Ocugen, Inc. OCGN announced that Health Canada has provided it a No Objection Letter to initiate the phase III liMeliGhT study evaluating its modifier gene therapy product candidate, OCU400, for treating retinitis pigmentosa (RP).
Shares of OCGN were up 4.6% on Aug. 26 following the announcement of the news.
Ocugen has already received clearance from the FDA to initiate a phase III study on OCU400 for the treatment of RP, a rare genetic disorder that can lead to vision loss and blindness.
The FDA had previously granted orphan drug and regenerative medicine advanced therapy designation to OCU400 for treating RP.
The study in Canada will run simultaneously with the study in the United States, which is aimed at offering a gene-agnostic treatment option for patients in the United States and Canada. Per the company, there are around 10,000 patients in Canada and 1.6 million patients worldwide with RP. Hence, the study is likely to help reach a broader patient population encompassing many gene mutations associated with RP.
OCGN Stock Outperforming Industry
Shares of Ocugen have skyrocketed 136.6% so far this year against the industry’s decline of 0.2%.
Image Source: Zacks Investment Research
Earlier this month, the company reported its second-quarter results and announced updates on its pipeline candidates, including OCU400.
OCGN is dosing subjects in the phase III liMeliGhT study investigating OCU400 for the treatment of RP. The disease is associated with mutations in more than 100 genes.
The phase III study will enroll 150 participants into two study arms. One study arm will constitute 75 participants with RHO gene mutations and the other will have 75 participants who are gene agnostic.
The primary endpoint of the study is the Luminance Dependent Navigation Assessment.
RP Market Holds Potential for OCGN
The RP market represents significant potential. Per the company, there is only a single marketed product to treat one of the 100 gene mutations associated with RP, and the gene-agnostic mechanism of action for OCU400 provides hope for a much larger RP patient population.
As of June 30, 2024, Ocugen’s cash, cash equivalents and restricted cash were $16 million. This is expected to extend the company’s cash runaway into the third quarter of 2025.
Zacks Rank & Stocks to Consider
Ocugen currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Illumina, Inc. ILMN and Fulcrum Therapeutics, Inc. FULC, each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Illumina’s 2024 earnings per share have moved up from $1.07 to $3.16. Earnings per share estimates for 2025 have improved from $2.93 to $4.50. Year to date, shares of ILMN have lost 6.3%.
ILMN’s earnings beat estimates in each of the trailing four quarters, the average surprise being 463.46%.
In the past 60 days, estimates for Fulcrum Therapeutics’ 2024 loss per share have narrowed from $1.24 to 48 cents. Loss per share estimates for 2025 have narrowed from $1.71 to $1.51. Year to date, shares of FULC have jumped 44.3%.
FULC’s earnings beat estimates in each of the trailing four quarters, the average surprise being 393.18%.
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