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.
Dyadic COO Hazelton Steers Modest $3.1M Revenue Rise Amid Grant‑driven Cost Shift
Dyadic (DYAI) posted Q4 2025 revenue of $3.1 million, a modest rise driven by COO Joseph P. Hazelton’s operational focus. The earnings call highlighted new product launches, global distribution deals and a growing reliance on grant‑linked R&D, offsetting a drop in traditional license income.
Corcept Therapeutics Stock Jumps 19.7% After FDA Approves Lifyorli Combo
Corcept Therapeutics saw its shares climb almost 20% after the U.S. FDA gave the green light to Lifyorli in combination with nab‑paclitaxel for platinum‑resistant ovarian, fallopian tube and primary peritoneal cancers. The approval, based on a 381‑patient Rosella trial, validates...
Biogen and Alteogen Partner for ALT-B4 to Advance Subcutaneous Formulations of Biologics
Biogen has signed an exclusive license with South Korean biotech Alteogen for ALT‑B4, a recombinant hyaluronidase enzyme that facilitates subcutaneous administration of biologics traditionally given intravenously. The agreement provides Alteogen with $20 million upfront, a $10 million payment upon initiation of a...
China’s Jiangsu Aidea Eyes Hong Kong Listing as Gateway to US and European Aids Markets
Jiangsu Aidea Pharmaceutical, a Shanghai‑Star Market listed firm specializing in HIV/AIDS therapies, is preparing a Hong Kong IPO to fund its expansion into the United States and Europe. The company projects the global AIDS‑treatment market to exceed $1.45 billion by 2027...
Breaking: Senator Ron Johnson's Investigative Subcommittee Letter Submitted as Supplemental Authority in Sansone V. DeSantis mRNA Bioweapons Case
Dr. Joseph Sansone has filed Senator Ron Johnson’s investigative subcommittee letter as supplemental authority in his appellate lawsuit against Florida Governor Ron DeSantis and Attorney General James Uthmeier, alleging that mRNA COVID‑19 injections function as biological weapons. The filing cites...
Lenz Therapeutics Shares Drop 11% After Q4 Earnings Miss
Lenz Therapeutics' shares slid 11.2% after the biotech reported a Q4 loss of $1.16 per share on $1.6 million in revenue, well below analyst expectations. The miss stemmed from weaker-than-anticipated uptake of its newly launched VIZZ eye‑drop and a surge in...
Ascentage Pharma Reports Full Year 2025 Unaudited Financial Results and Provides Business Updates
Ascentage Pharma reported unaudited 2025 results, showing product sales surged 90% to $82.1 million while total revenue fell 41.5% after a $92.9 million drop in intellectual‑property income. Olverembatinib generated $62.2 million, up 81% YoY, and the newly launched Lisaftoclax contributed $10.1 million in its...
MHRA’s Tallon on the Tall Order of Boosting the U.K. as a Destination for Clinical Trials
Lawrence Tallon, the MHRA chief, is set to oversee the launch of the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 on April 28, 2026. The amendment represents the most extensive overhaul of U.K. clinical‑trial rules in two decades, targeting faster approval,...
Passion Fruit Compound Shields Mitochondria, Improves Mouse Memory
Alpha-amyrin, a molecule found in passion fruit, has demonstrated the ability to protect brain mitochondria and reduce memory loss in Alzheimer's mouse models, suggesting potential for future therapeutic development. neuroscience
Regulatory Education for Industry (REdI) Annual Conference 2026: Innovative Regulatory Strategies to Advance Medical Products - 05/19/2026
The FDA’s Regulatory Education for Industry (REdI) Annual Conference will take place May 19‑20, 2026, offering both virtual and in‑person sessions at the White Oak Campus in Maryland. The two‑day program features three dedicated tracks—drugs, devices, and biologics—allowing participants to...
FDA Approves Avlayah as Treatment of Hunter Syndrome
Denali Therapeutics received accelerated FDA approval for Avlayon (tividenofusp alfa‑eknm), the first enzyme replacement therapy designed to cross the blood‑brain barrier for Hunter syndrome. The approval is based on a phase 1/2 trial of 47 boys up to 18 years, showing...
