Scinai Immunotherapeutics Secures Golden Power Clearance in Move to Acquire Pincell

• Scinai Immunotherapeutics has received Italian regulatory clearance under the Golden Power law to proceed with its option to acquire biotech firm Pincell S.r.l.

• The deal includes rights to PC111, a monoclonal antibody for severe dermatological conditions, with EMA Orphan Drug Designation already granted.

Scinai Immunotherapeutics Ltd. has received regulatory clearance from the Italian government to proceed with its option to acquire Pincell S.r.l., an Italian biotechnology company. The approval falls under Italy’s Golden Power regulation (Law Decree No. 21/2012), which allows the government to review transactions in strategic sectors.

The clearance follows an assessment by the Ministry of Health and was issued by the Coordination Group for the exercise of special powers. It relates to the transaction submitted on 5 April 2025, which also includes the licensing of Pincell’s intellectual property to Scinai’s Polish subsidiary.

Scinai first entered into a binding option agreement to acquire Pincell in March 2025. The acquisition would bring under its portfolio PC111, a fully human monoclonal antibody that targets the Fas/FasL pathway. PC111 is being developed to treat severe skin diseases such as Pemphigus, Stevens-Johnson Syndrome (SJS), and Toxic Epidermal Necrolysis (TEN), and has already been granted Orphan Drug Designation by the European Medicines Agency.

“This regulatory clearance… represents a significant step forward in our planned acquisition of Pincell,” said Amir Reichman, CEO of Scinai Immunotherapeutics. He added that while this milestone is important, further steps are needed before the transaction is completed.

As part of its preparations, Scinai’s Polish subsidiary has submitted a €12 million grant application under the EU’s FENG programme to support the next development phase of PC111. A decision on the funding is expected between mid-July and early August 2025. Completion of the acquisition remains subject to this and other standard closing conditions.