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Lilly targets six entities in legal bid to curb retatrutide black-market
business12 days ago

Lilly targets six entities in legal bid to curb retatrutide black-market

Eli Lilly filed six lawsuits to crack down on a growing black‑market for retatrutide, an experimental obesity drug not yet approved by the FDA. The company says online merchants, clinics, compounders and foreign sellers are offering untested versions of retatrutide, which could be fake, impure or mis‑dosed. Lilly has referred more than 200 entities to regulators and flagged over 14,000 listings across 100 countries as it prepares for a potential FDA filing next year.

via BioPharma Dive|
#black-market#business#lawsuits
business12 days ago

Lilly sues six US sellers over illegal retatrutide knockoffs in crackdown on weight-loss drug black market

Eli Lilly has filed lawsuits against six U.S. sellers—including California’s Aesthetic Envy and five Texas companies—for distributing illegal retatrutide copies marketed as research-use only but sold for human use, part of a broader effort after FDA warnings; Lilly says it has identified more than 200 entities and 14,000+ online listings worldwide. Retatrutide is investigational and, in Phase 3, has shown up to about 29% weight loss and targets GLP-1, GIP and glucagon; Lilly plans to seek FDA approval early next year.

via Fierce Pharma|
#business#counterfeit-sellers#lawsuits
Lilly rides GLP-1 wave, lifts 2026 outlook on Zepbound/Mounjaro demand
business20 days ago

Lilly rides GLP-1 wave, lifts 2026 outlook on Zepbound/Mounjaro demand

Eli Lilly beat Q2 estimates as demand for obesity and diabetes drugs fueled stronger earnings, prompting a raise in 2026 revenue guidance to $85–$87 billion. Q2 revenue was $22.97 billion with adjusted EPS of $8.38; Mounjaro worldwide sales reached $9.94 billion, Zepbound US sales were $4.93 billion, and Foundayo contributed $98 million in its first quarter of selling. International sales surged while price cuts trimmed some gains. The company highlighted ongoing aggressive M&A activity and expected benefits from Medicare coverage for obesity drugs.

via CNBC|
#2026-guidance#business#foundayo
Lilly lifts 2026 outlook on GLP-1 momentum and pipeline expansion
business20 days ago

Lilly lifts 2026 outlook on GLP-1 momentum and pipeline expansion

Lilly reported Q2 2026 revenue of $23.0B, up 48% from a year earlier driven by Mounjaro and Zepbound, with GAAP EPS of $7.94 and non-GAAP EPS of $8.38; the company raised its full-year guidance to $85-87B in revenue and $35.50-$36.50 in non-GAAP EPS (midpoint up about $2.78) offset by $3.03 of acquired IPR&D charges, and highlighted regulatory wins (EBGLYSS for atopic dermatitis, Jaypirca in the EU for CLL) and continued obesity pipeline progress (retatrutide) with a planned BLA in 1Q 2027; Lilly also completed multiple acquisitions and announced additional investments to expand manufacturing in Indiana, underscoring a broad, growing pipeline.

via Eli Lilly and Company|
#business#lilly#mounjaro
Lilly’s $3.8B bet signals a new era for psychedelic mental-health drugs
business1 month ago

Lilly’s $3.8B bet signals a new era for psychedelic mental-health drugs

Eli Lilly agreed to acquire AtaiBeckley for up to $3.8 billion, signaling Big Pharma’s embrace of psychedelic therapies such as BPL-003 (a synthetic 5-MeO-DMT nasal spray) for treatment-resistant depression, currently in Phase 3 with potential multi-billion-dollar returns. The broader field spans LSD, psilocybin, MDMA, and other compounds, buoyed by positive trial results and regulatory efforts, but faces challenges like insurance coverage and regulatory navigation; several companies eye rapid development under FDA fast-track programs as the psychedelics market aims for widespread clinical use.

via CNBC|
#ataibeckley#business#fda-breakthrough-therapy-designation
Lilly bets big on psychedelics with $2.8B AtaiBeckley deal
business1 month ago

Lilly bets big on psychedelics with $2.8B AtaiBeckley deal

Eli Lilly agreed to acquire AtaiBeckley for $2.8 billion upfront to expand into psychedelic mental-health therapy, led by BPL-003 (intranasal 5-MeO-DMT) which showed phase 2b improvements in treatment-resistant depression; the deal includes up to $1 billion in contingent payments tied to milestones for VLS-01 and BPL-003, plus a $6.75-per-share price with a 40% premium, positioning Lilly to compete with J&J’s Spravato in the TRD market.

