Shots:
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’…
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The EC has approved Imdylltra (tarlatamab) as a monotx. to treat adults with extensive-stage small cell lung cancer (ES-SCLC) who require systemic therapy following disease progression on or after 1L treatment with Pt-based CT
Approval was based on the P-III (DeLLphi-304) trial assessing Imdelltra vs SoC CT (topotecan globally excl. Japan; lurbinectedin in the…
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Servier has entered into an agreement with Edgewise Therapeutics to acquire its muscular dystrophy business, supporting Servier’s strategic ambition in rare neurology
As per the deal, Servier will acquire the muscular dystrophy business for ~$2.65B, incl. $1.55B upfront and ~$1.1B in regulatory & commercial milestone payments; closing is expected in Q3’26
The acquisition adds Edgewise’s…
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Haisco Pharmaceutical has entered into a licensing & research collaboration with Eli Lilly to develop novel medicines across multiple therapeutic areas
As per the deal, Haisco will be responsible for the discovery & identification of ~5 target programs, while Lilly will lead IND-enabling studies, clinical development, & commercialization
Lilly will gain exclusive global rights…

