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Inovio Pharmaceuticals, Inc. (INO)
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Reactions by analysts to VGX-3100 data:
1) From Evaluate Vantage:
"The latest data, from the phase III Reveal 1 study, are far from convincing. The company claimed a win here but admitted that the trial only met its primary endpoint when using a modified intent-to-treat analysis that excluded eight patients without endpoint data."
"The trial protocol-defined intention to treat (ITT) population (N=201) includes all randomized subjects regardless of availability of endpoint data and defines those without endpoint data as non-responders. There were eight such subjects (seven in the treatment group, one in the placebo group). Including subjects with missing endpoint data, the percentage of subjects meeting the primary endpoint was 22.5% (31/138) in the treatment group, versus 11.1% (7/63) in the placebo group (p=0.029; 11.4% difference in percentage, 95%CI: -0.4,21.2), which was not statistically significant."
3) From First Word Pharma:
"Inovio said the primary endpoint of histopathological regression of HSIL combined with virologic clearance of HPV-16 and/or HPV-18 at week 36 was met in the mITT population, but fell short when the analysis was conducted on all 201 randomised subjects (ITT), including those missing endpoint data who were defined as "non-responders" as per the study's protocol."
4) From The Street:
"I believe Inovio's goal from the outset was to find any nugget of positive data from the VGX-3100 study -- even if the study actually failed."
5) From Keith Speights:
"Normally, the FDA would like to you just look at everybody that you intended to treat. They had some issues with missing data in the VGX-3100 group compared to the placebo group, and so they decided to exclude those patients and that's how you get to this modified intention to treat population.
I think there's probably big questions on whether the FDA will accept that data that's with some of the patients removed from the datasets."
Monday morning will be telling, if we have another week like last week pack it up game over ,they cannot go into earnings without sale ...This will tank .
PLYMOUTH MEETING, Pa., Oct. 21, 2021 /PRNewswire/ -- INOVIO (NASDAQ:INO), a biotechnology company focused on bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases, cancer, and HPV-associated diseases, today announced the signing of a non-binding memorandum of understanding (MOU) with Colombia's Ministry of Health and Social Protection reflecting the intent to advance efforts to combat the pandemic and endemic threat posed by COVID-19 and to better prepare for future public health emergencies. The MOU creates a framework for a collaboration arrangement under which INOVIO and the government plan to explore knowledge sharing, technology licensing, and capacity building that support developing and producing vaccines and other biopharmaceuticals in Colombia. The potential results of these efforts include developing local manufacturing capabilities for INOVIO's DNA medicines and related products and technologies.
Dr. J. Joseph Kim, President and CEO of INOVIO, said, "INOVIO's memorandum of understanding with Colombia is a sign of our shared commitment to develop and advance potentially life-saving DNA medicines and vaccines to those in need. This partnership grew out of the intended advantages of INOVIO's DNA medicines platform to address current and future global health threats due to the anticipated stability of its product candidates, speed of design and manufacture, as well as the immune response and tolerability that have been observed to date in clinical trials."
The framework of the planned collaboration builds on INOVIO's recently announced authorization to proceed in Colombia with the Phase 3 segment of its global Phase 2/3 clinical trial, INNOVATE, for INO-4800, the company's DNA vaccine candidate for COVID-19. INOVIO is working with partner Advaccine Biopharmaceuticals Suzhou Co., Ltd. (Advaccine) on the INNOVATE Phase 3 segment in multiple countries, with a focus on countries underserved by COVID-19 vaccines throughout Latin America, Asia, and Africa. INOVIO previously announced approvals to conduct the trial in Brazil, the Philippines, and Mexico.
Dr. Fernando Ruiz Gomez, Minister of Health and Social Protection, Republic of Colombia, said, "Today is very special for us. We have a complete circle of what is possible with a North American company for the production of vaccines, including the possibility of integrating the work being carried out by the WHO Solidarity vaccine trial in Colombia that includes INOVIO as one of the four vaccine candidates in the clinical studies. As we discussed in the previous meeting today, the possibility of moving forward quickly is due to INOVIO considering Colombia as a priority country, a gesture that we appreciate, and is indicative of the will of our country and the Ministry of Health to advance the development of vaccines in Colombia."
