Today's Pharma Pulse
CMS to launch Medicare GLP‑1 Bridge program with $50 monthly copay for obesity drugs
The Centers for Medicare & Medicaid Services will start a short‑term demonstration on July 1 2026 offering eligible Part D beneficiaries a flat $50 monthly copay for three branded GLP‑1 obesity treatments. The program runs through December 31 2027 and aims to gather utilization data ahead of potential broader policy decisions.
The Biotech Bi-Weekly: Cell Barcoding, Compound Optimization and the Trillion Cell Atlas
The biotech sector is witnessing a wave of collaborations and product launches aimed at accelerating drug discovery and expanding genomic knowledge. Biotium introduced the ViaPlex™ 2‑Color Cell Barcoding Kit, enabling multiplex analysis of up to 15 cell populations in a single tube, while Optibrium released a PyMOL plugin that delivers rapid affinity predictions for lead optimization. Touchlight, together with New England Biolabs, unveiled an enzymatic dbDNA synthesis kit as a cell‑free alternative to plasmids. Meanwhile, Basecamp Research, backed by Anthropic, Ultima Genomics and PacBio, launched the Trillion Gene Atlas to map genetic diversity at unprecedented scale, and iXCells partnered with Rosebud, Kantify and Incite to assess off‑target chemotherapeutic toxicities in patient‑derived organoids.
Oric to Advance Prostate Cancer Drug to Phase 3, but Combo Choice Raises Doubts
Oric Pharmaceuticals announced that its PRC2 inhibitor will move into a registrational Phase 3 trial for prostate cancer after reporting encouraging safety and disease‑control signals in a Phase 1b study. The company plans to evaluate the drug both as a...
Frontier Medicines Grants Ex-China Rights of FMC-220 to LG Chem
Frontier Medicines has granted LG Chem an exclusive global license to develop and commercialize its covalent p53 Y220C activator FMC-220 outside Greater China, while retaining full rights within that region. LG Chem will manage regulatory filings, global clinical development, and...
Remaining Challenges in the Development of Partial Reprogramming Therapies
Partial reprogramming—brief exposure to Yamanaka factors OCT4, SOX2, KLF4 and MYC—has demonstrated modest rejuvenation in mouse studies but carries a substantial cancer risk if cells slip into full pluripotency. Funding is concentrated in a few well‑capitalized firms, notably Altos Labs,...
FDA Grants Accelerated Approval to Denali's Avlayah, First New Hunter Syndrome Therapy in 20 Years
The U.S. Food and Drug Administration granted accelerated approval to Denali Therapeutics' intravenous enzyme replacement therapy Avlayah, marking the first new treatment for Hunter syndrome in two decades. The approval could extend lives and curb cognitive decline for the roughly...
Rhythm Pharmaceuticals Stock Jumps 12.6% After FDA Expands Imcivree Label
Rhythm Pharmaceuticals saw its shares rise 12.58% after the FDA approved Imcivree for acquired hypothalamic obesity, expanding the drug’s addressable U.S. market by 10,000 patients. The move follows a 46% revenue jump to $189.8 million in 2025 but comes amid recent...
Patients Know Best and Heartfelt Technologies Collaborate to Accelerate Clinical Trial Recruitment
Patients Know Best teamed with Heartfelt Technologies to automate recruitment for the Innovate UK‑funded HF‑TRACK trial, enrolling 16 participants in just four weeks—a 135% increase over the trial’s average rate. The partnership leveraged PKB’s coded health‑record data to display a...
Ultragenyx (RARE) Shares Positive Results From DTX301 Phase 3 Study
Ultragenyx Pharmaceutical reported that its Phase 3 Enh3ance trial of DTX301, an AAV8 gene therapy for ornithine transcarbamylase deficiency, achieved an 18% reduction in 24‑hour plasma ammonia versus placebo at Week 36, with average ammonia levels staying within normal range. Eight of...
Soleno Therapeutics (SLNO) Still Appears Attractive Despite Slower U.S. Launch Ramp Projections
Oppenheimer kept an Outperform rating on Soleno Therapeutics but lowered its price target to $80 from $110, signaling a potential upside of more than 166%. Wells Fargo trimmed its target slightly to $110 while remaining Overweight. Both firms highlighted a slower‑than‑expected...
Mineralys Therapeutics (MLYS) Garnering Attention With Lorundrostat Progress
Mineralys Therapeutics (NASDAQ:MLYS) received a renewed Buy rating from Bank of America Securities, which lifted its price target to $51 from $46 after the company reported fourth‑quarter results. The firm highlighted progress on lorundrostat, an aldosterone synthase inhibitor, noting the...
