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.
Moderna (NASDAQ:MRNA) inks a research collaboration and licensing agreement with Vertex Pharmaceuticals (NASDAQ:VRTX) aimed at the discovery and development of lipid nanoparticles (LNPs) and mRNAs for the delivery of gene-editing therapies for cystic fibrosis (CF).
The initial focus of the three-year partnership will be on the discovery and optimization of novel LNPs and mRNAs that can deliver gene-editing therapies to cells in the lungs where cystic fibrosis transmembrane conductance regulator (CFTR) protein can be produced.
Under the terms of the agreement, Moderna will conduct research to discover and optimize novel LNPs for the delivery of gene-editing therapies to lung cells for the treatment of CF. It will also be responsible for the discovery and manufacturing of LNPs and mRNA constructs encoding gene-editing endonucleases.
Vertex will be responsible for providing other components of the gene-editing therapies to be formulated into LNPs as well as subsequent preclinical and clinical development and potential commercialization efforts.
Moderna will receive $75M upfront, up to $380M in milestones and tiered royalties on net sales.
This agreement builds on the companies’ first partnership deal, inked in July 2016, aimed at the discovery and development of mRNAs for CF.
MRNA up 3% after hours.
Moderna (NASDAQ:MRNA) will collaborate with Italian healthcare research group Chiesi Farmaceutici S.p.A. to discover and develop mRNA therapeutics for the treatment of pulmonary arterial hypertension (PAH), a rare disorder characterized by high blood pressure in the arteries of the lungs with concomitant right heart failure.
Under the terms of the agreement, Moderna will lead discovery while Chiesi Group will lead development and global commercialization. It will fund all expenses related to the partnership.
Moderna will receive $25M upfront, up to $400M in milestones and tiered double-digit royalties on net sales.
Shares up 1% after hours.
Bloomberg reports that Illumina (ILMN -4.2%) is in advanced talks to acquire Grail (GRAL), a spinout that it formed in 2015 to develop and commercialize liquid biopsy testing for cancer.
According to informed sources, a deal could be announced as soon as this week. Grail could fetch more than $6B based on its valuation from the last financing round.
A week ago, Grail filed a preliminary prospectus for an IPO.
AXIM Biotechnologies (OTCQB:AXIM) has filed an Emergency Use Authorization (EUA) application with the FDA for measuring COVID-19 neutralizing antibodies in plasma and serum through its rapid diagnostic test.
AXIM’s test is expected to be the market’s first COVID-19 rapid diagnostic test for measuring levels of functional neutralizing antibodies in a lateral flow assay format.
Last month, AXIM inked deal with Empowered Diagnostics for high volume production of Company’s rapid diagnostic test, “Tru-19 Neutralizing Antibody Test”. With the filing of this EUA, the Company can now sell Tru-19 to clinics immediately.
Revive Therapeutics’ (OTCPK:RVVTF) expanded access protocol (EAP) for compassionate use of Bucillamine in the treatment of COVID-19 received approval from the independent Institutional Review Board (IRB).
The EAP is being done to complement the Company’s Phase 3 COVID-19 study in the U.S. Revive expects patient enrollment in U.S. this month.
The objective is to monitor the safety and efficacy of Bucillamine (600 mg/day) and any clinical symptoms when administered up to 14 days in hospitalized patients with severe COVID-19. 14 and 42 days follow up assessment will be done after treatment completion.
The EAP for compassionate use provides physicians with access to Bucillamine under existing IND application for COVID-19.
