May 11, 2026

Hims Q1 2026 $608M + 2.6M Subscribers, MBX Biosciences Once-Monthly MBX 4291 + Imapextide STEADI, Viking VK2735 ECO Posters, Padova STEP 65+ 15.4% Semaglutide

Hims Q1 $608M, MBX once-monthly + STEADI PBH proof-of-concept, Viking VK2735 + Ascletis multi-program ECO, Padova STEP 65+ semaglutide 15.4%, LUNA18 TIDES.

10 stories · Covering industry, clinical-trials, research

Editor's Note

Convergence Week opened with a Hims & Hers Q1 print and a wave of ECO 2026 + TIDES USA setup data. Hims posted Q1 revenue of $608.1M (+4% YoY), 2.6M subscribers (+9%), and a $92.1M net loss as gross margin compressed from 73% to 65% on the wind-down of compounded semaglutide and the pivot to branded Novo Nordisk supply; the company raised full-year guidance to $2.8-3.0B revenue and $275-350M Adjusted EBITDA. MBX Biosciences posted a same-day obesity portfolio update with MBX 4291 Phase 1 MAD Part B data showing a ~26-day T1/2Cmax supporting once-monthly dosing, nominated MBX 5765 as an amycretin prodrug combining GLP-1, GIP, glucagon, and DACRA activity in a single construct for once-monthly delivery (IND-enabling Q2 2026), and a Phase 2a STEADI proof-of-concept for once-weekly imapextide in post-bariatric hypoglycemia — directly setting up a competitor track to Amylyx's avexitide. Three ECO 2026 abstract slates dominated the obesity preview cycle: Viking VK2735 (Phase 2 VENTURE-Oral 13-week + Phase 3 VANQUISH-1 design), Ascletis multi-program (ASC47 THRβ + semaglutide combination at 111.8% greater relative weight loss, ASC36 once-monthly amylin at 32-day half-life — six times petrelintide, ASC35 GLP-1R/GIPR dual at 14-day half-life — six times tirzepatide), and a Padova-led pooled subgroup analysis of STEP 1/3/4/5/8/9 showing 248 adults aged 65+ on semaglutide 2.4 mg lost 15.4% body weight vs 5.1% on placebo with 28.6% reaching ≥20% loss. A separate Wilding-led pre-print showed real-world greater GLP-1 weight loss tracks with lower osteoarthritis (–37%), CKD (–30%), OSA (–69%), and heart failure complications. On the non-GLP-1 side, TIDES USA Day 1 featured a peer-reviewed Organic Process R&D paper documenting kilogram-scale GMP synthesis of Chugai's LUNA18 — an N-alkyl-rich cyclic undecapeptide and oral KRAS inhibitor in Phase 1 — at >98.5% purity through a 24-step liquid-phase synthesis. Rice University published an International Journal of Obesity study showing semaglutide-driven weight loss carries more social stigma than diet-and-exercise loss. Pfizer's AVA6000 FAP-Dox peptide-drug conjugate set for ASCO 2026 in salivary gland cancers. Catalent's TIDES USA agenda centered on oral macromolecule delivery platforms.

Industry

Hims & Hers Q1 2026 Print: $608.1M Revenue (+4% YoY), 2.6M Subscribers, $92.1M Net Loss as Compounded Semaglutide Wind-Down Compresses Gross Margin; FY Guidance Raised to $2.8-3.0B

Hims & Hers reported Q1 2026 after market close May 11: revenue $608.1M (+4% YoY vs $586M prior year), missing the $616.9M consensus; subscribers up 9% to 2.6M; net loss of $92.1M ($0.41/share) vs $49.5M net income in Q1 2025. Gross margin compressed from 73% to 65% on the strategic pivot away from compounded semaglutide toward branded Novo Nordisk Wegovy/Ozempic supply (live since March 26). Q1 closed March 31 — meaningful Wegovy revenue contribution lands in Q2. Full-year 2026 guidance was raised: revenue to $2.8-3.0B and Adjusted EBITDA to $275-350M. The company is keeping limited compounded GLP-1 access alive alongside branded supply, threading the FDA April 30 503B bulks-list proposal.

#hims-hers #q1-2026 #wegovy #ozempic #novo-nordisk #compounding #guidance-raise

Clinical Trials

MBX Biosciences Obesity Portfolio Update: MBX 4291 Phase 1 Once-Monthly Profile, MBX 5765 Amycretin Prodrug Nominated, Imapextide Phase 2a STEADI Hits Proof of Concept in Post-Bariatric Hypoglycemia

MBX Biosciences (Nasdaq: MBX) released a May 11 obesity portfolio update covering three programs. MBX 4291, a GLP-1/GIP co-agonist prodrug, posted preliminary blinded Phase 1 MAD Part B data showing a T1/2Cmax1 of ~26 days, consistent with true once-monthly dosing; 12-week MAD Part C data expected Q4 2026. MBX 5765, a new amycretin prodrug combining GLP-1, GIP, glucagon, and DACRA (dual amylin and calcitonin receptor agonist) activity in a single construct, is in IND-enabling studies starting Q2 2026. Once-weekly imapextide hit proof of concept in the Phase 2a STEADI trial in post-bariatric hypoglycemia, with glucose nadir increased 17-34% across doses and insulin peak decreased 11-45% — directly competing with Amylyx's avexitide (Phase 3 LUCIDITY topline Q3 2026) for the same indication.

