| 01.22.24 | Ionis nails ph. 3 HAE trial, teeing up approval ask; Genentech hands back Alzheimer's meds to AC Immune

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Today’s Big News

Jan 22, 2024

Ionis’ HAE drug bests placebo in phase 3, setting up run to FDA approval

Roche’s Genentech returns Alzheimer’s assets to AC Immune, cutting 18-year tie to the biotech

2023's top 10 clinical trial flops

Sagimet stock doubles as phase 2b MASH trial hits primary goals, despite dropout queries

FDA lifts remaining hold on Pharvaris’ HAE drug, clearing path to phase 3

Itch treater Cara cuts 50% of team to extend cash runway into 2026

Arrivent anticipates $135M IPO as biotechs continue to eye public market

Approved IBS drug Bentyl may help overcome chemo-resistant prostate cancer


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Ionis’ HAE drug bests placebo in phase 3, setting up run to FDA approval

By James Waldron

Ionis Pharmaceuticals’ investigational treatment for hereditary angioedema (HAE) has hit the primary endpoint of a phase 3 trial, allowing the biotech to ready its approval application to the FDA.

Roche’s Genentech returns Alzheimer’s assets to AC Immune, cutting 18-year tie to the biotech

By Nick Paul Taylor

Genentech is walking away from an 18-year relationship with AC Immune, handing back global rights to a pair of Alzheimer’s disease drug candidates after suffering a series of setbacks in the clinic.

2023's top 10 clinical trial flops

By Annalee Armstrong

Fierce Biotech recounts the top 10 clinical trial failures of 2023 that sent ripples across the industry.

Six key considerations for cell and gene therapy patient support programs

Sagimet stock doubles as phase 2b MASH trial hits primary goals, despite dropout queries

By Nick Paul Taylor

Sagimet Biosciences has eased the pain of investors who backed its IPO last year, reporting phase 2b data in metabolic-associated steatohepatitis that sent its stock soaring. Yet, the 20% dropout rate in the drug arm and exclusion of patients from the analysis prompted questions from analysts.

FDA lifts remaining hold on Pharvaris’ HAE drug, clearing path to phase 3

By James Waldron

Pharvaris’ preventative oral medicine for hereditary angioedema (HAE) has had its remaining clinical hold lifted by the FDA weeks after the treatment proved its worth in a phase 2 study.

Itch treater Cara cuts 50% of team to extend cash runway into 2026

By Max Bayer

Cara Therapeutics is laying off up to 50% of its team as the company narrows its clinical ambitions. An oral version of FDA-approved Korsuva has failed to distinguish itself in studies.

Arrivent anticipates $135M IPO as biotechs continue to eye public market

By Gabrielle Masson

Arrivent Biopharma has said it will raise around $135 million in the company’s upcoming public offering.

Approved IBS drug Bentyl may help overcome chemo-resistant prostate cancer

By Helen Floersh

A drug used to treat irritable bowel syndrome appears to be effective against prostate cancer in mice when given in tandem with chemotherapy, a new study shows.

Gilead's Trodelvy fails to extend survival in lung cancer study, prompting selloff

By Zoey Becker

The antibody-drug conjugate did not significantly improve survival outcomes compared with a chemotherapy alone in previously treated patients with metastatic non-small cell lung cancer. The trial outcome marks a setback in Gilead's ambition to grow its presence in the oncology sector.

Natera offers $52.5M for Invitae’s reproductive health screening tests after patent spat

By Andrea Park

Just a few weeks after earning a permanent injunction barring the use of Invitae’s Personalized Cancer Monitoring tests, Natera is taking another of the diagnostic developer’s product portfolios off its hands.

Bristol Myers shows power of Opdivo-Yervoy combo in first-line colorectal cancer subset

By Angus Liu

More than five years after an FDA accelerated approval in a subtype of progressive colorectal cancer, Bristol Myers Squibb now has data supporting its checkpoint inhibitor doublet in newly diagnosed patients. But another approval may have to wait.

FDA clears vibrating belt to boost brittle bones in women facing osteoporosis

By Conor Hale

The Osteoboost belt, developed by Bone Health Technologies, is a far cry from the century-old mechanical devices that once claimed to promote weight loss and overall vigor.

Elevance Health wants to use AI to simplify and personalize healthcare. Here's how the insurance giant is doing it

By Heather Landi

The health insurance giant, which serves 117 million people, sees opportunities to leverage generative AI and other technologies to make healthcare easier to navigate, chief AI officer Shawn Wang said during an interview at CES 2024.

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Presented by Blue Matter, strategic consultants in the life sciences