Category Archives: Other

Sanofi to Unveil New Strategy in December; Novo Obesity Partnership; Lifescan to Expand BGM Access

A series of diabetes-related news has come out today including Sanofi’s plan to unveil its new business strategy during an Investor Day in December. Additionally, Novo Nordisk announced a partnership with Noom for a digital obesity coaching solution, and Lifescan is engaging with Willis Towers Watson to expand access to the OneTouch Reveal Plus digital platform. Below, FENIX provides thoughts and analysis for each respective news item.

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

Poxel Ph3 Imeglimin and vTv Ph2 TTP399 CGM Data; EASD 2019 Day 3

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.

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

New Zafgen Data Suggests Clinical Hold Will Remain; Strategic Options to be Explored

Zafgen announced that it is planning to “strategic options to maximize shareholder value,” including a merger, acquisition, or in-licensing opportunity. Following preliminary data from a new animal study, Zafgen believes that in the short-term, there is a low probability of resolving the clinical hold placed on ZGN-1061. Below, FENIX provides brief thoughts on potential outcomes for Zafgen and ZGN-1061. 

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

Biocon/Mylan Glargine CRL; BI/ZEAL Dual Agonist Moves to Ph2; Vertex Acquires Semma

Three key pieces of news have recently been observed: Biocon/Mylan received a CRL from FDA regarding their bs-glargine Malaysian manufacturing facility, Boehringer Ingelheim is advancing its dual agonist into Ph2 (licensed from Zealand), and Vertex entered into a definitive agreement to acquire Semma Therapeutics. Below, FENIX provides thoughts and insights on the respective news items including the uncertainty around Biocon/Mylan’s glargine in the context of the merger with Pfizer.

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

FENIX to Host EASD Social Event on Monday Sept 16

To celebrate our new office in Barcelona, FENIX will host a social event during EASD on Monday, September 16, 2019, from 7-10pm CET. The venue is in the heart of the city at: Cheri Restaurant (Carrer d’Enric Granados, 122, Barcelona https://goo.gl/maps/r4XujW93NVifKX7MA)

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

New Novo Nordisk Ph1 Compound With Unknown MOA

A new Novo Nordisk Ph1 first-in-human trial for an unknown compound (NNC0385-0434) has been observed on CT.gov. According to the CT.gov record, the trial will evaluate a single subcutaneous injection of NNC0385-0434 in both healthy volunteers and in patients with hypercholesterolemia. Below, FENIX provides potential insights into the new compound.

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

Novo: Updated FENIX Viewpoint; Novo Q2 ’19 London Earnings Update

Novo Nordisk hosted its post-Q2 ’19 earnings event in London. Consistent with previous quarters, the session included a brief presentation from Novo management followed by Q&A. Below, FENIX provides highlights from the call including a scenario of reasonable likelihood around FENIX’s previous assertion questioning whether Novo is able to pursue accelerated approval for its anti-IL 21 + liraglutide T1DM beta cell preservation therapy. Additionally, FENIX includes an example of recent precedence set by FDA whereby FDA used an adcom to inform a regulatory decision about granting accelerated approval.

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

Roche Q2 ’19 Earnings Update

Roche hosted its Q2 ‘19 earnings call and provided brief updates to their diabetes business. Of note, Roche’s earnings press release stated that the  Accu-Chek Guide Me, a low-cost version of the Accu-Chek Guide, has been launched in the US. Below, FENIX provides highlights from the call. 

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