Shots:
The EC has approved Koselugo for the treatment of symptomatic, inoperable plexiform neurofibromas (PN) in adults with neurofibromatosis type 1 (NF1)
Approval was based on the P-III (KOMET) study assessing Koselugo (PO) vs PBO in 145 adults with NF1 & symptomatic, inoperable PNs across 13 countries incl. North America, South America, Europe, Asia &…
Shots:
The US FDA has approved label expansion of Revuforj to treat pts (≥1yrs.) with nucleophosmin 1 (NPM1)-mutated r/r acute myeloid leukemia (AML) who have no satisfactory alternative treatment options
Approval was supported by P-II results from the P-I/II (AUGMENT-101) trial, which showed a 23% CR + CRh rate (15/65), median response time of 2.8mos.,…
Shots:
Incyte has partnered with Enable Injections to develop and commercialize specific assets in Incyte’s portfolio, incl. INCA033989, a mutCALR selective mAb, with Enable’s enFuse On-Body Delivery System
As per the deal, Incyte will obtain exclusive global rights to use enFuse tech with INCA033989 for essential thrombocythemia & myelofibrosis, with potential expansion to other assets &…
Shots:
Health Canada has approved Leqembi with conditions for adults with mild cognitive impairment or mild dementia due to early Alzheimer’s disease who are ApoE ε4 non-carriers or heterozygotes with confirmed amyloid pathology
Approval was based on the P-III (Clarity AD) trial assessing Leqembi vs PBO in pts with MCI or mild dementia due to…
Shots:
Syndivia has granted GSK exclusive global rights to develop and commercialize a preclinical ADC for the treatment of metastatic castration-resistant prostate cancer (mCRPC)
As per the deal, GSK will handle global development, manufacturing, & commercialization of the ADC in exchange for an upfront payment, along with development & commercial milestone payments up to a total of…
Shots:
Eli Lilly has entered into a definitive agreement to acquire Adverum Biotechnologies, incl. its asset Ixo-vec
As per the deal, Lilly will acquire Adverum for $3.56/share plus a CVR of ~$8.91 per share, tied to milestones: for ~$1.78 per CVR on Ixo-vec’s FDA approval within 7yrs. of closing & ~$7.13 per CVR upon achieving $1B…
Shots:
The US FDA has approved Lynkuet for the treatment of mod. to sev. vasomotor symptoms due to menopause based on P-III (OASIS-1, 2, & 3) trials, with commercial availability expected at the start of Nov 2025; MAA is under the EMA’s review
Efficacy was evaluated in OASIS-1 & 2 trials assessing Lynkuet vs PBO…
Shots:
Novartis has agreed to acquire Avidity Biosciences, strengthening its neuroscience pipeline with Avidity’s Antibody Oligonucleotide Conjugates (AOCs) platform & 3 late-stage programs
As per the deal, Novartis will acquire Avidity for $72/share, valuing the company at ~$12B with an enterprise value of ~$11B; closing expected in H1’26
Before the merger, Avidity will transfer its early-stage precision…
Shots:
Dumbo Health has launched a fully digital sleep clinic for the treatment of sleep apnea, integrating testing, diagnosis, therapy, & follow-up into one seamless digital clinic, showcased at HLTH USA & available in Texas & Florida, with gradual expansion planned across the US throughout 2026
Dumbo Health offers a $149 test & diagnosis with…
This week, PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Animal Health, and Biosimilars. Check out our full report below:
Daiichi Sankyo and Merck Report the P-II Study Data for Raludotatug Deruxtecan in Pt.-Resistant Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
Read More: Daiichi Sankyo and Merck
Gilead…

