Tag Archives: CLEAR Outcomes

JPM 2026 Day 4: IVA, JNGHF, LXRX, BMEA, ESPR; FDA Delays CNPV Approvals

On the fourth and final day of JPM 2026, FENIX has provided coverage of presentations by Inventiva Pharma, Jiangsu Hengrui Pharmaceuticals, Lexicon Pharmaceuticals, Biomea Fusion, and Esperion. Separately, one CVRM-related news item has been observed: FDA has delayed CNPV approval of Tzield and orforglipron (view article). Below, FENIX provides highlights and insights from the JPM presentations as well as insight into the CNPV delays.

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Esperion and Skye Bioscience Q2 ’24 Earnings; Sernova Appoints New CEO

Three cardiometabolic-related news items have been observed: Esperion (press release; slides) and Skye Bioscience (view press release) reported their respective Q2 ’24 earnings; and Sernova announced the appointment of a new CEO (view press release). Below, FENIX provides highlights and insights for the respective news items.

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Novo acquires Cardior Pharmaceuticals; Novo initiates Ph2 Dual Agonist Trials in T2DM and Obesity; Esperion CLEAR Outcomes Investor Call

Three cardiometabolic-related news items have been observed: Novo Nordisk announced the acquisition of Cardior Pharmaceuticals for its heart failure asset (view press release); Novo initiated two trials evaluating its GLP-1/GIP dual agonist in obesity (view CT.gov record) and T2DM (view CT.gov record); and Esperion hosted an investor event to discuss the CLEAR Outcomes FDA approval (view presentation). Below, FENIX provides highlights and insights for the respective news items.

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Novo Initiates Additional Ph3 Cagrisema T2DM Trials; CLEAR Outcomes Approved by FDA and Received Positive CHMP Opinion

Two cardiometabolic-related news items have been observed: Novo Nordisk initiated REIMAGINE 1 (view CT.gov record) and REIMAGINE 3 (view CT.gov record) as the third and fourth trials in its cagrisema T2DM pivotal program; Esperion announced FDA approved CLEAR Outcomes (view press release) and CHMP adopted a positive opinion (view press release). Below, FENIX provides highlights and insights for the respective news items.

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Abbott Q1 ’23 Earnings; Eversense 365-Day Sensor Inserted Into First Pediatric Patient; Esperion Partners With Currax for Nexletol/Nexlizet Promotion; Zucara ZT-01 Ph2 T1DM IND Cleared

Four cardiometabolic-related news items have been observed: Abbott hosted its Q1 ’23 earnings call (view press release; infographic); Senseonics announced the Eversense 365-day sensor has been inserted into the first pediatric patient as part of the ENHANCE clinical trial (view press release); Esperion announced a co-promotion agreement with Currax for Nexletol and Nexlizet (view press release); and Zucara Therapeutics announced FDA has cleared the ZT-01 IND application for the prevention of nocturnal hypoglycemia in patients with T1DM (view press release). Below, FENIX provides highlights and insights into the respective news items. 

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Esperion Launches Website Featuring CLEAR Outcomes; Abbott Receives 510(k) Approval for APIs; Novartis Initiates Ph3 Inclisiran Primary Prevention Trial; Nemaura and Viatris Q4 ’22 Earnings Updates

Five cardiometabolic-related news items have been observed: Esperion announced it has launched a new website (esperionscience.com) featuring information about CLEAR Outcomes (view press release); Abbott received FDA 510(k) approval to add APIs to the FreeStyle Libre 2 and 3 CGM systems (view 510(k) decision letter); Novartis has initiated a Ph3 trial evaluating inclisiran vs. placebo in a primary prevention cohort (VICTORIAN-1 PREVENT; view CT.gov record); Nemaura Medical published its CY Q4 ‘22 (FY Q3 ‘23) business update (press release); and Viatris hosted its Q4 ’22 earnings call (press release; slides). Below, FENIX provides highlights and insights from the respective news items.

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