Tuesday, 8 September 2026

Older, Heavier, Losing Muscle: (Nasdaq: VERU) Chose One Of The Hardest Patient Groups

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Older, Heavier, Losing Muscle: (Nasdaq: VERU) Chose One Of The Hardest Patient Groups


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September 8th

Greetings Readers,


For three years the weight management conversation has revolved around one number. The scale.


Down 20%. Down 25%.


Far fewer asked the harder question underneath it: which tissue is actually leaving the body?


A small Miami company built its whole thesis on that question, and in August it produced the filing that makes the answer defensible.


Veru Inc. (Nasdaq: VERU) disclosed a notice of allowance from the U.S. Patent and Trademark Office covering methods of using enobosarm with wei-ght lo-ss medicines.


The allowed claims run to at least October 3rd, 2044 before any adjustment, and they reach concurrent dosing with semaglutide, addition to an existing regimen, and use after semaglutide is stopped.


The evidence behind those claims already exists. In the completed Phase 2b QUALITY study of 168 patients aged 60 and older taking semaglutide, the placebo group's wei-ght lo-ss broke down as 34% lean mass and 66% fat.


In the 3 mg oral enobosarm arm, wei-ght lo-ss attributable to lean mass was 0% and estimated fat loss was 100%, meeting the primary endpoint at a p value below 0.001.

Body composition alone is a laboratory reading. Physical function is what a physician watches for, and the 3 mg arm cut the share of subjects losing at least 10% of stair climb power by 59.8%, at a p value of 0.0006.


That result is now being tested at scale. The Phase 2b PLATEAU study closed enrollment in July with 239 patients, above its target of roughly 200. It is double blind and placebo controlled, running 68 weeks in patients aged 65 and older with a body mass index of 35 or greater who are starting semaglutide.


Interim data at 32 weeks is guided to early 2027, topline to the fourth quarter.


The category around it is sized in serious numbers.


Morgan Stanley Research in April 2026 set a 2035 base case of $190Bn against $79Bn in 2025, with United States adoption rising toward roughly 30% of the obese and diabetic population.


Veru is not trying to compete with that market. It is trying to sit inside it.

About The Company: Veru Inc. (Nasdaq: VERU)


Veru Inc. is a late clinical stage biopharmaceutical company headquartered in Miami, FL, working on cardiometabolic and inflammatory disease.


Enobosarm, an oral selective androgen receptor modulator, has been studied across six clinical trials in more than 1,100 patients, producing gains in lean mass and reductions in fat mass.


Sabizabulin, aimed at chronic inflammation related to atherosclerotic cardiovascular disease, is held until additional funding is secured.


The company is pre-commercial, so value is built through clinical milestones, patent claims and partnering rather than product sales.


Veru sold its FC2 consumer health business for $18Mn at the end of December 2024, netting roughly $12.5Mn and eliminating a $9.9Mn royalty liability, and cut headcount from about 210 employees to 22.


Chief Executive Officer Mitchell Steiner, M.D., called it the step that let Veru operate as a pure biopharmaceutical company.

Behind The Scenes: The August Call


The tone on the third quarter call was closer to a project update than a pitch.


Steiner spent less time on mechanism than on arithmetic, noting that 62.6% of patients still had clinical obesity when they reached the one year plateau, and that older patients are most at risk of falling to a critically low muscle mass.


Chief Financial Officer Michele Greco said the June 30th balance is expected to fund operations beyond the interim analysis.

What Changed This Summer


Alongside the patent decision came a development that changes who is in the room.


Steiner shared on the Q3 earnings call that Novo Nordisk will supply Wegovy for PLATEAU at no charge, and that Veru granted Novo Nordisk a right of first negotiation on the enobosarm estate in combination with any Novo Nordisk G-L-P-1 product.


A supply agreement is not a partnership. It does put a name on the door.


Plus, cash and restricted cash strengthened over the same stretch, reaching $23.9Mn from $15.8Mn.

Seven Potential Catalysts Putting (Nasdaq: VERU) On Our Watchlist


#1. A Dated Interim Readout Sits Roughly Two Quarters Ahead. The 32 week interim analysis is guided to the first quarter of 2027, giving VERU a fixed calendar event rather than an open ended wait.


#2. Patent Claims Now Reach Into The Middle Of The 2040s. Allowed claims run to at least October 3rd, 2044 and a pending formulation application could carry protection for VERU into 2046 if it issues.


#3. A Fairly Low Float Could Create An Environment For Heightened Volatility. With approx. 15.48Mn shares in its float, VERU screens as a low float idea, meaning the potential for heightened volatility may be significant.


#4. Twelve Of Thirteen Technical Signals Are Flashing On Barchart’s Site. Barchart.com's Opinion page reported 12 of 13 technical indicators it tracks to be triggered at close on Friday. This includes the website’s composite “Trend Seeker” indicator.


#5. The Category Leader Already Has A Seat At The Table. Novo Nordisk supplies Wegovy at no charge and holds a right of first negotiation on combination rights, placing VERU inside the orbit of the category leader without a signed license.


#6. Coverage For The Exact Target Population Improved. Management has pointed to Medicare coverage of G-L-P-1 therapies beginning July 1st, 2026 as a shift in the payer backdrop for the older adults VERU is studying.


#7. Two Analyst Targets Point To Potential Triple-Digit Upside. An analyst target ($25) from Canaccord Genuity and a target ($24) from Oppenheimer hint at VERU potentially being undervalued from current chart levels.

Final Thoughts


Veru Inc. (Nasdaq: VERU) is not a finished story and does not present itself as one.

It is pre-commercial, one asset carries nearly all the weight, and a second program sits parked until funding allows.


What it does have is unusual for its size: a completed Phase 2b with significant results, a fully enrolled study with a dated readout, allowed claims running two decades out, and the category leader already at the table.


Management speaks at the Cantor Global Heal-thcare Conference on September 9th.


The field has spent several years rewarding the number on the scale. The next chapter may turn on what stays behind.


We’re initiating coverage on Veru Inc. (Nasdaq: VERU).


Be on the lookout for updates coming soon.


Sincerely,

Kai Parker

StockWireNews


(Always Remember The St-ock Prices Could Be Significantly Lower Now From The Dates I Provided.)


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