Last updated: August 19, 2026
On August 18, 2026, multiple outlets reported that President Trump is expected to nominate White House health adviser Dr. Heidi Overton as FDA commissioner; Amylyx said avexitide cut serious hypoglycemic events 55 percent in Phase 3; and BioMarin agreed to pay $275 million upfront for Alesta Therapeutics.
This page covers the reported FDA commissioner pick and what it does and does not change for pending decisions, the full LUCIDITY endpoint table, the term sheets for the BioMarin, LEO Pharma, and Sandoz deals, the third disclosed death in a Chinese investigator initiated trial, and the updated binary ledger for the week of August 17, 2026.
Who is Heidi Overton and is she the FDA commissioner?
Not yet. Reports on August 18 say President Trump is expected to nominate Dr. Heidi Overton, deputy director of the White House Domestic Policy Council, to lead the FDA. The White House had not formally announced the pick at the time of writing, and the job requires Senate confirmation.
Bloomberg first reported the choice, followed by STAT, The Washington Post, CNN, Axios, and Endpoints News, each citing an unnamed administration official or a person familiar with the matter. STAT describes Overton as a physician who has led health policy at the White House since the start of the term and worked closely with HHS, overseeing the food pyramid redesign, the overhaul of the childhood vaccine schedule, and the negotiation of pharmaceutical pricing deals. Axios notes she appeared at last week’s Oval Office signing on the childhood vaccine schedule. Former commissioner Marty Makary left the agency earlier this year, and the FDA has operated under acting leadership since.
| Item | What is known (August 18, 2026) | Source |
|---|---|---|
| Nominee | Dr. Heidi Overton, physician, deputy director, White House Domestic Policy Council | STAT, Axios, CNN |
| Status | Expected nomination; no formal White House announcement at time of writing | STAT, Bloomberg (first report) |
| Process | Senate HELP Committee hearing and floor vote required | STAT |
| Policy record | Food pyramid redesign; childhood vaccine schedule overhaul; drug pricing deal negotiations | STAT |
| Predecessor | Marty Makary exited earlier in 2026; agency under acting leadership | Axios |
What does a commissioner nominee change for drugs already under FDA review?
Very little in the near term. Confirmation typically takes months, review divisions keep working under existing leadership, and every decision on the current calendar through the fourth quarter will be made by the acting structure that has been in place since Makary’s departure.
That matters because the pending calendar is heavy: Capricor’s deramiocel date formally remains August 22 (the company has said the FDA is willing to extend it once a BLA amendment is received; the FDA has not published a new goal date), Scholar Rock’s apitegromab action date is September 30, rusfertide’s polycythemia vera decision is due this quarter, Summit’s ivonescimab decision is November 14, and Vertex’s povetacicept decision is November 30. None of those move because of a nomination. What a confirmed commissioner can change over 2027 is the settled philosophy the agency has lacked, from how post hoc analyses are treated to how manufacturing findings weigh against clean clinical data. Overton’s public record is in health policy rather than drug review, so how she would approach those questions is not yet on the record.
What did Amylyx report from the Phase 3 LUCIDITY trial of avexitide?
Amylyx Pharmaceuticals said on August 18 that avexitide, a GLP-1 receptor antagonist, reduced the composite of Level 2 and Level 3 hypoglycemic events by 55 percent versus placebo in patients with post bariatric hypoglycemia (p=0.000003), meeting the primary endpoint and all key secondary endpoints. Amylyx plans to file an NDA by the end of 2026.
