Tag Archives: Sanofi

Viking’s Topline AE Data Scares the Street; Medtronic Q2 ‘25 Earnings; Novo Partners for Oral Peptide Research; Rezdiffra Gains EU Marketing Authorization; UK Approves Tzield; Luna Closes Series A Funding Round; Health Canada Approves FLOW; EMA Accepts NewAmsterdam’s Obicetrapib MAA 

A series of cardiometabolic-related news items has been observed from Viking Therapeutics, Medtronic, Novo Nordisk, Madrigal Pharmaceuticals, Sanofi, Luna Health, and NewAmsterdam Pharma. Below, FENIX provides highlights and insights for the respective news items.

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FDA Publishes Slew of CRLs in Effort to Increase Transparency

FDA announced it has published more than 200 CRLs to increase transparency. The CRLs were issued to applications submitted between 2020 and 2024, and all are for drugs that have since gained approval from the agency, a Department of Health and Human Services spokesperson told Fierce Biotech (view article). Below, FENIX provides an overview of select CRLs and brief insight into the FDA openness policy.

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Obesity Spotlight: Regeneron’s Obesity Strategy Continues to Evolve

In the sixth installment of FENIX’s Obesity Spotlight Series, FENIX has conducted a deep dive analysis of Regeneron’s current position in the obesity market. Recall, Regeneron recently announced it entered into an in-licensing agreement with Hansoh for a QW SC GLP-1/GIP RA (previous FENIX insight), which may signal a fundamental shift in the company’s strategy.

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Lilly Stockpiles Orfoglipron; February CHMP Agenda Observed

Two cardiometabolic-related news items have been observed: Lilly has stockpiled $548M worth of orforglipron in a risky move ahead of the regulatory filing/approval (view 10-K); and the CHMP agenda (view here) for this month’s meeting (Feb 24-27) has been released. Below, FEINX provides highlights and insights for the respective news items.  

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Roche and Sanofi Q4 ‘24 Earnings; Tectonic Interim Ph1b HFpEF Data

Three cardiometabolic-related news items have been observed: Roche (press release; slides) and Sanofi (press release; slides; infographic) hosted their respective Q4 ’24 earnings calls; and Tectonic Therapeutic announced positive interim data from its Ph1b trial evaluating TX45 (LA relaxin fusion protein; view press release). Below, FENIX provides highlights and insights for the respective news items.

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JPM 2025 Day 2: LLY, AZN, SNY, NVS, BAY, AKRO, SRRK, SDZ, MRK, TDOC, VTRS; Dario Partners for GLP-1RA Solution Expansion

On the second day of JPM 2025, FENIX has provided coverage of presentations by major CVRM companies, including Lilly, AstraZeneca, Sanofi, Novartis, Bayer, Akero, Scholar Rock, Sandoz, Merck, Teladoc, and Viatris. Of note, JPM experienced webcast issues during the 9:45 AM PT time slot. Separately, one CVRM-related news item has been observed: Dario partnered with MediOrbis for GLP-1RA solution expansion (view press release).

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Metsera Initiates Ph2b MET-097 Obesity Trial; Arrowhead Files for Ph1/2a Obesity Trial Initiation; Sanofi Invests in New Beijing Insulin Plant

Three cardiometabolic-related news items have been observed: Metsera initiated a Ph2b MET-097 (SC GLP-1RA) obesity trial (view CT.gov record); Arrowhead Pharmaceuticals filed for regulatory clearance to initiate a Ph1/2a ARO-ALK7 (RNAi) obesity trial (view press release); and Sanofi announced it invested €1B ($1.05B) for a new insulin manufacturing facility in Beijing (view article; view Chinese press release). Below, FENIX provides highlights and insights for the respective news items.

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