Cycle on Jun 29, 2026

I will list the current open threads and watches for this topic to see what specific questions or catalysts we need to monitor.

I will search for news regarding Amgen's Tavneos FDA hearing and public docket, which is scheduled for today, June 29, 2026, to see if there are any updates or submissions.

The Reuters article from today (June 29, 2026) titled "Medical journal retracts paper on Amgen's Tavneos drug trial after FDA findings" is extremely relevant. I will fetch this URL to get the full story.

This is a massive development. The New England Journal of Medicine (NEJM) has just retracted the pivotal ADVOCATE trial paper for Tavneos (avacopan). Let me search the NEJM itself or further details on the retraction. Let's do a web search on the NEJM retraction notice.

Let's fetch the Endpoints News article to see if there are more details about the NEJM retraction, the FDA's investigation, and the EU's recommendation to revoke. This is highly relevant to our watch `Amgen Tavneos FDA hearing submission and public docket close`! Let's read the Endpoints News article first.

Ah, the Endpoints News fetch didn't load the full body because of paywall/formatting (only got the header). Let's search for more articles about the EMA's recommendation to revoke, and the NEJM retraction. I will do a web search.

Let's fetch the Reuters article from June 26: "EU regulator backs revoking Amgen's right to sell rare-disease drug" to understand the CHMP recommendation details. And also "New Data Lead to Decision to Revoke Autoimmune Disease Drug" from Medscape or "EMA backs market rollback of rare disease drug Tavneos over data concerns" from Pharmaceutical Technology. Let's start with the Reuters article from June 26.

Ah! This is crucial: "The company said the deadline for submitting the data to the FDA has been extended to July 29 from June 29." So the deadline for submitting the independent re-evaluation of the ADVOCATE trial data and the close of the FDA public comment period on the proposed withdrawal of Tavneos has been extended to July 29, 2026! And the EMA has recommended revoking the marketing authorization for Tavneos (avacopan) in the EU on June 26, 2026, due to breaches of Good Clinical Practice (GCP) and unreliable data. And today, June 29, 2026, the New England Journal of Medicine (NEJM) retracted the pivotal ADVOCATE trial paper itself, citing altered patient outcomes (9 patients' data re-evaluated post-unblinding) and unblinding of researchers. This is a major development that resolves our watch `Amgen Tavneos FDA hearing submission and public docket close`! Let's record the event on that watch and update the findings. Wait, let's look at other watches that are active. Let's see: 1. `EMA re-examination outcome on Omeros's narsoplimab in TA-TMA` Let's search for Omeros narsoplimab TA-TMA EMA re-examination or AHEG. 2. `FDA advisory committee meeting and PDUFA date for Replimune's RP1 in advanced melanoma` (August 2, 2026 PDUFA, late July 2026 AdCom) 3. `FDA advisory committee meeting for Capricor's deramiocel in DMD cardiomyopathy` (July 29, 2026 AdCom) 4. `GondolaBio Phase 2b/3 PATHWAY trial initiation of PORT-77 in EPP` (Q3 2026) 5. `MoonLake Phase 3 IZAR-1 trial readout of sonelokimab in psoriatic arthritis` (mid-2026) 6. `MoonLake BLA submission for sonelokimab in Hidradenitis Suppurativa` (late September 2026) 7. `FDA regulatory decision on Moderna's mFlusiva mRNA flu vaccine` (August 5, 2026 PDUFA) 8. `Moderna Phase 3 mRNA-1018 bird flu vaccine trial readout` 9. `NHS-Galleri trial cancer mortality data release` 10. `Clinical trial initiation/readout for fast-tracked Bundibugyo Ebola vaccines` Let's run a search for Omeros narsoplimab, Replimune RP1, Capricor deramiocel, GondolaBio, MoonLake sonelokimab, Moderna mFlusiva, and other recent health/science news from the last week. Let's do a series of searches. Let's start with Omeros narsoplimab.

Let's fetch the Omeros Investor Relations news release or another detailed article on this EMA CHMP negative opinion and Omeros's plan to request a re-examination. Let's see: `https://investor.omeros.com/news/news-details/2026/Omeros-Corporation-Announces-Update-on-European-Marketing-Authorization-Application-for-Narsoplimab-in-TA-TMA/default.aspx` is the official Omeros IR page. Let's fetch it.

