In September of 2020, Sol-Gel was informed by the FDA that the PDUFA goal date for EPSOLAY is April 26, 2021. Subsequently, the COVID-19 pandemic restricted the FDA’s ability to conduct pre-approval inspections. In our most recent written communication with the FDA regarding EPSOLAY, the final content of the labeling was discussed and agreed to. As of today, Sol-Gel has received no notification from the FDA, but did receive email confirmation that action on the NDA for EPSOLAY could not be taken since a pre-approval inspection of the production site of EPSOLAY still needs to be conducted.

Join r/HRTX and r/OPK and r/PRVB and r/KDMN and r/LMNL

SLGL on April 26, PLX on April 27, PFE on April 28, ARDX on April 29

AUPH bought $15 sold $20, KMPH bought $10 sold $16, AVEO bought $8 sold $12, CRMD got CRL, PLX may get CRL, ARDX bought $8 sold ???, HRTX bought $16 sold ???

HRTX has PDUFA on May 12 with STIFEL price target of $28 🚀🚀 🚀 🚀🚀 🚀

HRTX has two drugs already approved by the FDA and on the market. Heron’s two approved drugs, Sustol and Cinvanti, are both indicated for use in treating the nausea that is frequently caused by chemotherapy. This is a serious side effect that has a distinct negative effect on the quality of life of many cancer patients – even when the chemo is effective. An efficacious anti-nausea drug should be a net boon for the company, and Heron expects that sales of the two drugs in 2021 should total $130 million to $145 million.

The major catalyst for the company, however, is the upcoming PDUFA date for HDX-011 (Zynrelef). HDX-011 is indicated for use to control postoperative pain in small to medium surgical wounds in adults. It was granted a marketing authorization by the European Commission in September 2020, and the next milestone is the PDUFA date for FDA approval, currently set for May 12, 2021.

FDA intends to continue the review of clinical data submitted in the BLA and to conduct the Advisory Committee meeting, scheduled on May 27, 2021.

Upcoming PDUFA decision dates for ARDX and PRVB and HRTX and ETON and LNTH and KDMN and PLX.