Bavarian Nordic Reports EC Approval of Imvanex Against Smallpox & Mpox for Children Aged 2 to Less than 12 Years

Shots: The EC has approved type II variation MAA for Imvanex (MVA-BN) smallpox & mpox vaccine, extending its use to include children aged 2 to less than 12yrs. Approval was based on P-II trial data involving 227 children (2 to <12yrs.) & 224 adults, which showed non-inferior immune responses & a similar safety profile in children…

ByRidhi Rastogi3 days ago

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Summit Therapeutics Initiates P-II/III (HARMONi-GU1) Trial of Ivonescimab + Enfortumab Vedotin in Bladder Cancer

Shots: Summit has initiated P-II/III (HARMONi-GU1) trial of ivonescimab + enfortumab vedotin (EV) against Keytruda + EV as first-line treatment of locally advanced or metastatic urothelial (bladder) cancer The global, multi-regional trial will enroll ~800 pts through P-III, with site activations beginning later this year. P-II will determine the recommended P-III dose of ivonescimab in…

ByRidhi Rastogi5 days ago

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Leads Biolabs Reports NMPA IND Clearnce to Initiate P-Ib/II Trial for Opamtistomig Combination Therapy in mCRC

Shots: The NMPA has approved IND application to initiate P-Ib/II trial of opamtistomig (LBL-024) in combination therapy for metastatic colorectal cancer (mCRC) Trial will evaluate the safety & efficacy of opamtistomig combination regimens in pts with mCRC & explore potential predictive biomarkers. Opamtistomig mechanism was already validated across EP-NEC, NSCLC, SCLC, & biliary tract cancer…

ByRidhi RastogiAugust 3, 2026

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Akeso Reports First Patient Dosing in P-Ib/II Study of AK138D1 + Ivonescimab in NSCLC

Shots: Akeso has dosed the first patient in the P-Ib/II (AK138D1-201) trial assessing AK138D1, as monotx. or in combination with ivonescimab for advanced NSCLC The study will evaluate the regimen across multiple settings in advanced NSCLC, incl. 1L treatment, treatment after EGFR-TKI resistance, & treatment after immuno-CT resistance AK138D1 is a HER3-targeted ADC comprising a…

ByRidhi RastogiJuly 28, 2026

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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

Bavarian Nordic Reports EC Approval of Imvanex Against Smallpox & Mpox for Children Aged 2 to Less than 12 Years

Summit Therapeutics Initiates P-II/III (HARMONi-GU1) Trial of Ivonescimab + Enfortumab Vedotin in Bladder Cancer

Leads Biolabs Reports NMPA IND Clearnce to Initiate P-Ib/II Trial for Opamtistomig Combination Therapy in mCRC

Akeso Reports First Patient Dosing in P-Ib/II Study of AK138D1 + Ivonescimab in NSCLC

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

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