While oncology is the largest therapeutic area in the pharmaceutical industry by revenue, the anti-obesity space has grabbed the most attention over the past couple of years. This niche is still in its infancy, though, and it is projected to grow rapidly at least through the end of the decade. Many drugmakers, both large and small, are seeking to make a significant impact in this area. The most successful ones will reap substantial financial benefits and perhaps generate market-crushing returns in the process.
Two relatively unknown biotechs that are developing promising therapies in this field are Terns Pharmaceuticals (TERN +5.22%) and Rhythm Pharmaceuticals (RYTM +1.71%). These biotechs could soar provided they deliver solid progress. Here's what investors need to know.
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1. Terns Pharmaceuticals
Terns Pharmaceuticals is a small-cap, clinical-stage biotech. One of the company's leading candidates is TERN-601, a mid-stage oral GLP-1 candidate. Terns Pharmaceuticals has recently initiated a 12-week phase 2 clinical trial for this medicine in weight loss. It expects data from it in the fourth quarter. Although several approved anti-obesity medicines are generating substantial sales, an oral option could address some remaining issues. Oral pills come with lower manufacturing costs than subcutaneous injections.
With oral medications, drugmakers will have the opportunity to ramp up manufacturing and target even more patients, especially considering many are practically allergic to needles. TERN-601 is still just in mid-stage studies. And based on recent developments from competing biotech and pharmaceutical companies working on oral GLP-1 medicines, it won't be easy for Terns Pharmaceuticals to impress the market. However, if it can post strong results for TERN-601, Terns Pharmaceuticals' shares could soar later this year.
NASDAQ: TERN
Key Data Points
Terns Pharmaceuticals does have other pipeline candidates. It is developing TERN-501 as a potential medicine for metabolic dysfunction-associated steatohepatitis and as a potential combination therapy that could enhance the efficacy of GLP-1 medicines. Terns Pharmaceuticals' TERN-701 is a potential cancer therapy in a phase 1 study, with an upcoming data readout scheduled for the fourth quarter.
That said, Terns' performance will largely depend on progress related to TERN-601. And if this investigational medicine fails in mid-stage studies, the stock will plummet. So, although there is plenty of upside potential here, there is also above-average risk. Invest accordingly.
2. Rhythm Pharmaceuticals
Rhythm Pharmaceuticals is targeting a niche of the market for weight management drugs. The company is developing medicines that help patients with obesity due to various rare conditions. Rhythm's Imcivree, first approved in 2020, is indicated for weight management in patients with certain protein deficiencies. The medicine doesn't generate much sales, but it is making progress. In the second quarter, Rhythm Pharmaceuticals' revenue increased by 66.8% to $48.5 million.
Recent clinical progress has made Rhythm's prospects more attractive. It reported strong phase 3 results for setmelanotide (the active ingredient in Imcivree) in patients with obesity resulting from hypothalamic damage. Rhythm Pharmaceuticals recently submitted regulatory applications for the medicine in this indication. It could earn this label expansion by the end of the year.
NASDAQ: RYTM
Key Data Points
Elsewhere, the company's bivamelagon also aced a phase 2 study in hypothalamic obesity. Rhythm Pharmaceuticals plans to initiate phase 3 studies for bivamelagon next year. Bivamelagon has the added advantage of being an oral medicine, whereas setmelanotide is administered via subcutaneous injection. Strong phase 3 results for bivamelagon could also jolt the stock. Rhythm's addressable market is relatively small.
Between Imcivree's current indications and the potential new approvals and label expansions in hypothalamic obesity, the company is targeting a potential patient population of up to 35,500 patients in the regions it is focusing on: the U.S., Europe, and Japan. However, there is also a need for medications that target these conditions specifically -- most weight management medicines don't do that. There are no therapies approved for weight management in hypothalamic obesity, for example.
Rhythm Pharmaceuticals could be the dominant player in these smaller weight management markets. That's before we add several other phase 2 and phase 3 clinical trials that could lead to even more label expansions for setmelanotide. Rhythm Pharmaceuticals remains somewhat risky. Clinical or regulatory setbacks with setmelanotide or bivamelagon could negatively impact the stock. But the company could deliver outstanding returns in the next five years, provided it can launch bivamelagon and add new indications to setmelanotide.
