Peptide News Digest

Industry News

214 stories across all digests

Industry coverage tracks the money around peptides: Eli Lilly and Novo Nordisk earnings, pipeline shifts, M&A, IPOs, peptide CDMO capacity, and the telehealth and pharmacy economy that GLP-1s built.

The two stories that keep moving the most market cap: how fast oral GLP-1s reach approval (orforglipron, oral semaglutide, oral wegovy, danuglipron's exit), and what happens to the compounded-peptide channel as the FDA tightens. Hims, Ro, LifeMD, GoodRx, and Amazon Pharmacy have all rerouted distribution in the past year. Behind them, contract manufacturers like Bachem, PolyPeptide, and BASF have been the bottleneck no one talked about until they were.

Stories here name the company, the deal, and the dollars. Earnings, partnership, regulatory hit — whatever moved the share price gets covered.

· View digest

Reuters / US News (May 5): Novo Nordisk's Wegovy Pill Boom Faces Price War Test — IQVIA Tracks 721,000 US Q1 Prescriptions Ahead of Wednesday's Q1 Print

Reuters reported May 5 that Novo Nordisk's Wegovy pill posted roughly 721,000 US prescriptions in Q1 per IQVIA, beating analyst expectations on volume but raising margin questions: about 450,000 of those scripts were for the cheapest 1.5 mg starter dose at $149/month. Lilly's Foundayo approval in early April closed Novo's window as the only oral obesity pill, and Wegovy injection prices have fallen rapidly amid intensifying competition. The Danish company's market value has shed more than $400 billion from its 2024 peak. Wednesday's Q1 print (May 6, 7:30 CEST) is the test: investors are watching whether Novo holds February's guidance of a 5–13% sales and operating-profit decline at constant exchange rates, and whether direct-to-consumer NovoCare and the WW Med+ + GoodRx channels can offset price pressure.

· View digest

Drexel News Q&A (May 5): Why Are Peptides Becoming More Popular and Are They Safe?

Drexel University's news desk ran a May 5 Q&A on peptide popularity and safety, framed by the FDA's April Category 2 removals and the upcoming July 23–24 PCAC meeting on seven peptides for the 503A bulks list. The piece covers why peptides are surging — easier and cheaper synthesis since the 1980s genetic-engineering era, plus newer molecules like GLP-1 with broad therapeutic effects — and the safety gaps: pharmacy-to-pharmacy compounding variability, supply not keeping up with demand, and a gray-market problem that pushes patients to unverified online sources. The Q&A joins the AMA, AJMC, Pharmacy Times, MIT Technology Review, and the American Council on Science and Health pieces in the post-Category-2 consumer-education ecosystem.

· View digest

Pfizer Q1 2026 (April 29): Revenue $14.45B Beats Consensus on Strong Non-COVID Growth; 20+ Obesity Trials in 2026 Including 10 Phase 3 of PF'3944

Pfizer reported April 29 Q1 2026 revenue of $14.45 billion (vs. $13.92B consensus) and adjusted diluted EPS of $0.75 (vs. $0.72), with non-COVID operational revenue up 7%. The company reaffirmed 2026 guidance of $59.5–62.5B in revenue and $2.80–3.00 in adjusted EPS. On the obesity portfolio, Pfizer confirmed 20+ planned and ongoing studies across the diverse obesity pipeline acquired with Metsera, including 10 Phase 3 trials of PF'3944 (MET-097i) — the recently initiated Phase 3 VESPER-4 once-weekly study, the planned VESPER-5 in T2D, the planned VESPER-6 once-monthly maintenance study, and at least seven more. MET-233i, a monthly amylin analog, is in Phase 1 monotherapy and combination-with-PF'3944 development.

