Information on terminated and revoked EUAs can be found in archived information. For more information, please see the January 13, Federal Register notice. On February 4,the HHS Secretary determined that there is a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad, and that involves the virus that causes COVID EUAs for home collection kits reference this declaration.
On February 29,the FDA issued an immediately in effect guidance with policy specific to development of in vitro diagnostic tests during this public health emergency. This guidance was updated on March 16,May 4,and May 11, Templates for these EUA submissions are available to help facilitate the preparation, submission, and authorization of an EUA.
The EUA letter of authorization is here. Tests that are authorized under this EUA are designated by "U" in the table. For information on the applicable HHS Secretary determination and declaration supporting a particular EUA in the table below, as well as a link to any applicable PREP Act declaration, please use the expansion buttons on the left hand side of the table.
On August 20,the umbrella EUA for certain protective barrier enclosures was revoked.
See also the FDA's letter to healthcare providers and statement. Manufacturers of authorized respirators do not need to submit attestation to the FDA to request authorization. Strategic stockpilers of authorized expired filtering facepiece respirators FFRs do not need to submit a request to the FDA to request authorization.
The EUAs FDA subsequently authorized based on this determination and declaration are listed in the table below this blue box. Additionally, in light of ongoing serious cardiac adverse events and other serious side effects, the known and potential benefits of CQ and HCQ no longer outweigh the known and potential risks for the authorized use. Healthcare Providers KB. Decision Memorandum KB. Patients KB. Therefore, the doxycycline emergency dispensing order and EUI should be used by stakeholders for anthrax preparedness and response instead of the mass dispensing EUA.
FR notice. Also see FDA News Release: FDA takes action to support American military personnel by granting an authorization for freeze-dried plasma product to enable broader access while the agency works toward approval of the product July 10, Additional information from HHS.
Pandemic Influenza Medical Countermeasures-Amendment The amendment of the October 10,declaration as amended June 11,the December 17,declaration and February 29,declaration is effective as of January 1, The EUA detailed in the table below is still in effect. Zika virus response updates from FDA.All rights reserved.
Charles St, Baltimore, MD What gives? Is the steep decline a buying opportunity, or are investors losing interest in Sorrento for a reason?
Like so many biotech and pharmaceutical stocks inyou can chalk up the dramatic movement to the novel coronavirus. Sorrento Therapeutics has been hard at work in on solutions to the coronavirus pandemic. The drama actually began in May. You can open up a society without fear. Short-seller Hindenburg Research accused Sorrento of hyping a solution that was too good to be true.
In its reportHindenburg Research suggested Sorrento had ulterior motives. The fallout resulted in SRNE giving back much of its gains. However, in June it began to climb again. There has been plenty of drama surrounding Sorrento in August. On Aug. This move shook the stocks of many Covid vaccine chasers.Sorrento Therapeutics (SRNE) Stock Overview- Sorrento Stock On Cash App Stock Investing App Update
Pharmaceutical and biotech companies that are in the hunt for a coronavirus vaccine are a big deal right now. They both have the stock rated as a buy. However, any coronavirus wins would be relatively short-term. On the date of publication, Brad Moon did not have either directly or indirectly any positions in the securities mentioned in this article.
Log in. Log out. About Us Our Analysts. Source: Shutterstock. Sponsored Headlines. More from InvestorPlace.All rights reserved. Charles St, Baltimore, MD But other coronavirus plays have risen by more. At these lower levels, SRNE looks attractive — for investors with a high tolerance for risk. Nothing is ever guaranteed with biotech companies, and Sorrento is no exception.
But what makes SRNE stock particularly intriguing is that the company has multiple ways to win. T-VIVA targets a specific receptor, and in theory should induce the body to build neutralizing antibodies to ward off the coronavirus.
Sorrento also is working on testing. Given still-significant needs for capacity, both products should see strong demand upon approval. Here, too, Sorrento has two different offerings. Abivertinib is another potential treatment, currently in Phase 2 trials. Trying to figure out exactly how much profit Sorrento could make off any of these efforts is difficult. After all, diversified pharmaceutical companies have existing infrastructure in terms of sales, marketing, and relationships.
Bear in mind that Sorrento has a pipeline outside of the coronavirus and Covid area as well. But it might not be far off. At the least, the market still is pricing in seemingly limited odds of success. For one, across the board Sorrento is going up against larger and often better-funded companies trying to do much the same thing.
There are dozens of companies working on coronavirus vaccines and Covid treatments. Some are further along than Sorrento at the moment. But being first will be an advantage, as the earliest approved therapies and vaccines are most likely to become the standard of care. There are short-term risks as well.Sorrento has previously received guidance from the FDA in response to a pre-IND meeting package and believes it has addressed all questions and followed the recommendations from the agency for all sections of the IND.
Animal data generated by Dr. This established model, while limited, is the most predictive animal model currently available for this disease.
The data were presented to federal agencies and will be published as soon as possible in a scientific journal. The highest proposed dose mg per patient in the phase 1 safety trial is a much lower dose than currently being tested for other known antibodies in active clinical studies. The potentially higher potency of the antibody may allow for faster scaled manufacturing availability to patients and potentially a lower cost per dose as compared to other known antibodies currently being evaluated.
STI antibody has also been evaluated in preclinical studies against multiple strains of SARS-CoV-2, including the highly contagious DG mutant, the current dominant strain globally. More information about the phase 1 clinical trial can be found on www. About Sorrento Therapeutics, Inc. Sorrento is a clinical stage, antibody-centric, biopharmaceutical company developing new therapies to turn malignant cancers into manageable and possibly curable diseases.
