Biohaven Licenses Kv7 Epilepsy Platform to SK Biopharmaceuticals in $795M Deal

Shots: Biohaven has granted SK Biopharmaceuticals exclusive worldwide rights to its Kv7 ion channel platform, led by opakalim (BHV-7000), a P-II/III candidate for focal epilepsy, with RISE3 topline results are expected in H2’26 Biohaven will receive upfront & milestone payments up to $795M for the Kv7 platform, incl. $400M in cash ($350M at closing &…

ByRidhi RastogiAugust 26, 2026

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GSK’s Jemperli (Dostarlimab) Secures US FDA Priority Review for dMMR/MSI-H Locally Advanced Rectal Cancer

Shots: The US FDA has accepted the sBLA under Project Orbis & granted priority review to Jemperli in previously untreated stage II/III dMMR/MSI-H locally advanced rectal cancer (PDUFA: Feb 2027), with eligibility for an earlier decision through the NPV program sBLA was based on the global P-II (AZUR-1) trial assessing Jemperli (dostarlimab) monotx. (500mg, IV, Q3W…

ByRidhi RastogiAugust 25, 2026

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J&J Reports US FDA Approval of Imaavy for Warm Autoimmune Hemolytic Anemia (wAIHA)

Shots: The US FDA has approved Imaavy (nipocalimab-aahu) for the treatment of wAIHA in pts (≥12yrs.) currently or previously treated with corticosteroids Approval was based on the P-II/III (ENERGY) trial, which assessed 2 different dose schedules of Imaavy vs PBO in 115 adults living with wAIHA for 24wks. followed by an OLE period, where pts…

ByRidhi RastogiAugust 25, 2026

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Hanmi Pharm Licenses HM17321 to Genentech in ~$2.3B Deal

Shots: Hanmi Pharm has entered into an exclusive licensing agreement with Genentech for the development, manufacturing, & commercialization of HM17321, for obesity & associated conditions such as T2D & CV diseases, globally, excl. South Korea As per the deal, Hanmi will receive ~$190M upfront, with additional development, regulatory & commercial milestones representing the total deal…

ByRidhi RastogiAugust 24, 2026

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ArkBio’s Ziresovir Secures the US FDA Approval for P-II Trial in RSV Infant Patients

Shots: The US FDA has approved ziresovir (AK0529) for a P-II trial in the severely ill RSV infected infant patients, including those in the pediatric intensive care unit (PICU) The trial will compare ziresovir with PBO to evaluate clinical efficacy, particularly oxygen-treatment duration & sustained recovery time, generating data to support future registrational trials In…

ByRidhi RastogiAugust 14, 2026

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Pharming Group Launches Joenja in Japan for APDS

Shots: Pharming Group has launched Joenja in Japan for activated PI3K delta syndrome (APDS) patients aged 4 years and older following NHI reimbursement listing As per the agreement with Pharming, OrphanPacific serves as Joenja’s Marketing Authorization Holder in Japan &, alongside Pharming, manages the product’s supply & distribution Leniolisib is under regulatory review for pediatric…

ByRidhi RastogiAugust 13, 2026

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Belenos Biosciences Reports P-II Trial Results on BEL512 for CRSwNP

Shots: P-II trial, conducted by Belenos’partner Keymed Biosciences, assessed BEL512 (SC; 300mg, Q12W/Q24W or 600mg, Q24W) vs PBO, both on top of intranasal corticosteroid (QD), in 120 Chinese pts with CRSwNP with NPS of ≥5 (≥2 polyps/nostril) & a NCS of 2-3 Trial met its 1 & 2EPs, with the BEL512 showing statistically significant improvements…

ByRidhi RastogiAugust 12, 2026

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Silence Therapeutics Reports Topline P-II (SANRECO) Trial Results of Divesiran in Polycythemia Vera

Shots: Silence has reported topline P-II (SANRECO) trial results assessing divesiran (6mg/kg, SC, Q6W or Q12W) vs PBO in 48 phlebotomy-dependent patients with polycythemia vera (PV); P-III PV trial for Q12W dosing to initiate in H1’27 Trial met its 1EP, with significantly more PV pts responding to divesiran vs PBO (88% vs 19%). Response was…

ByRidhi RastogiAugust 11, 2026

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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 RastogiAugust 7, 2026

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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 RastogiAugust 5, 2026

Biohaven Licenses Kv7 Epilepsy Platform to SK Biopharmaceuticals in $795M Deal

GSK’s Jemperli (Dostarlimab) Secures US FDA Priority Review for dMMR/MSI-H Locally Advanced Rectal Cancer

J&J Reports US FDA Approval of Imaavy for Warm Autoimmune Hemolytic Anemia (wAIHA)

Hanmi Pharm Licenses HM17321 to Genentech in ~$2.3B Deal

ArkBio’s Ziresovir Secures the US FDA Approval for P-II Trial in RSV Infant Patients

Pharming Group Launches Joenja in Japan for APDS

Belenos Biosciences Reports P-II Trial Results on BEL512 for CRSwNP

Silence Therapeutics Reports Topline P-II (SANRECO) Trial Results of Divesiran in Polycythemia Vera

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

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