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.
Arq Inc (ARQ) Q4 2025 Earnings Call Transcript
Arcutis Biotherapeutics reported record Q4 2025 results, with net product revenue of $127.5 million, an 84% year‑over‑year increase, and full‑year revenue up 123% to $372.1 million. Management raised its 2026 net product revenue guidance to $480‑$495 million, citing strong prescription growth, expanded Medicare Part D access, and a larger dermatology sales force. The company achieved positive cash flow in the quarter and reaffirmed quarterly cash‑flow positivity throughout 2026. Clinical progress includes a supplemental NDA for pediatric psoriasis and promising infant atopic dermatitis trial data.
Logic‑gated Nanomedicine Activates STING to Boost Metastatic Tumour Immunotherapy
Researchers at the University of Massachusetts Amherst have engineered a logic‑gated nanoparticle that releases a STING agonist only under acidic pH and hypoxic conditions typical of metastatic tumor sites. The dual‑stimuli‑responsive system triggers robust innate immune activation while sparing healthy...
Editas Medicine Inc (EDIT) Q4 2025 Earnings Call Transcript
Editas Medicine reported Q2 2024 progress on its gene‑edited cell therapy reni‑cel, presenting interim data from the RUBY sickle‑cell and EdiTHAL beta‑thalassemia trials. All 18 RUBY patients were free of vaso‑occlusive events, with hemoglobin levels above 14 g/dL and fetal hemoglobin exceeding...
Anixa Biosciences Inc (ANIX) Q1 2026 Earnings Call Transcript
Anixa Biosciences reported $131.7 million in cash, no debt, and a cash burn of $7.1 million in Q1 2026, extending its runway to over three years. Operating expenses fell sharply, with R&D down 55% YoY and G&A reduced by 32%, reflecting the end...
MacroGenics Inc (MGNX) Q4 2025 Earnings Call Transcript
MacroGenics reported 2024 revenue of $150 million, up from $58.7 million, largely fueled by $85 million in milestone payments from its Incyte partnership. The company posted a net loss of $67 million versus $9.1 million a year earlier, while cash and marketable securities fell to...
ARS Pharmaceuticals Inc (SPRY) Q4 2025 Earnings Call Transcript
ARS Pharmaceuticals reported a pivotal quarter, with U.S. Neffy net product revenue soaring to $31.3 million—a 2.5‑fold quarter‑over‑quarter increase that beat consensus. New prescriber market share reached 10.3% and provider adoption rose 85% since August, while the Get Neffy On...
A $2.5 Billion Commitment to Children with Cancer: Servier Acquires Day One Biopharmaceuticals
French pharma group Servier announced a definitive agreement to acquire Nasdaq‑listed Day One Biopharmaceuticals for $2.5 billion, paying $21.50 per share—a 68% premium to the prior close. The cash‑only transaction will be funded from Servier’s reserves and is slated to close...
NR/NMN Lack Human Anti‑Aging Proof, Only PAD Benefits
stated as a critique but what does this mean as no drug has been demonstrated to have anti-aging effects in human clinical trials NR is active versus inflammaging and PAD, which is an age-related conditions affecting 10s of millions of americans you...
Vinay Prasad Mocked for Hosting Controversial HHS/FDA Call
Too funny. @emilyakopp (below) outs Vinay Prasad as the host of Thursday’s HHS/FDA media call to discuss $QURE.
Scientific Considerations in Demonstrating Biosimilarity to a Reference Product
The FDA has issued a final guidance titled “Scientific Considerations in Demonstrating Biosimilarity to a Reference Product.” The document outlines the agency’s scientific framework for establishing biosimilarity of therapeutic proteins submitted via the abbreviated licensure pathway. It details expectations for...
OSK Gene Combo Reverses Joint Damage via Epigenetics
Osteoarthritis & back pain affects millions of people. Instead of managing symptoms, imagine rebuilding joints by making them young New study shows the reprogramming gene combo OSK regrows joints in mice & effect depends on TET2 so it's epigenetic...🧵 https://t.co/AlOIwcEXEQ
A Single Dose of DMT Reverses Depression-Like Symptoms in Mice by Repairing Brain Circuitry
Researchers at Uppsala University reported that a single 30 mg/kg injection of the psychedelic N,N‑dimethyltryptamine (DMT) reversed depression‑like behaviors in mice subjected to chronic stress. The treated animals recovered their preference for sweetened water, displayed improved working‑memory performance, and showed reduced...