FY 2025 GDUFA Science and Research Report
The FDA’s Center for Drug Evaluation and Research released its FY 2025 GDUFA Science & Research Report, detailing more than 50 funded projects across eight priority scientific initiatives. The program targets bioequivalence, manufacturing standards, and advanced analytical methods to streamline abbreviated...
Patent Certifications and Suitability Petitions
Under the Hatch‑Waxman law, generic manufacturers must file a Paragraph IV certification asserting that a listed patent is invalid, unenforceable, or not infringed to obtain FDA approval. The first substantially complete ANDA with such a certification secures a 180‑day exclusivity period,...
This Cutting-Edge Treatment Hit the Rewind Button On Aging, Scientists Say
Researchers at Longeveron reported that a single infusion of laromestrocel, a mesenchymal stem‑cell therapy derived from donors aged 14‑18, significantly boosted mobility in frail seniors. In a double‑blind trial of about 150 participants aged 70‑85, the highest dose (200 million cells)...
IP Considerations Following FDA Announcement on Flexibility for Cell and Gene Therapies
The FDA announced new guidance that expands flexibility in chemistry, manufacturing, and controls (CMC) for cell and gene therapies (CGTs) across their development lifecycle. Sponsors can now defer full cGMP compliance until later trial phases and make iterative manufacturing changes...
FDA Approves Drug to Treat Neurologic Manifestations of Hunter Syndrome
The FDA granted accelerated approval to Avlayah (tividenofusp alfa‑eknm), a weekly IV infusion, for treating neurologic manifestations of Hunter syndrome in pediatric patients weighing at least 5 kg. The approval is based on a phase 1/2 trial that demonstrated a 91% average...
Kansas House Moves Forward on Bill to Tighten PBM Rules and Lower Drug Prices
The Kansas House of Representatives approved a bill that would tighten regulations on pharmacy benefit managers (PBMs) to help lower prescription‑drug prices. The measure now heads to the Senate, where it could reshape how insurers negotiate drug rebates and pricing.
Psilocybin Treatments for Treatment-Resistant Depression with Compass Pathways’ Dr. Steve Levine — Episode 248
The Xtalks Life Science Podcast featured Dr. Steve Levine, Chief Patient Officer at Compass Pathways, discussing the company’s push to develop psilocybin‑based therapies for treatment‑resistant depression (TRD). Levine, a board‑certified psychiatrist and founder of Actify Neurotherapies, highlighted the clinical promise...
Pharmaceutical Executive Daily: FDA Issues Warning Letter to ImmunityBio
The FDA issued a warning letter to ImmunityBio for misleading promotional claims about its bladder‑cancer drug Anktiva, triggering a roughly 26 percent drop in the company’s shares and giving it 15 days to submit a corrective plan. In parallel, Merck announced a...
GlycoNet – Sugar-Based Vaccine Against Bacterial Diarrhea Shows Promise in Phase 1 Trial
Researchers at the University of Guelph announced that their sugar‑based vaccine candidate against Campylobacter jejuni demonstrated safety and immunogenicity in a small Phase 1 human trial. Participants experienced only mild side effects, and the formulation generated measurable antibody responses even at...
Open-Source DIY Guide to Building mRNA Vaccines
Inspired by the man who built a personalized cancer vaccine for his dog, I’ve written an open-source guide to DIY mRNA vaccine production: philfung.github.io/openvaxx Drawing on my background in running lab startups, the guide covers the entire process - from sequencing...
Anavex Sinks After Pulling Alzheimer's Filing in EU
Anavex Life Sciences withdrew its European marketing authorisation application for blarcamesine, an add‑on therapy for early‑stage Alzheimer’s, after the EMA’s CHMP signaled a likely negative opinion. The committee criticized the trial’s efficacy data, methodological flaws, and safety reporting, including concerns...
Drug Quality Sampling and Testing Programs
The FDA’s Center for Drug Evaluation and Research (CDER) released its FY 25 Drug Quality Sampling and Testing results, showing that the vast majority of tested pharmaceuticals met USP specifications. The program uses a risk‑based, data‑driven approach introduced in 2018 to...
Summit Sparks Breakthroughs: AI, Gene Therapy, CRISPR, mRNA
One thing that really makes the in-person summits we run at STAT so amazing: the people in the room. Here's what happened when we asked some of them for the last big breakthrough they saw. Featuring: the infectious @DrBlytheAdamson, genomcis pioneer...
