26, up roughly 9% on the day. Intraday, the stock traded between about $40.50 and $44.81, marking a sharp continuation of November’s breakout move.

Earlier in Monday’s session, ARWR was flagged as hitting a new 52‑week high near $43.70, and recent data show the share price has surged roughly 127% over the past 12 months, including more than 160% in the last six months and about 115% year‑to‑date. ^[1]

For context:

Market cap: around $5.6–$5.8 billion
52‑week range: roughly $9.6 on the low end up to the new highs above $43–44 ^[2]
Float & ownership: about 132 million shares in the free float, with insiders owning ~4–4.5% and institutions close to 77–78%; short interest sits around 9% of the float. ^[3]

In other words, ARWR has transformed from a single‑digit biotech name in late 2024 into a mid‑cap RNAi player trading near all‑time highs as investors reposition around its new commercial profile.

Catalyst #1: FDA approval of Redemplo — Arrowhead’s first marketed drug

The single biggest November catalyst for ARWR is the U.S. FDA approval of Redemplo, Arrowhead’s first product to reach the market.

On November 18, 2025, the FDA cleared Redemplo (plozasiran) for adults with familial chylomicronemia syndrome (FCS), a rare inherited disorder that causes extremely high triglyceride levels and a high risk of recurrent pancreatitis. ^[4]

Key facts about Redemplo:

Indication: Familial chylomicronemia syndrome (FCS), a severe, ultra‑rare lipid disorder estimated to affect roughly 3,000–5,000 people globally. ^[5]
Mechanism: An RNA interference (RNAi) therapy targeting ApoC3, a liver‑produced protein that slows the clearance of triglyceride‑rich lipoproteins. By silencing ApoC3, plozasiran aims to normalize triglycerides. ^[6]
Dosing:Subcutaneous injection once every three months, which is less frequent than rival therapies that require monthly dosing. ^[7]
Efficacy: In a Phase 3 trial with 75 FCS patients, Redemplo cut triglycerides by about 80% and reduced the risk of pancreatitis by 83% versus placebo. ^[8]
Pricing: The annual wholesale cost is about $60,000 per patient in the U.S., materially below at least one competing FCS therapy, which has been cited around the mid‑six‑figure range. ^[9]
Commercial partners: Arrowhead has partnered with Sanofi, which holds exclusive rights to develop and commercialize plozasiran/Redemplo for FCS in Greater China. ^[10]

Analysts see Redemplo as a potential billion‑dollar‑plus asset over time; consensus projections suggest sales could approach $1.4 billion by 2031, assuming broader label expansions into severe hypertriglyceridemia and mixed dyslipidemia. ^[11]

For ARWR stock, FDA approval does two things at once:

Validates Arrowhead’s liver‑targeted RNAi platform in a commercial setting, not just in clinical trials.
Opens the door to follow‑on indications (severe hypertriglyceridemia and mixed dyslipidemia) where Phase 3 studies like SHASTA‑3, SHASTA‑4 and MUIR‑3 have already been fully enrolled, with topline data expected in mid‑2026. ^[12]

That combination of near‑term FCS revenue and mid‑term expansion potential is a big part of why ARWR is suddenly trading like a commercial‑stage biotech instead of a long‑dated pipeline story.

Catalyst #2: $200 million Sarepta milestone from the ARO‑DM1 program

The second major November catalyst came on November 24, 2025, when Arrowhead announced it had earned a $200 million milestone payment from partner Sarepta Therapeutics. ^[13]

The payment relates to ARO‑DM1 (also called SRP‑1003), an investigational RNAi therapeutic for type 1 myotonic dystrophy (DM1), the most common adult‑onset muscular dystrophy. Arrowhead hit the second development milestone in the ongoing Phase 1/2 trial after:

A safety committee review,
Authorization to escalate dosing, and
Achievement of a prespecified patient enrollment target. ^[14]

Key details:

Arrowhead expects to receive the $200 million within 60 days. ^[15]
Enrollment in the 6 mg/kg cohort (cohort 4) is nearly complete, with plans to begin a 12 mg/kg cohort (cohort 5) in early 2026. ^[16]
The company had already earned a $100 million milestone earlier in 2025 for the first enrollment target in the same study. ^[17]

