Medexus is making moves, Research Capital says

A new development at Medexus Pharmaceuticals (Medexus Pharmaceuticals Stock Quote, Chart, News, Analysts, Financials TSX:MDP) has Research Capital analyst Andre Uddin maintaining his bullish stance on the stock.

On March 26, MDp announced that the FDA had approved its supplemental biologics licence application for Ixinity for pediatric patients under 12 years of age with hemophilia B. The therapy is thereby now approved for all patients with hemophilia B.

“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 CEO Ken d’Entremont. “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.”

The analyst explained the importance of the news.

“This morning, Medexus announced that the FDA approved the sBLA for an expanded indication of its Ixinity label – to now include hemophilia B patients under 12 years of age,” he explained. “This approval is a key strategic addition to the Ixinity label as it should allow the drug to be used in the same age patient group as other competitive drugs. In addition, the Ixinity label should help provide better consistency of sales over the longer term. We expect the NDA for treosulfan to be filed at the FDA in CY Q2 2024 – once accepted for review it should either take 2 months or 6 months to be approved. We expect MDP to perform very well this year given that treosulfan should be approved by end of CY 2024, and it should provide solid growth (peak sales potential of US$100M+). Given where MDP is currently trading – investors clearly do not believe treosulfan has a shot of receiving FDA approval. The data collection phase of medac’s effort (570 patient data was collected) is now complete – pertaining to treosulfan and is being analyzed for the FDA. Based on our understanding, in the CRL, the FDA did not require any additional trials to be run & there were no manufacturing deficiencies. Recall the treosulfan Phase 3 trial showed strong efficacy in event free survival and overall survival with a clean safety profile. We are maintaining our SPECULATIVE BUY rating and target price of C$5.90. Our valuation is based on applying a 1.7x EV/S multiple to our 2025 revenue estimate discounted back by 25%.”

In a research update to clients March 26, Uddin maintained his “Speculative Buy” rating and price target of $5.90 on MDP, implying a return of 268.8 per cent at the time of publication.