Merck Strikes Deal with Antibody Discovery Startup
Merck has signed a research collaboration with AI‑driven antibody startup Infinimmune, potentially providing up to $838 million in payments tied to clinical milestones. Infinimmune’s platform scans human immune cells to uncover novel targets such as IL‑22 and IL‑13 for autoimmune indications. The deal grants Merck exclusive rights to any candidates discovered, reinforcing its push into next‑generation biologics as it prepares for Keytruda’s patent cliff. The partnership follows Merck’s recent acquisitions and alliances aimed at expanding its antibody portfolio.
MRNA Is Poised to Rise Beyond Infectious Diseases, if It’s Not Derailed by R&D Cuts
mRNA technology, once celebrated for COVID‑19 vaccines, now faces heightened political and regulatory scrutiny, including the cancellation of roughly $500 million in BARDA contracts. A new JAMA Network Open study shows NIH has invested $1.65 billion in 178 mRNA grants since 1997,...
Novo Nordisk Launches Subscription Program for Wegovy Drugs
Novo Nordisk introduced a subscription service for its obesity treatment Wegovy, allowing cash‑pay patients to lock in three‑month, six‑month or twelve‑month supplies. The model promises lower out‑of‑pocket costs compared with traditional pay‑per‑dose purchases. By bundling shots and oral pills, Novo...
Blackstone Closes $6.3B BXLS VI Fund, Making It the Largest Life Sciences Vehicle
Blackstone announced the final close of its Life Sciences VI fund at a hard cap of $6.3 billion, roughly 40% larger than the prior vehicle. The BXLS platform, launched in 2018, now manages about $15 billion and invests across the entire drug...
UCB Brings First Therapy for Rare Disease TK2d to EU
UCB’s Kygevi, a combination of doxecitine and doxribtimine, received its first EU approval for treating thymidine kinase 2 deficiency (TK2d) under exceptional circumstances. The drug, aimed at patients whose disease began before age 12, cut mortality risk by 95% compared with...
PepGen’s Muscle Disease Program Posts Poor Mid-Stage Results as One Patient's Data Get Markedly Worse
PepGen reported that its Phase 2 trial of an oligonucleotide therapy for a rare genetic nerve‑muscle disorder failed to meet its primary efficacy endpoints. The data showed no statistically significant improvement in muscle strength across the cohort, and one participant experienced...
Eli Lilly to Buy Centessa for $6.3B to Get Sleep Disorder Drug
Eli Lilly announced a $6.3 billion acquisition of Centessa Pharmaceuticals, marking its largest deal in years. The purchase secures Centessa’s orexin‑based insomnia candidate and a pipeline of early‑stage neurological programs. Lilly is channeling cash generated by its GLP‑1 blockbuster drugs into the...
First Clinical Trial of tRNA Therapy Will Start Soon
Alltrna, a biotech startup focused on transfer RNA (tRNA) therapeutics, has secured regulatory clearance to launch its first human clinical trial. The trial will evaluate a novel tRNA‑based drug designed to correct protein synthesis errors that underlie a range of...
Enveda's First Clinical Readout Shows Strong Eczema Results
Enveda Biosciences released its first clinical readout for an investigational atopic dermatitis therapy, showing efficacy comparable to AbbVie's Dupixent. The Phase 1 trial met its primary endpoints, demonstrating significant skin clearance and a safety profile similar to existing biologics. The...
Semarion Raises $3.8M to Scale Cell Assay Technology
Semarion, a Cambridge spin‑out, secured $3.8 million (≈£2.9 million) in a Series A round led by Parkwalk to scale its SemaCyte cell‑based screening platform. The funding follows a $2.89 million seed round in 2022 and will be used to expand manufacturing, field support,...
Alterity Receives Positive FDA Feedback on ATH434 Phase 3 Program
Alterity Therapeutics received positive written feedback from the U.S. Food and Drug Administration after a Type C meeting on its planned Phase 3 program for ATH434 in Multiple System Atrophy. The agency endorsed the company’s clinical pharmacology and non‑clinical development strategy and...
AZ Considers Filings for Long-Acting Strensiq Follow-Up
AstraZeneca’s Alexion unit intends to file a new long‑acting enzyme replacement therapy, efzimfotase alfa, as a successor to its Strensiq (asfotase alfa) for hypophosphatasia (HPP). Phase 3 data showed the drug met primary endpoints in pediatric patients but failed to achieve...
Homoharringtonine Extends Lifespan, Fights Obesity in Mice
Researchers reported that homoharringtonine (HHT), a plant‑derived alkaloid already approved for certain blood cancers, acts as a potent senolytic in mice. The compound selectively eliminated senescent cells across adipose, liver and muscle, leading to lower inflammation, improved glucose tolerance and...
Blackstone Closes $6.3bn Life Sciences Fund
Blackstone announced the closing of its newest life sciences fund at $6.3 billion, topping the original target. The vehicle will back biotech, pharmaceutical and medical‑technology companies from seed to growth stages. Investor enthusiasm for health‑tech has surged since the pandemic, allowing...
