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LLY

Eli Lilly

$139.20 /

+0.82 (+0.59%)

06:51
01/29/20
01/29
06:51
01/29/20
06:51

Eli Lilly receives priority review from FDA for selpercatinib NDA

Eli Lilly announced that the FDA has granted priority review for the new drug application, or NDA, for selpercatinib, or LOXO-292, for the treatment of patients with advanced RET fusion-positive non-small cell lung cancer, or NSCLC, RET-mutant medullary thyroid cancer, or MTC, and RET fusion-positive thyroid cancer. The NDA is based on data from the LIBRETTO-001 Phase 1/2 trial in RET-altered lung and thyroid cancers. The FDA has filed the NDA and set a Prescription Drug User Fee Act date in Q3. In December of 2019, Lilly opened two selpercatinib Phase 3 trials: LIBRETTO-431 for patients with treatment-naive RET fusion-positive NSCLC, and LIBRETTO-531 for patients with treatment-naive RET-mutant MTC. Each trial will enroll 400 patients.

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LLY Eli Lilly
$139.20 /

+0.82 (+0.59%)

01/23/20 H.C. Wainwright
Dermira downgraded to Neutral from Buy at H.C. Wainwright
01/13/20 Piper Sandler
Partnership termination not a negative for NextCure N318, says Piper Sandler
01/08/20 Piper Sandler
Eli Lilly still has edge over Blueprint in RET+ lung cancer, says Piper Sandler
12/30/19 Argus
Eli Lilly price target raised to $165 from $145 at Argus

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General Mills

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Consumer Goods Analysts Miller-Regan and Lavery, along with Bob Goldin, Co-Founder & Senior Partner of Pentallect, Inc., discuss the restaurant, food service and food distribution supply environment industry on an Analyst/Industry conference call to be held on March 31 at 11:40 am.

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LatAm Utilities Analyst Abdalla provides an update on the Electric/Other Utilities Industries on an Analyst/Industry conference call to be held on March 31 at 9 am.

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Vonage

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Conference call with CEO Masarek and CFO Pearson will be held on March 31 at 1 pm hosted by Stephens.

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Summit Wireless

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Special Shareholder Meeting to approve an amendment to the Company's Certificate of Incorporation to effect a reverse stock split of all of the outstanding shares of common stock will be held in Hillsboro, Oregon on March 31 at 5 pm.

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