Post by free air on Jul 30, 2021 23:39:37 GMT
The entire biotech sector has been selling off lately and I came across this company that looks interesting. It has three approved products Sustol, Cinvanti, and Zynrelef. This company recently had a less than flattering FDA approval for Zynrelef due to the narrow label. Zynrelef was developed for non-opioid pain management. Its a topical formulation and will compete with Pacira's Exparel. The current label only includes bunionectomy, TKA, and open inguinal herniorrhaphy. Management states they can expand the label and it seems doable as it is a topical analgesic. It is speculative due to the need for FDA label expansion but if they achieve it has significant advantages over the lead product in the field, Exparel. Namely Exparel requires 40+ injections to achieve analgesia vs Zynrelef which is topical. Zynrelef is also gearing for a cost advantage over Exparel(about 20-30%). When measuring opioid use post-operatively in each of their clinical trials Zynrelef appears equivalent if not better than Exparel, however there is no head to head trial. The company has frustrated investors over the years as Zynrelef was marketed with a lot potential (rightfully so IMO) only to receive 2 CRL and a narrower than expected label with FDA approval the third time around. The stock has currently sold off due to the narrower than expected FDA label however I think label expansion is likely as the FDA did not cite safety instead it needs data to increase the label.