Last updated: September 30, 2026
Eli Lilly’s retatrutide cut body weight 20.8% and A1c 1.5 points at the top dose in the Phase 3 TRIUMPH-2 trial in adults with obesity and type 2 diabetes, while uniQure’s AMT-130 lost statistical significance on its primary measure at 48 months and Beam Therapeutics sued two rivals over base editing trade secrets.
This report covers verified developments from Tuesday, September 29, 2026, with primary sourced trial figures, regulatory context, and the day’s consequential market moves.
What did Lilly’s retatrutide show in the TRIUMPH-2 trial?
Retatrutide, Lilly’s triple agonist of the GIP, GLP-1, and glucagon receptors, delivered up to 20.8% weight loss and a 1.5 point A1c reduction over 80 weeks in 1,152 adults with both obesity and type 2 diabetes, a population where incretin therapies historically underperform their obesity only results.
Eli Lilly released the topline on Tuesday evening ahead of the trial’s presentation at the European Association for the Study of Diabetes annual meeting in Milan, with simultaneous publication in The Lancet. TRIUMPH-2 (NCT05929079) is a randomized, double blind, placebo controlled Phase 3 trial that assigned participants 1:1:1:1 to retatrutide 4 mg, 9 mg, or 12 mg weekly or placebo, starting at 2 mg with stepwise escalation every four weeks.
| Arm | Weight change at 80 weeks | A1c change |
|---|---|---|
| Retatrutide 4 mg | −12.7% (−29.8 lb) | −1.4 |
| Retatrutide 9 mg | −19.1% (−45.4 lb) | −1.6 |
| Retatrutide 12 mg | −20.8% (−49.6 lb) | −1.5 |
| Placebo | −4.0% (−9.3 lb) | −0.2 |
Source: Lilly press release, September 29, 2026. In participants with baseline BMI of 35 or higher, the 12 mg dose delivered a 23.4% reduction, an average of 60.8 pounds.
What share of TRIUMPH-2 patients dropped below the obesity threshold?
At the 12 mg dose, 59.5% of participants no longer met the BMI criteria for obesity at 80 weeks, 40.0% reached an A1c in the normal range below 5.7%, and 79.0% reached an A1c at or below 6.5%. More than half achieved at least 20% weight loss.
| Milestone at 12 mg | Share of participants |
|---|---|
| No longer met BMI criteria for obesity | 59.5% |
| A1c below 5.7% (normal range) | 40.0% |
| A1c at or below 6.5% | 79.0% |
| Weight loss of 20% or more | 52.0% |
| Weight loss of 25% or more | 34.9% |
Cardiometabolic markers moved alongside the weight: at 12 mg, triglycerides fell 39.5%, non HDL cholesterol fell 19.6%, systolic blood pressure fell 10.8 mmHg, waist circumference shrank 6.7 inches, and high sensitivity C reactive protein fell 58.3%.
Safety followed the incretin class pattern. Diarrhea (33.6% at 12 mg vs 13.2% placebo), nausea (28.0% vs 8.0%), and constipation led the adverse events, described as generally mild to moderate. Discontinuations due to adverse events ran 3.8% at 4 mg, 11.6% at 9 mg, and 7.7% at 12 mg versus 4.9% for placebo. Lilly plans a US regulatory submission in the first quarter of 2027. Because the release crossed after Tuesday’s close, Wednesday is the first session in which the market can react.
What happened to uniQure’s Huntington’s gene therapy data at 48 months?
The treatment effect weakened as the dataset matured. AMT-130’s 44% slowing of disease progression on the composite cUHDRS scale at 48 months missed statistical significance (p=0.144), down from an 80% slowing at 36 months (nominal p=0.005), the dataset uniQure’s pending BLA rests on.
uniQure reported additional data Tuesday from its ongoing Phase 1/2 studies of ifezuntirgene inilparvovec (AMT-130), a one time AAV gene therapy for Huntington’s disease. In the high dose group, 12 patients reached the 48 month mark. Total functional capacity, a secondary measure the company emphasizes because it captures whether patients can work and manage daily life, held up better: 61% slowing at 48 months (nominal p=0.008) versus 67% at 36 months.
| Measure (high dose vs external control) | 36 months (n=15) | 48 months (n=12) |
|---|---|---|
| cUHDRS slowing of progression | 80% (nominal p=0.005) | 44% (p=0.144, not significant) |
| Total functional capacity slowing | 67% (nominal p=0.011) | 61% (nominal p=0.008) |
| CSF neurofilament light | 6% below baseline (n=14) | 4% above baseline (n=11) |
Source: uniQure press release, September 29, 2026. The comparisons run against 1,337 propensity score matched external controls from the ENROLL-HD natural history dataset. CEO Matt Kapusta told trade press that more than half of the external control data was missing by month 48 and that patients who left the control dataset were declining faster than those who stayed, an argument that the comparator, not the drug, deteriorated. Across 29 treated patients, five high dose participants had treatment related serious adverse events tied to CNS inflammation, all resolved.
