August 11, 2026

Hims -6% Tuesday After Q2, ITM 177Lu-Edotreotide CRL, Silence SANRECO 88% Response, Rhythm IMCIVREE Launch

Hims -6% after hours despite raised Q3 guide. ITM 177Lu-edotreotide gets CRL. Silence SANRECO 88% vs 19% placebo in PV. Rhythm IMCIVREE launch strong.

4 stories · Covering industry, regulatory, clinical-trials

Editor's Note

Tuesday's news picks up on Hims & Hers Health's (NYSE: HIMS) Monday-night Q2 print. Shares fell approximately 6% after hours despite a revenue beat and a Q3 guide of $890 million (+12.4% above consensus), as the GAAP loss of $0.37 per share ran below expectations and the gross margin compression to 64% (from 76% year-ago) hit its fourth consecutive quarter of decline. The market appears to be pricing the compounded-to-branded pivot as a durable margin drag rather than a temporary transition. Three fresh non-GLP-1 stories round out the day. ITM Isotope Technologies Munich SE received a Complete Response Letter (CRL) from the FDA on August 7 for 177Lu-edotreotide (ITM-11), a somatostatin analog radioligand for gastroenteropancreatic neuroendocrine tumors (GEP-NETs); the CRL cited chemistry, manufacturing, and controls (CMC) and third-party commercial facility issues rather than clinical or safety concerns. Silence Therapeutics (NASDAQ: SLN) reported positive Phase 2 SANRECO topline results for divesiran, a first-in-class TMPRSS6-targeting siRNA that increases hepcidin production to restrict iron availability to bone marrow in polycythemia vera; 88% of divesiran-treated patients responded versus 19% on placebo (P<0.0001), producing a placebo-adjusted response rate of 69%. And Rhythm Pharmaceuticals (NASDAQ: RYTM) has recorded 400+ patient start forms for IMCIVREE (setmelanotide, an alpha-MSH analog peptide) in the acquired hypothalamic obesity indication since FDA approval in late June, one of the stronger rare-disease peptide launches of the year to date.

Industry

Hims & Hers Health (NYSE: HIMS) Shares Fell Approximately 6% After Hours Monday and Extended the Decline Into Tuesday August 11 Trading Despite Q2 2026 Revenue of $753.2 Million (+38% YoY, Beating $698.9M Consensus) and Q3 Guidance of $890 Million (+12.4% Above Consensus); GAAP Loss of $0.37 per Share Was Well Below Analyst Estimates, and Gross Margin Compression to 64% (From 76% Year-Ago) Hit Its Fourth Consecutive Quarter of Decline as the Compounded-to-Branded GLP-1 Pivot Continued to Drag Unit Economics; Q2 Net Loss of $86.3 Million Versus $42.5 Million Net Income in Q2 2025

Hims & Hers Health (NYSE: HIMS) shares fell approximately 6% after hours Monday and extended the decline into Tuesday August 11, 2026 trading despite Q2 2026 revenue of $753.2 million (+38% year-over-year, beating $698.9 million consensus) and Q3 guidance of $890 million at the midpoint (+12.4% above analyst expectations). The GAAP loss of $0.37 per share ran well below analyst estimates, and gross margin compression to 64% (from 76% year-ago) hit its fourth consecutive quarter of decline. Q2 net loss reached $86.3 million versus $42.5 million net income in Q2 2025. The compounded-to-branded GLP-1 pivot through the Novo Nordisk (Wegovy, Ozempic) and Eli Lilly (Zepbound, Mounjaro) commercial partnerships since Q1 2026 continues to drag unit economics. Full-year 2026 guidance was raised to $3.1-3.3 billion revenue and $275-325 million Adjusted EBITDA. The market appears to be pricing the compounded-to-branded pivot as a durable margin drag rather than a transitory transition; the July 29 FTC lawsuit alleging consumer health data sharing with Meta and Snap plus unauthorized billing charges remains a substantive overhang. Chief Medical Officer Dr. Anant Vinjamoori's July 23 PCAC harm-reduction testimony framing continues to shape the peptide-strategy narrative for the stock.

