Cycle on Jul 30, 2026

I will start by listing the open threads and reading existing notes on this topic to see what is currently being tracked and what needs follow-up.

I will search for the outcomes of recent FDA advisory committee meetings, specifically focusing on Capricor Therapeutics' deramiocel for DMD cardiomyopathy (scheduled for July 29, 2026) and Replimune's RP1 for advanced melanoma.

I will fetch the BioSpace and Medscape articles to get detailed quotes and context on the Capricor CTGTAC meeting and the "SAP spat" (Statistical Analysis Plan dispute) mentioned in BioSpace and BioWorld. This is a crucial event, as it relates to the watch thread "FDA final regulatory decision on Capricor's deramiocel BLA in DMD cardiomyopathy" (ID: 019faae7-d4d4-7d74-a6b7-85d81f6821f0). I will first read the BioSpace article.

I will fetch the CancerNetwork or OncLive article about the Replimune CTGTAC vote to get the exact details of the 10-3 vote that favored RP1/Nivolumab. I will also check the exact wording of the vote question and quotes from the meeting.

I have sufficient primary source evidence for two major regulatory events that happened this week: 1. **Capricor's deramiocel for DMD associated cardiomyopathy**: - On July 29, 2026, the FDA's Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) voted 9-3 against recommending approval of deramiocel, concluding that the available evidence from the Phase 3 HOPE-3 trial did not provide substantial evidence of effectiveness. - There was a significant "statistical analysis plan (SAP) spat" where the FDA reviewers analyzed the study using an earlier draft protocol (SAP version 1.1) rather than Capricor's final pre-unblinding analysis plan (SAP version 3.0). Capricor's CEO Linda Marbán expressed intense frustration, comparing it to "your professor grading your term paper on an early draft you have never even submitted." - Meanwhile, on the same day, *The Lancet* published the HOPE-3 trial data, validating the design and showing a 54% slowing of upper limb decline and clinically meaningful cardiac benefit. - This directly updates the watch thread: "FDA final regulatory decision on Capricor's deramiocel BLA in DMD cardiomyopathy" (ID: 019faae7-d4d4-7d74-a6b7-85d81f6821f0). Since this is a non-binding *advisory committee vote* and the final PDUFA target action date is August 22, 2026 (or August 31, 2026 in the watch thread), the watch thread is *not* resolved yet, but I must record this major milestone. 2. **Replimune's RP1 (vusolimogene oderparepvec) for advanced melanoma**: - On July 30, 2026, the FDA's CTGTAC voted 10-3 in favor of Replimune's RP1 plus nivolumab (Opdivo) benefit-risk profile for adult patients with advanced melanoma who have progressed on prior anti-PD-1 therapy. - This is a major victory for Replimune after a long regulatory journey that included two prior Complete Response Letters (CRLs) in July 2025 and April 2026. This third review cycle has an upcoming PDUFA target action date of August 2, 2026. - The committee debated whether the single-arm Phase 1/2 IGNYTE trial was sufficient without a randomized comparator, but ultimately backed it. - This fires the watch thread: "FDA advisory committee meeting and PDUFA date for Replimune's RP1 in advanced melanoma" (ID: 019f0620-007b-7dab-87b4-0363a2496ea1). I should record the event and resolve this thread. Let's check if there are other recent developments or if there is anything else to search. I will search for "Wainua CARDIO-TTRansform ESC Congress August 2026" or "Moderna mFlusiva FDA regulatory decision August 5 2026" to see if there are any early releases or updates. Let's do a search for Moderna's mFlusiva.

The Moderna decision is on August 5, 2026, which is in the future relative to today's date of July 30, 2026. Therefore, that watch thread ("FDA regulatory decision on Moderna's mFlusiva mRNA flu vaccine", ID: 019edcf0-1d32-70e1-9a3e-6825808b2370) has not fired yet. Let's check if there are other updates, such as MoonLake's sonelokimab psoriatic arthritis IZAR-1 trial readout (ID: 019ef184-1ea4-72e1-a12e-ed934bbac64e) or Belite Bio's tinlarebant NDA filing acceptance (ID: 019ec855-8c35-71a4-b33b-90db344bf45d). I will search for these.

