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NEWS

Zymeworks
Zymeworks’ Zanidatamab Receives the NMPA’s Conditional Approval for the Treatment of Biliary Tract Cancer
Shots: The NMPA has granted conditional approval to zanidatamab for the treatment of pts with previously treated, inoperable or metastatic HER2+ biliary tract cancer (BTC) following the CHMP’s positive opinion in Apr 2025 Approval was based on P-IIb (HERIZON-BTC-01) trial, which assessed anti-tumor activity of zanidatamab monotx. in HER2+ inoperable & advanced or metastatic BTC Approval…
May 30, 2025
Reflow Medical
Reflow Medical’s Spur Peripheral Retrievable Stent System Receives the US FDA’s De Novo Clearance for BTK-CLTI Treatment
Shots: FDA has granted De Novo clearance to the Spur Stent System for treating de novo or restenotic lesions post-predilatation in pts with infrapopliteal arterial disease In recently concluded DEEPER REVEAL trial (n=130), the system achieved 99.2% technical success rate & 97% freedom from MALE & POD at 30 days post-predilatation for below-the-knee (BTK) treatment…
May 30, 2025
Astellas & Evopoint Bio
Astellas Enters a ~$1.54B Licensing Agreement with Evopoint Biosciences to Develop & Commercialize XNW27011
Shots: Evopoint Biosciences has granted Astellas exclusive license to develop & commercialize XNW27011 globally, excl. Mainland China, Hong Kong, Macao & Taiwan As per the deal, Evopoint will receive $130M upfront as well as ~$70M as near-term payments in addition to ~$1.34B in development, regulatory & commercial milestones, with net sales-based royalties XNW27011, an CLDN18.2-specific…
May 30, 2025
GSK & Spero Therapeutics
GSK & Spero Therapeutics Reports Early Conclusion of P-III (PIVOT-PO) Trial of Tebipenem HBr for Complicated Urinary Tract Infections (cUTIs) 
Shots: GSK & Spero Therapeutics have reported early conclusion of P-III (PIVOT-PO) trial for efficacy of tebipenem HBr to treat cUTIs, incl. pyelonephritis following IDMC recommendation based on positive interim analysis; US FDA’s filing is expected in H2’25 The P-III (PIVOT-PO) trial assessed tebipenem pivoxil HBr (600mg, PO, every 6hrs.) vs imipenem-cilastin (500mg, IV, every…
May 29, 2025
Alcon
Alcon Reports the US FDA’s Approval of Tryptyr to Treat Dry Eye Disease
Shots: The US FDA has approved Tryptyr (0.003% acoltremon ophthalmic solution; AR-15512) to treat signs & symptoms of dry eye disease (DED); US launch expected in Q3’25 Approval was backed by 2 P-III (COMET-2 & COMET-3) trials assessing Tryptyr vs vehicle in >930 pts with DED, where Tryptyr showed ≥10mm natural tear production increase by…
May 29, 2025
Bayar
The US FDA Grants Priority Review to Bayer’s Sevabertinib for HER2-mutant NSCLC
Shots: The US FDA has granted priority review to sevabertinib (BAY 2927088; reversible TKI) for the treatment of previously treated pts with advanced NSCLC harboring HER2 mutations Designation was based on the P-I/II (SOHO-01) trial assessing (20mg, BID, PO) in HER2-mutant NSCLC, with data previously reported from 2 cohorts: pts progressing on ≥1 systemic therapy who…
May 29, 2025
Snap Bio & Monarch Therapeutics
SNAP Biosciences Licenses Monarch Therapeutics’ Technology to Advance Snap-Car NK Cell Therapy for Cancer Targets
Shots: SNAP Biosciences & Monarch Therapeutics have entered into a licensing agreement for Monarch’s small molecule adaptor tech to develop & commercialize SNAP's Snap-Car NK cell therapy platform in oncology   Financial terms remain undisclosed but incl. an upfront licensing payment, future development milestones, with net sales-based royalties Monarch’s tech enables SNAP-CAR cells to be…
May 29, 2025
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