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BioWorld - Monday, April 6, 2026
Home » Topics » Regulatory » Breakthrough therapy

Breakthrough therapy
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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.
Read More
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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Vykat XR

First Prader-Willi treatment Vykat XR FDA-approved: Soleno soars

March 27, 2025
By Karen Carey
Becoming the first treatment for rare genetic disorder Prader-Willi syndrome, breakthrough therapy drug DCCR (diazoxide choline) gained U.S. FDA approval as Vykat XR the evening before its March 27 PDUFA date, sending shares of developer Soleno Therapeutics Inc. up 38%.
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3D illustration of mesenchymal stem cells

Nature Cell wins FDA breakthrough designation of Jointstem

March 25, 2025
By Marian (YoonJee) Chu
Nature Cell Co. Ltd. won U.S. FDA breakthrough therapy designation of its autologous adipose-derived mesenchymal stem cell therapy, Jointstem, March 20, becoming the first Korean company to earn the label in the field of cell therapy.
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Polycythemia vera illustration

Protagonist’s rusfertide hits phase III goals in rare leukemia

March 5, 2025
By Marian (YoonJee) Chu
Rusfertide could become a blockbuster therapy for polycythemia vera, H.C. Wainwright analyst Douglas Tsao wrote March 4 after the injectable hepcidin mimetic peptide hit its primary endpoint and all four key secondary endpoints in the ongoing phase III Verify study.
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