Category Archives: GLP-1RA

Pfizer to Advance Oral GLP-1RA Development; Pfizer EASD 2022 Investor Call

Pfizer hosted an EASD 2022 investor event during which the company discussed data for its two oral GLP-1RAs (PF-07081532 and PF-06882961), which were presented at the conference (view slides). For context, PF-07081532 is differentiated from PF-06882961 (danuglipron) as PF-07081532 is a QD oral GLP-1RA compared to danuglipron which is a BID oral GLP-1RA. Below, FENIX provides highlights and insights from the call relating to key commentary from management.

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Lilly’s Tempo Smart Button Receives 510(k) Clearance; EASD 2022 Key Press Releases (Sept 21)

On the third day of EASD 2022, three key press releases were observed from Zealand, Carmot Therapeutics, and Abbott. Separately, Lilly’s Tempo Smart Button received FDA 510(k) clearance on September 16, 2022 (view FDA website), although Lilly has not issued a press release. Below FENIX provides insights and context for the respective announcements.

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FENIX Analysis: Mounjaro Launch Update

Following approval of Lilly’s Mounjaro (tirzepatide) in T2DM in May 2022 (previous FENIX insight), FENIX has conducted an initial launch analysis, including early insights from prescription trends as well as a look into the Mounjaro promotional, sampling, and copay card tactics.

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Dexcom Promotes Jake Leach to COO; Biocon Receives More Form 483 Observations; Seraxis Appoints Paul Strumph as CMO; Intarcia ITCA-650 CRL Chronicle Concludes

A series of cardiometabolic-related updates have been observed: Dexcom announced Jake Leach (view LinkedIn) has been promoted to COO; Biocon announced it received more Form 483 observations; Seraxis announced the appointment of Paul Strumph (view LinkedIn) to CMO; and Intarcia Therapeutics received a letter from FDA (view here) denying a hearing for ITCA-650. Below, FENIX provides context and insight on the respective news items.

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Thoughts on SURMOUNT-MMO after SELECT Interim Analysis

At its Q2 ’22 earnings in August, Novo Nordisk disclosed that SELECT, the Wegovy CVOT, would not stop for overwhelming efficacy at a pre-specified interim analysis (previous FENIX insight). With all the hype now passed, the trial design lens turns to Lilly’s tirzepatide obesity CVOT, SURMOUNT-MMO. Below, FENIX provides thoughts on SURMOUNT-MMO, including Lilly’s potential strategy to get a broad metabolic indication, similar to what BI/Lilly did in HF with Jardiance by eliminating LVEF label language.

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“Mass” Layoff at Beta Bionics?; Novo Initiates Ph3 Ozempic + Lower-Dose Glargine Trial; Novartis to Spin Off Sandoz; Lannett and Adocia CY Q2 ’22 Earnings Updates; Hygieia Appoints New CEO

A series of cardiometabolic-related updates have been observed: Beta Bionics has reportedly laid off an unknown number of employees (view LinkedIn post); a Novo-sponsored Ph3 trial evaluating Ozempic and lower-dose insulin glargine has been observed (SUSTAIN OPTIMIZE; view CT.gov record); Novartis announced plans to spin off Sandoz (press release); Lannett (press release) and Adocia (press release) released their Q2 ’22 earnings; and Hygieia announced the appointment of a new CEO. Below, FENIX provides context and insight on the respective news items.

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Novo Announces Positive Ph2 Cagrisema Results; Insulet’s Omnipod 5 Receives Expanded FDA Clearance; Digbi Health Enrolled in Novo’s Accelerator Program; New Lyumjev Trial for Inreda’s Bi-hormonal AID System; Amarin Discontinues Vazkepa in Germany

A series of cardiometabolic updates have been observed: Novo announced positive topline results from its Ph2 study of cagrisema in T2DM; Insulet announced Omnipod 5 received expanded FDA clearance in patients down to 2 years of age; Digbi Health has enrolled in Novo’s Global Prevention Accelerator program; an Inreda-sponsored study has been observed evaluating Lyumjev in its bi-hormonal closed loop system (FAST 1; view CT.gov record); and Amarin announced it is discontinuing Vazkepa in Germany. Below, FENIX provides context and insight on the respective news items. 

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Novo Withdraws PIONEER START Trial; Onduo Partners with Sword Health; Nemaura and Movano Q2 ’22 Earnings Updates

A series of cardiometabolic updates have been observed: Novo’s PIONEER START trial (H2H oral sema vs. empa) has been withdrawn (CT.gov record); Onduo announced a partnership with Sword Health to integrate Sword Health’s musculoskeletal digital solution (press release); and Nemaura (press release) and Movano (press release; webcast) released their Q2 ’22 earnings. Below, FENIX provides highlights and insights from the respective news items.

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Novo Q2 ’22 London Earnings; Vertex and Amgen Q2 ’22 Earnings Updates

A series of cardiometabolic-related news items have been observed: Novo Nordisk hosted its post-Q2 ’22 earnings (see previous FENIX insight on Q2 ’22 Novo earnings from August 3); Vertex (press release; slides), and Amgen (press release; slides) hosted their Q2 ’22 earnings calls. Below, FENIX provides highlights and insights from the respective news items.

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SELECT Doesn’t Stop at Interim Analysis; Novo Nordisk Q2 ’22 Earnings Update

Novo Nordisk hosted its Q2 ’22 earnings call (press release; slides), which was ahead of the initially scheduled call on August 4. Of note, management disclosed that following an interim analysis, the DMC recommended SELECT CVOT (view CT.gov record) should continue in accordance with the trial protocol. Below, FENIX provides highlights and insights from the call.

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