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.
Noted investor Chamath Palihapitiya, who backs Clover Health (NASDAQ:CLOV), has responded on Twitter to a short call report issued by Hindenburg Research yesterday.
In his response, Palihapitiya says that the report was “rife with personal attacks, thin facts and bluster.”
In response to allegations that the Department of Justice is investigating him: “For Hindenburg to take such a request for information and use it to paint a case of malfeasance and fraud is spurious.”
Regarding short-sellers, the CEO of Social Capital notes that “they should remain a part of the capital markets and recognize the perspective that in some cases they can identify real anomalies. That is not the case here.”
Clover shares closed up 5.7% to $12.93.
The FDA has approved Breyanzi (lisocabtagene maraleucel; liso-cel) from Bristol Myers Squibb (NYSE:BMY) for patients with certain types of large B-cell lymphoma who have not responded to, or who have relapsed after, at least two other types of systemic treatment.
Breyanzi is the third gene therapy to receive FDA approval for certain types of non-Hodgkin lymphoma, including diffuse large B-cell lymphoma (“DLBCL”), the commonest form of non-Hodgkin lymphoma in adults.
The tradeable Contingent Value Right (NYSE:BMY.RT) received by Celgene shareholders when the company was acquired by Bristol Myers expired in 2020 as liso-cel failed to win FDA approval by December 31.
TG Therapeutics (NASDAQ:TGTX) has surged ~6.1% after the FDA announced the approval for Ukoniq (umbralisib) for the treatment of adults with relapsed or refractory marginal zone lymphoma who have received at least one prior anti-CD20 based regimen.
The approval is also granted for Ukoniq in the treatment of adult patients with relapsed or refractory follicular lymphoma who have undergone at least three prior lines of systemic therapy.
In August, TG Therapeutics announced that the regulator accepted the marketing application for the therapy in MZL under the priority review status setting an FDA action date of February 15, 2021. With a standard review, the FL indication had a PDUFA goal date of June 15, 2021
The new drug application was supported by umbralisib monotherapy MZL and FL cohorts in a Phase 2b trial evaluating patients with relapsed/refractory MZL or FL.
