Bristol-Myers’ ozanimod successful in pivotal ulcerative colitis study

Bristol-Myers Squibb (NYSE:BMY) announces positive results from a Phase 3 clinical trial, True North, evaluating Zeposia (ozanimod) in patients with moderate-to-severe ulcerative colitis (UC).

The stud met both primary endpoints demonstrating statistically significant results for induction of clinical remission at week 10 and maintenance at week 52 compared to placebo.

Key secondary endpoints were also met.

Zeposia is also being tested in a Phase 3 program in Crohn’s disease.

The FDA approved Zeposia in March for relapsing forms of multiple sclerosis. The EMA approved it last week.

Ozanimod is an oral, once-daily selective sphingosine 1-phosphate 1 and 5 receptor modulator being developed for the treatment of autoimmune diseases. It diminishes the activity of autoreactive lymphocytes (white blood cells), which is the cause of many types of autoimmune disorders. BMY unit Celgene obtained the rights to the drug via its $7.2B acquisition of Receptos.

https://seekingalpha.com/news/3579463-bristol-myers-ozanimod-successful-in-pivotal-ulcerative-colitis-study

Novocure launches MyLink tool in U.S.

Novocure (NASDAQ:NVCR) has launched MyLink, a new tool that allows patients to download their Optune usage data from the comfort of home.

Novocure initiated a phased launch with an initial wave of 30 U.S. patients to be followed by a broad rollout to all patients in the coming months.

Optune is a noninvasive, antimitotic cancer treatment for glioblastoma multiforme.

https://seekingalpha.com/news/3579479-novocure-launches-mylink-tool-in-u-s

Agenus on go to start study of cell therapy in COVID-19

The FDA has cleared Agenus (NASDAQ:AGEN) unit, AgenTus Therapeutics’ IND application for an allogeneic iNKT therapy, as a potential therapy for treatment of patients with COVID-19.

A clinical trial is expected to commence shortly.

https://seekingalpha.com/news/3579526-agenus-on-go-to-start-study-of-cell-therapy-in-covidminus-19

FDA accepts Y-mAbs naxitamab application for neuroblastoma

Under Priority Review status, the FDA accepts for review Y-mAbs Therapeutics’ (NASDAQ:YMAB) marketing application for Danyelza (naxitamab) for the treatment of patients with relapsed/refractory high-risk neuroblastoma, a cancer that develops from immature nerve cells.

The agency’s action date is November 30.

Naxitamab is a humanized monoclonal antibody called 3F8 that targets a protein called GD2 that is expressed on tumors of neuroectodermal origin like neuroblastoma.

https://seekingalpha.com/news/3579532-fda-accepts-y-mabs-naxitamab-application-for-neuroblastoma

SmileDirectClub expands presence in Hong Kong

SmileDirectClub (NASDAQ:SDC) has expanded its SmileShop partnership with Watsons, Asia’s largest health and beauty products retailer, with its first locations in Mong Kok and Kwun Tong in Hong Kong.
https://seekingalpha.com/news/3579542-smiledirectclub-expands-presence-in-hong-kong

AgeX Therapeutics +12% on ESI 053 deal for COVID-19

AgeX Therapeutics (NYSEMKT:AGE) inks a non-binding letter of intent with ImStem Biotechnology to obtain from AgeX, a non-exclusive license to use its embryonic stem cell line ESI 053 to derive ImStem’s investigational MSC product IMS001 for development in COVID-19 as well as acute respiratory distress syndrome (ARDS) due to other causes.

Financial terms and other provisions of agreement are yet to be finalized.

https://seekingalpha.com/news/3579547-agex-therapeuticsplus-12-on-esi-053-deal-for-covidminus-19

Planet Fitness sees about 60% of its customers return in early stages

Planet Fitness (NYSE:PLNT) says it has reopened about 800 stores across 30 states and one province in Canada. The company anticipates that an additional 200 stores may be able to open by mid-June.

As expected, Planet Fitness is taking extreme measures to sanitize high-touch areas and promote distancing.

So far, usage indexing is at about 60% for open PLNT locations compared to the same level last year.

SEC Form 8-K

https://seekingalpha.com/news/3579553-planet-fitness-sees-60-of-customers-return-in-early-stages