Category Archives: Topics

Biocorp Partners with Health2Sync and SocialDiabetes for Connected Pen Integration

Yesterday, Biocorp announced it has entered two diabetes-related partnerships with Health2Sync (view website) and SocialDiabetes (view website). For context, Mallya turns all disposable insulin pens into a connected device that collects dosing information and sends it to a companion app. Below, FENIX provides thoughts on the new Biocorp partnerships in the context of its existing partnerships (e.g. Roche, WaveForm, and Sanofi).

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Tirzepatide Continues to Perform; Positive Ph3 SURPASS-3 and SURPASS-5 Topline Results

Lilly announced positive topline results from the Ph3 SURPASS-3 (vs. degludec) and SURPASS-5 (add-on to glargine U100) trials evaluating the safety and efficacy of three tirzepatide doses (5mg/10mg/15mg). Recall, Lilly announced results from the first Ph3 tirzepatide study, SURPASS-1 (tirzep in treatment-naive patients), in December 2020. According to the press release, the 15mg dose of tirzepatide reduced A1C by -2.4% and weight by -12.9kg in the SURPASS-3 trial. In SURPASS-5, patients observed an average A1C reduction of -2.6% and weight loss of -10.9kg. Full results from SURPASS-3 and SURPASS-5 are scheduled to be presented at ADA 2021 (June 25-29). Below, FENIX provides an overview of the topline SURPASS data as well as updated thoughts on the tirzepatide market impact.

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Novartis Wins with Entresto PARAGON-HF FDA Approval

Novartis announced FDA has approved the Entresto sNDA based on results from the PARAGON-HF CVOT (view updated label here). For context, the new indication eliminates the qualifier of HFrEF; however, an additional statement is included, stating the benefit is most clearly evident in patients with LVEF below normal. While the updated label does not include a pure HFpEF indication, it is thought to represent the best-case scenario for Novartis. Below, FENIX provides thoughts on the new Entresto HF indication as well as implications to the evolving HF market, notably Lexicon’s sotagliflozin.

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Nemaura Q4 ’20 earnings; MET409 POC Data Published in Journal of Hepatology

Two cardiometabolic-related news items have been observed: Nemaura Medical published its CY Q4 ’20 (FY Q3 ’21) earnings update and Metacrine announced the results of the MET409 proof-of-concept study were published in the Journal of Hepatology. Below, FENIX provides highlights and insights for the respective news items.

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Biocon/Viatris Bs-aspart and Xeris RTU Glucagon Receive EC Approval; Poxel Q4 and FY ’20 Earnings Update

A series of cardiometabolic-related news items have been observed: Biocon/Viatris announced EC approval for their rapid-acting bs-insulin aspart, branded as Kixelle; Xeris announced it received EC approval for its RTU rescue glucagon product, branded as Ogluo; and Poxel announced its Q4 and FY ’20 earnings. Below, FENIX provides highlights and insights for the respective news items.

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AZ, DXCM, and Teva Q4 ’20 Earnings Updates; Supersapiens Partners with Ironman; Praluent Patent Litigation Upheld by US Court of Appeals; REGN Evinacumab Approved in US as Evkeeza; Former Novo Exec Hired as CMO for Hepion Pharma

Seven cardiometabolic-related news items have recently been observed from AstraZeneca, Dexcom, Supersapiens, Regeneron, Hepion Pharmaceuticals, and Teva. Below, FENIX provides highlights and insights for the respective news items.

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Lannett to Develop Bs-aspart; Seraxis Raises $40M in Series C Funding Round; Bayer Submits Finerenone for DKD in China

A series of cardiometabolic-related news items have been observed: Lannett announced a co-development agreement for biosimilar insulin aspart with HEC; Seraxis announced it raised $40M in a Series C funding round led by Lilly; and Bayer announced the Chinese submission of finerenone for the treatment of patients with CKD and T2DM. Below, FENIX provides highlights and insights for the respective news items.

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Novo Q4 ’20 Post-earnings Event; Sanofi Capital Markets Day 2021; Sanofi and Regeneron Q4 and FY ’20 Earnings Updates

A series of cardiometabolic-related news items have been observed: Novo Nordisk hosted its post-Q4 ’20 earnings event; Sanofi hosted its Capital Markets Day 2021 and Q4 and FY ’20 earnings call; and Regeneron hosted its Q4 and FY ’20 earnings call. Below, FENIX provides highlights and insights from the respective investor events.

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ViaCyte Initiates Ph2 Encapsulated Cell Therapy Trial in T1DM; Lannett, Merck, Roche, and BD Q4 and FY ’20 Earnings Updates; Merck CEO to Retire

A series of diabetes-related news items have been observed: ViaCyte announced the initiation of a Ph2 study of encapsulated cell therapy for the treatment of T1DM; and Lannett, Merck, Roche, and BD hosted their respective CY Q4 ’20 earnings calls. Importantly, Merck announced the retirement of CEO, Kenneth Frazier. Below, FENIX provides highlights and insights for the respective news items, including the observation that Januvia franchise US sales were -16% for FY 2020.

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Novo Broadens Icodec Ph3 program; CSO to Retire; Novo Q4 and FY ’20 Earnings Update

Novo Nordisk hosted its Q4 and FY ’20 earnings calls and provided updates across its pipeline and commercial activities, including plans to conduct a broader Ph3 QW insulin program and additional insight into the Ph3 high-dose oral semaglutide trial. Importantly, Novo disclosed Mads Krogsgaard Thomsen is retiring as EVP and CSO in February 2021 and Novo stock is trading at a near all-time high (view NVO). Below, FENIX provides highlights and insights from the call.

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