Incyte's $750M M&A play hit by trial pause, asset cull

Today’s Big News

Nov 19, 2024

J&J, Protagonist's oral psoriasis prospect scores in phase 3 pair, readying case against BMS' Sotyktu


‘Some call it the J.P. Morgan of Europe’: Jefferies' London conference goes big for 2024


Incyte's $750M buyout rocked by pause on key trial, asset cull


Lilly's lipoprotein-blocking heart med posts midstage win, turning up heat on potential AZ showdown


GSK scratches itch for phase 3 win, hitting goal in liver disease trial to open up untapped market


Neurogene stops Batten gene therapy after FDA denies request, dealing double dose of bad news


Nearing potential FDA approval, BridgeBio shows additional positive data on ATTR-CM candidate acoramidis


After seeing improved muscle function in phase 1/2 trial, Regenxbio launches pivotal DMD study


Cybin's psychedelic depression drug reduces 12-month symptom severity

The Top Line Podcast: Don’t miss out on the newest episode. Listen now.

 

Featured

J&J, Protagonist's oral psoriasis prospect scores in phase 3 pair, readying case against BMS' Sotyktu

The phase 3 successes pad the IL-23 blocker's case as J&J prepares to go against BMS' oral psoriasis treatment Sotyktu in a separate study.
 

Top Stories

‘Some call it the J.P. Morgan of Europe’: Jefferies' London conference goes big for 2024

Delegates told Fierce that the mix of pharma and finance attendees is helping add to the popularity of the expanding Jefferies Healthcare Conference in London.

Incyte's $750M buyout rocked by pause on key trial, asset cull

Incyte’s $750 million Escient Pharmaceuticals buyout has rapidly run into problems. Less than six months after closing the deal, Incyte has paused a key study over preclinical toxicology findings and axed another program altogether.

MRD Takes Center Stage: Accelerating Drug Approvals for Multiple Myeloma

Discover how minimal residual disease (MRD) assessment is accelerating multiple myeloma drug development through FDA's latest guidance.

Lilly's lipoprotein-blocking heart med posts midstage win, turning up heat on potential AZ showdown

Across three doses tested in a phase 2 study, Lilly’s lipoprotein (a) inhibitor muvalaplin helped significantly reduce patients’ heightened levels of Lp(a)—a genetic risk factor for heart disease—versus placebo. The win bodes well for Lilly after AstraZeneca picked up an experimental in-class rival last month.

Dell Technologies on the data transformation in life sciences

Head of Life Sciences Strategy Alex Long shares key insights and advice for IT professionals working to enable healthcare’s technology transformation.

GSK scratches itch for phase 3 win, hitting goal in liver disease trial to open up untapped market

A phase 3 trial of GSK’s linerixibat in a liver disease has hit its primary endpoint, keeping the drugmaker on track to launch the first treatment for the relentless itching experienced by some patients.

Neurogene stops Batten gene therapy after FDA denies request

Neurogene followed up a premarket setback to its Rett syndrome program Monday with a postmarket confirmation that development of another gene therapy has hit a wall.

Nearing potential FDA approval, BridgeBio shows additional positive data on ATTR-CM candidate acoramidis

As BridgeBio approaches its FDA target date for approval of TTR stabilizer acoramidis to treat the rare heart disease transthyretin amyloid cardiomyopathy, the company has presented more data indicating it can become a force in the indication.

After seeing improved muscle function in phase 1/2 trial, Regenxbio launches pivotal DMD study

Regenxbio’s investigational gene therapy improved muscle function for patients with Duchenne muscular dystrophy in a phase 1/2 study. After discussions with the FDA, the biotech has launched a pivotal study and plans on filing for accelerated approval in 2026.

Cybin's psychedelic depression drug reduces 12-month symptom severity

After failing to impress investors a year ago with an initial look at phase 2 data of a psilocybin-derived compound in major depressive disorder (MDD), Cybin momentarily boosted their spirits with a longer-term analysis. Twelve months after two 16 mg doses of the drug, called CYB003, seven patients saw their scores improve on the Montgomery–Åsberg Depression Rating Scale.

Despite fears over RFK Jr. pick, industry should focus more on FDA job: analyst

In a contrarian take offered by BMO Capital Markets' Evan Seigerman, the analyst said Robert F. Kennedy Jr. may not rock the boat as much as feared for the biopharma industry.

Fierce Biotech Fundraising Tracker '24: ATB activates with $57M series A; TRexBio roars with $84M

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

NeuroBo Pharmaceuticals rebrands to become MetaVia

Cardiometabolic disease biotech NeuroBo Pharmaceuticals is shaking up its corporate image with a complete rebrand.
 
Fierce podcasts

Don’t miss an episode

Misconduct and the future of neurodegenerative disease research

This week on "The Top Line," we explore a neuroscientist's alleged misconduct and its impact on the future of neurodegenerative disease research.
 

Resources

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The use of prefilled syringes to administer biotherapeutics is beginning to gain traction because they offer a range of stability, efficacy, and patient safety benefits. Download this white paper to learn how Lonza has developed a novel workflow to ensure confidence regarding functionality in PFS and autoinjectors.
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7 “Make or Break” Factors for Emerging Biopharma Companies

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Intensified Biomanufacturing

Unlock the secrets to faster, cost-effective biologics production with intensified biomanufacturing – download the whitepaper and power up your bioprocessing game!
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Planning for success in cell-based manufacturing

Learn how to evaluate quality documentation to help you select the right raw materials at early decision points for your cell-based manufacturing processes.
 

Industry Events

On Helix

Date: ‌4 ‌July ‌2024 ‌- ‌Location: ‌Babraham ‌Research ‌Campus, ‌Cambridge ‌UK

 

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