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Biotech catalyst, news and analysis PDUFA tracker

Merlintrader Trading Pub
Biotech catalyst, news and analysis PDUFA tracker
AI transparency: articles and reports are produced with the help of artificial intelligence and checked through a process that does not constitute specialist validation. They may contain errors: verify relevant information with independent sources. Read the full disclaimer.
Oct 27, 2026, 11:36 AM ET
Adults Living with Familial Chylomicronaemia Syndrome (FCS) in England and Wales Have REDEMPLO (Plozasiran) as a New Treatment Option to Reduce Triglycerides
Nasdaq: $ARWRREDEMPLO commercializationRNAi developmentPartner cash and spending
ARWR Stock Hub: Arrowhead Pharmaceuticals News, REDEMPLO and RNAi
Clinical progress must become durable product sales. REDEMPLO commercialization, investigational RNAi programs and partnership receipts have different economics and evidence requirements. The October 29 regular-session close was $60.49 (+0.47% versus October 28).
Full research report · PDF
Arrowhead Pharmaceuticals ($ARWR), research as of October 27, 2026
15 pages covering the original long-form hub with its October 27, 2026 page revision label. Any separately dated later updates are reproduced unchanged; original data dates are retained. This is a dated research snapshot; the hub follows later developments. For personal use only: redistribution prohibited.
Next company-guided filing window
Year-end 2026 · broader plozasiran application
The company targets a supplemental application in severe hypertriglyceridemia and has entered the FDA STAR pilot. Pilot participation and a planned filing are not a decision date or approval. Primary source
ARO-MAPT October 14 observations were in healthy volunteers, with Alzheimer’s-cohort data expected in 2027. CSF tau reduction is biological activity, not proven clinical benefit in patients.
ARWR stock at a glance
Close · October 29, 2026
$60.49
Regular-session close; +0.47% versus $60.21 on October 28.
Cash and investments
$1.60196B
June 30, 2026; includes $4.1M restricted cash · Source
Quarterly product contribution
$2.385M
Quarter ended June 30, 2026; calculated · Source
Net operating burn
$8.84M/month
Nine months ended June 30, 2026; calculated · Source
Convertible principal
$700M
June 30, 2026 · Source
Common shares outstanding
141.254M
July 30, 2026; actual count · Source
Short interest / float
6.97%
Dated market data data as of October 2, 2026 · Source
Priority-review voucher
$215M
Acquisition agreed July 31, 2026 · Source
Where Arrowhead Pharmaceuticals stands now
June cash and investments totaled $1.60196B including $4.1M restricted cash, versus $700M convertible principal. The calculated nine-month net operating burn of $8.84M monthly reflects partnership receipts and is not gross development spending or a stable future rate.
Partnership receipts can reduce reported burn while development spending continues.
The negative case would strengthen if the patient CNS data expected in 2027 failed to confirm the healthy-volunteer signal, if regulatory or commercial progress for plozasiran slowed, or if expenses expanded faster than reliable sources of cash. Existing debt obligations and potential equity issuance could then absorb more of the value attributed to the pipeline. A disappointing result would matter most where the valuation already assumed success. Source Source
The constructive case
The constructive case would strengthen if the ARO-MAPT target engagement seen in healthy volunteers carried over to the early Alzheimer’s cohorts expected in 2027 with acceptable tolerability, plozasiran reached the planned broader-indication filing, and REDEMPLO generated progressively larger recurring sales. Partnership receipts would then give Arrowhead time to develop its own assets without making financing the central catalyst. The different programs would support each other economically, while each would still need its own evidence. Source Source Source
The cautious case
The negative case would strengthen if the patient CNS data expected in 2027 failed to confirm the healthy-volunteer signal, if regulatory or commercial progress for plozasiran slowed, or if expenses expanded faster than reliable sources of cash. Existing debt obligations and potential equity issuance could then absorb more of the value attributed to the pipeline. A disappointing result would matter most where the valuation already assumed success. Source Source
Latest Arrowhead Pharmaceuticals news
Oct 27, 2026
REDEMPLO (plozasiran) authorised in the UK; NICE recommends NHS funding in England and Wales for genetically confirmed FCS
Arrowhead announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) granted marketing authorisation for REDEMPLO (plozasiran) as an adjunct to diet to reduce triglyceride levels in adults with familial chylomicronaemia syndrome (FCS) diagnosed via genetic testing or clinical criteria. Following the authorisation, the National Institute for Health and Care Excellence (NICE) issued technology appraisal guidance recommending funding for the NHS in England and Wales to use it as a treatment option for genetically confirmed FCS in adults whose response to diet and conventional triglyceride-lowering therapies has been inadequate, in accordance with a commercial arrangement whose terms the release does not give. The authorisation covers the United Kingdom, while the NICE guidance applies to the NHS in England and Wales; Northern Ireland has an additional process to validate NICE guidance, and NHS reimbursement in Scotland is considered separately by the Scottish Medicines Consortium. The release cites the Phase 3 PALISADE study (NCT05089084, 75 adults), whose primary endpoint was the median percent change in fasting triglycerides versus placebo at Month 10, and says the company is working to make plozasiran available in several European countries over the coming months.
