September 24, 2026

Lantheus BRAVNETSA Lutathera-Equivalent Approval, FDA Warns Empower Over GLP-1 Copies, Viking Raises $500M

FDA approves Lantheus's BRAVNETSA as a Lutathera equivalent, warns Empower Pharmacy over compounded GLP-1 copies, and Viking prices a $500M raise.

5 stories · Covering regulatory, industry, research

Editor's Note

Lutetium-177 dotatate, the peptide radioligand sold as Lutathera, now has two newly approved alternatives eight days apart: Curium's BEXLUTRY on September 14 through the 505(b)(2) pathway, and Lantheus's BRAVNETSA on September 22 as an ANDA the FDA rated bioequivalent and therapeutically equivalent. On compounding, a September 18 FDA warning letter reported on September 24 told Houston's Empower Pharmacy that its semaglutide and tirzepatide products appear to be 'essentially copies' of approved drugs, citing prescriber 'significant difference' notes repeated verbatim across many records. Two days after its VK2735 maintenance data, Viking Therapeutics priced an upsized $500 million offering of stock and convertible notes. An updated Annals of Internal Medicine systematic review of 38 trials found placebo-subtracted weight loss as high as 19.0% for tirzepatide among marketed drugs and 23.9% for amycretin among emerging agents. At Stanford, researchers used a model trained on antimicrobial peptides to find polymers that kill bacteria by tearing their membranes.

Regulatory

FDA Grants Final Approval to Lantheus's BRAVNETSA, a Lutetium Lu 177 Dotatate Rated Therapeutically Equivalent to Lutathera

Lantheus Holdings announced on Tuesday, September 22, 2026 that the FDA granted final approval to BRAVNETSA (lutetium Lu 177 dotatate) through the Abbreviated New Drug Application pathway for adults with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs). Lantheus says BRAVNETSA is the only radiopharmaceutical the FDA has determined to be bioequivalent and therapeutically equivalent to Lutathera, which contains the same active ingredient. The company did not give a launch date. Eight days earlier, on September 14, Curium announced FDA approval of BEXLUTRY, another lutetium Lu 177 dotatate for the same indication, approved as a 505(b)(2) NDA and available immediately.

#lantheus #bravnetsa #curium #lutathera #radioligand #neuroendocrine-tumors

Regulatory

FDA Warning Letter Says Empower Pharmacy's Compounded Semaglutide and Tirzepatide Appear to Be 'Essentially Copies' of Approved Drugs

The FDA issued a warning letter dated September 18, 2026 to Houston-based Empower Pharmacy after a November 3-14, 2025 inspection, saying its compounded semaglutide and tirzepatide products appear to be 'essentially copies' of FDA-approved drugs and did not meet the conditions of section 503A. The agency said prescriber determinations of a 'significant difference' appeared to be repeated verbatim across many records, suggesting they may be pre-generated, and called the differences between Empower's products and the approved drugs 'pretextual.' The letter also cites insanitary conditions, including inadequate smoke studies of airflow in the ISO 5 area and media fills not run under the most challenging conditions. Empower has 15 working days to respond; BioSpace reported the letter on September 24.

#empower-pharmacy #warning-letter #compounding #semaglutide #tirzepatide

Industry

Viking Therapeutics Prices Upsized $500 Million Offering of Common Stock and 2.00% Convertible Notes Due 2032

Viking Therapeutics announced on Thursday, September 24, 2026 that it priced 7,857,143 shares of common stock at $35.00 per share (about $275 million) and $225.0 million of 2.00% convertible senior notes due October 15, 2032, after proposing the offerings on September 23. The notes convert at about $50.75 per share, roughly a 45% premium to the stock price, and underwriters have options on another 1,178,571 shares and $33.75 million of notes. Viking estimates net proceeds of about $258.2 million from the stock and $218.0 million from the notes, for its VK2735 and VK3019 programs and general purposes. The offerings are expected to settle on September 25, three days after Viking reported VK2735 maintenance-study results.

#viking-therapeutics #vk2735 #financing #glp-1

Research

Updated Annals Systematic Review of 38 Trials Finds Placebo-Subtracted Weight Loss Up to 19.0% With Tirzepatide and 23.9% With Amycretin

An updated systematic review by Areesha Moiz, Mark Eisenberg, and colleagues, published online September 1, 2026 in the Annals of Internal Medicine, covered 38 randomized trials in 25,816 adults with overweight or obesity and without diabetes, adding 14 trials to the authors' earlier review. Among marketed drugs, the highest placebo-subtracted weight loss reported was 5.8% for liraglutide, 14.8% for subcutaneous semaglutide, 14.3% for oral semaglutide, 12.4% for orforglipron, and 19.0% for tirzepatide; emerging agents reached 23.9% with amycretin and 22.1% with retatrutide. Gastrointestinal adverse events occurred in 76.0% of patients on GLP-1 drugs versus 40.1% on placebo, and discontinuation for adverse events was 10.7% versus 3.4%. The authors said heterogeneity prevented a pooled quantitative analysis, so these figures are the highest values from individual trials rather than combined estimates.

#systematic-review #glp-1 #tirzepatide #semaglutide #amycretin #retatrutide

Research

Stanford Team Uses a Model Trained on Antimicrobial Peptides to Find Potent Bacteria-Killing Polymers

Stanford researchers led by Eric Appel reported in the journal Matter, as described by phys.org on September 22, 2026, that they trained an AI model on known antimicrobial peptides and used it to screen 1.7 million candidate polyacrylamide polymers designed to mimic how those peptides kill bacteria. The team synthesized and tested 10 of the model's picks; all 10 performed well above expectations against E. coli, one was especially effective against biofilms, and the approach also worked against Staphylococcus aureus. Co-author Shoshana Williams called them among the most potent antimicrobial polymers ever reported. The polymers rip holes in bacterial membranes, a mechanism the researchers say makes resistance harder to evolve; clinical use remains a future goal.

#antimicrobial-peptides #antibiotic-resistance #ai-drug-discovery #stanford