Productivity Enhancing Bioreactor for Scalable Organoid Culture
AMSBIO introduced RPMotion, a spinning organoid bioreactor that accelerates and automates 3‑D cell culture for drug discovery, disease modeling and regenerative medicine. The system delivers up to five‑fold faster organoid expansion while cutting reagent costs by roughly 60% and labor...
ACC 2026: Sotatercept Shows Signal in CpcPH-HFpEF at Lower Dose
At the 2026 ACC Scientific Session, the phase‑II CADENCE trial showed that sotatercept (WINREVAIR) reduced pulmonary vascular resistance in adults with combined post‑ and precapillary pulmonary hypertension linked to HFpEF (CpcPH‑HFpEF). The study randomized 164 patients, median age 75, to...
Six Biotech Companies in Berlin to Watch in 2026
Berlin’s biotech sector is gaining global traction, highlighted by six innovative firms. 3B Pharmaceuticals secured a Novartis licensing deal for its FAP‑2286 radioligand and is collaborating on an astatine‑211 candidate. Ariceum Therapeutics dosed its first patient in a phase 1/2 trial...
Symeres and Ambagon Collaborate for Colorectal Cancer Molecules
Symeres has partnered with Ambagon Therapeutics to evaluate molecular‑glue compounds for colorectal cancer. The collaboration will leverage Symeres’ in‑vitro assays, surface‑plasmon resonance kinetics, and fluorescence microscopy to characterize ternary‑complex formation and downstream pathway effects. Symeres will also profile each candidate...
Symeres and Ambagon Collaborate for Colorectal Cancer Molecules
Symeres has partnered with Ambagon Therapeutics to evaluate Ambagon’s molecular glue candidates for colorectal cancer. The collaboration will use Symeres’ in‑vitro assays, surface plasmon resonance, fluorescence microscopy and a 102‑cell line panel to characterize ternary complex kinetics and downstream pathway...
STAT+: The Biotech Scorecard for the Second Quarter: 23 Stock-Moving Events to Watch
STAT’s quarterly biotech scorecard lists 23 upcoming events that could move biotech stocks in Q2 2026. Highlights include Phase 3 results from Abivax’s obefazimod in ulcerative colitis and Allogene Therapeutics’ interim data on its cema‑cel CAR‑T therapy for B‑cell lymphoma. The...
Lilly Moves Deeper Into Sleep Medicine with up to $7.8 Billion Centessa Deal
Eli Lilly announced a definitive agreement to acquire UK‑based Centessa Pharmaceuticals for up to $7.8 billion, paying $38 per share in cash and up to $9 per share in contingent milestones. The acquisition gives Lilly control of Centessa’s orexin‑receptor‑2 agonist pipeline,...
Anavex Updates Regulatory Strategy for Blarcamesine
Anavex Life Sciences has withdrawn its European Union marketing authorization application for blarcamesine and will collect additional data while maintaining dialogue with the European Medicines Agency. The company has concurrently submitted new data to the U.S. FDA to explore a...
Insilico Medicine, Lilly Partner on AI-Driven Drug Discovery Deal
Insilico Medicine and Eli Lilly have entered a partnership to use Insilico’s AI‑driven Pharma.AI platform for discovering new oral therapeutics across several disease areas. Lilly receives an exclusive worldwide license to develop, manufacture and commercialize the preclinical candidates, while Insilico secures...
New Data Show TrenibotE Safety in Repeat Treatments
Allergan Aesthetics presented new Phase 3 data on its investigational neurotoxin TrenibotE at the 2026 American Academy of Dermatology meeting. The open‑label study evaluated up to three repeat glabellar line treatments, confirming a consistent safety profile, no neutralizing antibodies, rapid onset...
Elidah Reports US FDA Clearance of Elitone for Men to Treat Post-Prostatectomy Urinary Incontinence
Elidah announced that the U.S. Food and Drug Administration has cleared its at‑home device, Elitone for Men, to treat urinary incontinence after prostate surgery. The non‑invasive system delivers neuromuscular stimulation to the pelvic floor for a 20‑minute daily session, eliminating...
The Brave New World of Radiotherapeutics
Radiotherapeutics have moved from niche concepts to a burgeoning oncology platform, driven by unmet treatment gaps and the commercial breakthrough of Novartis' Pluvicto. Early data show Actinium‑225 delivering 45‑50% response rates in heavily pre‑treated prostate cancer, while Bayer's Xofigo adds...
AskBio Announces Completion of Enrollment in Phase 2 Clinical Trial of AB-1002 Investigational Gene Therapy for Heart Failure
AskBio, a Bayer subsidiary, announced that enrollment for its GenePHIT Phase 2 trial of the investigational gene therapy AB‑1002 has been completed, randomizing 173 patients with non‑ischemic cardiomyopathy and NYHA Class III heart‑failure symptoms. The trial, spanning 46 sites across North America...
