| 01.27.25 | Akero delivers 'transformational' MASH win; Metsera, Maze plot paths to IPOs

Klicken Sie hier, um Fiercebiotech.com zu abonnieren

Laden...

Vor 9 Tagen

Html
Text

Webinar: AI in Clinical Trials: Simplifying the Path to Insights

Thursday, February 20, 2025 | 2pm ET / 11am PT

Clinical trials only continue to increase in complexity. Join industry experts to explore how AI can transform workflows to help sponsors and CROs better manage data while maintaining speed, quality and compliance. Register now.

Today’s Big News

Jan 27, 2025

Akero's stock doubles as midphase MASH trial generates 'transformational' data: analyst

Metsera eyes $289M IPO to fund phase 3 weight loss trial

Maze rolls out map to $131M IPO, as phase 2 kidney disease trial readies for dosing

After White House transition, FDA’s diversity guidance for clinical trials no longer available

Allakos axes program, lays off 75% of staff and seeks strategic alternatives after phase 1 flop

Veru's drug conserves muscle mass for older patients taking Novo's Wegovy in phase 2 trial

Top 10 most anticipated drug launches of 2025

Nippon Shinyaku to pay $36M to reserve US rights to AB2 Bio's near-approval autoimmune drug

Though prevalent in the lab and middle management, east Asian Americans are underrepresented in biopharma C-suites: report

GSK offers up to £50M to conduct cancer vaccine research with the University of Oxford

Webinar: Innovations in aseptic processing for container closure systems

Wednesday, February 12, 2025 | 10am ET / 7am PT

If you are a company developing advanced therapies, don’t miss this webinar to learn about packaging innovations and aseptic filling solutions that meet the demands of emerging therapies and ensure product integrity, safety and efficiency. Register now.

Featured

Akero's stock doubles as midphase MASH trial generates 'transformational' data: analyst

By Nick Paul Taylor

Akero Therapeutics has hit a home run, reporting statistically significant results in two key 96-week metabolic dysfunction-associated steatohepatitis analyses to send its stock up about 100%.

Metsera eyes $289M IPO to fund phase 3 weight loss trial

By James Waldron

Metsera has set its sights on a hefty $289 million IPO as the next-gen obesity biotech seeks to fund a phase 3 trial of its GLP-1 receptor agonist.

Maze rolls out map to $131M IPO, as phase 2 kidney disease trial readies for dosing

By James Waldron

Maze Therapeutics has set out plans for a $131 million IPO as the company prepares to take its lead kidney drug through a phase 2 trial.

After White House transition, FDA’s diversity guidance for clinical trials no longer available

By Gabrielle Masson

The FDA’s guidance detailing diversity action plans for clinical trials that evaluate drugs, devices and other medical products has been taken down from the agency’s website.

Webinar: Breaking New Ground in ALS Research

Thursday, February 20, 2025 | 1pm ET / 10am PT

ALS remains one of the most complex neurological diseases to understand and treat. Join industry experts to learn about the latest advancements in ALS research, with exclusive insights into the latest scientific progress shaping the future of ALS therapies. Register now.

Allakos axes program, lays off 75% of staff and seeks strategic alternatives after phase 1 flop

By Nick Paul Taylor

Allakos is throwing in the towel. After seeing phase 1 data in hives, the biotech has decided to drop the drug candidate and lay off 75% of its employees to hunker down while exploring strategic alternatives.

Veru's drug conserves muscle mass for older patients taking Novo's Wegovy in phase 2 trial

By James Waldron

The study hit its primary endpoint of showing a statistically significant preservation of total lean body mass at 16 weeks in patients receiving enobosarm compared to those who received placebo.

Top 10 most anticipated drug launches of 2025

By Andrea Park,Nick Paul Taylor

According to Evaluate’s forecasts, the biggest potential drug launches of the coming year stand to generate a collective $29 billion in annual sales by the end of the decade, nearly double the estimate for last year’s top 10.

Nippon Shinyaku to pay $36M to reserve US rights to AB2 Bio's near-approval autoimmune drug

By James Waldron

Japan’s Nippon Shinyaku is continuing to scoop up the international rights to some intriguing drugs, this time penning a $650 million biobucks deal for AB2 Bio’s late-stage autoimmune disease therapy.

Though prevalent in the lab and middle management, east Asian Americans are underrepresented in biopharma C-suites: report

By Darren Incorvaia

Despite making up a sizable chunk of entry-level employees at the biggest U.S. biopharmas, the share of east Asian Americans drops dramatically as you move up the ranks. That’s according to a report from ElevAAte Biotech, a new nonprofit that seeks to boost the biopharma C-suite representation of Americans who descend from countries like China, Japan, South Korea and Taiwan.

GSK offers up to £50M to conduct cancer vaccine research with the University of Oxford

By Darren Incorvaia

British pharma giant GSK is heading back to school, pledging up to 50 million pounds sterling (about $62.4 million) to work with the University of Oxford on cancer vaccines.

Bristol Myers, Pfizer tout new standards of care in colorectal cancer subtypes

By Angus Liu

Old drugs from Bristol Myers Squibb and Pfizer have delivered what the companies and researchers believe could establish them as new standard treatments for certain colorectal cancer patients.

UnitedHealth estimates 190M people impacted by Change Healthcare cyberattack

By Paige Minemyer

Change Healthcare now estimates that 190 million people were affected in the massive cyberattack that took down its services nearly a year ago.

Gearing up to challenge Lilly in obesity, Kailera picks Zepbound brand leader as new commercial chief

By Andrea Park

Not long after reporting phase 2 data for one of its obesity candidates that appeared to put it on par with Eli Lilly’s Zepbound, Kailera Therapeutics is preparing for an eventual market launch with a new commercial leader.

Fierce podcasts

Don’t miss an episode

Recapping the 2025 J.P. Morgan Healthcare Conference

This week on “The Top Line,” we break down the biggest stories out of JPM, from J&J’s blockbuster acquisition of Intra-Cellular Therapies to former First Lady Jill Biden’s appearance at Fierce JPM Week.

Learnings from Indiana's behavioral health system overhaul

Fierce's forecasts for the next year in biopharma

Webinar: Optimizing Formulation Strategies: Insights into Bioavailability Enhancement and Accelerated Development

Wednesday, February 19, 2025 | 11am ET / 8am PT

This webinar takes a deep dive into effective formulation strategies to overcome current solubility and bioavailability hurdles. Join us to explore the latest advancements in bioavailability enhancement technologies and critical factors for selecting the right formulation approach. Register now.

Resources

Whitepaper

Communicating the Value of Biopharma Assets to Potential Investors

How can an emerging company attract the right partner for a therapeutic asset (& optimize its value in a transaction)? This paper offers some insights.

Presented by: Blue Matter, strategic consultants in the life sciences