Shots:
AbbVie has signed a definitive agreement to acquire Gilgamesh Pharmaceuticals’ Bretisilocin for moderate-to-severe major depressive disorder (MDD), currently in clinical development
As per the deal, AbbVie will acquire Gilgamesh’s bretisilocin program for ~$1.2B, including upfront and milestone payments. Gilgamesh will spin off Gilgamesh Pharma Inc. to retain its team and other programs, including blixeprodil…
NEWS
Shots:
PDS Biotech reported the final topline results from the P-II (VERSATILE-002) Study evaluating safety and efficacy of PDS0101 (Versamune HPV) + Keytruda in 1L R/M HPV16+ HNSCC (n=53)
In the Study PDS0101 (SC) with pembrolizumab (IV) for the first 4 cycles, then as a final single dose on cycle 12. Pembrolizumab monotx. was given…
Shots:
Royalty Pharma has acquired a royalty interest in Amgen’s Imdelltra from BeOne Medicines for ~$950M
As per the deal, Royalty Pharma will acquire BeOne’s ~7% royalty on global Imdelltra sales for ~$950M, including $885M upfront and an option for BeOne to sell more for $65M within 12mos. The royalty, including shared sales above $1.5B…
Shots:
China’s NMPA has approved Datroway for treating adults with HR+/HER2- (IHC 0, IHC 1+ or IHC 2+/ISH-) inoperable or recurrent breast cancer after previous CT
Approval was based on P-III (TROPION-Breast01) study assessing Datroway (6mg/kg, IV, Q21D) vs single-agent CT in adults (n=732) with HR+/HER2- metastatic breast cancer
Study showed improved PFS by 37%…
Terumo to Acquire OrganOx for ~$1.5B
Shots:
Eisai & Biogen have reported EU launch of Leqembi, starting with Austria on Aug 25, 2025 & Germany on Sep 1, 2025, following EC approval in Apr 2025
Approval was based on the P-III (Clarity AD) trial assessing Leqembi (n=757) vs PBO (n=764) in pts with MCI or mild dementia due to AD &…
Shots:
Japan’s MHLW has approved Enhertu monotx. for inoperable HR+, HER2-low/ultralow MBC whose disease progressed on & are ineligible for endocrine therapy
Approval was based on the P-III (DESTINY-Breast06) trial (N=866) assessing Enhertu (5.4mg/kg) vs CT in HER2-low (n=713) & ultralow (n=152) pts
Trial showed 38% PFS in CT-naïve HER2-low pts & mPFS of 13.2…
Shots:
Bio-Thera & STADA have expanded their partnership to BAT1806, a biosimilar version of Roche’s RoActemra (tocilizumab), whose 20mg/ml vial formulation received EMA’s approval in Jun 2024 for several arthritic conditions
As per the deal, STADA will obtain exclusive rights to commercialize BAT1806 in the EU, UK, Switzerland & select other countries under its own marketing…
Shots:
argenx has reported topline P-III (ADAPT SERON) trial data on Vyvgart (efgartigimod alfa; IV) for AChR-Ab seronegative generalized myasthenia gravis (gMG)
Trial (n=119) consist of 2 Parts: Part A assessed Vyvgart (QW × 4wks.) vs PBO, followed by 5wk. follow-up, while Part B was an OLE study, where pts received 2 fixed cycles of…
Shots:
Tyra Biosciences has dosed its first patient with dabogratinib (FGFR3 inhibitor) in P-II (BEACH301) trial for the treatment achondroplasia
Trial will evaluate dabogratinib in children (3–10 yrs) with achondroplasia & open growth plates across 2 cohorts: treatment-naïve & previously treated with growth-accelerating therapy, enrolling up to 10 pts per dose level (0.125, 0.25, 0.375…

