Cycle on Jul 19, 2026

I will start by listing the topic's open threads to see if there are any active investigations, questions, or watches that need attention.

I will search for recent news surrounding the FDA advisory committee meetings and regulatory actions scheduled for late July 2026, specifically looking at Capricor's deramiocel, Replimune's RP1, Saol's SL1009, and Amgen's Tavneos hearing.

The BioCentury article "Peptides, RP1 advisory committees will test FDA's credibility" and the STAT News article "Under a new leader, the FDA’s biologics center moves to steady itself after stormy chapter" look incredibly relevant. Let's fetch them to see what has changed with the FDA leadership (acting director Karim Mikhail of CBER?) and these upcoming advisory committees. This directly links to the prior finding `fda-regulatory-pivot-advisory-committees-capricor-replimune`. Let's fetch these two URLs first.

The STAT News article got truncated, but we got the title, author, date (July 15, 2026), and some introductory text. Let's search for more of this story or search for "Karim Mikhail" and "Vinay Prasad" to understand what happened at CBER, the FDA, and how it impacts the upcoming advisory committees (Capricor, Replimune, etc.). Let's do a search on BioCentury's article too, or search for details of the BioCentury article.

Let's search for "Karim Mikhail" "Vinay Prasad" STAT to fetch more content, or search specifically for details on why Vinay Prasad left or what Karim Mikhail is doing differently. Let's do a search on Bluesky or other sources to get a better summary of STAT's article or BioCentury's article. Or let's see if we can fetch the Bluesky post or Endpoints News "New FDA leadership strikes conciliatory note on rare diseases, staff morale". Let's fetch that Endpoints News article. It is from about 3 weeks ago (around late June/early July). Let's search for it.

Let's fetch the Endpoints News article. It is highly relevant to understanding the shift in CBER/FDA leadership, staff morale, and how they are handling rare diseases and rebuilding the workforce after the DOGE cuts. This provides essential context for the "Post-Makary FDA Pivot" and advisory committees. Let's do a fetch.

Ah, the Endpoints article is also truncated. Let's do a search for the text inside this article or details on the "rebuilding plan" and "rare disease framework" to get more specific information. Let's search for "Karim Mikhail" "Lowell Zeta" "Michael Davis" "BIO" to see what was discussed. Let's do a search.

Let's fetch the BioSpace and GEN articles to get the exact quotes. First, let's fetch BioSpace: "FDA hiring 2,200 people to staff up after last year's DOGE cuts". Then let's fetch GEN: "BIO 2026: FDA Leadership Confront Workforce Losses, China Competition in Drug Development". This will give us concrete evidence. Let's do that.

This is fantastic! Let's check the other threads. Is there any news on: 1. Capricor's deramiocel advisory committee (scheduled for July 29, 2026)? Let's search for "Capricor" OR "deramiocel" "July 29, 2026" or "advisory committee" "adcom". 2. Replimune's RP1 advisory committee (scheduled for late July 2026)? Let's search for "Replimune" OR "RP1" advisory committee. 3. Saol Therapeutics' NDA resubmission for SL1009 (DCA) in PDCD (expected late July 2026)? 4. Amgen's Tavneos FDA hearing submission extended deadline (July 29, 2026)? 5. H5N1 bird flu transmission to poultry or wildlife in New Zealand or Australia? Let's do a search on Capricor and Replimune first. Let's find out what the latest is on their upcoming advisory committees and their drugs. Let's do a search.

Wait, look at this: "Capricor Launches Legal Fight Over DMD Therapy Rollout Ahead Of FDA Review" and "CAPR Stock Gains Steam: Former Capricor Exec Could Become FDA's Top Gene Therapy Regulator Ahead Of High-Stakes DMD Decision". Let's search for "Capricor" "lawsuit" OR "legal" OR "former Capricor exec" FDA to understand what is going on here. This is extremely fresh and interesting. Let's run a search.

Ah, let's search specifically for the lawsuit between Capricor and Nippon Shinyaku. It seems Capricor filed a lawsuit or rescission filing against Nippon Shinyaku / NS Pharma. Let's do a search on Google for `"Capricor" "Nippon Shinyaku"` or `"Capricor" "NS Pharma" lawsuit`. Let's see what is going on. This is a crucial business/policy angle.

Very interesting! Capricor sued Nippon Shinyaku / NS Pharma because they failed to prepare for the commercial rollout of Deramiocel and refused to fix pricing flaws in the commercialization agreement. Let's search for "Capricor sues Nippon Shinyaku" or "Capricor sues NS Pharma" on Endpoints News or other biopharma news sites to get the full story. This is a very recent and important update! Let's do a search.

Let's search for "Capricor sues Nippon Shinyaku over Duchenne drug" to find the exact article on Endpoints News. Let's do a search.