The MoonLake PsA Phase 3 IZAR-1 trial readout is expected in Q3 2026 (or late 2026), so it has not happened yet. Let's do a search for Belite Bio's tinlarebant NDA acceptance. Belite Bio submitted the NDA in early June 2026, and the 60-day filing review period ends around early August 2026. Let's see if there is any announcement.

The Belite Bio tinlarebant NDA acceptance is still awaiting the "Day 74 letter" from the FDA, so that watch thread ("FDA filing acceptance and PDUFA date for Belite Bio's tinlarebant", ID: 019ec855-8c35-71a4-b33b-90db344bf45d) has not fired yet. Let's check if there are other updates or new topics to cover. Are there any other major outbreaks or public health moves? I will search for "H5N1 bird flu New Zealand" and "H5N1 bird flu Australia" to see if there are any updates regarding H5N1 bird flu transmission to poultry or wildlife in these regions, which is being monitored on: - "New Zealand H5N1 transmission to poultry or wildlife sanctuaries" (ID: 019f776d-f69b-75cf-93b1-ae8e6c95e559) - "Australia H5N1 transmission to poultry or local wildlife" (ID: 019f2f50-7f4d-7361-8f05-cdf170c2d727) Let's do a search.

The H5N1 bird flu situation in Australia and New Zealand is highly active. - **Australia**: Highly pathogenic H5N1 avian influenza was first detected in June 2026. On July 29, 2026, Australia's Minister for Agriculture, Fisheries and Forestry, Julie Collins, announced that **local transmission** of H5N1 has occurred in Australia's native bird population (specifically between greater crested terns in South Australia). On July 30, 2026, Victoria announced its first H5N1 detection in a greater crested tern near Portland. Queensland also confirmed its first case in a deceased petrel on Moreton Island. However, **there remains no detection of H5N1 in Australia's poultry population or commercial flocks**. - **New Zealand**: In mid-July 2026, New Zealand reported its second H5N1 detection, this time in a local bird (a swamp harrier). The first was in an ocean-going seabird. There are no reports of H5N1 in New Zealand's commercial poultry or wildlife sanctuaries. This is a very important update on the H5N1 situation in Australia/NZ. Since the watch thread "Australia H5N1 transmission to poultry or local wildlife" (ID: 019f2f50-7f4d-7361-8f05-cdf170c2d727) is ongoing, I should record an event on it because local transmission in wild native birds (local wildlife) has now been formally declared. The trigger was "Fires when Australia confirms the transmission of H5N1 to commercial poultry flocks, native land birds, or local marine mammal colonies." Native land birds (like greater crested terns or swamp harriers, though crested terns are seabirds, swamp harrier is a land bird) have now tested positive, and local transmission has been confirmed. Let's look at the exact trigger: "Fires when Australia confirms the transmission of H5N1 to commercial poultry flocks, native land birds, or local marine mammal colonies." Greater crested terns are seabirds, but swamp harriers are land birds (raptors), and New Zealand confirmed it in a swamp harrier. Australia confirmed local transmission between greater crested terns (seabirds). Let's record events on both H5N1 threads to capture these major developments. Let's do a quick search for Vera Therapeutics ORIGIN 3 trial (ID: 019f3ec3-9518-7baa-a4e4-19e437e0557f) to see if there is any early news, though it is expected in Q3 2026. Let's see.

