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OFFON

LONGEVERON INC.

(LGVN)
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Longeveron Shares Soar 120% on Key FDA Designation

11/18/2021 | 11:13am EST

By Colin Kellaher

Shares of Longeveron Inc. more than doubled on Thursday after the clinical-stage biotechnology company received a key U.S. Food and Drug Administration designation for its lead program.

The Miami company said the FDA granted rare-pediatric-disease designation to Lomecel-B for the treatment of a rare congenital heart defect in infants known as hypoplastic left-heart syndrome.

Drugmakers who eventually win FDA approval of a drug granted the rare-pediatric-disease designation receive priority-review vouchers, which they can use to obtain priority review for another drug or sell to other companies.

Mirum Pharmaceuticals Inc., which in September won a priority-review voucher upon FDA approval of its cholestatic pruritus drug Livmarli for patients with Alagille syndrome, on Wednesday said it agreed to sell the voucher for $110 million.

Longeveron is currently conducting a Phase 2 trial of Lomecel-B in hypoplastic left-heart syndrome and is also studying the drug in aging frailty, Alzheimer's disease and flu- and Covid-related acute respiratory distress syndrome.

Longeveron went public in February at $10 a share, and the stock rose as high as $12.48 in March after the FDA approved Lomecel-B for compassionate use for the treatment of a child with hypoplastic left heart syndrome.

However, the shares had fallen back since then amid disappointing study results, hitting a 52-week low of $2.84 on Wednesday.

In recent trading Thursday, Longeveron shares were up 120% to $6.42.

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

(END) Dow Jones Newswires

11-18-21 1113ET

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Financials (USD)
Sales 2021 1,30 M - -
Net income 2021 -17,8 M - -
Net Debt 2021 - - -
P/E ratio 2021 -7,46x
Yield 2021 -
Capitalization 143 M 143 M -
Capi. / Sales 2021 110x
Capi. / Sales 2022 151x
Nbr of Employees 12
Free-Float -
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Number of Analysts 1
Last Close Price 7,05 $
Average target price 20,00 $
Spread / Average Target 184%
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Managers and Directors
Geoff Green Senior Vice President-Clinical Operations
James Clavijo Chief Financial Officer & Treasurer
Joshua M. Hare Chairman & Chief Scientific Officer
Rock Soffer Independent Director
Donald M. Soffer Independent Director
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