| LUCIDITY element | Detail (Amylyx release, August 18, 2026) |
|---|---|
| Design | Multicenter, randomized, double blind, placebo controlled Phase 3; 78 participants; 21 US sites; 3:2 randomization |
| Dose | Avexitide 90 mg subcutaneous once daily |
| Duration | 6 week screening (including 3 week run in), 16 week double blind treatment, 32 week open label extension |
| Primary endpoint | 55 percent reduction in composite Level 2 and Level 3 hypoglycemic events versus placebo through week 16; p=0.000003 |
| Secondary endpoints | Level 2 events by self monitored blood glucose; Level 2 events by continuous glucose monitoring; independently adjudicated Level 3 events; all reported as highly statistically significant |
| Safety | No serious adverse events related to avexitide; most common events diarrhea, injection site erythema, injection site bruising; no change in body weight |
| Regulatory | Breakthrough Therapy designation in post bariatric hypoglycemia; NDA planned by end of 2026 |
| Population | Company estimate: about 8 percent of roughly 160,000 US patients who have had bariatric surgery; no FDA approved therapy |
Context and attributed figures: Fierce Biotech reports Amylyx acquired avexitide from Eiger BioPharmaceuticals for $35.1 million in 2024, and that patients entered the trial averaging about one severe event per week. BioSpace reports Stifel projects $1.7 billion in peak worldwide sales and Mizuho notes the trial was powered to detect a 35 percent effect. Shares closed more than 50 percent higher on the day, per market reports; the exact figure varied by outlet and time of quote. Amylyx withdrew its ALS drug Relyvrio in April 2024 after a confirmatory trial failed, so LUCIDITY is the company’s first pivotal win since that reset.
Why does a GLP-1 antagonist matter in the middle of the GLP-1 agonist boom?
Because it treats a complication of the same physiology. Post bariatric hypoglycemia is driven by an exaggerated GLP-1 mediated insulin response after surgery. Avexitide blocks the receptor that semaglutide and tirzepatide activate. It is a small, orphan sized market, but it is the first Phase 3 proof that antagonizing the pathway is safe and effective in humans.
The clinical read is narrow: nothing here bears on obesity drugs directly. The commercial read is that the bariatric surgery population is large and stable, the condition has no approved therapy, and a once daily injection with a Breakthrough designation and a p value this small has a clean path to a filing. The label question will be whether the FDA accepts the composite of Level 2 and Level 3 events as the clinical benefit, and whether the open label extension data support durability past 16 weeks.
What are the terms of BioMarin’s acquisition of Alesta Therapeutics?
BioMarin will pay $275 million upfront in cash plus up to $215 million in development and regulatory milestones, a maximum of $490 million, for Alesta Therapeutics and its oral hypophosphatasia candidate ALE1, currently in a Phase 1/2a trial. Closing is expected in the third quarter of 2026.
| Term | Detail (BioMarin release, August 18, 2026) |
|---|---|
| Upfront | $275 million, funded from cash on hand |
| Milestones | Up to $215 million on development and regulatory achievements |
| Total | Up to $490 million |
| Asset | ALE1, oral small molecule acting on inorganic pyrophosphate regulation to restore bone and mineral metabolism |
| Stage | Phase 1/2a (safety, tolerability, PK/PD) |
| Population | More than 9,000 people diagnosed with HPP in the US per BioMarin; adults are underserved |
| Guidance | Modestly dilutive to 2026 excluding the upfront; 2026 guidance to be updated after close |
| Close | Q3 2026 |
Per Fierce Biotech, Alesta will spin its non ALE1 assets into a new company with its current employees, so no staff move to BioMarin. AstraZeneca’s Strensiq is approved for perinatal, infantile, and juvenile onset HPP, and its next generation enzyme replacement failed a Phase 3 in patients 12 and older, per Fierce, which is the opening BioMarin is buying. BioMarin discontinued the ENPP1 deficiency enzyme replacement it acquired with Inozyme after a Phase 3 failure last year, so this is a second attempt to build a bone disease franchise around Voxzogo.
What did LEO Pharma buy from Tanabe Pharma and for how much?
