- Thinly traded ADMA Biologics (ADMA +14.4%) perks up on double normal volume, albeit on only 60K shares, in response to its progress in getting an acquired biologics manufacturing facility back on track after upgrades and renovations and relaunching key products.
- In a letter to shareholders, founder and CEO Adam Grossman says the Boca Raton, FL site should be "inspection ready" in about six months when it completes the work required to resolve GMP-related issues cited in a July 2016 FDA Warning Letter.
- The facility will produce BIVIGAM and Nabi-HB (Hepatitis B Immune Globulin, Human). BIVIGAM production was shut down by previous owner Biotest Pharmaceuticals in order to upgrade and renovate the site. BIVIGAM accounted for $50M of the $76.5M in 2016 sales from the Boca location.
- Mr. Grossman adds that his team expects to refile the Biologics License Application (BLA) for lead candidate RI-002 by mid-2018. RI-002 is derived from human plasma blended from normal donors and donors known to have high titers of RSV antibodies. The final product has naturally occurring antibodies against strep,flu, CMV, measles and tetanus. It will be used to prevent infections in immune-compromised patients.
- Previously: ADMA Biologics to acquire certain assets from Biotest Pharmaceuticals (Jan. 23)
- Now read: Repligen Corporation (RGEN) Updates On Merger Agreement with Spectrum - M&A Slideshow
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