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.
Assembly Biosciences (NASDAQ:ASMB) announces that it has regained global rights to all microbiome gastrointestinal (GI) programs out-licensed to AbbVie (NYSE:ABBV) unit Allergan in January 2017. Its decision was not based on efficacy or safety issues.
The transition, expected to be completed in Q4, includes Phase 1-stage ABI-M201 and preclinical-stage ABI-M301.
The company says the event will not change its projected cash runway, expected to be sufficient to fund operations into 2022.
California Governor Gavin Newsom minutes ago signed an order requiring his state’s citizens to wear face masks in public.
Alpha Pro Tech (NYSEMKT:APT) has jumped 12% on the news.
Unspecified by the Governor is how his order will be enforced, or what sorts of penalties might be issued to those in violation. Orange County one week ago pulled its face mask order. Fresno, San Bernardino, and Riverside counties have done the same.
Biogen (BIIB -6.4%) is down out of the gate after a West Virginia judge found that generic drugmaker Mylan (MYL +6.1%) demonstrated Biogen’s U.S. patent ‘514 for multiple sclerosis med Tecfidera (dimethyl fumarate) was “invalid for lack of written description.”
Mylan aims to market a biosimilar if patent issues can be surmounted.
Tecfidera accounted for 39% of the company’s 2019 product sales ($4,432.7M/11,379.8M).
Bernstein analyst Ronny Gal last week was cautious on the ability for Biogen to avoid an adverse ruling. Gal cited, among other things, the judge’s contention that there were issues with Biogen’s arguments.
HEXO (NYSE:HEXO) has completed the sale of its Niagara, Ontario facility for proceeds of ~$10.25M on June 15, 2020.
The Niagara facility included land and greenhouse facilities, as well as certain equipment.
The proceeds will be used to fund additional expansion of its Belleville, Ontario facility and for working capital and other general corporate purposes.
RedHill Biopharma Ltd. (RDHL -0.7%) has submitted applications in the UK and Italy for its Phase 2/3 clinical trial evaluating Yeliva (opaganib) on top of standard-of-care treatment in hospitalized patients with severe COVID-19 pneumonia who are receiving supplemental oxygen.
Up to 40 sites across a range of countries will be recruited for the study.
The primary endpoint will be the proportion of patients requiring mechanical ventilation by day 14 compared to those receiving standard-of-care therapy alone. Preliminary data should be available when ~100 participants have been evaluated for the primary objective.
Last week, it filed an application in Russia for the study.
Opaganib inhibits an enzyme called sphingosine kinase-2 (SK2) which blocks the synthesis of a lipid-signaling molecule called sphingosine 1-phosphate (S1P) that promotes cancer cell growth and pathological inflammation.