Agenus (AGEN) Initiates Rolling BLA Submission of Balstilimab

Agenus Inc. AGEN announced that it has initiated the rolling submission of its biologics license application (BLA) to the FDA for balstilimab alone for the treatment of recurrent/metastatic cervical cancer. Balstilimab is a novel anti-PD-1 human monoclonal antibody that has demonstrated promising clinical benefit in the second-line treatment of cervical cancer.

However, shares of Agenus have gained 27.3% year to date compared with the industry’s growth of 2.9%.


Agenus recently reported positive results from two independent phase II studies at the 2020 European Society for Medical Oncology (ESMO) Virtual Congress. Data showed that in patients with recurrent/metastatic cervical cancer, the PD-1 inhibitor balstilimab monotherapy or combined with the CTLA-4 inhibitor zalifrelimab demonstrated promising objective response rates (ORRs), irrespective of the patients PD-L1 status, plus a tolerable safety profile. In April 2020, the FDA granted Fast Track designation to balstilimab alone and in combination with zalifrelimab for this indication.

Data from more than 160 patients treated with balstilimab monotherapy achieved response rates of 19% in PD-L1 positive patients and 14% in all treated patients and will support the balstilimab BLA filing. Data from 155 patient balstilimab + zalifrelimab combination study achieved response rates of 22% in all patients and 27% in PD-L1 positive patients. These results demonstrate that both single-agent balstilimab and the balstilimab + zalifrelimab combination are effective and well tolerated in the second-line treatment of patients with recurrent/metastatic cervical cancer.

A rolling submission allows Agenus to submit each section of the BLA as it is completed, which enables the FDA to review the submitted sections in parallel with Agenus’ completion of the balance of the BLA application.

In June 2020, Agenus entered into an exclusive collaboration and license agreement with Betta Pharmaceuticals (SZ300558), a top Chinese pharmaceutical company, for the development and commercialization of balstilimab and zalifrelimab in Greater China, including Mainland China, Hong Kong, Macau and Taiwan.

Zacks Rank & Stocks to Consider

Agenus currently carries a Zacks Rank #3 (Hold).

Some other top-ranked stocks in the healthcare sector include Emergent Biosolutions Inc. EBS, Bio Techne Corp TECH and Alimera Sciences Inc. ALIM. While Emergent sports a Zacks Rank #1, Bio Techne and Alimera carry 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 $4.23to $6.58 for 2020 and from $5.55 to $7.62 for 2021 over the past 60 days. Shares of the company have increased 86.4% year to date.

Bio Techne’s earnings estimates have increased from $5.33 to $5.48 for 2020 and from $6.41 to $6.50 for 2021 over the past 60 days. Shares of the company have increased 11.1% year to date.

Alimera’s loss per share estimates have narrowed from $2.33 to $1.31 for 2020 and from 63 cents to 52 cents for 2021 over the past 60 days. Shares of the company have decreased 24.8% year to date.


Agenus Inc. Price

Agenus Inc. Price

Agenus Inc. price | Agenus Inc. Quote

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