Roche Reports CHMP Positive Opinion for Susvimo to Treat nAMD

Shots: The CHMP has recommended Susvimo (100mg/mL) for the treatment of neovascular age-related macular degeneration (nAMD) The opinion was based on the 3 studies, P-III (Archway), P-II (LADDER) & open-label LTE study (Portal), where Archway showed Susvimo (refilled in Q6M) maintained vision improvements equivalent to Lucentis (QM, IVT), with Portal showing maintenance of vision up…

ByRidhi RastogiJuly 27, 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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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 RastogiJuly 21, 2026

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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 RastogiJuly 17, 2026

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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 RastogiJuly 16, 2026

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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

Roche Reports CHMP Positive Opinion for Susvimo to Treat nAMD

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

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

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