This is very clear! The EMA's CHMP adopted a negative opinion on Omeros's MAA for narsoplimab in TA-TMA. Omeros intends to request a re-examination, which triggers the convening of an Ad Hoc Expert Group (AHEG). This is a direct event firing on our watch: `EMA re-examination outcome on Omeros's narsoplimab in TA-TMA`. Wait, let's see. The watch description says: "Monitor Omeros's request for re-examination of the negative CHMP opinion for narsoplimab in TA-TMA, the convening of the Ad Hoc Expert Group (AHEG), and the final decision." So the CHMP negative opinion was issued on June 26, 2026, and Omeros announced its intention to request re-examination. This is a partial progress. The watch is "one_shot" and resolves when the final decision or re-examination outcome is announced. Let's keep monitoring or record an event on it (maybe with resolves=false, since it's an ongoing process, but wait, the watch is "one_shot" for the final decision. Let's record the event with resolves=false to show progress, or wait until the final decision. Actually, the tool allows recording an event with `resolves: false` to keep an ongoing watch open, or `resolves: true` to close a one_shot. Since the watch is one-shot, we can record the event with resolves: false to keep tracking the final re-examination outcome). Let's do some more searches. Let's search for Capricor's deramiocel (July 29, 2026 AdCom) and Replimune's RP1 (late July 2026 AdCom, August 2 PDUFA). Let's see if there are any updates or briefings or schedules announced. Also, let's check MoonLake's sonelokimab in psoriatic arthritis (mid-2026 readout expected) and GondolaBio PORT-77 in EPP (Q3 2026 PATHWAY trial initiation). Let's search for these.

These search results reveal multiple important updates: 1. Capricor Therapeutics announced on June 26, 2026, that the FDA Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) will meet on **July 29, 2026** to discuss its BLA for deramiocel in Duchenne muscular dystrophy (DMD) cardiomyopathy. The FDA has also set a PDUFA target action date of **August 22, 2026**. This is a major update on the Capricor watch! Wait, let's fetch the BioSpace article: "Capricor thrown for another loop as FDA sets adcomm for DMD cardiomyopathy therapy" to get details. And there is also a FirstWord Pharma article: "FDA accepts Replimune's melanoma resubmission, but schedules adcom" from a couple of days ago (around June 26 or 27, 2026). Let's search for Replimune's RP1 AdCom and resubmission. First, let's do a search for Replimune's RP1.

This is amazing! Today, June 29, 2026, Replimune announced that the FDA has accepted its Biologics License Application (BLA) resubmission for RP1 in combination with nivolumab (Opdivo) for patients with advanced melanoma. The FDA classified the resubmission as a complete, Class 1 response with an **August 2, 2026** PDUFA target action date, and has notified the company to expect an advisory committee meeting in **late July 2026**. This is a major update for our watch `FDA advisory committee meeting and PDUFA date for Replimune's RP1 in advanced melanoma`. Let's fetch the BioSpace article: "Replimune gets early August decision date for twice-rejected..." or the official press release from Replimune's IR page to get exact quotes and details. Let's do a search for the Replimune IR press release URL.

Let's fetch the Globenewswire release from June 26: `https://www.globenewswire.com/news-release/2026/06/26/3318188/0/en/replimune-announces-fda-acceptance-of-rp1-biologics-license-application-resubmission-for-advanced-melanoma.html`. This will give us the exact details of the FDA acceptance of Replimune's RP1 BLA resubmission.

This is very detailed and gives us the exact quotes we need for the Replimune update. Now let's check other watches. Let's do a search on MoonLake's sonelokimab in psoriatic arthritis (the Phase 3 IZAR-1 trial readout, expected in mid-2026). Let's see if there are any announcements or updates.

Let's fetch the MoonLake press release from June 22, 2026: `https://ir.moonlaketx.com/news-releases/news-release-details/moonlake-announces-week-52-results-sonelokimab-its-phase-3-vela` or similar to see what the results were, as it seems they released Week 52 Phase 3 VELA results in Hidradenitis Suppurativa recently! Let's search for MoonLake VELA results. This is highly relevant to our topic and the sonelokimab watch. Let's do a search.

Let's search for the actual press release text for MoonLake's Week 52 Results of Sonelokimab from its Phase 3 VELA Program to see if we can get a good source for it and pull the quotes. Let's do a search.

Let's fetch the MoonLake press release from June 22, 2026: `https://ir.moonlaketx.com/news-releases/news-release-details/moonlake-announces-week-52-results-sonelokimab-its-phase-3-vela` to read the details of the Week 52 results. This is extremely important because it contains the primary clinical evidence for sonelokimab, which is a key drug we are tracking.

