Over the last few months, the fate of Lexicon and sotagliflozin have remained in question; however, in recent days it appears that both have the potential to make a strong comeback. Below, FENIX analyzes Lexicon’s stock price in the context of the recent DAPA-HF results and settlement with Sanofi.
On the third day of EASD, 2 key press releases and one new clinical trial were observed. Of note, results from Novo Nordisk’s H2H Tresiba vs. Toujeo trial (CONCLUDE) were presented but a Novo press release was not observed. There is a dedicated session on CONCLUDE tomorrow (September 19) from 12-1pm local time. Below FENIX provides insights and context from each respective announcement.
On the second day of EASD, 7 key press releases and one new clinical trial were observed across diabetes drugs and devices. Below FENIX provides insights and context from each respective announcement.
The CHMP agenda for this week’s meeting (September 16-20) has been released, and it includes two notable items (REWIND and dapa/saxa/met triple FDC opinions). Below, FENIX provides diabetes-related highlights and insights from the CHMP agenda.
With the start of the 2019 EASD conference, a series of diabetes drug and device-related press releases have been observed including connected care partnerships between Novo/Medtronic and Sanofi/Abbott. Additionally, AstraZeneca announced that FDA granted Fast Track designation for dapagliflozin in worsening heart failure. Below FENIX insights and context from each respective announcement.
Dance Biopharm and DarioHealth recently announced a partnership to integrate data from Dance’s smart inhaler into DarioHealth’s digital health management platform. Recall, Dance is developing inhalable insulin and GLP-1RA products. Below, FENIX provides thoughts on the partnership including context from MannKind similar partnership with OneDrop for the Afrezza BluHale platform.
Today, Lexicon announced that Sanofi and Lexicon have amicably settled their differences in the termination of their collaboration for sotagliflozin. The settlement includes Sanofi to pay Lexicon $208M up front with the balance of $52M to be paid within 12 months ($260M total). Below, FENIX provides thoughts and perspective from the press release and the associated investor call.
Xeris Pharmaceuticals announced FDA approval of its Gvoke pre-filled syringe (PFS) and auto-injector for hypoglycemia rescue in patients 2 years of age and older. Xeris held an associated call with investors following the approval announcement. The approval comes exactly 3-months after the PDUFA delay imposed by FDA. Below, FENIX provides an in-depth Gvoke label analysis in the context of the recent approval of Lilly’s nasal glucagon, Baqsimi.
Novo Nordisk announced plans to initiate a new US insulin savings program starting on January 2, 2020. Under the new plan, Novo will offer a $99 Cash Card Program for a select volume of any of its insulin analog products as well as the launch of NovoLog and NovoLog Mix Authorized Generics (AG). Below, FENIX provides thoughts on the New Novo insulin program in the context of similar programs by Lilly and Sanofi.
Lexicon participated in the 2019 Wells Fargo Healthcare conference and provided brief updates on the sotagliflozin development situation following Sanofi’s announcement that it was withdrawing from the partnership. Additionally, Lexicon briefly commented on sota’s potential in CV and CKD T2DM patients, but senior management made no statements regarding the recent Farxiga DAPA-HF results (previous FENIX insight). Below, FENIX provides highlights and insights from the event.