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Keytruda (pembrolizumab) · anti-PD-1 · Merck & Co.
PRE-APPROVAL pipeline page: the high-risk early ER+/HER2- breast-cancer indication (the KEYNOTE-756 regimen) only, not the full Keytruda franchise. Revenue is a conditional scenario. See all Keytruda indications →
pCR co-primary met (Nat Med 2025); EFS co-primary immature, key binary catalyst. Verified 2026-08-16, no change. pCR co-primary MET and published in Nature Medicine 21 Jan 2025: pCR in 154/635 (24.3%) with pembrolizumab-chemotherapy vs 100/643 (15.6%) with placebo-chemotherapy, difference 8.5 percentage points (95% CI 4.2-12.8), P=0.00005. The EFS co-primary remains immature ('EFS was not mature at the first interim analysis'); CT.gov primary completion is 2031-01-24, so this is a long-dated binary. Confirmed against the label that Keytruda has NO ER+/HER2- early breast indication - section 1.20 is entirely TNBC (KEYNOTE-522 neoadjuvant/adjuvant plus two metastatic CPS>=10 indications). VERIFIED 2026-08-16, pCR figures correct. Nat Med 2025;31(2):442-448: pCR 24.3% (95% CI 21.0-27.8) vs 15.6% (95% CI 12.8-18.6), difference 8.5 pp (95% CI 4.2-12.8), P=0.00005. PROVENANCE CORRECTION: first disclosed at ESMO 2023 / Merck release 28 Jul 2023; Nature Medicine (Jan 2025) is the full paper, not the readout. EFS: 'Event-free survival was not mature in this analysis.' CT.gov PCD is 2031-01-24, so EFS is a long-dated catalyst, not a near-term binary. No filing; no ER+/HER2- early-breast indication on the current Keytruda label.
All markets
Est. peak net revenue · modelled scenario, ~2032
$1.13B
CONCLUDED · 2032 modelled net revenue - indication slice, all markets; Merck & Co. reports no indication revenue. Modelled scenario · assumes approval · not guidance
No model change since the 20 Sep 2026 snapshot.
The 15-second read
This is a ~$1.13B (2032 peak) conditional scenario with nothing banked: the indication is unapproved, revenue is zero until an estimated 2028 launch, and the entire curve hangs on an EFS readout that has not happened. KEYNOTE-756 delivered the first positive Phase III IO pCR result in ER+/HER2- disease (24.3% vs 15.6%, Δ8.5pp, p=0.00005), but a pCR-only readout has never supported approval in this subtype the way it did in TNBC via KEYNOTE-522, so pCR buys the trial a hearing, not a label. Even if EFS reads out, two structural caps hold the number down: BMS's nivolumab (CheckMate 7FL) posted a near-identical pCR (24.5% vs 13.8%) and is modelled as a co-equal entrant taking a meaningful minority of the addressable high-risk neoadjuvant pool, and Keytruda's ~2028 US composition-of-matter LOE means biosimilars arrive around the same time the launch does. The honest read: the largest breast-cancer subtype is worth chasing, but this is a lifecycle move whose branded window closes almost as it opens.
Threats land:The immature dual-primary EFS reads out flat or fails to reach significance, and a modest 8.5pp pCR delta on its own does not carry an ER+/HER2- approval, the curve never starts and the whole $1.13B is stranded as a pCR signal.
Modelled path:EFS turns positive, approval lands ~2028, and pembrolizumab takes the leading share of the addressable high-risk ER+/HER2- neoadjuvant pool while nivolumab holds a meaningful minority, producing $503M in 2028 rising to a $1.13B peak in 2032 before biosimilar pressure flattens it to $1.06B by 2034.
Levers land:EFS is clearly positive with a larger effect in PD-L1-high tumours, pembrolizumab establishes itself as the reference neoadjuvant IO before nivolumab files, and uptake runs at the high end of the ~75-88% neoadjuvant-chemo-treated/IO-fit fraction across the ~17% high-risk slice of HR+/HER2- incidence.
The ~17% high-risk (grade-3 node-positive/bulky) fraction of HR+/HER2- breast-cancer incidence, the Ormeval scoping estimate modelled to KEYNOTE-756 eligibility and flagged in the model itself as the softest input. It sits directly under the peak: it is a scoping estimate of who qualifies, not an observed eligibility count, and moving it a few points moves the entire $1.13B proportionally.