LEO Pharma acquired worldwide rights to dersimelagon, an oral once daily melanocortin 1 receptor agonist for erythropoietic protoporphyria and X linked protoporphyria, for up to $435 million in upfront and near term milestone payments plus downstream milestones and tiered royalties. Tanabe submitted an NDA in June 2026; the drug has Fast Track and Orphan designations.
| Term | Detail (LEO Pharma release, August 18, 2026) |
|---|---|
| Consideration | Up to $435 million in upfront and near term milestones; downstream milestones and tiered royalties on net sales; split not disclosed |
| Asset | Dersimelagon, oral MC1R agonist that increases skin melanin to reduce phototoxic reactions |
| Indications | Erythropoietic protoporphyria (EPP) and X linked protoporphyria (XLP) |
| Data | Phase 3 INSPIRE (NCT06144840) met primary and secondary endpoints including time to first prodromal symptom during sunlight exposure; late breaker at AAD 2026 |
| Regulatory | NDA submitted June 2026; Fast Track and Orphan Drug designations; approval as early as 2027 per company comments reported by Reuters |
| Strategic context | Third recent medical dermatology deal after Spevigo partnership with Boehringer Ingelheim (2025) and Replay HSV gene therapy platform (April 2026); LEO exploring an IPO per Reuters |
LEO’s CEO Christophe Bourdon put the US EPP population at potentially 5,000 patients in comments reported by Reuters. BioPharma Dive reports LEO’s first half 2026 revenue at DKK 7.26 billion, about $1.12 billion, up 10 percent; that figure is from trade press and is attributed as such.
What is in the Sandoz and Henlius biosimilar agreement?
Shanghai Henlius Biotech and Sandoz signed a strategic collaboration on August 17 worth up to $322 million, covering three biosimilar candidates now, an option on a recombinant hyaluronidase, and a framework for up to ten monoclonal antibody or antibody drug conjugate biosimilars. Henlius says up to $100.5 million will be invoiced in 2026.
| Term | Detail (Henlius release, August 17, 2026; Fierce Pharma for reference drug figures) |
|---|---|
| Total value | Up to $322 million; up to $100.5 million invoiced in 2026 (Fierce Pharma describes $100.5 million upfront and $221.5 million in milestones) |
| Assets | HLX05-N (cetuximab biosimilar, Phase 1); HLX16 (evolocumab biosimilar, preclinical); belimumab biosimilar (preclinical); option on recombinant human hyaluronidase |
| Territories | HLX05-N: US, Canada, EU, UK, Switzerland, Japan, Australia, New Zealand plus semi exclusive rights in certain Asian markets; HLX16 and belimumab: worldwide outside China |
| Manufacturing | Henlius develops, manufactures, and supplies |
| Reference drugs | Erbitux (Eli Lilly and Merck KGaA), Repatha (Amgen), Benlysta (GSK); combined 2025 sales about $6.8 billion per Fierce Pharma |
| Prior deal | April 2025: HLX13 ipilimumab biosimilar, 46 countries |
What is the third disclosed death in China’s investigator initiated trials?
Endpoints News reported on August 18 that RiboX Therapeutics confirmed a patient died in its Chinese investigator initiated trial of RXIM002, an in vivo CAR T therapy for autoimmune disease, the third such disclosed death in recent weeks. The details of the case are behind Endpoints’ paywall and are attributed to that outlet.
The context is public. RiboX announced on August 8 that the FDA had cleared an IND for RXIM002, a lipid nanoparticle delivered circular RNA encoding an anti CD19 CAR that generates CAR T cells inside the body, for autoimmune cytopenias starting with immune thrombocytopenia. RiboX said it submitted complete investigator initiated trial data from China, covering safety and early efficacy from all treated patients, in the IND, and plans a US Phase 1 called POPULUS-1. Fierce Biotech reported on August 17 two previously undisclosed deaths in Chinese investigator initiated gene therapy trials, both from severe immune reactions to high dose viral vectors. China’s Order 818, effective May 2026, now requires GMP grade product, large animal toxicology, and serious adverse event reporting within five business days for these trials.
| Disclosure | Program | Reported by | Date reported |
|---|---|---|---|
| Death 1 | HuidaGene CRISPR Duchenne investigator initiated trial (immune reaction to high dose viral vector) | Fierce Biotech | August 17, 2026 |
| Death 2 | Base editing trial in a six year old with a rare neurodevelopmental disorder (immune reaction to high dose viral vector) | Fierce Biotech | August 17, 2026 |
| Death 3 | RiboX RXIM002 in vivo CAR T, autoimmune indication; confirmed by RiboX | Endpoints News | August 18, 2026 |
What did CSL say about Tavneos and what is the sales impact?
