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Lilly's (LLY) Tyvyt BLA Accepted for Review by FDA for NSCLC (Revised)

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Eli Lilly and Company LLY announced that the FDA has accepted for review its biologics license application (BLA) seeking approval for sintilimab injection for the first-line treatment of nonsquamous non-small cell lung cancer (NSCLC). The BLA, which was submitted in March, seeks approval of sintilimab in combination with pemetrexed and platinum chemotherapy.

The FDA is expected to give its decision in March 2022 and plans to hold Advisory Committee meeting to discuss this application. The BLA filing was based on data from the phase III ORIENT-11 study.

Sintilimab, a PD-1 inhibitor, is marketed by the brand name of Tyvyt in China by Lilly in collaboration with the country’s biopharmaceutical company, Innovent. The drug is approved in China for second or later line relapsed or refractory classic Hodgkin's lymphoma and also for first-line treatment of nonsquamous NSCLC. The latest BLA filing is the first regulatory submission of sintilimab in the United States and outside of China. Tyvyt is also being evaluated in several other cancer types.

Lilly’s shares have risen 15.8% this year so far compared with the industry’s increase of 6.5%.

Lilly currently has a Zacks Rank #4 (Sell).

You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Some better-ranked stocks in the healthcare sector are BioNTech BNTX, Atea Pharmaceuticals AVIR Repligen Corporation RGEN. While BioNTech has a Zacks Rank of 1, the other two companies carry a Zacks Rank #2 (Buy).

BioNTech’s earnings estimates have risen from $10.91 per share to $29.44 per share for 2021 and from $7.34 per share to $21.34 per share for 2022 in the past 60 days. The stock is up 143.2% this year so far.

Atea’s earnings per share estimates have increased from $3.70 to $8.37 for 2021 and from $16.14 to $17.21 for 2022 over the past 60 days.

Repligen’s earnings estimates have risen from $1.91 to $2.21 for 2021 and from $2.23 to $2.53 for 2022 over the past 60 days.

(We are reissuing this article to correct a mistake. The original article, issued on May 18, 2021, should no longer be relied upon.)

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Eli Lilly and Company (LLY) : Free Stock Analysis Report

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