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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

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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.

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.

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