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.
Viagra Shows Promise as Potential Treatment to Halt Peyronie’s Disease
A Phase‑II trial of 133 men with acute Peyronie’s disease tested an off‑label combination of a PDE5 inhibitor (sildenafil or tadalafil) and the SERM tamoxifen. After three months, 43% of participants reported a meaningful reduction in penile curvature versus 15% in the vitamin‑E control group, and painful erections fell from 65% to 1.5% compared with a modest drop in controls. The study, published in The Journal of Sexual Medicine, marks the first oral regimen that appears to halt the fibrotic process rather than merely palliate symptoms. Researchers cite the drugs’ known safety profiles and repurposing potential as catalysts for rapid clinical adoption.
Reviva Posts $3.2 M Q1 Loss, Stock Slides 55% as Pipeline Faces Pressure
Reviva Pharmaceutical Holdings Inc. posted a $3.19 million loss for Q1 2026 and saw its shares plunge 55% to a 52‑week low of $0.26. The company raised $10 million in a March equity offering but remains under pressure as it pushes its...
Biogen Seals $5.3 B Deal for Apellis, Adds Two Blockbuster Drugs
Biogen closed a $5.3 billion cash acquisition of Apellis Pharmaceuticals on May 14, 2026, bringing the complement‑driven therapies EMPAVELI and SYFOVRE into its portfolio. The transaction was financed with a new $2 billion unsecured term loan and includes a contingent value right...
FDA Approves First All‑Oral Decitabine/Cedazuridine + Venetoclax Regimen for Older AML Patients
Taiho Oncology announced that the U.S. FDA has approved Inqovi (decitabine/cedazuridine) combined with venetoclax for newly diagnosed acute myeloid leukemia patients aged 75 or older, or those unsuitable for intensive induction chemotherapy. The approval, based on a Phase 2 trial showing...
60 Degrees Pharmaceuticals Inc (SXTP) Q1 2026 Earnings Call Transcript
United Therapeutics reported $782 million in Q1 2026 revenue, with Tyvaso contributing $458 million and showing 9% year‑over‑year growth despite seasonal headwinds. Phase III data revealed ralinepag delivering a threefold reduction in PAH disease progression and meeting all primary endpoints. The company announced a...
Citius Oncology Inc (CTOR) Q2 2026 Earnings Call Transcript
CTI BioPharma reported a cash balance of $71.9 million at the end of Q2 2021, while operating losses widened to $19.5 million as the company prepared for a potential U.S. launch of pacritinib. The FDA accepted the pacritinib NDA with priority review, setting...
BioCardia Inc (BCDA) Q1 2026 Earnings Call Transcript
BioCardia reported Q1 2026 results, noting reduced SG&A expenses, a modest net loss, and a cash balance of $5.3 million that extends its runway into 2026. The company secured FDA breakthrough device designation for its CARDIAMP cell therapy and received positive...
DEA Reschedules Marijuana to Schedule III, Green Thumb Files First Federal Registration
The Drug Enforcement Administration issued a final rule on April 23, 2026, reclassifying marijuana as a Schedule III substance, and Green Thumb Industries became the first cannabis operator to submit DEA registration applications on May 4, 2026. The shift clears a path...
Roche Signs Agreement to Acquire AI Pathology Leader PathAI
Roche announced it has signed a definitive agreement to acquire PathAI, the AI‑focused digital pathology company, pending regulatory approval. The deal is intended to accelerate Roche’s use of artificial‑intelligence tools for drug discovery, companion diagnostics and clinical trial enrichment.
Sapu Nano Doses First Patient in Phase 1b Trial of IV Deciparticle Everolimus
Sapu Nano announced that the first patient has been dosed in its Phase 1b trial of Sapu003, an intravenous Deciparticle™ formulation of everolimus. The trial targets advanced mTOR‑sensitive solid tumors and aims to overcome oral delivery limits of the existing drug....
Harima B.Stem Corp. Posts 38% Profit Rise on Strong Stem‑Cell Revenue Surge
Harima B.Stem Corp. announced full‑year earnings of ¥1.183 billion ($7.6 million), a 38% increase over the prior year, while revenue rose 10.4% to ¥30.944 billion ($200 million). The results underscore growing demand for its stem‑cell‑based therapeutics in Japan and abroad.
The Effects of Resveratrol on Endothelial Progenitor Cells and Apoptosis Biomarkers in Postmenopausal Women with Chronic Coronary Heart Disease: A...
A randomized, double‑blind trial gave 20 post‑menopausal women with chronic coronary heart disease 1,000 mg of resveratrol daily for 90 days versus placebo. The intervention increased serum anti‑apoptotic markers Bcl‑2 and cIAP2 and reduced caspase‑9, indicating inhibition of the intrinsic apoptosis pathway....