Let's fetch the STAT News article: "Capricor Therapeutics accuses Nippon Shinyaku of slow-walking plans on Duchenne drug" from May 8, 2026. This will give us the details of the lawsuit which was filed in May 2026 and is ongoing as of July 2026. Let's do a fetch.

Very interesting! The lawsuit claims there's a "fatal flaw" in the pricing formula of the exclusive distribution agreement that ties Medicare reimbursement to the price Capricor charges NS Pharma. This makes it "economically impracticable" to reach patients, causing healthcare providers to get reimbursed less than they pay to acquire/administer deramiocel. Let's see if we can find more about how this is developing. Capricor filed a rescission filing against Nippon Shinyaku / NS Pharma, and is seeking court approval to pursue an alternative commercialization path and terminate parts of the agreement. Wait, let's look at the other scheduled events: Is there any news on: 1. Replimune's RP1 FDA advisory committee meeting and PDUFA date of August 2, 2026? Let's search for "Replimune" OR "RP1" OR "Woburn" in July 2026. 2. Saol's SL1009 (DCA) in PDCD NDA resubmission acceptance and PDUFA date? Let's search for "Saol" OR "SL1009" OR "pyruvate dehydrogenase" "July 2026" OR "NDA". 3. Amgen's Tavneos FDA hearing submission extended deadline (July 29, 2026)? Let's search for "Amgen" OR "Tavneos" "hearing" OR "ADVOCATE" OR "July 29". 4. Vera Therapeutics ORIGIN 3 Phase 3 eGFR confirmatory results in IgAN? Let's search for "Vera" OR "atacicept" OR "ORIGIN 3" OR "Trutakna". 5. MoonLake Phase 3 IZAR-1 trial readout of sonelokimab in psoriatic arthritis? Let's search for "MoonLake" OR "sonelokimab" OR "IZAR-1". Let's do a search on Replimune and RP1. Let's find out what the latest is on their upcoming advisory committee meeting and PDUFA date. Let's do a search.

Let's fetch the BioSpace article: "Replimune gets early August decision date for twice-rejected melanoma drug" from June 26, 2026. This will give us the background and exact details of why it was twice rejected, how the FDA leadership departures (Vinay Prasad and Marty Makary) opened the path for this third resubmission, and what the current status is. Let's do a fetch.

Ah, the search budget is spent! Let's carefully analyze the information we have. Let's look at the threads and watches we can resolve or update: 1. **The Post-Makary FDA Pivot / Rebuilding the Workforce:** - We have an update on the FDA leadership: CBER Acting Director is **Karim Mikhail**, and CDER Acting Director is **Michael Davis**. Acting Chief of Staff is **Lowell Zeta**. - After the massive attrition from the DOGE cuts last year (which lost over 3,000 employees), the FDA has been authorized to hire **2,200 people**. - As of late June 2026 (announced at the BIO International Convention in San Diego), the FDA has already secured **600 new hires** (with several hundred in onboarding clearance) and is actively recruiting for the remaining 1,600 slots. - Attrition rates have dropped back down to historical norms, and the new acting leadership is heavily focused on staff retention, employee morale, and restoring career staff confidence. - This directly updates the post-Makary FDA pivot. We should update the note: `fda-regulatory-pivot-advisory-committees-capricor-replimune` or write a new note / update the existing one. Wait, let's look at our previous findings: - `fda-regulatory-pivot-advisory-committees-capricor-replimune` - `hhs-clinical-trials-reform-operation-trailblazer` - `fda-crl-public-disclosure-policy` - `tolebrutinib-eu-approval-fda-regulatory-divergence` Let's read the current notes to see exactly what we have in them. I can use `read_notes` to see what is already in `fda-regulatory-pivot-advisory-committees-capricor-replimune`. Let's do that.

