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Today’s Big News

Aug 12, 2024

Lykos will ask FDA to reconsider its decision following rejection of MDMA therapy for post-traumatic stress disorder

Analysts dig into details of Avidity's DMD win, revealing nuances in strong data

Halda raises $126M to advance 'hold and kill' solid tumor drugs into the clinic

Bivictrix decides going private is only way to secure funding to take ADCs into clinic

Australian biotech's cortisol blocker fails to improve attention in phase 2 depression study

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Lykos will ask FDA to reconsider its decision following rejection of MDMA therapy for post-traumatic stress disorder

By Fraiser Kansteiner

On Friday, the FDA declined to approve Lykos’ midomafetamine (MDMA) therapy in patients with PTSD. Lykos had been seeking approval of its MDMA capsule along with psychological intervention, also known as MDMA-assisted therapy.

Analysts dig into details of Avidity's DMD win, revealing nuances in strong data

By Nick Paul Taylor

Avidity Biosciences impressed investors with phase 1/2 data in Duchenne muscular dystrophy Friday, extending its winning streak in the clinic. But closer examinations of the data revealed details that analysts said present a much more nuanced picture than what the headline result implies.

Halda raises $126M to advance 'hold and kill' solid tumor drugs into the clinic

By James Waldron

The initial stages of oncology R&D aren’t short of intriguing new modalities, and Halda Therapeutics is planning to join them by using $126 million in fresh funding to run its RIPTAC program into the clinic.

Bivictrix decides going private is only way to secure funding to take ADCs into clinic

By James Waldron

Antibody-drug conjugates have been at the center of many a billion-dollar biobuck licensing deal over the last year, but Bivictrix Therapeutics feels like it’s been missing out.

Australian biotech's cortisol blocker fails to improve attention in phase 2 depression study

By James Waldron

Actinogen Medical’s cortisol blocker has failed to hit the primary endpoint of a phase 2 study in depression, leaving the Australian biotech to focus on its potential in Alzheimer’s disease.

Paige and Microsoft roll out updated image-based AI models for cancer diagnosis

By Heather Landi

Nearly a year after it announced a collaboration with Microsoft, digital pathology player Paige unveiled the second generation of an image-based AI model to help detect cancer.

Ajinomoto will lay off 71 staffers in CA to streamline CDMO business following $620M Forge Biologics buy

By Fraiser Kansteiner

Following last year’s acquisition of viral vector and plasmid specialist Forge Biologics, Japan’s Ajinomoto Bio-Pharma Services is streamlining its business in San Diego. As a result, 71 California-based staffers—or 13% of the company’s overall workforce—are set to lose their jobs, Ajinomoto said in a memo shared with Fierce Pharma.

Would presidential hopeful Harris replace FTC Chair Khan? The implications for PBM reform

By Noah Tong

The donor class is not happy with Lina Khan's interpretation of antitrust enforcement at the FTC, and they want her gone. Here's how likely that is to happen and how it could impact pharmacy benefit managers under a new administration.

Fierce podcasts

Don’t miss an episode

What 'The Next Berlin Patient' and a PrEP’s 100% efficacy mean for HIV drug development

This week on “The Top Line,” we dive into two studies in HIV research that were presented at the 25th International AIDS Conference in Germany.

New mandatory bundled payment model for hospitals

Fierce 15: Where are they now?

Resources

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2024 Life Sciences Industry Outlook

The definitive report on the state of our industry. Readers will gain an understanding of key indicators to monitor, future predictions, and guidance for investors and founders navigating the therapeutic enabling tools and services, healthtech and techbio sectors through 2024 and beyond.