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Category: OCGN

OCGN – Where Will Ocugen Be in 1 Year?

On June 10, shares of Pennsylvania-based biopharma Ocugen (NASDAQ:OCGN) fell by an astonishing 26%. The decline came as the U.S. Food and Drug Administration (FDA) recommended the company file a Biologic License Application (BLA) for its coronavirus vaccine candidate, Covaxin (developed in partnership with India’s Bharat Biotech), instead of an Emergency Use Authorization (EUA). The agency also requested additional data supporting Covaxin’s efficacy and safety.

Ocugen is still a top-performing coronavirus stock despite the sell-off, with a return of 2,200% since last June. Aside from Covaxin, all of its product candidates are in the preclinical stage. Is now the time for investors to buy the dip?  

Doctor preparing syringe for coronavirus vaccine.

Image source: Getty Images.

The odds don’t look good

In clinical studies, Bharat Biotech’s Covaxin demonstrated 78% overall efficacy against COVID-19 and 100% efficacy against severe cases. The study mainly took place in India, where the highly contagious, highly resistant Delta variant of the disease is rampaging across the country. Therefore, its value proposition is evident. Covaxin has received regulatory clearance in over 13 countries. 

Unfortunately, Covaxin does not belong to Ocugen. The company merely licensed the distribution rights in the U.S. and Canada from Bharat Biotech. The agreement is for Ocugen to receive 45% of the profits for the vaccine’s commercialization. It also paid Bharat Biotech $15 million upfront for Canadian licensing rights.

Last month, the company told investors that it was “on track” to submit a EUA with the FDA for Covaxin by the end of June. But the regulatory agency has not just given that application a thumbs-down, it has also tasked Ocugen with conducting another clinical trial validating Covaxin’s efficacy.

There are three problems with this from an investment standpoint. First of all, the coronavirus pandemic is largely subsiding in the U.S. due to mass vaccination campaigns. Therefore, it would be very difficult for Ocugen to find people living in areas of high exposure to the virus. That’s not to mention the ethical issues around enrolling participants in the placebo cohort when safe and effective coronavirus vaccines are widely available.

Secondly, Ocugen planned to sell only 100 million doses of Covaxin in the U.S. Based on pricing assumptions, industry margins, and its deal with Bharat Biotech, that translates to an estimate of $135 million in pre-tax profits. However, it could cost up to $1 billion to conduct phase 3 clinical trials necessary for the vaccine’s full approval. Without government funding or cost-sharing programs, Ocugen will be hitting a dead end. 

Lastly, the U.S. and Canada have ordered a combined 1.2 billion doses of coronavirus vaccines, enough to vaccinate everyone in those nations multiple times over. So even if Ocugen conducts the study and succeeds, I don’t see how the company could start its BLA filings before next year, when demand for vaccines is likely to have evaporated.

The verdict

It’s looking more and more certain that Ocugen will not be able to commercialize Bharat Biotech’s coronavirus vaccine in a timely manner. For these reasons, it’s best to stay away from the biotech. One year from now, I expect Ocugen to still be seeking funding for another phase 3 trial or scrambling to file its BLA. 

This article represents the opinion of the writer, who may disagree with the “official” recommendation position of a Motley Fool premium advisory service. We’re motley! Questioning an investing thesis — even one of our own — helps us all think critically about investing and make decisions that help us become smarter, happier, and richer.

OCGN – OCUGEN ALERT: Bragar Eagel & Squire, P.C. is Investigating Ocugen, Inc. on Behalf of Ocugen Stockholders and Encourages Investors to Contact the Firm

NEW YORK–()–Bragar Eagel & Squire, P.C., a nationally recognized shareholder rights law firm, is investigating potential claims against Ocugen, Inc. (NASDAQ: OCGN) on behalf of Ocugen stockholders. Our investigation concerns whether Ocugen has violated the federal securities laws and/or engaged in other unlawful business practices.

Click here to participate in the action.

On May 26, 2021, Ocugen announced that it planned to submit to the FDA an Emergency Use Authorization (“EUA”) application for COVAXIN, a COVID-19 vaccine, in June 2021. On June 10, 2021, Ocugen announced that it “will no longer pursue an Emergency Use Authorization (EUA) for COVAXIN,” instead choosing to “pursue submission of a biologics license application (BLA) for its COVID-19 vaccine candidate, COVAXIN.” Ocugen’s Chairman and CEO stated, “Although we were close to finalizing our EUA application for submission, we received a recommendation from the FDA to pursue a BLA path,” and that “this will extend our timelines.”

