Prestige Management Doubles Down On Share Purchase After Setbacks
Recent Fall In Stock Price ‘Doesn’t Reflect Potential Value’ Insists CEO
Still reeling from the EMA’s recent rejection of its biosimilar trastuzumab candidate, Prestige BioPharma’s management have bought up more shares in the company, insisting that the “recent fall in stock price doesn’t reflect the potential value” of the firm.
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Prestige Pulls Trastuzumab After EMA Knockback
Prestige Biopharma has formally withdrawn its marketing authorization application for its Tuznue (trastuzumab) biosimilar candidate, following a negative opinion from the EMA’s CHMP as well as a requested re-examination.
EMA Re-Examines Decisions On Prestige’s Trastuzumab And Synchron Studies
Following decisions by the EMA’s CHMP to deny Prestige Biopharma a marketing authorization for its trastuzumab biosimilar and to suspend the marketing authorizations of dozens of generics due to concerns over bioequivalence tests, the European regulator has confirmed it will review the opinions.
Phase III Data And GMP Nod Bring Prestige’s Trastuzumab Closer To Launch
Prestige BioPharma says its proposed Tuznue trastuzumab rival to Herceptin is moving closer to launch in global markets, after reporting positive Phase III data for the biosimilar as well as a European GMP certification for its manufacturing facility in Korea.