Immunomedics, Inc. (NASDAQ:IMMU) incurred a loss of 50 cents per share in fourth-quarter 2019, wider than the Zacks Consensus Estimate of a loss of 45 cents but in line with the loss incurred in the year-ago quarter.
Total revenues were $0.3 million in the quarter, including service fee revenues earned related to the Janssen Promotion agreement.
Total costs and expenses were $91.5 million in the fourth quarter compared with $87.4 million a year ago, mainly due to increase in research & development expenses — mostly attributable to activities related to preparations for the approval and commercial launch of sacituzumab govitecan for patients with at least two prior lines of treatment for metastatic triple-negative breast cancer(mTNBC) in the United States — as well as CRL remediation costs.
Shares of Immunomedics have decreased 0.6% in the past year compared with the industry’s 10% decline.
Pipeline Update
The company resubmitted biologics license application (BLA) seeking accelerated approval for sacituzumab govitecan in mTNBC, which was accepted for filing by the FDA with an action date of Jun 2, 2020.
During the quarter, it initiated the phase 3 registrational TROPiCS-02 study of sacituzumab govitecan in hormone receptor-positive/human epidermal growth factor receptor 2-negative (HER2) metastatic breast cancer.
The company continues to expand clinical collaborations to move sacituzumab govitecan into earlier lines of therapy in breast cancer, including the combination with Roche Holding (SIX:ROG) AG’s (OTC:RHHBY) Tecentriq in frontline mTNBC and the German Breast Group’s phase III study in the curative setting of HER2 breast cancer as a single-agent.
The company also initiated the multi-cohort, Trop-2-enriched phase II TROPiCS-03 study of sacituzumab govitecan for patients with metastatic non-small cell lung cancer.
Milestones for 2020
Immunomedicsexpects to report top-line data from the phase III confirmatory ASCENT study at around mid-2020.
It also expects to report top-line data from full cohort of 100 patients with prior platinum-based and immune checkpoint inhibitor therapies from the phase II pivotal TROPHY U-01 study.
The company expects to complete enrollment for the 40-patient cohort of cisplatin-ineligible patients in TROPHY U-01.
Zacks Rank & Other Stocks to Consider
Immunomedics currently has a Zacks Rank #2 (Buy).
Other top-ranked stocks in the biotech sector include Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) and Agenus Inc. (NASDAQ:AGEN) . While Regeneron sports a Zacks Rank #1 (Strong Buy), Agenus carries a Zacks Rank #2. You can see the complete list of today’s Zacks #1 Rank stocks here.
Regeneron’s earnings per share estimates have moved up from $26.76 to $28.31 for 2020 and from $28.61 to $28.93 for 2021 in the past 90 days. The company delivered an average positive earnings surprise of 1.44% in three of the trailing four quarters.
Agenus’ loss per share estimates for 2020 have narrowed from $1.37 to $1.25 in the past 60 days. The company delivered a four-quarter positive earnings surprise of 23.79%, on average.
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Regeneron Pharmaceuticals, Inc. (REGN): Free Stock Analysis Report
Roche Holding AG (RHHBY): Free Stock Analysis Report
Immunomedics, Inc. (IMMU): Free Stock Analysis Report
Agenus Inc. (AGEN): Free Stock Analysis Report
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