NEWS

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…

10 hours ago

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…

11 hours ago

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…

12 hours ago

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…

14 hours ago

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…

15 hours ago

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…

16 hours ago

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…

3 days ago

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…

3 days ago

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…

4 days ago

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…