· View digest

Neurogan Health Launches 2% GHK-Cu Copper Peptide Body Care After 12-Week Clinical Trial Showing 32.8% Wrinkle Depth Reduction and 20–30% Skin Firmness Improvement

Neurogan Health expanded its product line with a topical 2% GHK-Cu copper peptide body care, supported by a 12-week clinical trial reporting 32.8% reduction in wrinkle depth and 20–30% improvement in skin firmness. The launch lands in a 2026 GHK-Cu market characterized by surging consumer interest — the peptide is the fastest-growing skincare ingredient by search volume, with patient interest spanning skin rejuvenation, hair loss, and systemic longevity. Topical GHK-Cu has the strongest evidence base among research peptides, going back decades on wound healing and collagen synthesis, and topical applications avoid the regulatory gray zone around the injectable formulation.

· View digest

Eli Lilly Releases Updated Foundayo Safety Data Following FDA Request, Cites 11,000-Patient Program with No DILI Signal

Eli Lilly's Global Patient Safety team responded to the FDA's request for updated Foundayo safety information on May 4, concluding the FAERS event was 'not reasonably related to Foundayo.' The company pointed to the 11,000-participant ACHIEVE and ATTAIN program — followed for up to two years — where the liver safety profile of Foundayo was similar to placebo and active comparator medicines, with no cases of drug-induced liver injury observed and no hepatic safety signal detected. ACHIEVE-4 specifically included a thorough drug-induced liver injury (DILI) analysis with no hepatic signals, consistent with the 57% lower all-cause death rate (HR 0.43) seen versus insulin glargine in that arm.

· View digest

RBC Capital Defends LLY: Foundayo Single Liver Case is 'Baseline Noise, Not a Mechanistic Safety Signal'

RBC Capital reiterated its Outperform rating on Eli Lilly May 4 with the framing 'baseline noise, not a mechanistic safety signal,' and put the single Foundayo case in context against the broader GLP-1 class hepatic failure tally: Mounjaro 30 cases, Zepbound 2, Ozempic 33, Wegovy 15. Other Street analysts followed similar reasoning. The defense rests on the 11,000-patient clinical program and the absence of any DILI signal across two years of follow-up. The framing matters because the launch trajectory for Foundayo had already been challenged by IQVIA tracker data showing the Wegovy pill running roughly 20× ahead in retail prescriptions; a sustained safety overhang would compound the commercial pressure.

· View digest

CordenPharma Confirms $500M Boulder SPPS Expansion to More Than 42,000 L Capacity by 2028, Adding 200+ Jobs and 64,000 sq ft Lab Space

CordenPharma's Boulder, Colorado expansion is now confirmed at $500 million, with the first phase coming online in 2026 and full completion in 2028. The site will add new large-scale manufacturing lines and a greenfield facility that more than doubles its solid-phase peptide synthesis (SPPS) capacity to over 42,000 liters by 2028 — positioning Boulder among the largest peptide production sites worldwide. CordenPharma Colorado leased 64,000 square feet at BioMed Realty's Flatiron Park 5505 Central — Boulder's first purpose-built speculative lab building — and will add more than 200 employees to the existing 700-person workforce. The expansion sits within CordenPharma's broader €900M+ ($1B+) global peptide platform investment that also includes a >€500M greenfield site near Basel.

· View digest

Pfizer to Present 40+ Oncology Abstracts at ASCO 2026 Including Peptide-Drug Conjugate and Bispecific Programs

Pfizer announced that data from more than 40 company-sponsored, investigator-sponsored, and collaborative research abstracts will appear at ASCO 2026 in Chicago (May 29–June 2). The slate spans Pfizer's diverse oncology pipeline including peptide-drug conjugate programs, bispecific T-cell engagers, and antibody-drug conjugates. Combined with previously announced ASCO 2026 acceptances from Bicycle Therapeutics, BriaCell, Greenwich LifeSciences, BioVaxys, and Immutep, the meeting is shaping up as the most peptide-and-immuno-conjugate-heavy ASCO in recent memory — building on the foundation laid at AACR 2026 in San Diego.