The search budget is spent! That is fine. Let's process the findings we have. Wait, let's look at the prior findings. We have: 1. `fda-regulatory-pivot-advisory-committees-capricor-replimune` This note was updated on 2026-07-18T22:50:00Z. It is about "The Post-Makary FDA Pivot: Reversals, Resubmissions, and a Return to Advisory Committees". We have fresh, highly specific information about the FDA's rebuilding plan, leadership changes, and upcoming advisory committees. Let's review what we learned: - FDA's Center for Biologics Evaluation and Research (CBER) is now led by Acting Director **Karim Mikhail**, and the Center for Drug Evaluation and Research (CDER) is led by Acting Director **Michael Davis**. Under their leadership, and with Acting Chief of Staff **Lowell Zeta**, the FDA is working to restore staff morale and career-staff autonomy. - The FDA is actively rebuilding its workforce after the massive "DOGE cuts" in 2025 (which resulted in over 3,000 lost jobs). The agency has been authorized to hire **2,200 people**. - As of late June 2026 (announced at the BIO International Convention), the FDA has already secured **600 new hires** (with several hundred in onboarding clearance) and is recruiting for the remaining 1,600 positions. CDER's attrition rates have dropped back down to historical norms, and qualitative morale is improving. - This leadership shift directly opened the door for **Replimune's third BLA resubmission** for its oncolytic immunotherapy **RP1** (vusolimogene oderparepvec) in combination with nivolumab for advanced melanoma. The FDA accepted the resubmission on June 26, 2026, treating it as an "urgent matter" and setting a PDUFA target action date of **August 2, 2026**. - The FDA has scheduled an advisory committee meeting for RP1 in late July 2026, ahead of the PDUFA date. This follows two previous rejections under former Commissioner Marty Makary and CBER chief Vinay Prasad (one in July 2025, and another in April 2026). - Meanwhile, the FDA's Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) is scheduled to meet on **July 29, 2026**, to review Capricor's BLA for **deramiocel** in Duchenne muscular dystrophy (DMD) cardiomyopathy. - This is a direct update to `fda-regulatory-pivot-advisory-committees-capricor-replimune`. Let's update that note! Wait, is there another note we should write or update? Let's look at the Capricor-NS Pharma commercialization dispute. We have a prior finding: `capricor-deramiocel-ns-pharma-dispute` ("Capricor Sues Partner NS Pharma Over Deramiocel Commercialization Pricing Flaws"), updated on 2026-07-15T22:48:44Z. Wait, let's see if we have any other new developments on it. The prior finding already covers Capricor suing partner NS Pharma over deramiocel commercialization pricing flaws. Let's see if there's any other new findings we can write. Wait! We can update `fda-regulatory-pivot-advisory-committees-capricor-replimune` with the details from the BioSpace and STAT articles. Let's make sure we quote the sources accurately. Let's look at the quotes we have from our fetches: From BioSpace ("FDA hiring 2,200 people to staff up after last year’s DOGE cuts"): - "The FDA has so far secured 600 new hires and is looking for 1,600 more as interim leadership at the agency aims to rebuild the workforce and morale after more than a year of intense attrition." - "After losing more than 3,000 staffers last year, the FDA is looking to hire some 2,200, according to Acting Chief of Staff and Deputy Commissioner Lowell Zeta—including some of the recently departed employees." - "“We’re at about 600 that are in onboarding clearance at sort of the various levels, with a couple hundred already through the process,” Zeta told attendees of an FDA Town Hall at the BIO International Convention on Tuesday." - "“Yes, we’re hiring, but if we’re losing at the same pace of hiring for whatever reason, because people are dissatisfied with what they do, then it’s not working,” Acting CBER Director Karim Mikhail said at the Town Hall." - "“I really make an effort to listen to as many staff as I can, have lunches with them and so forth, and I feel a lot of hope in people of things going forward,” [Davis] said. “I think the attrition numbers would support that with data, but qualitatively I do feel like there’s been improvement in morale.”" From BioSpace ("Replimune gets early August decision date for twice-rejected melanoma drug"): - "The FDA has accepted the regulatory resubmission for Replimune’s oncolytic immunotherapy RP1, which the biotech is proposing for the treatment of advanced melanoma. A verdict is expected on or before Aug. 2." - "Replimune is seeking accelerated approval for its product, and the FDA has advised the biotech to expect an advisory committee meeting to be held for the application in late July..." - "RP1 has been rejected twice... Both rejections kicked off a firestorm of controversy for the FDA. The second one was enough to prompt ex-Commissioner Marty Makary to publicly defend the agency..." - "At the start of the month, for instance, Vinay Prasad, former director of the Center for Biologics Evaluation and Research (CBER), left the FDA. Soon after, Makary stepped down as commissioner, ending what analysts at Capital Alpha called the 'most damaging period in FDA history.'" From STAT News ("Under a new leader, the FDA’s biologics center moves to steady itself after stormy chapter"): - "In a recent town hall meeting, Karim Mikhail told Food and Drug Administration staff that he was normal. 'I am with you on planet Earth,' he said in June. 'I understand very well what everybody is going through.' ... Mikhail is acting director of the FDA’s Center for Biologics Evaluation and Research, where the previous leader, Vinay Prasad, was decidedly outside the norm." Let's write a comprehensive update to `fda-regulatory-pivot-advisory-committees-capricor-replimune` using these quotes and facts. Wait, are there any other threads we can resolve or update? Let's check the list of threads: - `019f0620-007b-7dab-87b4-0363a2496ea1`: "FDA advisory committee meeting and PDUFA date for Replimune's RP1 in advanced melanoma" -> This watch is scheduled for late July 2026 / August 2, 2026. It hasn't fired yet because the meeting hasn't happened (it is scheduled for late July, and today is July 19, 2026). - `019f061f-f34a-7079-a276-d216329928b2`: "FDA advisory committee meeting for Capricor's deramiocel in DMD cardiomyopathy" -> This watch is for July 29, 2026. It hasn't fired yet. - `019f1ab8-f9db-7f35-b537-f4db6a56efeb`: "FDA finalization and launch of Expedited-IND Pilot Program" -> Comment period closes July 22, 2026. Hasn't fired. - `019f1fe0-09fc-7028-9aca-1d1dd5636118`: "Amgen Tavneos FDA hearing submission extended deadline" -> Deadline is July 29, 2026. Hasn't fired. - `019f67f8-1a98-7a61-a210-07071f61b308`: "FDA filing acceptance and PDUFA date for Saol's SL1009" -> Target is late July 2026. Hasn't fired. Since these watches are all in the future (late July or later), they should remain open. None of them have fired yet. Let's write the note updating `fda-regulatory-pivot-advisory-committees-capricor-replimune`. This is a direct update to an existing finding. Wait, let's double check if there are other findings we should write. Is there anything else? No, we don't have other fresh search results to draft a new note, and since the search budget is spent, we must focus on writing this high-quality update. Let's construct the body of the note for `fda-regulatory-pivot-advisory-committees-capricor-replimune`. No YAML frontmatter, first heading must be the title: `# The Post-Makary FDA Pivot: Reversals, Resubmissions, and a Return to Advisory Committees` Let's draft the note carefully. We'll include the details on: 1. The new acting leadership team at the FDA: Acting Chief of Staff Lowell Zeta, CBER Acting Director Karim Mikhail, and CDER Acting Director Michael Davis, who are working under Acting Commissioner Kyle Diamantas. 2. The massive rebuilding effort to recover from the 2025 "DOGE cuts" (which removed over 3,000 employees). The FDA is authorized to hire 2,200 people; as of late June 2026, they have secured 600 new hires (with several hundred in onboarding clearance) and are actively recruiting. CDER attrition rates have returned to historical norms, and employee morale is showing quantitative and qualitative signs of recovery. 3. The regulatory impact on Replimune's RP1: Following two rejections under former Commissioner Marty Makary and CBER chief Vinay Prasad (in July 2025 and April 2026), the new leadership has accepted Replimune's third BLA resubmission on June 26, 2026, treating it as an "urgent matter" with a PDUFA target action date of August 2, 2026. An advisory committee meeting is scheduled for late July 2026. 4. The regulatory impact on Capricor's deramiocel: The FDA's Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) is scheduled to meet on July 29, 2026, to review Capricor's BLA for deramiocel in DMD cardiomyopathy. Let's write this finding. Let's make sure the slug is exactly `fda-regulatory-pivot-advisory-committees-capricor-replimune`. Let's do it.

