drug · antibody
apitegromab
pre_registrationupdated 5mo agoby $SRRK Scholar Rock Holding Corp🔗 ChEMBL
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Antibody drug with a maximum clinical stage of Phase 2 (across all indications), with 4 investigational indications.
indications
indications
Obesity
targets
Growth/differentiation factor 8
all catalysts(0)
nothing on the calendar yet
Trials studying apitegromab
- phase2A Study to Evaluate How Apitegromab Works in Subjects Who Are Less Than 2 Years Old and Have Spinal Muscular Atrophy
- phase2Phase 2 Study Evaluating Apitegromab for the Treatment of FSHD
- phase2Efficacy and Safety of Apitegromab for the Treatment of Adults Who Are Overweight or Obese
- phase3Efficacy and Safety of Apitegromab in Patients With Later-Onset Spinal Muscular Atrophy Treated With Nusinersen or Risdiplam
- phase3Long-Term Safety & Efficacy of Apitegromab in Patients With SMA Who Completed Previous Trials of Apitegromab
- —EAP of Apitegromab for Patients With Spinal Muscular Atrophy
News(7)
- Scholar Rock SMA drug approved by FDAProjected by some analysts as a future blockbuster, Isembyld is the first “muscle-targeted” treatment for the disease and, in clinical testing, helped improve motor function in people on standard t…biopharma_dive · 16d ago
- Scholar Rock secures first FDA approval for muscle-targeting rare disease drugScholar Rock’s spinal muscular atrophy drug, now to be called Isembyld, was originally rejected in September 2025, when the FDA cited compliance problems at a third-party manufacturer.biospace · 16d ago
- Scholar Rock gets FDA nod for spinal muscular atrophy drugScholar Rock has won FDA approval for its drug treating a rare muscle-wasting disease, after facing delays due to a troubled manufacturing factory. The injectable drug apitegromab, branded as Isemb…endpoints · 16d ago
- Scholar Rock rejigs approval filing after FDA flags violations at Novo plantDespite earlier claims of improvement at the fill-finish plant, the FDA has classified the facility as Official Action Indicated based on inspection findings.biospace · 1mo ago
- Scholar Rock ditches Novo’s legacy Catalent plant in FDA refiling of SMA drugScholar Rock has dropped Novo Nordisk’s troubled Catalent facility as a contract manufacturer in its FDA refiling for apitegromab, a spinal muscular atrophy candidate, after a recent inspection of…fiercebiotech · 1mo ago
- Scribe's $96M IPO; Scholar Rock awaits site classification for apitegromabScribe writes in $96M IPO: The gene editing biotech expects net proceeds of about $96 million if it prices its Nasdaq listing at $14 per share, the midpoint of the ...endpoints · 2mo ago
- Bristol Myers to build ‘powerful’ AI factory; Samsung Biologics bids for peptide makerBristol Myers is the third pharmaceutical company to recently seek Nvidia’s help building a large AI data center. Elsewhere, a Novartis kidney drug gained a leg up on competitors.biopharma_dive · 2mo ago
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