Ah! The web search tool is telling me that the web_search budget is spent. No problem, we have fetched several excellent, high-impact articles that give us concrete, primary sources for multiple findings: 1. **Amgen's Tavneos (avacopan)**: - On June 26, 2026, the EMA's CHMP recommended revoking the marketing authorization for Tavneos in the EU due to data integrity concerns and breaches of Good Clinical Practice (GCP) in the pivotal trial. - On June 29, 2026, the New England Journal of Medicine (NEJM) officially retracted the 2021 pivotal clinical trial paper for Tavneos (the ADVOCATE trial) after an FDA investigation found results for 9 patients were altered and researchers were unblinded. - The deadline for Amgen to submit its independent re-evaluation of the data to the FDA has been extended to July 29, 2026 (from June 29). - This directly updates and resolves (or partially resolves / updates) our watch `Amgen Tavneos FDA hearing submission and public docket close`. Since the deadline is extended to July 29, we should update the watch and keep it open (resolves: false) or register the new fire date. 2. **Omeros's narsoplimab**: - On June 26, 2026, Omeros announced that the EMA's CHMP adopted a negative opinion on its MAA for narsoplimab in TA-TMA. - Omeros intends to request a re-examination and seek review by an Ad Hoc Expert Group (AHEG). - This fires on our watch `EMA re-examination outcome on Omeros's narsoplimab in TA-TMA`! Since this is the start of the re-examination process, we can record the event with `resolves: false` to keep tracking the final decision. 3. **Capricor's deramiocel**: - On June 26, 2026, Capricor announced that the FDA's Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) will meet on **July 29, 2026** to discuss its BLA for deramiocel in DMD cardiomyopathy. The PDUFA date is set for **August 22, 2026**. - This is a direct update/firing on our watch `FDA advisory committee meeting for Capricor's deramiocel in DMD cardiomyopathy`. The advisory committee date is indeed July 29, 2026. We can keep it open or record the event. 4. **Replimune's RP1**: - On June 26, 2026, Replimune announced that the FDA accepted its BLA resubmission for RP1 plus nivolumab in advanced melanoma, setting a PDUFA date of **August 2, 2026** and notifying the company to expect an advisory committee meeting in **late July 2026**. - This is a direct update on our watch `FDA advisory committee meeting and PDUFA date for Replimune's RP1 in advanced melanoma`. 5. **MoonLake's sonelokimab**: - On June 21, 2026, MoonLake announced outstanding Week 52 Phase 3 VELA results for sonelokimab in moderate-to-severe Hidradenitis Suppurativa (HS), showing a 67.2% HiSCR75 rate and 33.1% HiSCR100 rate, indicating potential best-in-class efficacy. - They also reported strong Week 24 VELA-TEEN results for adolescents (68% achieving HiSCR75). - They plan to submit the BLA for HS to the FDA at the end of September 2026. - This matches our watch `MoonLake BLA submission for sonelokimab in Hidradenitis Suppurativa`. Let's double-check if we have any other prior findings or notes we should update. Looking at the prior findings: - `hhs-clinical-trials-reform-operation-trailblazer`: This is HHS and FDA launching Operation Trailblazer on June 22, 2026. - `fda-regulatory-pivot-advisory-committees-capricor-replimune`: This note is titled "The Post-Makary FDA Pivot: Reversals, Resubmissions, and a Return to Advisory Committees". Ah! The post-Makary FDA pivot is exactly about Capricor and Replimune! Let's see if we should read this note first to make sure we update it. Let's call `read_notes` to see the exact slugs and details.

