Skin cancer vaccine BLA submitted by June 30, 2027?

- [2026-08-19] Merck and Moderna announced positive topline Phase 3 results from the INTerpath-001 trial of intismeran autogene (V940/mRNA-4157) plus pembrolizumab in resected stage IIB-IV melanoma, meeting the primary endpoint (RFS) and key secondary endpoint (DMFS) at a prespecified interim analysis. First and only combination regimen to demonstrate statistically significant and clinically meaningful improvements in RFS and DMFS compared to KEYTRUDA alone for these patients in the adjuvant melanoma setting. (https://www.merck.com/news/merck-and-moderna-announce-phase-3-interpath-001-trial-of-intismeran-autogene-plus-keytruda-met-endpoints-of-recurrence-free-survival-rfs-and-distant-metastasis-free-survival-dmfs-in-patient/) - [2026-08-19] Following the readout, the companies said they would now "engage with regulators on filing submissions." No BLA had been submitted at that time. (https://www.fiercebiotech.com/biotech/merck-and-modernas-personalized-cancer-vaccine-slows-recurrence-ph-3-trial) - [2026-08-19/20] Multiple outlets confirmed regulatory status as not-yet-filed: Regulatory status: Data to be shared with regulators; no filing submitted yet . (https://www.biopharminternational.com/view/merck-moderna-intismeran-autogene-pembrolizumab-phase-3-melanoma) - [2026-09-23] Moderna's Chief Development Officer David Berman said much of the discussion focused on intismeran... the Phase 3 melanoma study met both its primary endpoint and a secondary endpoint of distant metastasis-free survival at the first interim analysis , and he said the company believes the results provide a strong case for regulatory approval, though Moderna plans to focus first on filing its biologics license application. This confirms a BLA had still not been filed as of late September 2026, only intent to file. (https://finance.yahoo.com/healthcare/articles/moderna-eyes-cancer-vaccine-filing-150231769.html) - [2026-08-12] Moderna's Form 10-Q (for quarter ended June 30, 2026) lists forward-looking statements referencing "We expect Phase 3 adjuvant melanoma data potentially in 2026" for intismeran, with no mention of a BLA filing date for the program — contrasting with concrete PDUFA dates assigned to other Moderna products like mRNA-1010. (https://www.sec.gov/Archives/edgar/data/0001682852/000168285226000150/mrna-20260630.htm) - [2026-09-21] Moderna announced that Phase 3 data for intismeran autogene in the adjuvant treatment of patients with resected stage IIB-IV melanoma was selected for presentation at a Presidential Symposium at ESMO Congress 2026 (Madrid, Oct 23-27), with the INTerpath-001 full data set scheduled for Saturday, October 24, 4:30 PM CEST / 10:30 AM EDT, presented by Georgina V. Long . This full-data presentation — not yet occurred as of today — is the next major catalyst likely to precede any formal BLA submission. (https://www.biospace.com/press-releases/moderna-announces-late-breaking-data-to-be-presented-at-esmo-congress-2026) - [2026-09-21] Moderna will also host an investor event on October 24 to discuss findings , where further commentary on regulatory filing timing is likely. (https://www.biopharmawatch.com/news/MRNA/moderna-esmo-congress-2026-intismeran-autogene) - [2026-10-09, as of search] No company, FDA, or credible press report found stating a BLA for intismeran autogene has actually been submitted or accepted by the FDA; all sourcing describes only "plans to engage with regulators" or intent to file, not a completed submission. - [ongoing] The INTerpath-001 trial continues for overall survival follow-up; "the results come from a preplanned interim analysis, with the trial now set to continue so that overall survival can be analyzed down the line." (https://www.fiercebiotech.com/biotech/merck-and-modernas-personalized-cancer-vaccine-slows-recurrence-ph-3-trial) - [reference] The broader INTerpath program comprises nine Phase 2/3 trials across melanoma, NSCLC, bladder and renal cancer, with fully enrolled studies including a Phase 3 adjuvant melanoma, a Phase 2 adjuvant renal cell carcinoma, and a Phase 2 adjuvant muscle invasive bladder cancer; Phase 3 adjuvant melanoma data potentially in 2026 — melanoma remains the lead indication for any first BLA. (https://www.sec.gov/Archives/edgar/data/0001682852/000168285226000150/mrna-20260630.htm) BOTTOM LINE: As of October 9, 2026, intismeran autogene has cleared its pivotal Phase 3 melanoma readout (Aug 19, 2026) and companies have stated clear intent to file a BLA, but no submission or FDA acceptance has occurred yet; full data presentation at ESMO (Oct 24, 2026) is the next milestone, and management as recently as Sept 23, 2026 described filing as still a forward plan, not an accomplished fact — leaving roughly 8 months (to June 30, 2027) for an actual BLA submission to materialize. NOT FOUND: No specific target date or quarter for BLA submission announced by Moderna/Merck; no FDA designation (priority review, breakthrough-based accelerated filing) specifically tied to a filing timeline for the Phase 3 melanoma indication (breakthrough status was granted in Feb 2023 based on Phase 2b data, per Wikipedia, but no Phase-3-triggered new designation was found); no confirmation of a pre-BLA or Type B end-of-Phase-3 meeting with FDA having occurred.