Oct 14, 2026
ARO-MAPT cuts CSF tau by up to 73% in healthy volunteers
Arrowhead reported interim Phase 1/2a data for ARO-MAPT, its subcutaneous RNAi candidate for Alzheimer’s disease and other tauopathies, in healthy volunteers. Cerebrospinal-fluid total tau fell by a mean 40% and 69% at Day 105 with 2.1 mg/kg and 6.4 mg/kg given on Days 1, 8 and 15, and by a mean 73% (maximum 85%) with 12.8 mg/kg given on Days 1 and 15; Day 105 is 90 days after the last dose, which the company says supports potential quarterly or less frequent dosing. Most adverse events were mild, with no serious events or discontinuations. These are biomarker results in healthy volunteers, not evidence of clinical benefit; early Alzheimer’s cohorts continue, with data updates expected in 2027.
Oct 7, 2026
Plozasiran enters the FDA STAR pilot for the severe hypertriglyceridemia filing
Arrowhead said the FDA admitted plozasiran to the Split Real Time Application Review (STAR) pilot for the planned supplemental application in severe hypertriglyceridemia, which the company intends to submit by the end of 2026. Under the program the supplement gets a six-month priority review without using a priority review voucher, with an expedited efficacy review that makes an action at least a month before the goal date possible. Arrowhead therefore keeps the voucher bought in August 2026 for other use or sale. Faster review is not approval.
Sep 29, 2026
October CNS presentation announced
The company scheduled an October 14 webinar including interim ARO-MAPT Phase 1/2a results. The announcement shows the event and agenda; it did not disclose the human data, which followed on October 14. The market question is whether CNS target engagement and tolerability justify stronger expectations for the platform, while keeping early findings distinct from demonstrated patient benefit.
Sep 15, 2026
ARO-DIMER-PA interim findings
Arrowhead reported mean maximal single-dose reductions of 72% in PCSK9 and 88% in APOC3, with reductions of 54% in LDL cholesterol and 73% in triglycerides. These are early biomarker and lipid results. The release does not provide the participant count behind each maximum or a corresponding p-value, so the percentages do not show cardiovascular-outcome efficacy.
Aug 30, 2026
SHASTA results presented at ESC
Across 757 randomized patients, the company reported an overall pooled pancreatitis event-rate ratio of 0.22 versus placebo, or a 78% relative reduction, with p=0.008. The separate 91% and 100% reductions describe progressively narrower higher-risk groups. Arrowhead continues to target a supplemental application by year-end 2026; study success and regulatory approval remain separate steps.
ARWR stock catalysts and operating watchpoints
- Year-end 2026 — Broader plozasiran supplemental application target. Company filing window
- 2027 — ARO-MAPT early-Alzheimer’s cohort data expected. Company data window
- Next commercial disclosure — REDEMPLO uptake, retained revenue and spending after new market access. Operating watchpoint
REDEMPLO: approval is the beginning of commercialization
Pricing competition is documented at the list-price level. Arrowhead reported on May 7, 2026 that REDEMPLO’s U.S. wholesale acquisition cost had been set at $45,000 per patient per year. Ionis announced on March 25 that TRYNGOLZA (olezarsen) would carry an annual WAC of $40,000 from April 1. These are dated wholesale list prices, not the net revenue collected after rebates, patient support and other deductions, and they do not show comparative clinical superiority. Arrowhead fiscal 2026 second-quarter results release; Ionis investor relations document.
REDEMPLO received U.S. approval on November 18, 2025 as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome, or FCS. The June 2026 quarterly report also records approvals in the European Union, Canada, Australia and China. These approvals concern FCS; they do not automatically authorize the broader severe-hypertriglyceridemia population targeted by SHASTA. Source
Cash and monthly burn: the partnership effect
At June 30, 2026, consolidated cash, cash equivalents and restricted cash were $54.759 million, while available-for-sale securities were $1,547.201 million. The combined amount was therefore $1,601.960 million, including approximately $4.1 million of restricted cash. The cash total also included $35.074 million at consolidated variable-interest entity Visirna; it is not all a freely interchangeable parent-company bank balance. Source
The distinction is useful because the company holds most of its liquidity in securities. Those investments can support operations, but their maturities, market value and the contractual liquidity requirements remain relevant. A large cash-and-investments headline is not the same as cash in a checking account, nor is it money free of competing uses.