Why does the timing matter for uniQure’s FDA filing?
The BLA is already in. uniQure filed in early September for accelerated approval on the 36 month data, which the FDA had deemed acceptable at a June Type B meeting. The 48 month decay now lands in the middle of the acceptance window, and the company says it will address any FDA request to reanalyze.
The stakes extend beyond one program. A day earlier, Merck and Daiichi Sankyo withdrew the I-DXd accelerated approval filing after the FDA judged single arm data insufficient, part of a pattern this publication has tracked of the agency raising the evidence bar for surrogate and external control packages. AMT-130 is the most advanced Huntington’s program in development; the calendar had pointed to an acceptance and priority review decision around early November. QURE fell 37.3% Tuesday to 24.51 from Monday’s 39.11 close, our arithmetic, in the first session after the release.
What is Beam alleging against YolTech and Serapha Bio?
Beam Therapeutics alleges that a former scientist secretly founded Chinese biotech YolTech Therapeutics while still employed at Beam and took base editing trade secrets that now power a directly competing program. The complaint, filed September 25 in federal court in Massachusetts, also names venture backed Serapha Bio.
According to the complaint as reported by BioPharma Dive, STAT, and Bloomberg Law, Zi Jun “Emma” Wang worked at Beam from 2021 to 2022 and accessed dozens of internal records outside her ordinary work before departing. YolTech CEO Yuxuan “Jensen” Wu is also named as a defendant. The competitive overlap is specific: Beam’s BEAM-302 and Serapha’s SERP-01 target the same mutation in alpha-1 antitrypsin deficiency. Serapha, which launched from a reverse merger announced in June with $230 million from investors including RA Capital and RTW, said it “categorically refutes” the claims. Beam seeks to stop use of the alleged trade secrets and recover value. The suit opens a new front in the US and China biotech relationship: not licensing economics this time, but the provenance of the underlying technology.
What did Zealand and Roche’s petrelintide show at EASD?
Petrelintide, the amylin analog Roche licensed from Zealand Pharma, delivered up to 10.7% placebo adjusted weight loss at 42 weeks in the Phase 2 ZUPREME-1 trial, with gastrointestinal side effects at rates similar to placebo, and the partners have initiated a global Phase 3 monotherapy program.
The trial enrolled 485 adults with a mean BMI of 36.7. On the efficacy estimand, weight fell up to 10.7% versus 1.7% for placebo; on the treatment policy estimand, up to 10.2% versus 1.4%. At the maximally effective dose there were no vomiting cases and no discontinuations for gastrointestinal events. Results published simultaneously in The Lancet Diabetes and Endocrinology, with additional data presented Wednesday in Milan. Trade coverage noted the dose response plateaued, with the middle dose performing best. The tolerability first profile positions amylin agents as the gentler alternative in a field where retatrutide, on the same day, moved the efficacy ceiling to twice petrelintide’s number.
Did Novo report CagriSema REIMAGINE 1 body composition results?
The data was presented, but the figures are not yet independently reportable. The REIMAGINE 1 body composition late breaker was delivered Tuesday afternoon in Milan by Richard E. Pratley per the EASD program, but Novo Nordisk issued no press release and no trade coverage with verifiable figures had appeared by our check at roughly 8:20 pm Pacific Tuesday.
Body composition is the live question for the amylin plus GLP-1 combination: how much of CagriSema’s roughly 13.7% weight reduction in early type 2 diabetes preserves lean mass. We will report the figures when the presentation is corroborated by independent coverage or a company document, per our sourcing standard for conference presented data.
Who is the new head of PhRMA and when does he start?
PhRMA named former House Majority Leader Eric Cantor its next president and CEO, effective November 9, 2026. He succeeds Stephen J. Ubl, who departs January 15, 2027 after continuing as a strategic advisor through the transition.
Cantor represented Virginia in the House from 2000 to 2014, served as Majority Leader from 2011 to 2014, and has spent the past decade as Vice Chairman and Managing Director at investment bank Moelis and Company. The industry’s chief lobby changes leadership one day after the Section 232 pharmaceutical tariff’s general effective date and in the middle of most favored nation pricing negotiations that have already produced a string of company by company deals. The hire of a dealmaker and former legislative leader, rather than a trade association operator, says something about what the board believes the next five years will demand.
What happened on day one of the Section 232 pharmaceutical tariffs?
The 100% tariff on patented pharmaceutical imports took effect Monday September 29 for companies beyond the initial July 31 wave, and the first observable effect is the exemption architecture, not price moves. No company disclosed a same day financial impact as of our Tuesday evening check.