Shares of Ocugen fell by more than 24% in intraday trading on the same day, based on this news.

On June 10, 2021, the Company said it would no longer pursue a EUA for Covaxin and would instead aim to file for a full U.S. approval of the shot.

On this news, the stock price plummeted and closed on June 11, 2021 at $6.69 per share, representing a 25.17% drop from the June 10, 2021 closing price of $9.31 per share.

If you purchased or otherwise acquired Ocugen shares and suffered a loss, are a long-term stockholder, have information, would like to learn more about these claims, or have any questions concerning this announcement or your rights or interests with respect to these matters, please contact Brandon Walker, Melissa Fortunato, or Marion Passmore by email at investigations@bespc.com, telephone at (212) 355-4648, or by filling out this contact form. There is no cost or obligation to you.

About Bragar Eagel & Squire, P.C.:

Bragar Eagel & Squire, P.C. is a nationally recognized law firm with offices in New York, California, and South Carolina. The firm represents individual and institutional investors in commercial, securities, derivative, and other complex litigation in state and federal courts across the country. For more information about the firm, please visit www.bespc.com. Attorney advertising. Prior results do not guarantee similar outcomes.

OCGN – Ocugen (OCGN) to File Coronavirus Vaccine BLA in US, Stock Tanks

Ocugen, Inc. (OCGN Free Report) announced that it will submit a biologics license application (“BLA”) for its COVID-19 vaccine candidate, Covaxin, in the United States following the FDA’s recommendation.

The company will no longer pursue an Emergency Use Authorization (“EUA”) for the vaccine candidate, and instead, will seek more formal approval for Covaxin. This might delay the launch of the vaccine in the United States.

The regulatory body recommended Ocugen to pursue a BLA submission instead of an EUA application for Covaxin and requested additional information and data on the same. The company believes that data from an additional clinical study will likely be necessary to support the BLA.

Shares of Ocugen were down 28.1% on Thursday following the announcement of the news. However, the stock has skyrocketed 265.5% so far this year compared with the industry’s rise of 0.1%.

Zacks Investment ResearchImage Source: Zacks Investment Research

Please note that Ocugen has secured exclusive rights to commercialize Covaxin in Canada and has also initiated discussions with Health Canada for the regulatory approval of the same.

We note that, in April 2021, Bharat Biotech announced encouraging data from the second interim analysis of its phase III study of Covaxin, which showed 78% overall efficacy against COVID-19 disease, 100% efficacy against severe COVID-19 disease (including hospitalization), and 70% efficacy against asymptomatic COVID-19 infection.

Covaxin is generally well tolerated and has shown a good safety profile in studies conducted till date. More than 6.7 million doses of the vaccine have been administered in India without any potential thromboembolic event being reported so far.

Ocugen entered into a definitive agreement with India-based Bharat Biotech to co-develop and commercialize the latter’s COVID-19 vaccine, Covaxin, for the U.S. market, in February 2021. Ocugen is also in discussions with BARDA regarding the U.S. government’s support of Covaxin. It is also considering evaluating Covaxin in special populations, such as children, as well as in booster doses.

Other COVID-19 vaccines that have received EUA in the United States are Moderna’s (MRNA Free Report) mRNA-1273, Pfizer/BioNTech’s (BNTX Free Report) BNT162b2 and J&J’s (JNJ Free Report) single-shot COVID-19 vaccine.

Notably, companies like Pfizer/BioNTech and Moderna have already got a head start and initiated rolling submissions for a BLA with the FDA, seeking approval/licensure of their respective COVID-19 vaccines in the United States.

Zacks Rank

Ocugen currently has a Zacks Rank #4 (Sell). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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OCGN – OCGN Stock Price: 28.14% Decrease Explanation

  • The stock price of Ocugen Inc (NASDAQ: OCGN) fell by 28.14% today. This is why it happened.

The stock price of Ocugen Inc (NASDAQ: OCGN) fell by 28.14% today as it went from a previous close of $9.31 to $6.69. Investors are responding negatively to an announcement from the company that upon recommendation from the U.S. Food and Drug Administration (FDA), it will pursue submission of a biologics license application (BLA) for its COVID-19 vaccine candidate COVAXIN. And the company will no longer pursue an Emergency Use Authorization (EUA) for COVAXIN.

The FDA had provided feedback to Ocugen regarding the Master File the company had previously submitted and recommended that Ocugen pursue a BLA submission instead of an EUA application for its vaccine candidate and requested additional information and data. And Ocugen is in discussions with the FDA to understand the additional information required to support a BLA submission. Ocugen anticipates that data from an additional clinical trial will be required to support the submission.