This is another massive regulatory update! On July 7, 2026, Vera Therapeutics received FDA accelerated approval for **TRUTAKNA (atacicept-vymj)** for adult patients with primary IgA nephropathy (IgAN) at risk of disease progression, based on the interim Phase 3 data from the ORIGIN 3 trial. The continuing approval for this indication is contingent on the verification of clinical benefit in the ongoing ORIGIN 3 trial, which evaluates changes in estimated glomerular filtration rate (eGFR). The confirmatory eGFR kidney function data are expected in Q3 2026. This directly relates to the watch thread "Vera Therapeutics Phase 3 ORIGIN 3 eGFR confirmatory results in IgAN" (ID: 019f3ec3-9518-7baa-a4e4-19e437e0557f). While the eGFR confirmatory results themselves are still expected in Q3 2026, the drug has actually won **accelerated approval** under the brand name **TRUTAKNA (atacicept-vymj)** on July 7, 2026! This is a major update on the IgAN space. I should write a note on this and update the watch thread with the accelerated approval. Let's review the findings I want to write: 1. **Capricor's deramiocel DMD cardiomyopathy adcomm blow**: - Voted 9-3 against. - SAP spat: draft version 1.1 vs final version 3.0. - *Lancet* publication on the same day. - Slug: `capricor-deramiocel-dmd-cardiomyopathy-fda-adcomm` (or since there's no prior note on Capricor, I'll mint a fresh one: `capricor-deramiocel-dmd-cardiomyopathy-fda-adcomm`). Wait, let me check the list of prior findings: - `hhs-clinical-trials-reform-operation-trailblazer` - `fda-crl-public-disclosure-policy` - `saol-therapeutics-sl1009-mitochondrial-disease-fda-acceptance` - `amgen-tavneos-regulatory-crisis-advocate-retraction` There is no prior note on Capricor. So I will mint a fresh slug: `capricor-deramiocel-dmd-cardiomyopathy-fda-adcomm`. 2. **Replimune's RP1 advanced melanoma adcomm success**: - Voted 10-3 in favor. - This is a major regulatory victory after two prior complete response letters (CRLs). - Upcoming PDUFA date is August 2, 2026. - Fresh slug: `replimune-rp1-melanoma-fda-adcomm-success` (no prior note on Replimune). 3. **Australia and New Zealand H5N1 Bird Flu local transmission**: - Australia confirmed first local transmission in wild birds (greater crested terns in South Australia). - Victoria detected its first H5N1 bird. - No poultry infections confirmed yet. - New Zealand detected its second H5N1 case in a swamp harrier. - Fresh slug: `australia-new-zealand-h5n1-bird-flu-local-transmission` (no prior note on H5N1). 4. **Vera Therapeutics' TRUTAKNA (atacicept) FDA Accelerated Approval**: - On July 7, 2026, Vera Therapeutics' dual BAFF/APRIL inhibitor won FDA accelerated approval under the brand name TRUTAKNA (atacicept-vymj) for IgAN. - Confirmatory eGFR kidney function data from ORIGIN 3 still expected in Q3 2026. - Fresh slug: `vera-therapeutics-trutakna-fda-accelerated-approval` (no prior note on Vera Therapeutics). Let's double check if there are any other prior notes. Let me call `read_notes` to see if there are other notes in the system that were not retrieved by semantic search.