Merlintrader Health Score · $ARWR
3.25out of 5
Assessed October 2, 2026. Weighted calculation: 3.5×30% + 3.5×30% + 2.5×20% + 4.0×10% + 2.5×10% = 3.25. This describes financial and operational robustness over twelve to eighteen months, not an investment recommendation.
Red flags
- Financial balances retain their reporting dates and are not current cash.
- Milestone guidance is conditional; execution, collection and per-share outcomes remain separate tests.
ARWR Stock FAQ: Arrowhead Pharmaceuticals Questions Answered
What is the next dated Arrowhead catalyst?
After the October 14, 2026 ARO-MAPT interim data, the next company-stated milestone is the broader plozasiran supplemental application targeted for year-end 2026; it is a filing target, not an FDA decision date. ARO-MAPT data from the early Alzheimer’s disease cohorts are expected in 2027. Source
Do SHASTA's 78%, 91% and 100% results contradict each other?
They describe different populations in the August 30, 2026 presentation. The pooled overall pancreatitis event-rate ratio was 0.22, a 78% relative reduction with p=0.008, across the program’s 757 randomized patients. The 91% and 100% figures refer to progressively narrower groups with previous pancreatitis and different triglyceride thresholds. They come with those qualifications and do not replace the overall result. Source
Does reported burn imply many years of cash runway?
No. The nine months ended June 30, 2026 had $79.546 million operating outflow, a calculated $8.84 million monthly average, supported by $475 million of major partnership receipts. Removing those identified receipts illustratively gives $61.62 million monthly before capex. That is a sensitivity, not guidance. Future receipts, development spending, financing terms and the voucher cost prevent a reliable long-range runway estimate from a simple division. Source
How much dilution is already in the capital structure?
The July 30, 2026 actual common-share count was 141,254,467. At June 30, 2,467,828 shares underlay unexercised pre-funded warrants; the $700 million notes had an initial conversion equivalent of about 8.039 million shares, subject to settlement terms. Equity awards and ATM capacity are additional, different categories. These amounts do not mean that all those shares have already been issued. Source
Why are quarterly revenue and REDEMPLO sales so different?
For the quarter ended June 30, 2026, revenue was $75.253 million, including $72.868 million of collaboration and licensing revenue. The calculated difference is $2.385 million of product contribution. Collaborations can fund operations and recognize value from licensed programs, but they do not show the same recurring commercial demand as patients receiving and paying for an owned medicine. Source
Primary sources
- 1. Arrowhead Form 10-Q — quarter and nine months ended June 30, 2026; filed August 4, 2026
- 2. Arrowhead Form 10-K — fiscal year ended September 30, 2025
- 3. Arrowhead — ARO-MAPT/CNS webinar announced for October 14; September 29, 2026 announcement
- 4. Arrowhead — interim ARO-DIMER-PA results; September 15, 2026
- 5. Arrowhead — Phase 3 SHASTA-3/4 results presented at ESC; August 30, 2026
- 6. Arrowhead — REDEMPLO availability and reimbursement in Germany; August 17, 2026
- 7. Arrowhead — priority-review voucher acquisition announcement; August 4, 2026
- 8. PALISADE — Plozasiran for Managing Persistent Chylomicronemia and Pancreatitis Risk; NEJM, DOI 10.1056/NEJMoa2409368
- 9. BlackRock Schedule 13G/A — Arrowhead beneficial ownership at June 30, 2026; filed July 27
- 10. Avoro Schedule 13G/A — Arrowhead beneficial ownership at June 30, 2026, including pre-funded warrants
- 11. Adeoye Olukotun Form 4 — August 18, 2026 transaction
- 12. Michael Perry Form 4 — August 18, 2026 transaction
- 15. Arrowhead Pharmaceuticals — plozasiran granted entry in the FDA STAR pilot program, October 7, 2026
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Figures are taken from public filings with the U.S. Securities and Exchange Commission, company press releases and market-data providers, and are stated with their reference dates. Data can change without notice, and figures published before a results release become outdated the moment that release is issued. Merlintrader makes no representation that the information is complete or current at the time of reading. Readers should verify every figure against the primary source before acting on it.
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