Encoded's Gene Therapy Reduced Seizures in Dravet Syndrome
Encoded Therapeutics reported that its experimental gene therapy cut seizure frequency by 76 % in three children with Dravet syndrome, a severe childhood epilepsy. The effect was seen in patients receiving the second‑highest dose among four dose levels in a small...
Pharmaceutical Executive Daily: FDA Approves Beqalzi and Inqovi
The FDA granted accelerated approval to BeOne Medicines' Beqalzi, the first BCL2 inhibitor for relapsed or refractory mantle‑cell lymphoma, after a Phase 1/2 trial showed a 52% overall response rate and median 15.8‑month durability. Taiho Oncology also received approval for Inqovi...
Transforming Clinical Trial Design and Avoiding AI Wrappers: Q&A with Angela Schwab
Trialynx CEO Angela Schwab explains how AI is reshaping clinical trial design by moving away from manual copy‑and‑paste protocols toward data‑driven, predictive modeling. AI can scan millions of past studies to suggest optimal endpoints, procedures, and patient pathways, reducing missed...
ASGCT Dispatch: In Vivo CAR-T Is Everywhere
At the American Society of Gene & Cell Therapy (ASGCT) meeting in Boston, developers showcased a wave of in vivo CAR‑T programs, signaling a shift from traditional ex‑vivo manufacturing. Companies unveiled preclinical and early‑phase clinical data demonstrating tumor shrinkage using...
Pasteurized Akkermansia Muciniphila Emerges as Promising Tool in Obesity Management
Researchers have identified a pasteurized strain of Akkermansia muciniphila, called MucT, as a potential way to break the cycle of weight regain in people with overweight and obesity. The finding adds a microbiome‑focused option to the limited toolbox for long‑term...
Analysts See 11% Upside for Teva Despite 100% Rally
Thirteen analysts surveyed by S&P Global in May rated Teva Pharmaceutical as a buy or strong buy, forecasting an 11% price target upside even after the stock doubled in the past year. The optimism rests on strong branded drug sales,...
Clinical Trial Challenges Long Held Beliefs About Treating Brittle Bone Disease
A large eight‑year clinical trial (TOPaZ) involving 350 adults with osteogenesis imperfecta showed that drugs designed to increase bone density did not reduce fracture rates. Participants receiving the bone‑density regimen experienced a 37% fracture incidence, virtually identical to the 36%...
Aquestive Therapeutics Narrows Q1 Loss, Boosts Revenue as Anaphylm Advances
Aquestive Therapeutics posted a first‑quarter net loss of $8.1 million, a sharp improvement from $22.9 million a year earlier, while revenue jumped 66% to $14.4 million. The company also moved its sublingual epinephrine film, Anaphylm, closer to a Q3 2026 NDA resubmission after...
Generative AI System Could Cut Animal Testing by Up to 50% in Preclinical Research
Researchers at Goethe University Frankfurt, Philipps University of Marburg and the Fraunhofer Institute for Translational Medicine and Pharmacology have unveiled genESOM, a generative AI tool that creates synthetic preclinical data. Trained on small experimental sets, it can mimic real laboratory...
AstraZeneca Follows Merck with Phase 3 Win in Bladder Cancer
AstraZeneca announced that its checkpoint inhibitor Imfinzi, co‑developed with Pfizer, combined with Astellas’ antibody‑drug conjugate Padcev, significantly extended overall survival in a Phase 3 trial for advanced bladder cancer. The regimen outperformed the current standard of care, marking the company’s second...
Cyclarity Unveils Oxidized Cholesterol Excretion Data
Cyclarity Therapeutics presented Phase 1 data for UDP-003, its cyclodextrin drug that binds and removes oxidized cholesterol (7‑ketocholesterol) from humans. The Monash Victorian Heart Institute trial showed dose‑dependent urinary excretion of 7KC, with no serious adverse events and a short...
MacroGenics Sells Manufacturing Arm; West Pharma Discloses Cybersecurity Attack
MacroGenics announced the sale of its GMP‑manufacturing operations to Bora Pharmaceuticals, shifting its focus back to early‑stage antibody development. The transaction, terms undisclosed, transfers a fully qualified production suite and associated staff. In parallel, West Pharma disclosed a recent cybersecurity...
Orforglipron Enables Over 70% Weight‑Loss Maintenance After GLP‑1 Injections, Phase 3 Trial Shows
In the ATTAIN‑MAINTAIN phase 3 trial, adults who switched from injectable semaglutide or tirzepatide to the oral GLP‑1 agonist orforglipron kept over 70% of their weight loss after one year. The study, presented at the European Congress on Obesity, highlights...
