Clinical-stage biotechnology company NexImmune (NASDAQ:NEXI) received investigational new drug (IND) clearance from the U.S. Food and Drug Administration (FDA) for a cellular therapy product candidate addressing solid tumors. Due to this regulatory win, NEXI stock is catching a bid and moving up fast.
NexImmune’s technology uses the body’s own T cells to generate immune responses. Its Artificial Immune Modulation (AIM) platform constructs nanoparticles to help generate and direct these immune responses.
NexImmune already has two lead programs, NEXI-001 and NEXI-002, in Phase 1/2 clinical trials. However, those programs aren’t the focus on Wall Street today.
Instead, the medical community and financial traders are focused on NEXI-003. It describes this as an “autologous antigen-specific T cell product” that it is developing for “patients with relapsed or refractory human papillomavirus (HPV)-related cancers.”
Regulatory clearance for NEXI-003 is crucial for NexImmune, as it’s the company’s first cellular therapy product candidate addressing solid tumors. Granted, IND clearance isn’t a green light from the FDA for NexImmune to commercialize NEXI-003. However, it is a step in that direction, and a huge win for NexImmune.
What’s Happening with NEXI Stock?
Of course, we shouldn’t discount the medical significance of this clearance. For select patients with HPV-related cancers, this could be highly encouraging news.
On Wall Street, though, the bottom line is always the bottom line. NexImmune is a small biotech firm with a limited number of clinical programs. Therefore, a nod from the FDA is a major positive catalyst for the company, and is bound to have an impact on NEXI stock.
Indeed, we can see this in action as the NexImmune share price leaped 30% today. The buyers are likely eyeing the critical $2 level, and a high-volume break above it could precipitate an extension of the rally.
NexImmune CEO Kristi Jones understandably called the IND clearance a “significant milestone.” The next step is a Phase 1 trial for NEXI-003, in which NexImmune plans to enroll patients at multiple clinical sites across the U.S. It’s looking like a win-win for all stakeholders, and it will be interesting to see what’s next for NexImmune.
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On the date of publication, David Moadel did not have (either directly or indirectly) any positions in the securities mentioned in this article. The opinions expressed in this article are those of the writer, subject to the InvestorPlace.com Publishing Guidelines.