Prasad’s Missteps as CBER Chief Spark Criticism
On Prasad’s last few weeks as CBER chief: 1. It was absurdly inappropriate to bring a large group of reporters together and rail on a pending application “on background” 2. The walk back of the Moderna RTF was a bad...
Consumer Biotech Set to Outgrow Disease‑Focused Pharma
GLP-1s already have market cap close to 1/3 of the top 10 biopharma companies combined. Consumer health biotech products will dwarf disease-focused biotech products.
'It Could Revolutionize, Completely, the Way We Treat Depression': Researchers Are Exploring Promising Immune Therapy for Treating Psychiatric Symptoms
Researchers led by Dr. James Murrough and Dr. Emma Guttman‑Yassky identified the Th2 immune pathway as a contributor to major depressive disorder. Using proteomic profiling and computer modeling, they repurposed dupilumab—an IL‑4 receptor antibody approved for eczema—to target this pathway....
Patent Battles and GLP‑1 Turf Wars Prompt FDA Crackdown
Patent Fights, GLP-1 Turf Wars, and the FDA Tightens the Screws | Ep. 952 https://t.co/v0fulR3NfB https://t.co/9gGdkAVvlv
83% Unaware of DORAs: Sleep Knowledge Gap
There's a lot you can learn about sleep. Like 83% hadn't heard of DORAs. https://t.co/2lV3Fw6cwg https://t.co/IWRTdPTMOL
Bayesian Inferences and Frequentist Evaluations
Researchers Forster, Novelli, and Welch applied four frequentist and two Bayesian sequential designs to the COVID‑disrupted UK DISC clinical trial. All six approaches confirmed the trial’s original finding of treatment superiority but suggested different optimal points for restarting patient recruitment....
Cures for some Autoimmune Diseases Now a Reality
One of the most impressive advances we've ever seen for some autoimmune diseases: cures https://t.co/OZDuq4Iooy
AlphaFold Isn’t the Drug‑development Silver Bullet
Even with AlphaFold, protein structure is not a solved problem. And protein structure was never the bottleneck for drug development anyway. Let me explain.
Lysophosphatidylcholine Acyltransferase 1 Drives Cancer via COX17
Researchers have identified lysophosphatidylcholine acyltransferase 1 (LPCAT1) as a driver of head and neck squamous cell carcinoma (HNSCC) by amplifying mitochondrial oxidative phosphorylation through the COX17 chaperone. Overexpression of LPCAT1 reshapes mitochondrial membrane lipids, stabilizing COX17 and boosting cytochrome c oxidase activity,...
How Lilly Used AI To Crank Up Production Of Its Popular GLP-1s
Eli Lilly used an AI‑driven digital twin to dramatically increase manufacturing capacity for its high‑demand GLP‑1 drugs Zepbound and Mounjaro. The virtual factory model allowed real‑time optimization of equipment, process parameters, and defect detection, delivering production volumes the company says would...
ITK-Targeting Boosts Anti-CD19 CAR-T Therapy
A recent preclinical study shows that inhibiting interleukin‑2‑inducible T‑cell kinase (ITK) markedly improves the efficacy of anti‑CD19 CAR‑T cells. Researchers combined an ITK‑selective inhibitor with a second‑generation CD19‑CAR construct, observing enhanced cytotoxicity, reduced exhaustion markers, and prolonged persistence in mouse...
Bitter Compounds Protect Brain in Diabetic Cognitive Decline
Bitter Compounds as Multifunctional Agents against Diabetes-associated Cognitive Dysfunction: Bridging Metabolic Regulation and Neuroprotection https://t.co/Xv3xItlP20
Seasoned Scientist Still Innovating Vaccines and Writing
Baylor did some new pics photos by my friend Agapito Sanchez Jr. Gosh I’m old, estoy viejo, but still making new vaccines, hope to have results of our hookworm anemia vaccine soon, hoping to reproduce our low cost Covid vaccine...
