505(b)(2) Pathway Stocks

Biopharmaceutical developers utilizing the 505(b)(2) regulatory pathway focus on the reformulation, repositioning, or new clinical application of previously approved active ingredients to mitigate development risk and shorten time-to-market.

As of Oct 23, 2026, 505(b)(2) Pathway has 4 US-listed companies worth $6B combined. The median member moved +14.4% over the past week; MANE led at +27.5% and PLYX trailed at -1.6%.

Companies in 505(b)(2) Pathway

• MANE – Veradermics, Incorporated, $5.8B
• PLYX – Polaryx Therapeutics, Inc. Common Stock, $98.2M
• UNCY – Unicycive Therapeutics Inc, $92M
• EGRX – Eagle Pharmaceuticals Inc, $3.3M

Related groups

• Rare Diseases
• Clinical Stage
• Biotechnology
• Recent IPOs
• Healthcare
• Pharmaceuticals
• Clinical Stage Biotech
• Biopharmaceutical

All equity groups