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ADMA Biologics outlook rosy after manufacturing facility gets FDA compliance approval, says Baird report

FDA update will allow the company to ramp up production of its drugs

Hospital workers
ADMA Biologics is a commercial biopharmaceutical company.

ADMA Biologics Inc (NASDAQ:ADMA) stock should move higher now that it has passed an FDA inspection and is in position to ramp up production of an intravenous solution for people with immunodeficiency disease, a report by Oppenheimer Equity Research said on Wednesday.

Analyst Leland Gershell said in a research note to clients the announcement by the FDA "provides confirmation that ADMA's biologics manufacturing plant has been upgraded" to VAI (voluntary action indicated) status.

"This update provides us additional comfort that ADMA's manufacturing remediation is adequate to support approval of both Bivigam (10/25/18 PDUFA) and RI-002 (BLA to be re-filed by EO3Q)," Gershell said.

The company develops treatments such as Bivigam and RI-002 for patients who suffer humoral immunodeficiency disease. 

Gershell said in the note they would "reiterate our Outperform rating and US$13 PT (price target), and expect the shares to continue their upward move as ADMA achieves its near-term milestones."

ADMA Biologics stock gained 6.2% to US$6.86 in late trade on Wednesday.

ADMA Biologics is a commercial biopharmaceutical company that manufactures, markets and develops specialty plasma-based biologics for the treatment of Primary Immune Deficiency Disease (PIDD) and the prevention and treatment of certain infectious diseases.

The company is based in Ramsey, New Jersey, and Boca Raton, Florida.

 

 

 

Quick facts: ADMA Biologics Inc

Price: 3.51 USD

NASDAQ:ADMA
Market: NASDAQ
Market Cap: $208.21 m
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