As of the last check this morning, premarket trading for Fennec Pharmaceuticals Inc. (FENC) has seen the stock gain 11.31% to $7.38. Fennec stock gained 1.53% last session to conclude the session at $6.63. Volume traded for Fennec stock the last session was 0.15 million shares, which is in line with the average volume of 0.12 million shares traded in the past 50 days.
Within the last five days, FENC stock prices have declined -0.90%; however, within the last month, they have fallen -2.07%. In the last three months, the FENC stock price has dropped by -4.47%, and so far this year, it is down by -11.01 percent. As a result of approval by the US Food and Drug Administration (FDA), the price of FENC stock has increased.
The application was for what?
Fennec is a specialty pharmaceutical company developing PEDMARK as a preventive for pediatric patients suffering from platinum-induced ototoxicity. Furthermore, PEDMARK has been designated an Orphan Drug in the United States, indicating it may have applications in this area. A licensing agreement between FENC and Oregon Health and Science University (OHSU) gives OHSU exclusive world-wide access to intellectual property regarding sodium thiosulfate and its use in chemoprotection. Among other things, this includes the prevention of platinum ototoxicity in humans.
Fennec today announced that the FDA has accepted for filing the resubmission of its New Drug Application (NDA) for PEDMARK.
- In the Prescription Drug User Fee Act (PDUFA), November 27, 2021, has been set as the target action date.
- FENC appreciated FDA’s decision to accept PEDMARK resubmission.
- In the course of the FDA review process, FENCA committed to closely working with the agency.
- A significant unmet medical need is met by bringing this treatment to children undergoing cisplatin chemotherapy, a treatment that FENC is committed to providing.
- As a result of the FDA’s approval, FENC’s PEDMARK is set to become the first FDA-approved treatment to reduce pediatric patients’ ototoxicity caused by cisplatin.
- Over 10,000 children are estimated to receive platinum-based chemotherapy each year in the United States and Europe.
- Children who suffer from chemotherapy-induced ototoxicity require lifelong hearing aids based on the dose and duration of treatment.
FDA approved what?
The FDA awarded Fennec (FENC)’s PEDMARK Both Breakthrough Therapy and Fast Track Designation. Following receipt of the FDA’s Type A meeting minutes, PEDMARK was resubmitted.
The NDA was resubmitted on May 25, 2021, following receipt of a Complete Response Letter (CRL) on August 10, 2020. CRL referred to deficiencies in the manufacturing facility of the manufacturer; however, no clinical safety or efficacy concerns were identified, and further clinical data were not needed.
