Pfizer Receives the US FDA Priority Review for Talzenna + Xtandi to Treat HRR-Gene Mutated mCSPC

Shots: The US FDA has accepted sNDA & granted priority review to Talzenna (talazoparib) + Xtandi (enzalutamide) to treat men with HRR gene-altered mCSPC, with PDUFA action date in Q4’26. Regulatory review is ongoing in the EU sNDA was supported by the P-III (TALAPRO-3) trial data assessing Talzenna (talazoparib; 0.5mg/day) + Xtandi (160mg/day) vs PBO + Xtandi…

ByRidhi RastogiJuly 24, 2026

NEWS

Revolution Medicines Reports the US FDA NDA Acceptance of Daraxonrasib for Previously Treated Metastatic PDAC

Shots: The US FDA has accepted the NDA for Revolution Medicines’ daraxonrasib to treat pts with previously treated metastatic pancreatic ductal adenocarcinoma (PDAC), plus daraxonrasib was selected for the FDA CNPV pilot program NDA was backed by P-III (RASolute 302) trial assessing daraxonrasib (300mg, QD, PO) vs CT, in above-mentioned pts, regardless of RAS mutation, which…

ByRidhi RastogiJuly 23, 2026

NEWS

Arrowhead Reports P-III (SHASTA-3 & SHASTA-4) Results on Plozasiran in Severe Hypertriglyceridemia (sHTG)

Shots: Arrowhead has reported topline P-III (SHASTA-3 & 4) trial results assessing plozasiran (25mg, SC, Q3M) vs PBO in sHTG pts (n=~750), where both trials met their 1EP of reduced median TGs by 79% & 81%, respectively, at 12mos. vs ~27% Pooled analyses showed significant reductions in AP event rates & total incidence rate, with…

ByRidhi RastogiJuly 23, 2026

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Royalty Pharma Inks ~$425M Deal with Neurimmune to Acquire Royalty Interest in AstraZeneca’s Cliramitug

Shots: Royalty Pharma will pay Neurimmune up to $425M, incl. $125M upfront, in exchange for a 3% to 4% royalty on worldwide net sales of AstraZeneca’s cliramitug Royalty Pharma will pay Neurimmune an additional $125M in cash in Q1’27, with the remaining $175M contingent on the achievement of specified clinical & regulatory milestones Cliramitug is…

ByRidhi RastogiJuly 23, 2026

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BridgeBio Pharma Reports the US FDA’s NDA Acceptance for Encaleret to Treat Autosomal Dominant Hypocalcemia Type 1 (ADH1)

Shots: The US FDA has accepted NDA for encaleret to treat ADH1, with a PDUFA date of May 8, 2027, & no advisory committee planned. BridgeBio is prepared for a potential launch, while an EU MAA filing is expected in H2’26 Encaleret was evaluated in the P-III (CALIBRATE) trial, which met its 1 & 2EPs,…

ByRidhi RastogiJuly 22, 2026

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IMUNON Reports P-II MRD Trial Data on IMNN-001 for Newly Diagnosed Advanced Ovarian Cancer

Shots: IMUNON has reported preliminary data from its ongoing P-II MRD trial assessing IMNN-001 (intraperitoneally) in combination with SoC neoadj. & adj. CT (N/ACT) + Avastin, in women with newly diagnosed advanced ovarian cancer Data from nine pts per arm reaching second-look laparoscopy showed IMNN-001 achieved deeper antitumor responses than control, with lower MRD positivity…

ByRidhi RastogiJuly 22, 2026

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NMPA Accepts Junshi Biosciences’ Toripalimab + CT Supplemental Filing for Resectable Stage II–III NSCLC

Shots: NMPA has accepted the supplemental application of toripalimab + Pt-containing CT as perioperative treatment & subsequent monotx. as adj. therapy for the treatment of adult pts with resectable stage II-III NSCLC Filing was based on P-III (NEOTORCH) trial (n=501), which showed perioperative toripalimab + CT met 1EP of improved EFS by 60% (mEFS: not reached…

ByRidhi RastogiJuly 22, 2026

NEWS

Telix Reports the First Patient Dosing in P-III (LUTEON) Trial of TLX250-Tx for Renal Cancer

Shots: Telix has dosed the first patient with TLX250-Tx (lutetium-177 (177Lu) girentuximab tetraxetan) in the P-III (LUTEON) study to identify eligible pts with CAIX-positive tumors in r/r clear cell renal cell carcinoma (ccRCC) LUTEON trial in Australia is part of Telix’s global development program for TLX250-Tx, alongside the P-IIa (LUTEON ATLAS) study in the US…

ByRidhi RastogiJuly 21, 2026

NEWS

Almirall Reports EMA Acceptance of Ebglyss Pediatric Filing for Atopic Dermatitis in Children Aged 6 Months and Older

Shots: The EMA has accepted a submission to extend marketing authorization of Ebglyss (lebrikizumab) to pts (6mos. to <18yrs., weighing <40kg) with mod. to sev. atopic dermatitis Application was supported by interim data from the pediatric clinical program, incl. the ADorable-1 evaluating Ebglyss in pts (6mos. to <18yrs.), & the ADorable-2 LTE study assessing safety…

ByRidhi RastogiJuly 20, 2026

NEWS

4DMT Reports P-IIb (PRISM) Trial Data on 4D-150 in a Broad Wet AMD Population

Shots: 4DMT reported 2yr. data from the P-IIb (PRISM) trial evaluating intravitreal 4D-150 at 3E10 vg/eye (n=30) & 1E10 vg/eye (n=15) in 45 pts with wet age-related macular degeneration P-IIb subgroup incl. 15 recently diagnosed pts treated with 3E10 vg/eye, which was also selected for the P-III (4FRONT) trials, with the 2-year Phase 2b data…

ByRidhi RastogiJuly 20, 2026

Pfizer Receives the US FDA Priority Review for Talzenna + Xtandi to Treat HRR-Gene Mutated mCSPC

Revolution Medicines Reports the US FDA NDA Acceptance of Daraxonrasib for Previously Treated Metastatic PDAC

Arrowhead Reports P-III (SHASTA-3 & SHASTA-4) Results on Plozasiran in Severe Hypertriglyceridemia (sHTG)

Royalty Pharma Inks ~$425M Deal with Neurimmune to Acquire Royalty Interest in AstraZeneca’s Cliramitug

BridgeBio Pharma Reports the US FDA’s NDA Acceptance for Encaleret to Treat Autosomal Dominant Hypocalcemia Type 1 (ADH1)

IMUNON Reports P-II MRD Trial Data on IMNN-001 for Newly Diagnosed Advanced Ovarian Cancer

NMPA Accepts Junshi Biosciences’ Toripalimab + CT Supplemental Filing for Resectable Stage II–III NSCLC

Telix Reports the First Patient Dosing in P-III (LUTEON) Trial of TLX250-Tx for Renal Cancer

Almirall Reports EMA Acceptance of Ebglyss Pediatric Filing for Atopic Dermatitis in Children Aged 6 Months and Older

4DMT Reports P-IIb (PRISM) Trial Data on 4D-150 in a Broad Wet AMD Population

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