The Deep-Tech Founder Using AI to Address Immunology Challenges
Camille Bouget, CEO and co‑founder of Scienta Lab, launched EVA, a multimodal AI platform designed to accelerate immunology drug development. The model helps R&D teams identify viable therapeutic targets, predict preclinical efficacy, and stratify patients for clinical trials. By applying...
Regulating Payment of Participant Data in Clinical Trials
A team of scholars led by Steve Calandrillo proposes that FDA and IRBs adopt fair‑market‑value (FMV) payments for the data participants generate in clinical trials. Currently, participants receive modest compensation—about $4,000 per year—solely for trial involvement, not for the valuable...
The Role of Ethical Oversight and Algorithmic Bias in Automated Pharmacovigilance
Pharmacovigilance is rapidly adopting machine learning, natural language processing, and automation to ingest, categorize, and prioritize adverse event reports, dramatically shrinking backlogs and accelerating signal detection. While these technologies deliver speed and scale, they also inherit reporting biases and can...
Wegovy to Reach 1.2 Million Additional NHS Patients
Novo Nordisk $NVO obesity drug Wegovy will be an option for about 1.2 million more patients in England’s National Health Service - Bloomberg
Paragon Launches Korsana Biosciences, Targeting Alzheimer's
Paragon launched its 7th company today -- Korsana Biosciences, merging into the $CYCN public shell. New ticker will be $KRSA. Lead drug candidate is a shuttled anti-amyloid beta antibody for Alzheimer's disease in early studies. https://t.co/RcJ8adMakm
Lantern Pharma Narrows Q4 Loss, Schedules FDA Type C Meeting for LP‑300 in May 2026
Lantern Pharma Inc. posted a narrower fourth‑quarter net loss and saw its stock rise 26.3% to $1.56. The company also confirmed a mid‑May 2026 FDA Type C meeting for LP‑300, its phase‑2 lung‑cancer therapy, underscoring a pivotal regulatory milestone for...
Vertical AI Delivers Results; General AI Still Limited
Eli Lilly bet $2.75B on AI drug discovery. Best AI model in the world: 0.37% on a reasoning benchmark. Both facts are true simultaneously. Vertical AI that knows your domain: already working. General AI that reasons universally: still finding its ceiling. https://t.co/7iTOUGavT3
Scholar Rock’s Apitegromab BLA Resubmission Boosts Stock 11% in Pre‑Market
Scholar Rock Holding Corp. resubmitted its Biologics License Application for apitegromab to the FDA, adding a second U.S. fill‑finish site to secure supply. The move lifted the shares about 11% in early trading and positions the company for a PDUFA...
Eli Lilly to Acquire Centessa in $7.8 B Deal, Stock Jumps 45%
Eli Lilly agreed to buy Centessa Pharmaceuticals for up to $7.8 billion, paying $38 per share in cash plus a contingent value right worth up to $9 per share. The announcement lifted Centessa’s Nasdaq price 45% to a 52‑week high, underscoring...
Agios Pursues Accelerated FDA Approval for Mitapivat as Sickle‑Cell Therapy, Shares Jump 21%
Agios Pharmaceuticals announced it will seek accelerated U.S. approval for its oral drug mitapivat to treat sickle‑cell disease, prompting a 21.7% rise in its shares. The company has already filed a confirmatory trial proposal with the FDA and is preparing...
Antipsychotic-Like Effects of the Selective Rho-Kinase 2 Inhibitor KD025 in Genetic and Pharmacological Mouse Models of Schizophrenia
The selective ROCK2 inhibitor KD025 (belumosudil) demonstrated antipsychotic‑like activity in both genetic (Arhgap10 S490P/NHEJ) and pharmacological (methamphetamine and MK‑801) mouse models of schizophrenia. KD025 restored reduced spine density in the medial prefrontal cortex and rescued deficits in a touchscreen visual‑discrimination...
Jupiter Neurosciences Inc (JUNS) Q4 2025 Earnings Call Transcript
Jupiter Neurosciences reported total product sales of $2.8 billion in 2025, a 22% year‑over‑year increase driven by INGREZZA and the debut of CRENESSITY. INGREZZA generated just over $2.5 billion, up 9% on volume growth, while CRENESSITY posted $300 million in its first full...
Cysteine Steers T‑cells Toward Proliferation or Tumor Killing
Cysteine directs T cells to either multiply or attack tumors by fueling distinct metabolic pathways, suggesting new strategies to fine-tune immune responses in cancer therapy. immunometabolism
Weight-Loss Jabs Will Be Offered on NHS for People at Risk of Further Heart Attacks
The National Institute for Health and Care Excellence (NICE) has approved the GLP‑1 drug Wegovy (semaglutide) for free on the NHS to more than one million English patients who are overweight and have a history of heart attacks, strokes or...
