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Coherus' (CHRS) Toripalimab Gets Orphan Drug Tag for Rare Cancer
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Coherus BioSciences, Inc. (CHRS - Free Report) and its partner Shanghai Junshi Biosciences Co., Ltd. have announced that the FDA has granted an Orphan Drug designation to their anti-PD-1 antibody, toripalimab, for the treatment of esophageal cancer (“EC”), a rare and aggressive type of cancer.
The Orphan Drug designation is granted to drugs that are capable of treating rare diseases in the United States. This tag also entitles the company to certain other benefits and incentives to advance the development and commercialization of rare disease drugs upon potential approval.
Coherus and Junshi Biosciences are planning to submit a biologics license application supplement for toripalimab to treat EC next year.
In September 2021, the companies announced positive data from the placebo-controlled phase III JUPITER-06 study that evaluated toripalimab in combination with chemotherapy as a first-line treatment for patients with advanced or metastatic esophageal squamous cell carcinoma (ESCC). The study met the co-primary endpoints by demonstrating statistically significant and clinically meaningful improvements in progression-free survival and overall survival.
Shares of Coherus were up 1.6% on Monday following the announcement of the news. The stock has rallied 8.9% so far this year against the industry’s decrease of 14.2%.
Image Source: Zacks Investment Research
We note that, apart from esophageal cancer, toripalimab is also being evaluated in late-stage studies in lung, liver, breast, kidney, bladder, stomach and skin cancers.
The BLA for toripalimab for treating advanced recurrent or metastatic nasopharyngeal carcinoma is currently under priority review in the United States with a decision from the FDA expected in April 2022.
Please note that Coherus in-licensed the rights to develop/commercialize toripalimab in the United States and Canada earlier this year from Junshi Biosciences.
Toripalimab is approved in China as Tuoyi for treating different types of cancer indications.
Image: Bigstock
Coherus' (CHRS) Toripalimab Gets Orphan Drug Tag for Rare Cancer
Coherus BioSciences, Inc. (CHRS - Free Report) and its partner Shanghai Junshi Biosciences Co., Ltd. have announced that the FDA has granted an Orphan Drug designation to their anti-PD-1 antibody, toripalimab, for the treatment of esophageal cancer (“EC”), a rare and aggressive type of cancer.
The Orphan Drug designation is granted to drugs that are capable of treating rare diseases in the United States. This tag also entitles the company to certain other benefits and incentives to advance the development and commercialization of rare disease drugs upon potential approval.
Coherus and Junshi Biosciences are planning to submit a biologics license application supplement for toripalimab to treat EC next year.
In September 2021, the companies announced positive data from the placebo-controlled phase III JUPITER-06 study that evaluated toripalimab in combination with chemotherapy as a first-line treatment for patients with advanced or metastatic esophageal squamous cell carcinoma (ESCC). The study met the co-primary endpoints by demonstrating statistically significant and clinically meaningful improvements in progression-free survival and overall survival.
Shares of Coherus were up 1.6% on Monday following the announcement of the news. The stock has rallied 8.9% so far this year against the industry’s decrease of 14.2%.
We note that, apart from esophageal cancer, toripalimab is also being evaluated in late-stage studies in lung, liver, breast, kidney, bladder, stomach and skin cancers.
The BLA for toripalimab for treating advanced recurrent or metastatic nasopharyngeal carcinoma is currently under priority review in the United States with a decision from the FDA expected in April 2022.
Please note that Coherus in-licensed the rights to develop/commercialize toripalimab in the United States and Canada earlier this year from Junshi Biosciences.
Toripalimab is approved in China as Tuoyi for treating different types of cancer indications.
Zacks Rank & Stocks to Consider
Coherus currently carries a Zacks Rank #4 (Sell).
Better-ranked stocks in the biotech sector include Galera Therapeutics, Inc. (GRTX - Free Report) , vTv Therapeutics Inc. (VTVT - Free Report) and Editas Medicine, Inc. (EDIT - Free Report) , all carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Galera Therapeutics’ loss per share estimates have narrowed 19.5% for 2021 and 32.3% for 2022, over the past 60 days.
Earnings of Galera Therapeutics have surpassed estimates in only one of the trailing four quarters, and missed the same on the other three occasions.
vTv Therapeutics’ loss per share estimates have narrowed 21.7% for 2021 and 2.9% for 2022, over the past 60 days.
vTv Therapeutics’ earnings have surpassed estimates in three of the trailing four quarters and missed the same on the other occasion.
Editas Medicine’s loss per share estimates have narrowed 11.9% for 2021 and 4.1% for 2022, over the past 60 days.
Editas Medicine’s earnings have surpassed estimates in two of the trailing four quarters and missed the same on the other two occasions.