Recent 8-K filings for RYTM
Highest-materiality recent filing
Rhythm Pharma wins FDA approval for IMCIVREE in acquired hypothalamic obesity; Phase 3 shows -18.4% BMI reduction
- FDA approved IMCIVREE (setmelanotide) for acquired HO in adults and children 4+; first approved therapy for this indication.
- Phase 3 TRANSCEND: setmelanotide (-15.8% BMI) vs placebo (+2.6%) at 52 weeks; placebo-adjusted -18.4% (p<0.0001).
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Rhythm Q1 product revenue $60.1M; IMCIVREE HO launch >150 start forms; net loss $(0.83)/share
Q1 2026 net product revenue $60.1M (up 5% sequentially); U.S. revenue $36.9M, ex-U.S. $23.2M.
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Rhythm Pharma gets positive CHMP opinion to expand IMCIVREE label for acquired hypothalamic obesity
CHMP recommends expanding IMCIVREE (setmelanotide) marketing authorization to treat obesity/control hunger in patients >=4 years with acquired HO due to hypothalamic injury.
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FDA approved IMCIVREE (setmelanotide) for acquired HO in adults and children 4+; first approved therapy for this indication.
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Rhythm's Phase 3 EMANATE trial misses primary endpoints; post hoc signals in POMC/SRC1
Four substudies failed primary endpoint: placebo-adjusted BMI reductions of 4.3% (POMC/PCSK1), 3.6% (LEPR), 4.0% (SRC1), 1.7% (SH2B1); all p>0.05.
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Rhythm reports additional positive Phase 3 TRANSCEND data for setmelanotide in hypothalamic obesity
Placebo-adjusted BMI reduction of 18.8% (N=142); primary endpoint met with -16.4% BMI change on setmelanotide vs +2.4% on placebo (p<0.0001).
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Q4 2025 IMCIVREE revenue $57.3M, up 12% sequentially; full year revenue $194.8M vs $130.1M in 2024.
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Rhythm Pharma Q4 2025 IMCIVREE revenue ~$57M (+11% QoQ); FY2025 ~$194M (+50% YoY)
Q4 2025 net product revenue ~$57M, up 11% sequentially from Q3 2025.
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Rhythm Pharma reports positive Phase 2 setmelanotide data in PWS; plans Phase 3
18 patients enrolled; 17 remain on therapy; safety consistent with known profile.
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FDA extends review of Rhythm's setmelanotide sNDA to March 20, 2026
New PDUFA goal date March 20, 2026, extended 3 months from December 20, 2025.
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Rhythm Q3 IMCIVREE revenue $51.3M; net loss -$0.82/sh; PDUFA Dec 20
Q3 2025 IMCIVREE revenue $51.3M (+6% seq, +54% YoY); US $38.2M (+19% seq).
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Q2 net product revenue $48.5M, up 29% sequentially from Q1 2025; US revenue $32.0M (66% of total), up 31%.
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Rhythm Pharmaceuticals raises $188.7M in public equity offering; underwriters exercise full option
Offering of 2,058,824 shares at $85.00 per share; underwriters exercised 30-day option for 308,823 additional shares in full.
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Rhythm Pharma's bivamelagon Phase 2 meets endpoints: -9.3% BMI reduction at 14 weeks
BMI reduction -9.3% (600mg, p=0.0004) and -7.7% (400mg, p=0.0002) vs 2.2% increase on placebo.
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Rhythm Q1 product rev $37.7M; Phase 3 HO trial meets endpoint with -19.8% BMI reduction
Net product revenue $37.7M, up from $26.0M YoY; U.S. $24.5M, ex-U.S. $13.2M.
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Mean BMI change of -16.5% on setmelanotide vs +3.3% for placebo at 52 weeks (p<0.0001); 80% achieved ≥5% BMI reduction.
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Rhythm terminates RareStone license for IMCIVREE in China; reacquires rights for $6.3M
Termination of 2021 Exclusive License and Share Purchase agreements with RareStone Group Ltd.
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Rhythm Q4 2024 IMCIVREE revenue $41.8M; cash runway extended to 2027
Q4 2024 IMCIVREE net revenue $41.8M (+26% sequential, +73% YoY); FY2024 total $130.1M.
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Preliminary Q4 2024 IMCIVREE net revenues of ~$42M, up 26% sequentially; full year ~$130M vs $77.4M in 2023.
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Rhythm Pharma Q3 revenue $33.3M (+14% seq); FDA Priority Review for label expansion to age 2
IMCIVREE net revenue $33.3M (Q3 2024), up 48% YoY from $22.5M; US sales $23.3M (+8% seq), ex-US $10.0M (+35% seq).
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Rhythm Pharma Q2 2024 revenue $29.1M, up 52% YoY; net loss narrows to $33.6M
Net product revenue $29.1M vs $19.2M in Q2 2023; 74% generated in United States.
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Rhythm Pharma Q1 net revenue $26.0M (+126% YoY); net loss $141.4M on $92.4M LB54640 charge
Net product revenue $26.0M (Q1 2023: $11.5M); 74% from U.S. sales.
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Rhythm Pharmaceuticals closes $150M Series A Convertible Preferred issuance to Perceptive affiliates
Closed on April 15, 2024; issued 150,000 shares at $1,000 each for aggregate $150,000,000.
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Rhythm Pharma raises $150M in convertible preferred stock; conversion at $48 (19% premium)
$150M gross proceeds from sale of Series A Convertible Preferred Stock to Perceptive and other existing shareholders.
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Rhythm Pharmaceuticals amends sales agreement to allow up to $200M in at-the-market stock offerings
Amendment increases ATM offering limit from $100M to $200M, excluding $50M already sold.
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Rhythm Pharma Q4 IMCIVREE rev $24.2M; reports material weakness in IT controls
Q4 2023 net product revenue $24.2M (FY2023 $77.4M) vs $8.8M Q4 2022; net loss $41.6M ($0.70/share).
Earnings & guidance
Materiality & sentiment trend
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