Registered forecast
70% registered probability event by 2027-02-02 Unresolved
FDA approves once-weekly oral lenacapavir (YEZTUGO) for HIV-1 pre-exposure prophylaxis on or before the disclosed PDUFA goal date of 2027-02-02
FF-045 Registered - Registered probability
- 70%
- Event by
- 2027-02-02
- Resolution window
- 2026-10-16 → 2027-02-02
- Target rung
- 5 Guideline
- 6 Regulatory
- 7 Coverage
- Baselines it has to beat
-
- Authority base rate 85%
- Calendar cycle 80%
- Analyst proxy 70%
nextconsensus.com/forecast/ff-045/ registry snapshot 2026-10-15 Share image
NextConsensus registered this probability on 2026-10-15. It is one of 26 registered FDA goal-date forecasts.
The proposition
What was claimed
The FDA takes an approval action on Gilead Sciences' supplemental New Drug Application for YEZTUGO (lenacapavir) 300-mg tablets as a once-weekly oral regimen for HIV-1 pre-exposure prophylaxis, with an approval action date on or before 2027-02-02, the PDUFA target action date disclosed in Gilead's Form 10-Q filed 2026-08-06.
- Authority
- US Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER) (US)
- Target rungA step on the 12-rung ladder: rungs 1 to 4 are the evidence moving, rungs 5 to 7 are a guideline body, regulator, or payer acting. The ladder, rung by rung
- Rung 6: Regulatory action — Label/indication change, approval action, REMS modification, or withdrawal by FDA, EMA, PMDA, Health Canada, etc.
- Forecast classThe group of like forecasts this one is counted and scored with, such as FDA actions by their goal dates
- FDA action by goal date
- Scope
- HIV-1 pre-exposure prophylaxis, once-weekly oral
The estimate
The number and the baselines it has to beat
The alternatives it was registered against, each with the reasoning that produced it.
ESTIMATE FROM THE SHAPE OF THE CLASS, NOT AN ENUMERATED COUNT. Efficacy supplements to approved drugs are approved at their first goal date more often than original applications. The calendar's own count does not exist yet.
A clock-only model: the goal date is inside the window, FDA meets most goal dates, and most first-cycle supplement actions are approvals.
An HIV analyst reading the same filings on 2026-10-01 would weigh an approved active ingredient already labelled for interim weekly oral use against filings that describe neither the evidence nor the review type for a standalone once-weekly regimen. Estimated by reconstructing that read, not by surveying analysts.
Regulatory action (FDA): offered on judgment, with no calibration figure until 15 in the class have resolved.
The clock
Dates that constrain the record
- Evidence cutoff
- 2026-10-15
Nothing after this date informed the estimate. - Registered
- 2026-10-15
Frozen and hashed. - Resolution window
- 2026-10-16 → 2027-02-02
When the adjudicator can read the outcome. - Event by
- 2027-02-02
The final qualifying action date; the frozen resolution rule defines what counts. Add to calendar
8b208db8497b08d9f2b1d79efd1b3eb15e4c5ccd2cd78c455a887da72420f9d9 · operator record jc-1792036539479-aaeb1133
Around this record
- This kind of deadline
- Check it, follow it
Single-claim evaluation
Waiting on the FDA for an asset of your own?
Name the claim, who decides it, and the date your team commits to: a P&T meeting, an HTA submission, a label negotiation, a deal closing. Yours is registered under the same rules as the forecast on this page.
Resolution
The rule that settles the forecast
The filings do not give the application number; openFDA lists YEZTUGO 300 mg tablets under NDA220020 (SRC-003), so the approval is identified by content, applicant and date. The label approved with NDA220020 ORIG 1 on 2025-06-18 already permits oral lenacapavir 300 mg once every 7 days on an interim basis while injections are delayed (SRC-005); that does not count. Resolves YES if the openFDA Drugs@FDA records returned by https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22lenacapavir%22&limit=100 and by https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22LENACAPAVIR%20SODIUM%22&limit=100, read together, contain a Gilead application with a submission, original or supplement, whose submission_status is AP and whose submission_status_date is after 2026-10-01 and on or before 2027-02-02, and whose Drugs@FDA approval letter or label provides once-weekly oral lenacapavir as a regimen for HIV-1 pre-exposure prophylaxis in its own right, not only as interim dosing while injections are delayed. An approval for a narrower PrEP population than the applicant sought still resolves YES. Resolves NO if no approval action is dated on or before 2027-02-02: a complete response letter, a goal-date extension, withdrawal or no action. The goal date is frozen as disclosed at the cutoff; a later extension does not move it, and an approval dated after 2027-02-02 resolves NO as occurred_after_deadline. Read no earlier than 2027-02-16. If openFDA has not refreshed by then, the Drugs@FDA web record (https://www.accessdata.fda.gov/scripts/cder/daf/, searched by the name lenacapavir) governs, under the same content test. Resolves unresolvable only if none of these sources can be read after the read floor. Resolves VOID, with the reason recorded, only if FDA withdraws every public record of approval actions named above without an equivalent public successor, so that no approval date for this product can be read; while any of them publishes it, the rule stands.
