Shots:
The US FDA has accepted NDA & granted priority review to zilganersen for the treatment of Alexander disease (AxD), with PDUFA target action date of Sep 22, 2026
NDA was backed by the P-III trial assessing zilganersen (25 or 50mg) vs control in 54 AxD pts (1.5-53yrs.) for 60wks., followed by an open label…
NEWS
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The P-III (SENTRY) trial assessed Selinexor (60mg, QW) + ruxolitinib vs PBO + ruxolitinib in 353 pts with frontline myelofibrosis; FDA discussions on SENTRY data & its sNDA strategy is underway, with potential compendia inclusion in H2’26
As of Feb 20, 2026, trial met its first co-1EP, with 50% vs 28% achieving SVR35 at…
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Quotient has entered into a multi-year research collaboration agreement with Merck to discover novel drug targets in inflammatory bowel disease leveraging Quotient’s somatic genomics platform tech
Through its somatic genomics platform, Quotient analyzes patient tissue to identify disease-causing or protective mutations, generating insights that inform novel therapeutic strategies across multiple conditions, including IBD
As…
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Prestige has reported the topline P-III (SAMSON-II) trial results evaluating HD204, a biosimilar version of Avastin (bevacizumab), vs Avastin in 625 adults with advanced non-squamous NSCLC
Trial showed an ORR of 48.7% vs 46.5% at 18wks., meeting its 1EP & showing clinical equivalence between HD204 & Avastin; 2EPs supported the primary analysis, with similar Wk.…
Apogee Therapeutics Reports Part A P-II (APEX) Maintenance Data on Zumilokibart in Atopic Dermatitis
Shots:
Apogee has reported maintenance data from Part A of the P-II (APEX) trial assessing zumilokibart (APG777; 360mg at Q3M or Q6M) in pts with mod. to sev. atopic dermatitis
Trial showed 75% (Q3M) & 85% (Q6M) of Wk. 16 zumilokibart-responders maintained EASI-75, while 86% (Q3M) & 78% (Q6M) sustained vIGA 0/1, with continued deepening…
Shots:
Cencora has entered into a definitive agreement to acquire the retina business of EyeSouth Partners in a transaction of ~$1.1B
The deal will bring EyeSouth’s affiliated retina physicians under Retina Consultants of America (RCA), expanding Cencora’s footprint in retina care
Through this integration, physicians will gain access to RCA’s clinical, research, & operational infrastructure,…
Shots:
Gilead to acquire Ouro for a total of $1,675M in upfront cash & up to $500M in contingent milestone payments. Acquisition will add Ouro’s P-I/II asset OM336 (gamgertamig) to Gilead’s inflammation portfolio, with registrational studies to begin in 2027
Also, Gilead is in advanced discussions with Galapagos for a potential R&D collaboration on the…
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Pfizer & Valneva have reported the P-III (VALOR) trial data in pts (≥5yrs.) at high risk of Lyme disease randomized to either PF-07307405 vs saline PBO, with one dose administered at mos. 0, 2, 5-9 followed by a fourth dose 1yr. late
In pre-specified analyses, efficacy reached 73.2% at 28 days post-dose 4 &…
Shots:
Kali Therapeutics has entered into a license agreement with Sanofi for KT501 to treat a broad range of B cell-mediated autoimmune diseases
As per the deal, Sanofi will obtain exclusive worldwide rights to KT501, while Kali will receive upfront & near-term payments totaling $180M and up to $1.05B in development & commercial milestones, with tiered royalties…
Shots:
The Chinese NMPA has granted IND approval to HLX18, a biosimilar version of Opdivo (nivolumab) for the treatment of certain resected solid tumors following the US FDA IND clearance
Additionally, HLX17 (biosimilar, Keytruda) & HLX13 (biosimilar, Yervoy) are under P-I trials with first patient dosing completed, while the IND for HLX15-SC (biosimilar, Darzalex), was…