At a glance
Mechanism anti-PD-1
Clinical
Commercial
Development to approval
This indication is not yet approved: the phases show development stage and regulatory approval is expected, not granted (Est. launch ~2028 (EFS-gated)). Per-market timing reflects the company's own guidance (SEC / IR / earnings). Status cross-checked against Merck & Co. disclosures and trial registries.
This is Merck's bid to extend Keytruda from TNBC (KEYNOTE-522, approved) into the much larger ER+/HER2- early-breast-cancer setting, the biggest breast-cancer subtype, ahead of Keytruda's late-2028 US composition-of-matter LOE. Strategically it matters as a lifecycle/patent-extension move and as the first IO to hit a positive pCR endpoint in a 'cold' subtype. But the significance is heavily conditioned: the pCR delta is modest, EFS is unread, BMS's nivolumab (CheckMate 7FL) posted a near-identical pCR (24.5% vs 13.8%) and is a co-equal potential entrant, and any approval arrives near Keytruda's LOE, compressing the branded window before pembrolizumab biosimilars. A large opportunity if EFS is positive; a stranded pCR signal if it is not.
High-risk early-stage ER+/HER2- breast cancer (grade 3; T1c-2 cN1-2 or T3-4 cN0-2) is the largest breast-cancer subtype but the least IO-responsive. KEYNOTE-756 added neoadjuvant→adjuvant pembrolizumab to chemo + endocrine therapy → pCR 24.3% vs 15.6% (Δ8.5pp; p=0.00005), the first positive Phase III IO pCR readout here. The dual-primary EFS is still immature; unlike TNBC (KEYNOTE-522), a pCR-only result has not supported approval in ER+/HER2-, so this is a pre-approval, EFS-gated conditional scenario.
ER+/HER2- is the largest breast-cancer subtype (~65-70% of all breast cancer). Most is low/intermediate-risk and managed with endocrine therapy ± CDK4/6 inhibitors, not chemo-immunotherapy. KEYNOTE-756 targets a HIGH-RISK sliver, centrally-confirmed grade 3, invasive, node-positive or bulky (T1c-2 cN1-2 or T3-4 cN0-2), where neoadjuvant chemotherapy is already standard, so pembrolizumab is added on top. This subtype is historically the least immunotherapy-responsive (low TMB, low PD-L1, 'cold' tumours), which is why the pCR gain (Δ8.5pp) is real but modest versus the ~14-20pp seen in TNBC. Across the modelled Western + Japan markets the high-risk ER+/HER2- neoadjuvant pool is sizeable, but only a positive EFS readout would convert pCR into an approvable, adopted regimen. Nivolumab (CheckMate 7FL) is the direct in-class rival, with a nearly identical pCR readout.
KEYNOTE-756 tests whether adding pembrolizumab to a neoadjuvant chemotherapy backbone (then continued adjuvantly alongside endocrine therapy) improves outcomes in high-risk early-stage ER+/HER2- breast cancer, the largest breast-cancer subtype, historically the LEAST immunotherapy-responsive. It met its pCR endpoint (24.3% vs 15.6%; Δ8.5pp; p=0.00005), the first positive Phase III immunotherapy pCR result in this subtype. But the clinically decisive dual-primary endpoint, event-free survival, remains immature, and the pCR gain is modest in absolute terms, so the regimen's approvability and commercial size hinge on the pending EFS readout.
No guideline currently recommends neoadjuvant/adjuvant immunotherapy in high-risk ER+/HER2- early breast cancer. Both KEYNOTE-756 (pembrolizumab) and CheckMate 7FL (nivolumab) met pCR but not (yet) EFS; guideline inclusion and approval are contingent on the pending survival readouts. In TNBC, by contrast, pembrolizumab (KEYNOTE-522) is an established Category 1 neoadjuvant regimen.
Randomized, double-blind, placebo-controlled Ph3 (MK-3475-756); n=1,240; centrally-confirmed grade 3, invasive, ER+/HER2- breast cancer, T1c-2 cN1-2 or T3-4 cN0-2. Neoadjuvant pembrolizumab 200 mg (or placebo) q3w + paclitaxel ×4 then doxorubicin/epirubicin + cyclophosphamide ×4 → surgery → adjuvant pembrolizumab (or placebo) q3w up to 9 cycles + standard endocrine therapy. Dual primary endpoints: pCR (ypT0/Tis ypN0) and EFS.
Pre-approval · Phase III · conditional scenario
This indication is not approved. The revenue below is a modelled scenario that assumes approval and launch around 2028, every input (epidemiology, trial, pricing) is cited, but the approval itself is uncertain. It is an estimate, not guidance and not a reported figure. Read the pivotal-trial and development-timeline sections below for the regulatory basis.
