| 01.21.25 | 2 more biotechs prep for IPO plunge; RTW biotech offers $520M for InnoCare-Keymed bispecific rights

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The New Era of CDx in Oncology

Companion diagnostics play a vital role in oncology therapeutic development, but evolving regulations are changing the game. Join our webinar for expert guidance on adapting your assay development and study design strategies. Register to stay ahead!

Today’s Big News

Jan 21, 2025

Odyssey, Sionna join band of biotechs ready to brave thawing IPO waters in 2025

InnoCare, Keymed sell ex-China rights for bispecific to RTW-built biotech in $520M deal

HHS gives Moderna $590M to 'accelerate' bird flu vaccine trials

Sage sues Biogen as analyst detects little interest in buyout at initial price

New findings shed light on cause of Huntington's disease progression

FDA gives Amylyx green light for phase 1 ALS trial after clinical hold

Disc set to spin up confirmatory trial, seek approval after ironing out details with FDA

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

Odyssey, Sionna join band of biotechs ready to brave thawing IPO waters in 2025

By Nick Paul Taylor

Odyssey Therapeutics and Sionna Therapeutics have filed IPO paperwork, swelling the pack of startups that will provide an early look at how receptive public investors could be to biotech listings in 2025.

InnoCare, Keymed sell ex-China rights for bispecific to RTW-built biotech in $520M deal

By James Waldron

Chinese biotechs InnoCare Pharma and KeyMed Biosciences have sold the international rights to a clinical-stage bispecific antibody to a new company created by RTW Investments for $17.5 million in near-term cash.

HHS gives Moderna $590M to 'accelerate' bird flu vaccine trials

By James Waldron

The government wants Moderna to push forward with various bird flu vaccines as well as mRNA shots for other influenza strains with pandemic potential.

Sage sues Biogen as analyst detects little interest in buyout at original offer price

By Angus Liu

Sage Therapeutics has brought a lawsuit seeking a temporary restraining order against Biogen shortly after receiving an "unsolicited" offer from its neuroscience partner.

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.

New findings shed light on cause of Huntington's disease progression

By Darren Incorvaia

A new study of nerve cells affected by Huntington’s disease reveals that the disease-causing gene slowly expands over time but doesn't start causing harm until it hits a toxic threshold that rapidly leads to the nerve cell’s death.

FDA gives Amylyx green light for phase 1 ALS trial after clinical hold

By Gabrielle Masson

After raising questions surrounding dosing levels, the FDA has freed Amylyx’s early-stage amyotrophic lateral sclerosis (ALS) candidate from a clinical hold.

Disc set to spin up confirmatory trial, seek approval after ironing out details with FDA

By Nick Paul Taylor

Disc Medicine has finalized the design of the confirmatory trial for its rare blood disorder drug candidate, adding a co-primary endpoint at the request of the FDA to clear the path to accelerated approval.

Atara's Ebvallo and pipeline candidate put on clinical hold in US after partner's failed plant inspection

By Fraiser Kansteiner

Atara announced that the FDA has placed a clinical hold on the company’s investigational new drug applications for the Europe-approved Ebvallo and the allogeneic CD19-targeted CAR-T candidate ATA3219. Atara linked the hold to a recent FDA inspection of a third-party manufacturing facility for Ebvallo, which resulted in a U.S. rejection of the allogeneic cell therapy.

Datroway, 2nd ADC from AstraZeneca-Daiichi collab, wins first FDA nod in breast cancer

By Angus Liu

AstraZeneca and Daiichi Sankyo’s second antibody-drug conjugate, TROP2-directed Dato-Dxd, has crossed the U.S. regulatory finish line.

Fierce podcasts

Don’t miss an episode

Fierce's forecasts for the next year in biopharma

This week on “The Top Line,” we explore the trends that defined the industry in 2024 and predict how 2025 might shake out for biopharmas big and small.

How hospitals can avoid common price transparency compliance pitfalls

Breaking down the 55 new drug approvals of 2024

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