Concert Pharma up premarket on positive CTP-543 data

Thinly traded micro cap Concert Pharmaceuticals (NASDAQ:CNCE) is up 21% premarket on light volume on the heels of positive data from a Phase 2 clinical trial evaluating Fast Track-tagged CTP-543 in patients with moderate-to-severe alopecia areata, an autoimmune disorder characterized by patchy or complete hair loss.

The 8 mg and 12 mg dose arms both met the primary endpoint of a statistically significant proportion of patients achieving at least a 50% improvement from baseline at week 24 in an alopecia scale called SALT compared to placebo.

CTP-543 is an oral Janus kinase (JAK) 1/2 inhibitor discovered by the company by applying its deuterium chemistry technology to modify ruxolitinib (Incyte’s Jakafi).

https://seekingalpha.com/news/3496323-concert-pharma-21-percent-premarket-positive-ctpminus-543-data

Forty Seven’s magrolimab Fast Track’d for blood cancers

Thinly traded micro cap Forty Seven (FTSV -0.9%) is down on below-average volume on the heels of the FDA designating lead candidate magrolimab (formerly 5F9) for Fast Track review for the treatment of myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML).

Magrolimab is a humanized IgG4 monoclonal antibody that binds to a certain CD47 receptor on immune cells called macrophages. Blocking the receptor eliminates the way cancer cells avoid being killed by these cells.

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

https://seekingalpha.com/news/3496358-forty-sevens-magrolimab-fast-trackd-blood-cancers

Planet Fitness -3% after Berenberg cut

Planet Fitness (NYSE:PLNT) slumps after Berenberg warns on a lack of near-term catalysts for the chain.

The firm thinks PLNT already trades at a relatively high EV/EBITDA multiple and is fairly valued overall.

The rating from Berenberg goes to Hold from Buy, while the price target slides to $69 vs. $80 prior and the sell-side average PT of $82.43. The Quant Rating on Planet Fitness is at Neutral.

Shares of Planet Fitness are down 3.34% to cut into the 27% YTD rally.

https://seekingalpha.com/news/3496394-planet-fitness-minus-3-percent-berenberg-cut

Abeona to explore strategic alternatives

Abeona Therapeutics (ABEO +70.1%) is up a 10x surge in volume on its announced plan to explore shareholder value-boosting strategic alternatives, including a sale or merger.

Jefferies LLC is advising.

https://seekingalpha.com/news/3496364-abeona-explore-strategic-alternatives-shares-ahead-70-percent

Fate Therapeutics on go with clinical development of cancer candidate FT596

The FDA has signed off on Fate Therapeutics’ (FATE +3.7%) IND for FT596, an off-the-shelf chimeric antigen receptor (CAR) natural killer (NK) cell cancer immunotherapy that targets a range of tumor-associated antigens.

First up is a clinical trial evaluating FT596, as monotherapy and in combination with CD20-directed monoclonal antibodies, for the treatment of B-cell lymphoma and chronic lymphocytic leukemia.

CEO Scott Wolchko says, “FT596 is a ground-breaking product candidate with the potential to supplant current-generation patient-specific and allogeneic CAR19 T-cell immunotherapies, which recognize only one antigen and fail to address the significant risk of relapse due to antigen escape. Our robust clinical development strategy for FT596 is designed to target multiple tumor-associated antigens for the treatment of B-cell lymphomas and leukemias. We believe the product candidate’s engineered functionality, coupled with its ability to be cost-effectively administered on-demand in multiple treatment cycles, will deliver a deeper and more durable response to patients compared to single-antigen targeted CAR19 T cells.”

FT596 is derived from a clonal master induced pluripotent stem cell (iPSC) line engineered with three functional modalities designed to optimize anti-tumor activity: a proprietary CAR targeting B-cell antigen CD19; a novel high-affinity 158V, non-cleavable CD16 (hnCD16) Fc receptor; and an interleukin-15 receptor fusion (IL-15RF).

https://seekingalpha.com/news/3496371-fate-therapeutics-go-clinical-development-cancer-candidate-ft596

Akebia completes enrollment in late-stage vadadustat program

Akebia Therapeutics (AKBA +1.9%) perks up, albeit on light volume, in reaction to its announcement that its Phase 3 program evaluating vadadustat in chronic kidney disease (CKD) patients with anemia is now fully enrolled.

The INNO₂VATE studies completed the enrollment of 3,923 dialysis-dependent CKD patients in April and the PRO₂TECT studies are now fully enrolled with 3,513 non-dialysis-dependent CKD patients.

The trials are assessing vadadustat compared to darbepoetin alfa. The primary endpoints are the change in hemoglobin from baseline at week 36 and safety (major adverse cardiovascular events).

Topline data from INNO₂VATE should be available in Q2 2020 followed by PRO₂TECT in mid-2020.

https://seekingalpha.com/news/3496373-akebia-completes-enrollment-late-stage-vadadustat-program

Mustang Bio on board with BioLife’s CryoStor

BioLife Solutions (BLFS -2.2%) announces that Mustang Bio (MBIO -1%) has adopted its CryoStor cell freeze media and evo cold chain system for use in its clinical trials. Financial terms are not disclosed.

https://seekingalpha.com/news/3496386-mustang-bio-board-biolifes-cryostor