#hims-hers #hims #q2-2026-aftermath #stock-drop #6-percent-decline #gaap-loss #gross-margin-compression #890-million-q3-guide #compounded-to-branded #ftc-lawsuit

Regulatory

ITM Isotope Technologies Munich SE Received a Complete Response Letter (CRL) From the US Food and Drug Administration on August 7, 2026 for 177Lu-Edotreotide (ITM-11), a Somatostatin Analog Radioligand Peptide Therapeutic Under Investigation for Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs); The CRL Cited Chemistry, Manufacturing, and Controls (CMC) and Third-Party Commercial Manufacturing Facility Items to Address Before Resubmission, but the FDA Did Not Identify Any Concerns Regarding the Clinical Data Package, Nonclinical Data, or Safety Profile of ITM-11; The Company Intends to Resubmit to Complete the NDA Review and Continues to Pursue Approval Following the COMPETE Trial (NCT03049189) Phase 3 Comparison of 177Lu-Edotreotide Versus Everolimus in Inoperable Progressive Grade 1 or Grade 2 GEP-NETs

ITM Isotope Technologies Munich SE received a Complete Response Letter (CRL) from the US FDA on August 7, 2026, disclosed August 10-11, for 177Lu-edotreotide (ITM-11), a somatostatin analog radioligand peptide therapeutic under investigation for gastroenteropancreatic neuroendocrine tumors (GEP-NETs). The CRL cited chemistry, manufacturing, and controls (CMC) and third-party commercial manufacturing facility items that must be addressed before the application can be approved. Notably, the FDA did not identify any concerns regarding the clinical data package, nonclinical data, or safety profile of ITM-11. The COMPETE trial (NCT03049189) evaluated 177Lu-edotreotide compared to everolimus (an oral mTOR inhibitor targeted molecular therapy) in patients with inoperable, progressive Grade 1 or Grade 2 GEP-NETs. ITM-11 is a peptide radioligand therapy: a somatostatin receptor 2 (SSTR2)-targeting peptide chelated to the beta-emitting radionuclide lutetium-177 to deliver targeted radiation to SSTR2-expressing neuroendocrine tumor cells. The category is anchored commercially by Novartis's Lutathera (177Lu-dotatate) and Pluvicto (177Lu-vipivotide tetraxetan, PSMA-targeting for prostate cancer). ITM intends to resubmit and complete the NDA review process. The manufacturing-focused CRL is a substantially better outcome than a clinical-data CRL: resolution timelines for CMC-only CRLs typically run 4-8 months versus 12+ months for data-driven CRLs, and the fundamental commercial thesis remains intact.

#itm-radiopharma #177lu-edotreotide #itm-11 #somatostatin-analog #radioligand #peptide-drug-conjugate #gep-net #neuroendocrine-tumor #fda-complete-response-letter #crl #cmc #compete-trial #lutathera #pluvicto

Clinical Trials

Silence Therapeutics (NASDAQ: SLN) Announced Positive Topline Results From the Phase 2 SANRECO Trial of Divesiran, a First-in-Class TMPRSS6-Targeting siRNA That Increases Hepcidin Production to Restrict Iron Availability to Bone Marrow and Reduce Excessive Red Blood Cell Production in Polycythemia Vera (PV); Trial Enrolled 48 Phlebotomy-Dependent PV Patients With Divesiran 6 mg/kg Administered Subcutaneously Every 6 Weeks or Every 12 Weeks; 88% of Divesiran-Treated Patients Achieved a Response Versus 19% on Placebo (P<0.0001), Corresponding to a 69% Placebo-Adjusted Response Rate; Divesiran Has FDA Fast Track and Orphan Drug Designations for PV; Company Anticipates Initiating a Phase 3 Trial Evaluating Divesiran Every 12 Weeks Versus Placebo in H1 2027 Extending the Broader siRNA Cardiometabolic and Rare-Disease Franchise Landscape That Also Includes Alnylam's Amvuttra and Arrowhead's Redemplo (Plozasiran)

