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Ocugen (OCGN) Stock Down as FDA Puts Hold on Covaxin Study
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Ocugen’s (OCGN - Free Report) stock declined 3.8% on Tuesday after the FDA placed a clinical hold on a phase II/III immuno-bridging and broadening clinical study on its COVID-19 vaccine, Covaxin.
Ocugen had already voluntarily paused dosing in the phase II/III OCU-002 study temporarily after inspection of its India-based partner Bharat Biotech’s manufacturing facility by World Health Organization (WHO). The WHO identified some deficiencies in good manufacturing practices (GMP) at the facility. As a result, Bharat Biotech suspended the production of Covaxin for export.
Covaxin (BBV152) was developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) — National Institute of Virology (NIV). Ocugen is co-developing Covaxin with Bharat Biotech for the U.S. and Canadian markets. Covaxin is already authorized in India as well as several other countries outside the United States.
Ocugen is conducting the OCU-002 study to support its biologics license application for the approval of Covaxin in the United States. The company is seeking full approval for the use of Covaxin in adults following a discussion with the FDA.
The stock has declined 38.7% this year so far against the industry’s decrease of 13.7%.
Ocugen has faced several roadblocks in its attempt to bring Covaxin to the U.S. markets. In February, the FDA lifted a clinical hold that it had earlier placed on the Covaxin investigational new drug application (IND), clearing the way to begin the OCU-002 study.
Last month, the FDA declined to issue an emergency use authorization (EUA) to Covaxin for allowing the use of Covaxin in the pediatric population aged from two to 18 years. The pediatric EUA submission was based on data (in-vitro), which demonstrated Covaxin’s robust neutralization against Delta and Omicron variants of the virus. Meanwhile, at the FDA’s request, Ocugen also shared real-world safety data from 36 million teenagers who had been vaccinated with Covaxin.
Pfizer (PFE - Free Report) /BioNTech (BNTX - Free Report) and Moderna (MRNA - Free Report) lead the race for successfully developing mRNA-based COVID-19 vaccines. Last month, the FDA authorized a second booster dose of Pfizer and BioNTech and Moderna’s mRNA-based COVID-19 vaccines for older adults and some immunocompromised people.
The second booster dose of Pfizer and BioNTech and Moderna’s vaccine can be given to people 50 years of age and older at least four months after they have taken the first booster dose of any authorized or approved COVID-19 vaccine.
Pfizer/BioNTech and Moderna’s first booster doses were granted EUA for all adults 18 years of age and older in November 2021. Later, Pfizer’s EUA was extended to allow its use in individuals 16 and 17 years of age and thereafter in adolescents 12 to 15 years of age.
Image: Bigstock
Ocugen (OCGN) Stock Down as FDA Puts Hold on Covaxin Study
Ocugen’s (OCGN - Free Report) stock declined 3.8% on Tuesday after the FDA placed a clinical hold on a phase II/III immuno-bridging and broadening clinical study on its COVID-19 vaccine, Covaxin.
Ocugen had already voluntarily paused dosing in the phase II/III OCU-002 study temporarily after inspection of its India-based partner Bharat Biotech’s manufacturing facility by World Health Organization (WHO). The WHO identified some deficiencies in good manufacturing practices (GMP) at the facility. As a result, Bharat Biotech suspended the production of Covaxin for export.
Covaxin (BBV152) was developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) — National Institute of Virology (NIV). Ocugen is co-developing Covaxin with Bharat Biotech for the U.S. and Canadian markets. Covaxin is already authorized in India as well as several other countries outside the United States.
Ocugen is conducting the OCU-002 study to support its biologics license application for the approval of Covaxin in the United States. The company is seeking full approval for the use of Covaxin in adults following a discussion with the FDA.
The stock has declined 38.7% this year so far against the industry’s decrease of 13.7%.
Ocugen has faced several roadblocks in its attempt to bring Covaxin to the U.S. markets. In February, the FDA lifted a clinical hold that it had earlier placed on the Covaxin investigational new drug application (IND), clearing the way to begin the OCU-002 study.
Last month, the FDA declined to issue an emergency use authorization (EUA) to Covaxin for allowing the use of Covaxin in the pediatric population aged from two to 18 years. The pediatric EUA submission was based on data (in-vitro), which demonstrated Covaxin’s robust neutralization against Delta and Omicron variants of the virus. Meanwhile, at the FDA’s request, Ocugen also shared real-world safety data from 36 million teenagers who had been vaccinated with Covaxin.
Pfizer (PFE - Free Report) /BioNTech (BNTX - Free Report) and Moderna (MRNA - Free Report) lead the race for successfully developing mRNA-based COVID-19 vaccines. Last month, the FDA authorized a second booster dose of Pfizer and BioNTech and Moderna’s mRNA-based COVID-19 vaccines for older adults and some immunocompromised people.
The second booster dose of Pfizer and BioNTech and Moderna’s vaccine can be given to people 50 years of age and older at least four months after they have taken the first booster dose of any authorized or approved COVID-19 vaccine.
Pfizer/BioNTech and Moderna’s first booster doses were granted EUA for all adults 18 years of age and older in November 2021. Later, Pfizer’s EUA was extended to allow its use in individuals 16 and 17 years of age and thereafter in adolescents 12 to 15 years of age.
Ocugen currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.