AlzeCure Shares Soar over 300% After Eli Lilly Strikes Alzheimer’s Deal Worth over $1bn
Swedish biotech AlzeCure Pharma signed a collaboration and licensing deal with Eli Lilly, granting the pharma giant global rights to AlzeCure’s pre‑clinical gamma‑secretase modulator ACD680. AlzeCure will receive $10 million upfront and could earn more than $1 billion in milestones and royalties. The announcement sent AlzeCure’s shares up 313% to SEK 5.70. The partnership adds a novel amyloid‑production‑modulating asset to Lilly’s already extensive Alzheimer’s pipeline.
Eli Lilly Receives the US FDA Approval for Ebglyss as a Q8W Maintenance Therapy for Atopic Dermatitis
Eli Lilly has received U.S. FDA approval for Ebglyss (lebrikizumab‑lbkz) as a 250 mg subcutaneous injection administered every eight weeks for patients aged 12 years or older with moderate‑to‑severe atopic dermatitis. The decision was driven by exposure‑response modeling and eight‑week dosing data from...
Press Release: Sanofi Provides Update on MOBILIZE Phase 3 Study of Riliprubart in Chronic Inflammatory Demyelinating Polyneuropathy
Sanofi announced that the phase 3 MOBILIZE trial of riliprubart in patients with chronic inflammatory demyelinating polyneuropathy (CIDP) refractory to standard therapy has been stopped. An independent data monitoring committee’s interim analysis indicated the study is unlikely to meet efficacy...
Island Pharmaceuticals Expands USAMRIID Agreement for Galidesivir Marburg Study
Island Pharmaceuticals has broadened its Cooperative Research and Development Agreement with the U.S. Army’s USAMRIID and the Geneva Foundation to launch a dose‑optimization study of its antiviral Galidesivir against the Angola strain of Marburg virus. The study, slated to start...
T-Cell Synapse Formation Is Restrained by PTPN22–PSTPIP1 Signaling
Researchers led by Megan Joseph at University College London identified a new brake on T‑cell activation: the PTPN22‑PSTPIP1 signaling axis. Using super‑resolution DNA‑PAINT imaging, they showed that PTPN22 binds the adaptor PSTPIP1 to restrain actin remodeling at the immunological synapse....
BioPharm Brief: RNAi, Obesity, and Diabetes Advances
City Therapeutics secured a $99.5 million Series B round to accelerate its next‑generation RNAi platform, including the Phase 1 CITY‑FXI program for thromboembolic disease and a Stargardt disease candidate. Boehringer Ingelheim and Zealand Pharma reported that survodutide, a dual glucagon/GLP‑1 agonist, achieved significant...
OpenFold Adds 11 Members to Expand Open-Source AI for Drug Discovery
OpenFold Consortium announced eleven new members, including biotech firms Absci, Adaptive Biotechnologies, Benchling, Chemical Computing Group, Daiichi Sankyo, Flagship Pioneering, Kiin Bio, Nanome, Nxera, Pledge Therapeutics, and Superluminal Medicines. The additions broaden the consortium’s reach across therapeutic discovery, antibody design,...
Cellectis Receives FDA RMAT Designation for Lasme-Cel, the First Allogeneic CAR-T Therapy in a Pivotal Trial for Patients with R/R...
Cellectis announced that the U.S. FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to its CD22‑targeting allogeneic CAR‑T candidate, lasme‑cel, for relapsed or refractory B‑cell acute lymphoblastic leukemia (r/r B‑ALL). The designation follows Phase 1 BALLI‑01 data that demonstrated promising efficacy and...
Efgartigimod Effective in Broad Subsets of Patients With gMG
The phase‑3 ADAPT trial showed that efgartigimod markedly improves symptoms in generalized myasthenia gravis (gMG) across a wide patient spectrum. In the study’s 167 participants, 63.8% of those receiving efgartigimod met the primary MG‑ADL responder criteria versus 30.2% on placebo....
Biotech Rally Hits New Highs as ALVO Nears FDA Decision and Swiss Vote Threatens Talent Pool
Alvotech's interchangeable biosimilar to Entyvio cleared FDA review, pushing its stock higher, while Tango Therapeutics surged over 50% after promising pancreatic cancer data. Meanwhile, a Swiss referendum on population caps threatens biotech talent pipelines, underscoring broader market dynamics.
City Therapeutics Secures $99.5 Million to Advance Next‑Gen RNAi Drugs
City Therapeutics announced a $99.5 million financing package from U.S. banks to push its lead RNA interference candidate, CITY‑FXI, into Phase 1 trials for clotting disorders, and to prepare its second program, CITY‑RBP4, for Stargardt disease. The capital raise highlights growing market...
