Category Archives: Topics

Tandem Acquires Sigi Patch Pump; Novo Reports Ozempic Supply Shortages; Novo Initiates Second 7.2mg Sema Ph3 Trial in T2DM; Cytokinetics Host Post-adcom Investor Call

A series of cardiometabolic-related news items have been observed: Tandem announced it entered into a definitive agreement to acquire AMF Medical SA (view press release); it has been reported that Novo Nordisk is experiencing a shortage of Ozempic (view article); Novo Nordisk initiated a second 7.2mg QW SC semaglutide Ph3 trial (view CT.gov record) in T2DM; and Cytokinetics hosted an investor event to discuss the results of the omecamtiv adcom (view press release; webcast). Below, FENIX provides highlights and insights on the respective news items, including questions regarding Tandem’s acquisition decision.

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FDA Adcom Votes Against (3-8) Omecamtiv Approval

Today, FDA held an advisory committee meeting to discuss the use of Cytokinetics’s omecamtiv to reduce the risk of CV death and HF events in patients with HFrEF, and panelists voted overwhelmingly against (3-8) the omecamtiv benefit/risk profile. For context, in June 2022, FDA accepted the omecamtiv NDA and set a PDUFA date for February 28, 2023 (previous FENIX insight). Recall, the NDA submission is based on data from the Ph3 GALACTIC-HF trial (view CT.gov record) which were initially presented at AHA 2020 (previous FENIX insight) and published in the NEJM (view publication). Below, FENIX provides key commentary from the adcom panel as well as insight on the future for the asset.

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Lilly Green Lights Two Next-Gen Incretin Ph3 Programs; Lilly 2023 Guidance Call

Lilly hosted its 2023 guidance call (slides; webcast) and provided key pipeline updates and an overview of potential upcoming milestones. Importantly, Lilly announced plans to advance its GGG tri-agonist (retatrutide) and oral GLP-1R NPA (orfoglipron) into Ph3 development. Additionally, Lilly disclosed that the final pivotal QW insulin trial (QWINT-1) will evaluate a fixed dose using the same Mounjaro/Trulicity auto-injector. Below, FENIX provides highlights and insights from the event including a readthrough to new obesity development entrants, specifically Pfizer and Amgen.

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Pfizer Hosts 2022 R&D Day; Novo Initiates 7.2mg Sema Ph3 Obesity Trial; ADA 2023 Diabetes SoC Guidelines; December CHMP Agenda

A series of cardiometabolic-related news items have been observed: Pfizer hosted a Near-Term Launches and High-Value Pipeline investor event and discussed its two oral GLP-1RAs, PF-07081532 and danuglipron (slides; webcast); Novo Nordisk initiated a Ph3 semaglutide obesity trial evaluating up to a 7.2mg QW subcutaneous dose (STEP UP; view CT.gov record); ADA announced it published the 2023 SoC guidelines in Diabetes Care (view press release; view publication); and the CHMP agenda (view here) for this month’s meeting (December 12-15) has been released. Below, FENIX provides insight on the respective news items, including the impact of the updated ADA Standards of Care guidelines.

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Lilly Ends Ypsomed Partnership; Cytokinetics Adcom Documents Available

Two cardiometabolic-related news items have been observed: Ypsomed announced Lilly terminated the joint project with Ypsomed to enter the US insulin pump market in 2026 (view press release); and Cytokinetics announced FDA posted briefing documents (view here) for its upcoming omecamtiv adcom which is scheduled for December 13, 2022 (view press release). Below, FENIX provides brief insights on the news items, including how Lilly’s decision to terminate the partnership validates FENIX’s initial thoughts from 2020.

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Dexcom G7 receives FDA clearance

Dexcom announced it received FDA 510(k) clearance for the next-gen G7 CGM for patients two years of age and older with all types of diabetes, including T1DM, T2DM, and gestational diabetes. Of note, Dexcom continues to state that it plans to launch G7 in early 2023 (previous FENIX insight). Below, FENIX provides an overview of G7 features as well as an analysis of the G7 website and early messaging.

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Esperion’s CLEAR Outcomes CVOT Meets Primary Endpoint; Biocorp’s Mallya Receives FDA 510(k) Clearance; Jardiance Meets Primary Endpoint in Pediatric Trial; MediciNova MN-001 (tipelukast) T2DM and NAFLD Ph2 Data; Daewoong Looks to Commercialize Enavogliflozin Globally

A series of cardiometabolic-related news items have been observed from Esperion, Biocorp, BI/Lilly, MediciNova, and Daewoong Pharmaceutical. Below, FENIX provides highlights and insights for the respective news items, including thoughts on the positive clinical data.

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Amgen AMG 133 Updates @ WCIRDC 2022; Novo Initiates Ph3 Ziltivekimab Trial in HF

Two cardiometabolic-related news items have been observed: Amgen presented AMG 133 Ph1 data at WCIRDC and hosted an associated call with investors to discuss future development plans (press release; slides); and Novo has initiated a Ph3 trial (HERMES) evaluating the efficacy of ziltivekimab in patients with heart failure (LVEF >40%) and inflammation (view CT.gov record). Below, FENIX provides highlights and insights from the respective news items, including thoughts on how AMG 133 fits into the evolving obesity treatment market.

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Could Evkeeza’s New Peds Approval Result in a PRV for REGN?

Regeneron announced FDA has accepted the Evkeeza (evinacumab) sBLA for the treatment of homozygous familial hypercholesterolemia (HoFH) in children ages 5 to 11 with a PDUFA date of March 30, 2023. Recall, in February 2021, Evkeeza received FDA approval for the treatment of HoFH in patients 12 years of age and older (previous FENIX insight). Below, FENIX wonders if the approval could result in a PRV.

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Biocon Completes Viatris Biosimilars Business Acquisition; Nemaura Launches Miboko Pilot Program in UK; BMS Terminates CV Partnership with uniQure

Three cardiometabolic-related news items have been observed: Biocon announced (view press release) the completed acquisition of Viatris’s biosimilar business (view press release); Nemaura announced the launch of its Miboko pilot program in the UK (view press release); and BMS reportedly terminated its research collaboration with uniQure (view article). Below, FENIX provides context and insight on the respective news items, including Nemaura’s challenged balance sheet.

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