This company is covering EQ they are also covering FDIT. May be a nice play there as well.
TTENTION: Premarket Breakout Alert on:
Equillium Inc. (Nasdaq: EQ) • ElectroCore Inc. (Nasdaq: ECOR)
Dear Fellow Trader,
EQ Is On Immediate ALERT!
Wall Street is Showing Major Interest in EQ!
Clinical Trial Shows Itolizumab Reduces Mortality
in Patients Hospitalized with COVID-19
Equillium shares topline results of patients treated with itolizumab in clinical trial conducted in India by partner Biocon
Biocon has received emergency use approval from Drugs Controller General of India for itolizumab in the treatment of CRS in COVID-19 patients with moderate to severe ARDS
Equillium planning global randomized controlled clinical trial of itolizumab in COVID-19 patients under a U.S. IND
LA JOLLA, Calif., July 13, 2020 (GLOBE NEWSWIRE) -- Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company developing itolizumab to treat severe autoimmune and inflammatory disorders, today announced that as reported by its partner, Biocon Limited, a clinical trial conducted in India by Biocon demonstrated that itolizumab significantly reduced mortality in patients hospitalized with COVID-19. Biocon has announced that the Drugs Controller General of India (DCGI), the regulatory agency that oversees drug approvals, has granted restricted emergency use of itolizumab for the treatment of cytokine release syndrome (CRS) in COVID-19 patients with moderate to severe acute respiratory distress syndrome (ARDS) in India.
Based on the encouraging topline results of the study reported by Biocon and subsequent DCGI approval to treat COVID-19 patients, Equillium is planning to conduct a global randomized controlled clinical trial of itolizumab in COVID-19 patients for which it will file a U.S. investigational new drug application (IND).
Biocon conducted a randomized, controlled, open-label study at four hospitals in India, enrolling a total of 30 hospitalized COVID-19 patients with moderate to severe ARDS. Twenty patients were randomized to receive itolizumab plus best supportive care, while 10 patients received best supportive care alone. The primary endpoint was mortality at one month. As reported by Biocon:
• In the itolizumab arm there were no deaths and all patients have recovered; in the control arm three patients died and the remainder have recovered
• The mortality benefit observed in the itolizumab arm was statistically significant
• Consistent with the observed clinical improvement, patients who received itolizumab also experienced significant reductions in inflammatory cytokines such as IL-6 and TNFa
“The results of this clinical trial reported by Biocon are encouraging and support the hypothesis that itolizumab’s novel immune-modulating mechanism may have promise in addressing the severe immuno-inflammatory complications experienced by COVID-19 patients,” said Bruce Steel, co-founder and CEO of Equillium. “We are working with Biocon to review its full dataset with the goal to move swiftly in determining appropriate next steps to accelerate further development of itolizumab to treat moderate to severely ill COVID-19 patients in the U.S. and abroad in the face of this global crisis.”
“The results of this clinical trial reported by Biocon are encouraging and support the hypothesis that itolizumab’s novel immune-modulating mechanism may have promise in addressing the severe immuno-inflammatory complications experienced by COVID-19 patients,” said Bruce Steel, co-founder and CEO of Equillium. “We are working with Biocon to review its full dataset with the goal to move swiftly in determining appropriate next steps to accelerate further development of itolizumab to treat moderate to severely ill COVID-19 patients in the U.S. and abroad in the face of this global crisis.”
“As the entire world grapples with the ongoing COVID-19 pandemic it is critical to identify new treatments that improve outcomes for the sickest patients, and these reported early clinical data suggest that itolizumab holds promise,” said Siddhartha Mukherjee, M.D., Ph.D., a clinical advisor to Equillium and Biocon, Pulitzer Prize Award-winning author, and an Associate Professor of Medicine at Columbia University’s Herbert Irving Comprehensive Cancer Center.
