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.
Inovio Pharmaceuticals (NASDAQ:INO) has climbed 9.0% in the premarket after the medical journal, The Lancet, published the Phase 1 clinical trial data of its COVID-19 vaccine candidate, INO-4800.
In June, the company announced positive interim Phase 1 data for INO-4800 indicating 94% of immunogenicity of 40 healthy trial participants aged 18 to 50 years.
According to the journal report, 38 trial subjects have received both doses, and 100% (38/38) of them have achieved the immunogenicity with excellent safety and tolerability profile, with either or both humoral or cellular immune responses.
Phase 1 data have suggested the vaccine could be a safe booster, and one of the volunteers in the 1.0mg dose group has become seropositive at baseline due to prior infection with COVID-19. Notably, despite receiving both doses, the individual has not developed any adverse events.
Yet, the report highlights the need for a larger sample size and the inability to conclude the length of the vaccine-driven immunity.
Early December, Inovio announced the initiation of the Phase 2 portion of Phase 2/3 trial for the vaccine in a trial involving 400 individuals aged 18 years or older.
New Wave Holdings (OTCPK:TRMNF) announces that it has completed the acquisition of Way of Will Inc., a Canadian retailer of aromatherapy products.
Per the all-stock deal first announced early this week, New Wave has issued an aggregate of 28.2M common shares to the Way of Will stockholders, valuing the company at an implied price of $0.1718 per share.
Currently, the agreement does not stipulate any changes to the management or the Board of Directors of New Wave.
New Wave’s latest acquisition follows the announcement of another deal with N2 Logics Inc. this month to acquire Bloom Botanics, a European E-commerce platform for CBD products.
Nasdaq notified Titan Medical (TMDI +2.5%) that the company has cured the bid price deficiency and has regained full compliance with all applicable criteria for continued listing and trading.
Rising 2.3% today, Verrica Pharmaceuticals (NASDAQ:VRCA) is continuing the uptrend after H.C. Wainwright raised its price target on the stock to $21 from $18.
With a gain of 12.0% yesterday, the shares have risen 27.2% in the past five-day period as the company went on to resubmit the marketing application with the FDA for its lead product candidate, VP-102, in molluscum contagiosum (molluscum).
Noting that the timeline for refiling was ahead of the schedule, the analyst, Oren Livnat, called it ‘a culmination of strong execution.’
Livnat raises the candidate’s probability of success in claiming the market opportunity in molluscum, as he writes ‘the apparently successful completion of the stability and HF work as incrementally de-risking.’
In the CRL received by Verrica in June, the FDA did not request additional clinical data but highlighted the need for additional information related to chemistry, manufacturing, and controls and human factors validation.
Epizyme (NASDAQ:EPZM) said Boehringer Ingelheim International (BII) has elected to terminate a collaboration agreement between both the companies, without providing any cause for the termination, effective January 31.
Under the agreement, the parties had agreed to discover, research, develop and commercialize small molecule compounds that are inhibitors of an undisclosed histone acetyltransferase (HAT) target and an undisclosed helicase target in indications chosen by BII.
As per the pact, Epizyme granted to BII an exclusive, worldwide license to the Company’s undisclosed target inhibitors technology, and the parties had granted reciprocal licenses for each party to utilize the other party’s know-how, patents and technologies for activities. BII was solely responsible for developing and commercializing products containing compounds that inhibit the HAT target. The parties had agreed to jointly research and develop products containing compounds that inhibit the helicase target and share commercialization activities in the U.S.
BII was solely responsible for commercialization of such products outside of the U.S.