- [2026-01-05] Moderna's own investor letter stated: three of the nine expected clinical readouts are Phase 3 programs for intismeran, with Phase 3 data potentially in 2026, and "if the data are positive, we would then work to prepare for a potential launch, together with our partner Merck, of this important medicine as early as in 2027." This is the company's own stated outside-view timeline, implying filing well before any 2027 launch. https://www.sec.gov/Archives/edgar/data/1682852/000168285226000003/exhibit991-01052026lettert.htm - [2026-08-19] On the day of the positive Phase 3 readout, the companies' own language was non-committal on filing: forward-looking statements referenced only "engagement with regulators on potential filing submissions," not an actual submission or firm date. https://www.businesswire.com/news/home/20260819675697/en/Merck-and-Moderna-Announce-Phase-3-INTerpath-001-Trial-of-Intismeran-Autogene-Plus-KEYTRUDA-Met-Endpoints-of-Recurrence-Free-Survival-RFS-and-Distant-Metastasis-Free-Survival-DMFS-in-Patients-With-Completely-Resected-Stage-IIB-IV-Melanoma - [2026-08-19] Independent reporting on the same announcement confirmed no filing has yet occurred: "Regulatory status: Data to be shared with regulators; no filing submitted yet." https://www.biopharminternational.com/view/merck-moderna-intismeran-autogene-pembrolizumab-phase-3-melanoma - [2026-09-23] A Moderna executive (David Berman) reiterated, over a month after topline data, that Moderna plans to pursue regulatory filing for intismeran after the Phase 3 melanoma trial met endpoints, with the companies first focusing on a biologics license application — still framed as a future plan, not an action taken. https://finance.yahoo.com/healthcare/articles/moderna-eyes-cancer-vaccine-filing-150231769.html - [2026-08-20] Analyst commentary (Morningstar/Jefferies-style) set expectations consistent with, but not confirming, an on-time filing: Morningstar raised its assumed probability of approval for intismeran in melanoma from 60% to 100%, and expects "rapid approval, likely in the first half of 2027, once data is filed." This independent analyst base rate implies filing is expected to occur in 2026, well ahead of the June 30, 2027 deadline, but is a forecast, not a confirmed fact. https://www.morningstar.com/stocks/moderna-merck-intismerans-positive-phase-3-readout-confirms-mrna-potential-oncology - [Reference class] General industry benchmarks: after completing Phase 3 trials, sponsors typically require 6-12 months of intensive effort to assemble safety and effectiveness data for an NDA/BLA submission. Applied to intismeran's August 2026 topline, this suggests a plausible BLA submission window of roughly February–August 2027 under "typical" timelines — straddling the June 30, 2027 deadline. - [Reference class] However, expedited designations shorten this: comparing median development time for novel oncology agents using expedited programs (IND to NDA/BLA submission) to traditional approaches, expedited programs reduced median development time by 3.4 years; for approvals using two or more expedited approaches, median time to development was 5.76 years versus 9.62 years for single-program approvals. Intismeran already holds FDA Breakthrough Therapy designation (granted Feb 2023) and EMA PRIME designation, both of which historically correlate with faster sponsor-to-filing timelines. https://en.wikipedia.org/wiki/Intismeran_autogene - [Reference class] As a direct comparator, Moderna's own recent BLA experience (mRNA-1010 flu vaccine) shows the submission process is not always smooth: the company had to overcome a prior Refusal-to-File letter, engage in a Type A meeting with FDA, and submit an amended BLA before the FDA accepted the application for review and assigned a PDUFA goal date of August 5, 2026 — illustrating that even a seasoned sponsor can face filing delays and rework, a cautionary analog (though for a different product class/indication, not intismeran). - [2026-10 (current status)] As of the most recent development-timeline entries, the last confirmed events are the August 19, 2026 Phase 3 topline announcement and the June 1, 2026 presentation of 5-year Phase 2b data , with no subsequent entry indicating a BLA submission or FDA acceptance has occurred. https://www.drugs.com/history/intismeran-autogene.html - [Caveat] A Moderna SEC risk-factor passage referencing "Refusal-to-File," "Type A meeting," and "amended BLA" in 2026 refers to the unrelated mRNA-1010 flu vaccine program, not intismeran — care should be taken not to conflate the two when reading Moderna's 10-K. https://www.sec.gov/Archives/edgar/data/1682852/000168285226000033/mrna-20251231.htm