Genfit up 6% on positive NASH test data

hinly traded GENFIT (GNFT +5.9%) is up, albeit on a miniscule 17K shares, in reaction to results from a study that showed its noninvasive NASH test, NIS4, outperformed other noninvasive diagnostics in identifying NASH in type 2 diabetics. The data were presented at The Liver Meeting in Boston.

NIS4 showed statistically superior performance compared to FIB4, NFS, ELF and Fibrometer as determined by the area under receiver operating characteristic (AUROC) (a measure of how well a test can distinguish between two diagnostic groups – diseased & normal).

The company plans to file a U.S. marketing application in 2020. LabCorp is currently offering the test for research use only.

https://seekingalpha.com/news/3517626-genfit-6-percent-positive-nash-test-data

Myriad Genetics up 5% on positive prenatal screening test data

Findings from a new study, published Ultrasound in Obstetrics and Gynecology, showed a high rate of accuracy for Myriad Genetics’ (MYGN +4.7%) noninvasive Prequel Prenatal Screen test in addition to a low test-failure rate of 1/1,000.

Prequel uses whole-genome sequencing to identify chromosomal abnormalities, including trisomies 13 (associated with intellectual and physical disabilities), 18 (slow growth and physical defects) and 21 (Down syndrome).

Prenatal testing accounted for almost 14% of its FQ1 molecular diagnostic testing revenue ($23.5M/172.0M).

https://seekingalpha.com/news/3517621-myriad-genetics-5-percent-positive-prenatal-screening-test-data

Roche’s Gazyva successful in mid-stage lupus nephritis study

A Phase 2 clinical trial, NOBILITY, evaluating Roche’s (OTCQX:RHHBY) Gazyva (obinutuzumab) in patients with lupus nephritis, severe kidney inflammation related to autoimmune disorder systemic lupus erythematosus, met the primary endpoint.

Specifically, a statistically significantly greater proportion (40%) of patients receiving Gazyva + standard-of-care (SOC) treatment achieved complete renal response compared to placebo + SOC (18%) (p=0.007).

Key secondary endpoints were also met.

No new safety signals were observed.

A Phase 3 trial should launch in 2020.

Obinutuzumab is an engineered monoclonal antibody that binds to a surface protein found on certain types of B cells called CD20.  The company says it is believed to work by attacking cancer cells in conjunction with the body’s immune system.

Gazyva is currently approved in the U.S. for a range of blood cancers.

Related ticker: Biogen (BIIB -0.1%)

The company will host a conference call tomorrow, November 12, at 10:30 am ET to discuss the results.

https://seekingalpha.com/news/3517558-roches-gazyva-successful-mid-stage-lupus-nephritis-study

Assembly Bio up 7% on positive HBV core inhibitor data

Assembly Biosciences (ASMB +7%) is up out the gate in reaction to encouraging data on its  first- and second-generation hepatitis B virus (HBV) core inhibitors. The results were presented at The Liver Meeting in Boston.

24-week data on ABI-H0731 (Study 201) in HBV e-antigen-positive patients showed a favorable safety profile an 81% success rate (n=22/27) in reducing HBV DNA levels beyond the limit of detectability (patients with detectable DNA at baseline).

Final 24-week results from Study 202 showed faster and deeper HBV DNA declines in patients receiving ABI-H0731 + entecavir compared to entecavir alone.

Phase 1 results on ABI-H2158 also showed a favorable safety profile and pharmacokinetics. The study should wind up in Q1 2020.

https://seekingalpha.com/news/3517530-assembly-bio-7-percent-positive-hbv-core-inhibitor-data

Replimune Group EPS misses by $0.01

Replimune Group (NASDAQ:REPL): Q2 GAAP EPS of -$0.35 misses by $0.01.

Cash, cash equivalents, and short-term investments of $109.9M.

Press Release

https://seekingalpha.com/news/3517490-replimune-group-eps-misses-0_01

MyoKardia’s mavacamten successful in mid-stage HCM study

A 59-subject Phase 2 clinical trial, MAVERICK-HCM, evaluating MyoKardia’s (NASDAQ:MYOK) mavacamten in patients with non-obstructive hypertrophic cardiomyopathy (HCM) (the walls of the ventricles thicken compromising blood flow) met the primary endpoint of safety at week 16.

Meaningful reductions in cardiac stress biomarkers were also noted. The results will be submitted for presentation at a future medical conference.

The company intends to launch additional studies in patients with non-obstructive HCM (will provided a regulatory update in H1 2020) and heart failure with preserved ejection fraction (Phase 2 study should commence in Q2 2020).

On another note, new data from its PIONEER open-label extension study of mavacemten in symptomatic obstructive HCM showed consistent results at week 48 (12 participants) compared to weeks 12, 24 and 36.

Shares down 7% premarket on light volume after the 5% runup at the end of last week.

https://seekingalpha.com/news/3517522-myokardias-mavacamten-successful-mid-stage-hcm-study

Walgreens Boots Alliance up 8% premarket on KKR interest

Walgreens Boots Alliance (NASDAQ:WBA) is up 8% premarket on modest volume in apparent reaction to a report that KKR (NYSE:KKR) has approached it about a buyout.

Shares rallied last week over reports that private-equity shops were circling.

Update: Bloomberg reports that KKR is preparing a proposal to take WBA private, although no final decisions have been made.

https://seekingalpha.com/news/3517511-walgreens-boots-alliance-8-percent-premarket-kkr-interest