Tag Archives: Diabetes

Lilly Debuts Connected Pen at ATTD; ATTD 2021 Key News (June 3)

On Day 2 of ATTD 2021, a series of diabetes-related press releases and presentations have been observed from Lilly, Dexcom, Senseonics, and Provention Bio. Importantly, Lilly hosted a Symposium at ATTD dedicated to its new connected pen platform in which the company (for what is believed to be the first time) displayed the Tempo Smart Button device. Below, FENIX provides highlights and insights from the respective news items.

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ATTD 2021 Key Press Releases (June 2)

With the start of the ATTD 2021 conference, a series of cardiometabolic-related press releases have been observed from BI/Zealand, Medtronic, Metacrine, and Obatala Sciences. Below, FENIX provides highlights and insights from the respective news items.

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Novo Partners for HF Cell Therapy

Novo Nordisk and Heartseed announced a global partnership and license agreement for the development, manufacturing, and commercialization of Heartseed’s lead asset HS-001. For context, Heartseed’s lead candidate, called HS-001, is an investigational cell therapy for the treatment of heart failure that uses purified cardiomyocytes derived from induced pluripotent stem cells (iPSC). Below, FENIX provides highlights and insights from the press release.

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Novo Resubmits 2.0mg High-dose Ozempic to FDA

Novo Nordisk announced it has resubmitted the sNDA to FDA for QW high-dose 2.0mg injectable semaglutide for the treatment of T2DM. Recall, in March 2021, Novo announced it received a Refusal to File letter from FDA (previous FENIX insight) after initially filing the application on January 20, 2021 (previous FENIX insight). Below, FENIX provides thoughts on the refiling.

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Teplizumab Adcom: 10-7 Split Vote; Questions Raised on Teplizumab’s Approvability

Today, FDA held an advisory committee meeting to discuss the proposed teplizumab indication to delay the onset of T1DM based on results from the TN-10 study. The panel narrowly voted in favor (10-7) that the teplizumab benefits outweigh the risks. Recall, ahead of the adcom, FENIX correctly predicted a 10-7 vote favoring teplizumab. Below, FENIX provides a summary of key adcom panelist commentary as well as thoughts on the vote and next steps for Provention Bio and teplizumab.

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Medtronic CY Q1 ’21 Earnings Update; FDA Accepts IND for Lilly/Dicerna Cardiometabolic Asset; Dario Digital Therapeutics Publication

Three cardiometabolic news items have been observed: Medtronic hosted its CY Q1 ’21 (FY Q4 ’21) earnings call; Dicerna announced FDA accepted Lilly’s IND application for a novel cardiometabolic asset, LY3819469, targeting the LPA gene; and Dario announced the publication of “Digital Therapeutics for Type 2 Diabetes: Incorporating Coaching Support and Validating Digital Monitoring” in Diabetes Science and Technology. Below, FENIX provides highlights and insights for the respective news items.

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InPen and Guardian 4 Sensor Receive CE Mark; Oramed Ph3 Oral Insulin Update; Adocia Files Patents for Obesity, NASH, and T2DM

Three cardiometabolic-related news items have recently been observed: Medtronic announced it received CE Mark for expanded functionality of its InPen smart insulin pen and its Guardian 4 CGM (aka Zeus); Oramed issued a letter to shareholders in which it highlighted its Ph3 oral insulin program (press release); and Adocia announced it has filed three patent families, which include obesity, NASH, and T2DM. Below, FENIX provides highlights and insights for the respective news items.

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Provention Bio Teplizumab Adcom Pre-read Materials Posted

FDA posted the pre-read materials for the upcoming teplizumab advisory committee meeting on May 27, 2021 at 9AM EST. Of note, it is believed this is the first time the intended marketed name for teplizumab, “Tzield,” has been disclosed. While it remains to be seen, FENIX predicts a split adcom vote (10-7 favoring teplizumab) due to questions around the clinical meaningfulness of a 2-year delay in the context of the SAEs, including immunosuppression. Below, FENIX provides a brief overview of the key points the panel will consider as well as preliminary thoughts on the adcom.

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Xeris to Acquire Strongbridge; NGM Bio Discontinues NASH Program; BI Selects NASH Drug Candidate From Dicerna

A series of cardiometabolic news items have been observed: Xeris and Strongbridge announced they have entered into a definitive agreement under which Xeris will acquire Strongbridge for stock and contingent value rights; NGM Bio announced the discontinuation of its NASH program following topline results from the Ph2b trial; and Dicerna announced BI has accepted a GalXC RNAi candidate, referred to as DCR-LIV2, for advancement under its existing agreement. Below, FENIX provides highlights and insights for the respective news items.

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