BREAKING: Senate Investigation Finds Federal Officials Buried COVID-19 Vaccine Stroke Risk
A Senate investigation led by Sen. Ron Johnson uncovered that federal health officials identified a statistically significant ischemic stroke risk associated with the Pfizer COVID‑19 booster for adults 65 and older as early as November 2022. Internal HHS records show...
New Drug Candidates Debut in Atlanta
At the ACS Spring 2026 meeting in Atlanta, the Medicinal Chemistry division unveiled six new drug candidates transitioning from discovery to clinical testing. The molecules, presented by researchers from Biohaven, Bristol Myers Squibb, Regor Therapeutics, Olema Oncology, FoRx Therapeutics, and Iambic Therapeutics,...
How Seaport Is Hedging Against Failure in Phase 2b Depression Study
Seaport Therapeutics is embedding a fail‑safe mechanism into its Phase 2b trial of SPT‑300, an experimental therapy for major depressive disorder. The study will enroll roughly 300 patients at multiple U.S. sites and uses an adaptive design that can halt...
BREAKING STUDY: COVID-19 “Vaccines” DISRUPT THE BLOOD-BRAIN BARRIER — 63 Serious Brain & Spinal Cord Safety Signals Identified
A recent Substack post cites a study claiming COVID‑19 mRNA vaccines increase reports of rare neurological disorders by dozens to thousands of times compared with flu shots, based on VAERS data from 1990‑2024. The post lists specific conditions such as...
FDA Approves Relacorilant with Nab-Paclitaxel for Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
The FDA has approved relacorilant (Lifyorli), a glucocorticoid‑receptor antagonist, in combination with nab‑paclitaxel for adults with platinum‑resistant epithelial ovarian, fallopian tube or primary peritoneal cancer who have received up to three prior regimens, including bevacizumab. The approval is based on...
The Brain's Cleaning System Can Be Boosted to Rid Alzheimer's Proteins
Researchers identified a drug combination that enhances the brain's glymphatic system, improving clearance of Alzheimer‑related proteins. The regimen pairs a widely used sedative with a medication that prevents dangerously low blood pressure, showing safe and effective removal of amyloid and...
Bridging Virtual Cells to Real Patients: The Next Frontier
Virtual biology burst onto the scene a few years ago. The idea was simple. Model the cell well enough, and you can predict biology before you test it. Large pharma has been thinking about this longer than most. PK/PD models, systems biology,...
STAT+: FDA Approves Denali Therapeutics Drug for Hunter Syndrome
On March 27, 2026, the U.S. Food and Drug Administration granted approval to Denali Therapeutics’ drug Avlayah for the treatment of Hunter syndrome, a rare lysosomal storage disorder. The decision arrives amid a recent wave of stricter FDA scrutiny of...
Two Polyunsaturated Lipids Demonstrate Senolytic Activity
Researchers identified two conjugated polyunsaturated fatty acids, α‑eleostearic acid (α‑ESA) and its methyl ester (α‑ESA‑me), as potent senolytics that selectively eliminate senescent cells. In mouse models, short‑term dosing reduced senescence markers and SASP factors across liver, heart, kidney, and lung...
NOVOS Trial Shows Vascular Aging Biomarker Improvements in Midlife Adults
NOVOS launched a randomized, double‑blind, placebo‑controlled trial of a multi‑component supplement in adults over 40, enrolling 61 participants and completing six months with 43 finishers. Early preprint data show a 2.9% improvement in flow‑mediated dilation, a 1.18 m/s reduction in pulse‑wave...
Akeso Secures NMPA Clearance for Phase II Trials of First-in-Class ADCs
Akeso, Inc. has obtained clearance from China’s National Medical Products Administration to begin Phase II trials of two novel antibody‑drug conjugates, AK146D1 and AK138D1. The studies will combine the ADCs with the company’s approved bispecific immunotherapies cadonilimab and ivonescimab, marking the...
Shanghai Fosun Pharma Posts $472 Million Profit, Boosting R&D Outlook
Shanghai Fosun Pharmaceutical (Group) Co Ltd announced full‑year profit of RMB3.371 bn ($472 m), up 22% from the prior year, while revenue edged 1.4% higher to RMB41.498 bn. The earnings lift expands the group’s capacity to fund R&D and health‑technology projects amid a...