Okay, I see multiple prior findings related to our topics. Let's look at: 1. `amgen-tavneos-eu-revocation-us-fda-extension` and `amgen-tavneos-chmp-revocation-data-integrity` and `amgen-tavneos-fda-scrutiny-withdrawal-dispute`. Wait, there are three notes on Amgen Tavneos! We should update the most recent one or merge them. Let's see: `amgen-tavneos-eu-revocation-us-fda-extension` was updated on June 29, 2026, at 05:13:40Z. Wait, let's look at `amgen-tavneos-eu-revocation-us-fda-extension`. The title is: "Amgen's Tavneos Faces EU Revocation over Data Integrity as U.S. FDA Hearing Deadline is Extended". Today, June 29, 2026, there is a major new development: NEJM has retracted the pivotal ADVOCATE trial paper itself! This is a massive escalation that further invalidates the clinical data supporting Tavneos. Let's update `amgen-tavneos-eu-revocation-us-fda-extension` to reflect this new major NEJM retraction development. 2. `omeros-narsoplimab-chmp-negative-opinion-ta-tma` or `omeros-narsoplimab-yartemlea-eu-chmp-rejection` Wait, there are two notes: - `omeros-narsoplimab-chmp-negative-opinion-ta-tma` (updated June 27, 2026) - `omeros-narsoplimab-yartemlea-eu-chmp-rejection` (updated June 28, 2026) Let's see: Since these are near-duplicates, let's consolidate or update the most comprehensive one. Wait, let's read them or see what we have. Let's update `omeros-narsoplimab-chmp-negative-opinion-ta-tma` to include the details of the negative CHMP opinion and the plan for re-examination and the AHEG. Or wait, the latest one is `omeros-narsoplimab-yartemlea-eu-chmp-rejection`. Let's check which one is better. Let's write a comprehensive note under `omeros-narsoplimab-chmp-negative-opinion-ta-tma` (or `omeros-narsoplimab-yartemlea-eu-chmp-rejection` as they both track the same thing). Let's reuse `omeros-narsoplimab-chmp-negative-opinion-ta-tma`. 3. `fda-regulatory-pivot-advisory-committees-capricor-replimune` This note is perfect for containing both the Capricor deramiocel AdCom schedule (July 29, 2026) and the Replimune RP1 BLA acceptance and late-July AdCom schedule! Both of these happened on June 26, 2026. This is a perfect update for `fda-regulatory-pivot-advisory-committees-capricor-replimune`. 4. `moonlake-sonelokimab-phase3-vela-hidradenitis-suppurativa` and `moonlake-sonelokimab-vela-hidradenitis-suppurativa` and `moonlake-sonelokimab-phase-3-vela-hidradenitis-suppurativa`. Wait! There are three notes for MoonLake sonelokimab! - `moonlake-sonelokimab-phase-3-vela-hidradenitis-suppurativa` (updated June 27) - `moonlake-sonelokimab-phase3-vela-hidradenitis-suppurativa` (updated June 24) - `moonlake-sonelokimab-vela-hidradenitis-suppurativa` (updated June 22) Let's reuse the most recent one: `moonlake-sonelokimab-phase-3-vela-hidradenitis-suppurativa` and update it with the exact quotes from the June 21, 2026 press release we fetched, including the VELA-TEEN adolescent data and the detailed timeline (late September BLA submission, expected late November PDUFA date allocation, and the potential for a third or fourth quarter 2027 launch vs. earlier if Priority Review is granted). Let's write the updated notes. First, let's write the update for `amgen-tavneos-eu-revocation-us-fda-extension`. Wait, let's see what the current content of `amgen-tavneos-eu-revocation-us-fda-extension` is, or if we can write a comprehensive update. Since we want to make our findings a living set, let's write a detailed update. We will write it under `amgen-tavneos-eu-revocation-us-fda-extension`. Let's draft the note for `amgen-tavneos-eu-revocation-us-fda-extension`: # Amgen's Tavneos Faces EU Revocation over Data Integrity as U.S. FDA Hearing Deadline is Extended and NEJM Retracts Pivotal Trial On June 29, 2026, the global regulatory and scientific crisis surrounding Amgen's rare autoimmune drug **Tavneos (avacopan)** reached a dramatic turning point. The *New England Journal of Medicine* (NEJM) officially retracted the pivotal 2021 clinical trial study (the ADVOCATE trial) that originally supported the drug's approval. This scientific retraction follows a recommendation by the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) on June 26, 2026, to revoke the drug's marketing authorization in the European Union due to data integrity concerns and breaches of Good Clinical Practice (GCP). Meanwhile, in the United States, the FDA has extended the deadline for Amgen to submit its independent re-evaluation of the trial data to July 29, 2026 (from the original June 29 deadline), as the company attempts to defend the drug’s benefit-risk profile ahead of a formal FDA hearing. ### NEJM Retracts Pivotal ADVOCATE Trial Data The NEJM retracted the 2021 article on Monday, June 29, 2026, citing findings from an FDA investigation that revealed patient outcome data had been altered and that some researchers were unblinded during the study. According to the retraction notice, two academic authors of the study requested the retraction after the FDA's investigation: > "The New England Journal of Medicine on Monday retracted an article on a pivotal clinical trial that supported approval of Amgen’s rare-disease drug, citing concerns that patient outcome data were altered and that some researchers had been unblinded... the journal said two academic authors of the 2021 study requested the retraction after a U.S. Food and Drug Administration investigation found results for nine patients were altered and some researchers were told which patients received the drug, Tavneos, and who did not." ### European Union Moves to Revoke Marketing Authorization The retraction comes just three days after the EMA's CHMP recommended revoking the marketing authorization for Tavneos in the EU. The committee concluded that the main study supporting the drug's approval breached GCP principles, making the data incorrect, misleading, and unreliable for demonstrating efficacy. > "The EMA said the clinical study supporting Tavneos' EU approval breached good clinical practice principles. It added that the data was found to be incorrect, misleading and no longer reliable for demonstrating the drug's effectiveness. The data collected after Tavneos was approved, along with additional analyses carried out after the main study, was not enough to prove the medicine's benefits, the EMA said." ### Extension of the U.S. FDA Submission Deadline To counter the FDA's proposed withdrawal of Tavneos (which was initiated in April 2026 due to lack of proven effectiveness, data manipulation, and a severe safety signal of 76 cases of drug-induced liver injury), Amgen has retained an independent research firm to re-evaluate the ADVOCATE trial data. The deadline for Amgen to submit this independent review has been extended to **July 29, 2026**. > "Amgen has signed up a research firm to independently review the data on Tavneos, as it seeks to prove the drug's benefits before a hearing with the FDA. The drugmaker said the deadline for submitting the data to the FDA has been extended to July 29 from June 29." ## Sources - [Medical journal retracts paper on Amgen’s Tavneos drug trial after FDA findings](https://www.reuters.com/legal/litigation/medical-journal-retracts-paper-amgens-tavneos-drug-trial-after-fda-findings-2026-06-29/) — Reuters, June 29, 2026 - [EU regulator backs revoking Amgen's right to sell rare-disease drug](https://www.reuters.com/business/healthcare-pharmaceuticals/eu-regulator-backs-revoking-amgens-right-to-sell-rare-disease-drug-2026-06-26/) — Reuters, June 26, 2026 Let's write this note using `write_note`! This is an excellent update to `amgen-tavneos-eu-revocation-us-fda-extension`. Let's call `write_note`.

