RepliCel Life Sciences Inc (TSXV:RP)
RepliCel is a regenerative medicine company developing autologous cell therapies that address diseases caused by a deficit of healthy cells required for normal healing and function.
Sesen Bio (NASDAQ:SESN) is extending the intraday gains to the after-hours with a ~4.6% rise after analysts raised its price target following the company’s premarket announcement of FDA acceptance for the Biologics License Application for Vicineum.
With an action date set for August 18, 2021, and under Priority Review, the federal agency is set to evaluate the marketing application for Vicineum in the treatment of high-risk, BCG (bacillus Calmette-Guérin)-unresponsive non-muscle invasive bladder cancer .
Maintaining the buy rating, Canaccord Genuity analyst John Newman raised the target on Sesen Bio to $7 from $5, more than double today’s close.
Meanwhile, with a buy rating, the analysts at Jefferies have raised the price target to $6 from $3 per share. The review involving no Adcom has streamlined/de-risked the decision-making process, the analysts argue.
The firm also contends that Vicineum is on track to become the preferred therapeutic option to Keytruda from Merck (NYSE:MRK) citing ‘time-to-cystectomy benefit, better safety, and favorable intravesical admin route.’
In January 2020, the FDA approved Keytruda (pembrolizumab) as monotherapy for the treatment of patients with BCG-unresponsive, high-risk, non-muscle-invasive bladder cancer.
Sundial Growers (NASDAQ:SNDL) has made a $22M strategic investment in Indiva Limited (OTCQX:NDVAF), a Canadian manufacturer of cannabis edibles.
The investment calls for Sundial to make a private placement of 25M shares of Indiva worth gross proceeds of $11M and a $11M non-revolving term loan facility.
Net of fees, commissions, and expenses, Indiva is expected to receive gross proceeds of $20.9M
Indiva plans to use the proceeds to rid its outstanding debt completely, working capital, and general corporate services.
Sundial is up 7.2% to $2.23 and Indiva is unchanged at $0.40 premarket.
bluebird bio (NASDAQ:BLUE) has lost ~25.8% in premarket after the company announced the temporary suspension of two clinical trials for its gene therapy candidate, LentiGlobin, and the marketing of ZYNTEGLO™ gene therapy, approved in Europe for transfusion-dependent β-thalassemia.
The decision to halt Phase 1/2 (HGB-206) and Phase 3 (HGB-210) for LentiGlobin in sickle cell disease (“SCD”) (bb1111) was taken due to a suspected unexpected serious adverse reaction (“SUSAR”) of acute myeloid leukemia (“AML”), the company said.
A patient who received the experimental therapy more than five years ago in Group A of HGB-206 was diagnosed with AML. The investigations are ongoing to determine if the cause had any relationship to the use of BB305 lentiviral vector in the manufacture of LentiGlobin for SCD.
Though no cases of hematologic malignancy have been reported in any patient who has received ZYNTEGLO, the company has decided to temporarily suspend its marketing as ZYNTEGLO is also manufactured using the same BB305 lentiviral vector.
Based on Group C HGB-206 data as of August, bluebird bio previously announced that LentiGlobin gene therapy resulted in no serious treatment-related adverse events and had only one non-serious, Grade 2 adverse event of febrile neutropenia.
