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.
The FDA approves the use of Johnson & Johnson (NYSE:JNJ) unit Janssen Biotech’s Darzalex (daratumumab) to treat adults with relapsed/refractory multiple myeloma who have received one to three previous lines of therapy.
Janssen in-licensed global rights to CD38-directed cytolytic antibody from Genmab A/S (NASDAQ:GMAB) in August 2012.
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Darzalex accounted for 8.4% of JNJ’s Q2 pharmaceutical sales ($901M/10,752M).
Following through on its letter of intent announced on July 24, Sorrento Therapeutics (NASDAQ:SRNE) inks a formal merger agreement with SmartPharm Therapeutics.
Under the terms of the deal, SmartPharm equity holders will receive a total of $19.4M in SRNE common stock subject to adjustments.
The transaction should close next month.
Shares up 4% after hours.
Pfizer (PFE +0.3%) and development partner BioNTech SE (BNTX +2.3%) are proceeding with a large-scale Phase 3 clinical trial evaluating its newly crowned top COVID-19 vaccine candidate, BNT162b2.
Earlier studies tested another version, dubbed BNT162b1, but the companies made the switch after “B2” showed similar immunogenicity but with fewer side effects.
Details from an abstract of a 332-subject study posted yesterday showed an adverse event rate of 50% in participants aged 18-55 who received “B1” and 16.7% in older participants (aged 65-85). By comparison, the rates of adverse events for “B2” were 16.7% and 0%, respectively.
Recruitment is underway in the 30K-subject study, led by BioNTech. The estimated primary completion date is April 2021, but Pfizer plans to file for emergency use authorization in the U.S. as early as October.
Nano cap OpGen (NASDAQ:OPGN) rallies 53% premarket on robust volume in reaction to its announcement that subsidiary Curetis GmbH has received CE Mark certification for its SARS-CoV-2 molecular test with PCR-compatible universal lysis buffer (PULB).
The test uses real-time polymerase chain reaction (RT-PCR) technology for the qualitative (yes/no answer) detection of the coronavirus in oropharyngeal and nasopharyngeal samples.
Commercial launch is underway.
The UK’s Medicines and Healthcare products Regulatory Agency has signed off on a Phase 3 clinical trial evaluating CytoDyn’s (OTCQB:CYDY) leronlimab in severely ill and critically ill COVID-19 patients.
Yesterday, it requested Fast Track approval of the drug based on the results from a mid-stage study.
