Tag Archives: Lilly

Medtronic CY Q1 ’21 Earnings Update; FDA Accepts IND for Lilly/Dicerna Cardiometabolic Asset; Dario Digital Therapeutics Publication

Three cardiometabolic news items have been observed: Medtronic hosted its CY Q1 ’21 (FY Q4 ’21) earnings call; Dicerna announced FDA accepted Lilly’s IND application for a novel cardiometabolic asset, LY3819469, targeting the LPA gene; and Dario announced the publication of “Digital Therapeutics for Type 2 Diabetes: Incorporating Coaching Support and Validating Digital Monitoring” in Diabetes Science and Technology. Below, FENIX provides highlights and insights for the respective news items.

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SURPASS-4 Data Continue to Impress; Arecor and Lilly Partnership

Two diabetes-related news items have been observed: Lilly announced positive topline results from the Ph3 SURPASS-4 trial comparing tirzepatide to insulin glargine in patients with T2DM and an increased CV risk; and Arecor announced it has signed a formulation study partnership with Lilly, in which Arecor will use its proprietary tech platform Arestat for “one of Lilly’s proprietary products intended for self-administration.” Below, FENIX provides highlights and insights from the respective news items.

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Lilly Obesity Ph2 GGG Tri-agonist Trial; Novo QW Icodec Ph3 T2DM; Sigilon Q1 ’21 Earnings Update

A series of cardiometabolic-related news items have been observed: a CT.gov record for a Ph2 Lilly-sponsored trial investigating QW LY3437943 (GGG tri-agonist) in obesity has been observed; a CT.gov record for Novo Nordisk’s Ph3 QW insulin icodec T2DM trial (ONWARDS 4) has been observed; and Sigilon announced its Q1 ’21 earnings, though it did not provide a development update on SIG-002 nor did it host an associated webcast. Below, FENIX provides highlights and insights for the respective news items.

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Lilly Connected Pen Update; Novo Q1 ’21 Post-earnings Event; Provention Bio, BD, ICPT, and REGN Earnings Updates

A series of cardiometabolic-related news items have been observed: Lilly provided an update on its connected pen development, including the disclosure of the Tempo Smart Button (view press release); Novo Nordisk hosted its post-Q1 ’20 earnings event (see previous FENIX insight on Q1 ’21 Novo earnings from May 5); Provention Bio (press release), Becton Dickinson (press release), Intercept (press release; slides) and Regeneron (press release) hosted their respective CY Q1 ’21 earnings calls. Below, FENIX provides highlights and insights from the respective news items, including thoughts on BD’s decision to spin off its diabetes business.

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New Dual GLP-1/GIP RA from Carmot Receives IND; Lilly ESG Strategy Highlights; Pfizer Q1 ’21 Earnings Update

Three diabetes-related news items have been observed: Carmot Therapeutics announced it has received IND clearance from FDA for its dual GLP-1/GIP RA, CT-868, in overweight and obese adults with T2DM; Lilly hosted an investor call outlining its commitments for the company’s newly updated environmental, social, and governance (ESG) strategy; and Pfizer hosted its Q1 ’21 earnings call but did not mention its metabolic pipeline during the webcast. Below, FENIX provides highlights and insights for the respective news items.

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Lilly Ph4 Basal Insulin Titration Trial; Lilly Ph2 GGG Tri-agonist Trial; AZ Q1 ’21 Earnings Update; Xeris’s Ogluo Receives UK MHRA Approval

A series of cardiometabolic-related news items have been observed: a CT.gov record for a Ph4 Lilly-sponsored trial investigating Basaglar titration in 50 adults with T2DM has been observed; a CT.gov record for a Ph2 Lilly-sponsored trial investigating QW LY3437943 (GGG tri-agonist) has been observed; AstraZeneca hosted its Q1 ’21 earnings call; and Xeris announced it received UK MHRA approval for its RTU rescue glucagon product, branded as Ogluo. Below, FENIX provides highlights and insights for the respective news items.

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Lilly and Novartis Q1 ’21 Earnings Updates; New Trulicity TV DTC; Provention Meets with FDA

A series of cardiometabolic-related news items have been observed: Lilly and Novartis hosted their respective Q1 ’21 earnings calls; Lilly has initiated a new Trulicity DTC campaign; and Provention Bio announced it met with FDA on April 23, 2021 to discuss the ongoing teplizumab PK comparability issue. Importantly, Lilly disclosed that SURPASS-4 has accrued all of its pre-specified CV events and the trial is scheduled to close out in May with topline results expected by the end of Q2 ’21. Recall, Lilly has previously stated SURPASS 4 is the gating factor for tirzepatide T2DM global regulatory submissions later in 2021. Below, FENIX provides highlights and insights for the respective items.

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Heart Failure: Tirzepatide vs. Semaglutide HFpEF Ph3 Trial Analysis

Lilly has recently initiated the Ph3 tirzepatide HFpEF trial, called SUMMIT (view CT.gov record). Recall, during Lilly’s 2021 guidance call (December 15, 2020), Lilly first disclosed plans to develop tirzepatide for the treatment of HFpEF (previous FENIX insight). Below, FENIX provides an overview of SUMMIT, including a comparative analysis with Novo’s semaglutide HFpEF trial (STEP HFpEF).

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Xeris and Dario Q4 and FY ’20 Earnings Calls; Lilly Research Collaboration for Diabetes; Metacrine Initiates Ph2a Trial in NASH

A series of cardiometabolic-related news items have been observed: Xeris and Dario hosted their Q4 and FY ’20 earnings calls; Lilly announced it entered a research collaboration and license agreement with Biolojic Design for AI drug discovery of an antibody-based diabetes treatment; and Metacrine announced that it initiated a Ph2a trial of MET642 for the treatment of patients with NASH. Below, FENIX provides highlights and insights from the respective news items.

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Payback for Lilly as Tirzepatide Beats Ozempic in Ph3 SURPASS-2 H2H Trial

Lilly announced positive topline results from the H2H Ph3 SURPASS-2 trial comparing tirzepatide to 1.0 mg Ozempic in patients with T2DM. Lilly’s CSO provided further commentary on tirzepatide and SURPASS-2 during the 2021 Cowen Health Care Conference. According to the press release, the 15mg tirzepatide dose reduced A1C by -2.46% and weight by -12.4kg in the SURPASS-2 trial. Further, the lowest dose of tirzepatide (5mg) reduced A1C by -2.09% and body weight by -7.8kg compared to 1.0mg injectable semaglutide at -1.86% and -6.2kg. Full results from SURPASS-2 are scheduled to be presented at ADA 2021 (June 25-29). Below, FENIX provides an overview of the topline SURPASS data, what tirzepatide list pricing could be, Novo’s potential counter-message, and a summary of Lilly management commentary from today at Cowen.

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