Biotech Currents

The Friday Biotech Perspective #42

uniQure’s speculative Huntington’s catalyst soars because it was speculative

Oct 10 • 

Bill Langbein

Pushing Gene Editing Inside the Body: A Company's New Approach to Treating B-Cell Cancers and Autoimmune Disease

Assigning a 65.3% overall probability data will be positive.

Oct 8 • 

Bill Langbein

September 2025

Company takes aim at new cancer indications

Assigning a 61.5% overall probability the partners will report positive data

Sep 18 • 

Bill Langbein

IDEAYA (IDYA) scores phase II win in uveal melanoma (UM)

76% of patients saw tumor shrinkage in phase II; phase III registration trial now underway

Sep 12 • 

Bill Langbein

FDA turns back Telix’s (OTCPK:TLPPF) kidney cancer imaging agent BLA

The FDA issued a complete response letter (CRL) on August 28 for Telix Pharmaceuticals Ltd.’s (OTCPK:TLPPF) TLX250-CDx (Zircaix), an imaging agent…

Sep 2 • 

Bill Langbein

August 2025

The FDA chill continues as agency rejects PTC Thera’s (PTCT) vatiquinone

The FDA issued a complete response letter (CRL) on August 19 for PTC Therapeutics, Inc.’s (PTCT) vatiquinone to treat the rare neuromuscular disorder…

Aug 22 • 

Bill Langbein

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 • 

Bill Langbein

FDA slaps down Regeneron’s (REGN) odronextamab again

Déjà vu for Regeneron: FDA hits pause over same Indiana site

Aug 3 • 

Bill Langbein

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 • 

Bill Langbein

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 • 

Bill Langbein

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 • 

Bill Langbein

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 • 

Bill Langbein