YESAFILI

targets

all catalysts(2)

News(9)

• Scholar Rock rejigs approval filing after FDA flags violations at Novo plant
  Despite earlier claims of improvement at the fill-finish plant, the FDA has classified the facility as Official Action Indicated based on inspection findings.
  biospace · 17h ago
• Scholar Rock ditches Novo’s legacy Catalent plant in FDA refiling of SMA drug
  Scholar 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 · 1d ago
• Regeneron’s ‘aversion’ to M&A questioned as bumper Q2 builds war chest
  Calls for Regeneron to step up dealmaking have intensified as the company has established an $18 billion cash pile and suffered clinical trial setbacks.
  biospace · 12d ago
• FDA scientists question Capricor data; Legend CEO steps down
  Capricor shares lost much of their value ahead of a high-stakes advisory committee meeting. Elsewhere, Ying Huang’s resignation extended a stock slide for Legend and AstraZeneca disclosed more pipe…
  biopharma_dive · 15d ago
• Roche drops TCE for lupus, but hasn’t given up on autoimmune cell therapies
  Roche may have scrapped work on a T-cell engager being evaluated for lupus, but the company’s head of pharma told Fierce that still has a strategy for developing cell therapies for autoimmune disea…
  fiercebiotech · 20d ago
• ARPA-H puts $160M into bespoke drug therapies; Biohaven switches up scientific leadership
  The ARPA-H program could provide researchers with a roadmap to develop personalized gene editing drugs. Elsewhere, a Botox rival succeeded against migraines and two deals were struck.
  biopharma_dive · 1mo ago
• Regeneron immunotherapy combo comes up short in melanoma trial
  A two-drug regimen of Regeneron’s fianlimab and Libtayo didn’t significantly outperform Keytruda in a late-stage study, a finding that surprised Wall Street analysts and wiped out billions in marke…
  biopharma_dive · 2mo ago
• Bayer to buy Perfuse for up to $2.45B, bolstering eye drug pipeline
  Centered around a glaucoma therapy in mid-stage testing, the deal is Bayer’s first drug company acquisition in several years and potentially its largest since it purchased AskBio in 2020.
  biopharma_dive · 3mo ago
• Bristol Myers’ legacy lift, Biogen’s blue skies and Regeneron’s murky outlook
  Investors are still waiting to see whether Bristol Myers and Regeneron’s pipelines will deliver, while Biogen was lifted by better-than-expected results for newer drugs like Leqembi and Skyclarys.
  biopharma_dive · 3mo ago