Load-bearing 0/1 sourced. ASSUMED uptake is yours to change.
PRE-APPROVAL SCENARIO. KEYNOTE-756 met one dual-primary endpoint, pCR 24.3% vs 15.6% (Δ8.5pp; p=0.00005; ITT, all-comers), but the second dual-primary endpoint, event-free survival (EFS), is STILL IMMATURE and unreported. In the ER+/HER2- setting a pCR-only readout has not, to date, supported approval (contrast TNBC / KEYNOTE-522, which had positive EFS AND OS), so first approval is contingent on a positive EFS readout. Launch timing (~2028) and every revenue figure here are scenario estimates contingent on that readout, filing and approval. Not filed or approved in this indication anywhere as of Q2 2026.
This indication only, not Keytruda's total revenue
Neoadjuvant pembrolizumab + chemotherapy (paclitaxel → anthracycline/cyclophosphamide) → surgery → adjuvant pembrolizumab + endocrine therapy, in high-risk early-stage ER+/HER2- breast cancer (grade 3; T1c-2 cN1-2 or T3-4 cN0-2), the KEYNOTE-756 regimen. All-comers by PD-L1.
Reported actuals are always drawn and need no chip: a cited reported figure is a fact, not a claim. Everything forward of them is one of the 4 kinds above.
$0
8 modelled markets (US, EU5, JP, CN) · modelled net revenue · 2026 (forecast)
Peak $1.13B · launch 2028 → 2034
modeled history (left of today)·click any year to decompose its funnel below.
Measured band: none - no measured band: n<8
Bull / bear elsewhere in the product are a sensitivity (fixed multipliers), not this band.
There is NO reported revenue for this indication, it is unapproved. The entire curve is a CONDITIONAL SCENARIO contingent on a positive EFS readout and approval (est. ~2028), and is zero before the estimated launch. Figures are modelled from epidemiology × a KEYNOTE-522 pricing analogue × scenario penetration, capped by the modest pCR delta, the nivolumab co-entrant, and Keytruda's ~2028 US LOE.
No reported anchor exists at this grain: companies publish this asset as one product line and never split it by indication × country, so every year above is modelled, including the years already past. The claims below are scored against reported actuals wherever a program has them.
A forecast year closes when an actual is reported for it. A miss is the distance from that actual, signed as the claim fell: under it, or over it.
| Claim | Closed years | Worst miss | Worst miss % |
|---|---|---|---|
| Ormeval modelMODELLED · Ormeval · live | - | no closed year yet | - |
A superseded team version keeps its own row: what it was off by is still a fact about that version. A row with no closed year is not a good score.
What it shows. A modelled base-case net-revenue curve for this indication, year by year, split at 'today' into modelled history and forecast, with the branded curve shown against its in-class rivals.
What to look for. The peak year and how steep the decline is after loss of exclusivity, and where a rival's curve crosses yours, that crossing is the share the model has you losing.
Common misread. Reading the pre-'today' portion as reported actuals (it's modelled), or treating the base case as a company target. It is one deterministic Ormeval-modelled scenario anchored to cited actuals, not guidance and not analyst consensus.
Key model assumptions
The headline rests on three unobserved Ormeval inputs: the ~17% high-risk share of HR+/HER2- incidence (the softest, an eligibility estimate not a count), pembrolizumab's assumed leading share of the addressable neoadjuvant pool in a two-IO setting where nivolumab has near-identical data, and a US net of ~$135k per ~17-dose course borrowed wholesale from the KEYNOTE-522 TNBC analogue because no indication-specific net price is published.
What would change our mind
The base case is wrong if the dual-primary EFS readout in NCT03725059 fails to show an event-free-survival benefit, at that point there is no approval path and the curve is zero, not merely lower. Two independent falsifiers on the share side: if nivolumab (CheckMate 7FL) reaches EFS and files first, pembrolizumab is the follower rather than the reference regimen and the modelled share of the high-risk neoadjuvant pool is too high; and if pembrolizumab biosimilars enter the US in 2029 as the model assumes off the ~2028 LOE, the branded curve cannot hold a 2032 peak at all.
