Prestige Biopharma Reports Topline P-III (SAMSON-II) Study Results for HD204 (Biosimilar, Avastin)

Shots: Prestige has reported the topline P-III (SAMSON-II) trial results evaluating HD204, a biosimilar version of Avastin (bevacizumab), vs Avastin in 625 adults with advanced non-squamous NSCLC Trial showed an ORR of 48.7% vs 46.5% at 18wks., meeting its 1EP & showing clinical equivalence between HD204 & Avastin; 2EPs supported the primary analysis, with similar Wk.…

ByRidhi RastogiMarch 24, 2026

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Apogee Therapeutics Reports Part A P-II (APEX) Maintenance Data on Zumilokibart in Atopic Dermatitis

Shots: Apogee has reported maintenance data from Part A of the P-II (APEX) trial assessing zumilokibart (APG777; 360mg at Q3M or Q6M) in pts with mod. to sev. atopic dermatitis Trial showed 75% (Q3M) & 85% (Q6M) of Wk. 16 zumilokibart-responders maintained EASI-75, while 86% (Q3M) & 78% (Q6M) sustained vIGA 0/1, with continued deepening…

ByRidhi RastogiMarch 24, 2026

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Cencora to Acquire EyeSouth’s Retina Business for ~$1.1B

Shots: Cencora has entered into a definitive agreement to acquire the retina business of EyeSouth Partners in a transaction of ~$1.1B The deal will bring EyeSouth’s affiliated retina physicians under Retina Consultants of America (RCA), expanding Cencora’s footprint in retina care Through this integration, physicians will gain access to RCA’s clinical, research, & operational infrastructure,…

ByRidhi RastogiMarch 24, 2026

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Gilead to Acquire Ouro Medicine for ~$2.1B

Shots: Gilead to acquire Ouro for a total of $1,675M in upfront cash & up to $500M in contingent milestone payments. Acquisition will add Ouro’s P-I/II asset OM336 (gamgertamig) to Gilead’s inflammation portfolio, with registrational studies to begin in 2027 Also, Gilead is in advanced discussions with Galapagos for a potential R&D collaboration on the…

ByRidhi RastogiMarch 24, 2026

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Pfizer and Valneva Report Topline P-III (VALOR) Trial Data on PF-07307405 for Lyme Disease Prevention

Shots: Pfizer & Valneva have reported the P-III (VALOR) trial data in pts (≥5yrs.) at high risk of Lyme disease randomized to either PF-07307405 vs saline PBO, with one dose administered at mos. 0, 2, 5-9 followed by a fourth dose 1yr. late In pre-specified analyses, efficacy reached 73.2% at 28 days post-dose 4 &…

ByRidhi RastogiMarch 24, 2026

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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

Ridhi Rastogi

Prestige Biopharma Reports Topline P-III (SAMSON-II) Study Results for HD204 (Biosimilar, Avastin)

Apogee Therapeutics Reports Part A P-II (APEX) Maintenance Data on Zumilokibart in Atopic Dermatitis

Cencora to Acquire EyeSouth’s Retina Business for ~$1.1B

Gilead to Acquire Ouro Medicine for ~$2.1B

Pfizer and Valneva Report Topline P-III (VALOR) Trial Data on PF-07307405 for Lyme Disease Prevention

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

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