First-in-Human Trial Reports Promising Dual Lassa–Rabies Vaccine Data
Researchers at the University of Maryland reported interim data from a phase‑1 trial of LASSARAB, a novel dual vaccine targeting Lassa fever and rabies. The study enrolled 54 healthy adults and demonstrated a clean safety profile with no serious adverse...
3 New Ebola Vaccines Are Being Fast-Tracked Amid the Current Outbreak — when Could They Be Ready?
An outbreak of the Bundibugyo strain of Ebola in the DRC and Uganda has caused over 200 deaths and threatens to reach 20,000 cases within three months. Because no approved treatments exist for this strain, CEPI is fast‑tracking three vaccine...
FDA Demands Extra Run, Threatens Grace Science’s Gene Therapy
Grace Science (co-founded by Carolyn Bertozzi) is running out of cash and says the FDA didn't let them use the "plausible mechanism" pathway bc, although they're developing an ultra-rare gene therapy, it's not an n-of-1 therapy. The FDA is also...
Gene-Edited Stem Cells Guard Healthy Blood From Immunotherapy
Researchers have tested a gene-edited stem cell transplant designed to shield healthy blood-forming cells from powerful cancer-targeting immunotherapies. https://t.co/OYA1xBAQSd
Compounding Safety Information: Quinacrine Hydrochloride
On April 6, 2023 the FDA placed quinacrine hydrochloride (HCl) on the 503B bulk‑drug list, permitting oral compounding for patients with cutaneous lupus erythematosus. The agency emphasized that compounded quinacrine products are not FDA‑approved for safety or efficacy and must be used...
How Aging Cells May Trigger Heart Attacks and Strokes
Researchers at UT MD Anderson identified a molecular cascade in which loss of the regulatory proteins LATS1/2 forces endothelial cells into a senescent yet hyper‑active state. This triggers CD38‑driven metabolic reprogramming, inflaming plaques and destabilizing them into high‑risk, clot‑prone lesions. The work...
IDEAYA Biosciences Prices $300 Million Stock and Warrant Offering
IDEAYA Biosciences announced the pricing of a $300 million underwritten public offering of 5.56 million shares and an equal number of pre‑funded warrants at $27 per unit. The capital raise, backed by a syndicate led by J.P. Morgan and Jefferies, aims to...
Incyte to Acquire Vega Therapeutics for Up to $2 B, Expanding Into Bleeding Disorders
Incyte (NASDAQ:INCY) signed a definitive agreement to buy Vega Therapeutics for $1.25 billion upfront, with up to $750 million in milestone payments, bringing the potential total to $2 billion. The acquisition adds VGA039, a Phase‑3 monoclonal antibody for von Willebrand disease, to Incyte’s...
BioCardia Raises $4.4 Million in Financing for Its Heart Failure Cell Therapies
BioCardia raised $4.4 million by selling 3.509 million shares at an average price of $1.28, securing funding to advance its autologous (CardiAMP HF) and allogeneic (CardiALLO) heart‑failure cell therapies. The proceeds are expected to sustain operations through the first quarter of 2027...
FDA Clarifies Lumasiran's PH1 Approval, Keeps Givlaari as AHP Treatment
The FDA has reaffirmed that Lumasiran (Oxlumo) is approved only for primary hyperoxaluria type 1 (PH1), while Givlaari (givosiran) remains the approved RNAi therapy for acute hepatic porphyria (AHP). The clarification forces biotech business‑development teams and investors to separate the two...
ProtVar Update: A Discovery Engine for Genetic Missense Variation
EMBL‑EBI has launched a major upgrade to ProtVar, its platform for interpreting human missense variants. The revamped tool now indexes over 500 million potential missense changes and pulls together data from UniProt, AlphaFold, Open Targets, Ensembl and other resources. An AI‑powered...
Gilead and Merck’s Latest Trial Success and Flop
GlaxoSmithKline announced a $10.6 billion acquisition of Cambridge‑based biotech Nuvalent, paying $124 per share—a 26% premium to its recent average price. The deal adds two FDA‑reviewed lung‑cancer drugs to GSK’s oncology portfolio, which has traditionally focused on gynecologic cancers and multiple...
NVP-INE963
Novartis and Medicines for Malaria Venture have advanced NVP‑INE963, an oral fast‑acting blood‑stage antimalarial, into Phase 2 trials. The candidate emerged from a 1.5 million‑compound phenotypic screen and shows activity against multidrug‑resistant Plasmodium falciparum, though its mechanism remains unknown. Preliminary Phase 2 data...