Business Standard reported that specified specialty pharmaceuticals from India and 19 other jurisdictions, including the EU, Japan, South Korea, Switzerland, Taiwan, Thailand, the UK, and Vietnam, qualify for zero duty treatment under a September 23 Commerce Department Federal Register notice, covering categories such as orphan only drugs and cell and gene therapies. Generic drugs and their ingredients sit outside Section 232 entirely. We committed to reporting observed effects rather than predictions; the scope of Tuesday’s check was wire and trade coverage through the evening, and it surfaced implementation mechanics only.
Which other companies made news on September 29?
Viking closed its upsized raise with the greenshoe fully exercised, the FDA approved the first treatment for MCT8 deficiency, and two after hours filings landed: DBV Technologies submitted its peanut patch BLA and Vanda reported a positive Phase 3 in a circadian rhythm disorder.
Viking Therapeutics closed concurrent upsized offerings Monday evening: 9,035,714 shares at $35.00 plus $258.75 million of 2.00% convertible notes due 2032, with underwriters exercising their options in full on both legs, for gross proceeds of approximately $575.0 million (net approximately $547.8 million), earmarked for VK2735 and the oral VK3019 program. VKTX closed Tuesday at 31.81, 9.1% below the offer price, our arithmetic.
Egetis Therapeutics won FDA approval Monday for Emcitate (tiratricol), the first approved therapy for peripheral thyrotoxicosis in patients with MCT8 deficiency, a rare X linked disorder with a reported median life expectancy of about 35 years. The FDA issued its own press announcement. The Stockholm listed company received a rare pediatric disease priority review voucher and says it expects to explore monetizing it, potentially in the fourth quarter; US availability is expected in eight to ten weeks.
DBV Technologies submitted its BLA Tuesday evening for the Viaskin peanut patch in children aged 4 through 7, the second approval attempt for the epicutaneous immunotherapy after the 2020 complete response letter, this time under a safety exposure agreement reached with the FDA in July. Vanda Pharmaceuticals reported that a Phase 3 of Hetlioz (tasimelteon) in delayed sleep wake phase disorder met its endpoint, a label expansion push for a franchise long confined to non 24 hour sleep wake disorder. Both releases crossed after the close; Wednesday is the first reaction session for each.
Elsewhere: SK pharmteco unveiled a more than $200 million investment to expand CDMO capabilities, per Endpoints News. Enanta Pharmaceuticals cut staff ahead of key antiviral and immunology readouts, per Fierce Biotech. ai3Bio emerged with $48 million for STING pathway immunology programs, per Fierce Biotech. And Canada launched a $5 million accelerated clinical trial program that compresses study startup to 45 days, per Fierce Biotech, a small number attached to a large clinical trial infrastructure question.
Which biotech stocks moved on September 29, 2026?
uniQure’s 37% fall on the 48 month Huntington’s data was the day’s defining move, while Summit’s first session after the AstraZeneca investment added a more modest 5.9% and Kodiak held its 178% repricing.
| Ticker | Sept 29 close | Move | Context |
|---|---|---|---|
| QURE | 24.51 | −37.3% | First reaction to the AMT-130 48 month decay; BLA under FDA review |
| SMMT | 16.39 | +5.9% | First reaction session to AstraZeneca’s $2.0B equity investment disclosed Monday 5:30 pm ET |
| KOD | 91.12 | +1.3% | Second session after DAYBREAK; Monday’s 178% repricing held |
| VKTX | 31.81 | −3.7% | Now 9.1% below the $35.00 offer as the $575M raise closed with full greenshoe |
| HCM | 14.15 | +0.1% | Flat first reaction to the ORPATHYS plus TAGRISSO US NDA submission, a quiet print for a US filing on positive overall survival |
Closes are exchange settled prices; percentage moves are our arithmetic from prior settled closes. Lilly closed at 1184.63 before the retatrutide release crossed; Wednesday is its first reaction session.
Frequently asked questions
What is retatrutide and how does it differ from tirzepatide?
Retatrutide is an investigational once weekly injectable agonist of three receptors: GIP, GLP-1, and glucagon. Tirzepatide (Mounjaro, Zepbound) targets two, GIP and GLP-1. The added glucagon activity raises energy expenditure and appears to deepen weight loss in trials to date.
How much weight did patients lose on retatrutide in TRIUMPH-2?
At 80 weeks, participants with obesity and type 2 diabetes lost 12.7% at 4 mg, 19.1% at 9 mg, and 20.8% at 12 mg, versus 4.0% on placebo, per Lilly’s release. The 12 mg average was 49.6 pounds.
Is retatrutide approved by the FDA?
No. Retatrutide is investigational. Lilly says it plans a US regulatory submission in the first quarter of 2027, with TRIUMPH-2 among the supporting trials.
Why is 20.8% weight loss in type 2 diabetes notable?
