Eli Lilly delays FDA filing for next-generation weight-loss drug retatrutide
Eli Lilly's delay in filing retatrutide, a triple agonist seen as a potential successor to tirzepatide, pushes back the timeline for the next wave of obesity th
NewsNation · +14 outlets
FDA grants full approval to selpercatinib for RET fusion-positive advanced solid tumors
The full approval broadens access to this targeted therapy for patients with RET fusion-positive cancers across tumor types, underscoring the tumor-agnostic app
Oncodaily · +14 outlets
GSK wins FDA approval for Jideytro (formerly from Nuvalent) for lung cancer
Jideytro is GSK's first lung cancer approval, cleared ahead of schedule, following its acquisition of Nuvalent.
londoninsider.co.uk · +6 outlets
Vertex receives FDA expanded approval for Casgevy in patients ages 2 and older with sickle cell disease and beta thalassemia
The expanded label for Casgevy, the first CRISPR-based therapy, extends its use to younger pediatric patients.
CRISPR Medicine News · +14 outlets
FDA advisory panel narrowly votes to add 6 peptides to drug compounding list in controversial split
The vote could reshape the peptide market by allowing compounded versions of popular GLP-1 drugs amid shortages.
Rolling Out · +14 outlets
NTLA stock surges 35% ahead of first-ever Phase 3 readout for gene-editing therapy
Intellia Therapeutics' imminent Phase 3 data could be a pivotal moment for in vivo CRISPR gene editing.
Stocktwits
Scribe Therapeutics jumps 44% in market debut, targets heart disease with gene editing
Scribe's strong public market debut highlights investor appetite for gene-editing platforms beyond oncology.
Briefs Finance
RCKT stock dives despite gene therapy approval; Wall Street dismisses sell-off
Rocket Pharmaceuticals shares dropped after its gene therapy approval, with analysts calling the move overdone.
Stocktwits
Capricor Therapeutics' former exec could become FDA's top gene therapy regulator ahead of DMD decision
A former Capricor executive is reportedly in line to lead FDA gene therapy oversight as a decision on deramiocel for Duchenne muscular dystrophy approaches.
Stocktwits · +9 outlets
FDA fast-tracks psychedelic research after Trump executive order; CMPS and HELP stocks gain
An executive order prompts the FDA to expedite psychedelic therapy research, boosting related biotech stocks.
Stocktwits · +14 outlets
PFizer stock continues to drop as lung cancer trial disappointment overshadows Ibrance win
Pfizer shares fell as a lung cancer trial miss outweighed positive data for its breast cancer drug Ibrance.
Stocktwits · +1 outlets
MoonLake's Week 40 HS results show sustained efficacy; implications for investors
Long-term data for MoonLake's hidradenitis suppurativa treatment reinforce its competitive profile in immunology.
Kavout · +2 outlets
CHMP recommends marketing authorization for obicetrapib in EU
Obicetrapib, a novel CETP inhibitor for LDL-C reduction, moves closer to EU market as a potential oral add-on to statins.
The Clinical Trial Vanguard · +3 outlets
CRISPR makes prostate cancer vulnerable to immunotherapy, new study finds
Research shows CRISPR-mediated targeting of a specific RNA can sensitize prostate cancer to immune checkpoint blockade.
ScienceDaily · +13 outlets
UniQure stock suddenly plunges; clinical hold triggers data unblinding
UniQure was hit with a full clinical hold from the FDA, prompting a stock drop and unblinding of trial data.
Kavout · +1 outlets
FDA approves LYTENAVA, first ophthalmic bevacizumab for wet AMD
LYTENAVA becomes the first FDA-approved ophthalmic formulation of bevacizumab for age-related macular degeneration.
The Clinical Trial Vanguard · +14 outlets
GSK's Jideytro lung cancer approval follows Nuvalent acquisition
The accelerated approval validates GSK's deal for Nuvalent, bringing a ROS1/NTRK inhibitor to market.
londoninsider.co.uk · +7 outlets
Lonza Group stock steadies as investors weigh weaker guidance and new biologics focus
Lonza's shares stabilize as the CDMO shifts strategy amid lowered 2024 guidance and a renewed biologics push.
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