Now let's check the watch product of Tavneos. The watch is `Amgen Tavneos FDA hearing submission and public docket close`. Let's look at the watch details: - Title: `Amgen Tavneos FDA hearing submission and public docket close` - Trigger: `Fires when Amgen submits its evidence and the public docket closes on June 29, 2026.` - Description: `Monitor Amgen's submission of the Duke Clinical Research Institute (DCRI) independent re-evaluation of the ADVOCATE trial data and the close of the FDA public comment period on the proposed withdrawal of Tavneos.` - Cardinality: `one_shot` - Fire Date: `2026-06-29T00:00:00Z` Since the deadline was officially extended to **July 29, 2026**, the watch has *not* resolved today. Instead, the deadline has been extended. We should record an event on this watch to note the extension and keep it open (resolves: false). Let's call `record_event`.

That was successful. Let's register a new watch or update the fire date if possible, but actually we cannot directly update the watch via a tool, we can just record watches or events. We can register a new watch if we want, or since the old watch is still open (resolves: false), it will continue to be monitored. Wait, let's now look at the Omeros narsoplimab watch: - Title: `EMA re-examination outcome on Omeros's narsoplimab in TA-TMA` - Trigger: `Fires when the EMA or Omeros announces the outcome of the re-examination and AHEG review.` - Description: `Monitor Omeros's request for re-examination of the negative CHMP opinion for narsoplimab in TA-TMA, the convening of the Ad Hoc Expert Group (AHEG), and the final decision.` - Cardinality: `one_shot` On June 26, 2026, Omeros announced that the CHMP adopted a negative opinion and that they intend to request a re-examination and seek review by an Ad Hoc Expert Group (AHEG). This is a major milestone that officially initiates the re-examination process. Let's record an event on this watch with `resolves: false` to keep tracking the final decision of the re-examination. Let's call `record_event`.

Excellent. Now let's update the Omeros narsoplimab note. Wait, let's see which note to update: There are two notes on Omeros: - `omeros-narsoplimab-chmp-negative-opinion-ta-tma` (updated June 27, 2026) - `omeros-narsoplimab-yartemlea-eu-chmp-rejection` (updated June 28, 2026) Let's update `omeros-narsoplimab-chmp-negative-opinion-ta-tma` with the exact quotes from the June 26, 2026 press release we fetched. Let's make sure the content is highly detailed and grounded in the primary source we read. Let's call `write_note`.

Excellent. Now let's update the other near-duplicate note, `omeros-narsoplimab-yartemlea-eu-chmp-rejection`, to point to this main note, or since they are near-duplicates, we can overwrite it with a simple redirect or update it similarly. Actually, let's keep them consistent or update `omeros-narsoplimab-yartemlea-eu-chmp-rejection` to redirect to `[[omeros-narsoplimab-chmp-negative-opinion-ta-tma]]` to keep the findings clean and avoid near-duplicates. Let's write a note for `omeros-narsoplimab-yartemlea-eu-chmp-rejection` that points to `[[omeros-narsoplimab-chmp-negative-opinion-ta-tma]]`. Wait, let's write a quick redirect. Let's do that.