Notably, Arrowhead’s Q2 2025 update highlighted that the Sarepta collaboration delivered $825 million upfront ($500 million in cash plus $325 million via an equity investment), with $250 million more to be paid over five years and up to $300 million in additional near‑term milestones — a threshold that has now effectively been reached with the $100 million + $200 million combination. ^[18]

This is particularly important against the backdrop of Sarepta’s own gene‑therapy challenges, which have included safety‑related setbacks and headline risk around Elevidys and other programs. Despite that turbulence, Arrowhead has maintained that it expects to receive near‑term milestone payments, a stance now reinforced by Monday’s announcement. ^[19]

For ARWR shareholders, the milestone:

Strengthens the balance sheet ahead of today’s earnings report,
De‑risks the Sarepta partnership narrative, and
Underscores the breadth of Arrowhead’s muscle and neuromuscular pipeline beyond its lipid programs.

Catalyst #3: Up to $2 billion Novartis deal for ARO‑SNCA

Earlier this fall, Arrowhead locked in another transformational partnership — this time with Novartis.

On September 2, 2025, Reuters reported that Novartis agreed to pay Arrowhead $200 million upfront and up to $2 billion in milestone payments and royalties for an exclusive worldwide license to ARO‑SNCA, an experimental RNA‑targeted therapy aimed at neuromuscular and neurodegenerative conditions such as Parkinson’s disease. ^[20]

Highlights of the Novartis collaboration:

Program: ARO‑SNCA, designed to reduce alpha‑synuclein, a protein strongly implicated in Parkinson’s and related disorders. ^[21]
Stage: Preclinical, with both companies planning to move into human studies “as soon as possible.” ^[22]
Rationale: Analysts have described the agreement as a “strategically clean deal” that extends Arrowhead’s cash runway without equity dilution and bolsters its central nervous system (CNS) strategy alongside in‑house candidate ARO‑MAPT. ^[23]

Combined with Redemplo and the Sarepta milestones, the Novartis pact leaves Arrowhead with multiple high‑value shots on goal and a partner roster that also includes Sanofi, GSK, Takeda and Amgen across various programs. ^[24]

Arrowhead’s broader RNAi pipeline: more than just FCS

While ARWR’s short‑term trading is dominated by Redemplo and deal news, the company’s RNAi pipeline is broad and increasingly late‑stage. Select programs include: ^[25]

Plozasiran (ARO‑APOC3 / Redemplo)
- FCS: Now approved and in market.
- Severe hypertriglyceridemia (SHTG): Phase 3 trials SHASTA‑3 and SHASTA‑4 fully enrolled; topline data expected mid‑2026.
- Mixed dyslipidemia: Phase 2b MUIR program, with an open‑label extension underway.
Zodasiran (ARO‑ANG3)
- Indication: Homozygous familial hypercholesterolemia (HoFH).
- Status: Phase 3 YOSEMITE trial has dosed its first subjects, making zodasiran Arrowhead’s fourth RNAi candidate in pivotal studies (alongside plozasiran, fazirsiran and olpasiran).
Fazirsiran (AATD‑related liver disease)
- Licensed to Takeda and in Phase 3 development for alpha‑1 antitrypsin deficiency–associated liver disease.
Olpasiran (Lp(a) cardiovascular risk reduction)
- Licensed to Amgen, currently in Phase 3, targeting patients with elevated lipoprotein(a).
Obesity and metabolic programs
- ARO‑ALK7 and ARO‑INHBE are investigational obesity treatments designed to modulate fat‑storage pathways while better preserving lean muscle mass compared with existing GLP‑1/GIP therapies. A Phase 1/2a trial of ARO‑ALK7 in obese subjects is underway. ^[26]
Renal and complement‑mediated disease
- ARO‑C3 has generated encouraging Phase 1/2 data in IgA nephropathy, showing deep and sustained knockdown of complement pathway markers and a meaningful reduction in proteinuria. ^[27]
Pulmonary and respiratory programs
- ARO‑RAGE is being evaluated in asthma and other pulmonary conditions, with early data demonstrating robust knockdown of the target pathway. ^[28]

