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MarketScreener Homepage  >  Equities  >  Nasdaq  >  Immunomedics, Inc.    IMMU


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Immunomedics : drug Trodelvy extends survival in breast cancer patients

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09/19/2020 | 11:30am EDT

Sept 19 (Reuters) - Immunomedics Inc's cancer drug Trodelvy, which received accelerated U.S. regulatory approval in April, extended survival time in previously treated patients with an advanced form of breast cancer in a clinical trial, the company said on Saturday.

The positive new data could improve Immunomedics' chances of winning full U.S. Food and Drug Administration (FDA) approval for Trodelvy, the lead drug of the Morris Plains, New Jersey-based cancer drugmaker. Immunomedics is being acquired by Gilead Sciences Inc for $21 billion under a deal announced on Sept. 14.

The FDA granted the drug accelerated approval for its use in metastatic triple-negative breast cancer (mTNBC) patients who had previously received at least two prior therapies. Its continued approval is contingent upon the FDA's verification of a clinical benefit in confirmatory trials.

Trodelvy reduced the risk of death by 52 percent, with a median overall survival of 12.1 months for patients receiving the drug in the late-stage confirmatory trial compared to 6.7 months for patients receiving chemotherapy, Immunomedics said.

Immunomedics said it would file for full FDA approval of Trodelvy in the fourth quarter under the FDA's Real-Time Oncology Review (RTOR) process that allows the agency to review the data before the company submits its marketing application.

Trodelvy is an antibody-drug conjugate that delivers an anti-cancer drug called SN-38 directly to cancer cells by binding to a protein called Trop-2 found on their surface.

It is also being tested in multiple ongoing clinical trials for its potential use against urothelial cancer, non-small cell lung cancer and other forms of breast cancer, the company said.

Trodelvy's current label carries a boxed warning - the FDA's harshest - that flags risks of severe diarrhea and neutropenia, an abnormally low count of a type of white blood cells.

The results were due to be presented at the European Society for Medical Oncology meeting on Saturday, the company said.

(Reporting by Manojna Maddipatla in Bengaluru; Editing by Will Dunham)

Stocks mentioned in the article
ChangeLast1st jan.
GILEAD SCIENCES, INC. -0.65% 58.15 Delayed Quote.-10.51%
IMMUNOMEDICS, INC. 0.05% 87.86 End-of-day quote.315.22%
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Financials (USD)
Sales 2020 146 M - -
Net income 2020 -235 M - -
Net cash 2020 480 M - -
P/E ratio 2020 -84,5x
Yield 2020 -
Capitalization 20 324 M 20 324 M -
EV / Sales 2020 136x
EV / Sales 2021 58,1x
Nbr of Employees -
Free-Float 97,7%
Duration : Period :
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Behzad Aghazadeh Executive Chairman
Usama Malik Chief Financial & Business Officer
Loretta M. Itri Chief Medical Officer
Peter Barton Hutt Independent Director
Scott A. Canute Executive Director
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