Patients with type 2 diabetes consistently lose less weight on incretin drugs than patients without it; semaglutide and tirzepatide both showed several points less efficacy in diabetes populations. A 20.8% result in this population approaches what earlier agents achieved in obesity alone.
What is AMT-130 and how is it given?
AMT-130 (ifezuntirgene inilparvovec) is uniQure’s one time AAV gene therapy for Huntington’s disease, delivered directly into the striatum during neurosurgery. It is designed to lower the mutant huntingtin protein continuously after a single administration.
Did AMT-130 fail at 48 months?
Not outright. The primary composite measure, cUHDRS, showed 44% slowing versus external controls but missed statistical significance (p=0.144), down from significant 80% slowing at 36 months. Total functional capacity remained nominally significant at 61% slowing. The signal weakened; it did not disappear.
Does the 48 month data affect uniQure’s FDA filing?
The BLA was filed on the 36 month data the FDA had already deemed acceptable for an accelerated approval review. The open question is whether the agency asks for reanalysis incorporating month 48; uniQure says it will address any such request. An acceptance decision had been expected around early November.
What are external controls and why are they contentious?
External controls compare treated patients to a matched natural history dataset instead of a randomized placebo arm. They are common in rare disease trials where placebo surgery is unethical, but missing data accumulates over time; uniQure says over half its control data was missing at month 48, complicating interpretation in either direction.
What does Beam’s lawsuit claim was stolen?
Base editing trade secrets, the chemistry for changing a single DNA letter without cutting both strands. The complaint alleges a former Beam scientist founded YolTech while employed at Beam and that Serapha’s SERP-01 competes with BEAM-302 against the same alpha-1 antitrypsin deficiency mutation.
What is petrelintide and how does it compare to CagriSema?
Petrelintide is a pure amylin analog from Zealand Pharma, partnered with Roche, showing about 10% placebo adjusted weight loss at 42 weeks with placebo like GI tolerability in Phase 2. CagriSema combines an amylin analog with semaglutide, trading more efficacy for more GI burden.
When do the Section 232 pharmaceutical tariffs apply and to which products?
The 100% tariff applies to patented pharmaceutical imports, with the general effective date of September 29 following an initial July 31 wave. Specified specialty categories from 20 jurisdictions carry zero duty under the September 23 Commerce notice, and generics are excluded from Section 232 entirely.
What does Eric Cantor’s appointment signal for PhRMA?
The board chose a former House Majority Leader turned investment banker over a career association executive, effective November 9. The profile fits an era in which the industry’s biggest exposures, tariffs and most favored nation pricing, are resolved through negotiated deals rather than conventional lobbying.
What is MCT8 deficiency and what did the FDA approve for it?
MCT8 deficiency (Allan-Herndon-Dudley syndrome) is a rare X linked disorder in which thyroid hormone cannot enter cells properly, causing severe neurodevelopmental impairment and peripheral thyrotoxicosis, with reported median life expectancy near 35 years. The FDA approved Egetis Therapeutics’ Emcitate (tiratricol) Monday as the first US treatment.
Did the CagriSema body composition data get released?
The REIMAGINE 1 body composition late breaker was presented Tuesday at EASD in Milan, but Novo Nordisk issued no release and no independently verifiable figures had been published by Tuesday evening Pacific time. We will report the numbers once corroborated.
Sources
Primary sources (September 28 to 29, 2026): Eli Lilly press release on TRIUMPH-2 (September 29); The Lancet publication of TRIUMPH-2; uniQure press release on AMT-130 Phase 1/2 48 month data (September 29); Beam Therapeutics complaint, US District Court for the District of Massachusetts (filed September 25); PhRMA press release on Eric Cantor (September 29); Zealand Pharma press release on ZUPREME-1 and The Lancet Diabetes and Endocrinology publication; Viking Therapeutics closing press release (September 28); Egetis Therapeutics press release and FDA press announcement on Emcitate (September 28); DBV Technologies press release (September 29); Vanda Pharmaceuticals press release (September 29); Commerce Department Federal Register notice (September 23); EASD 2026 program, Novo Nordisk science hub.
Corroborating coverage: Endpoints News, Fierce Biotech, Fierce Pharma, BioPharma Dive, STAT, Bloomberg Law, Business Standard, Boston Globe. Market closes are exchange settled prices; percentage moves are our arithmetic.
Related coverage
- Kodiak’s DAYBREAK double win, Mirum’s hepatitis delta sweep, and AstraZeneca’s $2B Summit stake (September 29)
- Etentamig’s unreached median PFS, four FDA approvals in one day, and Novo’s delivery deal (September 28)
- GRAIL’s first session after the panel vote and Viking’s upsized offering (September 25)
- GRAIL’s 7 to 2 panel win and Roche’s sefaxersen IgA nephropathy hit (September 24)

