Clearmind Medicine Shares Surge 47% After Japan Patent Filing for Depression Drug
Clearmind Medicine Inc. announced a Japanese patent application covering its 5‑Methoxy‑2‑aminoindan (MEAI) depression treatment, sending the Nasdaq‑listed stock up 46.72% to $3.59. The filing strengthens the company's non‑hallucinogenic neuroplastogen IP portfolio and positions it for future market entry in Japan.
Immunome Announces Detailed Phase 3 RINGSIDE Data for Varegacestat in Adults with Progressing Desmoid Tumors at the 2026 ASCO Annual...
Immunome presented detailed Phase 3 RINGSIDE data for its gamma secretase inhibitor varegacestat at the 2026 ASCO meeting. The trial met its primary endpoint, showing an 84% reduction in progression‑free survival risk and a 56% objective response rate versus 9% with...
Encouraging Global Phase II Ivonescimab Data in First-Line Metastatic Colorectal Cancer Presented at ASCO 2026
Summit Therapeutics presented interim Phase II data from the AK112‑206 trial at ASCO 2026, evaluating ivonescimab combined with mFOLFOX6 in treatment‑naïve, microsatellite‑stable metastatic colorectal cancer. In 49 patients, the regimen achieved a 70.8% objective response rate and a disease control...
Tune Therapeutics Presents Positive Phase 1b/2a Proof of Concept Data on TUNE-401: A First-in-Class Epigenetic Silencer for Patients with Hepatitis...
Tune Therapeutics reported Phase 1b/2a data for TUNE‑401, an IV‑delivered LNP‑RNA epigenetic silencer, at the EASL 2026 Congress. The study showed dose‑dependent, durable repression of all key HBV biomarkers, including direct loss of cccDNA‑derived pgRNA and HBeAg in a subset of...
Melanoma's Progress, Persistent Gaps, and the Toxicity Criteria That Needed to Change: Igor Puzanov, MD
Immunotherapy has cut U.S. melanoma deaths roughly in half, dropping from about 15,000 to 7,700 annually, according to Roswell Park’s Igor Puzanov. He warns that a subset of tumors undergo epithelial‑mesenchymal transition (EMT), shedding immune‑visible markers and escaping checkpoint inhibitors. To...
Regimen May Become ‘a Standard’ for Aggressive Lymphomas
A phase‑3 frontMIND trial showed that adding tafasitamab and lenalidomide to standard R‑CHOP cuts the risk of progression or death by 25% in newly diagnosed high‑risk diffuse large B‑cell lymphoma (DLBCL) and high‑grade B‑cell lymphoma. The experimental arm achieved 71%...
Scientists Got Mouse Eyes to Perform Photosynthesis — and No, They Didn't Turn Green
Scientists have engineered eye drops containing spinach thylakoid grana that enable mouse eyes to perform light‑driven photosynthetic reactions. The formulation, dubbed LEAF, produces the antioxidant NADPH, reducing inflammation and restoring tear production in a dry‑eye mouse model. After five days,...
STAT+: Revolution Medicines Starts Shipping Experimental Pancreatic Cancer Drug
Revolution Medicines has begun shipping its experimental pancreatic cancer therapy, daraxonrasib, to physicians through an FDA‑authorized early‑access program. The rollout follows Phase 3 data released in mid‑April showing patients lived nearly twice as long as those on standard chemotherapy—the longest survival...
Sirona Pill Cuts 400 Calories Daily, Shows 4% Weight Loss in Early Trial
Oxford Medical Products' Sirona capsule, which swells in the stomach to create a feeling of fullness, cut participants' daily calorie intake by about 400 kcal and delivered an average 4.4% body‑weight loss over 24 weeks. The early‑stage trial suggests a...
AD109 Sleep Apnea Pill Shows >50% Reduction in Episodes in Late‑Stage Trials
Biopharma firm Apnimed reported that its oral drug AD109 cut obstructive sleep apnea episodes by more than 50% in late‑stage trials. The result positions the pill as a potential first‑in‑class, non‑CPAP treatment for the roughly 80 million Americans with the disorder.
Replimune Shares Jump 82% After FDA Aligns on RP1 Melanoma Filing
Replimune Group, Inc. saw its shares climb 82.34% to $8.54 after the U.S. Food and Drug Administration signaled an urgent, prioritized review of the company’s RP1 (vusolimogene oderparepvec) melanoma therapy combined with nivolumab. The alignment clears the way for a...
Six ASCO Trials Decoded: Data, Gaps, and Implications
ASCO’s opening day was filled with superlatives, yet the real insight lies in a deeper look at six highlighted trials. Those trials deliver promising efficacy signals but expose gaps such as limited safety follow‑up, short‑term endpoints, and weak control arms....