![[Comment] Aldosterone Synthase Inhibition in Resistant Hypertension: Promises and Unknowns](https://hixhlmpcokxhartfkpyi.supabase.co/storage/v1/object/public/images/thumbnails/0a5065acfb3787a2e2e6999bae6248e9.webp)
[Comment] Aldosterone Synthase Inhibition in Resistant Hypertension: Promises and Unknowns
Resistant hypertension affects up to 20 % of hypertensive patients and carries heightened cardiovascular risk. Recent phase‑3 studies of aldosterone synthase inhibitors such as baxdrostat and lorundrostat have demonstrated significant ambulatory blood‑pressure reductions, positioning them as potential fourth‑line agents beyond traditional...
Prasad Out At FDA, Turning Critics’ Focus Back To Makary
Vinay Prasad, the FDA’s controversial biologics chief, has announced his departure, marking his second exit within a year. His resignation follows a public dispute over the agency’s handling of rare disease drug approvals, intensifying scrutiny of FDA decision‑making. Critics are...
GLP-1 Drugs and 8 Healthy Lifestyle Habits May Lower Cardiovascular Risk
A large observational study of 98,261 U.S. veterans with type 2 diabetes found that using GLP‑1 receptor agonists together with six to eight healthy lifestyle habits lowered major adverse cardiovascular events (MACE) by 43% compared with low‑habit, non‑GLP‑1 users. Both the...
Vinay Prasad, Controversial FDA Leader, to Again Depart Agency
Vinay Prasad, the controversial head of the FDA's Center for Biologics Evaluation and Research, will leave the agency in April after a tumultuous year marked by stricter vaccine guidelines and a new pathway for ultra‑rare gene therapies. His tenure saw...
Norgine Announces £23 Million Investment to Expand Medicines Manufacturing in Wales
Norgine announced a £23 million injection to expand its Hengoed, Wales, manufacturing site, taking total investment at the location to more than £50 million since 2022. The upgrade will add high‑speed, energy‑efficient production lines and increase warehousing capacity, allowing the company to...
SpyGlass Pharma IPO Raises $172.5M to Develop Implantable Eye Therapies
SpyGlass Pharma completed an IPO that raised $172.5 million, selling 10.78 million shares at $16 each and listing on Nasdaq under the ticker SGP. The company’s SpyGlass Platform uses small implants to deliver drugs inside the eye, with its lead BIM‑IOL system...
New Eli Lilly Platform To Expand Obesity Drug Options For Employers
Eli Lilly launched an Employer Connect platform on March 5, linking more than 15 independent program administrators with a nationwide pharmacy and telehealth network to broaden discounted access to its obesity drugs, notably the GLP‑1 Zepbound (tirzepatide) pen. The service targets employer‑sponsored...
As Peptides Go Mainstream, USP and Matter More Than Ever
Peptide therapies have moved from niche compounding to mainstream outpatient care, driven by telehealth platforms and rapid market growth. This expansion has attracted regulatory attention, with state boards and courts increasingly referencing USP and as compliance benchmarks. Non‑sterile peptide...
5 FDA Developments From February: Kinase Inhibitors, GLP-1s, and a New Approval Pathway
In February 2026 the FDA approved a suite of targeted therapies, including the HER2‑mutant NSCLC kinase inhibitor zognertinib and the first all‑oral acalabrutinib‑venetoclax combo for CLL/SLL, as well as a BRAF‑targeted encorafenib regimen for metastatic colorectal cancer. A portable tumor‑treating‑fields...
Early Encouraging UC Davis Trial Data on Cell Therapy for Spina Bifida
A first‑in‑human phase 1 trial at UC Davis evaluated placental mesenchymal stem cells delivered intra‑uterinely to fetuses with myelomeningocele. Six pregnancies treated between June 2021 and December 2022 resulted in intact repair sites, no cerebrospinal fluid leaks, infections, or tumor formation, and MRI scans...
Market Turmoil Is Hitting Most Traditional Safe Havens. UBS Says This Is the Place to Hide
Geopolitical tensions between the U.S., Israel and Iran have rattled traditional safe‑haven assets, with gold and consumer staples slipping as oil prices breach $100 per barrel. UBS recommends pharmaceutical stocks as the new defensive refuge, citing their inverse link to...