BOTTOM LINE: The reference class of oncology BLAs following a clean, breakthrough-designated Phase 3 readout (as intismeran achieved in August 2026) typically files within 6-12 months, and analysts (Morningstar) explicitly expect filing to occur with approval targeted H1 2027 — both pointing toward a submission likely occurring before the June 30, 2027 deadline, though company language as of September 2026 still describes filing as a future plan rather than a completed or imminent action, leaving some base-rate risk of slippage past the deadline given Moderna's own recent BLA friction (mRNA-1010 RTF/delay) as a cautionary comparator. NOT FOUND: No specific confirmed BLA submission date or FDA acceptance for intismeran autogene as of the most recent search (early October 2026); no official company-stated target quarter for the intismeran BLA submission (only general "soon"/"2027 launch" framing); no FDA PDUFA date assigned for intismeran.

YES means: Moderna and/or Merck officially announce that a BLA for intismeran autogene (V940/mRNA-4157) has been submitted to the FDA, or that the FDA has accepted it for review, on or before June 30, 2027, 11:59 PM ET (or, alternatively, that FDA grants approval by that date even absent a separately disclosed submission). - [2026-08-19] On the day of the positive Phase 3 readout, CNN reported that Moderna said the company and partner Merck aim to file for approval from regulators within months, though they declined to provide a more specific timeline , which is a materially more concrete filing signal than the generic "engage with regulators" language used in the companies' joint press release the same day. - [2026-08-19] Analyst coverage noted the stock reaction underscored how central this program now is to both companies: these positive results from the drug's late-stage Phase 3 trials boosted Moderna's share price by 177% in a single day , creating strong market and management incentive to move the filing as fast as possible rather than risk delay. - [2023-02, per FDA SOPP 8212] Intismeran already holds FDA Breakthrough Therapy designation, and under FDA's own standard operating procedure, marketing applications for breakthrough therapy-designated products may be eligible for priority review, accelerated approval and/or rolling review, and products with an indication that has breakthrough therapy designation are eligible for rolling review — meaning Moderna/Merck could begin submitting completed modules of the BLA before the entire dossier (including longer-term safety follow-up) is finished, pulling the "submission" date earlier than a traditional single-block filing would allow. - [general FDA guidance] The same rolling-review mechanism is explicitly built for breakthrough products: Section 506(a) of the FD&C Act provides for designation of a drug as a breakthrough therapy... if FDA determines, after preliminary evaluation of clinical data submitted by the sponsor, that a breakthrough therapy product may be effective, the Agency may consider reviewing portions of a marketing application before the sponsor submits the complete application , a path that would let an initial rolling BLA submission "begin" well inside the June 30, 2027 window even if full completion takes longer. - [historical Merck precedent] Merck has a demonstrated track record of rapidly converting breakthrough-designated melanoma immunotherapy data into an accepted BLA: for Keytruda (MK-3475) in advanced melanoma, the FDA granted Priority Review designation with a PDUFA date of October 28, 2014, and the MK-3475 BLA will be reviewed under the FDA's Accelerated Approval program; the FDA previously granted MK-3475 Breakthrough Therapy designation for advanced melanoma — showing Merck/MSD's melanoma regulatory playbook (breakthrough designation → accelerated-pathway BLA → priority review) has precedent for speed in this exact disease area. - [2026-09-21] The INTerpath-001 full dataset will be unveiled at ESMO's Presidential Symposium on Oct 24, 2026, as three abstracts on intismeran autogene have been accepted for presentation at the European Society for Medical Oncology (ESMO) Congress 2026... LBA1- INTerpath-001: Phase 3 study... Session Type/Title: Presidential Symposium, Date & Time: Saturday, October 24, 4:30 PM CEST — full efficacy/safety data release this far ahead of the June 2027 deadline gives Moderna/Merck roughly 8 months of runway post-full-data to complete and submit a BLA, comfortably within historical 6-12 month post-Phase-3 filing norms for a breakthrough-designated oncology biologic. - [2026-10-08] Sell-side analysts expect the imminent ESMO