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BioWorld - Monday, June 8, 2026
Home » Topics » Regulatory » Breakthrough therapy

Breakthrough therapy
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Pancreas

Sonire starts US study of cancer HIFU after $18M series A

May 5, 2026
By Marian (YoonJee) Chu
No Comments
Sonire Therapeutics Inc. initiated a U.S.-based Sunrise II study of Suizenji, its novel ultrasound-guided high-intensity focused ultrasound (HIFU) system designed to ablate pancreatic tumors, after closing an $18 million series A financing round April 15.
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Pancreas

Sonire starts US study of cancer HIFU after $18M series A

May 1, 2026
By Marian (YoonJee) Chu
No Comments
Sonire Therapeutics Inc. initiated a U.S.-based Sunrise II study of Suizenji, its novel ultrasound-guided high-intensity focused ultrasound (HIFU) system designed to ablate pancreatic tumors, after closing an $18 million series A financing round April 15.
Read More
Illustration of monoclonal antibody treatment for cancer
Newco news

Pilatus PLT-012 takes immunometabolic approach to reprogram TME

April 28, 2026
By Marian (YoonJee) Chu
No Comments
Pilatus Bio Inc. is working to address a major under-addressed target of current checkpoint inhibitors: metabolic stress within solid tumors. “Traditional immunotherapies release immune ‘brakes,’ but they do not address the underlying metabolic stress in tumors,” Pilatus CEO and cofounder Raven Lin said. “That’s why more than 60% of solid tumor patients do not respond to treatment.”
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Brain with handshake and cityscape

Otsuka to acquire PTSD drugmaker Transcend in $1.2B deal

March 31, 2026
By Marian (YoonJee) Chu
No Comments
Otsuka Pharmaceutical Co. Ltd. is taking a neuroplastogen approach to posttraumatic stress disorder (PTSD) through its planned $1.22 billion acquisition of Transcend Therapeutics Inc. The deal gives Tokyo-headquartered Otsuka access to Transcend’s lead asset, TSND-201, an oral neuroplastogen that has begun patient recruitment for a phase III study in the U.S.
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Brain with handshake and cityscape

Otsuka to acquire PTSD drugmaker Transcend in $1.2B deal

March 30, 2026
By Marian (YoonJee) Chu
No Comments
Otsuka Pharmaceutical Co. Ltd. is taking a neuroplastogen approach to posttraumatic stress disorder (PTSD) through its planned $1.22 billion acquisition of Transcend Therapeutics Inc. The deal gives Tokyo-headquartered Otsuka access to Transcend’s lead asset, TSND-201, an oral neuroplastogen that has begun patient recruitment for a phase III study in the U.S.
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KRAS protein

D3 Bio raises $108M series B to move KRAS G12C into phase III

Dec. 16, 2025
By Marian (YoonJee) Chu
No Comments
D3 Bio Inc. secured $108 million in a series B financing round Dec. 9 to support its planned phase III program of lead oral KRAS G12C inhibitor, elisrasib (D3S-001).
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KRAS protein

D3 Bio raises $108M series B to move KRAS G12C into phase III

Dec. 10, 2025
By Marian (YoonJee) Chu
No Comments
D3 Bio Inc. secured $108 million in a series B financing round Dec. 9 to support its planned phase III program of lead oral KRAS G12C inhibitor, elisrasib (D3S-001).
Read More
Antibodies attacking cancer cell

Innovent rings up $11.4B deal with Takeda for three I-O/ADC assets

Oct. 22, 2025
By Marian (YoonJee) Chu
No Comments
Takeda Pharmaceutical Co. Ltd. agreed to codevelop and commercialize up to three of Innovent Biologics Co. Ltd.’s immuno-oncology (I-O) and antibody-drug conjugate (ADC) candidates with the signing of a $11.4 billion deal, including $1.2 billion paid up front.
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Knee pain illustration

Allay’s $57.5M extends postsurgical pain relief with ATX-101

June 10, 2025
By Karen Carey
No Comments
As it advances its nonopioid analgesic ATX-101 breakthrough therapy through a phase IIb registration trial, Allay Therapeutics secured $57.5 million in a series D round, which included an investment from the company’s Japanese partner.
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Knee pain illustration

Allay’s $57.5M extends postsurgical pain relief with ATX-101

June 6, 2025
By Karen Carey
No Comments
As it advances its nonopioid analgesic ATX-101 breakthrough therapy through a phase IIb registration trial, Allay Therapeutics secured $57.5 million in a series D round, which included an investment from the company’s Japanese partner. ATX-101, a configuration of sodium ion channel blocker bupivacaine and a biopolymer, which is in a phase IIb registration study, is designed to offer pain relief following total knee arthroplasty.
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