Ah! Let me review the notes already written. There are a few key notes already written on these subjects: 1. `capricor-deramiocel-dmd-cardiomyopathy-fda-adcomm-vote`: "FDA Advisory Committee Recommends Against Approval of Capricor's Deramiocel in DMD Cardiomyopathy" (updated on July 29, 2026). 2. `replimune-rp1-melanoma-fda-advisory-committee`: "FDA Reviewers Deem Replimune's RP1 Melanoma Data Package "Not Interpretable" Ahead of Adcomm" (updated on July 28, 2026). 3. `vera-trutakna-fda-accelerated-approval-igan`: "Vera's Trutakna (Atacicept) Wins FDA Accelerated Approval for IgA Nephropathy" (updated on July 23, 2026). 4. `h5n1-avian-influenza-arrival-new-zealand-australia-poultry-lockdowns`: "H5N1 Avian Influenza Situation Escalates in Australia and New Zealand as Local Transmission Confirmed and Poultry Regulations Mandated" (updated on July 29, 2026). This is very important. I must revise/extend the existing notes using the same slugs rather than creating new ones! LETS REUSE THE SLUGS: 1. For Capricor's AdComm vote, we have `capricor-deramiocel-dmd-cardiomyopathy-fda-adcomm-vote`. This was updated yesterday, but we can do a quick check of what is in it, or we can update it with more details if needed. Wait, let's see. The user's kickoff says: "The reader wants to know what is NEW and what has CHANGED since the last cycle — not a fresh deep-dive into the whole subject." Since `capricor-deramiocel-dmd-cardiomyopathy-fda-adcomm-vote` was updated on July 29, 2026, and captures the vote, let's see if there is any other update. 2. For Replimune's AdComm vote, we have `replimune-rp1-melanoma-fda-advisory-committee` which was updated on July 28, 2026, and said "FDA Reviewers Deem Replimune's RP1 Melanoma Data Package 'Not Interpretable' Ahead of Adcomm". Today is July 30, 2026, and the AdComm met *today* and voted 10-3 in favor! This is a massive update. I should update `replimune-rp1-melanoma-fda-advisory-committee` with the outcome of the vote. 3. For H5N1, the note `h5n1-avian-influenza-arrival-new-zealand-australia-poultry-lockdowns` was updated yesterday (July 29, 2026). Today, Victoria reported its first case, South Australia reported its 15th case, and local transmission was officially confirmed by the Agriculture Minister Julie Collins. This is also a very fresh update. Let's update `h5n1-avian-influenza-arrival-new-zealand-australia-poultry-lockdowns` with these new details. 4. For Vera Therapeutics, `vera-trutakna-fda-accelerated-approval-igan` was updated on July 23, 2026, and covers the approval. It is already present, so no need to rewrite it unless there are new details. Let's look at the watch threads. The watch thread "Vera Therapeutics Phase 3 ORIGIN 3 eGFR confirmatory results in IgAN" is for Q3 2026, so it's not fired yet. Let's read `replimune-rp1-melanoma-fda-advisory-committee` and `h5n1-avian-influenza-arrival-new-zealand-australia-poultry-lockdowns` first to see their current contents, so we can update them accurately. I will fetch the contents of `replimune-rp1-melanoma-fda-advisory-committee` first, but wait, `read_notes` does not return the full body, it only returns the preview. I will check if there is a tool to read the note body. Ah, wait, there is no `read_note` tool, but since I am updating the note, I can overwrite/update it. Let's see if I have a tool to read the file. Yes, I can use shell or other tools if needed, but since I am an agent, I should check if there's any file in the workspace. Let's list files in the workspace. No, wait, notes are stored in the system database via the API, but some findings might be in the workspace. Let's check. No, I don't have a direct tool to read the full body of a note from the API, but I can use `write_note` which updates the note by slug. Let's see if there is any other way. I can construct a comprehensive, updated note for `replimune-rp1-melanoma-fda-advisory-committee` and `h5n1-avian-influenza-arrival-new-zealand-australia-poultry-lockdowns` based on the new evidence. Let's check the watch threads. We have: - "FDA advisory committee meeting and PDUFA date for Replimune's RP1 in advanced melanoma" (ID: 019f0620-007b-7dab-87b4-0363a2496ea1). I should record the event and resolve this thread! - "Australia H5N1 transmission to poultry or local wildlife" (ID: 019f2f50-7f4d-7361-8f05-cdf170c2d727). This is ongoing. Since H5N1 local transmission in native wild birds has been confirmed, I should record an event on it. Wait, the trigger is "Fires when Australia confirms the transmission of H5N1 to commercial poultry flocks, native land birds, or local marine mammal colonies." Native land birds or local marine mammal colonies. South Australia confirmed local transmission between greater crested terns (seabirds). Let's see if it's considered native land birds. Swamp harrier in NZ is a native land bird. Let's record the event on the Australian thread since H5N1 has officially spread locally in native birds. Let's write the note for the Replimune RP1 AdComm outcome. I will use the slug `replimune-rp1-melanoma-fda-advisory-committee` and update it with the 10-3 vote. Wait! Let's double check if there are other open threads we can resolve. - "FDA advisory committee meeting and PDUFA date for Replimune's RP1 in advanced melanoma" (ID: 019f0620-007b-7dab-87b4-0363a2496ea1). - "FDA final regulatory decision on Capricor's deramiocel BLA in DMD cardiomyopathy" (ID: 019faae7-d4d4-7d74-a6b7-85d81f6821f0). The advisory committee met on July 29, 2026, and voted 9-3 against. The final regulatory decision is expected on or before August 22, 2026 (or August 31, 2026 as in the thread). This thread is *not* resolved yet, as the FDA has not made its final decision. But we can record an event on it if there is a watch for the adcomm. Wait, the watch description is "Monitor the FDA's final regulatory decision (approval or complete response letter) on Capricor Therapeutics' Biologics License Application (BLA) for deramiocel in DMD cardiomyopathy, expected following the July 29, 2026 CTGTAC advisory committee meeting." So it watches for the final decision. I will not resolve it yet. Let's write the updated note for Replimune's RP1. I will write a high-quality note with the slug `replimune-rp1-melanoma-fda-advisory-committee` to capture the 10-3 vote.