Hundreds of millions and so many years spent on VGX-3100 development... And it failed?
Someday I want to a know about the head comparison of mRNA vs DNA vaccine efficacy! May be WHO solidarity trial will get us that info. Apart from Zylus cadilla, INO is leading as a pioneer in DNA therapy. However the share did not rocket like mRNA companies in this pandemic, INO is conducting a worldwide trial proving the efficacy and eventually getting dna therapy market across world. I would be happily holding INO for potential benefits in 2023 and beyond. It’s easy to badmouth any company like they did with Tesla and Amazon and Netflix until they made their significant revenue. INO May need a CEO replacement who can lobby well, but what I think is that looking at the scientific publication Merit inovio has, they eventually will make it. Only time and patience is needed. My 2 cents. Happy weekend longs.
4800 P3 is effectively fully funded by the WHO. MOU signed with Columbia to manufacture there. 4800 heterologous Prime-Booster is funded by Advaccine. 4802 P1/2 will be externally funded by CEPI, BARDA, or NIAID under HHS pending news. AZN COVID-19 dMAb was funded by DARPA. MERS, Lassa fever are funded by CEPI, stockpiled by DoD, CEPI after P2. Ebola booster is funded by DoD. VGX-3100 was licensed to Apollo in China. C2K was licensed to Apollo in SK for $37M per GeneOne. JK said GBM success would expand collaboration with REGN to new diseases.
4802 will likely become a Blockbuster.
Many NGOs and BPs know that and are very interested in it. Hope BPs don’t resort to hostile takeover as Sanofi has done for the following CV vaccine company.
Sanofi acquired all outstanding shares of Translate Bio for $38.00 per share in cash, representing a total equity value of about $3.2 billion.
Ino has a deep pipeline and several platforms.
“In terms of funding for 4800 P3 trial we are asking various parties for support and are also considering doing the P3 together with Advaccine in order to save on costs.
Various NGOs have expressed interest in our 4802 program; now, it can be a long road from interest to actual financial support but we are trying to do everything possible to minimize our burn rate. We hope that today’s pre print is the first step on that road.
We are working with our CRO to select and prepare required documents to agencies of various nations where we are targeting our P3 trial. We are hoping to have additional news to share with you in the coming days and weeks.” 5/12/21
“We have begun talks with various organizations like CEPI, Barda, etc for the support of our INO-4802. Hopefully, we will receive a positive response....” 4/15/21
Colombia will manufacture vaccines against Covid with the pharmaceutical company Inovio | Government | business
October 21, 2021
As part of the strategies and projects to manufacture vaccines in the country and to achieve a CONPES of sanitary security, Colombia signed a new Memorandum of Understanding this time with the American pharmacist Inovio.
At the signing ceremony in the Casa de Nariño, the Minister for Health and Social Protection, Fernando Ruiz Gómez stated that for the portfolio and the sector “it is a very special moment for the opportunity to sign this agreement“.
“Since the last week of July of this year, our first mission to look into health security was chosen to be in the United States and we had the opportunity with Ambassador Pinzón to hold discussions with various pharmaceutical companies in the United States, with Moderna, Pfizer, AstraZeneca“He counted.
In these discussions the possibility of producing vaccines in Colombia was addressed. “We arrived a little disappointed because Latin America was not a priority for production and unfortunately we had no relationship with Inovio. We have to thank Ambassador Goldberg, his persistence and work have helped us a lot“Declared Minister Ruiz.
Inovio knows the four experiences of clinical trials in the country and this will be the basis to move forward quickly, in the development of vaccines in Colombia, In addition, health security is a goal and should be concretized in the country on the basis of these agreements.
Colombia will manufacture vaccines against Covid with the pharmaceutical company Inovio | Government | business
You must accept that I am omnipotent, perfect and all knowing.
What is Inovio worth – VGX3100 – Cervical Dysplasia
Reported by the WHO, there are globally 570,000 cases diagnosed annually. This disease has an approximate 50% death rate. The treatment market for HSIL CD is 7.9Billion with a 5% annual growth rate. There is also a 22Billion dollar PAP test market. Treatments cost is up to $79,000 - $118,000 annually, depending on the severity and stage of the disease.