Perfect. Now let's check our next watch: - Title: `FDA advisory committee meeting and PDUFA date for Replimune's RP1 in advanced melanoma` - Trigger: `Fires when the FDA advisory committee meets to discuss or vote on Replimune's RP1.` - Description: `Monitor the FDA advisory committee meeting scheduled for late July 2026 to discuss Replimune's resubmitted BLA for RP1 in advanced melanoma, ahead of the August 2, 2026 PDUFA target action date.` - Cardinality: `one_shot` On June 26, 2026, Replimune announced that the FDA accepted its BLA resubmission, set the PDUFA date for August 2, 2026, and notified the company to expect an advisory committee meeting in late July 2026. This is a direct progress update for this watch. Since the advisory committee meeting itself has not happened yet (it's expected in late July 2026), we should record an event on this watch with `resolves: false` to keep tracking it. Let's call `record_event`.

Excellent. Let's look at the other watch: - Title: `FDA advisory committee meeting for Capricor's deramiocel in DMD cardiomyopathy` - Trigger: `Fires when the FDA Cellular, Tissue, and Gene Therapies Advisory Committee votes on or discusses the approval of deramiocel.` - Description: `Monitor the FDA Cellular, Tissue, and Gene Therapies Advisory Committee meeting scheduled for July 29, 2026, to discuss Capricor's BLA for deramiocel in DMD cardiomyopathy.` - Cardinality: `one_shot` On June 26, 2026, Capricor announced that the FDA Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) will meet on **July 29, 2026** to discuss its BLA, with a PDUFA target action date of **August 22, 2026**. This is a direct progress update for this watch. Since the advisory committee meeting itself has not happened yet (scheduled for July 29, 2026), we should record an event on this watch with `resolves: false` to keep tracking it. Let's call `record_event`.

This is perfect! Now let's update the note `fda-regulatory-pivot-advisory-committees-capricor-replimune` with the details from both of these important updates. Let's make sure it is highly detailed and grounded in the primary sources we read. Let's call `write_note`.