#mbx-biosciences #mbx-4291 #mbx-5765 #imapextide #steadi-trial #post-bariatric-hypoglycemia #amycretin #once-monthly

Clinical Trials

Viking Therapeutics ECO 2026 Posters: VK2735 Phase 2 VENTURE-Oral 13-Week Efficacy + Phase 3 VANQUISH-1 Subcutaneous Design

Viking Therapeutics announced two poster presentations at ECO 2026 in Istanbul (May 12-15) on its VK2735 dual GLP-1/GIP agonist program. The first poster details 13-week efficacy and safety data from the Phase 2 VENTURE-Oral trial of oral VK2735, supporting Viking's Q4 2026 plan to launch a Phase 3 trial of the oral formulation following positive FDA feedback. The second poster details Phase 3 VANQUISH-1 design and enrollment demographics for subcutaneous VK2735, which completed enrollment of approximately 4,650 adults with obesity in November 2025. VANQUISH-2 (subcutaneous VK2735 in T2D + obesity, ~1,000 adults) completed enrollment March 26, 2026. Posters display May 12-15 with networking sessions Thursday May 14 18:00-19:15 TRT.

#viking-therapeutics #vk2735 #venture-oral #vanquish-1 #vanquish-2 #eco-2026 #oral-glp-1 #dual-agonist

Clinical Trials

Ascletis Multi-Program ECO 2026 Slate: ASC47 + Semaglutide 111.8% Greater Relative Weight Loss, ASC36 Once-Monthly Amylin 32-Day Half-Life, ASC35 Dual GLP-1R/GIPR 14-Day Half-Life

Ascletis Pharma will present multiple poster sessions at ECO 2026 covering programs beyond the already-presented ASC30. ASC47, an adipose-targeting thyroid hormone receptor beta (THRβ) agonist designed for muscle-preserving weight loss, demonstrated up to 111.8% greater relative weight loss when combined with semaglutide vs semaglutide monotherapy in obesity participants. ASC36, a once-monthly next-generation amylin receptor agonist peptide, posted a 32-day average observed half-life — six times longer than Zealand's petrelintide. ASC35, a once-monthly next-generation GLP-1R/GIPR dual agonist peptide, showed a 14-day average observed half-life (six times longer than tirzepatide) and 71% more relative weight loss than tirzepatide in a diet-induced obesity mouse model. Session Thursday May 14, 18:00-19:15 TRT.

#ascletis #asc47 #asc36 #asc35 #thr-beta #amylin #glp-1-gip-dual #eco-2026 #muscle-preservation

Clinical Trials

Padova-Led STEP Pooled 65+ Analysis at ECO 2026: Semaglutide 2.4 mg Delivered 15.4% Weight Loss vs 5.1% Placebo, 28.6% of Older Adults Hit ≥20%

Prof. Luca Busetto (University of Padova) and colleagues will present at ECO 2026 a pooled subgroup analysis of 358 adults aged 65 and older (mean age 69, 72% women) drawn from STEP 1, 3, 4, 5, 8, and 9 — 248 received semaglutide 2.4 mg, 110 placebo. The semaglutide arm lost 15.4% body weight on average vs 5.1% on placebo; 46.8% of semaglutide users hit ≥15% weight loss vs 6.4% on placebo, and 28.6% reached ≥20% vs 2.7%. Waist circumference fell 14.3 cm vs 6.0 cm. 27% on semaglutide reached a healthy BMI (<27) vs 5.5%. Serious adverse events occurred in 19.0% on semaglutide vs 12.7% on placebo. The analysis complements Lilly's ECO 2026 orforglipron 65+ subgroup analysis from ATTAIN-1 and ATTAIN-2 — both filling the geriatric data gap for the first generation of mainstream obesity drugs.

#semaglutide #wegovy #step-trials #older-adults #eco-2026 #padova #novo-nordisk #subgroup-analysis

Research

Wilding ECO 2026 Pre-Print: Real-World GLP-1 Weight Loss Correlates With Reduced Osteoarthritis, CKD, OSA, and Heart Failure Complications

Prof. John Wilding (University of Liverpool) and colleagues will present at ECO 2026 a real-world observational study tracking obesity-linked complication rates by degree of GLP-1-driven weight loss. In the year following GLP-1 treatment initiation, 27.0% of patients had BMI reductions <5%, 22.4% had 5-<10%, 14.1% had 10-<15%, 15.8% had ≥15%, and 20.8% gained BMI. Over a mean 11-month follow-up, patients with ≥15% BMI reduction had 37% lower osteoarthritis odds, 30% lower CKD odds, 69% lower OSA odds, and 32% lower heart failure odds versus those with 0-5% reduction (all statistically significant except heart failure). Incidence per 1,000 person-years: 21.4 OA, 21.1 CKD, 20.3 OSA, 3.9 HF. The data quantifies the value of pushing for deeper weight loss rather than cruise-control dosing.