EpiciphAI: Reading Disease States From Blood’s Epigenetic Fingerprints
EpiciphAI, a Chinese pre‑seed biotech, is building a liquid biopsy that reads histone modifications on cell‑free chromatin to pinpoint a fragment’s tissue of origin and its disease state. Unlike most epigenetic tests that focus on DNA methylation, this platform targets...
Senior FDA Official’s Attack Sparks Debate Over Leadership
Gee, who could this "senior FDA official" be? It's a head scratcher. But he might tell Vinay Prasad that thinly veiled attacks against, oh, UniQure, and going off on advisory councils is a great way of keeping the political pot...
HGH May Harm Tendon‑Bone Healing Recovery
Human Growth Hormone May Be Detrimental When Used to Accelerate Recovery from Acute Tendon-Bone Interface Injuries https://t.co/L4EOFMKjys
Canada and CSL Seqirus – a Global Leader in Influenza Vaccines, Agree on New Pandemic Preparedness Contract
Canada’s Public Health Agency has signed a new agreement with CSL Seqirus to provide millions of doses of adjuvanted cell‑based influenza vaccine in the event of a WHO‑declared pandemic. The contract replaces a previous egg‑based arrangement and builds on the...
Major Peptide Supplier Closes, Gray Market Faces Crackdown
Assuming this is real it may have something to do with their “must pay by Venmo to the following name” (at least that’s how it used to be). FDA is easing up on some aspects of peptides but gray market...
PEP Slows Aging by Blocking Inflammation Pathway
PEP protects against age-related inflammation, puts the brake on the aging process in mice, high levels in humans correlate with low inflammation So what is PEP, you ask? phosphoenolpyruvate, from glucose metabolism, a, master regulator, blocks cGAS-STING https://t.co/glMvaHSjOq https://t.co/MSVMBJbHm4
STAT+: The FDA, Urged to Avoid Controversy, Creates a New Headache with Attack Against UniQure
The FDA staged a media call where an anonymous senior official publicly criticized UniQure’s experimental Huntington’s disease gene therapy. The official, identified only as a practicing hematology‑oncology professor, framed his comments as serving the public interest while hinting at personal...
Roche, Zealand Stocks Tumble After Bland Obesity Drug Data
Roche, Zealand shares fall on ‘undifferentiated’ obesity drug results https://t.co/5pSR2vcHBD by @Lilah_Alvarado $RHHBY $ZEAL $LLY $NVO #obesity
Servier Spends $2.5B to Expand Cancer Pipeline
Servier to build cancer drug pipeline with $2.5B purchase of Day One https://t.co/aH0z8jt9tr by @realJacobBell $DAWN #biotech
Recapping AAAAI 2026: Updates on Remibrutinib and Innovative Treatments for Food Allergy, Atopic Disease, Asthma
At AAAAI 2026, Novartis presented data confirming remibrutinib’s rapid and sustained efficacy in chronic spontaneous urticaria, with a 25 mg BID dose delivering significant UAS7 reductions. Phase 2 trials also demonstrated the BTK inhibitor’s potential in peanut allergy, achieving 86.7% tolerance at...
FDA's New Attack on UniQure Sparks Controversy
New from me on $QURE and FDA. Free, no paywall. The FDA, urged to avoid controversy, creates a new headache with attack against UniQure Anonymous diatribe from a senior official plunges agency back into headlines https://t.co/ceDE0TXjdI
Drug Shortages | Additional News and Information
The FDA’s Drug Shortages portal aggregates letters, temporary import authorizations, and annual reports that detail current and historic medication scarcities. Recent communications include temporary import permits for Lederle Leucovorin, Tafenoquine, and Physostigmine to bridge supply gaps. The site also hosts...
B7‑H3 ADC HS‑20093 Shows Early Lung Cancer Activity
HS-20093, a B7-H3-targeted antibody-drug conjugate in lung cancer: Results from the ARTEMIS-001 phase 1a/b trial https://t.co/Jr90iovVeo https://t.co/Nl2WkprjU3
Exploring the Edge: 14 Innovators, 10 Biobanks
The edge is always weirder and more surprising than we can imagine, excited to follow the work of these 14 scientists and innovators. My personal favorite innovator is @ceeceeboom and her 10 biobanks 👀