Category Archives: Topics

Lexicon’s Sota HF NDA Accepted by FDA in Patients With and Without T2DM

Lexicon announced FDA accepted the sotagliflozin HF NDA with a PDUFA date in May 2023. Importantly, Lexicon disclosed the filed indication includes a broad patient population for those with and without T2DM despite the SCORED and SOLOIST trials being conducted in patients with T2DM. Recall, Lexicon resubmitted the sota NDA in May 2022 after a voluntary NDA withdrawal in February 2022 due to an unintentional exclusion of supportive documents (previous FENIX insight). Below, FENIX provides brief thoughts on the sota standard review, including a potential savvy maneuver by Lexicon.

This content is for Read Less members only.
Already a member? Log in here

vTv Receives $10M Investment from CinPax, LLC; Oramed Reaches 50% Enrollment in Second Ph3 Oral Insulin Trial; Esperion Establishes Scientific Advisory Board

Three cardiometabolic-related news items have been observed: vTv announced it received a $10M investment from CinPax; Oramed announced it has reached over 50% enrollment in its second Ph3 oral insulin trial in T2DM; and Esperion established a Scientific Advisory Board to support pipeline and LCM initiatives. Below, FENIX provides highlights and insights for the respective new items.

This content is for Read Less members only.
Already a member? Log in here

Abbott Q2 ’22 Earnings Update; Lilly to Initiate Fourth Trial in Ph3 QWINT Program; Ionis’s Ph3 Lp(a) HORIZON CVOT Completes Enrollment

Three cardiometabolic-related news items have been observed: Abbott hosted its Q2 ’22 earnings call (press release; view infographic); a fourth trial from Lilly’s Ph3 QW insulin program has been observed (view CT.gov record); and Ionis announced that the Ph3 Lp(a) HORIZON CVOT evaluating has completed enrollment (view CT.gov record). Below, FENIX provides highlights and insights for the respective new items.

This content is for Read Less members only.
Already a member? Log in here

Novartis and J&J Q2 ’22 Earnings Updates

Two cardiometabolic-related news items have been observed: Novartis (press release; slides) and J&J (press release; slides) hosted their respective Q2 ’22 earnings calls. Below, FENIX provides highlights and insights for the respective new items.

This content is for Read Less members only.
Already a member? Log in here

Tirzepatide up for CHMP Opinion; July 18-21 CHMP Agenda; Lilly Initiates QW Insulin T2DM MDI Trial (QWINT-4); UHC Eliminates Insulin OOP Costs

A series of cardiometabolic-related news items have been observed: the CHMP agenda for this month’s meeting (July 18-21) has been released and it appears Lilly’s tirzepatide is up for an opinion; a third trial from Lilly’s Ph3 QW insulin program (BIF; LY3209590) has been observed (view CT.gov record); and UnitedHealthcare announced that starting January 1, 2023, it will eliminate out-of-pocket costs for certain preferred prescription drugs, including insulin and four medical emergency drugs. Below, FENIX provides highlights and insights for the respective new items.

This content is for Read Less members only.
Already a member? Log in here

Abbott Progresses Libre 3 US Launch; New Trial Dasiglucagon Trial for Inreda’s Bi-hormonal AID system; NICE Recommends Amarin’s Vazkepa for Reimbursement in England and Wales

Three cardiometabolic-related news items have been observed: Abbott has recently posted a series of eight new instructional videos on its FreeStyle US YouTube channel (view YouTube Channel) for the Libre 3 CGM; an Inreda-sponsored study has been observed evaluating the feasibility of Zealand’s dasiglucagon in its bi-hormonal closed-loop system (STABLE-1; view CT.gov record); and Amarin announced NICE issued final guidance recommending reimbursement for Vazkepa (icosapent ethyl) in England and Wales. Below, FENIX provides highlights and insights for the respective new items.

This content is for Read Less members only.
Already a member? Log in here

Novo Buys Another PRV; Thoughts on Potential Uses

Novo has reportedly purchased a PRV from Marinus for $110M (view SEC filing). There have been no press releases issued from Novo or Marinus. Of note, Novo previously purchased PRVs from Chemo Research SL and another from Medicines Development for Global Health (view article). However, the company has only used one of its PRVs in late 2020 to expedite FDA’s review of its Wegovy. Now, in addition to the newly acquired PRV from Marinus, Novo is believed to have two PRVs in its pocket. Below, FENIX has conducted an analysis and rationale for where the PRV may be used.

This content is for Read Less members only.
Already a member? Log in here

Lilly to Initiate GGG Ph1 DDI Study

A Lilly-sponsored Ph1 trial has been observed evaluating the effects of Lilly’s GGG tri-agonist (GLP/GCG/GIP) on drug-drug interactions with midazolam, warfarin, and caffeine (view CT.gov record). Below FENIX provides additional details from the trial record as well as insight into how Lilly’s GGG DDI trial is different from prior DDI studies with the incretin class.

This content is for Read Less members only.
Already a member? Log in here