Inovio’s VGX3100 is 95% effective on 24% of the population who has HSIL CD. In order for them to effectively target this 24%, they will use the Qiagen biomarker which is 85% effective at detecting these candidates. This will open up a 20.5% market share for Inovio, which would be roughly 116,280 annual cases or $1.6 Billion of the current market share.
Now we can only make assumptions on how much revenue INO will generate from their piece of the pie as we don’t know how much they’ll charge for their treatment. However, using information that we know, I can make the following assumptions.
• Reveal 1 used 3 doses
• Revel 1 used the 5PSP device, each device costing approx. $10K
• Current vaccine prices range from 2.5 to $20 a pop. This is not an apples to apples comparison but the algorithm they use to develop their construct is similar, as well as the manufacturing process. Since current treatment is significantly more than $60 (60x3 doses), I’m going to be very conservative and say each does will be $2,500.
With now 348,840 does needed (3x116,280) @ 5000 = $872,100,000 annually
With 15K doses per device, 23 devices are needed @ 10K = $232,560 Annually
With a current annual operating cost of $83,747,759, the net revenue and EPS would be $788,584,801 and 3.75
With an EPS of 3.75 and current P/E ratio of 18, we can expect the SP to be about $67. Again, many assumptions have to be made, doses, dose cost, EP cost, market share, operating expenses, P/E, efficiency of both VGX3100 @ 24% and Qiagen biomarker at 85%. However, these numbers could also be far better that what I have projected here.
VGX3100 – Cervical Dysplasia is worth nearly $60 to our current share price.
Feel free to scrutinize, criticize and provide any feedback.
Funding? Tracy, if 4800 works why doesn't Inovio run the trials? What will the cash hoard be used for? Why were shareholders massively diluted if the funds won't be used for trials? Is the cash reserved for managements' lavish compensation packages?
11/30/21 2:25 PST DNA encoded monoclonal antibody (dMAb®) treatment for infectious disease and beyond
Dr Laurent Humeau, CSO–EVP of R&D, Engineering and Clinical Developments, Inovio
The Vaccine & Immunotherapy Congress West Coast is returning to reunite the community in real life (yes, in-person!) - on 30 November - 2 December in San Diego!
COVID-19 dMAb P1/P2 to start before 12/15/21.
“The dMAb candidates will then be advanced into preclinical studies and then into rigorous, first-in-human clinical trials within one year of funding.” 12/15/20
10/5 AZN seeks EUA for AZD7442 also being dMAb®-cloned by Ino
Under DARPA’s two-year grant, INOVIO and Wistar teams will construct COVID-19 dMAb candidates designed to mirror AZN’s traditional recombinant monoclonal antibody candidates now being tested in clinical trials to treat COVID-19, such as AZD7442.
Kimmie introducing global mouse trial patients:
Why hasn't Kimmie answered the easy FDA questions? Kimmie is to blame, not the FDA. He knows that 4800 doesn't work. If it goes to trial, his scam will be exposed and $90,000 weekly would go down the drain. He claimed to have started a trial in S Korea in May of last year. Where is the data? He will never run a trial in Columbia, Mexico or anyplace else. If he eventually starts one, it will be canceled without any results and the reason given will be: there's no market for the vaccine.
Colombia will produce vaccines against covid-19 in association with the pharmaceutical company Inovio
This decision opens the way for the country to continue associating with more pharmaceutical companies and to have its own vaccines
October 20, 2021
The Colombian Minister of Health, Fernando Ruiz Gómez, speaks in an interview with Efe today, at the Colombian embassy in Washington (USA). EFE / Lenin Nolly
This October 20, it was known that Colombia signed a new memorandum of understanding, this time with the US pharmaceutical Inovio. At the signing ceremony held at Casa de Nariño, the Minister of Health and Social Protection, Fernando Ruiz Gómez, indicated that for the portfolio and the sector, "it is a very special moment due to the possibility of signing this understanding agreement."
“Since the last week of July of this year, our first mission, to seek the issue of health security, was elected to the United States and we had the opportunity with Ambassador Pinzón to establish conversations with various pharmaceutical companies in the United States, with Moderna, Pfizer, AstraZeneca ” , he said in his speech.
