Precigen, Inc. (NASDAQ:PGEN) is one of the 12 Best NASDAQ Penny Stocks to Buy According to Hedge Funds. On September 3, Precigen, Inc. (NASDAQ:PGEN) announced that it signed a credit facility agreement with total funds of up to $125 million. Precigen entered into a credit facility agreement with investment funds managed by Pharmakon Advisors. The credit facility will allow Precigen to receive up to $125 million in two tranches, subject to the conditions of the agreement. According to the agreement, the fi ...

Core Insights - Precigen is a biopharmaceutical company focused on innovative precision medicines for difficult-to-treat diseases with high unmet needs [1] - The company has received FDA approval for PAPZIMEOS, the first drug approved for treating recurrent respiratory papillomatosis in adults [2] - PAPZIMEOS is a nonreplicating adenoviral vector-based immunotherapy targeting HPV 6 and 11, which are believed to cause the disease [2] - The FDA granted full approval on August 15, ahead of the PDUFA date of August 27, and the drug is set to launch in early Q4 of this year [2]

Product & Indication - PAPZIMEOS is the first and only FDA-approved therapy for the treatment of adults with Recurrent Respiratory Papillomatosis (RRP)[11, 44, 55] - PAPZIMEOS is a non-replicating adenoviral vector-based immunotherapy indicated for the treatment of adults with recurrent respiratory papillomatosis[27] - The recommended dose of PAPZIMEOS is 5×10^11 particle units (PU) per injection, administered subcutaneously four times over a 12-week interval[27] Clinical Data - The pivotal study demonstrated a 51% Complete Response Rate (95% CI [34-69%])[37] - 15 out of 18 Complete Responders evaluated at 2 years demonstrated continued Complete Response[37] - PAPZIMEOS was well-tolerated with no dose-limiting toxicities and no treatment-related adverse events greater than Grade 2[37] Commercial Strategy & Launch - The company is employing a targeted launch strategy with a field team covering >90% of ENT patient potential[47] - 93 IDNs and community hospitals account for 80% of initial target potential, with a total target universe of ~500 accounts[48] - 18 dedicated sales territories will cover >90% of ENT patient potential[47] RRP Market - Approximately 27,000 adult patients in the US have RRP[16] - IDNs and Community hospitals account for >90% of identified patient potential[46]