Tag Archives: Lilly

Lilly and Genesis Therapeutics Collaboration; Esperion Q1 ’22 Earnings Update; Oramed’s Pivotal Ph3 Oral Insulin Trial Completes Enrollment; MySugarWatch Launches HCP-focused Ad Campaign for sugarBEAT in MIMS

A series of cardiometabolic-related news items have been observed: Genesis Therapeutics announced a strategic collaboration with Lilly; Esperion (press release; slides) hosted its Q1 ‘22 earnings call; Oramed announced the Ph3 study (ORA-D-013-1) of its oral insulin capsule (ORMD-0801) in T2DM has completed enrollment; and Nemaura Medical announced that its UK licensee, MySugarWatch, has launched a series of ads in MIMS as part of a large-scale awareness campaign for the company’s sugarBEAT non-invasive CGM. Below, FENIX provides highlights and insights for the respective new items.

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Did Lilly Cure Obesity? SURMOUNT-1 Topline Results; Q1 ‘22 Earnings Updates

Lilly hosted its Q1 ’22 earnings call (press release; slides) and provided updates across its CVRM portfolio. Prior to the earnings call, Lilly announced highly positive topline results from the first Ph3 tirzepatide obesity study (SURMOUNT-1) which demonstrated up to 22.5% weight loss (press release). In prepared remarks, management briefly discussed other CVRM-related topics, including regulatory approvals of EMPEROR-Preserved (previous FENIX insight), the initiation of its QW insulin Ph3 program (QWINT-3; previous FENIX insight), and early termination of EMPA-KIDNEY (previous FENIX insight). Importantly, Lilly confirmed it purchased a PRV in Q1 ’22. Below are highlights and insights from the call.

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Lannett Initiates Bs-glargine Pivotal Trial; Tirzepatide Meta-analysis Shows No Increased MACE Risk in T2DM; Provention Bio’s PRV-101 Vaccine Positive Final Results

A series of cardiometabolic-related news items have been observed: Lannett announced the initiation of its biosimilar insulin glargine pivotal trial; A CV safety meta-analysis for the tirzepatide Ph3 SURPASS program was published in Nature Medicine and showed no increased MACE risk in T2DM (view publication); and Provention Bio announced PRV-101 vaccine positive final results (press release). Below, FENIX provides highlights and insights for the respective new items.

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Lilly Initiates First QW Insulin Ph3 Trial (QWINT-3); New Novartis Ph1b T1DM Immunotherapy (MHS552) Trial

Two cardiometabolic-related news items have been observed: Lilly has initiated the first Ph3 trial (QWINT-3) from its Ph3 QW basal insulin Fc (QWINT) program (view CT.gov record); and a Novartis-sponsored Ph1b multiple ascending dose study evaluating the safety and tolerability of MHS552 in adults with T1DM has been observed (view CT.gov record). Below, FENIX provides highlights and insights for the respective new items.

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Jardiance EMPULSE Trial Published; Senseonics Q4 ’21 Earnings Update; Novo Initiates Icosema COMBINE 2 Ph3 Trial; Merck’s Oral PCSK9i Enters Ph2; BI Partners with Lifebit; Intercept and Amarin Q4 ’21 Earnings Updates

A series of cardiometabolic-related news items have been observed from BI/Lilly, Senseonics, Novo, Merck, BI/Lifebit, Intercept, and Amarin. Below, FENIX provides highlights and insights for the respective new items.

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Lilly Moves Forward with Dicerna ANGPTL3 Asset; Ionis and MannKind Q4 ’21 and FY ’21 Earnings Updates

A series of cardiometabolic-related news items have been observed: Lilly initiated a Ph2 study evaluating LY3561774 (ANGPTL3 from Dicerna) despite the Novo Nordisk acquisition of Dicerna (view CT.gov record); and Ionis (press release; slides) and MannKind (press release) hosted their respective earnings calls. Below, FENIX provides highlights and insights for the respective new items.

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EMPEROR-Preserved Approved by FDA; Wegovy Supply Restored for Existing US Patients; Provention Bio Q4 and FY ’21 Earnings Update; Omada Closes $192M Series E

A series of cardiometabolic-related news items have been observed: FDA approved BI/Lilly’s HFpEF indication (view FDA press release; view BI/Lilly press release); Novo Nordisk’s Wegovy supply for existing US patients has been restored (view Novo Nordisk website); Provention Bio hosted its Q4 and FY ’21 earnings call (view press release); and Omada Health raised $192M in a Series E round (view press release). Below, FENIX provides highlights and insights for the respective new items.

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Provention Bio Refiles Teplizumab BLA; Medtronic and Tandem Q4 ’21 and FY ’21 Earnings Updates; Lilly Invests $700M in New Lilly Institute for Genetic Medicine; RosVivo Therapeutics and Lilly Sign MTA for RSVI-301; February 21-24 CHMP Agenda

A series of cardiometabolic-related news items have recently been observed from Provention Bio, Medtronic, Tandem, Lilly, RosVivo Therapeutics, and the CHMP. Below, FENIX provides highlights and insights for the respective new items.

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ICER Report Questions Tirzepatide’s Effectiveness Compared to Ozempic and Jardiance; Signos and Dexcom to Launch CGM+AI-Enhanced App Trial; Teladoc Launches Chronic Care Complete Program; Movano Completes Second Glucose Pilot Study; Better Therapeutic Enrolls First Patient in BT-001 RWE Study

A series of cardiometabolic-related news items have been observed: The Institute for Clinical and Economic Review (ICER) released its report on Lilly’s tirzepatide (view article); Signos announced intentions to conduct a health outcomes study (in partnership with Dexcom) investigating CGM+AI-enhanced app use in people without diabetes; Teladoc announced it has launched its Chronic Care Complete program; Movano announced the completion of its second IRB-approved glucose pilot study evaluating its wrist-worn wearable biosensor prototype; and Better Therapeutics announced the first patient has been enrolled in an RWE study evaluating BT-001 for the treatment of T2DM. Below, FENIX provides highlights and insights for the respective new items.

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Did Lilly Purchase BioMarin’s PRV?; Rivus Announces Positive Ph2a HU6 Trial Results; Second Sight to Merge with Nano Precision for GLP-1RA Implantable

Three cardiometabolic-related news items have been observed: BioMarin announced it sold a PRV for $110M but did not disclose the buyer; Rivus Pharmaceuticals announced positive results from its Ph2a HU6 trial; and Second Sight Medical Products and Nano Precision Medical (NPM) announced that they have entered into a definitive merger agreement. Below, FENIX provides highlights and insights for the respective new items, including thoughts on why Lilly may have been the company to purchase BioMarin’s PRV.

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