| 09.03.24 | Sanofi moves MS med forward despite ph. 3 fails; How Bayer's $5B blockbuster dreams collapsed

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Today’s Big News

Sep 3, 2024

Sanofi's tolebrutinib fails 2 of trio of phase 3 MS trials, but pharma still plans FDA filing

New data reveal how Bayer's asundexian failed to prevent strokes, imperiling $5.5B blockbuster hopes

Three execs resign as Dyne posts mixed data for DMD candidate

Vaxcyte's 'stunning' 31-valent pneumococcal vaccine win against Pfizer's Prevnar 20 has analysts thinking big

Fierce Biotech Fundraising Tracker '24: Circle rounds up $90M; Navigator notches $100M

Arrowhead fires off phase 3 data in rare metabolic disease ahead of market clash with Ionis

Recursion's phase 2 brain disease trial yields scant evidence of efficacy

Praxis’ sodium channel blocker reduces seizures in two types of epilepsy in phase 2

Pfizer, Valneva unveil phase 2 proof that Lyme disease shot is still effective for 2nd booster

ProKidney halts one CKD cell therapy phase 3 trial considered surplus to FDA approval

Announcing the 2024 Fierce CRO Awards

Who’s Leading the Way in Clinical Research? Nominate Them for the CRO Awards!

The Fierce CRO Awards shine a spotlight on the organizations that are setting new standards in clinical research and development. If your CRO excels in innovation, quality, and leadership, it’s time to get the recognition you deserve. Submissions close October 3rd.

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Featured

Sanofi's tolebrutinib fails 2 of trio of phase 3 MS trials, but pharma still plans FDA filing

By James Waldron

Sanofi is still set on taking its multiple sclerosis med tolebrutinib drug to the FDA, executives have told Fierce Biotech, despite the BTK inhibitor falling short in two of three phase 3 trials that read out on Monday.

New data reveal how Bayer's asundexian failed to prevent strokes, imperiling $5.5B blockbuster hopes

By Darren Incorvaia

The full picture of how Bayer's factor XIa inhibitor asundexian showed "inferior efficacy" compared to Eliquis has come into focus: patients receiving asundexian actually suffered strokes or systemic embolisms at a higher rate than those receiving Eliquis.

Three execs resign as Dyne posts mixed data for DMD candidate

By Fraiser Kansteiner

In tandem with a data drop on its Duchenne muscular dystrophy candidate in patients suited to exon 51 skipping therapy, Dyne Therapeutics has announced a slew of executive changes, including multiple appointments and departures.

Fierce Biotech Editor-in-Chief Ayla Ellison Talks Shop with Michelle Benz on the Future of Biotech.

Digital Pharma East

September 9-12, 2024 | Philadelphia, PA

Join us at Digital Pharma East, the leading event for digital innovation in the pharmaceutical industry. Dive into key topics including Digital Marketing, Data & Analytics, and Patient Engagement. Learn from industry experts, network with peers, and explore cutting-edge strategies to drive your digital initiatives forward.

Only 1 WEEK LEFT to Join us in Philadelphia!

Vaxcyte's 'stunning' 31-valent pneumococcal vaccine win against Pfizer's Prevnar 20 has analysts thinking big

By Angus Liu

Vaxcyte unveiled what analysts called “stunning” phase 1/2 data for its 31-valent pneumococcal vaccine candidate that, if replicated in a large pivotal study, could pose a serious threat to Pfizer’s stalwart Prevnar 20.

Fierce Biotech Fundraising Tracker '24: Circle rounds up $90M; Navigator notches $100M

By Gabrielle Masson,Annalee Armstrong,Darren Incorvaia,Max Bayer

Welcome to Fierce Biotech's Fundraising Tracker, 2024's version.

Arrowhead fires off phase 3 data in rare metabolic disease ahead of market clash with Ionis

By Nick Paul Taylor

Arrowhead Pharmaceuticals has shown its hand ahead of a potential showdown with Ionis, publishing phase 3 data on a rare metabolic disease treatment that is racing toward regulators.

Recursion's phase 2 brain disease trial yields scant evidence of efficacy

By Nick Paul Taylor

Recursion has stumbled through an early test of its tech-enabled approach to drug discovery, reporting a hit on its phase 2 primary endpoint of safety and tolerability but failing to wow on the efficacy front.

Praxis' sodium channel blocker reduces seizures in 2 types of epilepsy in phase 2

By James Waldron

Praxis Precision Medicines has scored another midphase win in epilepsy this year, with its sodium channel inhibitor shown to reduce seizures in children with two specific types of the neurological disorder.

Pfizer, Valneva unveil phase 2 proof that Lyme disease shot is still effective for 2nd booster

By James Waldron

Pfizer and Valneva may have about two more years to wait before they make the first approval filing to the FDA for a Lyme disease vaccine, but that hasn’t stopped the companies pointing out more positive data in the meantime.

ProKidney halts one CKD cell therapy phase 3 trial considered surplus to FDA approval

By James Waldron

ProKidney has stopped one of a pair of phase 3 trials for its cell therapy for kidney disease after deciding it wasn’t essential for securing FDA approval.

Bayer's Kerendia reduced the risk of cardio death by 16% in tough-to-treat class of heart failure patients

By Kevin Dunleavy

At the European Society of Cardiology event, Bayer unveiled data from the phase 3 FINEARTS-HF trial that showed Kerendia reduced the risk of cardiovascular death as well as well as first and recurrent HF events by 16% compared to placebo in patients with mildly reduced or preserved ejection fraction.

In Europe, shortages of Novo Nordisk's Ozempic to persist into Q4: letter

By Zoey Becker

The company and the European Medicines Agency warned European healthcare providers to continue limiting new patient prescriptions until the shortages let up.

Fierce podcasts

Don’t miss an episode

What Chevron’s overturn means for biopharma

This week on "The Top Line," we look at the potential effects of the Chevron overturn on the biopharma industry.

The Coalition for Health AI wants local governance and national standards for health AI

The TROP2 race for supremacy

Fierce L ife Sciences Innovation Awards

Shape the Future of Life Sciences

Submissions for the Fierce Life Sciences Innovation Awards are coming to a close September 5th, 2024. Click to submit your entry for our new 2024 category: AI Innovation. Enter now!

Resources

Whitepaper

Building a “Best Practice” Commercial Organization in Biopharma

We interviewed dozens of biopharma leaders on the critical success factors for building a Best Practice commercial organization. This report shares what we learned.

Epilepsy Clinical Trials

Finding an effective epilepsy treatment can be arduous. Download this brochure to delve into how IQVIA's expertise and innovative strategic approach can streamline the clinical trial process, helping to get new therapies to patients who need them sooner.