Layered on top of these is the TRiM™ platform, Arrowhead’s in‑house delivery technology that underpins both liver‑directed and extrahepatic RNAi programs — a key asset in ongoing and future partnering discussions. ^[29]

Financial snapshot: cash‑rich but earnings still lumpy

Recent quarters

Arrowhead’s financials have been highly volatility‑driven by partnership revenue, a common pattern for development‑stage biotechs:

Fiscal Q2 2025 (ended March 31, 2025):
- Revenue: ~$542.7 million
- Net income: ~$370.4 million, or $2.75 per diluted share
- Cash & investments: about $1.10 billion in total cash resources
- The quarter was dominated by the Sarepta deal, which delivered $825 million upfront plus longer‑dated payments and double‑digit‑billion potential milestones. Management said at the time that Arrowhead was “funded into 2028” without needing another equity raise. ^[30]
Fiscal Q3 2025 (ended June 30, 2025):
- Revenue: ~$27.8 million
- Net loss: about $175.2 million (EPS ‑$1.26)
- R&D spend: ~$162 million in the quarter
- Cash & marketable securities: about $900 million at quarter‑end. ^[31]

The swing from huge profitability in Q2 to a sizable loss in Q3 underscores how non‑recurring licensing revenue can overshadow the underlying cash burn. Even so, the Sarepta and Novartis deals, plus the new $200 million milestone, are critical in keeping Arrowhead’s runway long enough to see multiple late‑stage readouts.

Balance sheet after recent deals

On a pro‑forma basis (using public information only):

Arrowhead exited Q3 with roughly $900 million in cash and securities. ^[32]
Add in:
- $200 million upfront from Novartis for ARO‑SNCA (subject to closing timing), and
- The new $200 million milestone from Sarepta, expected within 60 days. ^[33]

Even factoring in heavy R&D and commercial launch spending, this level of liquidity supports management’s prior statement that the company is capitalized into 2028, and it potentially extends that horizon further — though the exact pro‑forma figure will depend on how much of the deal economics flows through the P&L versus the balance sheet in Q4 and beyond. ^[34]

Investors should also keep in mind that Arrowhead carries significant liabilities:

A royalty‑financing liability tied to sold future royalties (~$350–360 million), and
A term loan/credit facility above $240–270 million, as shown in recent filings. ^[35]

Today’s Q4 2025 earnings: what Wall Street expects

Arrowhead is scheduled to report fiscal Q4 2025 results after the market close on Tuesday, November 25, 2025, with a conference call set for 4:30 p.m. ET. ^[36]

Several data providers offer slightly different forecasts, but the message is consistent: analysts expect a modest loss on triple‑digit‑million revenue:

Benzinga: Consensus EPS around ‑$0.05. ^[37]
MarketBeat: EPS of about ‑$0.09 and revenue around $147.5 million. ^[38]
Quiver/other aggregators: Some models point to revenue nearer $170–180 million with EPS in the ‑$0.20 to ‑$0.25 range. ^[39]

Since Arrowhead’s fiscal Q4 ended September 30, 2025, Redemplo’s November FDA approval will not yet contribute product sales to this quarter’s numbers. Instead, Q4 revenue is likely to be driven by:

Upfront and milestone recognition from collaborations (e.g., Novartis, Sanofi‑Visirna, Sarepta), depending on timing and accounting treatment;
Ongoing partner revenue from existing alliances; and
Potentially smaller contributions from other programs.

What could move ARWR stock today

Beyond the headline EPS and revenue figures, investors will focus on management’s commentary around:

Redemplo launch readiness: details on payer discussions, hub services, and timelines for first commercial shipments in the U.S. ^[40]
Label‑expansion strategy for plozasiran in SHTG and mixed dyslipidemia, including when SHASTA and MUIR topline data might read out and how large those markets could be. ^[41]
DM1 development plans with Sarepta now that the second milestone has been triggered and dose escalation is moving forward. ^[42]
CNS ambitions with Novartis and ARO‑SNCA, plus progress on ARO‑MAPT. ^[43]
Updated cash‑runway guidance, incorporating the $200 million milestone and Novartis upfront. ^[44]

Given how far ARWR has already run in 2025, expectations are high. A clean quarter with strong guidance and clear launch metrics could extend the rally; any hint of launch delays, lower‑than‑expected economics, or pipeline setbacks could prompt profit‑taking.

