What happened Axsome Therapeutics (NASDAQ: AXSM), a newly minted commercial-stage biopharma, is set for a strong session today. Specifically, the company's shares are up by a whopping 52% in pre-market trading Monday morning. What's going on? Ahead of the opening bell this morning, Axsome released an 8-K filing with the Securities and Exchange Commission revealing that it has received the proposed labeling from the Food and Drug Administration (FDA) for the experimental major depressive disorder drug known as AXS-05. Image Source: Getty Images. So what The FDA reportedly sent Axsome this long-awaited regulatory update last Friday. Per the filing, the company said that it is reviewing the drug's proposed label and intends to respond soon in order to secure a final label. What does this all mean? AXS-05, in short, appears to be on the cusp of a formal approval from the FDA as an important new treatment option for patients with major depressive disorder. The big deal is that AXS-05 has the potential to generate multibillion-dollar annual sales for this high-value indication. That's an enormous commercial opportunity for a company that was valued at less than $1 billion as of Friday's closing bell. Now what Novel depression medications are highly sought-after commodities in the world of biopharma. As such, Axsome could turn into a red-hot takeover target following this positive regulatory development. That doesn't mean that Axsome is absolutely guaranteed to fetch an offer soon. But it wouldn't be shocking if the biotech does get a rich tender offer before the year's end -- especially if AXS-05's label is favorable. 10 stocks we like better than Axsome TherapeuticsWhen our award-winning analyst team has a stock tip, it can pay to listen. After all, the newsletter they have run for over a decade, Motley Fool Stock Advisor, has tripled the market.* They just revealed what they believe are the ten best stocks for investors to buy right now... and Axsome Therapeutics wasn't one of them! That's right -- they think these 10 stocks are even better buys. See the 10 stocks *Stock Advisor returns as of June 2, 2022 George Budwell has positions in Axsome Therapeutics. The Motley Fool has positions in and recommends Axsome Therapeutics. The Motley Fool has a disclosure policy.Source