Ivor S. Douglas, M.D., FRCP (UK) Professor of Medicine, Chief of Pulmonary and Critical Care and Medical Director, Medical Intensive Care Denver Health Medical Center, added, “Patients with COVID-19 experience acute respiratory failure caused by the immune system flooding the bloodstream with inflammatory proteins, which can kill tissue, damage organs and pathologically activate clotting cascades in the lungs, heart, and kidneys.
The novel mechanism of itolizumab, which works by inhibiting CD6 to reduce the activation and trafficking of pathogenic T cells that release pro-inflammatory cytokines, may be well suited to address SARS-CoV-2 induced inflammation that drives respiratory failure in patients with COVID-19. The preliminary data as reported by Biocon is encouraging and highlights the urgent importance of further evaluating the potential therapeutic efficacy of itolizumab in treating patients diagnosed with COVID-19.”
Itolizumab is a first-in-class immune-modulating antibody therapeutic with a novel mechanism of action that inhibits the activity and trafficking of pathogenic T cells that release pro-inflammatory cytokines in a range of autoimmune and inflammatory diseases. Equillium acquired rights to develop and commercialize itolizumab in the U.S., Canada, Australia and New Zealand through an exclusive collaboration and license agreement with Biocon.
Equillium is currently evaluating itolizumab under two open U.S. INDs for the treatment of acute graft-versus-host disease and lupus nephritis, as well as conducting a clinical study in uncontrolled asthma in Australia and New Zealand.
Biocon previously developed and received approval of Itolizumab for the treatment of plaque psoriasis in India, demonstrating the product was safe and well tolerated. Biocon manufactures itolizumab at commercial scale at its cGMP bio-manufacturing facility that is regulated by the U.S. Food & Drug Administration.
In March of this year, as a result of the emerging COVID-19 pandemic, Equillium announced that it was pausing enrollment in the EQUIP trial for uncontrolled asthma and the EQUALISE trial for lupus nephritis. Today Equillium announces that patient enrollment in both of these studies has resumed.
About Equillium
Equillium is a clinical-stage biotechnology company leveraging deep understanding of immunobiology to develop novel products to treat severe autoimmune and inflammatory disorders with high unmet medical need.
Equillium’s initial product candidate, itolizumab, is a clinical-stage, first-in-class monoclonal antibody that selectively targets the CD6-ALCAM pathway. This pathway plays a central role in modulating the activity and trafficking of T cells that drive a number of immuno-inflammatory diseases. Itolizumab is a clinically validated therapeutic that has demonstrated a favorable safety and tolerability profile. Equillium acquired rights to itolizumab through an exclusive partnership with Biocon Limited. Itolizumab is currently marketed in India under the trade name, “ALZUMab” for the treatment of chronic plaque psoriasis and in July 2020 received emergency use approval in India to treat CRS in COVID-19 patients with moderate to severe ARDS. Equillium believes that itolizumab has the potential to be a best-in-class disease modifying therapeutic and is advancing the clinical development of itolizumab in the following severe immuno-inflammatory disorders: uncontrolled asthma, acute graft-versus-host disease, and lupus nephritis.
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ECOR Is On Immediate ALERT!
Wall Street is Showing Major Interest in ECOR!
ElectroCore Announces FDA Emergency Use Authorization for use of GammaCore Sapphire™ CV for the Acute Treatment of Asthma Exacerbations in Known or Suspected COVID-19 Patients
Intended use allows gammaCore Sapphire CV use at home or in a healthcare setting
BASKING RIDGE, N.J., July 13, 2020 (GLOBE NEWSWIRE) -- electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today announced that the FDA has issued an Emergency Use Authorization (EUA) authorizing the use of gammaCore Sapphire™ CV non-invasive vagus nerve stimulation (nVNS) at home or in a healthcare setting to acutely treat adult patients with known or suspected COVID-19 who are experiencing exacerbation of asthma-related dyspnea and reduced airflow, and for whom approved drug therapies are not tolerated or provide insufficient symptom relief.
