Recent 8-K filings for PTCT
Highest-materiality recent filing
FDA denies approval of PTC Therapeutics' vatiquinone NDA for Friedreich's ataxia
- FDA CRL states substantial evidence of efficacy not demonstrated; additional well-controlled study needed for resubmission.
- PTC plans to meet with FDA to discuss potential steps to address CRL issues.
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PTC Therapeutics shareholders elect four Class I directors and ratify Ernst & Young
Jessica Chutter, Matthew Klein, Stephanie Okey, and Jerome Zeldis elected Class I directors with >83% of votes cast.
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PTC Therapeutics Q1 revenue $273M, raises FY product revenue guidance to $750-850M
Q1 2026 total revenue $273M; product revenue $226M, up 47% YoY.
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Stage 2 HD participants showed 52% (10 mg) and 28% (5 mg) slowing on cUHDRS vs natural history at 24 months.
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PTC Therapeutics appoints biotech banking veteran Jessica Chutter to board
Jessica Chutter appointed to board effective March 24, 2026, as Class I director.
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PTC Therapeutics reports FY2025 product/royalty rev $831M, beats guidance; Sephience Q4 rev $92M
Full-year 2025 product/royalty revenue $831M, exceeding guidance; total revenue $1.73B (includes $998M Novartis collaboration).
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PTC Therapeutics withdraws Translarna NDA resubmission after FDA cites insufficient efficacy data
Withdrew NDA resubmission for Translarna (ataluren) for nonsense mutation Duchenne muscular dystrophy.
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Preliminary 2025 total product & royalty revenue ~$823.4M, exceeding prior guidance; product revenue ~$587.8M.
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PTC Therapeutics sells remaining Evrysdi royalty stake to Royalty Pharma for $240M upfront
Sold remaining 9.5111%/16.6666% royalty interest in Evrysdi worldwide net sales for $240M upfront cash.
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PTC Therapeutics Q3 net income $15.9M, Sephience launch revenue $19.6M
Total revenue $211.0M vs $196.8M YoY; net income $15.9M vs loss of $106.7M.
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FDA denies approval of PTC Therapeutics' vatiquinone NDA for Friedreich's ataxia
FDA CRL states substantial evidence of efficacy not demonstrated; additional well-controlled study needed for resubmission.
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PTC Therapeutics Q2 2025: Sephience approved in EU and US; total revenue $179M; net loss narrows
Sephience (sepiapterin) received EC and FDA approval with broad label for PKU across all ages and subtypes; global launch initiated.
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PTC Therapeutics pays ~$225M upfront to cancel Censa sepiapterin royalty obligations
Upfront cash payment of ~$225M to former Censa securityholders eliminates 8-12% annual net sales royalties.
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FDA approved Sephience for hyperphenylalaninemia in adult/pediatric patients ≥1 month with sepiapterin-responsive PKU.
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PTC Therapeutics reports results of 2025 annual meeting; all three proposals approved
Elected Allan Jacobson (60,386,986 for), David Southwell (59,200,375), Alethia Young (54,894,657) as Class III directors to 2028 term.
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PTC Therapeutics Q1 net income $866.6M on Novartis deal; guides FY revenue $650-800M
Net income $866.6M vs loss $91.6M YoY, driven by $986.2M upfront from Novartis PTC518 license deal.
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PTC518 Phase 2 PIVOT-HD meets primary endpoint with dose-dependent HTT lowering at Week 12
Primary endpoint met: dose-dependent blood HTT protein reduction (p<0.0001) at Week 12.
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European Commission refuses renewal of Translarna (ataluren) marketing authorization in EU
EC adopted CHMP negative opinion; renewal of conditional MA for nonsense mutation DMD denied.
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PTC Therapeutics reports FY2024 revenue $807M above guidance; cash >$2B after Novartis deal
FY2024 total revenue $806.8M, exceeding guidance; net loss $363.3M vs $626.6M prior year.
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Preliminary 2024 total revenue ~$814M, net product revenue ~$601M, and Evrysdi royalties ~$211M.
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PTC Therapeutics cuts leased space in half, reduces base rent by $57.7M
Surrendered one of two buildings; premises reduced from 360k to 180k sq ft.
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PTC Therapeutics signs $1B upfront license deal with Novartis for PTC518 HD program
PTC receives $1.0B upfront; eligible for up to $1.9B in development, regulatory and sales milestones.
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PTC Therapeutics sells Rare Pediatric Disease PRV for $150 million cash
Sale price of $150 million payable in cash upon closing to an affiliate of a large pharmaceutical company.
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PTC Therapeutics Q3 revenue $196.8M, raises FY2024 guidance to $750-800M, multiple FDA submissions
Q3 total revenue $196.8M (vs $196.6M YoY); DMD franchise $124M (Translarna $72M, Emflaza $52M).
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CHMP maintains negative opinion on PTC's Translarna renewal; EC decision awaited in ~67 days
CHMP upheld negative opinion on renewal of conditional marketing authorization for Translarna (ataluren) in nmDMD after re-examination.
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PTC Therapeutics Q2 revenue $187M; net loss narrows to $99M; NDAs submitted
Q2 total revenue $186.7M vs $213.8M YoY; DMD franchise $118M (Translarna $70M, Emflaza $47M).
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CHMP issues negative opinion on Translarna renewal; PTC plans re-examination
CHMP issued negative opinion on renewal of conditional marketing authorization for Translarna (ataluren) for nmDMD.
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PTC518 Ph2 PIVOT-HD shows mHTT lowering and clinical trends; FDA lifts partial clinical hold
PTC518 lowered mHTT in blood by 22% (5mg) and 43% (10mg) at Month 12; similar CSF levels.
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EC rejects CHMP negative opinion on Translarna; returns for re-evaluation; 2024 guidance paused
EC decided not to adopt CHMP's negative opinion for Translarna annual renewal; returns to CHMP for re-evaluation.
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PTC Therapeutics Q1 total revenue $210M, net loss narrows to $91.6M; pipeline milestones on track
Q1 total revenue $210M (down ~5% YoY); DMD franchise $161M (Translarna $104M, Emflaza $57M).
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PTC Therapeutics 2023 revenue up 34% to $938M; guides 2024 revenue $600-680M
Total revenue $937.8M (+34% YoY); net loss $626.6M vs $559.0M in 2022.
Earnings & guidance
Materiality & sentiment trend
Max materiality 0.90 · Median 0.80 · Most common event earnings