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Biotech catalyst, news and analysis PDUFA tracker
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Oct 29, 2026, 6:50 AM ET
Pharvaris announced acceptance of one oral and five poster abstracts at the ACAAI 2026 Annual Scientific Meeting, including Phase 3 CHAPTER-3 data on oral deucrictibant extended-release tablet for HAE attack prophylax…
$PHVSBiotechnologyClinical evidenceDevelopment risk
PHVS Stock Hub: Pharvaris News, Deucrictibant and Angioedema
Two oral formulations have positive pivotal evidence. Regulatory decisions, patient access and the cost of commercialization now determine whether that evidence becomes a sustainable business.
Full research report · PDF
Pharvaris ($PHVS), archive captured October 31, 2026
14 pages covering Archived research distinguishes RAPIDe-3 on-demand response times from CHAPTER-3 prevention endpoints and the acquired-angioedema CREAATE program. It examines safety, longer-term exposure, regulatory sequencing, commercial differentiation, euro cash consumption, equity financing and the gap between pivotal evidence and an approved business. The original research revision date is not stated; the date above records when this archive copy was captured. The hub follows later developments. For personal use only: redistribution prohibited.
Next listed investor event
November 9, 2026
Guggenheim Healthcare Innovation Conference, 1:30 p.m. EST, in the current company event calendar.
CHAPTER-3 scientific presentation November 14 at ACAAI; CREAATE Part 1 in Q1 2027; immediate-release on-demand FDA target April 23, 2027.
PHVS stock at a glance
Close · October 30, 2026
$33.53
Regular-session close; -0.15% versus $33.58 on October 29, 2026.
Equity value · dated ordinary shares
~$2.35B
Calculated with October 30 close and 70,204,506 ordinary shares at June 30, 2026; later issuance excluded.
CASH AND EQUIVALENTS
€318.282M
June 30, 2026 · Source
HISTORICAL MONTHLY CONSUMPTION
€14.441M
H1 2026 operating cash plus capex, calculated · Source
ORDINARY SHARES
70,204,506
June 30, 2026; incentive awards separate · Source
FDA TARGET ACTION DATE
April 23, 2027
IR on-demand NDA; announced July 6, 2026 · Source
CHAPTER-3 ATTACK REDUCTION
83% vs placebo
September 8, 2026; n=85; p<0.0001 · Source
CREAATE PART 1
Q1 2027 expected
Company window announced September 8, 2026 · Source
Where Pharvaris stands now
Pharvaris has positive randomized evidence for oral on-demand treatment and prevention, with distinct regulatory paths. The April 2027 FDA target applies to IR; XR applications and the acquired-angioedema readout remain company windows. June liquidity and the May financing support the transition, but spending is already rising before revenue. The central test is whether useful labels, access and patient adoption convert the clinical evidence into a sustainable business without disproportionate additional capital needs.
On-demand and prevention have different regulatory clocks. The April 23FDA target concerns immediate-release on-demand treatment. Prevention filings and acquired-angioedema results are separate milestones; euro June cash is not converted into current dollar cash.
The constructive case
The constructive case is that Pharvaris converts the successful deucrictibant studies into approvals with commercially useful labels. The immediate-release formulation for treating hereditary angioedema attacks already has an accepted U.S. application and an April 23, 2027 FDA target action date, announced July 6, 2026. The extended-release prevention program reported positive CHAPTER-3 results on September 8 and now points toward marketing applications beginning in the first half of 2027. These are related opportunities with separate regulatory decisions. Source Source
The cautious case
The adverse case includes an unfavorable FDA outcome, additional evidence requirements, a restricted label, manufacturing problems or adoption that does not justify the commercial investment. A common active molecule creates strategic coherence but also concentration: a material safety or manufacturing issue can affect confidence in more than one formulation. The annual report identifies regulatory, supply and commercialization risks that remain relevant after positive trials. Source
Latest Pharvaris news
October 29, 2026
CHAPTER-3 late-breaking presentation announced
The company scheduled a CHAPTER-3 oral presentation for November 14 at 7:33 p.m. EST/5:33 p.m. MST at ACAAI. The September topline result is already public; this meeting announcement is not a new efficacy result, FDA approval or changed regulatory date.
October 8, 2026
RAPIDe-3 results published in The Lancet
Pharvaris announced on October 8 that RAPIDe-3 phase 3 results for deucrictibant in the acute treatment of hereditary angioedema attacks were published in The Lancet (DOI: 10.1016/S0140-6736(26)01296-1). This is publication of the previously reported trial results, not a new pivotal readout, approval or change in a regulatory goal date. It is distinct from the earlier CHAPTER-1 publication in The Lancet Haematology.