CSL reported fiscal 2026 results on August 18 Australian time and, per Endpoints News, called the European withdrawal of Tavneos (avacopan) a significant headwind for CSL Vifor. CSL’s June 29 ASX update put Tavneos revenue at approximately $145 million for fiscal 2026 and said new patient starts in the EU would stop pending the European Commission’s decision.
Results coverage from Investing.com and Endpoints puts CSL Vifor’s fiscal 2027 revenue guidance at a decline of around 25 percent, with the Tavneos revocation cited alongside generic iron competition; those guidance figures are from results coverage rather than a document we could retrieve and are attributed accordingly. Tavneos was developed by ChemoCentryx, now part of Amgen, and licensed to CSL Vifor outside the US in 2016. The pivotal ADVOCATE study has been retracted, the FDA has asked for US removal, and newly released EMA documents said incorrect and misleading data drove the European decision, per Endpoints. This is the third payoff of the “evidence base unraveling” call we published earlier this summer.
What is Tauklarify and why does the Lantheus approval matter?
The FDA approved Lantheus’ Tauklarify (florquinitau F 18 injection, formerly MK-6240) on August 14, 2026 for PET imaging of tau neurofibrillary tangle pathology in adults with cognitive impairment being evaluated for Alzheimer’s disease. Lantheus is the same company that agreed to be acquired by Curium for up to $8.0 billion, so this is a diagnostics asset inside the infrastructure story we have tracked all month.
Per the Lantheus release, two blinded read studies covered 279 and 338 subjects; positive percent agreement against histopathology ranged from 80 to 88 percent and 68 to 82 percent, negative percent agreement 98 to 99 percent and 93 to 99 percent, with inter reader kappa of 0.92 and 0.86. Safety was evaluated in 1,734 subjects with headache the most common reaction at 0.7 percent. The label carries a limitation that safety and effectiveness are not established for non Alzheimer’s tauopathies. Lantheus said it will keep supporting Alzheimer’s therapeutic programs through its Pharma Solutions business while assessing the path to broader commercial availability, so this is not yet a broad commercial launch.
What else moved on August 18, 2026?
Kolon TissueGene reduced its workforce after its Activion II Phase 3 of TG-C in knee osteoarthritis missed its co primary endpoints in July, per Fierce Biotech, with a second Phase 3 due in October; BioSpace reported that CDMO demand should recover in late 2026 or early 2027 as biotech funding rebounds; and STAT’s policy newsletter noted that states have until September 30 to decide whether to join the GENEROUS Medicaid most favored nation drug pricing model.
On the CDMO piece, BioSpace cites PitchBook data of 27 manufacturing and distribution deals worth $1.9 billion in the first half of 2026 and quarterly biopharma venture deployment above $10 billion, with Lonza’s CFO describing a six to nine month lag between funding and manufacturing demand; those are Tier 2 figures attributed to the outlet. Capricor had no new release and the FDA has not published a new goal date for deramiocel; the August 22 date formally stands.
How does the binary ledger look after Tuesday, August 18?