The note has been successfully written! This is a great update to a living document. Let's call `finish_cycle` to complete this research cycle. Since we have written an update, we don't need to pass a `no_findings_reason`. Let's end the cycle.

I have completed this research cycle on the topic of consequential science and health policy. ### Summary of Findings & Updates 1. **The Post-Makary FDA Workforce Rebuilding & Interim Leadership** - **New Leadership Focus:** Following the exits of former Commissioner Marty Makary and CBER Director Vinay Prasad, an acting leadership team consisting of **Lowell Zeta** (Acting Chief of Staff), **Karim Mikhail** (Acting CBER Director), and **Michael Davis** (Acting CDER Director) is working to restore scientific autonomy and rebuild staff morale. - **Massive Rebuilding Plan:** The FDA has been authorized to hire **2,200 employees** to recover from the loss of over 3,000 staffers during the 2025 "DOGE cuts." As of late June 2026, the agency has secured **600 new hires** (with several hundred currently in onboarding clearance) and is actively recruiting for the remaining 1,600 positions. Davis reported that CDER's attrition rates have returned to historical norms, and employee morale is showing clear signs of recovery. - **Living Document Updated:** This operational pivot has been updated in the existing finding `[[fda-regulatory-pivot-advisory-committees-capricor-replimune]]`. 2. **Replimune's RP1 and Capricor's Deramiocel Advisory Committees** - **Replimune's RP1 (vusolimogene oderparepvec):** Following two rejections under the previous administration (in July 2025 and April 2026), the FDA has accepted Replimune's third BLA resubmission, treating it as an "urgent matter." The PDUFA target action date is scheduled for **August 2, 2026**, with an advisory committee meeting scheduled for late July 2026. - **Capricor's Deramiocel:** The FDA's Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) is scheduled to meet on **July 29, 2026**, to review the BLA for deramiocel in DMD cardiomyopathy. This review proceeds despite Capricor's ongoing high-stakes lawsuit against commercialization partner NS Pharma over contract pricing flaws. All watches remain active and will be monitored in future cycles as these regulatory milestones approach.