I have successfully updated the Replimune RP1 note. Now, I will update the H5N1 bird flu note `h5n1-avian-influenza-arrival-new-zealand-australia-poultry-lockdowns` to record the confirmation of local transmission in Australia among greater crested terns in South Australia, Queensland's first case on Moreton Island, and Victoria's first case near Portland. I will do this by writing an updated note on that slug.

I have successfully updated the H5N1 avian influenza note. Now, let's record events on the relevant watch threads. - For Replimune's AdComm vote (ID: `019f0620-007b-7dab-87b4-0363a2496ea1`), the committee met and voted 10-3 in favor. I should record this event and resolve this thread. - For Australia's H5N1 transmission (ID: `019f2f50-7f4d-7361-8f05-cdf170c2d727`), local transmission has been confirmed in native wild birds (local wildlife) in South Australia, Queensland, and Victoria, though not yet in commercial poultry. Since it is an *ongoing* thread, I will record the event but keep it open (resolves: false). - For New Zealand's H5N1 transmission (ID: `019f776d-f69b-75cf-93b1-ae8e6c95e559`), New Zealand reported its second detection in a local resident swamp harrier (local wildlife), but not yet in commercial poultry or wildlife sanctuaries (like Pūkaha Mount Bruce). I will record this event but keep it open (resolves: false). Let's make these calls. I will start with recording the event on Replimune's thread and resolving it.

I have recorded the event on the Replimune thread. Now I will formally resolve this thread.

I have resolved the Replimune thread. Now I will record the event for Australia's H5N1 transmission thread (ID: `019f2f50-7f4d-7361-8f05-cdf170c2d727`). This is an ongoing watch, so `resolves: false`.

I have recorded the event on the Australian H5N1 thread. Now I will record the event for New Zealand's H5N1 transmission thread (ID: `019f776d-f69b-75cf-93b1-ae8e6c95e559`). This is also an ongoing watch, so `resolves: false`.

I have recorded the event on the New Zealand H5N1 thread. Let's check if there are other threads we can resolve or record events on. - Capricor's Adcomm: "FDA final regulatory decision on Capricor's deramiocel BLA in DMD cardiomyopathy" (ID: `019faae7-d4d4-7d74-a6b7-85d81f6821f0`). The final decision is expected on or before August 22 (or August 31). The adcomm voted 9-3 against on July 29, 2026. This is a critical regulatory milestone, so I should record an event on it, but *keep the thread open* since it is waiting for the final FDA decision (approval or CRL). Let's record the event on Capricor's thread.

I have recorded the event on Capricor's thread. Let's check if there are other threads. - "FDA final rule on Complete Response Letter public disclosure (RIN 0910-AJ16)" (ID: `019f776d-bb48-7bc5-a4eb-95b8eb646712`). - "FDA traditional approval decision on Novartis's Vanrafia (atrasentan) in IgAN" (ID: `019edcf0-5dc1-74d6-8b2c-b1f669d18326`). - "CARDIO-TTRansform full dataset presentation at ESC Congress 2026" (ID: `019f490e-b47d-7dea-817e-56ffbad19c83`). - "Dianthus CAPTIVATE Part B top-line guidance in CIDP" (ID: `019ed7c8-c4ff-7494-a610-b2f8739d15a3`). - "Dianthus MoMeNtum Phase 2 top-line data in MMN" (ID: `019ed7c8-fd94-77de-9b10-887275ba994c`). None of these have fired yet because their target dates are in the future (August, September, Q4 2026, or 2027). Wait, let's look at the active watch threads and register any new forward-looking watches if we surfaced any. - We have the upcoming PDUFA date for Replimune's RP1 on August 2, 2026. This is a crucial dated catalyst! Let's register a new watch for the FDA's final decision on Replimune's RP1 BLA. Yes, let's register it. It is expected on August 2, 2026. It is a `one_shot` watch. Let's see if there are other forward-looking catalysts we found. - For Australia's H5N1, we are already tracking if it jumps to commercial poultry operations. The current thread tracks transmission to poultry or local wildlife. Since local wildlife has been confirmed, maybe we should keep tracking if it jumps to commercial poultry flocks specifically, which could trigger culls and price hikes. The current thread already tracks that ("Australia H5N1 transmission to poultry or local wildlife"). Let's register a new watch for Replimune's final FDA decision.

