Immunomedics, Inc. announced that the FDA has granted orphan drug status to its lead product candidate,Trodelvy (sacituzumabgovitecan-hziy), for the treatment of adult and pediatric patients with glioblastoma. Glioblastoma is an aggressive cancer that can occur in the brain or spinal cord.
Notably, orphan drug designation is granted to drugs that are capable of treating rare diseases that affect less than 200,000 people in the United States. This tag also makes the company entitled to certain other benefits, including tax credits related to clinical trial expenses, an exemption from the FDA user fee and a designated period of market exclusivity following approval.
Shares of Immunomedics have surged 306.9% year to date compared with the
industry’s growth of 2.6%.
We note that Trodelvy is a first-in-class Trop-2 directed antibody-drug conjugate (ADC) for the treatment of adult patients with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies for metastatic disease. This indication was approved under accelerated approval based on tumor response rate and duration of response. Immunomedics plans to submit a biologics license application (sBLA) to support the full approval of Trodelvy in the United States for the treatment of mTNBC in the fourth quarter of 2020 under the RTOR program. The company also plans to submit a marketing authorization application (MAA) to the European Medicines Agency in the first half of 2021.
In September 2020, the company announced results from a single-center study, wherein patients with brain metastasis from breast cancer (BMBC) or recurrent glioblastoma (rGBM) were enrolled to receive a single intravenous dose of Trodelvy at 10 mg/kg one day before surgical resection. Tumor and corresponding serum were collected during surgery to measure their levels of SN-38 and the metabolites. In the study, Trodelvy delivered 150-fold and 40-fold the 50% inhibitory concentration (IC50) of SN-38 for BMBC and rGBM, respectively, and produced partial responses in both cohorts of brain cancer patients.
Zacks Rank & Other Stocks to Consider
Immunomedics currently carries a Zacks Rank #2 (Buy).
Some other top-ranked stocks in the healthcare sector include Emergent Biosolutions Inc. (
EBS Quick Quote EBS - Free Report) , Castle Biosciences, Inc. ( CSTL Quick Quote CSTL - Free Report) and AVEO Pharmaceuticals Inc. ( AVEO Quick Quote AVEO - Free Report) . While Emergent and Castle Biosciences sport a Zacks Rank #1 (Strong Buy), AVEO carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here .
Emergent’s earnings estimates have increased from $4.03 to $6.61 for 2020 and from $5.07 to $8.42 for 2021 over the past 90 days. Shares of the company have increased 106.6% year to date.
Castle Biosciences’ loss per share estimates have narrowed from 51 cents to 11 cents for 2020 over the past 90 days. Shares of the company have increased 183.4% year to date.
AVEO’s loss per share estimates have narrowed from $1.68 to $1.25 for 2020 and from $1.71 to $1.22 for 2021 over the past 60 days. Shares of the company have increased 5.8% year to date.
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