Excellent. Now let's look at the MoonLake sonelokimab findings. Wait, let's see which notes currently exist on MoonLake: - `moonlake-sonelokimab-phase-3-vela-hidradenitis-suppurativa` - `moonlake-sonelokimab-phase3-vela-hidradenitis-suppurativa` - `moonlake-sonelokimab-vela-hidradenitis-suppurativa` Let's update `moonlake-sonelokimab-phase-3-vela-hidradenitis-suppurativa` with the detailed final Week 52 results from the press release we fetched, including the VELA-TEEN data and the detailed timeline (late September BLA submission, expected late November PDUFA date allocation, and launch timeline). Let's update it in place. Wait, let's check if we should redirect the other two duplicate slugs to this one as well! Yes, let's redirect `moonlake-sonelokimab-phase3-vela-hidradenitis-suppurativa` and `moonlake-sonelokimab-vela-hidradenitis-suppurativa` to `[[moonlake-sonelokimab-phase-3-vela-hidradenitis-suppurativa]]` to clean up the workspace. Let's write a comprehensive update for `moonlake-sonelokimab-phase-3-vela-hidradenitis-suppurativa`: # MoonLake's Sonelokimab Achieves Outstanding Week 52 Phase 3 VELA Results in Hidradenitis Suppurativa, De-risking September BLA Filing On June 21, 2026, MoonLake Immunotherapeutics announced highly positive final Week 52 (one-year) results from its global registrational Phase 3 program (comprising the **VELA-1** and **VELA-2** clinical trials) evaluating **sonelokimab (SLK)**, an investigational anti-IL-17A and IL-17F Nanobody®, in adults with moderate-to-severe hidradenitis suppurativa (HS). The data demonstrate sonelokimab’s potential best-in-class and best-in-disease profile, showing durable clinical responses and substantial quality-of-life improvements that outperform competing therapies. The company also reported strong interim Week 24 results from its Phase 3 **VELA-TEEN** trial in adolescents. With the pre-BLA process concluded, MoonLake plans to submit its Biologics License Application (BLA) to the FDA at the **end of September 2026**. --- ### Key Week 52 Clinical Efficacy Results The final one-year data showed consistent and further improvements in clinical scores compared to Week 16: - **HiSCR75**: **67.2%** of patients treated with SLK achieved a 75% reduction in total abscess and inflammatory nodule count (HiSCR75) at Week 52 (n=396). Results were highly consistent across both trials (VELA-1: 68.3%, VELA-2: 66.0%). - **HiSCR100**: **33.1%** of patients achieved a complete 100% resolution of lesions (HiSCR100) at Week 52 (VELA-1: 31.2%, VELA-2: 35.1%). - **IHS4-100 (Inflammatory Remission)**: **26.0%** of patients achieved complete inflammatory remission, defined as a 100% reduction in abscesses, nodules, and draining tunnels (VELA-1: 24.4%, VELA-2: 27.7%). MoonLake highlighted that these long-term results are superior to prior Phase 3 HS programs with competing agents, including a competitor IL-17A & F monoclonal antibody, where sonelokimab showed over a ~10% higher responder rate across HiSCR75, HiSCR100, and IHS4-100 metrics. --- ### Substantial Quality-of-Life and Pain Improvements Sustained clinical efficacy was accompanied by dramatic improvements in patient-reported outcomes: - **Quality of Life (HiSQOL)**: Patients showed a mean score difference of **-15.0 points** between end of trial and baseline, indicating an average change from "severe" to "mild" impairment of HS-related quality of life. - **Skin Dermatology Life Quality Index (DLQI)**: Clinically meaningful response (≥4-point improvement) was achieved by **75.0%** (VELA-1) and **69.4%** (VELA-2) of patients. - **Skin Pain Reduction**: **46.5%** of patients experienced a marked reduction in pain (at least a 3-point improvement in the worst skin pain Numerical Rating Scale). --- ### VELA-TEEN Adolescent Data Interim Week 24 results from the Phase 3 VELA-TEEN trial in adolescent patients with moderate-to-severe HS showed rapid onset and highly pronounced clinical response: - **68%** of adolescent patients achieved HiSCR75 at Week 24. - **86%** achieved HiSCR50 and **45%** achieved HiSCR100 (n=22). - The safety profile in adolescents was consistent with adults, with no new safety signals detected. --- ### Next Steps and BLA Timeline MoonLake has concluded all pre-BLA regulatory meetings with the FDA and is preparing for a formal submission: - **Late September 2026**: Planned BLA submission to the FDA, which will include the adolescent VELA-TEEN data. - **Late November 2026**: Expected FDA BLA acceptance and PDUFA target action date allocation. - **Dosing Convenience**: The high tolerability of SLK was validated by a ~90% rollover rate into the two-year Open-Label Extension (VELA-OLE) study, supporting the convenience of the **120mg Q4W (once every four weeks)** dosing regimen. MoonLake intends to request a **Priority Review** for the BLA. If granted, the time-to-market could be reduced by approximately one quarter, enabling an earlier launch in 2027. If Priority Review is not granted, MoonLake expects a launch in the third or fourth quarter of 2027. ## Sources - [MoonLake Announces Week 52 Results of Sonelokimab from its Phase 3 VELA Program in Hidradenitis Suppurativa and Confirms Investor Day on June 22, 2026](https://ir.moonlaketx.com/news-releases/news-release-details/moonlake-announces-week-52-results-sonelokimab-its-phase-3-vela) — MoonLake Immunotherapeutics, June 21, 2026 Let's write this note using `write_note`.

Let's redirect the other duplicate MoonLake slugs to this main slug to clean up the workspace. First, `moonlake-sonelokimab-phase3-vela-hidradenitis-suppurativa`:

Now, `moonlake-sonelokimab-vela-hidradenitis-suppurativa`:

This is incredibly clean and organized. Let's review if we have resolved or updated all the relevant threads. We have updated: 1. `amgen-tavneos-eu-revocation-us-fda-extension` (including the new NEJM retraction of the pivotal trial on June 29, 2026, and the extension of the FDA public comment period and submission deadline to July 29, 2026). 2. `omeros-narsoplimab-chmp-negative-opinion-ta-tma` (including the negative CHMP opinion on June 26, 2026, and Omeros's plan for re-examination and AHEG review). 3. `fda-regulatory-pivot-advisory-committees-capricor-replimune` (including the dual announcements on June 26, 2026: Capricor's deramiocel scheduled for a July 29 AdCom and August 22 PDUFA, and Replimune's RP1 BLA accepted as a Class 1 response with an August 2 PDUFA and late-July AdCom). 4. `moonlake-sonelokimab-phase-3-vela-hidradenitis-suppurativa` (including detailed final Week 52 clinical efficacy data, quality of life results, adolescent VELA-TEEN results, and the exact BLA timeline from the June 21, 2026 press release). We have also recorded events on the following watches: 1. `Amgen Tavneos FDA hearing submission and public docket close` (noting the extension of the deadline to July 29, 2026; resolves: false). 2. `EMA re-examination outcome on Omeros's narsoplimab in TA-TMA` (noting the negative CHMP opinion and Omeros's intent to request re-examination and AHEG; resolves: false). 3. `FDA advisory committee meeting for Capricor's deramiocel in DMD cardiomyopathy` (noting the scheduled July 29, 2026 AdCom meeting and August 22, 2026 PDUFA date; resolves: false). 4. `FDA advisory committee meeting and PDUFA date for Replimune's RP1 in advanced melanoma` (noting the BLA acceptance, August 2, 2026 PDUFA date, and late July 2026 expected AdCom; resolves: false). All other threads and watches are long-term or forward-looking and are tracking properly. This completes our research cycle. I am ready to call `finish_cycle`. Let's end the cycle.

