On January 19, Marker Therapeutics Inc. (MRKR) announced FDA Orphan Drug designation for its pancreatic cancer T-cell therapy. Following the announcement, the stock became bullish in the after-hours on Wednesday.
In the regular trading session, MRKR stock declined by 2.69% at its closing price of $0.8396. Consequent to the news, the stock added 13.15% at a heavy volume of 2.9 million shares in the after-hours. Therefore, the stock was trading at $0.9500 per share in the after-hours session.
Marker Therapeutics Inc., the clinical-stage immune-oncology company has a market capitalization of $71.68 million. Currently, the company has 83.08 million shares outstanding in the market. Furthermore, MRKR stock has added 4.04% in the past five days. As of now, the stock stands at a year-to-date loss of 11.64% while it subtracted 61.84% last year.
MRKR’s FDA Designation
As per the announcement, MRKR’s MT-601 has been granted orphan drug designation by the FDA Office of Orphan Products Development. The MT-601 is the company’s multi-tumor-associated antigen-specific T cell product developed for pancreatic cancer treatment.
Moreover, MT-601 has been reported to show encouraging results in its ongoing Phase 1 trial. The trial is sponsored by the company’s partners at the Baylor College of Medicine. Additionally, MT-601’s data was recently presented at the 2020 American Society of Clinical Oncology Virtual Annual Meeting. According to the data, in combination with chemotherapy MT-601 has shown safe, durable responses as first-line treatment for pancreatic cancer.
Further, the company plans to commence a Phase 1 multicenter study of MT-601 in combination with chemotherapy. The study will evaluate MT-601 in locally advanced unresectable or metastatic pancreatic cancer.
Also, in 2022, the company intends to file an Investigational New Drug Application for MT-601 for pancreatic cancer treatment.
In addition, MRKR may receive certain benefits like grant funding, user-fee benefits, tax credits, etc., from FDA under its Orphan Drug Act.
Recent Addition to the Board
On December 09, the company announced the addition of Katharine Knobil, M.D. to its Board of Directors. Currently, Dr. Knobil serves at Agilent Technologies, Inc. as its Chief Medical Officer.
MRKR’s Q3 Highlights
In the third quarter of 2021, the company incurred a net loss of $12.4 million, against $7.4 million in the year-ago quarter.
MRKR ended the quarter with cash and cash equivalents of $48.7 million. Thus, the company believes it to enough to fund its expenses into the first quarter of 2023.
