Category Archives: Other

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.

This content is for Read Less members only.
Register

Already a member? Log in here

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.

This content is for members only.
Register

Already a member? Log in here

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.

This content is for members only.
Register

Already a member? Log in here

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.

This content is for Read Less members only.
Register

Already a member? Log in here

Lilly and Life for a Child Expand Partnership; ViaCyte Appoints Michael Yang as CEO

Two diabetes-related news items have been observed: Lilly and Life for a Child announced an expansion of their partnership to continue addressing inequity in accessing quality diabetes care for children and young adults around the world; and ViaCyte announced the appointment of Michael Yang as the company’s CEO and member of the Board of Directors. Below, FENIX provides highlights and insights for the respective news items.

This content is for Read Less members only.
Register

Already a member? Log in here

Abbott Q4 ’20 Earnings Update and US DTC; Apple and Samsung Watch CGM?; Dario Acquires Upright Technologies

A series of diabetes-related news items have been observed: Abbott hosted its Q4 and FY ’20 earnings call; Abbott recently published an article on its website titled “FreeStyle Libre 2 Puts NBA Legend Ray Allen at Ease;” the Apple Watch Series 7 and the Samsung Galaxy Watch4 are both reportedly going to feature glucose monitoring; and DarioHealth announced its acquisition of Upright Technologies, a digital musculoskeletal company. Below, FENIX provides highlights and insights for the respective news items.

This content is for Read Less members only.
Register

Already a member? Log in here

New Novartis CV Regulatory Comments; Novartis and J&J Q4 ’20 Earnings Updates

Novartis and J&J hosted their Q4 and FY ’20 earnings calls and provided updates to their respective cardiometabolic businesses. Of note, Novartis highlighted the upcoming Q1 ’21 PDUFA date for PARAGON-HF and discussed the inclisiran CRL issued in December 2020. Novartis anticipates responding to FDA’s CRL for inclisiran in Q2 or Q3 ’21. Additionally, J&J comments on its CV/Met portfolio were limited as a majority of the call was focused on the company’s COVID-19 vaccine development. Below, FENIX provides highlights and insights for the respective news items, including thoughts on what the Entresto HFpEF indication may cover.

This content is for Read Less members only.
Register

Already a member? Log in here

New Diabetes/COVID-19 Publication in JDST

The Diabetes Technology Society announced the publication of a report titled, “How to Best Protect People With Diabetes From the Impact of SARS-CoV-2: Report of the International COVID-19 and Diabetes Summit” in the Journal of Diabetes Science and Technology. The report is a summary of the Virtual International COVID-19 and Diabetes Summit, which was held on August 26-27, 2020, and included 79 speakers from NIH, CDC, ADA, HCPs, and manufacturers.

This content is for Read Less members only.
Register

Already a member? Log in here

Verquvo (Vericiguat) Approved by FDA; Label Analysis, Entresto and CYTK Implications

Merck and Bayer received FDA approval of vericiguat, branded as “Verquvo,” for symptomatic chronic HF (Merck press release here and Bayer press release here). Recall, vericiguat received Priority Review from FDA in July 2020 despite the modest 10% RRR in the VICTORIA CVOT primary endpoint (view NEJM publication). For context, Verquvo is the first treatment for chronic HF approved specifically for patients following a hHF or need for outpatient intravenous diuretics. Below, FENIX details its Verquvo label analysis, including the potential for counter-detail by SGLT2i manufacturers, as well as thoughts on the cumulative regulatory tailwinds for Cytokinetics’s omecamtiv.

This content is for Read Less members only.
Register

Already a member? Log in here

High-Dose Ozempic Filed with FDA; Andy Ajello Joins Vifor

Novo Nordisk announced it has filed the sNDA for high-dose Ozempic (2.0mg) based on results from the SUSTAIN FORTE trial, which read out in November 2020 (previous FENIX insight). Additionally, Andrew (Andy) Ajello, former Lexicon Commercial Lead and Novo SVP of US Diabetes/Obesity Sales, has joined Vifor Pharma as the VP of US sales (view LinkedIn profile). Below, FENIX provides thoughts and insights on the respective news items.

This content is for Read Less members only.
Register

Already a member? Log in here