Amgen, Inc.

Eli Lilly's Zepbound outperformed Novo Nordisk's Wegovy in a clinical trial, showing 47% greater relative weight loss. Zepbound targets both GLP-1 and GIP receptors, while Wegovy targets only GLP-1. The trial involved 751 participants, with Zepbound achieving an average 20.2% weight loss versus Wegovy's 13.7%. Lilly plans to publish more details in 2025.

Eli Lilly's Zepbound showed 47% more relative weight loss than Novo Nordisk's Wegovy in a Phase III trial, with Zepbound participants losing an average of 22.8 kg vs. 15 kg for Wegovy users. Lilly's stock rose 2.5% following the news, with a market cap of $750.9bn.

Antag Therapeutics raises 80 million euros to advance its GIP-inhibiting weight loss drug AT-7687 into clinical testing, exploring its combination with Novo Nordisk's Wegovy. The Series A round, led by Versant Ventures, includes Novo Holdings, SR One, Pictet, KKR-related entities, Broadview Ventures, and the Danish Export and Investment Fund. Antag's approach contrasts with Eli Lilly's GIP-activating Zepbound, with both methods debated. Combining GIP with GLP-1 appears more effective than GLP-1 alone, as seen in Lilly's SURMOUNT-5 trial. Antag's AT-7607, a GIP-blocking peptide, aims for fewer side effects and potential synergies with current and future therapies.

Refoxy Pharma secures $9.58 million to develop IPF drug RP-01 targeting FOXO3. Boehringer Ingelheim plans NDA submission for nerandomilast. Insilico's ISM001-055 and Endeavor's ENV-101 show disease improvement. Vicore's buloxibutid and BMS' BMS-986278 also chart progress. Pliant's bexotegrast mitigates chronic cough in IPF. IPOs and partnerships fuel IPF therapeutic field.

Dr. Marty Makary, Trump's FDA nominee, questions conventional medical wisdom in his book 'Blind Spots,' advocating alternative treatments and criticizing medical establishment 'groupthink.' His potential leadership could shift FDA focus to food regulation, but his book's selective use of evidence raises concerns about undermining FDA's drug approval standards and public trust. Makary's contrarian views, often based on observational studies, contrast with FDA's traditional reliance on rigorous clinical trials.

DelveInsight's report highlights a robust lupus nephritis pipeline with 30+ companies developing 35+ therapies, including key players like AstraZeneca and Novartis. Promising therapies like Anifrolumab and Ianalumab are in various clinical phases, with recent updates from companies like Adicet Bio and Kyverna Therapeutics. The report provides comprehensive insights into the pipeline, therapeutic assessments, and market dynamics.

MEDIPOST, Inc. appoints five senior executives to lead its U.S. expansion of CARTISTEM, a regenerative therapy for knee osteoarthritis, aiming for IND approval and Phase III clinical trial initiation.

Johnson & Johnson filed two sBLAs for Tremfya, seeking expanded use in pediatric patients with moderate-to-severe plaque psoriasis and active juvenile psoriatic arthritis. Tremfya, an IL-23 inhibitor, is already approved for adult patients with psoriasis and psoriatic arthritis. The filings are based on phase III studies and PK data. Tremfya sales grew 21.6% year-over-year to $2.7 billion in the first nine months of 2024. J&J expects Tremfya to reach $5 billion with approvals for inflammatory bowel disease conditions.

T.C. has consulted/advised/spoken for ASCO Post, AstraZeneca, Bio Ascend, Bristol Myers Squibb, Clinical Care Options, Daiichi Sankyo, Genentech, IDEOlogy Health, Medical Educator Consortium, Medscape, Merck, OncLive, oNKo-innate, PEAK Medicals, PeerView, Pfizer, Physicians’ Education Resource, RAPT Therapeutics, Regeneron, Targeted Oncology. W.N.W.Jr. has consulted/advised/spoken for Amgen, AstraZeneca, Bayer, BMS, Boehringer Ingelheim, Daiichi-Sankyo, Eli Lilly, Genentech/Roche, Ipsen, Janssen, Merck, MSD, Novartis, Pfizer, Sanofi-Aventis, Takeda, United Medical.

Amgen’s MariTide showed 20% weight loss in non-diabetic and 17% in diabetic participants over 52 weeks, with no plateau observed. MariTide, a GLP-1 receptor agonist and GIPR antagonist, offers monthly dosing via a handheld device, improving cardiometabolic parameters without significant adverse effects. Amgen plans to initiate Phase III trials, targeting obesity and related conditions.