Specialty pharmaceuticals is a unique niche in the pharma sector. Where companies like Eli Lilly pour billions into developing a drug candidate from scratch with the very real possibility that the drug will fail during trials and never make it to market, specialty pharma companies, like Medexus Pharmaceuticals (MDP.T), find already approved drugs from other jurisdictions and bring them to the North America market. Drug development risk averted.
Today the Company announced that the US Food and Drug Administration (FDA) recently approved Medexus’s supplemental Biologics License Application (sBLA) for IXINITY® [coagulation factor IX (recombinant)] for the on-demand, prophylactic, and perioperative treatment of pediatric patients under 12 years of age with hemophilia B. IXINITY®, an intravenous recombinant factor IX therapeutic, is now approved for use in all patients with hemophilia B, a hereditary bleeding disorder characterized by a deficiency of clotting factor IX in the blood.
“We are pleased to secure approval for IXINITY for use in pediatric patients, a population that comprises approximately one third of individuals with hemophilia B in the United States*,” said Ken d’Entremont, Chief Executive Officer of Medexus. “The newly expanded indication makes IXNITY a viable factor IX option for children living with hemophilia B. We hope the greater availability of IXINITY will help ease the burden on children and families who face the challenge of managing hemophilia B and allow children living with this lifelong condition to enjoy more active lives.”
“IXINITY effectively prevented and controlled bleeding episodes in the Phase 3/4 pediatric study,” commented Prof Johnny Mahlangu, BSc, MBBCh, MMed, FCPath, one of the study’s principal investigators. “The study supported the efficacy and safety of IXINITY in pediatric patients, and the pharmacokinetics and safety profile were consistent with those observed in adults, although dose adjustment may be needed in pediatric patients. The results thus provide further validation of the clinical utility of IXINITY as a treatment for all people living with hemophilia B.”
The stock is up 12.50% on this news at time of writing.
The stock is bouncing at the major support at $1.50 after ranging there for a few days. Very strong price reaction on today’s news. The current lower high comes in at the $1.90 zone. A close above this level is what bulls want to see for making a run to recover the loss from earnings. A close above $1.90 sets a move to the $2.40 zone.