via Fierce Biotech|
#acquisition#ataibeckley#business
Sangamo Goes Chapter 11 as Lilly and Astellas Target Its Assets
business2 months ago

Sangamo Goes Chapter 11 as Lilly and Astellas Target Its Assets

Sangamo Therapeutics filed for voluntary Chapter 11 bankruptcy and cut about 40% of its staff as Lilly and Astellas act as stalking horse bidders to acquire key asset platforms, including AAV capsid delivery and gene-editing tools. Lilly is also eyeing the prion therapy ST-506, while Astellas pursues Fabry disease gene therapy ST-920; Giroctocogene fitelparvovec may be sold separately. The restructuring aims to maximize value amid cash constraints and creditor claims.

via BioSpace|
#asset-sale#astellas#bankruptcy
Lilly Acquires 4E Therapeutics to Fast-Track Non-Opioid Pain Therapy
business2 months ago

Lilly Acquires 4E Therapeutics to Fast-Track Non-Opioid Pain Therapy

Eli Lilly has acquired Austin-based 4E Therapeutics to advance a non-opioid pain program that targets the MNK-eIF4E signaling pathway in peripheral sensory neurons. 4E’s lead MNK inhibitor 4ET1103 showed favorable Phase 1 safety, and Lilly will integrate 4E’s neuroscience capabilities into its broader pain portfolio. Terms were not disclosed.

via PR Newswire|
#4e-therapeutics#business#chronic-pain
Lilly bets big on Ajax asset as early data show rapid JAK2 inhibitor activity in MF
business2 months ago

Lilly bets big on Ajax asset as early data show rapid JAK2 inhibitor activity in MF

Lilly’s up-to-$2.3 billion acquisition of Ajax Therapeutics is being justified by early AJX-101 data showing AJ1-11095, a Type II JAK2 inhibitor, produced rapid spleen size reduction and symptom improvement in pretreated myelofibrosis patients, with reductions in mutant JAK2 allele burden and a generally favorable safety profile though anemia and thrombocytopenia occurred; most patients remained on therapy, and the company plans a Phase 3 in second-line MF while expanding to other MF subtypes, signaling a potential challenge to Incyte’s Jakafi dominance and underscoring Lilly’s strategy to back de-risked, validated assets.

via Fierce Biotech|
#aj1-11095#ajax-therapeutics#business
Lilly’s next-gen obesity drug shows weight loss potential but safety signals need more data
health2 months ago

Lilly’s next-gen obesity drug shows weight loss potential but safety signals need more data

Lilly’s obesity drug retatrutide, which previously showed rapid weight loss and diabetes benefits, yielded new safety data at the ADA meeting and in Lancet: in TRANSCEND-T2D-1, 7 of 403 participants on retatrutide had arrhythmias and 3 had major cardiovascular events versus none on placebo, a small event count that experts say is insufficient to draw firm cardiovascular risk conclusions.

via statnews.com|
#arrhythmias#health#lilly
Lilly inks up to $3B multi-program deal with Haisco to expand global portfolio
business2 months ago

Lilly inks up to $3B multi-program deal with Haisco to expand global portfolio

Eli Lilly expanded its global portfolio by signing a multi-program collaboration with China’s Haisco Pharmaceutical to co-develop up to five innovative targets across multiple therapeutic areas. Lilly will lead IND-enabling and may own global rights or rights outside Greater China per program, in exchange for $87 million upfront and up to $2.97 billion in milestones plus tiered single-digit royalties. The deal adds to Lilly’s ongoing spending spree to broaden its pipeline, which recently included a $1.2 billion Hanmi deal and other biotech acquisitions and partnerships.

via Fierce Biotech|
#business#haisco#ind-enabling
Lilly inks $1.26B deal to license Hanmi's GLP-2 drug for short bowel syndrome
business2 months ago

Lilly inks $1.26B deal to license Hanmi's GLP-2 drug for short bowel syndrome

Eli Lilly is licensing Hanmi’s phase 2 GLP-2 agonist sonefpeglutide for short bowel syndrome, paying $75 million upfront and potentially up to $1.185 billion in milestones; Hanmi will complete its ongoing mid-stage SBS trial, while Lilly will initiate new studies based on existing data, positioning a monthly GLP-2 option to compete with Takeda’s Gattex as Lilly expands its GI/GLP-2 portfolio.

via Fierce Biotech|
#business#glp-2#hanmi