#wilding #liverpool #glp-1 #real-world-evidence #osteoarthritis #ckd #osa #heart-failure #eco-2026

Research

TIDES USA Day 1: Chugai LUNA18 Kilogram-Scale GMP Production Paper — Oral Cyclic Peptide KRAS Inhibitor Cleared Through 24-Step Liquid-Phase Synthesis

TIDES USA 2026 opens in Boston May 11-14 with a featured presentation on Chugai's LUNA18 (paluratide), an N-alkyl-rich cyclic undecapeptide oral KRAS inhibitor. The corresponding paper in Organic Process Research & Development describes a convergent 24-step liquid-phase synthesis route delivering kilogram-scale GMP material at >98.5% purity and >30% overall yield. LUNA18 binds KRAS, NRAS, and HRAS mutants plus wildtype, inhibiting the inactive-state RAS-GEF protein-protein interaction; it achieves 21-47% oral bioavailability without special formulation. The molecule is in Phase 1 monotherapy and combination-with-cetuximab dose escalation. LUNA18's chemistry is a milestone for the oral-cyclic-peptide-against-intracellular-targets thesis that Bicycle Therapeutics, Circle Pharma, and Unnatural Products are advancing through different platform architectures.

#luna18 #chugai #kras #cyclic-peptide #tides-usa-2026 #liquid-phase-synthesis #oral-peptide #rb1-inhibitor

Research

Rice University Study (Int'l Journal of Obesity, May 5): Semaglutide-Driven Weight Loss Carries More Social Stigma Than Diet-and-Exercise Loss

Rice University assistant professor Erin Standen and colleagues at the Mayo Clinic (Sean Phelan) and UCLA (Janet Tomiyama) published in the International Journal of Obesity on May 5 a study finding that adults who lose weight via GLP-1 receptor agonists like Ozempic and Wegovy face more judgment than those who lose weight through diet and exercise — or who do not lose weight at all. The stigma framing centers on 'easy way out' perceptions and intensifies if the patient later regains weight. The work joins the broader social-context literature shaping the GLP-1 era — including the Ozempic Face plastic-surgery surge, GLP-1-related shame disclosures, and patient-reported drift away from disclosing medication use to friends and family.

#rice-university #stigma #semaglutide #ozempic #wegovy #social-research #international-journal-of-obesity

Clinical Trials

Avacta AVA6000 FAP-Dox Peptide-Drug Conjugate Set for ASCO 2026 Oral Presentation in FAP-Positive Salivary Gland and Solid Tumors

Avacta Therapeutics's AVA6000, a fibroblast activation protein (FAP)-activated peptide-drug conjugate releasing doxorubicin selectively in the tumor microenvironment, will be presented at ASCO 2026 (Chicago, May 29-June 2) covering Phase Ia/Ib data in FAP-positive solid tumors with activity against salivary gland cancers — a rare cancer subset with no approved targeted therapies. The pre|CISION platform attaches a peptide tetrazolyl moiety that is cleaved by FAP, an enzyme overexpressed in cancer-associated fibroblasts and selectively present in the tumor stroma, allowing systemic dosing without the cardiotoxicity that limits free doxorubicin. AVA6000 joins Bicycle's nuzefatide pevedotin and Lilly's CRN09682 in the broader peptide-drug conjugate Phase 2/3 cohort.

#avacta #ava6000 #fap-dox #peptide-drug-conjugate #asco-2026 #salivary-gland-cancer #doxorubicin #tumor-microenvironment

Industry

Catalent TIDES USA 2026 Agenda: Zydis Fast Dispersion + ZipDose + Oral Macromolecule Delivery Platforms for Peptides Up to 100,000 Da

Catalent's TIDES USA 2026 presence centers on oral macromolecule delivery — the bottleneck that has kept all but a handful of peptides off the oral-route market. The contract development and manufacturing organization is showcasing its Zydis fast-dispersion platform, ZipDose 3D-printed dose-form technology, and oral macromolecule delivery systems engineered for peptides and proteins up to ~100,000 Da. The portfolio targets the post-orforglipron oral-GLP-1 reference architecture: SNAC permeation enhancers (Novo Nordisk's oral semaglutide approach), lipidation chemistry, and protective formulation matrices. Catalent's positioning aligns with the broader CDMO build-out — PolyPeptide's May EUR 200M credit facility, CordenPharma's $500M Boulder SPPS expansion — converging on Boston this week.

#catalent #tides-usa-2026 #oral-peptide-delivery #zydis #zipdose #macromolecule-delivery #cdmo