Seagen (SGEN) Adcetris Label Expansion OK'd, New CEO Named

Seagen Inc. SGEN announced that the FDA approved its lead cancer drug, Adcetris (brentuximab vedotin), for a new indication.

Adcetris is now approved in combination with doxorubicin, vincristine, etoposide, prednisone and cyclophosphamide for treating pediatric patients aged two years and above with previously untreated high-risk classical Hodgkin lymphoma (cHL).

The latest FDA nod was based on data from a phase III study – AHOD1331 – conducted by the Children's Oncology Group and funded by the National Cancer Institute. Data from the same showed that treatment with Adcetris in combination with standard-of-care dose-intensive chemotherapy AVE-PC (adriamycin [doxorubicin], vincristine, etoposide, prednisone and cyclophosphamide) had superior event-free survival compared with patients who received standard of care chemotherapy ABVE-PC (Adriamycin [doxorubicin], bleomycin, vincristine, etoposide, prednisone and cyclophosphamide) alone.

Also, treatment with the Adcetris combo resulted in a 59% reduction in the risk of disease progression or relapse, second cancer or death in the given patient population.

Please note that the Adcetris label carries a boxed warning, which says that the JC virus infection resulting in progressive multifocal leukoencephalopathy and death can occur in patients treated with it.

Shares of Seagen have lost 15.2% so far this year compared with the industry’s decline of 21.2%

Image Source: Zacks Investment Research

Seagen’s top line mainly comprises contributions from Adcetris sales. The drug contributes to the majority of the company’s top line.

In the first nine months of 2022, Adcetris generated sales worth $601 million, reflecting an increase of 14% year over year. Successful label expansion of the drug is likely to boost sales further in the days ahead.

In a separate press release, SGEN announced that it has appointed David R. Epstein as the new chief executive officer (CEO) of the company.

In May 2022, Dr. Clay Siegall, Seagen’s former CEO, resigned from all his current positions. The company announced that Dr. Siegall was on a leave of absence after he was allegedly arrested for an incident of domestic violence.

Seagen is a leading developer of transformative cancer medicines, boasting a strong pipeline of innovative therapies.

Though the company is making good progress with its portfolio of marketed drugs, it remains to be seen whether the new CEO can continue the impressive growth trajectory and drive revenues further in future years.

Zacks Rank & Stocks to Consider

Seagen currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector are Aeglea BioTherapeutics, Inc. AGLE, Amarin Corporation plc AMRN and ASLAN Pharmaceuticals Limited ASLN, 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.

Loss per share estimates for Aeglea BioTherapeutics have narrowed 7.3% for 2022 and 13.2% for 2023 in the past 60 days.

Earnings of Aeglea BioTherapeutics surpassed estimates in two of the trailing four quarters and missed the same on the remaining two occasions. AGLE witnessed an earnings surprise of 3.60% on average.

Loss per share estimates for Amarin have narrowed 21% for 2022 and 50% for 2023 in the past 60 days.

Earnings of Amarin surpassed estimates in two of the trailing four quarters and missed the same on the other two occasions. AMRN witnessed a negative earnings surprise of 14.29% on average.

Loss per share estimates for ASLAN Pharmaceuticals have narrowed 6.1% for 2022 and 5.7% for 2023 in the past 60 days.

Earnings of ASLAN Pharmaceuticals surpassed estimates in two of the trailing four quarters and missed the mark on the remaining two occasions. ASLN witnessed an earnings surprise of 1.64% on average.

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