What happened
Shares of Outlook Therapeutics (OTLK 1.65%) were up 6.3% early Tuesday afternoon after rising as much as 16% earlier in the day. The stock went past $2 a share, reaching a 52-week high in the morning at $2.03 before falling back. It was the second consecutive day the healthcare stock reached a 52-week high, as it climbed to $1.895 on Monday.
So what
The clinical-stage biotech is awaiting a key prescription drug user fee action date (PDUFA) on Aug. 29 for ONS-5010 (bevacizumab) to treat wet age-related macular degeneration (AMD). The drug is already being used extensively off label by compounding pharmacies to treat wet AMD.
With the anticipation of an approval from the Food and Drug Administration (FDA), investors have been piling in on the stock. It didn't hurt that the company also reported smaller-than-expected losses in the second quarter last month.
If approved, ONS-5010 will end the need to use unapproved repackaged IV bevacizumab from compounding pharmacies to treat wet AMD. Outlook says it plans to sell ONS-5010 in vial and prefilled syringe formulations.
Now what
The target market for ONS-5010 is potentially large, as wet AMD is the leading cause of vision loss for those 50 and older, according to Johns Hopkins Medicine. In wet AMD, abnormal blood vessels grow beneath the retina and often leak fluid and blood, creating a large blind spot in the center of the eye.
Retinal diseases, including wet AMD, diabetic retinopathy, diabetic macular edema, and retinal vein occlusion, impact 34.5 million patients in the U.S., Great Britain, Europe, China, Japan, and Australia, according to Outlook, and it is possible ONS-5010 could have wider applications beyond wet AMD.
Last September, the company entered into a partnership with AmerisourceBergen to help with marketing and distributing ONS-5010 in the U.S. With only $43.7 million in cash as of the second quarter, Outlook will need to raise funds to help ramp up the launch of the drug.