Silence Therapeutics (NASDAQ: SLN) announced positive topline results from the Phase 2 SANRECO trial of divesiran, a first-in-class TMPRSS6-targeting siRNA product candidate developed from the company's proprietary mRNAi GOLD platform. The trial enrolled 48 phlebotomy-dependent adults with polycythemia vera (PV) and evaluated divesiran 6 mg/kg administered subcutaneously every 6 weeks (Q6W) or every 12 weeks (Q12W) versus placebo over a 36-week randomized double-blind period. Results: 88% of divesiran-treated patients achieved a response versus 19% on placebo (P<0.0001), corresponding to a 69% placebo-adjusted response rate. How divesiran works: it silences TMPRSS6 (transmembrane serine protease 6) expressed almost exclusively in the liver; TMPRSS6 is a negative regulator of hepcidin, the body's master regulator of iron metabolism. By silencing TMPRSS6, divesiran increases hepcidin production and release by liver hepatocytes, which restricts iron availability to bone marrow and reduces the excessive red blood cell production that drives PV symptoms. Divesiran has FDA Fast Track and Orphan Drug designations for PV. Silence Therapeutics anticipates initiating a Phase 3 trial evaluating divesiran Q12W versus placebo in the first half of 2027. Shares rose sharply on the news, touching a 52-week high. The read-through extends the broader siRNA cardiometabolic and rare-disease franchise landscape that also includes Alnylam's Amvuttra and Arrowhead's Redemplo (plozasiran) in adjacent hepatic-target siRNA categories.

#silence-therapeutics #sln #divesiran #sanreco #tmprss6 #sirna #hepcidin #polycythemia-vera #pv #phase-2 #88-percent-response #fast-track #orphan-drug #phase-3-h1-2027 #alnylam #arrowhead-pharmaceuticals

Industry

Rhythm Pharmaceuticals (NASDAQ: RYTM) Reported on the August 4 Q2 2026 Earnings Call That the US Launch of IMCIVREE (Setmelanotide, an Alpha-Melanocyte-Stimulating Hormone (Alpha-MSH) Analog Peptide That Activates Melanocortin-4 Receptor for Appetite Suppression) in the Newly-Approved Acquired Hypothalamic Obesity Indication Has Recorded More Than 400 Patient Start Forms Since FDA Approval in Late June 2026; The Launch Ranks Among the Stronger Rare-Disease Peptide Launches of the Year to Date and Extends the Melanocortin-Agonist Franchise Beyond the Original Rare Genetic Obesity Syndromes (POMC, LEPR, PCSK1 Deficiency) That IMCIVREE Was Initially Approved For; The Acquired Hypothalamic Obesity Indication Addresses Patients With Hypothalamic Damage From Brain Tumors, Radiation, or Trauma That Disrupts Normal Melanocortin Signaling and Leads to Severe Obesity

Rhythm Pharmaceuticals (NASDAQ: RYTM) reported on the August 4, 2026 Q2 2026 earnings call that the US launch of IMCIVREE (setmelanotide) in the newly-approved acquired hypothalamic obesity indication has recorded more than 400 patient start forms since FDA approval in late June 2026. Setmelanotide is a synthetic alpha-melanocyte-stimulating hormone (alpha-MSH) analog peptide that activates the melanocortin-4 receptor (MC4R) to produce appetite suppression; the peptide is administered as a daily subcutaneous injection. The launch ranks among the stronger rare-disease peptide launches of the year to date and extends the melanocortin-agonist franchise beyond the original rare genetic obesity syndromes (POMC, LEPR, PCSK1 deficiency) that IMCIVREE was initially approved for in 2020. The acquired hypothalamic obesity indication addresses patients with hypothalamic damage from brain tumors (particularly craniopharyngioma), radiation therapy, surgery, or trauma that disrupts normal melanocortin signaling and leads to severe obesity with dysfunctional appetite regulation. The therapeutic story is mechanistically adjacent to but distinct from the alpha-MSH gray-market use of melanotan II (which activates the same broader melanocortin receptor family for tanning and appetite suppression); setmelanotide has substantially more selectivity for MC4R specifically, an established safety monitoring program, and full FDA approval under the rare-disease pathway. IMCIVREE full-year 2026 revenue guidance is expected to reflect the acquired hypothalamic obesity launch trajectory.

#rhythm-pharmaceuticals #rytm #imcivree #setmelanotide #alpha-msh #melanocortin-4-receptor #mc4r #hypothalamic-obesity #rare-disease-peptide #craniopharyngioma #400-patient-starts #rare-genetic-obesity