From Free Rider to Innovator: How China Became a Global Pharmaceutical Powerhouse
China has transformed from a pharmaceutical free rider into a leading innovator, largely after the 2016 National Reimbursement Drug List (NRDL) reform. The policy slashed prices by 50‑60% while guaranteeing near‑universal coverage, prompting a five‑fold rise in annual clinical trials...
28 Months Later: FDA Still Hasn't Revealed Rick Bright and Janet Woodcock's Communications
The episode delves into the controversy surrounding the FDA’s handling of hydroxychloroquine during the COVID‑19 pandemic, focusing on whistleblower Dr. Rick Bright’s claims that Dr. Janet Woodcock pressured him to pursue an Emergency Use Authorization (EUA) rather than an expanded‑access protocol....
The War on Peptides — Why Retatrutide Is at the Center
In this episode of Business Game Changers, host Sarah Westall and Dr. Diane Kayser discuss the rapidly evolving peptide market, focusing on the upcoming weight‑loss peptide retatrutide (also called Reditrutide). They explain how big‑pharma is moving to control peptide supplements,...
How Ireland Became Dependent on Big Pharma — and the Risks Ahead
Over the past five decades Ireland has transformed into the world’s third‑largest pharmaceutical exporter, with drug manufacturing now contributing roughly 20 % of its GDP. The sector’s rapid growth was driven by generous tax incentives, a skilled workforce and proximity to...
Dual-Target Strategy Shows Promise in Overcoming Drug Resistance in MCL
A recent preclinical study identified BIRC5 and MCL‑1 as co‑drivers of survival in mantle cell lymphoma (MCL) and demonstrated that simultaneous inhibition with YM155 and S63845 produces strong synergistic killing of cancer cells. The combination was effective across both treatment‑naïve...
Targeting Tumor Supporting Cells: Lipid Nanoparticles Advance CAR T Success in Pancreatic Cancer
Researchers at Penn Vet used lipid nanoparticles (LNPs) to deliver FAP‑CAR mRNA directly to patients' T cells, enabling in‑vivo engineering of CAR T cells that attack cancer‑associated fibroblasts in pancreatic ductal adenocarcinoma. In a preclinical mouse model, a single dose of...
BREAKING STUDY: Half of COVID-19 Vaccinated Military Personnel Suffered Subclinical Heart Stress
A new longitudinal study of 83 healthy military personnel tracked cardiac biomarkers after two mRNA COVID‑19 vaccine doses. Within two weeks of the second shot, 49% of participants exhibited a rise in NT‑proBNP exceeding 1.5 times their baseline, indicating subclinical...
Off-the-Shelf CAR T-Cell Therapy Granted Breakthrough Therapy Designation for Aggressive T-Cell Cancers
Soficabtagene geleucel (WU‑CART‑007), an off‑the‑shelf CRISPR‑engineered CAR‑T therapy, received FDA Breakthrough Therapy Designation for relapsed or refractory T‑cell leukemia and lymphoma. In a phase 1/2 trial of 28 patients, the drug achieved a 91% overall response rate and a 73% complete...
Using “Left-Handed” Proteins to Block Alzheimer’s
Kobe University researchers engineered a synthetic right‑handed (D) peptide that binds amyloid‑beta, the disordered protein driving Alzheimer’s plaques, and blocks its aggregation. In mouse brain cell cultures the mirror peptide restored cell viability to 100%, compared with 50% survival when...
Key Takeaways: AI-Assisted Innovation and Patent Protection in Biotech
AI‑assisted tools are reshaping biotech research, delivering faster discovery and more complex experiments. A recent Sterne Kessler webinar clarified that U.S. patent law still requires a human to be named as inventor, even when AI contributes substantially. Inventorship is judged claim‑by‑claim,...
4th Circuit Upholds Block on West Virginia’s 340B Law
The Fourth Circuit affirmed a preliminary injunction that blocks West Virginia’s Senate Bill 325, which would have forced drug manufacturers to extend 340B discounts to prescriptions filled by contract pharmacies. The injunction, originally issued by a West Virginia district court,...
First‑In‑Human Nuclease‑Free Gene Editing Shows Promise for Methylmalonic Acidemia
Researchers led by Dr. Bedoyan, Dr. Morgan and Dr. Sun completed a phase 1/2 trial that used nuclease‑free homologous recombination to edit the genes of children with methylmalonic acidemia. The therapy lowered toxic metabolite levels and showed durable engraftment without...
FDA Set to Lift Peptide Compounding Ban After RFK Jr. Push
The Food and Drug Administration is preparing to reverse its 2023 restriction on dozens of experimental peptides, permitting licensed compounding pharmacies to produce them again. The move follows Health Secretary Robert F. Kennedy Jr.’s public promise on the Joe Rogan...