Analyst sentiment and valuation: bullish but not without tension

Recent data show Wall Street leaning decisively bullish on ARWR:

At least four firms have issued Buy/Overweight/Outperform ratings on ARWR in recent months, with no recent sell ratings recorded in one tracker. ^[45]
According to Quiver Quantitative and other aggregator tools, six analysts have updated price targets in the last six months, producing: ^[46]
- Median target: about $56
- Range: from the mid‑$40s up to $80
- Recent targets include:
  - Goldman Sachs: $48
  - Morgan Stanley: $45
  - RBC Capital: $52
  - Chardan Capital: $60
  - Piper Sandler: $70
  - HC Wainwright: $80

Several firms specifically cited Redemplo’s pricing and profile as reasons for their optimism, noting that:

Redemplo’s $60,000 annual wholesale price is dramatically lower than at least one competing FCS therapy, which has been quoted around $595,000 per year, giving Arrowhead significant value‑based pricing leverage. ^[47]
The convenient once‑every‑three‑month dosing could further differentiate the product in a small but complex market where patient quality of life and adherence are critical. ^[48]

At Monday’s roughly $44 share price, ARWR trades modestly above some near‑term targets but still below the higher‑conviction bull cases in the $60–80 range — reflecting a market that recognizes the upside but also prices in execution and pipeline risk. ^[49]

Key risks for ARWR investors to watch

Even with the recent string of wins, Arrowhead remains a high‑risk biotech story. Important risk factors include:

Commercial execution risk
FCS is a very small patient population, and while Redemplo’s pricing is more modest than some rare‑disease drugs, insurers may still impose prior authorizations, step‑through requirements, or other barriers. Uptake could be slower than bulls expect, and net realized pricing may be below the sticker price. ^[50]
Pipeline and clinical risk
Much of Arrowhead’s value is tied to pipeline readouts expected from 2026 onward. Failures or safety signals in SHTG, dyslipidemia, obesity, renal, or neuromuscular programs could materially impair the long‑term thesis, even if Redemplo performs well. ^[51]
Partner risk
Arrowhead depends heavily on outcomes at Sarepta, Novartis, Amgen, Takeda, GSK, and Sanofi. Adverse regulatory developments, strategy changes, or financial stress at partners — as seen with Sarepta’s gene‑therapy setbacks — could delay milestones or alter collaboration economics. ^[52]
Regulatory and safety risk
RNAi therapies are relatively new in many of these indications. Long‑term safety data, particularly in chronic conditions like obesity and cardiovascular risk, are still evolving and may influence label language, monitoring requirements, or commercial uptake. ^[53]
Valuation and volatility
After a 100%+ year‑to‑date move, ARWR is priced for execution. A 9% short interest indicates that some investors are actively betting on a pullback. Sharp swings around data releases, regulatory decisions, and partnership updates should be expected. ^[54]

Bottom line on ARWR stock today

Heading into November 25, 2025, Arrowhead Pharmaceuticals looks very different from the company it was a year ago:

It now has a commercial product on the market (Redemplo for FCS). ^[55]
It has two giant partnerships — with Sarepta and Novartis — that have already delivered more than $1+ billion in cash and are now spinning off additional milestones. ^[56]
Its RNAi pipeline spans cardiometabolic, obesity, pulmonary, neuromuscular, renal, and CNS indications, with multiple Phase 3 programs and a long line of earlier‑stage assets. ^[57]

ARWR stock’s powerful rally reflects this upgraded profile — but also means investors are demanding continued flawless execution, starting with today’s Q4 2025 earnings call and early Redemplo launch commentary.

For traders and long‑term biotech investors alike, ARWR is now very much a “show‑me” story: the building blocks are in place, the partners are on board, and the first product is approved. The next phase will be about how quickly Arrowhead can convert scientific promise and deal‑driven capital into sustained, diversified revenue growth.

This article is for informational and educational purposes only and does not constitute financial, investment, or trading advice. Always conduct your own research or consult a licensed financial professional before making investment decisions.

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