Mereo Bio’s navicixizumab Fast Track’d for ovarian cancer

Thinly traded nano cap Mereo BioPharma Group (NASDAQ:MREO) is up 6% premarket on increased volume, albeit on turnover of only 29K shares, in reaction to Fast Track designation in the U.S. for Phase 1-stage bispecific antibody navicixizumab for heavily pretreated patients with high grade ovarian, primary peritoneal or fallopian tube cancer who have received at least three prior lines of therapy and/or prior treatment with Roche’s Avastin (bevacizumab).

Fast Track status provides for more frequent interaction with the FDA review team and a rolling review of the marketing application.

Celgene was investigating the candidate but declined to exercise its license option about a year ago.

https://seekingalpha.com/news/3504171-mereo-bios-navicixizumab-fast-trackd-ovarian-cancer-shares-6-percent-premarket

Brainstorm up on U.S. patent covering NurOwn

Thinly traded nano cap BrainStorm Cell Therapeutics (BCLI +1.4%) is up on below-average volume in reaction to the issuance of a new U.S. patent covering its NurOwn cell therapy.

The patent, entitled “Method of Qualifying Cells,” covers a pharmaceutical composition for MSC-NTF cells secreting neurotrophic factors (NurOwn) consisting of a culture medium as a carrier and an isolated population of differentiated bone marrow-derived mesenchymal stem cells (MSCs) that secrete neurotrophic factors.

https://seekingalpha.com/news/3504271-brainstorm-1-percent-u-s-patent-covering-nurown

NGM Bio down on underwhelming data on NASH candidate

Thinly traded NGM Biopharmaceuticals (NASDAQ:NGM) is down 17% premarket on light volume in apparent reaction to preliminary 24-week data from Cohort 4 in a Phase 2 clinical trial evaluating daily 1 mg doses of aldafermin in NASH patients.

Absolute liver fat content dropped 7.9% in treated patients compared to a reduction of 2.0% in the placebo arm (p<0.05). The relative reduction was -39.6% versus -5.9% for control (p<0.05).

The results appear to be shy of Viking Therapeutics’ (NASDAQ:VKTX) VK2809 and similar to Madrigal Pharmaceuticals’ (NASDAQ:MDGL) MGL-3196.

On the safety front, the most common treatment-related adverse events (mostly mild/moderate) were diarrhea, headache, nausea and joint pain.

Topline data should be available in Q1 2020.

https://seekingalpha.com/news/3504182-ngm-bio-17-percent-premarket-underwhelming-data-nash-candidate

Livongo up 8% on diabetes contract win

Livongo Health (LVGO +8.3%) is up out of the gate in reaction to the award of a contract for its Diabetes solution from the Federal Employees Health Benefits Program covering ~5.3M employees, retirees and family members with type 1 or 2 diabetes.

The two-year agreement, commencing on January 1, 2020, will add ~25K Diabetes Members next year and ~45K in 2021. Additional revenue should be $20M - 25M in 2020 and $30M - 35M the year after.

https://seekingalpha.com/news/3504197-livongo-8-percent-diabetes-contract-win

Supreme Court declines to hear Acorda appeal of adverse Ampyra patent ruling

The U.S. Supreme Court has declined to hear an appeal from Acorda Therapeutics (ACOR +1%) aimed at reviving certain patents covering MS med Ampyra (dalfampridine). In September 2018, the U.S. Court of Appeals for the Federal Circuit voted 2-1 invalidating four of its U.S. patents.

Sales have plummeted since the launch of generic alternatives.

https://seekingalpha.com/news/3504200-supreme-court-declines-hear-acorda-appeal-adverse-ampyra-patent-ruling

Zimmer strikes out in appeal of patent infringement judgement with Stryker

The U.S. Supreme Court has declined to hear an appeal by Zimmer Biomet Holdings (ZBH +0.6%) over the tripling a $70M patent-infringement award to competitor Stryker (SYK -0.7%) related to devices that clean bones during surgery.

The final judgement was $230M based on ZBH’s “willful” infringement.

https://seekingalpha.com/news/3504206-zimmer-strikes-appeal-patent-infringement-judgement-stryker

Syndax’s entinostat advances in late-stage breast cancer study

Syndax Pharmaceuticals (SNDX -0.6%) announces the fifth and final successful interim futility analysis of survival data in the Cancer Research Group-sponsored Phase 3 clinical trial, E2112, evaluating the combination of lead drug entinostat and exemestane (Pfizer’s Aromasin) in patients with advanced HR+/HER2- breast cancer.

The study will continue until 410 of the 608 participants have died, currently expected to occur in Q2 2020. If all goes well, the company expects to file a U.S. marketing application in late 2020.

Investors should be cautious here. A year ago, the company announced that E2112 failed to achieve the progression-free survival (PFS) endpoint.

Entinostat is an orally available small molecule called an HDAC inhibitor designed to block the function of immune suppressive cells in the tumor microenvironment.

https://seekingalpha.com/news/3504229-syndaxs-entinostat-advances-late-stage-breast-cancer-study