Shots:
Ascidian has entered a global research & licensing agreement with Eli Lilly to discover & develop therapies for undisclosed monogenic kidney diseases, with an option to expand the collaboration to additional targets
As per the deal, Lilly will obtain exclusive target-specific rights to Ascidian’s RNA exon editing tech for undisclosed targets, with Ascidian leading…
NEWS
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Celcuity has reported the PIK3CA mutant cohort data from P-III (VIKTORIA-1) study of gedatolisib + fulvestrant ± palbociclib vs SoC in HR+/HER2- advanced breast cancer pts who progressed on or after treatment with CDK4/6 inhibitor & an aromatase inhibitor
In the cohort, the gedatolisib triplet showed mPFS of 11.1 vs. 5.6mos., & an ORR…
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The FDA has granted IDE approval to initiate a multi-center pivotal study evaluating the Separo Vessel Sealing System vs standard mucosal cautery vasectomy
The trial will enroll 120 adult male subjects across ~5 US centers, with the primary endpoint measuring azoospermia or rare non-motile sperm (≤100,000/mL) within 6mos. following the procedure
The Separo System…
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Oncolytics has reported initial data from a preclinical study assessing pelareorep, a systemically active immunotherapy, in combination with RAS inhibitor modalities, which showed greater anti-tumor activity in a solid tumor model vs either therapy alone
Based on the findings, Oncolytics is planning additional studies of the combination in pancreatic ductal adenocarcinoma & colorectal cancer…
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AZ's trial assessed camizestrant (n=157) vs AI (anastrozole/letrozole; n=158), both in combination with CDK4/6 inhibitor in 315 pts with LA/M HR+/HER2- advanced breast cancer harboring ESR1 mutation; filings supported by the trial are under review in the US, EU & Japan
Trial showed 24mos. PFS rate of 34.9% vs 14.2% (mPFS: 16.8 vs…
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Gilead has reported the P-III (IDEAL) trial data assessing Livdelzi (seladelpar) vs PBO in 96 adults (18-75yrs.) with PBC who have inadequately controlled disease, on or intolerant to ursodeoxycholic acid
Trial showed that a higher proportion of pts treated with Livdelzi achieved normalization of ALP after 52wks.; data to be presented at a future conference & discussed…
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Travere has entered into an exclusive licensing & collaboration agreement with Everest Medicines for the development & commercialization of civorebrutinib (EVER001) worldwide (excl. China & certain countries in East & Southeast Asia)
As per the deal, Everest will receive $112.5M upfront & ~$1.03B in cash payments tied to development, regulatory & commercial milestones across…
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The US FDA has accepted NDA & granted priority review to Genentech’s giredestrant as an adj. treatment for adults with ER+, HER2-, ESR1-mutated stage I, II, and III breast cancer (PDUFA: Nov 30, 2026)
NDA was supported by the P-III (lidERA Breast Cancer) trial (n>4,100), where adj. giredestrant reduced iDFS by 30%, with 92.4%…
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The EC has approved AbbVie's Aquipta (atogepant) for the acute treatment of migraine in adults with or without aura, to be taken as needed
Approval was supported by the P-III (ECLIPSE) trial data assessing Aquipta/Qulipta (60mg, PO) vs PBO as an acute treatment of migraine with or without aura in 1,328 adults (18-75yrs.)
Trial met…
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Rallybio has entered into a definitive agreement to acquire Avenzo through a merger transaction, after which the combined company will operate under the name Avenzo Therapeutics & is expected to trade on Nasdaq under the ticker symbol "AVZO"
As per the deal, Avenzo shareholders will receive newly issued Rallybio shares based on the companies’…