“Needless to say, we are very pleased to have received this EUA, and we intend work vigorously to make this novel therapy available to physicians treating known or suspected COVID 19 patients who are experiencing exacerbation of asthma-related breathing difficulty,” said Dan Goldberger, Chief Executive Officer of electroCore.
Peter Staats, MD, Chief Medical Officer, went on to say, “Results from prior pilot studies that evaluated gammaCore for the acute treatment of asthma support our belief that nVNS may provide much needed relief to patients who are experiencing asthma-related breathing difficulty, which can be particularly debilitating in patients with COVID-19.”
JP Errico, electroCore Board member, co-founder and co-inventor of gammaCore, commented, “This FDA decision is an encouraging first step toward developing evidence that may provide a basis for electroCore to pursue expansion of nVNS into reactive airway disease (RAD), which was the first area of research for electroCore.”
The trading session is about to begin shortly, so don't delay and pull up it on your trading screen before you miss out on another easy profitable day trading idea scenario.
?Immediately Turn Your Attention To My Focus Stock Findit Inc. (FDIT)
This is my next stock ready to potentially move in a big way, here's why...
FDIT is now displaying the holy grail of bullish breakout signals - GOLDEN CROSS.
Also, on our side is Wall Streets leading provider of market data to the global financial, media, and commodity industries just issued FDIT a bullish 50% BUY Rating Short Term. See here
Technical Analysis:
FDIT is now displaying the holy grail of bullish breakout signals - GOLDEN CROSS.
A golden cross is formed when the 50 day moving average crosses the 200 day moving average, signaling the beginning of a breakout rally.
The medium term (faster) average price of the stock has crossed its long term (slower) average. Look at the chart below, you will see the short-term moving average (blue line) moves up through the long-term moving average (red line).
It's an extremely bullish signal that indicates the beginning of a Breakout Rally!
Check out the chart and you'll see this stock has a history of days where double and even triple digit gains are unleashed.
?FDIT Chart Looks To Be On The Verge Full-On BREAKOUT
The 50 Day MA Just Crossed The 200 Day MA
Signaling Bullish Golden Cross
4 Reasons To Get FDIT On Your Watch-list Right Now
FDIT has Triggered 4 New Bullish Trade Signals
FDIT is experiencing a "Golden Cross"
FDIT has a very small float
My Track Record Speaks For Itself
Multiple Breakout Catalysts Signaling Breakout Potential
With several potential bullish catalysts working in FDIT favor, I believe it could be setting up for its next big potential breakout.
It’s important to note, FDIT is no stranger to explosive breakouts and just like our recent winners, our latest trade idea has a razor thin float and double and even triple-digit gain potential.
In fact, I first initiated coverage on FDIT Monday June 22nd and it broke-out to a high of $.0999, running up 53% from previous close, then we saw some profit-taking set in on Tuesday June 23rd and it retraced, bottoming out at a low of $.0455, before rocketing to a high of $.08 Wednesday June 24th, allowing this ticker to bounce hard creating an awesome swing trade opportunity providing 75% gains from Tuesdays low.
It surged from $.0115 on May 1st to a high of $.086 on June 10th booking over 647% in Gains, virtually overnight.
It surged from a low of $.0151 on Dec 31st, 2019 to a high of $.04 Jan 28th booking over 164% in Gains, virtually overnight.
Then back in Nov of last year it ran from $.03 to a high of $.069 on Nov 15th running up 130% in gains.
Another example was on July 22nd, 2019 it ran from $.023 to a high of $.10 ON Aug 21, 2019 running up 233% in gains.
I hope you are as excited as I am for Monday’s trading action! You don't want to miss it.
As you can see, there are multiple bullish catalysts signaling breakout potential!
So, without wasting any more time, don't delay and pull up FDIT on your trading screen before you miss out on another potential winner, with tremendous upside potential.
Chief Editorial,
PTA Team
AI
