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NEWS

Revolution Medicines Highlights P-III (RASolute 302) Trial Results on Daraxonrasib for Previously Treated Metastatic Pancreatic Cancer

Shots: As of Feb 10, 2026 (mFU: 8.5mos.), the P-III trial assessing daraxonrasib (300mg, QD, PO; n=248) vs CT (n=252) in previously treated metastatic PDAC, regardless of RAS mutation, met all 1 & key 2EPs, showing benefits in both the RAS G12 mutant (daraxonrasib n=228; CT n=231) & overall population Daraxonrasib improved OS by 60% in…
June 1, 2026

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Immedica Receives EC Approval for Zepzelca + Tecentriq to Treat 1L ES-SCLC 

Shots:  The EC has approved Zepzelca (Lurbinectedin) + Tecentriq (Atezolizumab) as a 1L therapy for adults with ES-SCLC whose disease remains stable after initial treatment with Tecentriq, carboplatin, & etoposide  Approval was based on P-III (IMforte) trial results, showing Zepzelca + Tecentriq reduced the risk of progression or death by 46% & death risk by 27% vs Tecentriq alone. Trial showed mOS of 13.2 vs 10.6mos. & mPFS of 5.4 vs 2.1 mos. for Zepzelca + Tecentriq vs Tecentriq alone,…
June 1, 2026

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Eli lilly
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Eli Lilly Highlights P-III (LIBRETTO-432) Trial Data on Retevmo for Early-Stage RET Fusion–Positive NSCLC at ASCO 2026

Shots: Lilly's global P-III (LIBRETTO-432) trial assessed Retevmo (selpercatinib; 160mg, BID) vs PBO in 151 pts with early-stage (IB-IIIA) RET fusion-positive NSCLC following completion of definitive radiotherapy or surgery with curative intent, & other adjuvant therapy Trial met the 1EP, improving the EFS by 83% in stage II–IIIA RET-positive NSCLC (n=109), with 24mos. EFS rates of…
June 1, 2026

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NEWS

Altimmune Reports the P-IIb (IMPACT) Trial Data on Pemvidutide for Metabolic Dysfunction-Associated Steatohepatitis (MASH)

Shots: Altimmune has reported 48wk. data from the P-IIb (IMPACT) trial assessing pemvidutide (1.2 or 1.8mg, SC, QW) vs PBO in 212 pts with MASH & fibrosis stages F2 or F3, with & without diabetes Pemvidutide (1.8mg) showed a reduction in triglycerides by 23.7%, total cholesterol by 15.4%, BMI by 3kg/m², waist circumference by 5.3cm,…
May 29, 2026

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Cogent Biosciences Receives the US FDA Priority Review for Bezuclastinib Combination to Treat Gastrointestinal Stromal Tumors (GIST)

Shots: The US FDA has accepted NDA & granted priority review to Cogent's bezuclastinib + sunitinib for the treatment of pts with GIST who were treated with imatinib, with no advisory committee meeting planned yet (PDUFA: Nov 30, 2026) NDA was supported by the P-III (PEAK) trial data assessing bezuclastinib + sunitinib vs sunitinib monotx.…
May 29, 2026

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AstraZeneca Receives the US FDA Approval for Imfinzi Regimen to Treat High-Risk Non-Muscle-Invasive Bladder Cancer (NMIBC)

Shots: The US FDA has approved AZ's Imfinzi (durvalumab) in combination with Bacillus Calmette-Guérin (BCG) induction & maintenance therapy for the treatment of adults with BCG-naïve, high-risk NMIBC; regulatory review is ongoing in the EU & Japan Approval was based on the P-III (POTOMAC) trial of 1018 high-risk, BCG-naïve NMIBC pts post-TURBT, randomized to Imfinzi…
May 29, 2026

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Ironwood Pharmaceuticals Reports the US FDA Approval of Linzess to Treat Pediatric Patients (≥2yrs.) with Functional Constipation

Shots: The US FDA has approved label expansion of Linzess (linaclotide) in pts (≥2yrs.) for the treatment of functional constipation (FC) Approval was supported by data from a 12wk. P-III trial assessing Linzess in pediatric pts (2-5yrs.) with FC, where Linzess (72mcg) showed improvement in spontaneous bowel movement frequency vs PBO Linzess contains linaclotide, a…
May 28, 2026

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