Gilead Primary Endpoint Not Met in Phase 2 ATLAS NASH Study

Gilead Sciences Inc. (GILD) said the primary endpoint wasn’t met in the Phase 2 ATLAS study of combination and monotherapy investigational treatments for advanced fibrosis due to non-alcoholic steatohepatitis.

Gilead said no regimen led to a statistically significant increase in the proportion of patients who achieved the primary efficacy endpoint of a greater than or equal to 1-stage improvement in fibrosis without worsening of NASH. But, statistically significant improvements in multiple response measures of fibrosis and liver function were observed in patients treated with a combination of firsocostat and cilofexor, compared with placebo in patients with advanced fibrosis.

The Phase 2 ATLAS study is a randomized, double-blind, placebo-controlled study that evaluated the safety and efficacy of monotherapy and dual combination regimens of cilofexor 30 mg, firsocostat 20 mg and selonsertib 18 mg in patients with advanced fibrosis due to NASH.

Statistically significant improvements in multiple secondary endpoints were observed in patients treated with firsocostat and cilofexor compared with placebo, the company said.

https://www.marketscreener.com/GILEAD-SCIENCES-4876/news/Gilead-Sciences-Says-Primary-Endpoint-Not-Met-in-Phase-2-ATLAS-Study-29733257/

Bayer asks U.S. appeals court to reverse $25 million Roundup verdict

Bayer AG on Monday said it has asked a U.S. federal appeals court to throw out a $25 million judgment it was ordered to pay to a California man who blamed the company’s Roundup weed killer for his cancer.

In a filing in the U.S. Court of Appeals for the 9th Circuit dated Friday, Bayer said the verdict defied regulatory findings and sound science, adding that the “speculative case” should never have made it before a jury.

Bayer in a statement said it stood behind the safety of Roundup and its active ingredient glyphosate and planned to vigorously defend the more than 42,700 U.S. Roundup cancer lawsuits it faces.

In its court filing, Bayer said the Hardeman appeal had the potential to shape how every subsequent Roundup case is litigated.

The widely-used weed killer is made by Monsanto, which Bayer acquired last year for $63 billion. Bayer stock has lost about 23% in value since the first Roundup verdict for plaintiffs in August 2018.

The case on appeal before the 9th Circuit involved the claims of Edwin Hardeman, which was the third Roundup case to go to trial in a U.S. court. A jury in March ordered Monsanto to pay $80 million in damages, saying Roundup had caused the man’s non-Hodgkin’s lymphoma. The trial court judge in July reduced that verdict to $25 million.

Lawyers for Hardeman on Monday did not immediately respond to a request for comment on Bayer’s appeal.

The lawyers during the trial argued Monsanto had failed to warn consumers of Roundup’s cancer risk and said the company concealed damaging evidence from public and regulatory view. Bayer rejects those allegations.

The German company’s main appeal argument in Hardeman’s case centers on repeated findings by the U.S. Environmental Protection Agency that glyphosate is not a carcinogen and not a risk to public health when used in accordance with its current label.

Bayer argued it would be impossible to comply with the Hardeman verdict, a lawsuit brought under state law, because any warning label would be in conflict with guidance from a federal agency.

Some legal experts consider this preemption defense a “silver bullet” because it would stop claims across the board, but said the argument faced big hurdles on appeal.

The company also said the trial judge had committed “a host of errors” by allowing jurors to hear unreliable expert testimony.

https://www.marketscreener.com/news/Bayer-asks-U-S-appeals-court-to-reverse-25-million-Roundup-verdict–29734464/

Medtronic recalls implantable infusion pump due to potential motor stall

Medtronic (MDT +1%) has initiated a recall of 7,317 SynchroMed II pumps, Models 8637-20 and 8637-40, due to the risk of motor stall due to the potential presence of foreign particles in the pump motor assembly.

There have been five reports of the problem thus far.

https://seekingalpha.com/news/3526505-medtronic-recalls-implantable-infusion-pump-due-to-potential-motor-stall

FDA lifts partial hold on Regulus’ early-stage study of RGLS4326

The FDA has removed the partial clinical hold on a Phase 1 study evaluating Regulus Therapeutics’ (RGLS -0.1%) RGLS4326 for the potential treatment of autosomal-dominant polycystic kidney disease. The trial should restart next quarter.

The FDA instituted the partial hold, which suspends recruitment, after “unexpected findings” in a mouse toxicity study in July.

https://seekingalpha.com/news/3526517-fda-lifts-partial-hold-on-regulus-early-stage-study-of-rgls4326

Rocket Pharma up 10% on PRIME status for RP-L102 in Europe

The European Medicines Agency has granted PRIME status to Rocket Pharmaceuticals’ (RCKT +9.9%) gene therapy RP-L102 for the treatment of a rare bone marrow failure called Fanconi anemia.

PRIME, akin to Breakthrough Therapy status in the U.S., provides for more intensive guidance on development and accelerated review of the market application.

A Phase 2 study is in process.

https://seekingalpha.com/news/3526520-rocket-pharma-up-10-on-prime-status-for-rp-l102-in-europe

USPTO allows challenge to key Intuitive Surgical patent

The USPTO’s Patent Trial and Appeal Board (PTAB) has agreed to review the validity of Intuitive Surgical’s (ISRG +1.4%) U.S. Patent No. 8,801,601 covering its surgical navigation guidance system.

Johnson & Johnson (JNJ +0.5%) unit Auris Health filed a petition in June seeking to have the patent invalidated saying that it covers well-known ideas.

Intuitive counters that the patent covers ways to limit the risk of perforation or tissue damage from an endoscope. It sued Auris in August 2018 for infringement.

The PTAB declined Auris’ petition to review a second patent.

https://seekingalpha.com/news/3526526-uspto-allows-challenge-to-key-intuitive-surgical-patent

Novartis exit from fevipiprant pressures Gossamer Bio

Gossamer Bio (NASDAQ:GOSS) slumped 38% premarket on light volume in reaction to Novartis’ decision to terminate development of DP2 antagonist fevipiprant for asthma.

Gossamer’s lead candidate, GB001, also an DPS antagonist, is in Phase 2 development for rhinosinusitis and asthma.

https://seekingalpha.com/news/3526363-novartis-exit-from-fevipiprant-pressures-gossamer-bio-down-38-premarket