Ocugen had recently announced that it secured exclusive rights to commercialize COVAXIN in Canada and has initiated discussions with Health Canada for regulatory approval. And the company will pursue expedited authorization for COVAXIN under the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 in Canada.

KEY QUOTES:

“Although we were close to finalizing our EUA application for submission, we received a recommendation from the FDA to pursue a BLA path. While this will extend our timelines, we are committed to bringing COVAXIN to the US. This differentiated vaccine is a critical tool to include in our national arsenal given its potential to address the SARS-CoV-2 variants, including the delta variant, and given the unknowns about what will be needed to protect US population in the long term.”

— Dr. Shankar Musunuri, Chairman of the Board, Chief Executive Officer, and Co-founder of Ocugen

“In clinical trials to date, the emerging safety profile of COVAXIN is supportive of it being generally well tolerated with a good safety profile, with Ministry of Health and Family Welfare of Republic of India reporting no potential thromboembolic events following the administration of over 6.7 million doses of COVAXIN in that country.”

— Dr. Bruce Forrest, Acting Chief Medical Officer and member of the vaccine scientific advisory board of Ocugen

Disclaimer: This content is intended for informational purposes. Before making any investment, you should do your own analysis.

OCGN – OCGN Stock Price: $10 Target By Roth Capital

  • The shares of Ocugen Inc (NASDAQ: OCGN) have received a price target of $10 by Roth Capital. These are the details.

The shares of Ocugen Inc (NASDAQ: OCGN) have received a price target of $10 by Roth Capital. And Roth Capital analyst Zegbeh Jallah is maintaining a “Buy” rating on the company shares.

Jallah assigned the $10 price target after Ocugen and Bharat Biotech announced an amendment to their existing agreement — which is going to grant Ocugen exclusive commercialization rights to Covaxin in Canada as an extension to current commercialization rights in the U.S. And Jallah noted that this is a smart move for Ocugen especially as it approaches Emergency Use Authorization application submission for Covaxin in the U.S.

Jallah believes that even though Canada has entered agreements for substantial vaccine supplies, the need for boosters as well as annual vaccinations will create a positive commercial outlook for Covaxin going forward.

Disclaimer: This content is intended for informational purposes. Before making any investment, you should do your own analysis.

OCGN – Take Your Ocugen Stock Profits and Run If You Haven't Already

Because the novel coronavirus pandemic has more twists and turns than the Monaco Grand Prix, my take on biotechnology firm Ocugen (NASDAQ:OCGN) stock has been admittedly all over the map.

The concept image of a vaccine passport with a needle and map.

Source: Shutterstock

Still, it’s very possible that the recent volatility in OCGN stock finally provided some much-needed clarity.

First, let’s back up for a moment. Prior to the Covid-19 catastrophe, OCGN stock was itself a disaster. Though the underlying company features a compelling business — using the latest advancements in biomedicine to address rare eye diseases — Ocugen for years suffered from a credibility problem.

It’s helpful to remind ourselves that going into 2020, you could buy OCGN stock for less than a dollar a pop. Throughout most of last year, Ocugen never gave an inkling that it was about to go on a mercurial ride.

However, a partnership with Bharat Biotech to deliver whole-virion inactivated Covid-19 vaccines quickly changed the narrative.

Out of nowhere, OCGN stock jumped into single-digit territory, then into double digits in early February of this year. As shares tumbled down from their wild peak, I noted on March 30 that OCGN could be a crisis trade that might pan out.

At the time, new strains of the SARS-CoV-2 virus threatened to sink the world back into lockdown.

While it took an initial dive, OCGN stock would find itself again in double-digit territory. But on May 3, I warned that if you’re profitable on Ocugen, now would be the time to take profits. Essentially, the U.S. has too many vaccines. There’s plenty of supply for those who want to be protected, and contrary to conspiracy theories, no one is forcing never-vaxxers to get the jab.

Therefore, yet another Covid vaccine seemed utterly superfluous. While I don’t mean to toot my horn, my cautionary take came out on a high note for OCGN stock. Since then, shares have looked very ugly.

Take the Commonsense Approach With OCGN Stock

Admittedly, what makes Ocugen intriguing for speculators right now is the terrible situation that’s afflicting India, Bharat Biotech’s home market. Clearly, a desperate need exists to inoculate the population. Further, other countries have requested doses of Bharat’s vaccine, called Covaxin. This possibly opens the door to additional opportunities for Ocugen.

