Plus, news about Caliway Pharmaceuticals, argenx, Halozyme Therapeutics, Verrica, Liquidia and Pharmosa:
FDA lifts partial clinical hold on Avidity Biosciences’ drug:
The treatment
, called delpacibart etedesiran, is in the Phase 3 HARBOR trial in patients with myotonic dystrophy type 1, a progressive and often fatal neuromuscular disease with no approved therapies. The
FDA first handed down
a partial clinical hold in 2022, following a serious adverse event in an earlier-stage study. Avidity’s stock
$RNA
rose about 3% on Thursday.
— Katherine Lewin
Orum Therapeutics outlines IPO in South Korea:
The biotech plans to list on the KOSDAQ market to help fund its protein degrader at a time when antibody-drug conjugates are still hot. Orum is
seeking
between $67 million to $80 million in the IPO. Earlier this year, it
partnered with Vertex
, and last year it
sold an asset
to Bristol Myers Squibb.
— Kyle LaHucik
Caliway Biopharmaceuticals also has IPO plans, in Taiwan:
The biotech uplisted to the Taipei Exchange and raised about $206 million, or NT $6.4 billion, which it
described
as the “largest IPO in Taiwan’s biotech industry history.” The company expects to have Phase 2b results by the end of the year for a subcutaneous fat reduction injectable. It also has preclinical injections for hyperpigmentation and osteoarthritis.
— Kyle LaHucik
Argenx picks four new targets per deal with Halozyme Therapeutics:
The company is using Halozyme’s ENHANZE drug delivery technology to pick a total of six targets. It will now
pay Halozyme $30 million
upfront for the exclusive rights to the four new targets. Argenx could also pay up to $85 million per target for milestone payments, regulatory approvals, and sales. Halozyme’s stock
$HALO
gained about 2% in premarket trading on Thursday.
— Katherine Lewin
Verrica slashes commercial team headcount:
The West Chester, PA-based biotech said it
cut
its workforce by 47 employees in a bid to “streamline operations, reduce costs and preserve capital.” The layoffs are part of the company’s broader
push
to trim its commercial organization, which includes focusing on 35 sales territories, down from an original 80. It had 100 full-time employees as of Dec. 31.
— Ayisha Sharma
Liquidia expands drug licensing deal with Pharmosa:
Under the terms of the updated
pact
, Liquidia will get the rights to Pharmosa’s pulmonary arterial hypertension candidate, L606, in markets outside of North America, including Japan and parts of Europe. Liquidia is set to pay Pharmosa $3.5 million upfront and up to $157.75 million in milestones in the new territories.
— Ayisha Sharma