Category Archives: Topics

Leqvio PDUFA Date Disclosed; Verquvo EC approval; Ph1b Trial to Delay the Onset or Progression of T1DM Meets Primary Endpoint; Novartis and J&J Q2 ’21 Earnings Updates

Four cardiometabolic-related news items have been observed: Novartis hosted its Q2 ’21 earnings call (press release; slides) and disclosed the Leqvio (inclisiran) PDUFA date is on January 1, 2022; Merck and Bayer received EC approval of vericiguat, branded as “Verquvo,” for the treatment of symptomatic chronic HF (Merck press release here and Bayer press release here); IM Therapeutics announced positive topline results from a Ph1b study evaluating IMT-002 in adults with T1DM and the HLA-DQ8 gene; and Johnson & Johnson hosted its Q2 ’21 earnings call (press release; slides). Below, FENIX provides highlights and insights from the respective news items.

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Ascensia Launches Patient Assistance Program for Eversense; Dario Digital Health Contract; Xeris EU Distribution Agreement for Ogluo; Medtronic Extended Wear Infusion Set 510(k) Clearance; Nimium Partnership for G3PP Activator Development; TempraMed Launches Insulin Cooler Cap

Six cardiometabolic-related news items have been observed from Ascensia, Dario, Xeris, Medtronic, Nimium Therapeutics, and TempraMed. Below, FENIX provides context and analysis for the announcements.

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GSK Releases Positive Dapro Topline Results Day After Negative Roxa Adcom; Dexcom Cleared for Third-party Integration; New Medtronic Klue Trial Observed

A series of cardiometabolic-related news items have recently been observed: GSK announced positive topline results from five Ph3 studies in the ASCEND program evaluating daprodustat in patients with anemia due to CKD; Dexcom announced FDA has cleared Dexcom Partner Web APIs which now allows third-party integration with other digital health apps and devices; and a new Medtronic closed-loop trial leveraging its Klue acquisition has been observed. Below, FENIX provides highlights and insights for the respective news items.

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Roxa Adcom Votes Overwhelmingly Against Approval in NDD (1-13) and DD (2-12)

Today, FDA held an advisory committee meeting to discuss the proposed roxadustat indication for the treatment of anemia due to CKD in non-dialysis dependent (NDD) and dialysis-dependent (DD) adults. The panel voted 1-13 and 2-12 against either NDD or DD approval, respectively. Below, FENIX provides a summary of key adcom panelist commentary as well as thoughts on the vote and next steps for AZ/Fibrogen and Akebia/Otsuka’s vadadustat.

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Lilly Acquires Protomer Technologies

Lilly announced the acquisition of Protomer Technologies for an undisclosed amount, although Lilly said the deal is valued at >$1B, including development and commercial milestones. For context, Protomer (view website) is a private biotech company developing novel drug therapies, including glucose-responsive insulin. Below, FENIX provides thoughts on the acquisition in the context of other glucose-responsive programs like Novo Nordisk’s.

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Roxa Adcom Docs Released: FDA Mixed on Risk-Benefit

Today, FDA released the briefing documents for the July 15 roxadustat advisory committee. Overall, the documents have a mixed tone, making the outcome unclear for the two voting questions posed to the 15 voting panelists. Below, FENIX provides highlights and insights from the documents, including a prediction that the adcom vote will be split while still favoring Fibrogen/AZ due to the composition of the adcom panel.

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Novo Buys Cardiomyopathy Asset From Prothena; Teplizumab Receives UK Innovation Passport; Poxel Reorganizes Strategic Direction; Dario Announces New Employer Contracts; New Generic Sitagliptin Received Tentative Approval

Five cardiometabolic-related news items have recently been observed: Novo Nordisk and Prothena Corporation announced a definitive purchase agreement in which Novo has acquired Prothena’s clinical-stage antibody PRX004 and broader ATTR amyloidosis program; Provention Bio announced teplizumab was awarded an “Innovation Passport” in the UK for the delay of clinical T1DM in at-risk diabetes; Poxel announced a new strategic direction for its pipeline which focuses on high value, rare metabolic indications and NASH; Dario announced three new employer contracts; and Unichem Laboratories Limited announced tentative FDA approval of its generic sitagliptin. Below, FENIX provides highlights and insights for the respective news items.

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Finerenone Approved in US as “Kerendia”

Bayer announced the FDA approval of 10mg and 20mg finerenone, branded as “Kerendia,” to reduce the risk of sustained eGFR decline, end-stage kidney disease, CV death, non-fatal MI, and hHF in adults with CKD associated with T2DM (see logo below). The approval of finerenone is based on the positive results of the FIDELIO-DKD study and the timing comes in-line with FENIX’s projection. Recall, results from FIDELIO-DKD were presented at Kidney Week in October 2020 and demonstrated an 18% RRR in the primary composite endpoint. Finerenone is currently under review in the EU, China, and multiple other countries worldwide. FENIX will conduct a full label analysis of finerenone in the coming days once the label is available.

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Roxadustat Adcom May Be Impacted By Roster Changes

Ahead of the AstraZeneca/Fibrogen roxadustat FDA adcom on July 15, 2021, FENIX has identified a recent event that may be impactful to the overall result. More specifically, the Cardiovascular and Renal Drugs Advisory Committee (CRDAC) roster has been updated with three committee member terms ending and two new members being added. Below, FENIX provides thoughts on how the updated roster could favor/disfavor AZ/Fibrogen.

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