NEWS

Sanofi Reports the EC Approval of Rezurock (Belumosudil) to Treat Chronic Graft-vs-Host Disease (GVHD)

Shots: The EC has approved Rezurock (200mg) to treat chronic GVHD pts (≥12yrs., ≥40kg) Approval was based on safety and efficacy clinical data, incl. the P-II (ROCKstar) trial (n=77), which showed an improved ORR of 74% in chronic GVHD pts post–stem cell transplant & after ≥2 prior systemic therapies Under the conditional marketing authorisation, Sanofi will conduct a confirmatory randomized study Ref:…

March 26, 2026

Biogen and Alteogen Partner for ALT-B4 to Advance Subcutaneous Formulations of Biologics

Shots: Alteogen has granted Biogen exclusive rights to ALT-B4 (berahyaluronidase alfa) to develop & commercialize SC formulations of two biologics, with an option for Biogen to develop a third product As per the deal, Alteogen will receive $20M upfront, $10M upon initiation of second product development, along with ~$549M in development, regulatory, & sales milestones…

March 26, 2026

UCB Reports the EC Approval of Kygevvi for Thymidine Kinase 2 Deficiency (TK2d)

Shots: The EC has approved kygevvi (doxecitine and doxribtimine) under exceptional circumstances for adults & pediatric pts with TK2d whose symptom onset occurred ≤12yrs. of age Supportive evidence for approval came from pooled data from 2 studies of Kygevvi in pts with genetically confirmed TK2d & symptom onset ≤12yrs. The studies showed improved functional outcomes & survival vs matched external controls after long-term treatment (>5yrs.) …

March 26, 2026

The US FDA Grants Accelerated Approval Denali Therapeutics’ Avlayah (Tividenofusp alfa-eknm) for Hunter Syndrome (MPS II)

Shots: FDA has granted accelerated approval to Avlayah, an enzyme replacement therapy (ERT), for the treatment of presymptomatic or symptomatic MPS II pediatric pts (≥5kg), along with a RPD PRV to Denali; US availability is expected shortly Approval was based on the P-I/II trial of Avlayah (QW) in 47 pts, incl. ERT-naïve (n=15) & previously…

March 26, 2026

Corcept Therapeutics Reports the US FDA Approval of Lifyorli (Relacorilant) to Treat Platinum-Resistant Ovarian Cancer

Shots: The US FDA has approved Lifyorli (relacorilant) + nab-paclitaxel for the treatment of adults with epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received 1-3 prior systemic therapies, ≥1 of which included Avastin NDA was supported by P-III (ROSELLA) assessing Lifyorli + nab-paclitaxel vs nab-paclitaxel alone in the above-mentioned pts (n=381) with no…

March 26, 2026

Merck to Acquire Terns Pharmaceuticals for ~$6.7B

Shots: Merck has entered into a definitive agreement to acquire Terns, incl. its asset TERN-701 asset, expanding its oncology pipeline As per the deal, Merck will acquire Terns for $53/share in cash, representing a total equity value of ~$6.7B (~$5.7B net of acquired cash); closing is expected in Q2’26 TERN-701 is being evaluated in the…

March 25, 2026

Regeneron and Sanofi Report MHLW’s Approval of Dupixent to Treat Bullous Pemphigoid

Shots: The Japanese MHLW has approved Dupixent to treat adults with mod. to sev.bullous pemphigoid based on P-II/III (ADEPT) trial assessing Dupixent vs PBO for 52wks. Pts (n=106) received a loading dose of Dupixent (300mg; n=53) or PBO (n=53), followed by Q2W dosing with OCS. OCS tapering began at Wks. 4 to 6 if disease control was…

March 25, 2026

The United Laboratories and Novo Nordisk Report P-II Trial Data on UBT251 in Chinese Patients with Type 2 Diabetes

Shots: The P-II trial assessed UBT251 (2, 4 & 6 mg, QW, SC) vs PBO & semaglutide (1mg) in 211 Chinese T2D pts, which showed HbA1c reduction of 2.16% vs 1.77% (semaglutide) & 0.66% (PBO) at 24wks. from a baseline of 8.12% Trial also showed weight loss of up to 9.8% vs 4.8% (semaglutide) &…

March 25, 2026

Pixee Medical’s Knee+ NexSight Receives the European CE Mark for Knee Arthroplasty

Shots: Pixee Medical has received CE mark for Knee+ NexSight, its AR-based total knee arthroplasty solution, with initial procedures completed in EU & a 510(k) submission under FDA review Knee+ NexSight projects a virtual display with voice control during knee arthroplasty, without the need for a robot, console, or disposables, while delivering robotic-level accuracy with…

March 25, 2026

Ionis’ Zilganersen Receives US FDA Priority Review for Alexander Disease

Shots: The US FDA has accepted NDA & granted priority review to zilganersen for the treatment of Alexander disease (AxD), with PDUFA target action date of Sep 22, 2026 NDA was backed by the P-III trial assessing zilganersen (25 or 50mg) vs control in 54 AxD pts (1.5-53yrs.) for 60wks., followed by an open label…

March 25, 2026

NEWS

Sanofi Reports the EC Approval of Rezurock (Belumosudil) to Treat Chronic Graft-vs-Host Disease (GVHD)

Biogen and Alteogen Partner for ALT-B4 to Advance Subcutaneous Formulations of Biologics

UCB Reports the EC Approval of Kygevvi for Thymidine Kinase 2 Deficiency (TK2d)

The US FDA Grants Accelerated Approval Denali Therapeutics’ Avlayah (Tividenofusp alfa-eknm) for Hunter Syndrome (MPS II)

Corcept Therapeutics Reports the US FDA Approval of Lifyorli (Relacorilant) to Treat Platinum-Resistant Ovarian Cancer

Merck to Acquire Terns Pharmaceuticals for ~$6.7B

Regeneron and Sanofi Report MHLW’s Approval of Dupixent to Treat Bullous Pemphigoid

The United Laboratories and Novo Nordisk Report P-II Trial Data on UBT251 in Chinese Patients with Type 2 Diabetes

Pixee Medical’s Knee+ NexSight Receives the European CE Mark for Knee Arthroplasty

Ionis’ Zilganersen Receives US FDA Priority Review for Alexander Disease

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