The agency granted the designation to pelareorep in combination with bevacizumab and leucovorin, fluorouracil, irinotecan for the treatment of certain patients with metastatic colorectal cancer.
- The company said that the designation is supported by clinical data which demonstrates a 33% objective response rate for pelareorep-based therapy.
- According to Oncolytics, there are an estimated 2 million new colorectal cancer cases each year globally.
- Pelareorep now has Fast Track Designation for two gastrointestinal cancers including pancreatic cancer.
Shares of Oncolytics Biotech Inc. (ONCY) rallied 8% at the time of writing ON Wednesday after the company announced that the U.S. Food and Drug Administration has granted a fast track designation to its cancer drug pelareorep in combination with other drugs.
The agency granted the designation to pelareorep in combination with bevacizumab and leucovorin, fluorouracil, irinotecan for the treatment of certain patients with metastatic colorectal cancer for whom few effective treatment options exist.
Why The Designation?
The company said that the designation is supported by clinical data which demonstrates a 33% objective response rate for pelareorep-based therapy compared to approximately 10% ORR with standard-of-care in the particular patient population.
According to Oncolytics, there are an estimated 2 million new colorectal cancer cases each year globally, with an annual total addressable market of approximately $3-5 billion for the subgroup it targets.
Plans Ahead
The company now intends to initiate a controlled clinical study in the subgroup comparing standard-of-care therapy alone versus standard-of-care plus pelareorep.
The first clinical site, it noted, is expected to be activated in March, with up to 10 additional sites expected to open shortly thereafter. Interim data from the study are expected by year-end, it added.
Perks Of The Designation
The Fast Track Designation enables more frequent meetings and communication with the regulator to ensure alignment on development plans and the collection of clinical data needed to support approval. Programs with Fast Track Designation may also be eligible for accelerated approval and priority review if certain criteria are met.
Pelareorep now has Fast Track Designation for two gastrointestinal cancers including pancreatic cancer. The company is also studying the drug in metastatic breast cancer.
How Did Stocktwits Users React?
On Stocktwits, retail sentiment around ONCY stock rose from ‘bearish’ to ‘neutral’ territory over the past 24 hours, while message volume increased from ‘low’ to ‘high’ levels.
A Stocktwits user highlighted high price targets on the stock.
According to data from Koyfin, of the seven analysts covering the stock, six have a ‘buy’ or higher rating on the shares of the company while one rates it ‘hold’.
The stock has an average price target of $5.49, representing a potential upside of over 400% from current trading levels.
ONCY stock has gained 32% over the past 12 months.
For updates and corrections, email newsroom[at]stocktwits[dot]com.<
