Aytu Biopharma Inc. (NASDAQ: AYTU ) (NASDAQ: AYTU)
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Novavax (NASDAQ:NVAX) enters into an agreement with CDMO FUJIFILM Diosynth Biotechnologies for the manufacture of bulk drug substance for NVX-CoV2373, its COVID-19 vaccine candidate.
Production of the first batch is underway at FUJIFILM’s Morrisville, NC site which is earmarked for a 30K-subject Phase 3 clinical trial expected to launch in the fall.
Manufacturing costs will be funded under the $1.6B award from the U.S. government’s Operation Warp Speed initiative.
Results from a Phase 1 trial in 130 healthy volunteers will be released during the first week of August. The Phase 2 portion will begin shortly thereafter.
Shares down 2% after hours.
Israel’s Channel 12 reports that the Israeli government is about to sign a commitment to buy 4M doses of the mRNA-based COVID-19 vaccine being developed by Arcturus Therapeutics (ARCT -10.4%) and Singapore’s Duke-NUS Medical School contingent on, of course, positive results from in-human studies.
Yesterday, the developers announced a go-ahead from Singapore’s Health Sciences Authority for a Phase 1/2 clinical trial, LUNAR-COV19, in up to 108 healthy volunteers.
Moderna (MRNA -9.1%) is down, albeit on average volume, in apparent response to a decision from the USPTO’s Patent Trial and Appeal Board denying the company’s motion for an inter partes review of a patent (U.S. #8,058,069) held by Arbutus Biopharma (ABUS +80.9%) due to its failure to present sufficient evidence that the patent is unpatentable.
The ‘069 patent covers lipid formulations for nucleic acid delivery.
Update: In a statement, Moderna said it believes the PTAB erred in its decision, considering that it previously invalidated the claims of U.S. Patent No. 9,404,127 and some of the claims of U.S. Patent No. 9,364,435, adding that it may “further pursue” these matters. The company is “unaware” if there are any significant intellectual property impediments for any product it plans to commercialize, including COVID-19 vaccine candidate mRNA-1273.
Curaleaf (OTCPK:CURLF +1.5%) has closed its previously announced acquisition of Grassroots, private vertically-integrated multi-state operator in the U.S.
Mitchell Kahn, Grassroots’ Co-Founder and CEO, has been appointed to the Curaleaf board.
The transaction expands Curaleaf’s presence from 18 to 23 states, with affiliated operations spanning 135+ dispensary licenses, 88 operational dispensaries, 30+ processing facilities and 22 cultivation sites with 1.6M sq. ft. of current cultivation capacity.
Zimmer Biomet’s (NYSE:ZBH) Dental division has agreed to distribute AcelRx Pharmaceuticals’ (NASDAQ:ACRX) opioid pain med Dsuvia (sufentanil sublingual tablet) within the U.S. dental and oral surgery markets. Financial terms are not disclosed.
ACRX up 3% premarket on increased volume.