Still, the point remains that Ocugen’s deal with Bharat is to “co-develop, supply, and commercialize the Indian vaccine maker’s Covid-19 vaccine Covaxin in the US market.” Therefore, it’s not entirely clear that OCGN stock will benefit from expansion into non-U.S. markets.

Nevertheless, even if it did, the advantage might be short-lived for Ocugen. Mainly, this is due to the competition. While the marshaling of resources to produce multiple solutions for Covid-19 represents the power of the human spirit against overwhelming odds, the reality is that there will be few sustained winners following this mess.

For example, Novavax (NASDAQ:NVAX) was a massive standout early in the pandemic. Through its proven subunit approach, Novavax had the potential to deliver a trusted solution (the hepatitis B vaccine is a subunit) to a leery public.

Unfortunately, it just couldn’t beat Pfizer (NYSE:PFE) and Moderna (NASDAQ:MRNA), which punched their way to the finish line first.

It’s the same narrative with Ocugen. Going with a more traditional inactivated virus approach, Ocugen has gone with a proven, trusted approach. But a track record wasn’t just the only issue here — the world needed a solution quickly. That’s where Pfizer and Moderna, which both utilized a messenger-RNA approach, enjoyed the pivotal advantage.

“[E]ven with modern fermentation equipment, reaching adequate biomass to begin manufacture of a viral vaccine takes about four to six weeks. Once underway, each growth and production cycle might take a week. An mRNA vaccine is synthesized in a matter of minutes,” said Dr. Simone Blayer, global head of chemistry, manufacturing, and control at PATH’s Center for Vaccine Innovation and Access

It’s Time to Sell Ocugen

Typically, I don’t like to make a declarative statement to buy or sell stock. I lean toward one direction or another, which helps to cut down on the hate mail, but with OCGN stock, I think it’s time to sell while you still can.

Please don’t get me wrong — I’m not speaking out of malice or ill intent. Rather, with so much competition in the space, and with mRNA vaccines having proven themselves brilliantly in the face of much scientific and public scrutiny, the case of OCGN seems rather anachronistic.

Essentially, Ocugen took the field goal instead of going for six. It may have been a smart move. But with Pfizer and Moderna taking the risk and converting, it’s only a matter of time before investors lose interest in speculative ideas like OCGN. That’s especially the case now that the storyline has become even riskier.

On the date of publication, Josh Enomoto did not have (either directly or indirectly) any positions in the securities mentioned in this article. The opinions expressed in this article are those of the writer, subject to the InvestorPlace.com Publishing Guidelines.

A former senior business analyst for Sony Electronics, Josh Enomoto has helped broker major contracts with Fortune Global 500 companies. Over the past several years, he has delivered unique, critical insights for the investment markets, as well as various other industries including legal, construction management, and healthcare.

OCGN – Ocugen Faces Long Odds Before Gaining From Its Covid-19 Support Role

While Ocugen (NASDAQ:OCGN) stock is up over 200% this year, it hasn’t been a case of slow and steady growth. On two separate occasions, the shares have been much higher. Yet when I wrote about OCGN stock a month ago, the stock was about 40% below its current price. 

A needle rests on a reflective table next two clear glass vials of a clear liquid.

Source: Shutterstock

Volatility like that merits some explanation. The first time OCGN stock popped, in mid-February was likely due to the meme stock craze. But when the stock spiked in April, it was due to a more fundamental reason. Ocugen had become a recognized player in the Covid-19 vaccine rollout.

That would be more intriguing if Ocugen was developing its own vaccine. Not that it would make it any less of a long shot, but right now the company is serving the role of a middleman. And it could wind up getting cut out entirely.

America Doesn’t Need Covaxin 

As I noted last month, Ocugen is in a partnership with India’s Bharat Biotech regarding the latter company’s Covid-19 vaccine, Covaxin. Specifically, Ocugen will get 45% of the profits from the sale of Covaxin in the United States.

The concern I had then is the same concern I have now. The U.S. does not require another Covid-19 vaccine. And, although Covaxin has received an emergency use authorization in India, it continues to undergo Phase 3 trials.

Under terms of the agreement, Ocugen will be responsible for the vaccine’s clinical development, regulatory approval (which includes its EUA) and commercialization in the U.S. 

And as my InvestorPlace colleague Larry Ramer points out, that approval appears unlikely. Ramer recently observed that the FDA’s written protocols state that to grant an EUA it “should carry out visits to the sites at which Phase 3 trials are being carried out.” 

That would mean the FDA would have to go to India which is currently under a travel ban by the U.S.