· View digest

Novo Nordisk Officially Retires Rybelsus Brand in US, Re-launches Same Molecule as 'Ozempic Pill' to Tap Blockbuster Recognition

Novo Nordisk announced May 1 that Rybelsus is being retired as a US brand and the molecule re-launches Monday May 4 as Ozempic Pill at 1.5/4/9 mg in 70,000+ pharmacies. Bloomberg and Fierce Pharma framed it as a marketing-driven move: same active ingredient as Rybelsus, but reformulated for improved absorption and bioavailability so smaller tablets achieve equivalent efficacy. Aligning the oral and injectable products under a single brand is meant to simplify prior authorizations and prescribing discussions, and to capitalize on Ozempic's recognition as Novo defends market share against Lilly's Foundayo. Rybelsus continues outside the US.

· View digest

Wegovy Pill IQVIA Tracker: ~113,000 US Prescriptions in Latest Week vs. Foundayo's 5,612 — Oral GLP-1 Race Tilts Decisively to Novo Early

IQVIA data cited by Deutsche Bank analysts and Pharmaphorum showed Novo Nordisk's Wegovy pill at roughly 113,354 prescriptions in its most recent reported week, up from 105,366 the week prior. That puts Novo's January-launched oral semaglutide more than 20× ahead of Lilly's Foundayo Week 3 reading of 5,612, and the gap is from US retail-channel data alone — NovoCare Pharmacy direct-to-consumer volumes are additional. Lilly executives have asked analysts to wait 8–12 weeks for a clearer read, but the early Foundayo-versus-Wegovy-pill comparison continues to favor Novo on raw volume.

· View digest

AJMC Oral Peptides FAQ Mainstreams the Bioavailability and Safety Conversation Ahead of July PCAC

AJMC ran a consumer-grade FAQ on oral peptides covering bioavailability (typically <1% even with optimized formulations), delivery technologies (SNAC for oral semaglutide, liposomal systems, lipidation as in liraglutide and insulin detemir), and the safety distinction between FDA-approved oral peptides and the wave of unverified products. The piece sits alongside the AMA's late-April primer on injectable peptides and STAT, Scientific American, Washington Post, and ABC News coverage from earlier in the year — collectively building the public-facing safety narrative ahead of the July 23–24 PCAC meeting. The FAQ explicitly flags the FDA expert-panel review and the gap between Category 2 removal and FDA approval.

· View digest

TIDES USA 2026 Conference Set for May 11–14 Boston, Featuring Bachem, Gilead, Novo Nordisk on Peptide and Oligonucleotide CMC + GMP Capacity

TIDES USA 2026 — the year's leading oligo, peptide, and mRNA therapeutics conference — opens May 11–14 in Boston, with six concurrent scientific tracks and 200+ presentations. Programmatic highlights include CMC strategy for complex dual and triple agonists under regulatory scrutiny, defining defensible starting materials for GLP-1 APIs, and how CDMOs are securing scarce GMP suite capacity dominated by big-pharma volume contracts. Bachem, PolyPeptide, CordenPharma, Gilead, and Novo Nordisk teams are scheduled to speak — the same week as Hims & Hers' Q1 print and within the new AJMC oral-peptides public-facing news cycle.

· View digest

Hims & Hers May 11 Q1 2026 Print Preview: $600–625M Revenue Guide, Testosterone Rx+ Diversifies Beyond GLP-1, Peptide Manufacturing Pivot Looms Post-PCAC

Hims & Hers reports Q1 2026 results May 11 after market close. Company guidance: $600–625M revenue (2–7% YoY) and $35–55M adjusted EBITDA (~7% margin), with Q1 carrying a roughly $65M timing impact from the weight-loss shift to 503A fulfillment. Outlook (ex-Eucalyptus) is $2.7–2.9B revenue and $300–375M EBITDA. Hims also launched Testosterone Rx+ — a once-daily pill for low-libido idiopathic hypogonadism — as a non-GLP-1 specialty addition, signaling the wider longevity and peptide play the company has telegraphed for 2026. The California peptide-manufacturing facility acquired in February 2025 sits as a post-PCAC option for producing reclassified Category 1 peptides if the July meeting clears the path.