Trial of Multi-Cancer Blood Test Among 142,000 NHS Patients Fails to Meet Main Aim
A randomized controlled trial of Grail's Galleri multi‑cancer blood test involving 142,942 NHS patients failed to meet its primary goal of reducing late‑stage cancer diagnoses. Participants were split evenly between Galleri screening and standard care, with blood drawn annually for...
DNA Framework Nucleator‐Enabled Intelligent Hydrogel Interfaces on Living Cells
Researchers introduced a DNA framework nucleator (DFN) that creates ordered hydrogel interfaces on living cell membranes. The rigid tetrahedral DNA scaffold directs localized branched hybridization chain reactions, delivering an ATP‑responsive hydrogel with ~90.7% efficiency—2.9‑fold higher than flexible dsDNA nucleators. The...
FDA Clears Eli Lilly's Foundayo Pill, First Oral GLP‑1 Weight‑Loss Drug Since Novo Nordisk
The U.S. FDA has approved Eli Lilly’s once‑daily oral weight‑loss pill, Foundayo, marking the second oral GLP‑1 therapy on the market. Priced between $149 and $349 per month, the drug offers a pill‑based regimen with comparable 12% average weight loss over...
Verve Therapeutics’ One‑Dose Gene Edit Cuts LDL 62% for Six Months
Verve Therapeutics announced that a single intravenous infusion of its base‑editing drug reduced LDL cholesterol by an average 62% in patients with heterozygous familial hypercholesterolemia, with the effect persisting for at least six months. The result, from a small phase...
Exercise and NAD+ Boost Safety and Function in Friedreich’s Ataxia
Safety and efficacy of individualised exercise and NAD+ precursor supplementation in patients with Friedreich's ataxia in the USA: a single-centre, 2 × 2 factorial, randomised controlled trial https://t.co/1Pll9b0d4q
VCs Redirect Billions to Biotech as Hedge Against AI Bubble, PitchBook Reports
Crossover investors, asset managers, mutual funds and hedge funds are reallocating capital toward biopharma, with recent IPOs like Kailera raising $625 million and Eli Lilly completing $20 billion in acquisitions. The shift reflects a defensive strategy as the AI sector shows signs of...
Exercise Undoes Calorie Restriction’s Anti‑Metastatic Benefit
The antimetastatic effects of calorie restriction are negated by voluntary exercise in an aggressive breast cancer mouse model https://t.co/e4WJspZAgu
China’s Rise in Drug Development Looms Over U.S.
At this year’s American Society of Clinical Oncology (ASCO) meeting in Chicago, a clinical trial conducted solely in China was featured as one of five headliners, underscoring China’s rapid ascent in biotech. Over the past few years, China’s biotech sector...
Pembrolizumab Combination Therapy Improves Survival in Recurrent Endometrial Cancer Patients
The phase 3 NRG‑GY018 trial presented at ASCO 2026 confirms that adding pembrolizumab to carboplatin‑paclitaxel extends overall survival in advanced or recurrent endometrial cancer. In the mismatch‑repair‑deficient (dMMR) cohort, 48‑month survival rose to 79% versus 60% with chemotherapy alone (HR 0.56). In...
Busy June at FDA with 11 Upcoming PDUFA Dates
The FDA has a packed June agenda with 11 PDUFA decision dates, covering at least eight new drug approvals and three new indication expansions. Among the high‑profile reviews is Ionis Pharmaceuticals’ antisense therapy Tryngolza, currently approved for familial chylomicronemia syndrome....
Corcept Presents New Data at ASCO 2026: Lifyorli™ Overall Survival Across All Subgroups of Patients with Platinum-Resistant Ovarian Cancer, Including...
Corcept Therapeutics reported overall survival data from its Phase 3 ROSELLA trial of Lifyorli (relacorilant) plus nab‑paclitaxel in platinum‑resistant ovarian cancer at ASCO 2026. The combination cut the risk of death by 35% (HR 0.65, p = 0.0004) and extended median overall survival to 16.0...
The CFO Helping to Bring His Biotech “to the Finish Line”
CFO Robert Hoffman joined CytoDyn in May 2025 and quickly tackled its capital shortfall while driving cost discipline. He secured a $30 million standby equity purchase agreement with Yorkville Advisors and closed a $17.5 million private placement, while renegotiating a $57 million convertible...
Teclistamab Extends Remission in Relapsed Myeloma, with 70% Progression-Free at 18 Months
A Phase III MajesTEC‑9 trial of the bispecific antibody teclistamab showed that 70% of relapsed multiple myeloma patients remained progression‑free after 18 months, far outpacing the 27% rate for standard therapies. Nearly two‑thirds of participants achieved complete remission, many reaching MRD‑negative status....