Boehringer/Zealand Obesity Drug Delivers Phase III Weight Loss, but Side Effects Raise Questions
Boehringer Ingelheim presented Phase III data for survodutide, a once‑weekly dual GLP‑1/glucagon agonist, showing up to 16.6% body‑weight loss after 76 weeks and substantial reductions in visceral and liver fat. In the Synchronize‑1 trial, visceral fat fell up to 34% and...
First Glaucoma Patient Treated with Partial Cellular Reprogramming
The first participant to receive partial cellular reprogramming for eye disease (advanced glaucoma) in a pilot study of 12 patients was treated. Using 3 of the 4 Yamanaka stem cell factors to potentially achieve cellular rejuvenation @Nature https://t.co/R4oJlrPhnS
How Programmable Nanobiology Could Drive the Fifth Industrial Revolution
Professor Jonathan Heddle of Durham University describes how programmable biological matter—particularly protein cages such as the TRAP‑cage—can transform drug delivery and vaccine design, positioning nanobiology as a catalyst for a Fifth Industrial Revolution. His work on DNA gyrase provides structural...
Some Drugs 'Fail' Because of Unrealistic Testing Conditions, Scientists Discover
Northwestern University researchers found that drug activity can flip when experiments mimic human body temperature and calcium levels. Their study showed the synthetic molecule TPPO, previously deemed inactive, robustly activates the TRPM4 channel at 37 °C with physiological calcium. Conversely, the...
MRNA Liver Therapy Reverses Immune Aging in Mice, Study Shows
Researchers delivered mRNA encoding thymic factors DLL1, FLT3L and IL‑7 to the livers of old mice, achieving a transient rejuvenation of the immune system. The treatment enhanced naïve T‑cell output, improved vaccine efficacy and synergized with checkpoint blockade to curb...
Will Obesity Drugs Save Pfizer From Its Post-COVID Slump?
Pfizer’s post‑COVID revenue surge has evaporated, and a wave of patent expirations will shave $1.5 billion off earnings this year, rising to $4.5 billion by 2027. To offset the loss, the company has poured roughly $80 billion into acquisitions and licensing, most notably...
GSK to Acquire Nuvalent for $10.6 B, Bolstering Oncology Pipeline
GSK plc agreed to buy clinical‑stage biotech Nuvalent for $10.6 billion, a deal that brings three late‑stage lung‑cancer candidates into GSK’s oncology pipeline. The transaction, priced at $124 per share, is expected to be accretive to earnings by 2029 and hinges...
Merck, Gilead Serve ‘Sweet and Sour’ Spread After HIV Win, Cancer Stumble
Merck and Gilead reported that their once‑weekly oral HIV combo of islatravir and lenacapavir (IS/LEN) achieved non‑inferior virologic suppression versus Biktarvy and other standard regimens in two Phase 3 trials. At the same time, they halted the Phase 3 KEYNOTE‑D46 study of...
Moderna Jab on Trial for Cancer-Causing Syndrome
Moderna and the University of Oxford have received clearance to begin human trials of mRNA‑4194, an mRNA‑based vaccine aimed at preventing cancers linked to Lynch syndrome. The phase 1/2 INTERCEPT‑Lynch study will start dosing patients at two Oxford clinical sites, with...
Brazilian Researchers Launch Preclinical Trials of Gene‑Silencing Nanoparticles for Psoriasis
Scientists at the University of São Paulo’s NanoGeneSkin lab announced that their liquid‑crystal lipid nanoparticles, designed to deliver siRNA and silence psoriasis‑related genes, have entered preclinical testing. The move marks the first nanomedicine to target skin‑cell gene expression for a...
World's First WWOX Gene Therapy Given to Infant with WOREE Syndrome
An eight‑month‑old infant received the world’s first WWOX gene replacement therapy at Schneider Children’s Medical Center in Israel, marking a historic first‑in‑human treatment for WOREE syndrome. The AAV9‑based vector, developed by Mahzi Therapeutics and licensed from Hebrew University, was delivered...
DDW Highlights: 9 June 2026
In this episode, Bruno Quinney highlights four major developments: Greywolf Therapeutics' experimental oral ERAP1 inhibitor GRWD‑5769, which shrank tumors up to 55% in early trials; UK researchers warning that obesity drugs like semaglutide could widen health inequities without broader support;...
NAD Precursors - Save Your Money Folks
Recent human trials have shown that oral nicotinamide riboside (NR) and nicotinamide mononucleotide (NMN) are equally effective at doubling circulating NAD⁺ levels, contradicting earlier claims of NMN superiority. Pharmacokinetic studies reveal that both compounds are rapidly broken down by gut...
ADA: Lilly Bests Novo Again, Takes GLP-1 Pill Foundayo to FDA for Diabetes Approval
Eli Lilly’s oral GLP‑1 drug orforglipron, marketed as Foundayo, demonstrated superior blood‑sugar control and greater weight loss than Novo Nordisk’s oral semaglutide and AstraZeneca’s Farxiga in three Phase 3 ACHIEVE trials. In the 52‑week ACHIEVE‑3 study, a 9 mg dose cut HbA1c by 1.9%...