I have successfully registered the watch for Replimune's final FDA decision. Let's double-check if there are any other actions or if we can conclude the cycle. - We listed threads. - We updated `replimune-rp1-melanoma-fda-advisory-committee` with the 10-3 vote outcome. - We updated `h5n1-avian-influenza-arrival-new-zealand-australia-poultry-lockdowns` with the local transmission confirmation in Australia, the first cases in Victoria and Queensland, and New Zealand's case in a swamp harrier. - We recorded events on: - Replimune's adcomm thread (and resolved it). - Australia's H5N1 thread (ongoing). - New Zealand's H5N1 thread (ongoing). - Capricor's adcomm/decision thread (ongoing). - We registered a new watch for Replimune's final FDA decision on August 2, 2026. This is a very thorough, comprehensive and grounded research cycle that directly answers the user's brief, focuses on the newest developments, and ensures all findings are accurately saved and tracked. I will now call `finish_cycle` to end the cycle.

I have completed the research cycle. Here is a summary of the findings and actions taken during this cycle: ### 1. Key Findings & Updated Notes * **Replimune's RP1 Endorsed by FDA Advisory Committee (10-3 Vote)**: * **What Happened**: On July 30, 2026, the FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) voted **10 to 3** that the benefit-risk profile of Replimune’s oncolytic immunotherapy **vusolimogene oderparepvec (RP1)** in combination with **Opdivo (nivolumab)** is favorable for adult patients with advanced melanoma refractory to anti-PD-1 therapy. * **Significance**: This is a massive regulatory victory for Replimune, especially after FDA staff released highly critical briefing documents on July 28, 2026, which questioned the interpretability of its single-arm Phase 1/2 IGNYTE trial. The endorsement clears a major pathway ahead of the upcoming **August 2, 2026 PDUFA target action date**. * **Action**: Updated the existing note `replimune-rp1-melanoma-fda-advisory-committee` to document the vote and committee debates. * **H5N1 Avian Influenza Local Transmission Confirmed in Australia**: * **What Happened**: On July 29, 2026, Australia's Agriculture Minister, Julie Collins, officially announced that **local transmission** of the highly pathogenic H5N1 avian influenza (clade 2.3.4.4b) has occurred in native wild birds (specifically greater crested terns in South Australia). Immediately following this, **Victoria** reported its first H5N1 case near Portland, and **Queensland** confirmed its first case on Moreton Island. * **Current Status**: While wild bird infections are spreading across WA, SA, VIC, and QLD, **there remains no detection of H5N1 in Australia's commercial poultry industry or domestic flocks**. However, major poultry producers have initiated strict lockdowns to keep free-range chickens indoors. * **New Zealand**: Reported its second H5N1 case in mid-July in a resident wild swamp harrier, marking the first case in a local resident bird. * **Action**: Updated the existing note `h5n1-avian-influenza-arrival-new-zealand-australia-poultry-lockdowns` with these critical developments. ### 2. Resolved & Monitored Threads * **Resolved**: * *FDA advisory committee meeting on Replimune's RP1 in advanced melanoma* (ID: `019f0620-007b-7dab-87b4-0363a2496ea1`). The committee met on July 30, 2026, and voted 10-3 in favor. * **Recorded Events (Ongoing Monitoring)**: * *Australia H5N1 transmission* (ID: `019f2f50-7f4d-7361-8f05-cdf170c2d727`): Recorded the official confirmation of local transmission in native wild birds and the first detections in Victoria and Queensland. * *New Zealand H5N1 transmission* (ID: `019f776d-f69b-75cf-93b1-ae8e6c95e559`): Recorded the detection in a native wild swamp harrier (first resident bird case). * *Capricor deramiocel FDA decision* (ID: `019faae7-d4d4-7d74-a6b7-85d81f6821f0`): Recorded the CTGTAC advisory committee's 9-3 vote *against* recommending approval on July 29, 2026, ahead of the final FDA decision in late August. * **Registered New Watch**: * *FDA final regulatory decision on Replimune's RP1 BLA in advanced melanoma* (ID: `019fb532-0016-7ab5-8085-425a945b5ccc`): Registered a `one_shot` watch for the FDA's final decision expected on or before the **August 2, 2026 PDUFA date**.