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Omicron variant impact on ocugen stocks
As the market awaits the final approval of COVID-19 vaccine in the EU, it's important to consider the potential impact of the omicron variant. A new drug candidate targeting the omicron variant is being developed by BioNTech and Pfizer, and they hope to make a vaccine for this specific omicron variant available in March 2022. The news could also spur further development of Ocugen's Covaxin vaccine, and thus increase its stock price.
Vaccine makers are scrambling to find a cure for the dominant omicron variant. While there are no immediate plans to approve the vaccine, recent studies show that Covaxin could extend protection to COVID-19 variant. Meanwhile, Ocugen, a late entrant in the COVID-19 vaccine market, has recently reported promising stage 3 results. The company intends to release the results of this study once it is complete.
COVID-19 pandemic could change market dynamics for ocugen stocks
Ocugen is a clinical-stage biotechnology company focused on gene therapies for diseases causing blindness. Its pipeline of gene therapy products includes OCU200, a novel fusion protein currently in preclinical development. Ocugen has a partnership with India-based Bharat Biotech to commercialize COVAXIN, a vaccine candidate for COVID-19, in North America. The company is headquartered in Malvern, Pennsylvania.
The COVID-19 pandemic is still a major concern, with new mutations of the virus being discovered and a rapidly spreading Delta strain causing new infections. While the pandemic is unlikely to affect the United States, it could significantly change market dynamics for Ocugen stocks. Among the companies fighting COVID, Ocugen is one of the most unexpected additions to the group this year.
Omicron variant impacts on ocugen stocks
As the Covid variant spreads, vaccine makers have been scrambling to find a solution. Ocugen, a vaccine player, has some promising vaccine results. On the news of the promising vaccine, the OCGN stock spiked by 10%. Since then, it has cooled off, trading up slightly. At the time of writing, the stock is trading 3% higher. It will be interesting to see how the Omicron variant impacts the company's stock price.
The Company reported a seven-cent net loss for the three months ended Dec. 31. However, the stock is roughly $3.04 or $4. The company is also riding the fast track clinically, announcing that it had lifted a clinical hold on its Covaxin application. On top of that, it has initiated a Phase 1/2 clinical trial for OCU400, a modifier gene therapy candidate.
What is Ocugen and What is it Doing to Fight Blindness?
Are you wondering what is Ocugen and what it is doing to fight blindness? Read on to discover more about this clinical-stage biopharmaceutical company. Find out who Ocugen has partnered with including Pfizer, Moderna, and CarSense. If you're looking for an investment opportunity, consider checking out Ocugen's valuation analysis. It may help you decide whether or not it is worth your time and money.
Ocugen is a clinical-stage biopharmaceutical company
Ocugen is a clinical-stage, biotech company focused on developing gene therapies for blindness diseases. Its pipeline currently includes OCU400, which is undergoing a phase 1/2 clinical trial, and COVID vaccine COVAXIN. Its CEO, Dr. Shankar Musunuri, will speak at the 34th Annual Roth Conference on May 12. The conference will feature over 400 companies and executive management from 40+ sectors.
The Company is currently developing two novel biologicals and one marketed drug product. All three are intended to treat diseases that cause blindness. OCU100 is a recombinant form of lens epithelium-derived growth factor (LEGF), which received orphan drug status from the FDA. OCU200 is an anti-angiogenic tumstatin fusion protein in preclinical development, and it is being studied for wet age-related macular degeneration. In addition, OCU300 is in preclinical development as a treatment for ocular graft versus host disease.
Ocugen's missing assignment in one of its recent studies could reveal deeper problems with FDA clinical trial oversight. The company has been warned by the FDA to turn over study results on time. The FDA's study of brimonidine tartrate nanoemulsion was meant to evaluate the safety and efficacy of the drug. This trial, which was also funded by the pharmaceutical company, has since been suspended.
The Company intends to resume its Phase 2/3 immuno-bridging clinical trial in the U.S. and to complete additional studies for its biologics license application. Ocugen is also in talks with Health Canada regarding funding to acquire Liminal BioScience's manufacturing facility in Ontario. It envisions using this facility to manufacture COVAXIN and gene therapies. However, the company's pipeline is a bit delayed, and investors should be cautiously optimistic.
It has a contract with Pfizer and Moderna
A contract with Pfizer and Moderna would help Ocugen to gain access to millions of patients. The company hopes to produce 700 million doses a year. Despite this contract, Ocugen is still a pre-revenue company. It is undergoing trials to prove the efficacy of its product. Ocugen has zero percent market share in the $1.3 trillion biopharmaceutical industry. The company hopes to sell its coronavirus vaccine, which is currently in the development stage. In fact, it has received interest from more than 40 countries, including the Philippines and Brazil.
However, the vaccine has faced numerous setbacks. In the past, the vaccine failed to secure regulatory approval in the United States. The company's Phase 2/3 trial in India did not result in the approval of the vaccine, and the World Health Organization suspended its supply after an inspection found manufacturing problems. However, Ocugen has worked through these setbacks and still believes that it can find a market in the U.S., despite the numerous hurdles.