A scenario is your own assumptions layered on Ormeval’s cited baseline. We never change the baseline; save as many named scenarios as you like and click one to load it back later.
| Driver · 2026 | US | FR | DE | IT | ES | UK | JP | CN | Total | Source |
|---|---|---|---|---|---|---|---|---|---|---|
| Female breast cancer incidence | 316k | 61k | 75k | 57k | 36k | 59k | 95k | 357k | 1.06M | GLOBOCAN 2022 |
New female breast-cancer cases per year (GLOBOCAN 2022 / national registries); +1%/yr for demographics. Female breast-cancer incidence base (GLOBOCAN 2022 cross-checked to national registries; US = ACS ~316k invasive female cases). +1%/yr demographic trend. China is listed for completeness but kept ~zero downstream (no China filing visibility). | ||||||||||
| × HR+/HER2- | 68% | 68% | 68% | 68% | 68% | 68% | 66% | 66% | share, not summed | SEER subtypes (~68%) |
Hormone-receptor-positive, HER2-negative, the largest breast-cancer subtype. HR+/HER2- is the dominant subtype at ~65-70% of all breast cancer (SEER). A consistent ~68% is applied across markets; KEYNOTE-756 required centrally-confirmed ER+/HER2-. | ||||||||||
| × High-risk (grade 3; node+/bulky)est | 17% | 17% | 17% | 17% | 17% | 17% | 18% | 18% | share, not summed | modelled (KN-756 eligibility) |
KEYNOTE-756 eligibility: centrally-confirmed grade 3, T1c-2 cN1-2 or T3-4 cN0-2. The trial required centrally-confirmed grade 3 AND node-positive/bulky presentation (T1c-2 cN1-2 or T3-4 cN0-2). Grade-3 is ~10-15% of ER+/HER2-, but the node/bulk requirement and the real-world high-risk clinical band that would be treated push the addressable share to ~17%. The SOFTEST funnel input, flagged estimated. | ||||||||||
| × Neoadjuvant-chemo fit/treatedest | 86% | 85% | 85% | 83% | 83% | 83% | 85% | 75% | share, not summed | modelled estimate |
Of high-risk eligible, those who receive neoadjuvant chemotherapy (the KEYNOTE-756 backbone) and are IO-fit. Neoadjuvant chemotherapy is already standard for high-risk grade-3 node-positive early breast cancer, so most eligible patients are candidates for the pembrolizumab-on-top regimen; a minority are unfit (age/comorbidity/cardiac for anthracycline). Modelled at ~80-88% by market. | ||||||||||
| = Addressable high-risk ER+/HER2- neoadjuvant pool | 31k | 6.0k | 7.3k | 5.4k | 3.5k | 5.7k | 9.6k | 32k | 101k | computed |
Incidence × HR+/HER2- share × high-risk (grade 3; node+/bulky) share × neoadjuvant-chemo-treated/IO-fit, the population matching KEYNOTE-756 eligibility this year (all-comers by PD-L1). The high-risk ER+/HER2- neoadjuvant pool drifts up modestly with rising breast-cancer incidence and broader use of neoadjuvant therapy in high-risk disease. China is carried in the funnel structurally but held near zero via a 2028 'launch' with negligible penetration (no filing visibility). | ||||||||||
| × Keytruda uptake (branded) | 0% | 0% | 0% | 0% | 0% | 0% | 0% | 0% | share, not summed | ASSUMED |
Per-market branded uptake of the addressable pool this year (launch ramp net of competitors & biosimilars). See the competitive curve below; pick a market for its access basis. | ||||||||||
| = Treated with Keytruda | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | computed · assumed input |
Addressable pool × branded uptake. | ||||||||||
| × Net price / patient | $135K | $78K | $92K | $72K | $62K | $74K | $82K | $30K | per patient, not summed | derived (KN-522 analogue) |
The KEYNOTE-756 course mirrors KEYNOTE-522: neoadjuvant pembrolizumab through chemo + up to 9 adjuvant cycles (~1 year, ~17 × 200 mg q3w doses). At US ASP ~$11.8k/dose gross ≈ ~$200k list; net of Part-B/rebate discounts modelled at ~$135k US, scaled down to EU/Japan net levels. −4%/yr forward; flagged modelled. | ||||||||||
| = Net revenue / yrOutput | $0 | $0 | $0 | $0 | $0 | $0 | $0 | $0 | $0 | computed · assumed input |
Treated patients × realized net price. | ||||||||||
Regional revenue mix · 2026 modelled
Model estimate, sourced from the funnel table above
No reported competitor-share series exists for this setting, so every trajectory below is modelled from approval timing, label breadth and the funnel, not reported data.