Not Part of the Arsenal 

One of the recent bullish arguments for OCGN stock is that the company will benefit from India’s pause on exporting Covaxin. India will not export the vaccine until at least October to stem the ongoing surge in that country. The rationale is that Ocugen will benefit as more vaccines will need to be created and exported.

But again, I’m skeptical. First, as I’ve pointed out, the United States is not a nation that needs to import vaccines. In fact, President Biden is pledging that the U.S. will be an arsenal for global distribution of Covid-19 vaccines. On May 17, 2021 the president announced that the U.S. would share an additional 20 million doses of the vaccine. This was in addition to the 60 million doses that have already been exported. 

This brings me to a second point. CurrentlyCovaxin is not part of that arsenal. And even if it were, it’s unclear how exporting Covaxin would work with Ocugen’s agreement in which the company receives compensation for sales of Covaxin within the United States (emphasis mine).

There Are Better Options Than OCGN Stock 

Ocugen specializes in treating rare eye diseases. They don’t currently have a product in market. But one of their candidates, INO-4000, is beginning the clinical trial stage. The partnership with Bahrat Biotech may be successful in raising some non-dilutive revenue. But for reasons I’ve noted in this article, that should not be seen as a given. 

There are other small-cap biotech companies that may have better odds of bringing an additional Covid-19 vaccine to market. I would suggest Inovio Pharmaceuticals (NASDAQ:INO) or iBio (NYSEAMERICAN:IBIO). These companies also face long odds. However both are at least manufacturing their own vaccine. And both companies are bringing something innovative to the table. 

I’m assuming Ocugen’s motives for trying to assist in the Covid-19 vaccine race are pure. I imagine all biotech companies want to alleviate suffering and needless death from this virus. But the company is facing longer odds to achieve that goal than I believe short-term traders are considering.

On the date of publication, Chris Markoch did not have (either directly or indirectly) any positions in the securities mentioned in this article. The opinions expressed in this article are those of the writer, subject to the InvestorPlace.com Publishing Guidelines. 

Chris Markoch is a freelance financial copywriter who has been covering the market for seven years. He has been writing for Investor Place since 2019. 

OCGN – Will Covaxin's Success Against COVID Variants Make Ocugen a Big Winner?

Ocugen (NASDAQ:OCGN) recently announced encouraging results from studies that indicated the potential for COVID-19 vaccine Covaxin to be effective against coronavirus variants. In this Motley Fool Live video, recorded on May 5, 2021, Motley Fool contributors Keith Speights and Brian Orelli discuss whether or not Covaxin’s success against emerging variants could help make Ocugen a big winner in the U.S. market.

Keith Speights: There’s another story as well on the COVID-19 front. Ocugen, O-C-G-N is the ticker there. The company announced this week some studies that showed that the COVID-19 vaccine Covaxin appears to be effective against three of the new coronavirus variants. Ocugen stock soared on this news. How significant is this for the biotech?

Brian Orelli: Yeah. The studies are looking at serum from people that were vaccinated with Covaxin. They took the antibodies and looked at whether they could neutralize the different variants and that was able to neutralize the Brazil variant, the UK variant, and the India double mutant variant.

It’s certainly good news and it will likely translate into protection of humans, but there’s no way to know unless you run a prospective study and then look and see how many people that got placebo got infected with the different variants, and then how many people who got the vaccine were infected with the variants and show that there is a difference there. Beyond that, you can’t really claim that it’s protection. It’s just a laboratory experiment that suggests that there should be protection.

Investors, I think, should be way more focused on Ocugen’s plan to gain approval than actually worrying about the protection of the variants although obviously, it’s good news. They licensed this drug from Bharat Biotech in India, but we still don’t know whether the FDA will accept the study that was run by Bharat Biotech to gain emergency use authorization in the US, and that’s the only place where Ocugen and it’s still an open question. I think it’s a much bigger issue for the evaluation of Ocugen and whether the vaccine can protect against the variants.

Speights: Yeah. You and I have spoken before about some of the challenges that Ocugen could have in getting that FDA authorization. Although over the longer term, a vaccine that can be effective against variants could have a shot anyway, no pun intended, could have a shot at being a success in the U.S. market.

Orelli: Yeah. I don’t think the FDA is going to accept serum laboratory experiments as proof that the vaccine protects against the variants.

Speights: Right. The threshold is much higher and more definitive studies will definitely be needed.

This article represents the opinion of the writer, who may disagree with the “official” recommendation position of a Motley Fool premium advisory service. We’re motley! Questioning an investing thesis — even one of our own — helps us all think critically about investing and make decisions that help us become smarter, happier, and richer.