At ASCO, Merck Makes Case for a ‘Cornerstone’ Cancer Drug
Merck is positioning sacituzumab tirumotecan (sac‑TMT), an ADC discovered by China’s Kelun‑Biotech, as a potential cornerstone therapy as its blockbuster Keytruda nears patent expiry. The drug entered a 17‑study Phase 3 program and showed a 65% reduction in disease progression or...
Linvoseltamab Data ‘Encouraging’ in Relapsed AL Amyloidosis
Regeneron's bispecific antibody linvoseltamab showed rapid and deep activity in a phase 1/2 trial for relapsed or refractory systemic AL amyloidosis, with all 20 patients achieving an objective response and 90% attaining a hematologic complete response. The safety profile was manageable,...
Cornell Team Introduces Safer DNA‑Nick CRISPR Method for Gene Editing
Researchers at Cornell University have unveiled a DNA‑nick based CRISPR method that replaces double‑strand cuts with single‑strand nicks, cutting toxicity in the MAGIC platform. Published in the Proceedings of the National Academy of Sciences on May 27, 2026, the work...
Depemokimab Reduces Exacerbations in Type 2 Asthma, CRSwNP Over 2 Years
Depemokimab, GSK's ultra‑long‑acting biologic, achieved a 51% overall reduction in asthma exacerbations and a 69% reduction in patients with chronic rhinosinusitis with nasal polyps (CRSwNP) in the phase 3 SWIFT‑1/2 trials. The drug was administered subcutaneously at 100 mg every 26 weeks, with...
Pfizer Inks $10 Billion Oncology Pact with China’s Innovent Biologics
Pfizer announced a global licensing and collaboration deal with Innovent Biologics to co‑develop 12 early‑stage cancer medicines. Innovent receives a $650 million upfront payment and could earn up to $9.85 billion in milestones, signaling a major boost to both firms' oncology pipelines.
Resmetirom Cuts CV Risk in MASH: Meena Bansal, MD
Resmetirom, a thyroid hormone receptor‑β agonist, showed in secondary analyses of the phase 3 MAESTRO‑NASH and MAESTRO‑NAFLD‑1 trials that it reduces LDL‑C, apolipoprotein B and lipoprotein(a) in patients with metabolic dysfunction‑associated steatohepatitis (MASH) even when they are already receiving statins. The lipid...
Pfizer, Innovent Ink Up-to-$10.5B+ Cancer Treatment Collaboration
Pfizer and China’s Innovent Biologics have signed a global licensing and collaboration deal to co‑develop and co‑commercialize 12 early‑stage antibodies and antibody‑drug conjugates (ADCs) targeting cancer. Pfizer will pay Innovent $650 million upfront and up to $9.85 billion in milestone payments, plus...
‘The Most Significant Change in 20 Years’: Cancer Centers Prepare for Daraxonrasib Demand
U.S. health systems are seeing a surge in demand for daraxonrasib after the FDA issued a May 1 expanded‑access letter. The drug, a KRAS‑G12C inhibitor from Revolution Medicines, showed a 35% response rate and median overall survival of 13.1 months in...
‘Like Christmas’: Woman’s Relief After Test Finds She Can Skip Chemotherapy
A multinational Optima trial involving 4,429 breast‑cancer patients showed that the Prosigna genomic test can reliably identify women who may forgo chemotherapy. The five‑year disease‑free survival was 93.7% for patients who skipped chemo, statistically indistinguishable from the 94.9% rate in...
RNA Therapy for Genetic Heart Failure Moves Closer to Patients After Lab Gains
Researchers at University Medical Center Groningen demonstrated that RNA therapy targeting the PLN R14del mutation reduces protein aggregation and restores cellular function in patient‑derived heart cells. Using induced pluripotent stem cell‑derived cardiomyocytes, the treatment reversed phosphoproteomic abnormalities linked to calcium regulation....
New Approach Methodologies (NAMs)
The FDA announced that it has achieved its Year 1 objectives for New Approach Methodologies (NAMs), dramatically reducing reliance on animal testing in drug development. By focusing first on monoclonal antibodies, the agency outlined a step‑wise roadmap that validates AI‑driven models,...
Pharmaceutical Executive Daily: WHO Identifies Priority Treatment Candidates for Ebola
The World Health Organization has named three experimental therapies—from Mapp Biopharmaceutical, Regeneron and Gilead Sciences—as priority candidates for treating the Bundibugyo strain of Ebola amid a spreading outbreak in the Democratic Republic of the Congo and Uganda. In a separate...
