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.

Medexus has methodically built a diverse drug portfolio in both the U.S. and Canada that generates a sustainable growing revenue. We have seen this with recent quarterly earnings which have continued to break company records. Preliminary fiscal Q4 2023 and full year 2023 financial are expected to be another record breaking results for the company with full revenue of US$107-108 million representing record annual revenue and a year-over-year increase of at least 39.5%.

Today, the company announced that the FDA has accepted for review Medexus’ IXINITY supplemental biological license application (sBLA) for pediatric patients under 12 years of age with hemophilia B – a hereditary bleeding disorder characterized by a deficiency of clotting factor IX in the blood. IXINITY®, an intravenous recombinant factor IX therapeutic, is currently approved for use in patients 12 years of age or older with hemophilia B.

IXINITY® is approved by the FDA for sale and use in the United States only and is not intended for export outside the United States. IXINITY® [coagulation factor IX (recombinant)] Lyophilized Powder for Solution for Intravenous Injection is a coagulation factor IX (recombinant) indicated in adults and children ≥12 years of age with hemophilia B for on-demand treatment and control of bleeding episodes, perioperative management, and for routine prophylaxis to reduce the frequency of bleeding episodes.

“Approximately one third of patients treated for hemophilia B in the United States are children 13 years of age and under,” said Ken d’Entremont, Chief Executive Officer of Medexus. “Risk of bleeding events can severely limit these children’s daily activities. The FDA’s commitment to review our sBLA brings us a step closer to making IXINITY® a viable factor IX treatment option for this important population.”

This news comes after Medexus released news about their Treosulfan drug and that it’s been shown to be useful in saving lives in certain patients.

At time of writing, the stock is up 1.67% on the news and sits at a market cap of just over $24.5 million.

In the past few months, Medexus saw a reaction at the major resistance zone at $1.70. The reaction is evident by the long wick candle printed on April 11th 2023. Since then, we have held above recent lows until now. The stock has broken below the $1.17 lows but quickly recovered back over this price level. Price action and volume need to be watched to gauge if the buyers are really coming in strong.

Going forward, the $1.30 zone is an important level as it is the previous lower high the stock is working with. A break above this level will go a long way in confirming a trend reversal. It should be noted that the downtrend line I have drawn at the beginning of the year remains intact, which shows that the current market structure is a downtrend.

What can shift this? Earnings have been good and the stock has seen big green candle reaction days. But not enough to break us above key technical levels to confirm a trend reversal. It seems that the primary mover for this stock remains the Treosulfan news.