INO On Track, MITO All Powered Up, TGTX Braces For Busy Year, COVID-19 Update
Today’s Daily Dose brings you news about an update on Inovio’s COVID-19 DNA Vaccine trials, Ocular Therapeutix’s preliminary fourth-quarter revenue, Stealth BioTherapeutics’ receipt of Rare Pediatric Disease designation for Elamipretide and near-term catalysts of TG Therapeutics.
Shares of Inovio Pharmaceuticals Inc. (INO) soared to a new high after the Company announced that it expects to begin human clinical trials of its COVID-19 DNA Vaccine in the U.S. in April and soon thereafter in China and South Korea, where the outbreak is impacting the most people.
In January of this year, the Coalition for Epidemic Preparedness Innovations (CEPI) awarded Inovio a grant of up to $9 million to develop a vaccine against the recently emerged strain of coronavirus (COVID-19). Inovio’s COVID-19 DNA Vaccine is known by the name INO-4800.
The Company expects to present results from the human clinical trial of INO-4800 by Fall 2020 and has set a target of delivering one million doses of INO-4800 vaccine by year-end with existing resources and capacity.
Additional information about the Company pipeline is available in our report titled “Inovio Pharma (INO) Has Started The Year Off Right, More To Come?”, posted on January 27, 2020.
INO has traded in a range of $1.92 to $7.48 in the last 1 year. The stock closed Tuesday’s trading at $7.45, up 69.70%.
Shares of Ocular Therapeutix Inc. (OCUL) jumped more than 16 percent on Tuesday, following preliminary unaudited net product revenue for the fourth quarter of 2019, and interim results from its phase I clinical trial for OTX-TKI intravitreal implant that is being evaluated for the treatment of wet age-related macular degeneration and other retinal diseases.
The Company markets Dextenza ophthalmic insert for the treatment of post-surgical ocular inflammation and pain and ReSure Sealant for sealing corneal incisions following cataract surgery.
The total net product revenue was $2.3 million for the fourth quarter ended December 31, 2019, reflecting a 172% sequential increase over total net product revenue reported in the third quarter ended September 30, 2019. DEXTENZA accounted for $1.6 million and ReSure Sealant accounted for $0.7 million in the fourth quarter of 2019.
The initial data from the phase I study with OTX-TKI has demonstrated its potential to decrease intraretinal and subretinal fluid in patients with wet age-related macular degeneration. The trial, being conducted in Australia, includes two cohorts of six subjects each – a lower dose cohort of 200 µg and a higher dose cohort of 400 µg.
The Company plans to continue the long-term evaluation of the first two cohorts. This phase I trial is not powered to measure any efficacy endpoints with statistical significance, added the Company.
OCUL closed Tuesday’s trading at $5.46, up 16.42%.
Shares of Stealth BioTherapeutics Corp (MITO) rose as much as 150 percent on Tuesday, following the receipt of FDA’s Rare Pediatric Disease designation for Elamipretide for the treatment of Barth syndrome.
Barth syndrome is an ultra-rare genetic condition characterized by muscle weakness, cardiac abnormalities often leading to heart failure, recurrent infections, delayed growth, and reduced life expectancy.
The Company’s investigational drug Elamipretide has demonstrated its potential to improve cardiac function in patients with genetically confirmed Barth syndrome in a phase II/III crossover study, dubbed TAZPOWER.
An end-of-phase meeting with the FDA for Barth syndrome trial is planned for this quarter (Q1, 2020).
Elamipretide is also being evaluated in a phase IIb study in geographic atrophy, with results expected in 2021.
The Company has submitted a phase III protocol for Elamipretide in Leber’s hereditary optic neuropathy and expects the trial to be initiated in 2021 or beyond.
MITO closed Tuesday’s trading at $3.07, up 61.58%. In after-hours, the stock was up 4.23% at $3.19.
TG Therapeutics Inc. (TGTX), which considers 2019 to be a transformational year, expects 2020 to be yet another impactful year.
The Company expects to complete the submission of its New Drug Application for Umbralisib to treat adult patients with previously treated marginal zone lymphoma and follicular lymphoma in the first half of 2020.
An interim efficacy analysis of the Company’s phase III UNITY-CLL trial evaluating “U2” (the combination of Umbralisib and Ublituximab) in patients with frontline and previously treated chronic lymphocytic leukemia in the second quarter.
Two phase III trials evaluating Ublituximab monotherapy in relapsing multiple sclerosis, dubbed ULTIMATE I and ULTIMATE II, are underway, with top-line data expected in the second half of this year.
The Company ended the year 2019 with cash, cash equivalents and investment securities of $140.4 million, which will be sufficient to fund its planned operations well into 2021.
TGTX closed Tuesday’s trading at $13.52, down 3.43%. In after-hours, the stock was up 0.83% at $13.63.
As per the latest WHO report, a total of 90,893 people have been infected with COVID-19 globally, and 3,110 people have died due to this coronavirus. The mortality rate of COVID-19 has now been revised to 3.4% from the prior estimate of about 2%.
In the U.S., nine people have died, with all the deaths occurring in Washington state.
WHO estimates that each month, 89 million medical masks will be required for the COVID-19 response; 76 million examination gloves, and 1.6 million goggles.
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