Eli Lilly’s Weight‑loss Dominance Challenged by Oral GLP‑1 and Dose‑reduction Options
Eli Lilly announced Phase 3b results showing its oral GLP‑1 drug Foundayo and lower‑dose Zepbound can preserve most weight loss after switching from higher‑dose injectables. The data intensify competition within Lilly’s own portfolio and signal rising pressure from oral agents and rivals...
AstraZeneca Reports the P-III (VOLGA) Trial Data on Imfinzi + Enfortumab Vedotin (EV) for Muscle-Invasive Bladder Cancer
AstraZeneca presented Phase III VOLGA data showing that the combination of Imfinzi (durvalumab) and Enfortumab Vedotin improves event‑free survival and overall survival in muscle‑invasive bladder cancer patients who cannot receive cisplatin. The trial enrolled 695 patients undergoing radical cystectomy and compared two...
Why AI Fails in Drug Development and How to Build Tools That Actually Deliver Real Value
Artificial intelligence can add real value to drug development only when it is tightly woven into existing expert‑led workflows and respects real‑world constraints. The authors, drawing on their experience at Intrepid Labs and Quotient Sciences, illustrate how AI tools that...
BeOne Wins Mantle Cell Lymphoma Approval, Opening New Therapy Class
The FDA granted accelerated approval to BeOne Medicines’ BCL2 inhibitor sonrotoclax, marketed as Beqalzi, for patients with relapsed or refractory mantle‑cell lymphoma who have failed at least two prior therapies, including a BTK inhibitor. The drug is the first BCL2...
STAT+: Biogen’s Tau-Targeting Alzheimer’s Drug Posts Mixed Results in Mid-Stage Study
Biogen’s Phase 2 trial of the tau‑targeting Alzheimer’s drug diranersen (BIIB080) showed that the compound lowered tau protein in cerebrospinal fluid and brain tissue and was linked to a modest slowing of cognitive decline. The study evaluated three escalating dose levels,...
FDA Hands BeOne, Taiho Approvals for Blood Cancers
BeOne Medicines’ BCL‑2 inhibitor Beqalzi (sonrotoclax) earned FDA accelerated approval as a third‑line treatment for mantle‑cell lymphoma, marking the first U.S. approval of a BCL‑2 drug for this indication. The approval is based on a phase 1/2 trial showing a 52%...
RGNX Shows 71% Microdystrophin, Eyes 2027 Approval
$RGNX Duchenne gene therapy study results are out: microdystrophin expression reached an average of 71% of normal across all 31 boys at 12 wks. Functional improvements in a subset of boys followed for one year also seen. The big question...
Ensitrelvir Outperforms Paxlovid yet Faces Approval Hurdles
Ensitrelvir is pretty clearly also a better acute treatment than Paxlovid. More potent and many fewer drug-drug interactions. Just proved too hard to get approval for acute treatment.
Regulatory Round-Up: A Month of Key FDA Approvals for Cancer Drugs
The FDA approved four oncology drugs in May 2026, marking a focused regulatory push in cancer therapeutics. Taiho Oncology received clearance for the oral Inqovi‑venetoclax regimen for elderly acute myeloid leukemia patients, while BeOne Medicines earned accelerated approval for Beqalzi...
Chemo-Free Padcev‑Keytruda Shows Promise for Cis‑eligible Patients
$AZN Volga might have matched $MRK $PFE KN-905 in cis-ineligible patients, but here comes chemo-free Padcev + Keytruda in the cis-eligible setting. Via @ApexOnco -> https://t.co/KmwCfgZLBm
Precigen Narrows Q1 Loss as PAPZIMEOS Launch Fuels $21.6M Revenue
Precigen (PGEN) reported a first‑quarter net loss of $7.9 million, a sharp improvement from $54.2 million a year earlier, driven by $21.6 million in product revenue from its newly launched PAPZIMEOS therapy. The company said broad U.S. payer coverage and a permanent J‑code...
Top 7 Fastest Growing Pharma & Biotech Companies in Asia for 2026
The Financial Times’ 2026 ranking spotlights the seven fastest‑growing Asian pharma and biotech firms, each posting double‑digit revenue surges and landmark milestones. SillaJen earned an FDA IND for its oncolytic virus BAL0891, while Oscotec leveraged lazertinib royalties to boost 2024...
