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Compounded Drug Drama: Hims, Hers, Or Theirs?

3 Mins read

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Seahawks prevail: The Super Bowl indicator returns as Wall Street’s superstition and check out a recap of some of the most notable corporate ads.

U.S. Treasuries: Chinese regulators have reportedly asked major financial institutions to limit their exposure, citing concentration risk and market volatility.

The final frontier: SpaceX is now prioritizing building a city on the moon over Mars, while iPhones might be journeying where no smartphones have gone before.

A high-profile fight in the world of compounded drugs looks like it has been resolved, with telehealth firm Hims & Hers (HIMS) backing off a plan to offer a knockoff Wegovy pill for as little as $49 (which would be $100 less than what Novo Nordisk (NVO) charges for its branded pill). Shares of NVO are on the move again premarket, soaring another 7% on the news, while HIMS shares are down 16% in early trading. However, questions continue to surface about cheaper medication alternatives, regulations, and the marketing of these products to the general population.

What are compounded drugs? These medicines are generally more affordable and accessible than the big-name brands, but consumers still need a prescription from a doctor to purchase these “compounds”—in this case, semaglutide. While both official drugmakers and compounding pharmacies have to source active pharmaceutical ingredients (APIs) from FDA-registered manufacturers, the difference is in the final mixed product. Drugs from commercial players have to meet strict federal manufacturing standards, while compounded drugs are not reviewed by the FDA for safety or quality, meaning no official seal of approval on the manufacturing environment, dosage, or effectiveness.

There are many compounded drugs on the market, including allergy-specific versions, or types of liquid-form medications, and while the FDA has sometimes cracked down on the compounds, they are technically not illegal. This is because of a provision in the Federal Food, Drug, and Cosmetic Act, which allows for compounded drugs to be manufactured if there is a nationwide shortage or for personalized doses that aren’t offered elsewhere. The shortage list is updated regularly by the FDA, and weight loss has been an area of high demand, prompting the need for more supply for the masses.

Outlook: Hims & Hers (HIMS) and others have capitalized on the GLP-1 shortage, making things more affordable with their compounded products, but the latest $49 pill seemed to take things too far. Mass-compounding or selling knockoffs is only legal if there is a national shortage – which is no longer the case for Wegovy and Ozempic – and the arguments of custom formulation (like specialized liposome delivery systems to help with absorption) no longer hold up. Threatened with legal action and an FDA response, Hims & Hers (HIMS) decided to “stop offering access to this treatment” after having “constructive conversations with stakeholders across the industry.” Take the WSB survey.

Here’s the latest Seeking Alpha analysis

Best Tech Stocks To Buy On The Earnings Week Dip

The Next Big Market Rotation Has Begun

Bitcoin Is The Noise, Google Is The Signal: Buying The ‘Industrial Revolution’

Microsoft: It Is Just A Dip, Not A Bargain

The Market’s AI Freakout Creates A Massive Mispricing

What else is happening…

Japan’s Nikkei hits record high on Takaichi’s landslide election win.

Kroger (KR) taps former Walmart (WMT) executive as CEO.

Anthropic’s (ANTHRO) latest funding round likely to surpass $20B.

Will exorbitant capex continue to affect tech stocks’ performance?

Judge orders Trump administration to resume Hudson Tunnel funding.

Washington Post CEO Will Lewis steps down after sweeping layoffs.

Europe is worrying about its reliance on Visa (V) and Mastercard (MA).

Tax season reshapes planning for investors, workers and crypto traders.

Bessent: Fed unlikely to rush balance sheet changes under Warsh.

Here’s the next country to consider a social media ban for children.

Today’s Markets

In Asia, Japan +3.9%. Hong Kong +1.8%. China +1.4%. India +0.6%.
In Europe, at midday, London -0.1%. Paris +0.1%. Frankfurt -0.4%.
Futures at 7:00, Dow -0.1%. S&P -0.2%. Nasdaq -0.4%. Crude +0.4% to $63.78. Gold +1.1% to $5,034.10. Bitcoin -2.7% to $69,017.
Ten-year Treasury Yield +1 bp to 4.23%.

On The Calendar

Companies reporting today include Cleveland-Cliffs (CLF) and ON Semiconductor (ON).

See the full earnings calendar on Seeking Alpha, as well as today’s economic calendar.

Read the full article here

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