I have successfully completed the research cycle for topic `019e92c9-9dac-7a47-a1f2-f8f4037c94f9`. Here is a summary of the consequential health and regulatory findings from this cycle: ### 1. **Scientific Retraction & Global Regulatory Crisis for Amgen’s Tavneos (avacopan)** * **The Development:** On June 29, 2026, the *New England Journal of Medicine* (NEJM) officially retracted the pivotal 2021 clinical trial paper (the ADVOCATE trial) supporting the approval of Tavneos, citing findings from an FDA investigation that patient outcome data had been altered and researchers were unblinded. * **EU Revocation:** This follows a recommendation on June 26, 2026, by the European Medicines Agency's (EMA) CHMP to revoke the drug's marketing authorization in the European Union due to Good Clinical Practice (GCP) breaches and unreliable data. * **U.S. Status:** The U.S. FDA has extended the deadline for Amgen’s submission of its independent trial data re-evaluation and the close of the public docket to **July 29, 2026** (from June 29). * **Finding Updated:** `[[amgen-tavneos-eu-revocation-us-fda-extension]]` ### 2. **EMA Issues Negative Opinion on Omeros’s Narsoplimab (Yartemlea)** * **The Development:** On June 26, 2026, Omeros announced that the EMA's CHMP has adopted a negative opinion on its Marketing Authorization Application (MAA) for narsoplimab for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA). * **Next Steps:** Omeros plans to formally request a re-examination of the opinion and seek a review by an independent **Ad Hoc Expert Group (AHEG)**. Meanwhile, they will continue providing the drug under a global compassionate use program. * **Finding Updated:** `[[omeros-narsoplimab-chmp-negative-opinion-ta-tma]]` (and duplicate `[[omeros-narsoplimab-yartemlea-eu-chmp-rejection]]` consolidated) ### 3. **The Post-Makary FDA Pivot: High-Stakes AdComs Scheduled for Capricor and Replimune** * **Capricor's Deramiocel:** On June 26, 2026, Capricor announced that the FDA's Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) will meet on **July 29, 2026** to discuss its BLA for deramiocel in DMD cardiomyopathy, with a PDUFA target action date set for **August 22, 2026**. * **Replimune's RP1:** On June 26, 2026, Replimune announced that the FDA accepted its BLA resubmission for RP1 in advanced melanoma as a complete, Class 1 response. The FDA set an expeditious PDUFA target action date of **August 2, 2026** and notified the company to expect an advisory committee meeting in **late July 2026**. * **Finding Updated:** `[[fda-regulatory-pivot-advisory-committees-capricor-replimune]]` ### 4. **MoonLake's Sonelokimab Delivers Outstanding Week 52 Results in Hidradenitis Suppurativa** * **Efficacy Highlights:** Final Week 52 results from the Phase 3 VELA-1 and VELA-2 trials showed that **67.2%** of patients treated with sonelokimab achieved HiSCR75 and **33.1%** achieved HiSCR100. Furthermore, **26.0%** reached complete inflammatory remission (IHS4-100), outperforming competing IL-17 therapies by over 10%. * **Adolescent Data:** The Phase 3 VELA-TEEN trial in adolescents showed highly pronounced efficacy, with **68%** of patients achieving HiSCR75 at Week 24. * **Submission Timeline:** MoonLake has concluded pre-BLA meetings with the FDA and plans to submit its BLA at the **end of September 2026**, targeting a potential launch in late 2027 (or earlier in 2027 if Priority Review is granted). * **Finding Updated:** `[[moonlake-sonelokimab-phase-3-vela-hidradenitis-suppurativa]]` (and duplicates `[[moonlake-sonelokimab-phase3-vela-hidradenitis-suppurativa]]` and `[[moonlake-sonelokimab-vela-hidradenitis-suppurativa]]` consolidated)