Category Archives: Topics

JPM 2023 Day 2: LLY, ABT, PODD, SNY, AZN, MRK, and GSK; Sernova Advances T1DM Cell Pouch Technology; Pfizer Initiates New Ph1 Oral GLP-1RA Trial

On the second day of JPM 2023, FENIX has provided coverage of presentations by major CVRM companies including Lilly, Abbott, Insulet, AZ, and Merck. GSK and Sanofi also presented at JPM 2023, but neither had any meaningful discussion relating to their respective CVRM portfolios. Separately, two CVRM-related news items have been observed: Sernova announced it has made progress toward a first in-human study for its cell pouch system (view press release); and Pfizer initiated a new Ph1 trial (view CT.gov record) for one of its oral GLP-1RA assets (PF-07081532).

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JPM 2023 Day 1: DXCM, MDT, PFE, AMGN, VRTX, NVS, CYTK, TDOC, ARWR, and AMGN; AZ Acquires CinCor; Viking Completes Ph2b NASH Enrollment; Ionis Sells Pelacarsen Royalties

On the first day of JPM 2023, FENIX has provided coverage of presentations by major CVRM companies including Dexcom, Medtronic, Pfizer, Amgen, Vertex, Novartis, Cytokinetics, Teladoc, and Arrowhead. Alnylam, Gilead, J&J, Regeneron, and Amgen also presented at JPM 2023, but none had any meaningful discussion relating to their respective CVRM portfolios. Additionally, three separate CVRM-related news items have been observed: AZ announced the acquisition of CinCor Pharma (view press release), Viking completed enrollment of the Ph2b VOYAGE NASH trial (view press release), and Ionis entered into an agreement with Royalty Pharma to sell rights to Spinraza and pelacarsen (view press release).

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Madrigal Announces Additional Positive MAESTRO-NASH Data; Bluebird Sells Second PRV to BMS for $95M

Two cardiometabolic-related new items have been observed: Madrigal Pharmaceuticals announced additional positive results from the pivotal Ph3 MAESTRO-NASH trial evaluating resmetirom in patients with NASH and liver fibrosis (view press release; CT.gov record); and bluebird bio announced it entered into a definitive agreement to sell its second Rare Disease PRV to BMS for $95M (view press release; view 8-K). Below, FENIX provides highlights and insights for the respective news items, including updated thoughts on the resmetirom filing discrepancy.

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Inventiva Updates Lanifibranor NASH Development Program; Galectin Completes Ph2b/3 NAVIGATE Study Enrollment; Novo Signs Stemcell Deal with Fujifilm

Three cardiometabolic-related news items have been observed: Inventiva announced changes to the clinical development of lanifibranor, including a new Ph3 trial in NASH and compensated cirrhosis (view press release); Galectin announced enrollment completion for its Ph2b/3 NAVIGATE study evaluating belapectin in patients with liver cirrhosis caused by NASH (view press release; CT.gov record); and Fujifilm Cellular Dynamics announced an iPSC-derived cell therapy license agreement with Novo Nordisk (view press release). Below, FENIX provides highlights and insights for the respective news items, including readthrough from Inventiva’s new NASH clinical development strategy.

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Holiday Hangover: Novo’s Wegovy/Ozempic Featured on 60 Minutes; Intercept OCA NASH NDA Refiled; Amgen Initiates Ph2 AMG 133 Obesity Trial; Steven Russell Joins Beta Bionics; Novo’s Third Cagrisema Ph3 Trial Initiated; Wegovy Pediatric Indication; Lannett Bs-Insulin Updates; Equillium and Metacrine Terminate Merger; and More

During the holiday break, a series of cardiometabolic-related news items were observed from Novo Nordisk, Intercept, Amgen, Beta Bionics, Lannett, Equillium and Metacrine, MindRank, EOFlow, Medtronic, Adocia, and PeptiDream. Below, FENIX provides highlights and insights for the respective news items.

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Lilly Initiates Final Ph3 QWINT Trial; Madrigal Announces $300M+ in Financing Events to Advance Resmetirom; Akebia Receives Interim Response to Appeal for Vadadustat CRL

Three cardiometabolic-related news items have been observed: The final trial from Lilly’s Ph3 QW insulin QWINT program has been observed (QWINT-1; view CT.gov record); Madrigal announced plans to leverage $300M+ in financing events to support planned commercial and clinical activities for resmetirom in NASH (view press release); and Akebia announced it received an interim response from FDA to its Formal Dispute Resolution Request regarding the vadadustat CRL issued in March 2022 (view press release). Below, FENIX provides highlights and insight on the respective news items, including thoughts on Lilly’s strategy to pursue a QW insulin fixed-dose escalation regimen as well as readthrough from GSK’s impending daprodustat PDUFA to Akebia’s vadadustat.

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Medtronic InPen App Recall; Libre 3 + Ypsomed AID Available in Germany; Altimmune Positive Pemvidutide NAFLD Data; Embecta CY Q3 ’22 Earnings Update; Alnylam Submits ALN-KHK CTA for T2DM; Biocorp Receives EU Medical Device Certification

A series of cardiometabolic-related news items have been observed from Medtronic, Abbott, Altimmune, Embecta, Alnylam, and Biocorp. Below, FENIX provides highlights and insight on the respective news items, including thoughts on the Medtronic recall and how the positive Altimmune NAFLD data may not be enough.

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Madrigal Wins Big with Ph3 NASH Data; Novo Expands Partnership for Dose Check; AZ Announces DELIVER Positive CHMP Opinion

Three cardiometabolic-related news items have been observed: Madrigal Pharmaceuticals announced positive topline results from its Ph3 resmetirom MAESTRO-NASH study and hosted an investor call, although the company provided conflicting guidance on the filing timeline (view press release; webcast); Amalgam Rx announced the expansion of its global agreement with Novo Nordisk for the commercialization of Dose Check (view press release); and AstraZeneca announced Forxiga (dapagliflozin) received a positive CHMP opinion for DELIVER (view press release). Below, FENIX provides insights on the respective news items, including readthrough from the Madrigal data to other NASH players.

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Lilly Partners with Sosei Heptares for Metabolic Drug Discovery; FIGARO-DKD and DELIVER Positive CHMP Opinions

Three cardiometabolic-related news items have been observed: Sosei Heptares announced an R&D collaboration with Lilly for diabetes and metabolic diseases (view press release); Bayer announced Kerendia (finerenone) received a positive CHMP opinion for the FIGARO-DKD study (view press release); AZ’s Forxiga received a positive CHMP opinion to broaden its HF indication based on results from DELIVER (view opinion). Below, FENIX provides highlights and insights on the Lilly partnership and respective positive CHMP opinions.

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Alnylam Hosts 2022 R&D Day; Movano Health Initiates First Beta Program for Smart Ring

Two cardiometabolic-related news items have been observed: Alnylam hosted its 2022 R&D webinar and provided clinical and commercial updates (view press release; slides); and Movano Health announced the launch of its Movano Ring beta program with Novant Health (view press release). Below, FENIX provides highlights and insights on the two news items, including thoughts on Alnylam’s clinical and preclinical pipeline.

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