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VERVE THERAPEUTICS, INC.

(VERV)
  Report
Delayed Nasdaq  -  04:00:00 2023-02-01 pm EST
22.07 USD   -2.99%
02/01Cantor Fitzgerald Initiates Verve Therapeutics at Neutral With $21 Price Target
MT
01/09Transcript : Verve Therapeutics, Inc. Presents at 41st Annual J.P. Morgan Healthcare Conference, Jan-09-2023 04:30 PM
CI
01/03Verve Therapeutics to Present at the 41st Annual J.P. Morgan Healthcare Conference
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Verve Therapeutics Shares Tumble on FDA Study Hold Update

12/05/2022 | 10:37am EST

By Colin Kellaher


Shares of Verve Therapeutics Inc. slid more than 15% on Monday after the genetic-medicines company reported details of the U.S. Food and Drug Administration's clinical hold on planned studies of its lead drug candidate.

The Cambridge, Mass., company, which is seeking FDA approval for a U.S. study of Verve-101, the cardiovascular disease heterozygous familial hypercholesterolemia, said the agency has requested additional preclinical data relating to potency differences between human and non-human cells, risks of germline editing, and off-target analyses in non-hepatocyte cell types.

Verve said the FDA also requested available data from an ongoing Phase 1 study in New Zealand and the U.K., and that the agency wants the company to modify the U.S. trial protocol to incorporate additional contraceptive measures and to increase the length of the staggering interval between dosing of participants.

Verve, which filed in October for FDA approval of the planned study, in early November said it received notification of the hold, and that it expected an official letter with the FDA's questions within 30 days.

Verve on Monday said it plans to submit a response to the FDA as expeditiously as possible, adding that it expects to report initial safety and pharmacodynamic data from the dose-escalation portion of the New Zealand/U.K. study in the second half of 2023.

Verve shares were recently changing hands at $20.05, down more than 16%.


Write to Colin Kellaher at colin.kellaher@wsj.com


(END) Dow Jones Newswires

12-05-22 1036ET

All news about VERVE THERAPEUTICS, INC.
02/01Cantor Fitzgerald Initiates Verve Therapeutics at Neutral With $21 Price Target
MT
01/09Transcript : Verve Therapeutics, Inc. Presents at 41st Annual J.P. Morgan Hea..
CI
01/03Verve Therapeutics to Present at the 41st Annual J.P. Morgan Healthcare Conference
GL
01/03Verve Therapeutics to Present at the 41st Annual J.P. Morgan Healthcare Conference
GL
2022Goldman Sachs Initiates Verve Therapeutics at Sell With $13 Price Target
MT
2022Verve Therapeutics Shares Tumble on FDA Study Hold Update
DJ
2022Sector Update: Health Care Stocks Flat to Lower Pre-Bell Monday
MT
2022Verve Therapeutics Receives FDA Request to Remedy Clinical Hold on VERVE-101 Study
MT
2022Verve Therapeutics, Inc. : Other Events (form 8-K)
AQ
2022Verve Therapeutics to Participate in Upcoming Investor Conferences
GL
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Analyst Recommendations on VERVE THERAPEUTICS, INC.
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Financials (USD)
Sales 2022 1,02 M - -
Net income 2022 -158 M - -
Net cash 2022 332 M - -
P/E ratio 2022 -7,31x
Yield 2022 -
Capitalization 1 360 M 1 360 M -
EV / Sales 2022 1 005x
EV / Sales 2023 663x
Nbr of Employees 113
Free-Float 90,1%
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Technical analysis trends VERVE THERAPEUTICS, INC.
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Income Statement Evolution
Consensus
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Mean consensus OUTPERFORM
Number of Analysts 11
Last Close Price 22,07 $
Average target price 42,40 $
Spread / Average Target 92,1%
EPS Revisions
Managers and Directors
Sekar Kathiresan Chief Executive Officer & Director
Andrew D. Ashe President, Chief Operating & Financial Officer
Allison Dorval Chief Financial Officer
Burt A. Adelman Chairman
Andrew Bellinger Chief Scientific & Medical Officer
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