He pointed out that in those conversations the possibility of producing vaccines in Colombia was raised, which, since the instruction of the President of the Republic and Ministry of Health, has been working on.
We arrived a little disappointed because Latin America was not a priority for production and, unfortunately, we did not have a relationship with Inovio. We have Ambassador Goldberg to thank, his persistence and hard work has helped us a lot.
“Today it is special for us to have this complete circle of having the possibility, which was the first one we sought, to have interaction with a company in the United States, to integrate it with the work that has been carried out by the WHO with the Solidarity study, in which Inovio is like one of the four experiences of clinical studies that we will do ”, said the minister.
In addition, all the possibilities of advancing "very quickly, because the will of Inovio, which considers Colombia as a priority country, and also the will of our country and Minsalud to advance in everything that is the development of vaccines in Colombia" Ruiz said, recalling that health security is an objective and is expected to be realized from these agreements.
"We need to go up and grow more in vaccination speed": MinSalud
On the other hand, the Minister of Health and Social Protection, Fernando Ruiz Gómez, presented an overview of the progress of vaccination against covid-19, highlighting the intensification days held during this week in different regions of the country.
Likewise, the minister assured that although vaccination has grown in recent weeks, with 250,000 and 300,000 daily doses applied, “we need to go up and grow even more at that speed. We need to vaccinate 7.5 million people for the first doses, ” said Ruiz Gómez.
On the other hand, the head of the health portfolio stressed that it has been observed that there is still a population of 70 and 80 years old and more who still do not receive their vaccines, which is risky, since it is the population group that is reporting the most deaths from covid today.
"In highly rural municipalities we still have very large populations that have not been vaccinated," said the minister, noting that efforts must be added to reach these populations with vaccines.
“We are doing well, but we need to meet the goal; therefore, we need to cover the Colombian population, protect it, it is our responsibility to move forward, "he added.
Capitulation will happen sub $1.00.
4800 will be shelved due to an oversupply of vaccines.
3100 with 22% efficacy will fail in trial (it already has once).
I look at these post and wonder what does any of this have to do with ( INO ) , ( INO ) has been a huge disgrace and disappointment and I'm losing my ask.. Kim and Crew have made this a joke story, no one in the world trust Kim and Crew, you can have all the good news which isn't even news like last week , that news about Columbia was 3 weeks old and he left Washington DC with nothing ... As for 4800 or 4802 I don't know what the hell is going on with data , sales, EUA.. CEPI won't even fund INO and the FDA and CDC got out early ..Kim and Crew have been on major news outlets and TV shows and not one mention of INO anywhere, overseas countries won't even place a order, maybe the data is only as good as the other's or worse...Kim and Crew and Sippy Cup and Fauci and Milkshake Milley and the FDA and CDC have lied to all of us and the world..I'm not sure if INO can make it back , and insiders and institutions are heading out of INO this last week , selling has increased by 29 % .. It's not retail investor's like us...
News is increasingly good. Our overall pipeline is progressing. VGX-3100 (HPV Precancerous Dysplasia) and INO-4800 (Covid-19) now both in Phase 3. INO-5401 for GBM looks very promising. All we need is one EUA and one significant order to launch INO to new highs. Then the real potential of INO's DNA platform will be recognized and valued. Tell your friends, family and neighbors! Shorts beware!!
Follow the leader.
Kimmie bought $69,975 of INO shares and sold $12,633,274
Information for StockHound: "Inovio hopes that VGX-3100 will become an alternative to surgery; however, the latest data, from the phase III Reveal 1 study, are far from convincing. The company claimed a win here but admitted that the trial only met its primary endpoint when using a modified intent-to-treat analysis that excluded eight patients without endpoint data."
Look hard facts are INO is running out of money ...Kim and Crew has beaten this stock to 💀💀💀 death. He better have answers soon or us longs are going to lose everything..I'm not in as deep about I still don't want to lose my investment..Kim can and will do a split if needed ,sadly he doesn't care about investor's...So if this goes into next year, hope to break even , the 35$ price target is a castaway...Not true !!! Institutions would be the first to speak out and ask Kim and Crew step down ..With today's volume and 5 percent fall insider's and institutions are lowering there position in INO. .. INO has hit this level of volume in a year , today wasn't about retail investor's... The Rive Runs Deep..
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