Category Archives: Topics

Tandem Mobi Receives FDA Clearance; Better Therapeutics’s AspyreRx Receives FDA Authorization for T2DM

Two cardiometabolic-related news items have been observed: Tandem announced FDA clearance of the Tandem Mobi insulin pump for PWD ≥6 years of age (view press release); and Better Therapeutics announced FDA authorized AspyreRx to provide cognitive behavioral therapy for adults with T2DM and held an associated investor call (view press release; webcast). Below, FENIX provides highlights and insights into the respective news items.

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FENIX Analysis: Thoughts on a Potential Zealand Acquisition

Following ADA 2023, FENIX conducted an analysis regarding a potential impending obesity development/commercialization partnership between two large pharma/biotech companies (view here); however, another compelling question has arisen: with all of the hype around the obesity market, has Zealand Pharma become a more attractive acquisition target? Below, FENIX provides insights and analysis for a potential Zealand acquisition by Boehringer Ingelheim, Novo Nordisk, AstraZeneca, or Amgen, as well as thoughts as to why Amgen could be the most likely suitor.

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Novo’s GLP-1RA Drugs Under EMA Review; Novartis’s Entresto Patent Ruled Invalid; FDA Approves Expanded Indication for Leqvio; Tonix Initiates Ph2 Intranasal TNX-1900 Study for Pediatric Obesity

Four cardiometabolic-related news items have been observed: Novo Nordisk’s diabetes and obesity drugs, Ozempic/Wegovy (semaglutide) and Saxenda (liraglutide), are under EMA review following two cases of suicidal ideation and one case of self-harm from users in Iceland (view article); Novartis announced the U.S. District Court for the District of Delaware ruled the patent covering Entresto and combinations of sacubitril and valsartan is invalid (view press release); Novartis also announced FDA approved a label update for Leqvio (inclisiran) to enable earlier use in patients with elevated LDL-C, as an adjunct to diet and statin therapy for patients who have not had a CV event but are at an increased risk for heart disease (view press release); and Tonix Pharmaceuticals announced the first participant has been enrolled in its Ph2 POWER study of TNX-1900, an intranasal potentiated oxytocin, for the treatment of pediatric obesity (view press release; CT.gov record). Below, FENIX provides highlights and insights into the respective news items.

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Lilly Initiates Three New Ph3 Retatrutide Obesity Trials; Zealand Ph1 Amylin Analog Results; Zealand Dasiglucagon CHI NDA Submitted; Sanofi Signs M1Pram Exclusivity Agreement with Adocia; Dexcom G7 Approved in Canada

Five cardiometabolic-related news items have been observed: Lilly initiated three new trials in the Ph3 retatrutide obesity program, TRIUMPH (TRIUMPH-1; TRIUMPH-2; TRIUMPH-4); Zealand announced positive results from Part 1 of the Ph1 MAD trial evaluating its amylin analog, ZP8396 (view press release); Zealand also submitted the dasiglucagon NDA for congenital hyperinsulinism (view press release); Adocia signed an exclusivity agreement with Sanofi for M1Pram (view press release); and Dexcom’s G7 CGM received Health Canada approval for individuals aged 2 years and older (view press release). Below, FENIX provides highlights and insights into the respective news items, including a projected regulatory timeline for retatrutide and brief thoughts on next-gen obesity drugs.

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Madrigal Submits Resmetirom NASH NDA

Madrigal Pharmaceuticals announced it initiated a rolling submission with FDA for an NDA seeking accelerated approval for resmetirom for the treatment of NASH with liver fibrosis. According to the press release, Madrigal has submitted the majority of the NDA to FDA and plans to submit the remaining components in July 2023 along with a request for priority review. For context, in April 2023, resmetirom received Breakthrough Therapy designation for the treatment of NASH with liver fibrosis (previous FENIX insight). Recall, on June 22, 2023, Madrigal announced new MAESTRO-NASH data at EASL 2023 (previous FENIX insight).

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Lilly to Acquire Sigilon Therapeutics; FDA Approves First Beta Cell Replacement Therapy for T1DM

Two cardiometabolic-related news items have been observed: Lilly announced it entered into an agreement to acquire Sigilon Therapeutics for ~$309.6M (view press release); and FDA approved Lantidra as the first beta cell replacement therapy for the treatment of T1DM in adults with severe hypoglycemia (view press release). Below, FENIX provides highlights and insights into the respective news items, including brief thoughts on the future of T1DM cell therapies.

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STEP HFpEF Topline Results; Novo ADA 2023 Investor Event

Novo Nordisk hosted an investor event during ADA 2023 (view slides) and also raised its FY 2023 financial guidance to 24-30%. During the call, Novo provided an overview of the QW insulin icodec Ph3 program and value proposition, insight into the Ph3 cagrisema T2DM program, high-dose oral semaglutide in T2DM and obesity, and topline STEP-HFpEF results. Of note, management briefly mentioned that SELECT CVOT data will be presented in the near future. Below, FENIX provides highlights and insights from the Novo ADA 2023 investor event.

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FENIX Analysis: Breaking Through Novo and Lilly’s Obesity Duopoly

With all of the (justified) hype surrounding the obesity market and the promising pipelines from a multitude of companies, a question has arisen regarding the potential of a new mega-partnership to compete with Novo Nordisk and Lilly. Below, FENIX provides thoughts and rationale on why CVRM history could repeat itself with a partnership between AstraZeneca and either Boehringer Ingelheim, Amgen, or Pfizer could be on the horizon. FENIX will also soon author a follow-up to this obesity partnership blast with a subsequent analysis discussing the rationale for why a Zealand acquisition could be an alternative option.

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