On Monday, December 14, 2020 the share price of Revive Therapeutics (RVV.C) surged from .52 to .87 (+67%) by 8:20 a.m. – then fell to .65 by mid-morning, before starting to climb again.
RVV is a specialty life sciences company focused on the R&D of therapeutics for medical needs and rare disorders.
The company is benefiting from FDA regulatory incentives for Orphan Drugs, Breakthrough Therapies and Rare Pediatric Diseases.
The only news to drop from the company today, was a scientific report announcing that “Thiol-based drugs decrease binding of SARS-CoV-2 spike protein to its receptor and inhibit SARS-CoV-2 cell entry.”
This report was available on RVV’s website, but not disseminated though RVV’s normal distribution channels. Nor did it contain ticker symbols or quotes from the CEO.
The report was a heavy slog.
“Panel (a): Cystine map for SARS-2-S domain S1, amino acids 15 – 685, comprising the sequence from the mature N-terminus to the first TMPRSS2 proteolytic site R685 (UniProt Entry: P0DTC2)” etc.
Panels (b) and (c) came with a helpful graphic.
“Luckily this micro-cap stock journalist has a PHD in Biochemistry with a specialty in autoimmune disease research,” stated No Truthful Writer Ever.
The Coles Notes deconstruction of the report is that RVV’s core bio-technology is capable of doing what it is supposed to do.
On September 29, 2020 RVV announced that the U.S. Food & Drug Administration (FDA) phase 3 clinical trial is evaluating the safety and efficacy of bucillamine in patients with mild-moderate COVID-19.
Bucillamine is a versatile organic molecule with an array of utilities including “regulating B-cell function” “thiol antioxidant” and “cisplatin-induced otoxicity”.
“Bucillamine has potential to attenuate or prevent damage during myocardial infarction, cardiac surgery and organ transplantation,” states the University of Colorado Health Sciences Center, it “enters the cells by the same mechanism that normally transports the amino acid cysteine”.
Revive has identified bucillamine as potentially useful in the treatment of COVID-19.
With the FDA’s approval, Revive has set-up five clinical sites in Florida, Texas and California for enrolment of patients in the phase 3 clinical study.
“We have made significant progress in advancing the phase 3 clinical trial since the FDA approval allowed us to proceed with the study,” stated Michael Frank, Revive’s CEO, “and we are expanding on and engaging with clinical sites in high-prevalence-COVID-19-infected states.”
Phase 3 Clinical Trial Highlights:
- Enroll up to 1,000 patients
- Randomized 1:1:1 to receive bucillamine 100 milligrams three times a day, bucillamine 200 milligrams three times a day or placebo three times a day.
- 14-day trial
- Primary objective ito compare the frequency of hospitalization or death in patients with mild-moderate COVID-19 receiving bucillamine therapy with those receiving placebo.
- Trial will track hospitalization or death from the time of the first dose through Day 28 following randomization.
- Efficacy will be assessed by comparing clinical outcomes (death or hospitalization) amongst the three groups.
- Disease severity to be assessed using the 8-category NIAID COVID ordinal scale.
Safety will be assessed by comparing pre-treatment adverse events and treatment-emergent adverse events.
RVV is also moving aggressively into the shroom business.
Last month, RVV announced that it had entered into an exclusive research collaboration agreement with PharmaTher (PHRM.C) – a specialty psychedelics pharmaceutical company.
The collaboration will “accelerate the development of psilocybin in the treatment of cancer and the discovery of novel uses of undisclosed psychedelic compounds”.
“Revive continues to be focused on developing novel uses for psilocybin that leverages our proprietary oral thin film delivery technology as a differentiated therapeutic approach,” stated Frank.
The collaboration gives Revive the exclusivity to advance the research of psilocybin in the treatment of cancer and leverage PharmaTher’s panaceAI psychedelic discovery AI platform to screen, identify and evaluate undisclosed psychedelic compounds directed at pre-specified targets for use with Revive’s drug delivery technology.
Unaware of – or unable to comprehend – today’s quietly-released scientific report, RVV investors were left scrambling trying to explain the day’s SP volatility.
“Long and Strong,” declared IceCold Beer on one RVV investor bull-board, “Why would anyone sell unless you don’t believe they will get FDA approval on their drug? If that’s the case, you made good money and on to the next. I will be here when they get approval and the shroom portion of the business takes off”.
“This is the only company that has phase 3 and psychedelic side this stock will dance in the price of mindmed in a short time,” stated The Wolf.
“Someone just posted a 1 million share ask at .80 and the shorts have come in under it as it offers protection,” explained 1ottrunner, “Love to see it get taken down. Shorts will have to cover what they’ve been burnt this week. Yep..now shorting at .78. Hopefully they burn….”
“An FDA approval, will put this in the 4-6 dollar range IMO,” stated Bullchart1.
Twitter’s hashtag #ShroomBoom was another repository of thoughtful analysis.
By the time the dust settled at 1:30 p.m. Vancouver time, RVV was up .26 to .78 on the day (+ 50%).
29.7 million shares had traded.
Investor focus is currently bifurcated between a potential FDA bucillamine approval, and RVV’s ambitions and partnerships in the shroom space.
- Lukas Kane
Full Disclosure: RVV is an Equity Guru marketing client.