FDA Clears Denali's AVLAYAH, 91% CSF
FDA clears Denali's AVLAYAH (macro), 91% CSF HS drop and analysts lift estimates (key). Risk: COMPASS confirmatory readout, infusion reactions. Trade: buy DNLI on 50‑day pullback 🚀 — Viktor Kopylov, PhD, CFA More insights: t.me/si14Kopylov
First Full GlyphAllo Data Reveal From Discovery to Human Proof‑of‑Concept
Proud of the work of our Seaport team & collaborators published today in @ScienceTM. This ~13 page peer reviewed paper is the first comprehensive data disclosure of our GlyphAllo™ program from discovery through initial human proof‑of‑concept.
Scout-Triggered Proteomics Sharpens HCP Control
Host-cell proteins (HCPs) remain a persistent impurity risk in biomanufacturing, with regulators demanding levels below 100 ppm in final drug products. Traditional ELISAs measure total HCPs but cannot identify individual proteins, while conventional multiple reaction monitoring (MRM) suffers from retention‑time shifts...
Study’s Bias: Excluding TAD Nonresponders, Uncontrolled Therapy
Here it is again. Amazing how researchers could get away with this back then. Regular systematic bias of excluding TAD nonresponders. Also note another thing inconsistent with core psychedelic trial period i.e., that Ps were allowed to continue psychotherapy outside...
Blueprint for Affordable, Accessible AAV Gene Therapy
When people ask "How can we make #AAV #GeneTherapy accessible and affordable" --> this is how 👇
Improving Early Detection and Treatment of Liver Cancer
Early-stage liver cancer survival hinges on timely diagnosis, yet ultrasound and AFP tests miss many cases. Helio Genomics has introduced the HelioLiver blood test, a multi‑analyte cfDNA and protein assay that flags tumor‑associated epigenetic signals earlier than imaging. A new...
Escitalopram Yields -16.6 HAM‑D Drop After 8 Weeks
Anyone have a PDF of this? Perhaps there isn't a digital copy... This one showed an impressive -16.6 HAM-D drop with 8 weeks of escitalopram. It would be good to know their methodology. https://t.co/P5GCYcbxjk
Venlafaxine Shows Unexpected -15.2 HAM‑D Drop in TAD Trial
See this for just 1 of the TAD trials from recent @psybalazs and @QuantPsychiatry comparative analysis. 1 of several deck stacks favoring TADs. This trial reported a surprising -15.2 HAM-D drop with venlafaxine. Not so surprising when you look closer......
Beam Looks to Accelerated Approval for AATD Base Editing After Promising Update
Beam Therapeutics announced encouraging Phase 1/2 data for its base‑editing therapy targeting alpha‑1 antitrypsin deficiency (AATD). The trial demonstrated a 30% reduction in the disease‑causing SERPINA1 mutation and a 45% rise in functional protein levels, while confirming a clean safety profile....
Guidance Recap Podcast | Use of Bayesian Methodology in Clinical Trials of Drug and Biological Products
The FDA released a draft guidance on using Bayesian methodology in clinical trials, outlining how sponsors should incorporate prior data, define success criteria, and document analyses. It emphasizes systematic prior construction, transparent operating characteristics, and extensive simulation documentation. The guidance...
Guidance Snapshot Pilot
The FDA has launched a Guidance Snapshot Pilot that distills complex guidance documents into visual, plain‑language one‑page snapshots complemented by podcasts, timelines, and social‑media links. The pilot targets cross‑cutting topics such as Bayesian trial methodology, decentralized clinical elements, and neonatal...
Boehringer Ingelheim Plans for Dealmaking and R&D Spending Amid US Price Pressure
Boehringer Ingelheim announced it will maintain its high‑level R&D spending while exploring dealmaking opportunities in China to counteract mounting U.S. drug‑price pressure. The company is prioritising an obesity‑focused pipeline, betting on the fast‑growing weight‑loss market to sustain revenue. By keeping...
Ozempic Pill Improves Multiple Cardiometabolic Risk Factors
A post‑hoc analysis of the SOUL trial shows that once‑daily oral semaglutide (Ozempic pill) significantly improves several cardiometabolic risk factors in adults with type 2 diabetes at high risk for atherosclerotic cardiovascular disease. Compared with placebo, participants experienced a 3.2 mm Hg greater...