TGTX stock has been crushing the market this year with its shares surging high following the news that TG Therapeutics’ (NASDAQ:TGTX) refractory and relapsed MZL drug candidate umbralisib has been granted orphan drug designation by the FDA.
Umbralisib Achieved Primary Endpoint
Early this year TG Therapeutics released mid-stage trial results for MZL, which showed that the drug achieved its primary endpoint of overall response rate. Following the positive results, umbralisib was granted Breakthrough Therapy Designation by the FDA for MZL which is good news for TGTX stock.
It is tricky to predict the near-term outlook of most clinical-stage biotech companies such as TG Therapeutics because of a lack of institutional support and wild swings. However, TGTX could continue growing because it has the necessary ingredients for doing so.
Umbralisib is a major milestone for the company, and it sports an efficacy and safety profile that is favorable compared to drugs like Imbruvica, which is produced by AbbVie (NYSE:ABBV). If umbralisib gets approved by the FDA for its accelerated pathway, it will bring TGTX considerable revenue from annual sales in the refractory/relapsed MZL segment. This will be a significant milestone for TG Therapeutics, which has a market capitalization of $686 million.
In the near future, the company plans to add small lymphocytic lymphoma and follicular lymphoma onto the umbralisib label. The two indications are a great opportunity and could significantly increase the TGTX stock price if umbralisib succeeds in treating the two lymphomas.
The company is currently waiting for the maturity of the progression-free survival data for the combination of ublituximab and umbralisib in the treatment of chronic lymphocytic leukemia. The data is expected between late 2019 and early 2019.
TGTX is looking to have at least one of its drug candidates in the market soon, considering the clinical data that it has so far released.
TGTX stock is up over 101% so far this year. However, the stock is still down 45% over the past year.
Featured image: DepositPhotos @ lightsource