In-class share, neoadjuvant immunotherapy in high-risk ER+/HER2- breast cancer: 8 modelled markets (US, EU5, JP, CN)
Each agent's share of the addressable high-risk ER+/HER2- neoadjuvant pool. This is a PRE-APPROVAL setting: pembrolizumab (KEYNOTE-756) is modelled as first entrant (est. 2028, EFS-gated), with nivolumab (CheckMate 7FL) a close co-entrant taking a meaningful minority. The gap below the lines is patients on chemo + endocrine therapy alone (no IO). All shares are scenario assumptions, not reported figures.
Share of the 101k-patient addressable high-risk ER+/HER2- neoadjuvant pool this regimen is modelled to treat, by year
Keytruda is modelled at 0% of this pool in 2026, peaking at 12% in 2032; each point of share is revenue on the chart above.
Scope: 8 modelled markets (US, EU5, JP, CN) · follows the market selector above
Rivals' share, same pool
Nivolumab (CheckMate 7FL) holds the largest rival share in 2026, 0% of the pool; that is the share Keytruda has to take or hold.
Rivals, rescaled - note the axis maximum (20%), which is smaller than the plot above. Same data, a linear axis of its own, so a low-share entrant is readable rather than a hairline on the baseline.
No agent is approved in this indication as of Q2 2026. Category timing and shares are SCENARIO assumptions: pembrolizumab first (est. 2028, contingent on EFS), nivolumab close behind (contingent on CheckMate 7FL EFS). Shares reflect a two-player IO split of a chemo-anchored setting, capped by the modest pCR delta and the near-term Keytruda LOE. Not reported figures.
Readouts, approvals and LOE events for pembrolizumab and its rivals in this setting. Estimated timing is flagged; confirmed dates cited from Merck & Co. disclosures and regulator databases.
Estimated first approval (US), CONTINGENT on a positive EFS readout and filing; scenario timing
Keytruda US composition-of-matter LOE (~2028), pembrolizumab biosimilars compress the branded window soon after any launch
Pivotal EVENT-FREE-SURVIVAL readout, the endpoint that decides approvability; the single biggest swing factor for this forecast
✓ = reported public fact, cited. Upcoming timing is estimated from company guidance and trial registries, a projection, not a commitment. Approvals = US (FDA) · EU (EMA) · Japan (PMDA) · China (NMPA). ● = pembrolizumab, competitor tag = a same-setting rival.
Residual unmet need: why the field stays alive
High-risk ER+/HER2- disease still relapses despite chemo + endocrine therapy ± CDK4/6 inhibitors, and immunotherapy benefit in this 'cold' subtype is unproven beyond pCR. Whether a modest pCR gain translates into an event-free-survival benefit, the question that decides approvability, is unresolved, and adjuvant CDK4/6 inhibitors (abemaciclib/ribociclib) already occupy the high-risk adjuvant space, so any IO regimen must show it adds value on top.
The synthesis for this indication, grounded in the cited trial, guideline and access facts above.
Rivals in this setting (Neoadjuvant/adjuvant high-risk early ER+/HER2- breast cancer)
Swipe to explore →
| Rival / regimen | Developer | Position in this setting | Approved (date, trial, n) | Head start vs this regimen (months) | Source |
|---|---|---|---|---|---|
| Nivolumab neoadjuvant (CheckMate 7FL) (Live threat) | BMS | Live threatwhyThe direct in-class rival, near-identical pCR (24.5% vs 13.8%; p=0.0021) in high-risk ER+/HER2-; EFS also pending. A co-equal potential entrant. | not in the record | not in the record | CheckMate 7FL, neoadjuvant nivolumab in ER+/HER2- (Loi et al., Nature Medicine 2024) |
| Abemaciclib adjuvant (monarchE) (Pool erosion) | Eli Lilly | Pool erosionwhyOwns the high-risk node-positive ER+/HER2- ADJUVANT space (IDFS benefit); a different mechanism/line but competes for the same high-risk patient. | not in the record | not in the record | monarchE |
| Ribociclib adjuvant (NATALEE) (Pool erosion) | Novartis | Pool erosionwhyBroadens adjuvant CDK4/6 into a wider high-risk ER+/HER2- population; further occupies the adjuvant high-risk space. | not in the record | not in the record | NATALEE |
| Pembrolizumab biosimilars (Watch) | Multiple | WatchwhyKeytruda US composition-of-matter LOE ~2028; biosimilars would erode the branded molecule soon after any KEYNOTE-756 launch. | not in the record | not in the record | Keytruda composition-of-matter LOE (~2028) |
Not every rival is approved in every region, so a share here is the modelled position in the markets where it competes, not a global one.