· View digest

Amgen Q1 2026 (April 30): MariTide MARITIME-1 Phase 3 Ongoing, MARITIME-2 EXTENSION Initiated, Three T2D Phase 3 Studies Slated for 2026

Amgen reported Q1 2026 revenue of $8.6 billion (+6%) on April 30 alongside an obesity-pipeline update. MariTide — a peptide-antibody conjugate that activates the GLP-1 receptor and antagonizes the GIP receptor with monthly or less frequent dosing — has the Phase 3 MARITIME-1 study ongoing in adults with obesity or overweight, and Amgen has now launched the MARITIME-2 EXTENSION study to evaluate weight-loss maintenance. Three Phase 3 studies of MariTide in people with type 2 diabetes are planned to start in 2026, alongside a Phase 2b liver-fat-reduction study and the Phase 1 study of follow-on candidate AMG 513 in obesity.

· View digest

Partnership for Safe Medicines Applauds FDA's 503B GLP-1 Bulks-List Proposal, Plans Federal Register Comment

The Partnership for Safe Medicines issued a May statement strongly supporting the FDA's April 30 proposal to exclude semaglutide, tirzepatide, and liraglutide from the 503B outsourcing-facility bulks list, citing 'sound science, sound law, and a clear-eyed commitment to patient safety.' The Partnership cited more than 455 adverse-event reports linked to compounded semaglutide and more than 320 tied to compounded tirzepatide — many involving dosing errors from multidose vials, some leading to hospitalization — as the safety basis. The group plans to submit a full comment to the Federal Register docket before the June 29 deadline and is encouraging other patient-safety groups to do the same.

· View digest

Lilly Q1 Earnings Call: Foundayo Reaches 20K Patients, 8K+ Prescribers (33% First-Time Oral GLP-1), Mid-May Major PBM Access

On the April 30 call, Lilly USA executive Ilya Yuffa said roughly 20,000 patients are now on Foundayo (orforglipron) for obesity or overweight and more than 8,000 prescribers have written it. Notably, 80% of patients are new to the GLP-1 class and one-third of prescribers had not previously written an oral GLP-1, suggesting Foundayo is expanding the addressable market rather than purely cannibalizing injectables. Lilly also confirmed commercial access at two of the three largest U.S. pharmacy benefit managers effective mid-May. Active sales-force promotion only began the week of April 23, two weeks after broad supply-channel availability on April 9.

· View digest

Hims & Hers Stock Up 9% Heading into May 11 Q1 Print as Investors Bet on Peptide Pipeline + Novo Nordisk Partnership

Hims & Hers shares climbed roughly 9% in early-week trading from $28.82 to $31 ahead of the company's May 11 Q1 2026 earnings, extending a five-session run that has lifted the stock about 49%. The catalysts: renewed FDA interest in peptides via the upcoming July PCAC meeting and the company's Novo Nordisk collaboration providing branded Wegovy and Ozempic access. Hims also flagged a 2026 longevity specialty launch covering peptides, coenzymes, and GLP/GIP treatments, and continues to invest in the California peptide-manufacturing facility acquired in February 2025 — which could pivot to producing reclassified Category 1 peptides if the July PCAC clears the path.

· View digest

Novo Nordisk Ozempic Pill (Oral Semaglutide) Lands in US Pharmacies May 4 — First FDA-Approved Oral Peptide GLP-1 with CV Risk Reduction

Novo Nordisk announced May 1 that Ozempic (semaglutide) tablets at 1.5 mg, 4 mg, and 9 mg will be available across 70,000+ U.S. pharmacies starting Monday, May 4, for adults with type 2 diabetes. The product is the only FDA-approved oral peptide GLP-1 medication cleared for both primary and secondary cardiovascular risk reduction in adults with T2D, manufactured end-to-end in the United States. Insured patients can access the pill for as little as $25 for up to a 3-month supply; self-pay patients face $149–$299/month depending on dose strength.