Today's Pharma Pulse
Ona lands $86.6M Series B, one of Spain’s biggest biotech rounds
Spanish biotech firm Ona announced an $86.6 million Series B financing, ranking among the largest venture rounds in Spain’s life‑science sector this year. The round was led by Seventure Partners with participation from existing backers and new strategic investors. The funding will be used to scale Ona’s AI‑driven drug discovery platform and accelerate its pre‑clinical programs.
Carvykti Shows Promise Before Multiple Myeloma; Two Megarounds; AstraZeneca Wins Twice
Researchers at Dana‑Farber Cancer Institute reported that all 20 high‑risk smoldering multiple myeloma patients treated with Carvykti, Janssen's BCMA‑directed CAR‑T therapy, achieved disease clearance. The single‑infusion regimen produced complete responses without immediate relapse, and patients remained progression‑free at a median 12‑month follow‑up. These early results suggest that intervening before overt multiple myeloma could transform the standard watch‑and‑wait approach. The data also position Carvykti for potential regulatory fast‑track status.
SMMT Spikes as Akeso OS Data Lands Plenary
Summit Thera. $SMMT Well… that answers that. SMMT shares initially popped (as much as ~15%) on today’s release of ASCO abstract titles with the unexpected news that the much-anticipated OS data from Akeso’s HARMONi-6 will be released in a Plenary slot...
BioAge Says Early Data Suggest ‘Best-in-Class’ Potential for Inflammation Drug
BioAge Labs released Phase 1 data for the 60‑mg dose of its NLRP3 inhibitor BGE‑102, confirming tolerability and inflammation‑lowering activity similar to the earlier 120‑mg readout. The oral pill crosses the blood‑brain barrier, opening possibilities for cardiovascular, obesity, eye and central‑nervous‑system...
Early Myocarditis Onset After Immunotherapy May Predict Treatment-Related Fatality
A new analysis of WHO VigiBase data presented at the AACR 2026 meeting shows that immune checkpoint inhibitor (ICI)‑induced myocarditis occurring within the first month of therapy dramatically increases the risk of death. Patients who develop myocarditis early are 59%...
Intralesional Nivolumab May Be Effective Against Precancerous Oral Lesions, Phase I Trial Results Indicate
A Phase I trial presented at AACR 2026 showed that injecting low‑dose nivolumab directly into precancerous oral lesions produced an 85% clinical response rate, with lesions shrinking an average of 60% and 41% achieving histologic downgrading. Patients received 10 mg or 20 mg...
CellCarta Eliminates 9-Hours-Per-Week Regulatory Bottleneck with RegASK’s AI-Driven Intelligence Platform
CellCarta, a global contract research organization, partnered with RegASK to overhaul its regulatory intelligence function. By deploying RegASK’s agentic AI platform, the CRO replaced a manual nine‑hour‑per‑week monitoring process with near‑real‑time updates. The new centralized hub automatically captures, validates and...
Agenus Names BAP Pharma as Exclusive Global Partner for BOT+BAL Access Programs
Agenus appointed BAP Pharma as its exclusive global partner to manage early‑access programs for the botensilimab‑balstilimab (BOT+BAL) immunotherapy combo. The collaboration will handle France’s government‑reimbursed Autorisation d’Accès Compassionnel (AAC) pathway and paid named‑patient programs in several other markets. Agenus has...
Charles River Highlights Effectiveness of VCGs in Toxicology
Charles River Laboratories published a retrospective analysis of 20 nonclinical toxicology studies that replaced traditional concurrent control groups with virtual control groups (VCGs). The review found 100% concordance in No Observed Adverse Effect Level (NOAEL) determinations and demonstrated up to...
Star Therapeutics Receives FDA Rare Pediatric Disease and Breakthrough Therapy Designations for VGA039 in Von Willebrand Disease Prophylaxis
Star Therapeutics announced that the FDA has granted both rare pediatric disease and Breakthrough Therapy designations to its lead candidate VGA039, a monoclonal antibody aimed at preventing bleeding in von Willebrand disease (VWD). The designations support the ongoing Phase 3 VIVID‑6 study,...
Simulations Plus Announces Collaboration with Lonza and U.S. FDA to Advance Predictive Frameworks for Complex Oral Drug Products
Simulations Plus announced a funded collaboration with CDMO Lonza and the U.S. FDA to create a mechanistic, predictive framework for amorphous solid dispersion (ASD) oral drugs. The partnership will combine Lonza's advanced in‑vitro dissolution testing with Simulations Plus' GastroPlus and...
Combining Cannabis with Opioids Offers No Added Pain Relief for Knee Arthritis Patients, Study Concludes
Researchers conducted a double‑blind, placebo‑controlled trial with 21 knee‑osteoarthritis patients to evaluate whether dronabinol, a synthetic THC, enhances the analgesic effect of hydromorphone. The study found that neither drug alone, nor their combination, produced meaningful acute pain relief during laboratory...