VA Launches MDMA Trial; Psilocybin Shows Fast, Lasting Relief
Veterans Affairs announces new MDMA clinical trial; Psilocybin’s antidepressant effects are both rapid and long-lasting https://t.co/T5eCTPW77O
WHO Prioritizes Regeneron's Maftivimab for Ebola Trials Amid Outbreak
The World Health Organization’s Therapeutics Advisory Group has recommended Regeneron’s antibody maftivimab for prioritized evaluation in clinical trials targeting the Bundibugyo ebolavirus outbreak in the Democratic Republic of Congo and Uganda. The endorsement places the drug alongside other candidates from...
Putin’s $26 Billion Longevity Push
Russian President Vladimir Putin has earmarked $26 billion for a national longevity program that targets organ bioprinting and xenotransplantation in genetically engineered mini‑pigs. State scientists claim early successes, such as printed cartilage and a mouse thyroid, with a goal of human organ...
Illumina Announces MRD Kit Ahead of ASCO Meeting
Illumina announced a molecular residual disease (MRD) kit ahead of the ASCO meeting, offering solid‑tumor and blood‑cancer genomic profiling on NovaSeq systems. The kit delivers whole‑genome sequencing sensitivity down to 10 ppm and 99.5% analytical specificity, with an end‑to‑end workflow completed...
ASCO: BMS Hails "Compelling" Phase 3 Celmod Readout
Bristol Myers Squibb presented phase 3 data for mezigdomide, a cereblon E3 ligase modulator, combined with carfilzomib and dexamethasone in relapsed/refractory multiple myeloma. The SUCCESSOR‑2 trial showed a 52% reduction in progression or death risk and a median progression‑free survival of...
Tempus Receives FDA Approval for Tumor Only xT CDx, Enabling Migration of Its Entire DNA Solid Tumor Portfolio
Tempus AI announced that the FDA has approved its xT CDx next‑generation sequencing platform for a tumor‑only indication, making it the first lab to hold companion diagnostic clearance for both tumor‑only and tumor‑normal comprehensive genomic profiling. The 648‑gene assay can now...
NeuroPace Announces FDA Approval of ECoG Assistant™, Advancing AI-Driven Epilepsy Care
NeuroPace received FDA clearance for ECoG Assistant™, its first AI‑driven clinician‑enabled feature for the RNS System. The tool leverages a proprietary dataset of 124,450 epileptologist‑labeled intracranial EEG records to flag ECoGs of interest and present trends in a single view....
Seven-Year Analysis From Pfizer’s LORBRENA CROWN Trial Shows Longest Progression-Free Survival Reported to Date in Advanced Non-Small Cell Lung Cancer
Pfizer reported seven‑year follow‑up from the Phase 3 CROWN trial, showing that lorlatinib (LORBRENA) achieved a 55% progression‑free survival (PFS) rate versus just 3% for crizotinib (XALKORI). Median PFS was not reached for LORBRENA, translating to an 81% reduction in risk...
Cracked Gaskets and Rust-Like Residues Trigger FDA Warning Letter to Alchymars
The U.S. Food and Drug Administration issued a second warning letter to Indian API maker Alchymars ICM SM Private Limited after an unannounced inspection uncovered cracked gaskets, rust‑like residues and wet paint on equipment used for U.S. drug production. The...
BREAKING: Largest Human Cancer Study of Ivermectin + Mebendazole Is Now PEER-REVIEWED and PUBLISHED in a Major Cancer Journal
A prospective real‑world cohort of 197 cancer patients treated with a compounded ivermectin‑mebendazole capsule (25 mg ivermectin, 250 mg mebendazole) has been peer‑reviewed and published in Anticancer Research. After roughly six months, 84.4% of participants reported a clinical benefit—remission, tumor regression, or...
WHO Prioritizes Three Experimental Treatments for Bundibugyo Ebola Strain
The World Health Organization has named three experimental therapies—Mapp Biopharmaceutical’s MBP134, Regeneron’s maftivimab, and Gilead’s remdesivir—as priority candidates for treating the Bundibugyo strain of Ebola. The agency urges immediate clinical trials as the outbreak spreads across the Democratic Republic of...
STAT+: Pharmalittle: We’re Reading About Replimune Drug Getting Third Try at FDA Approval, a Pfizer Deal in China, and More
An FDA advisory panel recommended that this fall’s COVID‑19 vaccines be updated to target the fast‑growing XFG (“stratus”) variant. Pfizer signed a global licensing and collaboration deal with China’s Innovent Biologics worth up to $10.5 billion to co‑develop 12 early‑stage cancer...
Replimune Gives Cancer Immunotherapy a Third Try After FDA Leadership Shakeup
Replimune is filing a third biologics license application for its oncolytic melanoma therapy RP1, now paired with Bristol Myers Squibb’s PD‑1 inhibitor Opdivo. The FDA has labeled the resubmission an urgent matter and will prioritize its review. Earlier submissions were rejected...