Category Archives: Topics

Beta Bionics Secures $100M in Series D Funding; Senators Ask for Clarity on Lilly, Novo, and Sanofi’s Low-cost Insulin Products

Two cardiometabolic-related news items have been observed: Beta Bionics announced its Series D funding round has been closed at $100M (view press release); and senators have sent a letter to the CEOs of Lilly, Novo Nordisk, and Sanofi asking for greater clarification on how patients may participate in each company’s Patient Assistance Programs to obtain insulin at an affordable price (view letter; view article). Below, FENIX provides highlights and insights for the respective news items.

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The ITCA 650 Story Lives on; i2o Therapeutics Appoints Kurt Graves as CEO; Biomea Appoints Juan Pablo Frias as CMO

Two cardiometabolic-related news items have been observed: i2o Therapeutics announced the appointment of Kurt Graves as CEO and disclosed ITCA 650 was granted an FDA adcom on September 21, 2023 (view press release); and Biomea Fusion announced the appointment of Juan Pablo Frias as CMO (view press release). Below, FENIX provides highlights and insights for the respective news items, including thoughts on why i2o may not actually be looking to commercialize the ITCA 650 drug/device combo.

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Novo to Acquire Another Obesity Company; Zealand Receives Priority Review for Dasiglucagon CHI NDA

Two cardiometabolic-related news items have been observed: Embark Laboratories announced that Novo Nordisk acquired the company and its lead obesity asset (view press release); and Zealand announced FDA granted priority review for its dasiglucagon NDA for the prevention and treatment of hypoglycemia in pediatric patients 7 days of age or older with congenital hyperinsulinism (CHI; view press release). Below, FENIX provides highlights and insights for the respective news items.

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Novartis Presents Long-Term Leqvio Data; Insulet Launches Omnipod 5 in Germany; Esperion Presents Additional CLEAR Outcomes Results; Amgen Presents Olpasiran Ph2 OCEAN(a)-DOSE Extension Results

Four cardiometabolic-related news items have been observed: Novartis announced long-term Leqvio (inclisiran) data from ORION-8 were presented at the ESC 2023 conference (view press release); Insulet initiated the full market release of the Omnipod 5 AID system in Germany (view press release); Esperion presented additional bempedoic acid (BA) results from the CLEAR Outcomes study at ESC 2023 (view press release); and Amgen presented results from the off-treatment extension of the Ph2 olpasiran OCEAN(a)-DOSE study (view press release). Below, FENIX provides highlights and insights for the respective news items.

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Novo and Lilly Win Again with Positive STEP HFpEF Full Results

Novo Nordisk announced positive full results from the Ph3 STEP HFpEF trial (view CT.gov record) demonstrating QW semaglutide 2.4mg led to reductions in HF-related symptoms, reductions in physical limitations, and improvements in exercise functions vs. placebo. The full results were presented at the ESC 2023 (August 25-28) conference in Amsterdam, Netherlands, and simultaneously published in the NEJM (view publication). Importantly, Novo stated it anticipates filing for the Wegovy label update in H1 2024 following the completion of STEP HFpEF-DM (view CT.gov record) in participants with HFpEF and obesity with T2DM in Q4 2023. Below, FENIX provides an overview of the STEP HFpEF results as well as thoughts on the impact to the HFpEF treatment paradigm, including potential readthrough to Lilly and other manufacturers looking to enter the obesity market.

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Wegovy Faces Supply Shortage in Germany; Abata Announces Novel Pre-clinical Treg Cell Therapy Candidate for T1DM; Bayer Initiates Additional Ph3 Finerenone HF Trials; Merck Initiates Oral PCSK9i CVOT

Four cardiometabolic-related news items have been observed: Novo Nordisk is reportedly having difficulties meeting Wegovy demand in Germany (view article); Abata Therapeutics disclosed its development candidate, ABA-201, to be a disease-modifying Treg cell therapy for T1DM (view press release); Bayer announced it will initiate three additional finerenone Ph3 studies as part of its HF MOONRAKER development program (view press release); and Merck initiated its oral PCSK9i (MK-0616) CVOT (view CT.gov record). Below, FENIX provides highlights and insights into the respective news items.

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Novo Partners with Thermo Fisher as Second Wegovy Manufacturer; Bayer Initiates New Finerenone HF Study; Welldoc’s BlueStar Receives 510(k) Clearance for CGM-mediated Dose Recommendations

Three cardiometabolic-related news items have been observed: Novo Nordisk has hired Thermo Fisher as its second contract manufacturer for Wegovy (view article); Bayer initiated a Ph3 study evaluating the safety and efficacy of finerenone in patients hospitalized with acute decompensated HF and mildly reduced or preserved LVEF (REDEFINE-HF; view CT.gov record); and Welldoc announced it received its eleventh 510(k) clearance for BlueStar to provide bolus insulin dose recommendations based on CGM data (view press release). Below, FENIX provides highlights and insights into the respective news items.

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Medtronic CY Q2 ’23 (FY Q1 ’24) Earnings; Lilly Initiates Retatrutide Test Device Study

Two cardiometabolic-related news items have been observed: Medtronic hosted its CY Q2 ’23 (FY Q1 ’24) earnings call (press release; slides); and Lilly initiated a Ph1 relative bioavailability study comparing SC retatrutide (LY3437943) administered by a test device vs. a reference device in healthy participants (view CT.gov record). Below, FENIX provides highlights and insights into the respective news items.

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Gan & Lee Submits Bs-glargine MAA

Gan & Lee Pharmaceuticals announced the MAA for its biosimilar insulin glargine U100 (Basalin) has been accepted for review by EMA. According to the press release, the MAA filing is supported by two randomized, multicenter Ph3 studies in the US and EU comparing its bs-glargine injection to Lantus in which bs-glargine demonstrated comparable immunogenicity, efficacy, and safety to Lantus in T1DM (n=576) and T2DM (n=567) patients (previous FENIX insight). G&L said it will continue to collaborate with Sandoz to commercialize its bs-glargine in the EU. Recall, in February 2023, G&L announced FDA accepted the BLA for its bs-glargine (previous FENIX insight). Below, FENIX provides brief thoughts on the G&L bs-glargine MAA in the context of the evolving basal insulin market.

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