Shots:
Sun Pharma to acquire Checkpoint Therapeutics for ~$355M to strengthen its onco-derm innovative portfolio with Unloxcyt (cosibelimab-ipdl); closing expected in Q2’25
As per the deal, Checkpoint stockholders will get $4.10 cash/share (~66% premium) upfront & CVR/share without interest allowing stockholders to receive additional $0.70 cash/share if Unloxcyt is approved before certain deadlines in…
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J&J has reported P-III trial data incl. ICONIC-LEAD (vs PBO) & ICONIC-ADVANCE 1&2 (vs Sotyktu) assessing icotrokinra (JNJ-2113, QD, PO) to treat mod. to sev. plaque Ps
OICONIC-LEAD showed that pts achieved IGA 0/1 (65% vs 8%) & reached PASI 90 (50% vs 4%) at 16wks. By Wk. 24, 74% achieved IGA 0/1,…
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Incyte has reported P-III (TRuE-PN: TRuE-PN1 & TRuE-PN2) clinical program data assessing Opzelura (BID) vs vehicle in ~180 PN pts (≥18yrs.) each for 12wks
TRuE-PN1 showed ≥4-point WI-NRS4 improvement at 12wks. (1EP; 44.6% vs 20.6%), with itch relief by Day 7 (22.4% vs 8.0%). It also met its 2EPs, incl. higher IGA-CPG-S-TS score…
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The EC has approved Opdivo + Yervoy as 1L therapy to treat inoperable or advanced HCC adult pts in 30 EEA states; sBLA under the US FDA’s priority review (PDUFA: Apr 21, 2025)
Approval was based on P-III (CheckMate-9DW) trial assessing Opdivo (1mg/kg, Q3W) + Yervoy (3mg/kg, Q3W), followed by Opdivo alone (480mg,…
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GumPaws has launched gummy supplements to support dental health in dogs
GumPaws gummies are designed with specific density & chewiness to improve friction, helping clean plaque & support dental care in dogs, offering dual-benefit compared to conventional supplements
Gummies are formulated with scientifically-backed natural ingredients that start absorbing through the gums &…
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Biocon Biologics has entered into strategic collaboration agreement with Civica to extend access & affordability of Insulin Aspart in the US
As per the deal, Biocon will supply Insulin Aspart drug substance to Civica, which will manufacture prefilled pens & vials of insulin at its Petersburg, Virginia facility. Civica will commercialize it in the US…
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AstraZeneca has reported P-III (MATTERHORN) trial data assessing perioperative Imfinzi + FLOT (fluorouracil, leucovorin, oxaliplatin, & docetaxel) vs PBO + FLOT in 948 pts with stage II-IVA G/GEJ cancers
Pts received Imfinzi (1500mg) + FLOT or PBO + FLOT for Q4W × 2 cycles before surgery followed by Imfinzi or PBO for Q4W × 12…
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The US FDA has approved Encelto (revakinagene taroretcel-lwey) to treat macular telangiectasia type 2 (MacTel); commercially available in the US by Jun 2025
Approval was based on P-III trial data demonstrating reduced macular photoreceptor loss for ~24mos. post-implantation
Encelto (intravitreal implant) utilizes an encapsulated cell therapy tech to continuously deliver ciliary neurotrophic…
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Tris has reported topline data from P-III (ALLEVIATE-2) trial in post-bunionectomy pts, plus additional data from P-III (ALLEVIATE-1) trial in post-abdominoplasty pts. Data from both trials, plus HAP studies will support the US FDA’s NDA filing in 2025
ALLEVIATE-2 evaluated cebranopadol (400µg QD, PO) vs oxycodone (10mg QID, PO) vs PBO, meeting its…
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HUTCHMED has reported enrollment completion in P-II trial of fanregratinib to treat intrahepatic cholangiocarcinoma (IHCC) in pts with FGFR2 fusion or rearrangement; favorable trial results will support NMPA’s NDA submission
The P-II trial of fanregratinib will assess ORR as 1EP whereas PFS, DCR, DoR, & OS as 2EPs in pts (n=87). Topline data…

