RJ Hamster
Innoviva’s Nuzolvence Boosts Biotech Momentum
| UnsubscribeDouble-digit gains from wilds stock swings (From Brownstone Research)Biotech Is Heating Up—These 2 Red-Hot Stocks Stand OutWritten by Nathan Reiff on January 8, 2026 At a GlanceBiotech names tend to spike on exciting drug approvals and clinical trial data, though these firms are highly volatile and can be risky as well.Two key FDA updates for Axsome could further boost revenue, which has already climbed by nearly two-thirds year-over-year in the latest quarter.Innoviva’s Nuzolvence meets a significant need in the treatment of a condition affecting 82 million globally each year.Biotech companies provide the medical innovations and technological breakthroughs that improve healthcare and can achieve tremendous financial results in the process. However, these names also tend to be highly volatile as a result of the difficult and complex process associated with drug and medical device development as well as the hard-to-navigate regulatory environment. Still, investors look to companies with strong pipelines or exciting projects in progress for a hint about which biotech names may stand out in the months or quarters to come.Two biotech names in particular—Axsome Therapeutics Inc. (NASDAQ: AXSM)and Innoviva Inc. (NASDAQ: INVA)—may draw particular attention from investors at the start of 2026. Each of these companies has potentially transformational products in various stages of development. Although nothing is guaranteed, these standouts might be worth watching this year.The Market Reset Is Coming—Here’s How to Read It Early (Ad)See Early-Stage Activity Before It Reaches Mainstream Screens We highlight micro-cap and small-cap companies gaining early traction based on research, visibility shifts, and market interest.Get the Free Guide — Join Now2 Major FDA Updates Boost Axsome’s Standing in the New YearAxsome develops small-molecule drugs for central nervous system disorders including fibromyalgia, migraine, and more. The company is a popular biotech name at the start of 2026 thanks in large part to key regulatory updates announced at the very end of 2025. The FDA accepted for filing in December a supplemental New Drug Application for Axsome’s oral investigational therapy AXS-05 for the treatment of agitation associated with Alzheimer’s. The drug is already approved for the treatment of major depressive disorder.Given that about three-quarters of Alzheimer’s patients experience agitation, the potential market for this application of AXS-05 is significant. However, it’s not Axsome’s only positive development heading into the new year. The FDA also signaled support for a New Drug Application filing for the company’s AXS-12 for narcolepsy applications based on prior data.Axsome’s late-stage pipeline is thus very strong, and expanding indications across these and other drugs would open up significant new revenue streams. The company’s product revenue is already strong, having climbed 63% year-over-year (YOY) in the latest quarterand helping to narrow net losses. However, cash-flow positivity is still elusive, and margin pressures are lingering, so investors should be aware of these risks.Wall Street is exceedingly bullish when it comes to Axsome shares, as 19 out of 20 analysts have rated the stock a Buy. A flurry of reiterated ratings started the year, including from Needham & Co., Guggenheim, Oppenheimer, and Cowen. Collectively, analysts see shares rising more than 8% to over $188 each.Approval of Nuzolvence May Be Transformational for InnovivaInnoviva’s approach is somewhat different from traditional biopharma names in that it primarily acquires and monetizes royalty interests in drugs, rather than develop them in-house. The company’s particular focus has been on inhaled respiratory therapies.In December, the FDA approved Innoviva’s Nuzolvence, a first-in-class, single-dose oral antibiotic to treat gonorrhea. The drug is the first approved alternative to an injectable treatment which was the only available option previously. Gonorrhea is one of the most prevalent sexually transmitted infections, with close to 1 million cases annually in the United States and 82 million around the world. As a result, Innoviva’s new treatment option has a massive potential market and little by way of competition. It also stands out as gonorrhea has developed resistance to many existing antibiotics.The success of Nuzolvence highlights a win for Innoviva Specialty Therapeutics, a unit of the broader company that develops and commercializes its own therapies. This could point the company toward continued internal development of new drug candidates rather than a primary focus on royalties of externally developed treatments.Innoviva’s financials have already been strong in multiple respects, even prior to the FDA’s approval and the impending launch of Nuzolvence this year. The company beat on both earnings per share (EPS) and revenue estimates in the latest quarterly report, with total revenue climbing by 20% YOY to nearly $108 million on strong product sales on products like Giapreza and Xacduro. Zevtera, a specialized antibiotic for certain types of bloodstream infections and bacterial pneumonia, was launched in July 2025 and is likely to continue ramping up sales heading into the first quarter of this year.A majority of analysts view INVA shares optimistically, and the company’s consensus price target is $38.80, nearly double where it is trading at the start of the year. With sales expected to increase as Nuzolvence launches and Zevtera takes off, this target may well be within reach.Read this article online ›Featured Stories3 Stocks With Analyst Revisions That Could Drive Earnings SurprisesBig gains from crazy market swings? (From Brownstone Research)Higher-for-Longer Rates Could Reward These 3 Overlooked StocksNo AI Bots. Just Real Signals. (From Market Pulse Today)3 of the Most Important Charts to Watch Right NowRocket Lab’s Rally Isn’t Random—Big Catalysts Are AheadSable Offshore: The Court Ruling That Changes Everything Did you enjoy this article? Thank you for subscribing to DividendStocks.com‘s daily newsletter for dividend and income investors that covers ex-dividend stocks, new dividend declarations, dividend stock ideas, and the latest market news. If you have questions about your account, please don’t hesitate to email MarketBeat’s U.S. based support team at contact@marketbeat.com. 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