data release and subsequent regulatory progress to remain a dominant near-term catalyst for Merck, with Guggenheim noting ahead of Merck's Oct 29 earnings call that Merck's earnings call to focus on pipeline progress, including full data for intismeran and Sac-TMT to be released at the ESMO Congress from Oct. 23-27 , and other analysts already raising price targets on the strength of the data, consistent with market expectation that filing progress will follow quickly. - [2026-10-29 and 2026-10-29 respectively, scheduled] Both Merck and MSD list an "Investor Event at ESMO 2026" alongside their Q3 2026 earnings calls on October 29, 2026 — two near-term, officially scheduled corporate disclosure events (within three weeks of full Phase 3 data release) at which management could plausibly confirm BLA submission timing or even an initial filing, materially increasing the odds of an early, specific, and favorable update well before the June 2027 deadline. - [2026-09-23] Even Moderna's most recent (and most cautious) public comment still affirmed that the company's near-term strategic priority is this filing, with the Chief Development Officer stating the company would focus first on filing its BLA — signaling organizational resourcing and prioritization consistent with a near-term (sub-10-month) filing rather than indefinite delay. - [reference class] Despite friction on Moderna's unrelated mRNA-1010 flu BLA (a Refusal-to-File in Feb 2026 followed by a Type A meeting and resubmission), that episode also demonstrates Moderna's capacity to execute a full submission-acceptance-resubmission cycle within about six months once in motion, suggesting that even if intismeran encountered an initial complication, there would likely still be time to reach a qualifying "submission" event before the June 2027 deadline. BOTTOM LINE: The strongest YES path is a rolling or traditional BLA submission for intismeran autogene in adjuvant melanoma, enabled by its Breakthrough Therapy designation (which make it eligible for rolling review), following presentation of the full Phase 3 INTerpath-001 dataset at ESMO's Oct 24, 2026 Presidential Symposium; management's own "file within months" language (Aug 19, 2026), Merck's historical speed with breakthrough-designated melanoma immunotherapies (Keytruda precedent), and two scheduled investor/earnings events on Oct 29, 2026 together support a submission comfortably materializing within the roughly 8-month window before June 30, 2027. NOT FOUND: No official company statement giving a specific target month/quarter for BLA submission; no confirmation of a pre-BLA (Type B end-of-Phase-3) meeting having occurred with FDA; no evidence yet that a rolling submission has actually begun.

YES means: Merck/Moderna (or the FDA) officially confirm that a Biologics License Application for intismeran autogene (any indication) has been submitted to or accepted by the FDA, by June 30, 2027, 11:59 PM ET — or that full FDA approval is granted by that date. This dimension argues the NO case: that no such submission/acceptance/approval will be confirmed in time. - [2026-08-19] The only two companies authorized to make a qualifying announcement described next steps solely as planning to "present the INTerpath-001 data at an upcoming international medical meeting" and to "engage with regulators on filing submissions" — language of intent, not action, with the trade press explicitly logging "Regulatory status: Data to be shared with regulators; no filing submitted yet." (https://www.biopharminternational.com/view/merck-moderna-intismeran-autogene-pembrolizumab-phase-3-melanoma) - [2026-08-19] Moderna President Stephen Hoge had earlier only said a positive interim readout "would obviously make the case for an accelerated review" — a hypothetical framing from before the data even read out, underscoring that no concrete filing pathway or timeline had been locked in even as of the readout. (https://synapse.patsnap.com/drug/f60ec011f17745d8a786099fceb5e562) - [2026-10, filed] Moderna's most recent 10-Q (for the quarter ended June 30, 2026) lists intismeran only among trials with data "potentially in 2026," with zero reference to a BLA filing date, in explicit contrast to the same filing's concrete PDUFA date for mRNA-1010 — showing the company itself has not yet attached a filing timeline to intismeran in its formal SEC disclosures. (https://www.sec.gov/Archives/edgar/data/0001682852/000168285226000150/mrna-20260630.htm) - [2026-02-13/2026-02-18] Moderna's own recent BLA track record is a cautionary comparator: its mRNA-1010 flu vaccine BLA drew a Refusal-to-File letter, requiring a Type A meeting and a