Tortugas Takes Neuro Deep Dive with $106M to Develop Eisai, Hansoh Programs
Tortugas, a Massachusetts‑based biotech, launched with $106 million in seed and Series A funding, securing clinical assets from Japan’s Eisai and China’s Hansoh Pharmaceutical. The capital will support two mid‑stage, oral small‑molecule trials targeting CNS disorders such as schizophrenia, tinnitus, and focal...
NIMBLE Trial Shows Efficacy of Cemdisiran in gMG: Tuan Vu, MD
The phase 3 NIMBLE trial evaluated cemdisiran, an RNA‑interference therapy, in patients with generalized myasthenia gravis (gMG). Over 26 weeks, cemdisiran monotherapy and its combination with pozelimab both achieved statistically significant improvements on the MG‑ADL scale versus placebo, and met the key...
Boehringer Targets AI-Driven Advances in Disease Research
Boehringer Ingelheim announced a £150 million (US$203 million) AI and machine‑learning accelerator in King’s Cross, London, expanding its global computational R&D network. The new hub, part of the UK Knowledge Quarter, will focus on disease biology, target identification and predictive modeling to...
BioAge Reports Positive Phase 1 Data for BGE-102
BioAge Labs announced Phase 1 results for BGE‑102, an oral, brain‑penetrant NLRP3 inhibitor, showing up to 86% reductions in high‑sensitivity C‑reactive protein (hsCRP) in obese participants. A 60 mg once‑daily regimen over 21 days achieved biomarker improvements comparable to the previously tested...
![[Comment] Is Partial Complement Blockade Enough in Myasthenia Gravis?](https://hixhlmpcokxhartfkpyi.supabase.co/storage/v1/object/public/images/thumbnails/efeb4e97504f7f1cdd947972b3a5f013.webp)
[Comment] Is Partial Complement Blockade Enough in Myasthenia Gravis?
The past eight years have seen a rapid expansion of targeted therapies for generalized myasthenia gravis, including complement C5 inhibitors, neonatal Fc receptor antagonists, and the anti‑CD19 B‑cell‑depleting antibody inebilizumab. Clinical trials have demonstrated meaningful reductions in disease activity, prompting...
Research Shows Nicotine May Boost Cognition, Guard Against Parkinson's
The New York Times mentioned me in an article about nicotine. They're skeptical. Here's what they didn't include... Dr. Paul Newhouse at Vanderbilt ran controlled trials showing nicotine improved concentration and cognitive function in people with mild cognitive impairment. Peer-reviewed, published...
MRNA Brand Stigmatized by COVID Vaccine Backlash, Says Bhattacharya
That is literally a lie, as Bhattacharya wrote an op-ed trying to explain their move. He essentially was arguing that the "brand" of mRNA is tainted by public backlash to the COVID vaccine. https://t.co/5KXQJtCCxM https://t.co/HDQRvQK0ki
Re: Alzheimer’s Drugs Targeting Amyloid Do Not Produce Clinically Meaningful Effects, Concludes Cochrane Review
A recent Cochrane review concluded that amyloid‑targeting drugs for Alzheimer’s disease do not deliver clinically meaningful benefits, prompting disappointment among researchers, investors, and caregivers. In a BMJ rapid response, emeritus professors Elaine and Robert Perry argue that cholinergic therapy—available for...
Promising Mufemilast Results Unveiled at DDW
Strong mufemilast data being presented at DDW this week for anyone still following the $PALI story. https://t.co/Oi4WI6R0iW
AI Accelerates Small Molecule Synthesis, Says Martin Burke
Small molecule synthesis made faster for the AI era: Listen to Martin Burke on The Long Run. Sponsors: @AlphaSenseInc and Dash Bio. https://t.co/D990phgzg8
Merck, Eisai’s Keytruda Triplet Fails to Improve Survival in Kidney Cancer
Merck and Eisai announced that their Phase 3 LITESPARK‑012 trial of a three‑drug regimen—Keytruda, Welireg and Lenvima—failed to improve overall survival or progression‑free survival in first‑line renal cell carcinoma. The control arm received the approved Keytruda‑Lenvima doublet, which also did not...
SaNOtize - 727784 - 04/17/2026
The U.S. Food and Drug Administration issued a warning letter to SaNOtize, the maker of “NOWONDER™ Nasal Cleanser,” on April 17, 2026. The agency determined the product is an unapproved new drug because its labeling and website claim nitric‑oxide‑based immune benefits, violating sections 505(a)...
Pro Numb Tattoo Numbing Spray, LLC - 722589 - 04/14/2026
The FDA issued a warning letter to Pro Numb Tattoo Numbing Spray, LLC for multiple Current Good Manufacturing Practice (CGMP) violations, including failure to test finished drug batches, inadequate raw‑material verification, and lack of stability data. The firm also marketed...
