Skip to content Skip to footer

Synlogic and Caldera Report Merger Agreement and Concurrent $278M Private Placement to Advance CLD-423

Shots: Synlogic & Caldera have agreed to merge in an all-stock transaction, forming a new holding company that will operate as Caldera Therapeutics & plans to list on Nasdaq under the ticker “CALD” Upon closing, Synlogic, Caldera, and private placement investors are expected to own ~2.3%, ~62.8%, and ~34.9% of the combined company, respectively, with…

Read more

Biocon’s Yesintek (Biosimilar, Stelara) Receives Health Canada Approval for its Autoinjector Presentation

Shots: Health Canada has approved Yesintek Autoinjector (45 mg/0.05 mL & 90 mg/mL), a biosimilar version of Stelara (ustekinumab) Yesintek is indicated for the treatment of mod. to sev. plaque psoriasis in pts (≥6yrs.), active psoriatic arthritis in adults, mod. to sev. active Crohn’s disease & ulcerative colitis in adults Yesintek was previously approved as…

Read more

Incyte

Incyte Reports EC Approval of Opzelura (Ruxolitinib) Cream for Moderate Atopic Dermatitis

Shots: The EC has approved Opzelura (ruxolitinib) cream for the treatment of moderate atopic dermatitis in adults for whom topical corticosteroids (TCSs) & topical calcineurin inhibitors (TCIs) are inadequate or inappropriate Approval was based on the P-IIIb (TRuE-AD4) study assessing Opzelura vs vehicle in 241 adults with moderate AD, which met its co-1EPs of EASI75…

Read more

Corbus Pharmaceuticals Reports FDA Clearance to Initiate TEMPO-1 Trial of CRB-701 in OPSCC

Shots: The US FDA has granted clearance to initiate a registrational study (TEMPO-1) of CRB-701, a Nectin-4-targeted ADC, in 2L oropharyngeal squamous cell carcinoma (OPSCC), with enrolment beginning in Sep 2026 Trial (n=250) will evaluate the efficacy & safety of CRB-701 vs investigator’s choice of capecitabine, cetuximab or docetaxel, assessing ORR as the 1EP to…

Read more

CORE Biomedicine Licenses Preclinical Oncology Portfolio from Eisai

Shots: CORE Biomedicine has entered into a licensing agreement with Eisai, securing exclusive global rights to develop & commercialize multiple preclinical oncology programs As per the deal, CORE will obtain exclusive, global rights to certain preclinical oncology programs spanning distinct targets & biological pathways, providing CORE with a broad pipeline to develop next-generation precision medicines…

Read more