Onconova Therapeutics Inc (NASDAQ: ONTX) is running for the top in the market this morning, trading on gains over 20%. The gains come after the company announced that it has entered into a pre-approval access agreement surrounding rigosertib. Here’s what’s happening:
ONTX Stock Runs For The Top On Pre-Approval Access Agreement
Onconova Therapeutics issued a press release early this morning, announcing that it has entered into a pre-approval access agreement. The agreement was signed with Inceptua Medicines Access.
Under the agreement, the two companies have entered into a collaboratoin to make intravenous rigosertib available through a Pre-approval Access Program. As a result, the drug will be available in select countries around the world.
Pre-approval Access Programs are commonly called expanded access, early access, compassionate use, or named patient supply. Nonetheless, these types of programs are regulatory-compliant processes that permit experimental drugs in development to be made available upon request.
Rigosertib is a small molecule under development at ONTX that inhibits signalling in cancer cells by acting as a RAS mimetic. At the moment, the treatment is being studied in a Phase 3 trial as a potential option for higher-risk MDS patients.
In the release, ONTX said that the program is expected to launch in the first half of 2020. In the beginning, the program will be made available in select countries in Europe. Over time, the program will be made available in countries including Australia, Denmark, Finland, France, Ireland, Italy, the Netherlands, Portugal, South Africa, Spain and the UK.
In a statement, Steven M. Fruchtman, M.D., President and CEO at ONTX, had the following to offer:
The rigosertib Pre-approval Access Program is a key strategic initiative for Onconova. We are pleased that intravenous rigosertib will be made compliantly available to suitable patients with higher-risk MDS through their physicians in designated countries. The program will run alongside our ongoing Phase 3 INSPIRE Trial, and is expected to continue until commercial launch in such countries. We are pleased to work with Inceptua, given their strong record of administering such programs successfully.
Why Investors Are So Excited
At the end of the day, there are multiple reasons for the excitement surrounding Onconova Therapeutics. Here’s how I see it:
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