Source the rule names: https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22lenacapavir%22&limit=100, https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22LENACAPAVIR%20SODIUM%22&limit=100, https://www.accessdata.fda.gov/scripts/cder/daf/
Readers: Resolver A, clinical methodology; Resolver B, payer evidence. The same two reader roles are assigned to every forecast registered so far.
What this record will show once it resolves
Beside every result, the count for its class (FDA action by goal date): registered, resolved, unresolved, and expired. One forecast is one instance, not a rate.
- The finding
- As the rule above reads it: occurred on time, did not occur, or left unscored.
- The readers and their sources
- Two reader roles read the source named above: Resolver A, clinical methodology; Resolver B, payer evidence. Who adjudicated it is named here, with the sources they read when the adjudication lists them. Being named as a reader means applying the frozen rule to the public record; it is not support for the estimate, the method, or NextConsensus.
- The number against its baselines
- 70% beside three baselines, each scored by the same rule (squared error), so a reader can see how the record did against each of them.
Reasoning
What the number rests on
The facts it was built from are below, as they stood at the cutoff, with every source archived; each baseline above carries the reasoning that produced it. The written mechanism and the conditions that would make the proposition ill-posed were frozen with the record and are held in the ledger, which the hash on this page covers.
Frozen covariatesThe facts about the evidence and the authority's process that were frozen with the forecast at its cutoff
The state of the record at the cutoff
Recorded as they stood on 2026-10-15, including the 4 fields whose values were unknown then. Those are left unknown rather than filled in.
- review pathway
- unknown — not stated in the archived sources
- submission type
- Supplemental NDA (SRC-001, SRC-002).
- evidence class
- unknown — not stated in the archived sources
- pivotal n
- unknown — not stated in the archived sources
- endpoint type
- unknown — not stated in the archived sources
- approved competitors in class
- Lenacapavir is already approved for PrEP as YEZTUGO (NDA220018 injection, NDA220020 tablets, approved 2025-06-18) and for treatment as SUNLENCA and in BIXLENVO (SRC-003, SRC-004); other PrEP products (e.g., DESCOVY FOR PREP, TRUVADA FOR PREP) are Gilead trademarks listed in SRC-001.
- months since last guideline revision
- not applicable — no guideline is the subject of this proposition
- panel cycle position
- not applicable — the act is an FDA approval action
- sponsor request status
- FDA acceptance of the sNDA is stated in the Q2 2026 results filed 2026-08-04 and the 10-Q filed 2026-08-06; neither states the submission date (SRC-001, SRC-002).
- odac referral
- none announced in the archived sources
- sponsor state change
- None reported.
Sources
Everything the estimate was built from
Each was retrieved on or before the 2026-10-15 cutoff and archived at the digest shown. If a publisher edits a page after the fact, the digest stops matching and the substitution is visible.
-
SRC-001Gilead Form 10-Q for the quarter ended 2026-06-30, filed 2026-08-06 (latest filing stating the date). States FDA accepted a supplemental NDA submission for Yeztugo 300-mg tablet as a potential once-weekly oral formulation for HIV PrEP with PDUFA target action date February 2, 2027. -
SRC-002Gilead Form 8-K Exhibit 99.1 (Q2 2026 results), filed 2026-08-04. Same statement: supplemental NDA for Yeztugo (lenacapavir) 300-mg tablets as a potential once-weekly oral formulation for PrEP accepted, PDUFA target action date February 2, 2027. -
SRC-003openFDA drugsfda application_number:"NDA220020", retrieved 2026-10-01 (meta last_updated 2026-09-29): YEZTUGO tablet, lenacapavir sodium eq 300 mg base; ORIG-1 approved 2025-06-18; no supplements. -
SRC-004openFDA drugsfda products.active_ingredients.name:"LENACAPAVIR", retrieved 2026-10-01: six Gilead lenacapavir applications (YEZTUGO, SUNLENCA, BIXLENVO). -
SRC-005Drugs@FDA prescribing information for YEZTUGO approved with NDA 220020 ORIG 1 (2025-06-18). Its dosing table for anticipated delayed injections gives oral lenacapavir 300 mg once every 7 days for interim use only. This is why the rule requires an approval after the cutoff for a standalone weekly regimen.