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 &…
NEWS
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The US FDA has approved Omvoh (200mg/2mL, SC, QM) as a maintenance treatment of adults with mod. to sev. active ulcerative colitis; PFS & prefilled pen to be available in early 2026
Approval was based on P-I trial assessing Omvoh (200mg/2mL, SC) single injection vs 2 100mg/1mL injections in participants, which showed bioequivalence between the…
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The US FDA has approved Winrevair to treat adults with PAH (WHO Group 1) functional class (FC) II or III
Approval was based on the global P-III (ZENITH) trial (N=172) evaluating Winrevair (n=86; 0.7 mg/kg; SC; Q3W) + background therapy vs PBO (n=86) in adults with PAH (WHO FC III/IV) at high mortality risk. WINREVAIR…
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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…
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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…
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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…
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Merck Animal Health has reported data on Bovillis Nasalgen-C (Lyophilisate & Solvent for Suspension; intranasal vaccination) for the prevention of bovine coronavirus in veal calves at Vlaamse Buiatriecongres’25
Data was presented from a study titled “Intranasal vaccination against bovine coronavirus significantly improves production parameters in cross-bred veal calves: Results from a randomized field trial”,…

