NEWS

Incyte Reports Positive P-I Data of INCA033989 in Essential Thrombocythemia (ET) at ASH 2025

Shots: Incyte reported updated data from two P-I trials showing the safety, tolerability, and efficacy of INCA033989 (INCA33989-101 and INCA33989-102) in 455 adults(age≥18) with mutCALR-positive MPNs, including ET & MF, findings were presented at ASH'25 In ET pts receiving higher starting doses of INCA033989 (400–2,500 mg; n=30), 90% achieved a HR, including 83.3% with CHR…

December 9, 2025

Junshi Biosciences Reports NMPA Acceptance of the NDA for Roconkibart (IL-17A) to Treat Moderate to Severe Plaque Psoriasis

Shots: Junshi Biosciences reported that the NMPA has accepted the NDA for roconkibart injection (JS005), for adults with moderate to severe plaque psoriasis eligible for systemic therapy or phototherapy The submission is backed by a multicenter P-III study (n=747) showing significant improvements in PASI 75/90/100 and sPGA 0/1 vs PBO at 12wks., with sustained efficacy…

December 8, 2025

Viatris Enters Agreement to Monetize Equity Stake in Biocon Biologics for ~$815M

Shots: Viatris has signed definitive agreements to sell its Biocon Biologics stake to Biocon for ~$815M Under the agreements, Viatris will sell its Biocon Biologics stake to Biocon for $400M in cash and $415M in Biocon shares, to be listed on NSE with a six-month lock-up. As part of the agreement, the biosimilar non-compete restrictions…

December 8, 2025

Nurix Therapeutics Presents New Data from P-I of Bexobrutideg (NX-5948) in Relapsed/Refractory CLL at ASH’25

Shots: Nurix reported updated P-Ia/I b data for bexobrutideg in which P-Ia (n=48) showed an ORR of 83% incl. 2 CRs & a median PFS of 22.1mos. across all doses (50 mg to 600 mg OD) in heavily pretreated relapsed/refractory CLL/SLL pts.; P-Ib data (n=42) indicated higher ORR i.e. 83.3% & longer PFS at the 600mg…

December 8, 2025

Zoetis’ Portela (Relfovetmab) Receives the Health Canada Approval for Osteoarthritis Pain Relief in Cats

Shots: Health Canada has approved Portela for alleviating osteoarthritis pain in cats. The company plans to launch Portela commercially in Canada and the EU in 2026 In a nine-month European trial, Portela eased OA pain and was well tolerated, including in cats with IRIS stage 1–3 kidney disease. Approved in the EU Portela is a…

December 8, 2025

CARsgen Therapeutics Presents Trial Data of CT0596 for Relapsed/Refractory Multiple Myeloma (R/R MM) at ASH’25

Shots: CARsgen reported that early clinical results of CT0596, in Pts with R/R MM, were shared in ASH’25. The company plans a P-Ib registrational study in 2026, following an IND submission expected in H2'25 The P-I trial enrolled 8 pts with R/R MM who received CT0596, with a median of 4.5 prior therapy lines. Enrollment…

December 8, 2025

Natera Acquires Foresight Diagnostics for ~$450M to Strengthen Ultrasensitive MRD Testing in Solid Tumors & Lymphoma

Shots: Natera has acquired Foresight Diagnostics, adding its PhasED-Seq phased variant technology with LOD95 of 0.3ppm & detection below 0.1ppm, further enhancing Natera’s capabilities in solid tumor MRD and expanding its IP portfolio of >500 issued/pending patents As per the agreement, Natera completed the acquisition in an all-stock transaction incl. $275M upfront & up to…

December 8, 2025

Hope Medicine’s HMI-115 Receives the US FDA Fast Track Designation for Endometriosis-Associated Pain Relief

Shots: The US FDA has granted FTD to HMI-115 for the treatment of mod. to sev. pain associated with endometriosis Designation was based on the global P-II dose-finding study assessing HMI-115 vs PBO for 12wks. in 108 females with surgically diagnosed endometriosis across the US, Poland & China, showing significant improvement Trial showed that HMI-115…

December 5, 2025

Alexion (AstraZeneca) and Neurimmune Expand Alliance to Develop NI009 for AL Amyloidosis

Shots: Neurimmune has entered into an exclusive global collaboration & licensing deal with Alexion to develop NI009, a preclinical human mAb for the treatment of AL amyloidosis Alexion will obtain an exclusive global license to Neurimmune’s AL amyloidosis–targeting Abs, incl. NI009, with Neurimmune handling preclinical activities, early manufacturing & the FIH study, while Alexion will…

December 5, 2025

Cardiawave Receives CE Mark for Valvosoft to Treat Severe Symptomatic Aortic Stenosis

Shots: Cardiawave has received the European CE Mark for its Valvosoft to treat Severe Symptomatic Aortic Stenosis (sSAS) Valvosoft delivers precise high-intensity ultrasound that induces non-thermal, mechanical energy to soften aortic valve leaflets tissues, restoring their mobility & improving anatomical & hemodynamic function Valvosoft was evaluated in the Valvosoft FIM Study (24mos.) & Pivotal Study…

December 5, 2025

NEWS

Incyte Reports Positive P-I Data of INCA033989 in Essential Thrombocythemia (ET) at ASH 2025

Junshi Biosciences Reports NMPA Acceptance of the NDA for Roconkibart (IL-17A) to Treat Moderate to Severe Plaque Psoriasis

Viatris Enters Agreement to Monetize Equity Stake in Biocon Biologics for ~$815M

Nurix Therapeutics Presents New Data from P-I of Bexobrutideg (NX-5948) in Relapsed/Refractory CLL at ASH’25

Zoetis’ Portela (Relfovetmab) Receives the Health Canada Approval for Osteoarthritis Pain Relief in Cats

CARsgen Therapeutics Presents Trial Data of CT0596 for Relapsed/Refractory Multiple Myeloma (R/R MM) at ASH’25

Natera Acquires Foresight Diagnostics for ~$450M to Strengthen Ultrasensitive MRD Testing in Solid Tumors & Lymphoma

Hope Medicine’s HMI-115 Receives the US FDA Fast Track Designation for Endometriosis-Associated Pain Relief

Alexion (AstraZeneca) and Neurimmune Expand Alliance to Develop NI009 for AL Amyloidosis

Cardiawave Receives CE Mark for Valvosoft to Treat Severe Symptomatic Aortic Stenosis

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