Three of the seven columns gained entries on Tuesday, one binary resolved to the right tail, and the counterparty on every regulatory line item may be about to get a name. The tally below carries into Friday’s payoff.
| Column | Entries through August 18 | Added August 18 |
|---|---|---|
| 1. Deferrals granted by regulators | Capricor (FDA willing to extend Aug 22 date on BLA amendment, per company) | No change; no FDA notice |
| 2. Contingent payments in litigation | Celgene CVR (2nd Circuit revival, Aug 13) | None |
| 3. Winners selling equity into the pop | Silence Therapeutics $201.3M (Aug 14) | Watch Amylyx after a 55 percent win and a share move above 50 percent |
| 4. Royalties sold ahead of decisions | Zealand/rusfertide to Royalty Pharma $100M | None |
| 5. Creation vehicles absorbing binaries | Fibrx (Skye + Redx); Slate/Fulcrum ($245M PIPE) | None |
| 6. Contingent consideration written | Lilly/OmniAb (up to $370M milestones); Lilly/Sangamo platforms ($50M cash) | BioMarin/Alesta ($275M upfront + up to $215M); LEO/Tanabe dersimelagon (up to $435M upfront and near term milestones + royalties, on a filed NDA); Sandoz/Henlius (up to $322M, up to $100.5M in 2026) |
| 7. Binaries returned to sender | J&J prizlon-cel to AbelZeta (per BioSpace) | None |
| Resolved, right tail | SAFFRON, DESTINY-Lung04 (Aug 17) | Amylyx LUCIDITY |
| Resolved, left tail | EyePoint LUGANO, eVOLVE-Lung02, REGN7041 (Aug 17) | Kolon workforce cut after July miss; CSL Tavneos headwind (regulatory) |
Frequently asked questions
Has Heidi Overton been confirmed as FDA commissioner?
No. As of August 18, 2026 she is reported to be President Trump’s expected nominee, per Bloomberg, STAT, Axios, CNN, and The Washington Post. A formal nomination and Senate confirmation would follow.
Who is running the FDA right now?
The agency has been under acting leadership since former commissioner Marty Makary left earlier in 2026. Pending drug decisions through the end of the year will be made under that structure regardless of the nomination.
What is avexitide?
Avexitide is a GLP-1 receptor antagonist developed by Amylyx Pharmaceuticals for post bariatric hypoglycemia. It blocks the same receptor that semaglutide and tirzepatide activate, preventing the exaggerated insulin response that causes low blood sugar after bariatric surgery.
What did the LUCIDITY trial show?
In 78 patients, avexitide 90 mg once daily reduced composite Level 2 and Level 3 hypoglycemic events by 55 percent versus placebo through 16 weeks (p=0.000003) and met all key secondary endpoints, per Amylyx.
When will Amylyx file for approval of avexitide?
Amylyx plans to submit an NDA by the end of 2026. Avexitide holds Breakthrough Therapy designation in post bariatric hypoglycemia.
How many people have post bariatric hypoglycemia?
Amylyx estimates about 8 percent of roughly 160,000 US patients who have undergone common bariatric procedures. There is no FDA approved treatment.
How much is BioMarin paying for Alesta Therapeutics?
$275 million upfront in cash plus up to $215 million in development and regulatory milestones, up to $490 million in total, with closing expected in the third quarter of 2026.
What is ALE1?
ALE1 is an oral small molecule in a Phase 1/2a trial for hypophosphatasia. It acts on inorganic pyrophosphate regulation to restore bone and mineral metabolism and could be the first oral therapy for the disease, per BioMarin.
What is dersimelagon?
Dersimelagon is Tanabe Pharma’s oral once daily melanocortin 1 receptor agonist for erythropoietic protoporphyria and X linked protoporphyria. It increases skin melanin to reduce painful phototoxic reactions to sunlight. An NDA was submitted in June 2026 and LEO Pharma has acquired worldwide rights for up to $435 million plus royalties.
What does the Sandoz and Henlius deal cover?
Biosimilar candidates referencing cetuximab, evolocumab, and belimumab, plus an option on a recombinant hyaluronidase and a framework for up to ten antibody or ADC biosimilars, for up to $322 million with up to $100.5 million invoiced in 2026, per Henlius.
What is Tauklarify?
Tauklarify (florquinitau F 18) is Lantheus’ PET imaging agent approved by the FDA on August 14, 2026 to identify tau neurofibrillary tangle pathology in adults with cognitive impairment being evaluated for Alzheimer’s disease.
