Shots:Moleculin received approval from Georgia’s RAMPA to initiate its global P-IIb/III (MIRACLE) study of AnnAraC (Annamycin + cytarabine) in R/R AML, and first pt dosing expected by Aug-end; CTA already approved in EUThe study includes adaptive design; Part A will randomize 75-90 pts (1:1:1) to HiDAC + PBO or Annamycin (190 or 230…
Shots:HanchorBio entered into an out-licensing agreement with Shanghai Henlius Biotech and granted exclusive rights to develop and commercialize HCB101 in Greater China, Southeast Asia, and MENAUnder the terms and agreement, HanchorBio will receive $10M upfront and up to $192M in development and regulatory milestones, plus tiered royaltiesHenlius will also oversee development, production,…
Shots:Following the US FDA approval, EMA's CHMP issued a positive opinion of Brukinsa (zanubrutinib) film‑coated tablets for all approved indications. EC will now review the opinion for MAA in the EU, Norway, and IcelandBRUKINSA tablets (160mg) are bioequivalent to the capsule form, supported by a P-I study. With a recommended daily dose of 320mg,…
Shots:Bio‑Thera reported the dosing of the first patient in a P‑III study assessing the efficacy of BAT8006 vs. the investigator’s choice of single-agent CT in individuals with Pt resistant high‑grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancerEarly clinical Data (N=133; irrespective of FRα expression or treatment history) presented at ASCO’25, from…
Shots:Xcell Biosciences entered into a strategic collaboration with ThermoFisher Scientific to advance the development of Treg and TIL cell therapies for autoimmune and solid tumor treatmentsThe joint research aims to develop methodologies for enhancing the efficacy of Tregs and TILs, while streamlining and scaling cell therapy manufacturing for improved accessibility and reproducibility across…
Shots:BioNTech has entered into a definitive purchase agreement to acquire CureVac in an all-stock transaction, strengthening its mRNA tech & capabilitiesAs per the deal, each CureVac share will be exchanged for ~$5.46 in BioNTech ADSs, implying a total equity value of ~$1.25B, with a collar-adjusted exchange ratio (0.04318 if BioNTech’s 10-day VWAP >$126.55; 0.06476…
Shots: Recently, at ASH 2024, Takeda presented data from several ongoing clinical trials across hematology and oncology, including the Phase II OPTIC and Phase III PhALLCON studies, among others Phuong Khanh Morrow, Head of the Oncology Therapeutic Area Unit at Takeda, shed light on Takeda’s key presentations at ASH 2024 Phuong also highlighted the findings…
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 royaltiesMonarch’s tech enables SNAP-CAR cells to be…
Shots:Genentech has entered into a multi-year collaboration with Orionis to discover small-molecule monovalent glue drugs for novel & difficult oncology targets using Orionis’ Allo-Glue platformAs per the deal, Orionis will receive $105M upfront & ~$2B in research, development, commercial, & sales milestones, with tiered royalties; Orionis will lead discovery & optimization, while Genentech…
Shots:AbbVie has entered into collaboration & license option agreement with ADARx to develop siRNA therapeutics across multiple disease areas, incl. neuroscience, immunology & oncology, leveraging ADARx's RNA techAs per the deal, ADARx will receive $335M upfront & will be eligible to receive several billion in additional contingent payments incl. option fees, milestones, plus tiered royalties…

