Category Archives: Other

Intercept Faces Uphill Battle for Impending FDA Adcom; Briefing Documents Released

Briefing documents have been posted (view here) for FDA’s Gastrointestinal Drugs Advisory Committee (GIDAC) meeting to discuss the use of Intercept’s obeticholic acid (OCA) for the treatment of pre-cirrhotic liver fibrosis due to NASH. For context, the OCA adcom is on Friday, May 19, 2023 (previous FENIX insight). Recall, in January 2023, FDA accepted the NDA for OCA seeking accelerated approval as a Class 2 resubmission and assigned a PDUFA date of June 22, 2023 (previous FENIX insight). Of note, Intercept’s stock price decreased as much as -22% in intraday trading following the release of the briefing documents. Below, FENIX provides insight into the potential outcome of the OCA FDA adcom.

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Viking Topline Ph2b VK2809 NASH Data; Chinook and Ionis Partner to Develop ASO Therapy for CKD

Two cardiometabolic-related news items have been observed: Viking Therapeutics announced positive topline results from its Ph2b VOYAGE study evaluating VK2809, an oral thyroid beta receptor (TRβ) agonist, in patients with biopsy-confirmed NASH (F2 and F3; view CT.gov record) and hosted an associated call with investors (view press release; webcast); and Chinook Therapeutics announced it has entered into a collaboration agreement with Ionis for the discovery, development, and commercialization of an antisense oligonucleotide (ASO) therapy for a rare, severe CKD with significant unmet medical need (view press release). Below, FENIX provides highlights and insights into the respective news items.

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Senate Targets PBMs and Insulin Manufacturers; Zealand and Dario Q1 ’23 Earnings; Cytokinetics Initiates Ph1 Trial for Potential HFpEF Therapy

Four cardiometabolic-related news items have been observed: On May 10, 2023, the Senate Committee on Health, Education, Labor, and Pensions (HELP) held a widely covered hearing with Sanofi, Lilly, and Novo Nordisk’s CEOs as well as executives from top PBMs (view broadcast here); Zealand Pharma (view press release; slides) and Dario (press release) hosted their respective Q1 ‘23 earnings calls; and Cytokinetics announced the initiation of a Ph1 trial evaluating CK-4021586 (CK-586) as a potential treatment for HFpEF (view press release). Below, FENIX provides highlights and insights into the respective news items.

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BI and Zealand Announce Positive Ph2 BI 456906 Obesity Results; Senseonics and MannKind Q1 ’23 Earnings; Sanofi Study Demonstrates Benefit of Dario; MyFitnessPal and Google Health CGM Integration; Diamyd’s Remygen Fails To Support Durable Treatment Effect

A series of cardiometabolic-related news items have been observed from BI and Zealand, Dario and Sanofi, MyFitnessPal and Google Health, and Diamyd Medical. Additionally, Senseonics and MannKind hosted their respective Q1 ’23 earnings calls. Below, FENIX provides highlights and insights into the respective news items.

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AZ’s Farxiga Receives FDA Approval for DELIVER; Esperion, Xeris, Madrigal, and Sigilon Q1 ’23 Earnings; Ascensia Expands Eversense PASS Program; and Glooko Redesigns App

A series of cardiometabolic-related news items have been observed from AstraZeneca, Ascensia, and Glooko. Additionally, Esperion, Xeris, Madrigal, and Sigilon provided Q1 ’23 earnings updates. Below, FENIX provides highlights and insights into the respective news items.

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Akebia and Viatris Q1 ’23 Earnings

Two cardiometabolic-related news items have been observed: Akebia Therapeutics (view press release) hosted its Q1 ’23 earnings call and discussed the recent approval of Vafseo (vadadustat) by the European Commission and regulatory proceedings for vadadustat in the US. Viatris (view press release; slides) also hosted its Q1 ’23 earnings call and provided brief CVRM-related updates. Below, FENIX provides highlights and insights into the respective news items.

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Insulet Q1 ’23 Earnings and Organizational Changes; Tidepool Secures Funding to Support Tidepool Loop for Android

Three cardiometabolic-related news items have been observed: Insulet hosted its Q1 ’23 earnings call (view press release; slides) and provided updates to its commercial and R&D activities; in a separate press release, Insulet announced a new organizational structure, effective July 1, 2023 (view press release); and Tidepool announced it has secured funding to develop Tidepool Loop for Android devices (view press release). Below, FENIX provides highlights and insights into the respective news items.

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Novo Nordisk, Tandem, Alnylam, and Regeneron Q1 ’23 Earnings

Four cardiometabolic-related news items have been observed: Novo Nordisk (view press release; slides), Tandem Diabetes Care (view press release), Alnylam Pharmaceuticals (view press release; slides), and Regeneron (view press release; slides) hosted their respective Q1 ’23 earnings calls and provided CVRM-related updates. Below, FENIX provides highlights and insights from the earnings calls.

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Ionis, Lexicon, and Amarin Q1 ’23 Earnings; AstraZeneca Collaborates with Sernova for Cell Therapies

Four cardiometabolic-related news items have been observed: Ionis (view press release; slides), Lexicon (view press release), and Amarin view press release; slides) hosted their respective Q1 ‘23 earnings calls and provided CVRM-related updates; and Sernova announced a preclinical research collaboration with AstraZeneca to evaluate the use of its Cell Pouch System with AstraZenaca’s therapeutic cells (view press release). Below, FENIX provides highlights and insights into the respective news items.

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D&D Pharmatech Announces Positive Ph1 DD01 NAFLD Topline Results; FDA Clears NeuroBo’s IND for Ph2a DA-1241 NASH Trial; Pfizer Q1 ’23 Earnings

Three cardiometabolic-related news items have been observed: D&D Pharmatech announced positive topline results from its Ph1 SAD/MAD trial of DD01, a long-lasting dual GLP-1/glucagon receptor agonist, in overweight/obese patients with T2DM and NAFLD (view press release; CT.gov record); NeuroBo Pharmaceuticals announced FDA has cleared its IND application for DA-1241, a novel G-protein-coupled receptor 119 (GPR119) agonist (view press release); and Pfizer hosted its Q1 ’23 earnings call (view press release; slides) and provided a few GLP-1RA comments during Q&A. Below, FENIX provides highlights and insights into the respective news items.

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