What happened in China’s investigator initiated trials?
Three deaths have been disclosed in recent weeks: two in gene therapy trials reported by Fierce Biotech on August 17 and one in RiboX’s in vivo CAR T trial reported by Endpoints News on August 18. China’s Order 818, effective May 2026, tightened requirements for these trials.
Is Capricor’s deramiocel decision still due August 22?
Formally yes. Capricor has said the FDA is willing to extend the date once it receives a BLA amendment, but neither the FDA nor Capricor has published a new goal date as of August 18.
What is Tavneos and why is CSL flagging it?
Tavneos (avacopan) is a treatment for ANCA associated vasculitis marketed by CSL Vifor outside the US. European regulators moved to revoke its authorization after the pivotal ADVOCATE study was retracted; CSL put fiscal 2026 Tavneos revenue at about $145 million in June and, per Endpoints, called the withdrawal a significant headwind for fiscal 2027.
Sources
Primary sources
Amylyx Pharmaceuticals press release, “Amylyx Pharmaceuticals Announces Positive Topline Results from Phase 3 LUCIDITY Clinical Trial of Avexitide in Post-Bariatric Hypoglycemia,” Business Wire, August 18, 2026. BioMarin Pharmaceutical press release, “BioMarin to Acquire Alesta Therapeutics to Gain ALE1,” August 18, 2026. LEO Pharma press release, “LEO Pharma Further Strengthens Late-Stage Pipeline With the Acquisition of Dersimelagon,” August 18, 2026. Shanghai Henlius Biotech press release, “Henlius and Sandoz Enter Strategic Collaboration to Unlock Global Value of Biosimilars Platform,” August 17, 2026. Lantheus press release, “Lantheus Announces FDA Approval of TAUKLARIFY (Florquinitau F 18 Injection),” GlobeNewswire, August 14, 2026. RiboX Therapeutics press release, “RiboX Therapeutics Announces FDA IND Clearance for RXIM002,” PR Newswire, August 8, 2026. CSL Limited ASX announcement, “Update on TAVNEOS,” June 29, 2026. Capricor Therapeutics Q2 2026 results, August 13, 2026.
Trade and general press
STAT, “Trump set to nominate Heidi Overton to be FDA commissioner,” August 18, 2026. Axios, “Trump to tap Heidi Overton as FDA commissioner,” August 19, 2026. CNN, Endpoints News, and The Washington Post reports on the expected nomination, August 18, 2026. Fierce Biotech, “Amylyx readies approval push after GLP-1 inhibitor halves blood sugar crashes in ph. 3 win,” August 18, 2026. BioSpace, “Amylyx eyes FDA filing for GLP-1 blocker after late-stage win in post-bariatric hypoglycemia,” August 18, 2026. Fierce Biotech, “BioMarin bulks up bone unit with $275M Alesta buyout to challenge AstraZeneca,” August 18, 2026. BioPharma Dive, “Leo Pharma buys rare skin disease drug in $435M deal,” August 18, 2026. Reuters via Yahoo Finance, “LEO Pharma buys worldwide dersimelagon rights for up to $435 million,” August 18, 2026. Fierce Pharma, “Sandoz strikes $322M biosimilars deal with Shanghai Henlius,” August 17, 2026. Endpoints News, “Exclusive: Third death in China’s popular but opaque trials revealed, this time in CAR-T,” August 18, 2026. Endpoints News, “CSL calls Tavneos withdrawal in Europe a ‘significant headwind’ for sales,” August 18, 2026. Investing.com, CSL FY26 results coverage, August 18, 2026. Fierce Biotech, Kolon TissueGene coverage, July 20 and August 18, 2026. BioSpace, “Rebounding biotech funds expected to spur CDMO growth within year,” August 18, 2026. STAT D.C. Diagnosis, August 18, 2026. RTTNews and The Motley Fool market reports on Amylyx shares, August 18, 2026.
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