Mabwell’s T‑mab Subsidiary Clears First‑Time GMP Inspection in Jordan, Boosting Middle‑East Push
Mabwell announced that its subsidiary T‑mab successfully passed a Jordan Food and Drug Administration on‑site GMP inspection, earning a “Compliance” rating for its denosumab biosimilars. The milestone, the company’s first approval from a PIC/S member country, is expected to accelerate...
Eli Lilly to Acquire Kelonia Therapeutics in $7 B Cash Deal
Eli Lilly agreed to acquire Cambridge‑based Kelonia Therapeutics for up to $7 billion in cash, including an undisclosed upfront payment. The deal adds Kelonia’s in‑vivo gene‑delivery platform and its lead candidate KLN‑1010 to Lilly’s oncology portfolio, and sent Lilly’s shares up 2.5%...
Chinese Researchers Propose Saliva Test to Detect Stomach Cancer Early
Researchers from Shanghai Jiao Tong University School of Medicine have pinpointed 20 bacterial species that appear in both the mouths and stomachs of gastric‑cancer patients. Their study, published in Cell Reports Medicine, proposes a non‑invasive saliva test that could identify...
BBOT Secures FDA Fast Track for Pan-KRAS Inhibitor BBO-11818 in KRAS‑Mutant Pancreatic Cancer
BridgeBio Oncology Therapeutics (BBOT) announced that the FDA granted Fast Track designation to its pan‑KRAS inhibitor BBO-11818 for advanced KRAS‑mutant pancreatic ductal adenocarcinoma. The designation accelerates development of a drug that showed a confirmed partial response in early data and...
Neolaia Synthesizes New CD38 Inhibitors
Biohaven disclosed detailed preclinical data on BHV‑2100, a TRPM3 calcium‑channel modulator aimed at neuropathic pain. A new meta‑analysis concluded that anti‑amyloid therapies for Alzheimer’s have not demonstrated clinically meaningful benefits, intensifying debate over the approach. Jiangsu and Shanghai Hengrui patented...
What New Atopic Dermatitis Treatments Are in the Pipeline in 2026?
The atopic dermatitis pipeline in 2026 is dominated by next‑generation biologics and selective small molecules that aim to improve efficacy while reducing side‑effects. Connect Biopharma’s rademikibart achieved near‑complete skin clearance in a phase 3 trial, and Apogee’s extended‑half‑life zumilokibart showed durable...
Incyte Discloses New TYK2 And/Or JAK1 Inhibitors
Incyte announced the discovery of a new series of small‑molecule inhibitors that selectively target TYK2 and JAK1, two kinases central to cytokine signaling in autoimmune disorders. The compounds demonstrated sub‑nanomolar potency in cell‑based assays and favorable safety margins in early...
The AI Drug Discovery Capital Stack in 2026: Who Has Raised the Most, Why Their Technical Approaches Actually Differ, and...
The essay maps AI‑driven drug‑discovery firms’ capital stacks as of April 2026, highlighting that Eikon, Xaira, Isomorphic Labs and Recursion sit at the top of disclosed funding. It separates the sector into four technical lanes—structure foundation models, generative chemistry, phenomics/perturbational biology,...
Regulatory Hurdles, Not Tech, Slow Biotech Breakthroughs
"We need 6 'AlphaFold' moments to compress the drug delivery timeline from 10yrs to a few months" -Demis Yes and the FDA will still take 10yrs to approve it. Safetyism has throttled biotech unnecessarily and the only way to accelerate is to...
Pharma Exporters Facing Issues with Online National Drug Licensing System
Indian pharmaceutical exporters are encountering technical problems with the Online National Drug Licensing System (ONDLS), which issues Certificates of Pharmaceutical Products (COPP) under the WHO Good Manufacturing Practices scheme. The Pharmaceuticals Export Promotion Council (Pharmexcil) has launched a feedback drive...
Biocon Receives Health Canada Approval for Bosaya and Vevzuo (Biosimilars, Prolia and Xgeva)
Biocon has secured a Notice of Compliance from Health Canada for its denosumab biosimilars, Bosaya and Vevzuo, which mirror Amgen’s Prolia and Xgeva. The approval follows a comprehensive data package demonstrating comparable quality, safety and efficacy to the reference products....
This Biotech Firm Has Room to Run Despite Surging Nearly 500% in Past Year, Morgan Stanley Says
Arrowhead Pharmaceuticals’ stock has rocketed 473% over the past year, prompting Morgan Stanley to upgrade the shares to overweight and lift its price target to $100 from $78, indicating roughly a 44% upside. The firm is set to release Phase‑3...