RTX is completing a phase IB trial for intractable pain associated with cancer and a phase 1B trial in osteoarthritis patients. For more information, visit www.
Forward-looking statements include statements regarding the potency and potential blocking capabilities of STI and the impact on SARS-CoV-2; the preclinical testing of STI; the safety and efficacy of STI; the expectation of the commencement of any pivotal trials for STI; the potential receipt of an EUA for STI and expected timing for any receipt thereof; the expected availability of doses of STI and the timing thereof; the belief that the IND addresses all questions and recommendations from the FDA; the predictive value of the animal model used in preclinical studies; the proposed dosages in the phase 1 clinical trial; the potentially faster manufacturing speed, availability and potential lower cost for STI and Sorrento's potential position in the antiviral industry.
Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release and we undertake no obligation to update any forward-looking statement in this press release except as required by law. All other trademarks are the property of their respective owners. All Rights Reserved. Subscribe via RSS. Subscribe via ATOM. Register Sign In. Email Print Friendly Share. Sorrento Therapeutics, Inc. Formats available: Original Medium Small.
GlobeNewswire is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.The rapid antibody test allows for results to be available in eight minutes or less. Sorrento has secured manufacturing capacity to support the production of up to five million test kits per month.
Sorrento Therapeutics gets FDA approval for COVID-19 drug trial
Sorrento is a clinical stage, antibody-centric, biopharmaceutical company developing new therapies to treat cancers. RTX is completing a phase IB trial for intractable pain associated with cancer and a phase 1B trial in osteoarthritis patients. For more information visit www. This press release and any statements made for and during any presentation or meeting contain forward-looking statements related to Sorrento Therapeutics, Inc. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release and we undertake no obligation to update any forward-looking statement in this press release except as required by law.
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PDF Version. Tools Print. Email Alerts. RSS Feeds. Email Page.We already got the approval for go ahead to get into human testing. And we'll get into August, and we'll be able to start the trials. And the trials probably last about four to six weeks.
And if everything goes well, we should be able to see some safety and efficacy data. If it looks good, then we're going to move into phase three, large trials. The virus induces a tremendous immune response in the body, and that's way over excess.
That's causing cytokine storm. This drug is tempering the immune response to calm down the storm by suppress the cytokine release, which is a multiple of them.
Sorrento Stock Looks Volatile on Drama and FDA’s Covid-19 Moves
That the single anticytokine type of drug that may sell, but if you can broad spectrum the type of inhibition of the cytokine release, you may be able to do the job tame the immune response. Looking at your pipeline, you see that there is a multiple-- a variety of therapeutics that you're looking at, and one of them includes cancer pain. So this is a very interesting and new sort of platform to get into when you're looking at the response to the pandemic.
How are you planning on getting this out there, and what are-- what is the strategy to ensure that, you know, your drug actually gets to people the way that we're looking at remdesivir?
These drugs have been tested already in over patients in the cancer space, and the drugs already finished the registration of phase-three trials in the non-small-cell lung cancer.
U.S. Food and Drug Administration
For the cancer patient, it's a long-term use. So the safety profile is very encouraging, and we're very comfortable with the safety profile. The same cytokine release syndrome happens with cancer when you do CAR T therapy. And this drug potentially could be a perfect combination for CAR T therapy.
In this case, going to be perfect for COVID patients when they have a cytokine storm hitting them. Henry Ji of Sorrento Therapeutics, thanks for being with us this morning. But after alerting the online brokerage to what she believed was a theft in progress, she received a frustrating email.
Because the wildly popular app has no emergency phone number, some said they tried in vain to intervene, only to watch helplessly as their money vanished. Two of those customers said they have heard back from an official at the SEC seeking more information.Sorrento indeed had some really good news. The company announced Friday morning that its experimental antibody STI was able to completely inhibit infection by the novel coronavirus in a preclinical test.
With this promising news, is Sorrento Therapeutics stock a buy? To be sure, Sorrento's preclinical data is encouraging. The company said that it screened billions of different antibodies to identify the most promising candidates for defending against infection by the novel coronavirus. Also, Sorrento's previously announced approach of developing an antibody cocktail seems like a smart strategy.
The company expects that STI will be the first antibody in its experimental cocktail. Investors and the public in general rightfully cheered Sorrento's update. Before we let the cart get ahead of the horse, though, it's important to note that tests conducted in test tubes and petri dishes in a lab don't always translate to success in human clinical testing. And Sorrento's announcement late last week pertained only to results from a lab test.
Success is far from a slam dunk even after that point. Fewer than one out of five experimental drugs targeting infectious diseases that make it to a phase 1 clinical trial go on to win FDA approval, according to historical data compiled by biopharmaceutical industry trade organization BIO. Sorrento currently has one approved product, ZTlido, which was launched commercially in October as a treatment for pain associated with shingles.
ZTlido is a topical delivery for lidocaine, a local anesthetic that's been around for more than 70 years. Outside of ZTlido, Sorrento hasn't completed any clinical trials thus far. ZTlido hasn't been a huge moneymaker. Even worse, it doesn't have a lot of cash remaining to fund operations. Without raising additional capital, the company won't be able to keep the lights on much less fund clinical studies for its coronavirus program.
It's a virtual certainty that a stock offering is on the way in the near future. That means the value of existing shares will be diluted. In the meantime, Sorrento said that it's trying to obtain government support as well as potentially line up pharmaceutical partners to scale up its manufacturing capacity for STI This financial assistance would be a must for the company to deliver on its ambitious goal of producing millions of doses of the antibody.
So is Sorrento Therapeutics stock a buy right now? But despite the promising preclinical results, there's still a long way to go and a lot of hurdles to be jumped.