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Tuesday, September 3, 2019

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.

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.

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).

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.

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.

J&J RSV vaccine nabs accelerated review status in U.S.

The FDA designates Johnson & Johnson (JNJ -0.2%) unit Janssen Pharmaceutical’s prophylactic respiratory syncytial virus (RSV) senior vaccine a Breakthrough Therapy for the prevention of RSV-mediated lower respiratory tract disease in adults at least 60 years old.
The candidate is currently in Phase 2b development in people at least 65 years old.
Breakthrough Therapy status provides for more intensive guidance from the FDA on development, the involvement of more senior agency personnel and a rolling review of the marketing application.

Sanofi started at Outperform by Bernstein

Target $52