METiS TechBio Raises $270M in Record HKEX AI‑Biotech IPO
METiS TechBio listed on the Hong Kong Stock Exchange, selling 201.23 million H‑shares for HK$2.11 billion ($270 million). The offering, underwritten by Jefferies, Deutsche Bank Securities Asia and CITIC Securities, was oversubscribed more than 6,900 times, setting a new benchmark for AI‑driven biotech...
BeOne’s Next-Gen BCL2 Inhibitor Wins FDA Approval, Taking Aim at Venclexta
BeOne Medicines received accelerated FDA approval for sonrotoclax, its next‑generation BCL‑2 inhibitor, for mantle cell lymphoma. The decision rests on a single‑arm trial that delivered a 68% overall response rate in heavily pre‑treated patients. Sonrotoclax is positioned to compete directly...
METiS TechBio's $270 M AI‑Drug Delivery IPO Sets HKEX Record
METiS TechBio listed on the Hong Kong Stock Exchange, raising HK$2.11 bn ($270 m) and becoming the world’s first publicly traded AI‑powered drug‑delivery company. The offering was oversubscribed more than 6,900 times, drawing $148 m from 18 cornerstone investors including BlackRock. The IPO...
Molecular Grappling Hooks Boost Cancer Drug Retention and Tumor Shrinkage
Scientists led by Michael Evans and Charles Craik reported a nanodevice that physically tethers anticancer agents to tumor cell membranes. In mouse models the device cut tumor size more sharply than the drug alone while sparing healthy tissue. The breakthrough...
The Case for Smarter Neuroinflammation Clinical Trials
INmune Bio, led by CEO David Moss, is developing non‑immunosuppressive therapies that target innate immune pathways, including the XPro1595 program for neurodegenerative disease and the CORDStrom mesenchymal stromal cell platform for recessive dystrophic epidermolysis bullosa (RDEB). The company argues that...
AZ Cues up Broader Use of Imfinzi in Bladder Cancer
AstraZeneca’s immunotherapy Imfinzi (durvalumab) demonstrated a significant survival benefit in the phase‑3 VOLGA trial for muscle‑invasive bladder cancer (MIBC) patients who cannot receive platinum chemotherapy. The study combined Imfinzi with Pfizer‑Astellas’ antibody‑drug conjugate Padcev before surgery, extending both event‑free and...
From MSCs to iPSCs: Building the Cell Therapy Future
In a live session at the ISCT annual meeting, Miguel Forte and Jon Ellis discussed the evolving roles of mesenchymal stem cells (MSCs) and induced pluripotent stem cells (iPSCs) in cell‑therapy development. They examined the scientific advantages of each platform, highlighted persistent...
Osel and Partners Launch Phase IIb FLIP-2 Trial of Lactin-V
Osel, Imperial College London and the March of Dimes have launched the Phase IIb FLIP‑2 trial to evaluate Lactin‑V, a live‑biotherapeutic containing Lactobacillus crispatus, for preventing preterm birth in high‑risk pregnancies. The study will enroll 360 women across four UK maternity...
Pfizer Receives EC Approval for Hympavzi to Treat Haemophilia
Pfizer secured European Commission marketing authorisation for Hympavzi (marstacimab) to treat hemophilia A or B patients with factor inhibitors aged 12 and older who weigh at least 35 kg. The once‑weekly subcutaneous therapy eliminates routine lab monitoring and delivered a 93%...
Pfizer Receives EC Approval for Hympavzi to Treat Haemophilia
Pfizer secured European Commission marketing authorisation for Hympavzi (marstacimab) to treat hemophilia A or B with inhibitors in patients aged 12 years and older weighing at least 35 kg. The once‑weekly subcutaneous therapy showed a 93% reduction in mean annualised bleeding rate versus on‑demand...
Cell and Gene Therapy Catapult Invests in Lir Therapeutics to Accelerate Development of Its AI-Driven AAV Design Platform
The UK’s Cell and Gene Therapy Catapult is investing in Lir Therapeutics through Innovate UK’s Cross‑Catapult Investment Pilot to fast‑track Lir’s AI‑driven AAV capsid design platform, nAAVigator. The funding will support biological validation, benchmarking, and data generation to prove the platform’s...
PreVenTB Trial: A Critical Appraisal
WHO’s technical advisory group welcomed the PreVenTB phase 3 trial results but warned that the interpretation may be flawed. The letter points out that the study emphasized per‑protocol analyses despite the protocol designating a modified intention‑to‑treat (mITT) analysis as primary, which...
Therapeutic Peptides: The Next Pillar of Modern Medicine
I just finished reading one of the most comprehensive research reviews ever published on therapeutic peptides, and it explains why peptides are becoming one of the most important categories in modern medicine. Here's what you need to know: