Kali Therapeutics Partners with Sanofi for KT501 in a ~$1.2B Deal

Shots: Kali Therapeutics has entered into a license agreement with Sanofi for KT501 to treat a broad range of B cell-mediated autoimmune diseases As per the deal, Sanofi will obtain exclusive worldwide rights to KT501, while Kali will receive upfront & near-term payments totaling $180M and up to $1.05B in development & commercial milestones, with tiered royalties…

ByRidhi RastogiMarch 23, 2026

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Henlius Receives NMPA IND Clearance for HLX18 (Biosimilar, Opdivo)

Shots: The Chinese NMPA has granted IND approval to HLX18, a biosimilar version of Opdivo (nivolumab) for the treatment of certain resected solid tumors following the US FDA IND clearance Additionally, HLX17 (biosimilar, Keytruda) & HLX13 (biosimilar, Yervoy) are under P-I trials with first patient dosing completed, while the IND for HLX15-SC (biosimilar, Darzalex), was…

ByRidhi RastogiMarch 23, 2026

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IntraBio Reports the US FDA’s sNDA Submission of Aqneursa for Ataxia-Telangiectasia

Shots: The US FDA has received sNDA of Aqneursa (levacetylleucine) for the treatment of Ataxia-Telangiectasia (A-T) sNDA was backed by the P-III trial assessing Aqneursa in adult and pediatric pts with A-T, which met its 1 & key 2EPs & showed that Aqneursa has a favorable safety profile Aqneursa was previously approved by both the…

ByRidhi RastogiMarch 23, 2026

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HUTCHMED Initiates P-III Trial of HMPL-760 + R-GemOx for R/R Diffuse Large B-cell Lymphoma in China

Shots: HUTCHMED has initiated a P-III trial of HMPL-760 + R-GemOx (rituximab, gemcitabine and oxaliplatin) in r/r DLBCL Chinese pts, with first patient dosing achieved on Mar 20, 2026 Trial will evaluate efficacy, safety, & PK of HMPL-760 vs PBO, both in combination with R-GemOx in r/r DLBCL pts (n=~240) who are who are relapsed or…

ByRidhi RastogiMarch 23, 2026

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Novo Nordisk Reports the US FDA Approval of Wegovy HD for Weight Management

Shots: FDA has approved Wegovy HD (7.2mg semaglutide, QW) under CNPV along with lifestyle intervention for chronic weight management in adults with obesity; Wegovy HD will be launched as a single-dose pen by Apr 2026 Backed by STEP UP trial (~1,400 adults without T2D) & STEP UP T2D trial (~500 obese adults with T2D), based…

ByRidhi RastogiMarch 23, 2026

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Dizal Reports the P-III (WU-KONG28) Trial Results on Zegfrovy (Sunvozertinib) in EGFRm NSCLC

Shots: Dizal has reported the topline P-III (WU-KONG28) trial data assessing Zegfrovy monotx. (QD, PO) vs Pt-based CT as the 1L treatment of pts with advanced NSCLC harboring EGFR exon 20 insertion mutations across Asia, EU, North America & South America The trial met its 1EP of improved PFS, assessed by BICR, plus showed superiority across…

ByRidhi RastogiMarch 23, 2026

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Rhythm Pharmaceuticals Reports the US FDA Approval of Imcivree (Setmelanotide) for Acquired Hypothalamic Obesity

Shots: The US FDA has approved Imcivree for the treatment of pts (≥4yrs.) with acquired hypothalamic obesity (HO) Approval was supported by the global P-III (TRANSCEND) trial assessing setmelanotide (n=94) vs PBO (n=48) in 142 pts with acquired HO Trial met its 1EP with a 18.4% PBO-adjusted reduction in BMI, showing -15.8% vs +2.6% mean…

ByRidhi RastogiMarch 20, 2026

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Novartis to Acquire Pikavation Therapeutics from Synnovation for ~$3B

Shots: Novartis has entered into a definitive agreement with Synnovation to acquire Pikavation Therapeutics (Synnovation’s subsidiary) & its portfolio of PI3Kα inhibitor programs, incl. SNV4818, a P-I/II asset for HR+/HER2- metastatic breast cancer & other solid tumors As per the deal, Synnovation will receive $2B upfront, & ~$1B in development, regulatory, & commercial milestones, representing…

ByRidhi RastogiMarch 20, 2026

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Embecta to Acquire Owen Mumford for ~£150M

Shots: Embecta has entered into a definitive agreement to acquire Owen Mumford, expanding drug-delivery capabilities & strengthening global presence in the chronic care market As per the deal, Embecta will acquire Owen Mumford for ~£150M (~$199.9M), incl. £100M (~$133.2M) upfront & up to £50M (~$66.6M) in sales-based milestones tied to Aidaptus, with closing expected in…

ByRidhi RastogiMarch 20, 2026

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LivaNova’s aura6000 System Secures the US FDA Premarket Approval to Treat Obstructive Sleep Apnea (OSA)

Shots: Approval for adults with mod. to sev. OSA (AHI: 15–65) who failed, cannot tolerate, or are ineligible for 1L therapies, was backed by OSPREY RCT, which met its 1EPs at 6mos. (M6) vs control, showing reductions in AHI, ODI, & improved PROs in sleep disturbance In the RCT (therapy start: M1 vs M7), M12…

ByRidhi RastogiMarch 20, 2026

Ridhi Rastogi

Kali Therapeutics Partners with Sanofi for KT501 in a ~$1.2B Deal

Henlius Receives NMPA IND Clearance for HLX18 (Biosimilar, Opdivo)

IntraBio Reports the US FDA’s sNDA Submission of Aqneursa for Ataxia-Telangiectasia

HUTCHMED Initiates P-III Trial of HMPL-760 + R-GemOx for R/R Diffuse Large B-cell Lymphoma in China

Novo Nordisk Reports the US FDA Approval of Wegovy HD for Weight Management

Dizal Reports the P-III (WU-KONG28) Trial Results on Zegfrovy (Sunvozertinib) in EGFRm NSCLC

Rhythm Pharmaceuticals Reports the US FDA Approval of Imcivree (Setmelanotide) for Acquired Hypothalamic Obesity

Novartis to Acquire Pikavation Therapeutics from Synnovation for ~$3B

Embecta to Acquire Owen Mumford for ~£150M

LivaNova’s aura6000 System Secures the US FDA Premarket Approval to Treat Obstructive Sleep Apnea (OSA)

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