Kyowa Kirin Reports the EC Approval for Crysvita for X-Linked Hypophosphataemia

Shots: The EC has approved an expansion of the indication for Crysvita (burosumab) for the treatment of X-linked hypophosphataemia (XLH), to incl. infants from 1mos. to 1yr. of age Approval was supported by data from P-I/II (BUR-CL207) study assessing safety, tolerability, PK & efficacy of burosumab in pts with XLH from birth to 1yr. Trial showed…

ByRidhi Rastogi1 hour ago

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Mission Therapeutics Inks a ~$292M Deal with Dimerix for MTX652

Shots: Mission Therapeutics has reported the divestment of its P-II-ready asset MTX652, to Dimerix for initial development in Acute Kidney Injury (AKI) As per the deal, Mission will receive ~$292M in upfront, development & commercial milestones, plus up to double-digit tiered royalties on global net sales The divestment aligns with Mission’s strategy to maximize its…

ByRidhi Rastogi4 days ago

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Diagonal Therapeutics Reports First Patient Dosed in P-I/II (DIAMOND) Trial of DIAG723 for HHT

Shots: Diagonal has dosed the first patient with DIAG723, a clustering agonist antibody, in P-I/II (DIAMOND) trial (n=~93) for people living with hereditary hemorrhagic telangiectasia (HHT) Trial will evaluate DIAG723 (SC) vs PBO in 3 parts: Part A (P-I) will assess single ascending doses; Part B (P-II) will evaluate multiple doses over 14wks. for safety…

ByRidhi Rastogi5 days ago

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Roche Receives the US FDA Priority Review for Gazyva to Treat Primary Membranous Nephropathy

Shots: The US FDA has granted Priority Review to the sBLA of Gazyva/Gazyvaro (obinutuzumab) in pMN, based on the P-III (MAJESTY) study assessing Gazyva vs tacrolimus in adults (n=142), with a decision expected by Nov 2026 Trial met its 1EP, with 36.9% adults achieving CR at 2yrs. vs 5.7%, plus showed superiority across key 2EPs…

ByRidhi RastogiJuly 15, 2026

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GSK Reports P-II (AZUR-1) Trial Data on Jemperli for dMMR/MSI-H Locally Advanced Rectal Cancer

Shots: GSK has reported global P-II (AZUR-1) trial data assessing Jemperli (dostarlimab) (500mg, IV, Q3W for 9 cycles) in 154 pts with stage II/III mismatch repair deficient/microsatellite instability-high (dMMR/MSI-H) locally advanced rectal cancer Trial met its 1EP, with a meaningful & sustained clinical complete response rate at 12mos. Interim AZUR-1 data will be shared with global…

ByRidhi RastogiJuly 13, 2026

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HUTCHMED Reports NMPA Conditional Approval of Orpathys (Savolitinib) for Gastric Cancer Patients with MET Amplification

Shots: The NMPA has granted conditional approval to Orpathys for the treatment of LA/M gastric cancer or gastroesophageal junction (GC/GEJ) adenocarcinoma pts with MET amplification who have failed ≥2 prior systemic treatments Approval was supported by the P-II trial of Orpathys in GC/GEJ adenocarcinoma pts with MET amplification in China, which showed 32.3% ORR (1EP), & improved 2EPs, incl. 63.1% DCR, 1.4mos.…

ByRidhi RastogiJuly 2, 2026

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Ipsen to Acquire Memo Therapeutics for >€700M

Shots: Ipsen has entered into a definitive share purchase agreement to acquire all issued & outstanding shares of Memo Therapeutics, with closing expected in Q3’26 As per the deal, Memo shareholders will receive €200M upfront at closing, with total consideration exceeding €700M upon achieving development, regulatory, & sales milestones. Assets & employees unrelated to potravitug…

ByRidhi RastogiJuly 1, 2026

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Edgewise Therapeutics Reports the P-II (CIRRUS-HCM) Trial Data on EDG-7500 for Obstructive and Nonobstructive Hypertrophic Cardiomyopathy

Shots: Edgewise has reported the 12wk. P-II Part D (CIRRUS-HCM) trial data assessing EDG-7500 (PO) in obstructive (oHCM; n=20) and nonobstructive (nHCM; n=33) Hypertrophic Cardiomyopathy, where pts in both groups received doses ranging from 25 to 150mg In oHCM pts, EDG-7500 showed 90% pts had improved LVOT-G, 74% achieved NT-proBNP normalization, or ≥50% reduction, KCCQ-OSS…

ByRidhi RastogiJune 17, 2026

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Akeso Reports First Patient Enrolment in P-Ib/II Trial of AK138D1 ± Ivonescimab for Breast Cancer

Shots: Akeso has enrolled the first patient in the P-Ib/II (AK138D1-202) study assessing its AK138D1 monotx. or in combination with ivonescimab for the treatment of advanced breast cancer The trial is evaluating AK138D1 in 2 breast cancer subtypes: HR+/HER2- & triple-negative breast cancer. The study incl. pts ranging from treatment-naïve to heavily pretreated & enrolls…

ByRidhi RastogiJune 15, 2026

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J&J Reports the P-II/III (ENERGY) Trial Data on Imaavy for Warm Autoimmune Hemolytic Anemia (wAIHA)

Shots: The P-II/III (ENERGY) trial assessed 2 different dose schedules of J&J's Imaavy vs PBO in 115 adults living with wAIHA for 24wks. followed by an OLE period, where pts received Imaavy for 144wks. with a follow-up of 6wks. after the last assessment In the 30mg/kg group, Imaavy showed mean increase of 1g/dL in Hgb…

ByRidhi RastogiJune 11, 2026

Kyowa Kirin Reports the EC Approval for Crysvita for X-Linked Hypophosphataemia

Mission Therapeutics Inks a ~$292M Deal with Dimerix for MTX652

Diagonal Therapeutics Reports First Patient Dosed in P-I/II (DIAMOND) Trial of DIAG723 for HHT

Roche Receives the US FDA Priority Review for Gazyva to Treat Primary Membranous Nephropathy

GSK Reports P-II (AZUR-1) Trial Data on Jemperli for dMMR/MSI-H Locally Advanced Rectal Cancer

HUTCHMED Reports NMPA Conditional Approval of Orpathys (Savolitinib) for Gastric Cancer Patients with MET Amplification

Ipsen to Acquire Memo Therapeutics for >€700M

Edgewise Therapeutics Reports the P-II (CIRRUS-HCM) Trial Data on EDG-7500 for Obstructive and Nonobstructive Hypertrophic Cardiomyopathy

Akeso Reports First Patient Enrolment in P-Ib/II Trial of AK138D1 ± Ivonescimab for Breast Cancer

J&J Reports the P-II/III (ENERGY) Trial Data on Imaavy for Warm Autoimmune Hemolytic Anemia (wAIHA)

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