October 5, 2026
Real-world HAE analysis published in Advances in Therapy
A Pharvaris-funded analysis of the Adelphi Real World HAE Disease Specific Programme (225 physicians, 1,131 patients, 2023–2024 survey in the US, Europe and Japan) reports that many attacks go untreated and that daily oral treatment was preferred over biweekly or monthly injections. Context on unmet need; not new deucrictibant efficacy data. Company event archive
October 1, 2026
October 1–4, 2026 — scientific meeting materials listed
The company event archive lists RAPIDe-3 and CHAPTER-1 extension materials for the October 1–3 German Allergy Congress, followed by receptor-modeling material for the October 2–4 Specialty Healthcare Consortium meeting. These are scientific presentations; the event listing itself does not announce a new regulatory decision. The calendar also lists the October 15–18 JSA/WAO/APAPARI congress. Company event archive
September 8, 2026
CHAPTER-3 primary endpoint met
Pharvaris reports an 83% reduction in monthly attack rate versus placebo, p<0.0001, in 85 randomized participants. The 87% figure concerns the type 1/2 subset. Prevention applications are planned from H1 2027; CREAATE Part 1 data are expected in Q1 2027. Source
September 3, 2026
longer follow-up and response analyses
The Bradykinin Symposium update presents RAPIDe-3 response analyses and completed CHAPTER-1 open-label follow-up. Long-term findings support the program but remain distinct from a randomized long-term comparison. End of Progression measures cessation of worsening, not complete attack resolution. Source
PHVS stock catalysts: development and reporting dates
- November 9, 2026 — Guggenheim investor conference,1:30 p.m. EST. Company event calendar
- November 14, 2026 — CHAPTER-3 late-breaking oral presentation. Company scientific schedule
- Q1 2027 — CREAATE Part 1 topline. Company target
- April 23, 2027 — Immediate-release on-demand FDA target. Regulatory target
Scientific presentation schedule · Current company event calendar
Deucrictibant response endpoints and prevention evidence
The December 3, 2025 RAPIDe-3 presentation reports 134 enrolled participants, with the primary efficacy analysis based on paired treated attacks from 88 participants. Median time to onset of symptom relief was 1.28 hours with deucrictibant; the placebo median was not reached within the defined twelve-hour period. The primary comparison had p<0.0001. These figures describe the tested response to an attack, not the percentage of patients cured of HAE. Source Source
On September 8, 2026, Pharvaris reported that CHAPTER-3 reduced mean monthly attack rate by 83% relative to placebo, with p<0.0001. The study randomized 85 participants: 55 to deucrictibant extended-release and 30 to placebo. The result covered the enrolled HAE population, including people with normal C1 inhibitor, and all secondary efficacy endpoints met statistical significance. The earlier expectation for a third-quarter readout has been replaced by this reported outcome. Source
Pharvaris euro cash and development spending
At June 30, 2026, Pharvaris reported €318.282 million of cash and equivalents, compared with €291.679 million at December 31, 2025. The interim financial statements do not report restricted cash balances; the management discussion separately notes approximately €0.1 million related to guarantees. The balance is a dated financial resource, not an October cash estimate. Source Source The increase does not mean the business generated cash. First-half operating activities consumed €86.567 million and capital expenditure used €0.079 million. Net financing cash flow was positive €105.813 million, while exchange-rate movements added €7.437 million to the reported cash bridge. Equity funding and currency translation explain why cash could rise despite continuing losses and operating outflows. Source
Merlintrader Health Score · $PHVS
3.25out of 5
Assessed October 4, 2026. Weighted calculation: 3.5×30% + 4.0×30% + 2.5×20% + 3.0×10% + 2.0×10% = 3.25. This describes financial and operational robustness over twelve to eighteen months, not an investment recommendation.
Red flags
- The April 23FDA target concerns immediate-release on-demand treatment. Prevention filings and acquired-angioedema results are separate milestones; euro June cash is not converted into current dollar cash.
- The adverse case includes an unfavorable FDA outcome, additional evidence requirements, a restricted label, manufacturing problems or adoption that does not justify the commercial investment. A common active molecule creates strategic coherence but also concentration: a material safety or manufacturing issue can affect confidence in more than one formulation. The annual report identifies regulatory, supply and commercialization risks that remain relevant after positive trials. Source
PHVS Stock FAQ: Pharvaris Questions Answered
Does April 23, 2027 cover both formulations?
No. The July 6, 2026 announcement sets that FDA target for the accepted immediate-release on-demand application. The September 8 plan places prevention applications in the first half of 2027. Those are different submissions and regulatory stages. Source Source
Does CHAPTER-3's 83% mean 83% of patients had no attacks?
No. The September 8, 2026 primary result is an 83% reduction in mean monthly attack rate relative to placebo in 85 randomized participants, with p<0.0001. An attack-free patient proportion is a different measure. The separate 87% reduction concerns the 80 participants with HAE type 1 or type 2. Source
Did on-demand treatment completely resolve attacks in seventeen minutes?
No. The September 3, 2026 update reports roughly 17.5 minutes to End of Progression, when worsening stops. RAPIDe-3’s median onset of symptom relief was 1.28 hours and complete resolution was 11.95 hours. These endpoints describe different stages of response. Source Source
Does the 22-month calculation establish a financing deadline?
No. Approximately 22.0 months divides June 30, 2026 cash of €318.282 million by the first-half operating-plus-capital average of €14.441 million monthly. It is a static historical ratio. The August guidance into 2028 uses a forward-looking operating plan, and later spending can differ. Source Source
Should the July 2025 pre-funded warrants be added to June shares?
No. The June 2026 financial statements say those warrants were exercised in September 2025, issuing 500,000 ordinary shares. They are already reflected in the subsequent share base. Options and RSUs outstanding at June 30 are separate potential shares subject to their terms. Source
Primary sources
- October 29, 2026 · CHAPTER-3 late-breaking presentation announced
- October 8, 2026 · RAPIDe-3 results published in The Lancet
- October 5, 2026 · Real-world HAE analysis published in Advances in Therapy
- October 1, 2026 · October 1–4, 2026 — scientific meeting materials listed
- September 8, 2026 · CHAPTER-3 primary endpoint met
- September 3, 2026 · longer follow-up and response analyses
- Current company event calendar
Disclaimer. This content is published by Merlintrader for educational and informational purposes only. It is independent analysis and research. It does not constitute investment advice, an investment recommendation, an offer or a solicitation to buy or sell any security, and it is not a research report within the meaning of applicable United States securities regulation. Nothing here should be read as a recommendation to buy, sell or hold $PHVS or any other security.
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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