Rethinking When to Start Long-Acting HIV Therapy
Real‑world data from the OPERA cohort of over 5,000 patients show that starting long‑acting cabotegravir plus rilpivirine (CAB+RPV LA) in individuals with detectable viral loads—about 11% above 50 copies/mL—can still achieve virologic suppression comparable to patients who begin treatment already...
Monopar Therapeutics Reports P-III (FoCus) Trial Data on ALXN1840 in Wilson Disease
Monopar Therapeutics reported Phase III FoCus trial results for ALXN1840, an oral copper‑binding agent, in Wilson disease patients with neurologic involvement. The study enrolled 77 patients on ALXN1840 and 35 on standard of care, showing neurologic worsening in only 9% versus...
Tortugas Neuroscience Launches to Develop Brain Disorder Drugs
Tortugas Neuroscience launches with hopes to develop drugs for brain disorders, other conditions https://t.co/zoM69VEQtV via @ADeAngelis_bio
Trump Order Boosts Psychedelic Biotech Stocks
Trump executive order lifts psychedelics biotechs https://t.co/3H00cxuF4A by @realJacobBell $GHRS $HRELP $DFTX $ENVB $COMP $ATAI #biotech
Patients Stay Cancer-Free Three Years After Clinical Trial
A phase II trial at UCL tested pembrolizumab as neoadjuvant therapy for 32 patients with stage II‑III MMR‑deficient/MSI‑high bowel cancer. After up to nine weeks of immunotherapy before surgery, 59% showed no detectable tumor and none experienced recurrence over a median...
STAT+: Tortugas Neuroscience Launches with Hopes to Develop Drugs for Brain Disorders, Other Conditions
Tortugas Neuroscience launched with a $106 million financing round led by Cure Ventures, The Column Group and AN Ventures. The startup has licensed two schizophrenia and tinnitus candidates from China’s Jiangsu Hansoh and two additional therapies for focal epilepsy and encephalopathies...
STAT+: BioAge Says Experimental Pill Aimed at Reducing Heart Risks Significantly Reduced Inflammation
BioAge Labs reported that its investigational cardiovascular‑risk pill BGE‑102 dramatically lowered inflammation in a Phase 1 trial. A 60‑mg dose cut high‑sensitivity C‑reactive protein (hs‑CRP) by 85% after one week, with the effect persisting through three weeks. The same reduction was...
Serif Targets Revolutionary Genetic Medicine Platform
Serif, Flagship’s latest biotech, aims to make a new kind of genetic medicine https://t.co/kvmbF3xYKu by @gwendolynawu #biotech #startups @FlagshipPioneer
“Cancer Isn’t Political, It’s Personal”: A Funding Update From the 2026 AACR Annual Meeting
At the 2026 American Association for Cancer Research (AACR) Annual Meeting in San Diego, scientists displayed “Thank you, Congress” signs after lawmakers blocked a proposed 40% cut to NIH funding. A policy town‑hall highlighted how the 2025 funding uncertainty delayed trials,...
A Pivotal Year for Regulatory Reform and Innovation
Britain’s Medicines & Healthcare products Regulatory Agency (MHRA) is advancing its MedTech regulatory reform, introducing a pre‑market statutory instrument that adds an international reliance scheme, updated classification, mandatory UDIs and stricter claim rules. The agency also plans an Early Access...
Merck-Eisai’s Kidney Cancer Drug Combo Fail to Improve Survival in Late-Stage Trial
Merck and Eisai reported that their late‑stage trial of Keytruda plus Lenvima with Welireg, as well as a Lenvima‑MK‑1308A combo, failed to improve overall survival or progression‑free survival in clear cell renal cell carcinoma. The study enrolled 1,688 patients and...
AtaiBeckley Shares Jump 21% After Trump Orders Faster Psychedelic Drug Reviews
AtaiBeckley Inc. (ATAI) surged more than 21% in Monday trading after President Donald Trump issued an executive order to accelerate FDA reviews of psychedelic treatments. The move lifted the biotech’s market cap to roughly $1.8 billion and put its Phase 2‑tested nasal...
Akeso's Cadonilimab Shows Survival Gain in Phase II Pancreatic Cancer Trial
Akeso announced that its bispecific antibody cadonilimab combined with chemotherapy delivered a median overall survival of more than 23 months in a Phase II study of advanced pancreatic ductal adenocarcinoma, marking a notable efficacy signal for a disease with limited options.
Akeso Announces P-II (COMPASSION-26) Trial Results on Cadonilimab + CT in 1L PDAC
Akeso reported Phase II COMPASSION‑26 data showing its bispecific antibody cadonilimab combined with chemotherapy as a first‑line option for advanced pancreatic ductal adenocarcinoma. With a median progression‑free survival of 11.1 months and median overall survival exceeding 23 months, the regimen delivered 12‑month and...