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Company on track to be fast follower in Friedreich’s ataxia
Assigning a 62.5% overall probability the FDA will sign off on the company's treatment of Friedreich’s ataxia.
Aug 5
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Bill Langbein
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Company on track to be fast follower in Friedreich’s ataxia
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FDA slaps down Regeneron’s (REGN) odronextamab again
Déjà vu for Regeneron: FDA hits pause over same Indiana site
Aug 3
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Bill Langbein
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FDA slaps down Regeneron’s (REGN) odronextamab again
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July 2025
Company seeks to turn around treatment of congenital hyperinsulinism
Assigning a 69.2% overall probability there will be positive data from the trial.
Jul 29
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Bill Langbein
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Company seeks to turn around treatment of congenital hyperinsulinism
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Company seeks to boost oncology franchise with approval of treatment for follicular lymphoma
Assigning a 64.4% overall probability the FDA will sign off!
Jul 22
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Bill Langbein
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Company seeks to boost oncology franchise with approval of treatment for follicular lymphoma
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Bids for Verona (VRNA), Monogram (MGRM) may signal new life for M&A
Tracking the catalysts behind biotech’s return to the M&A spotlight
Jul 16
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Bill Langbein
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Bids for Verona (VRNA), Monogram (MGRM) may signal new life for M&A
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After brief delay, FDA approves KalVista’s (KALV) sebetralstat as on-demand HAE treatment
Approval positions KalVista to compete in $1B U.S. market
Jul 10
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Bill Langbein
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After brief delay, FDA approves KalVista’s (KALV) sebetralstat as on-demand HAE treatment
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New Data Could Redefine the Market for a Vision Disorder Treatment Company on the Verge of FDA Approval
We assign a 68.2% overall probability the FDA give the greenlight
Jul 1
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Bill Langbein
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New Data Could Redefine the Market for a Vision Disorder Treatment Company on the Verge of FDA Approval
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June 2025
Clinical trial data from Ascendis (ASND), Tourmaline (TRML) push stocks higher
Data-driven rallies highlight potential in rare disease and cardiovascular care
Jun 19
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Bill Langbein
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Clinical trial data from Ascendis (ASND), Tourmaline (TRML) push stocks higher
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aTyr Pharma's (ATYR) efzofitimod aims to get in front of pulmonary sarcoidosis, lung disease
Assigning a 62.5% overall probability aTyr Pharma will report positive topline data from a phase III trial testing its drug efzofitimod to treat…
Jun 10
•
Bill Langbein
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aTyr Pharma's (ATYR) efzofitimod aims to get in front of pulmonary sarcoidosis, lung disease
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IDEAYA's (IDYA) darovasertib to address uveal melanoma at various stages of disease
Assigning a 71.1% overall probability IDEAYA will report positive updates from the phase II trial.
Jun 10
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Bill Langbein
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IDEAYA's (IDYA) darovasertib to address uveal melanoma at various stages of disease
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The Friday Biotech Perspective #41
A personal vaccine journey and … the Makary-Prasad-RFK Jr. guidance
Jun 2
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Bill Langbein
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The Friday Biotech Perspective #41
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May 2025
ORR from Merus N.V.’s (NASDAQ:MRUS) H&N cancer drug triggers stock surge
The interim data from 43 evaluable patients revealed a 63% overall response rate
May 29
•
Bill Langbein
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ORR from Merus N.V.’s (NASDAQ:MRUS) H&N cancer drug triggers stock surge
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