resubmitted amended BLA before the FDA even accepted it for review and set an August 5, 2026 PDUFA date — demonstrating that Moderna-sponsored BLAs do not always proceed smoothly or quickly, even for established vaccine platforms. (https://www.sec.gov/Archives/edgar/data/1682852/000168285226000033/mrna-20251231.htm) - [2026 reference] By contrast, a true "fast-filer" biotech in a comparable Phase-3-to-filing window (Intellia, RMAT-designated) had already begun a rolling BLA submission within days of its own Phase 3 topline, explicitly leveraging "rolling submission" status enabled by RMAT designation; no equivalent rolling-submission announcement or RMAT-type designation has been reported for intismeran, implying Moderna/Merck are following a slower, non-rolling, assemble-then-file path. (https://ir.intelliatx.com/news-releases/news-release-details/intellia-therapeutics-initiates-rolling-submission-biologics) - [ongoing] The INTerpath-001 trial is continuing specifically to collect mature overall-survival data, and the August 2026 result was from a "preplanned interim analysis" — regulators reviewing a filing based on RFS/DMFS alone (a surrogate-heavy package) may request additional maturity or a pre-submission Type B/EOP3 meeting before accepting a complete application, a process step not yet confirmed to have even begun. (https://www.fiercebiotech.com/biotech/merck-and-modernas-personalized-cancer-vaccine-slows-recurrence-ph-3-trial) - [2026-09-24] The underlying Phase 3 trial record (NCT05933577) still lists an estimated primary completion date of October 2029 and overall estimated completion of September 2030, reflecting that the study is formally far from "complete" in regulatory terms even though an interim readout was positive — a technicality that could support FDA requests for more data before accepting a BLA. (https://clinicaltrials.gov/study/NCT05933577) - [2026-10-24, upcoming] The full INTerpath-001 dataset will only be unveiled at ESMO's Presidential Symposium on October 24, 2026; until granular efficacy/safety tables are shared publicly and with regulators, Merck/Moderna cannot credibly claim a package is complete enough to file — pushing the earliest plausible filing-readiness point to very late 2026 at best. - [2026-10-29, upcoming] Moderna's Q3 2026 earnings call (confirmed for October 29, 2026) is the first corporate disclosure event after the ESMO data unveiling; historically the company has only given specific program-level regulatory timing in its January JPMorgan Healthcare Conference "business update" letters (as with the January 5, 2026 letter), suggesting the first concrete filing-quarter guidance for intismeran may not arrive until around January 2027 — leaving as little as 5 months to actually complete and submit a complex individualized-therapy BLA before the June 30, 2027 deadline. - [reference] Merck's own 10-K describes BLA review timelines of six months (priority) to ten months (standard) only after an application is accepted, and warns that FDA can extend review if "a major amendment has been submitted" — meaning even a timely filing does not guarantee an "acceptance" announcement well before the deadline if any amendment or RTF-equivalent event (as happened with mRNA-1010) recurs. (https://www.merck.com/wp-content/uploads/sites/124/2026/02/MRK-12.31.2025-10K-FINAL.pdf) - [status quo] As of October 9, 2026 — nearly two months after the positive Phase 3 readout — no company, FDA, or credible press source has announced an actual BLA submission, rolling-filing initiation, or FDA acceptance for intismeran; all public language remains forward-looking ("plan to," "engage with regulators," "would make the case for"), consistent with status-quo inertia continuing absent a specific triggering event. BOTTOM LINE: Nothing found indicates intismeran's BLA has moved beyond "intent to file" as of early October 2026; the individualized-therapy's immature/interim data package, lack of any announced rolling-review or RMAT-type mechanism, Moderna's own recent BLA friction (mRNA-1010 RTF), and a corporate disclosure cadence that likely delays concrete filing-timeline guidance until around January 2027 all argue that a confirmed submission could easily slip past, or land only narrowly before, the June 30, 2027 deadline. NOT FOUND: No announced target quarter or specific filing date for the intismeran BLA from Merck or Moderna; no confirmed pre-BLA, Type B, or End-of-Phase-3 meeting with FDA; no rolling-review or priority-review mechanism specifically tied to intismeran's melanoma filing; no post-ESMO (Oct 24, 2026) company statement yet, as that event has not occurred as of this research.