The agreement signed with Moderna and Pfizer has been an important boost for the company's stock price. Ocugen's shares soared nearly 21 percent on Monday and Tuesday combined, but have fallen by 6.4% since then. In addition, the company has a contract with Pfizer and Moderna to market their drug. Getting this approval is a critical step for the company, as each approval adds to its revenue. However, failure to gain approval would delay the company's return by years and leave investors with empty hands.
Ocugen has partnered with Bharat Biotech to develop COVAXIN, a two-dose whole-viron inactivated vaccine. The vaccine has received regulatory approval in India and has already been administered to front-line workers and health care providers in the country. The company also has assembled a Vaccine Scientific Advisory Board to evaluate the product. The company intends to launch the COVID-19 vaccine in the U.S. by the second quarter of this year.
The partnership also includes co-development with Bharat Biotech of India, and a contract with Pfizer and Moderno in North America. Covaxin is a whole virion inactivated COVID-19 vaccine candidate, which has shown efficacy in mild, moderate and severe disease. The drug is already being used in India under emergency use authorization, where Ocugen will keep 45% of the profits.
Ocugen Inc. has begun the phase 3 clinical trials for its covaxin coronavirus vaccine candidate. In partnership with Bharat Biotech, Ocugen has a 45 percent share in the profits generated from the sale of Covaxin. The vaccine is one of the most anticipated in recent years. The company submitted its Emergency Use Authorization to the FDA earlier than expected. It has also initiated a rolling submission for Covaxin in Canada.
It has a contract with CarSense
According to its latest earnings report, Ocugen is on track to make $1.1 million in revenue in 2020. Its sales and profit projections are also based on a contract with CarSense. While the company hasn't disclosed the details of this deal, the agreement was signed to increase its visibility in the auto market. As such, Ocugen expects the deal to benefit both the automaker and the company.
The company expects to submit its EUA to the FDA by the end of June. Its Covaxin application was denied, however, and the company is now faced with a new set of trials. Since the coronavirus pandemic is subsiding in the U.S., finding subjects with high exposure is difficult. Furthermore, ethical concerns would arise if the company chose to enroll a placebo group.
Ocugen News Coverage
When it comes to trading Ocugen, news coverage is often overlooked. We will cover the recent EUA for Covaxin in children, the letter of intent with Liminal BioSciences to purchase its manufacturing facility, and the stock price reaction to these events. We'll also discuss the reasons for Ocugen's high volatility. Read on to learn more about this promising biotech. We hope you'll find our Ocugen news analysis useful!
Ocugen's EUA for Covaxin in children
While Ocugen has expressed confidence in its ability to win the U.S. EUA for Covaxin, Mr. Market has doubts. The FDA has never said it would not grant EUAs for vaccines. Instead, the agency has said that it will "decline to review and process" an EUA filing without an FDA review. That suggests that Ocugen has a steep uphill battle to win authorization for Covaxin in children.
A recent announcement from Ocugen indicates that it is continuing to build up its clinical data in the United States. Ocugen's submission for an EUA for Covaxin in children is the latest in a series of steps towards ensuring that this vaccine is available in the United States. The FDA's approval of Covaxin in adults was granted last month. In Canada, a similar decision was made on the safety and efficacy of the vaccine.
Ocugen's letter of intent with Liminal BioSciences for the acquisition of its manufacturing site
Ocugen, Inc., a biopharmaceutical company focusing on discovering, developing, and commercializing breakthrough gene therapies, has announced that it has signed a non-binding letter of intent to acquire a manufacturing facility from Liminal BioSciences, Inc. in Belleville, Ontario, Canada. The acquisition would provide Ocugen with the manufacturing capabilities necessary to expand its pipeline, research, and development efforts.
As previously disclosed, Ocugen has entered into an underwritten public offering of its common stock. The company expects to raise net proceeds of $50.0 million before estimated offering expenses, which will be used to support product candidate development and general corporate expenses. The company has $95.1 million in cash as of December 31, 2021, and approximately 199.4 million shares of common stock outstanding.
Ocugen's stock price reaction to recent events
Recently, Ocugen announced that its Covaxin shot is effective in children and reported strong trial results for Covaxin boosters against Omicron. Moreover, the company merged with Histogenics, which reported disappointing phase 3 clinical trials for its treatment of knee cartilage. While this merger helped Ocugen get into the market, it also resulted in the continued decline of Histogenics stock. By December 2019, the company's stock price was below $1, and its Nasdaq listing was threatened.
Ocugen's stock price reaction to news about the company's non-binding letter of intent with Liminal BioSciences, a publicly traded company from Canada, appears to be weighing on the company's share price. Despite the recent events, Wall Street analysts rate Ocugen's stock as a 'hold'. According to MarketBeat data, five analysts have a neutral view of the company, with one advocating buying and three opposing selling. Their average price target is $7.50.