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April 24, 2017

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Today's Rundown

  1. NASH front-runner Genfit says phase 3 enrollment delayed by up to 6 months

  2. Immune Pharma starts major R&D restructure, CEO jumps ship to spinoff

  3. Bristol-Myers NASH drug hits primary endpoint in phase 2

  4. Merck-backed NGM Bio hits its marks in midstage NASH trial

  5. EMA relocation's possible impact on safety monitoring 'alarming,' EU R&D chiefs say

  6. Argenx files for IPO to take autoimmune drug to phase 3

  7. BD pens $24B Bard buyout to create medtech powerhouse

Featured Story

NASH front-runner Genfit says phase 3 enrollment delayed by up to 6 months

French biotech Genfit, a leader in the race to develop a fatty liver disease drug, said in its financials that it will delay its phase 3 NASH trial by four to six months in patients with liver scarring.

Top Stories

Immune Pharma starts major R&D restructure, CEO jumps ship to spinoff

Daniel Teper has stepped down immediately as CEO of New York biotech Immune Pharma as he looks to head up its new oncology spinoff.

Bristol-Myers NASH drug hits primary endpoint in phase 2

A phase 2 trial of Bristol-Myers NASH candidate BMS-986036 met its primary endpoint. The data position Bristol-Myers to talk to regulators about further development of a drug it hopes will snag a slice of the NASH market in the face of competition from Allergan, Gilead and others.

Merck-backed NGM Bio hits its marks in midstage NASH trial

Fierce 15 company NGM Bio says it met its primary endpoint of reducing liver fat in NASH patients, with hints of antifibrotic activity, as the small biotech looks to get into the mix with its big biopharma rivals for a blockbuster market.

EMA relocation's possible impact on safety monitoring 'alarming,' EU R&D chiefs say

As the saga of the EMA's location after Brexit rumbles on, European pharma leaders have drafted an open letter calling for strenuous efforts to avoid disruption at the regulator.

Argenx files for IPO to take autoimmune drug to phase 3

Argenx has filed to raise up to $75 million (€69 million) in a Nasdaq IPO. The European biotech is heading across the pond in search of cash to take lead candidate ARGX-113 to the cusp of a pivotal trial while also hustling cancer candidate ARGX-110 through mid-phase studies.

BD pens $24B Bard buyout to create medtech powerhouse

BD has struck a $24 billion deal to buy C.R. Bard. The takeover will strengthen BD’s position in the markets for catheters, pumps and other items while also giving it a bigger presence in fast-growing fields including oncology and biosurgery.

News of Note

Private biotech HitGen has penned a new R&D collaboration with The Scripps Research Institute, as well as Calibr, that will focus on cancer, regenerative medicine and virology. Statement

In its most recent late-stage trial round, known as Monarch 3, Eli Lilly says its soon-to-be-submitted CDK 4/6 breast candidate abemaciclib met its primary endpoint of showing statistically significant improvement in progression-free survival. Release

As biopharmas post new data from their experimental fatty liver candidates in Amsterdam, Reuters outlines the challenges and opportunities of this future market. Reuters Health story

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