) -- Three drug approval decisions and a cancer drug data presentation highlight a busy week ahead in biotech.
Traders will be eyeing
(ACUR - Get Report)
early Monday to see how the stock reacts following the
U.S. approval of the company's tamper-resistant painkiller Oxecta
on Friday night.
(PFE - Get Report)
, Acura's marketing partner, will sell Oxecta in the U.S.
Acura shares closed Friday's regular session down 5% to $3.87 but is sure to rebound and move higher when trading opens Monday. How much so likely depends on the data and language FDA allowed in the Oxecta label describing the drug's tamper-resistant qualities.
is expecting an
FDA approval decision on Thurs. June 23
for its own tamper-resistant opioid, Remoxy, which is also being developed in a partnership with Pfizer.
Remoxy was first submitted for FDA approval three years ago so Pain Therapeutics shareholders are hoping this week brings a positive end to what's been a long wait. Pain Therapeutics shares closed Friday at $8.64 -- watch Monday to see if investors move the stock higher on bullish sentiment stemming from the approval of Acura's Oxecta.
(CRIS - Get Report)
shares will be under a spotlight Monday on the release of data from a phase II study of vismodegib in basal cell carcinoma, a form of skin cancer.
The overall response rate in the study, assessed independently, showed vismodegib shrank tumors in 43% of patients with locally advanced basal cell carcinoma and 30% of patients with metastatic basal cell carcinoma. The median duration of response was 7.8 months, according to Curis. Patients in the phase II study had advanced basal cell carcinoma that was no longer responsive to any other therapy.
is developing vismodegib under a partnership agreement with Curis and has already announced plans to seek U.S. approval later this year.
Switching back to FDA drug approvals this week,
awaits a June 22 decision on
laViv, a personalized cell therapy for the treatment (smoothing out) of nasolabial fold wrinkles
-- those are the skin folds that run from each side of the nose to the corners of the mouth.
What makes laViv different from Botox and the myriad of dermal fillers used commonly in cosmetic skin procedures today is its active ingredient -- a patient's own fibroblasts. These are a form of stem cell that matures into connective tissue fibers and help give skin strength and elasticity.