Net pricing: assumptions & basis
Pembrolizumab is given as a defined ~1-year course: 200 mg q3w through neoadjuvant chemotherapy, then up to 9 adjuvant cycles alongside endocrine therapy (~17 doses total), the same course structure as the approved KEYNOTE-522 TNBC regimen, used here as the pricing analogue. Per-patient revenue is modelled from each market's per-dose net × the ~17-dose course. No indication-specific net price is disclosed.
Figures below are 2026 net prices, the basis the model is anchored on. The funnel applies -4%/yr from 2026, so the price it consumes for a later year is lower than the figure quoted here. Both come from this one value; the funnel row states the year it is showing.
KEYNOTE-756 mirrors the KEYNOTE-522 course: neoadjuvant pembrolizumab 200 mg q3w through the chemotherapy backbone, then up to 9 adjuvant cycles with endocrine therapy (~1 year, ~17 doses). At US ASP ~$11.8k per 200 mg dose the gross course is ~$200k; net of Medicare Part-B/rebate discounts is modelled at ~$135k US, scaled to EU/Japan net levels (FR ~$78k, DE ~$92k AMNOG, IT ~$72k, ES ~$62k lowest Western, UK ~$74k PAS, JP ~$82k NHI). −4%/yr forward. All figures are modelled: no indication-specific net price is publicly disclosed, and none applies until approval.
What it shows. The approval-to-reimbursement journey by market: when each payer granted access, on what terms (PD-L1 or comparator restrictions), and the lag between regulatory approval and reimbursed revenue.
What to look for. The access-lag column, approval is not revenue and some markets take a year or more. And the restrictions that narrow the eligible population below the full label.
Common misread. Assuming a US price or approval transfers to other markets. Ex-US payers benchmark against comparators and reference prices, so the net price and the covered population are usually smaller.
Rows ordered by access speed. The approval→reimbursement lag is commercially load-bearing, and it is not one number per drug: a monotherapy indication and a later combination extension file separately with a payer and can reach routine commissioning years apart, even within the same asset’s first-line setting.
| Market | HTA body | Decision | Access lag | PD-L1 | Comparator | Key outcome / MEA note |
|---|---|---|---|---|---|---|
| US | FDA | Not filed (est. ~2028) | reference | None (all-comers) | Chemo + placebo → endocrine therapy | PRE-APPROVAL. pCR met but EFS immature; a pCR-only filing is unlikely to support approval in ER+/HER2-, est. first approval EFS-gated ~2028 |
| EU | EMA / EC | Not filed (est. ~2028-29) | ~0.7 yr | None | Chemo + placebo → endocrine therapy | PRE-APPROVAL; contingent on EFS and FDA precedent |
| Japan | PMDA | Not filed (est. ~2028-29) | ~1.0 yr | None | Chemo + placebo → endocrine therapy | PRE-APPROVAL; Japan follows the global EFS readout |
| UK | NICE | Not filed (est. ~2029) | ~0.8 yr | None | Chemo + placebo → endocrine therapy | PRE-APPROVAL; NHS access would follow EMA/MHRA approval and a NICE appraisal |
| France | HAS | Not filed (est. ~2029) | ~0.9 yr | None | Chemo + placebo → endocrine therapy | PRE-APPROVAL; reimbursement contingent on approval + SMR/ASMR assessment |
| Germany | G-BA | Not filed (est. ~2028-29) | ~0.2 yr | None | Chemo + placebo → endocrine therapy | PRE-APPROVAL; AMNOG assessment would follow EC approval |
| China | NMPA | No visibility | n/a | None | - | No China filing/approval visibility for this setting; kept at ~zero in the model |
How much each assumption could move the forecast, one at a time, over the same cited baseline.
This is a sensitivity illustration, not a probability: it shows how far each assumption could move the forecast, never how likely it is.
Set a target and solve for one lever, what it would have to reach, benchmarked against real comparable launches.
One lever at a time: the other assumptions stay at baseline, so the trade-off stays visible.
A model that shows where its own risk is, not a number to trust. Never investment advice.
Cite this forecast as recorded on Q2 2026 → A permanent record of these figures that does not change when the model does.
Every reported figure here traces to a public source below; the model's own assumptions are labelled where they appear.
Reported figures are public facts from company filings; the forward peak is Ormeval's own modelled estimate, not company guidance and not analyst consensus. Approval and readout dates are cross-checked against public regulator and company disclosures. Not investment advice.