David Sinclair Enters $101 Million XPrize with Oral Rejuvenation Drug
Harvard’s David Sinclair confirmed he will launch human trials of an oral “reprogramming” drug, code‑named SL‑100, as part of the XPrize Foundation’s $101 million health‑span competition. The prize rewards teams that can demonstrate a ten‑year improvement in immune, cognitive and muscle...
Seaport Therapeutics Posts $25.4M Q1 Loss, Eyes Phase 2b BUOY‑1 Readout in H1 2027
Seaport Therapeutics announced a Q1 2026 net loss of $25.41 million, nearly double the loss a year earlier, as R&D spending surged to $21.43 million. The company also signaled that data from its Phase 2b BUOY‑1 trial are slated for the first half...
GSK to Acquire Nuvalent in $10.6 B Deal, Bolstering Lung Cancer Pipeline
GlaxoSmithKline (GSK) agreed to buy US biotech Nuvalent for $10.6 billion in cash, paying $124 per share—a 40% premium. The acquisition adds three late‑stage lung‑cancer candidates to GSK’s oncology portfolio and is expected to be accretive to earnings by 2029.
Zai Lab Reports the NMPA Approval of Tivdak (Tisotumab Vedotin) for Recurrent or Metastatic Cervical Cancer
Zai Lab’s antibody‑drug conjugate Tivdak has secured approval from China’s National Medical Products Administration for adults with recurrent or metastatic cervical cancer who have progressed after chemotherapy. The decision follows the global Phase III innovaTV 301 trial, which showed a 45 % reduction...
Scientists Use Inactive Virus to Safe-Deliver Spasticity-Reversing Spinal Genes
A preclinical study used an inactive AAV9 vector to deliver GAD65 and VGAT genes directly into the spinal cord of rats with chronic injury‑induced spasticity. The single subpial injection restored GABAergic inhibition, leading to progressive reductions in muscle stiffness and...
FDA Expands Hympavzi to Children 6+, Boosting Hemophilia Care
The FDA has broadened approval of Pfizer's Hympavzi (marstacimab-hncq) to include all patients aged six and older with hemophilia A or B, with or without inhibitors. The once‑weekly subcutaneous treatment showed a 92% drop in annualized bleeding rates in trials,...
David Sinclair Plans to Test Whole-Body Rejuvenation Drugs in the XPrize Competition
Harvard biologist David Sinclair plans to test an oral epigenetic reprogramming drug, code‑named SL‑100, in the XPRIZE Healthspan competition, which offers $101 million for teams that can demonstrate a ten‑year functional improvement after a year of treatment. The trial would be...
New Non-Invasive Tool Lowers Cancer DNA Tracking Threshold to 5%
Researchers at Chalmers University of Technology and the University of Gothenburg have unveiled BayesCNA, a statistical algorithm that can identify cancer‑derived DNA in blood samples at a tumor fraction as low as 5%, far below the current 15‑20% threshold. The...
Bial Drops Pariceract After Phase IIb Failure in GBA-Associated Parkinson’s
Portuguese drugmaker Bial has halted development of pariceract (BIA 28‑6156) after its Phase IIb ACTIVATE trial failed to meet primary and key secondary endpoints in 273 GBA‑associated Parkinson’s patients. The oral GCase activator was well tolerated but showed no significant difference from...
New 3D Microscope Technology Captures High-Resolution Tissue Images at a Fraction of the Cost
Columbia University researchers led by Prof. Raju Tomer unveiled HySIL, a hybrid solid‑liquid optics system that lets inexpensive air lenses achieve oil‑immersion‑level resolution across centimeter‑scale tissues. The concept is packaged in the modular SCOPE attachment, which retrofits existing light‑sheet microscopes,...
GSK Pursues $10.6bn Takeover of Cancer Biotech Nuvalent
GSK announced a $10.6 billion tender offer for Boston‑based Nuvalent, paying $124 per share—a 40 % premium. The deal brings two late‑stage lung‑cancer drugs, the ROS1 inhibitor zidesamtinib and the ALK inhibitor neladalkib, into GSK’s oncology pipeline, both under FDA review with...
Shift in Biosimilar Commercial Landscape Essential for Sector Sustainability, Expert Says
The biosimilar market faces a sustainability gap as development costs are roughly 100 times higher than generics, while U.S. biosimilar producers capture less than 10% of list‑price revenue. Gillian Woollett of Samsung Bioepis warns that without clearer regulatory pathways and transparent pricing,...