UBriGene and Cellinfinity BIO Collaborate to Accelerate in Vivo CAR-T Therapies
uBriGene Biosciences has entered a strategic partnership with Cellinfinity BIO to accelerate the development of in‑vivo CAR‑T therapies for both solid tumors and hematologic cancers. The collaboration will apply uBriGene’s LVV Turbo platform, which delivers up to 80% purification recovery...
UBriGene and Cellinfinity BIO Collaborate to Accelerate in Vivo CAR-T Therapies
uBriGene Biosciences has entered a strategic partnership with Cellinfinity BIO to fast‑track in‑vivo CAR‑T programs for both solid and hematologic cancers. The deal leverages uBriGene’s LVV Turbo platform, which delivers GMP‑grade lentiviral vectors with up to 80% purification recovery and...
ACC 2026: Lorundrostat Lowers BP but Raises Hyperkalemia Risk
At the 2026 ACC Scientific Session, Brazilian investigators presented a meta‑analysis of three placebo‑controlled trials (1,060 patients) evaluating lorundrostat in uncontrolled hypertension. Lorundrostat 50 mg reduced systolic blood pressure by 9.08 mm Hg and diastolic by 3.48 mm Hg, while the 100 mg dose achieved an...
Merck Reports P-III (CORALreef AddOn) Trial Data on Enlicitide Decanoate in Hypercholesterolemia
Merck presented Phase III CORALreef AddOn trial results for enlicitide decanoate, an oral PCSK9 inhibitor, in hypercholesterolemic adults on statins. At eight weeks, the drug lowered LDL‑C by 64.6%, outperforming bempedoic acid, ezetimibe and their combination. It also achieved 54.6%...
STAT+: Over-the-Top Psychedelic Promos Could Undermine the Field’s Drug Development Efforts
Psychedelic biotech firms Helus Pharma and AtaiBeckley have hired marketing agencies to produce YouTube videos that tout exaggerated efficacy claims and alleged FDA fast‑track status for their investigational drugs. The ads, labeled only as “informational,” suggest near‑perfect Phase 2 results and...
Teva Advances Biosimilars Portfolio with Ponlimsi (Denosumab) FDA Approval and Dual Omalizumab Filing Acceptance
Teva Pharmaceutical received U.S. FDA approval for Ponlimsi, a biosimilar to Amgen’s Prolia (denosumab), covering all approved indications. The approval was granted after extensive analytical and clinical studies demonstrated comparable efficacy, safety, and immunogenicity to the reference product. In parallel,...
Bioinspired Anti‐VEGF Peptide Nanoparticle with Immune Regulating and Corneal Epithelium Penetration Capability for Corneal Neovascularization Therapy
Researchers have engineered a bioinspired nanoparticle that co‑assembles an anti‑VEGF peptide with copper ions, adds a ROS‑scavenging moiety and a cell‑penetrating peptide, and achieves deep corneal delivery. The formulation extends ocular residence to roughly 70 minutes and reaches 300 µm in a...
Imunon Inc (IMNN) Q4 2025 Earnings Call Transcript
Imunon reported Q3 2025 results, highlighting $5.3 million cash and a runway extending to mid‑Q1 2026 after a $4.5 million equity raise. Operating expenses fell 31% year‑over‑year, reducing monthly burn to $1.25‑$1.5 million. The pivotal OVATION 3 phase III ovarian‑cancer trial enrolled nine patients, surpassing internal targets,...
Tevogen Bio Holdings Inc (TVGN) Q4 2025 Earnings Call Transcript
VistaGen Therapeutics reported completing the randomized portion of its PALISADE III Phase 3 trial and using the data to implement operational and statistical refinements for the ongoing PALISADE IV study. The company is leveraging third‑party AI and machine learning to...
Tvardi Therapeutics Inc (TVRD) Q4 2025 Earnings Call Transcript
Teva reported Q4 2025 revenue of $4.5 billion, up 3% year‑over‑year, with adjusted EBITDA rising 6% and non‑GAAP EPS of $0.78, a 14% increase. The innovative portfolio contributed over $800 million, driven by AUSTEDO’s $618 million U.S. sales (+38%) and solid gains from...
Omeros Corp (OMER) Q4 2025 Earnings Call Transcript
Omeros Corp reported a Q3 2025 net loss of $30.9 million, but secured a transformative agreement with Novo Nordisk that could deliver up to $2.1 billion in upfront and milestone payments. The $240 million upfront cash will retire most short‑term debt and fund more...
Bioatla Inc (BCAB) Q4 2025 Earnings Call Transcript
BioAtla reported that it is in the final stages of a strategic partnership transaction expected to close by year‑end and disclosed FDA alignment on the phase‑3 design of its OSFI (OSV) trial for second‑line oropharyngeal squamous cell carcinoma. The trial...
Galmed Pharmaceuticals Ltd (GLMD) Q4 2025 Earnings Call Transcript
MediWound reported a sharp Q4 revenue drop to $1.9 million, driven primarily by a U.S. government shutdown that delayed contract awards. R&D spending rose to $4.5 million as the company pushed the Phase III VALUE study for its EscharEx wound‑debridement therapy. A new...
Milestone Scientific Inc (MLSS) Q4 2025 Earnings Call Transcript
Milestone Scientific reported that the FDA accepted the New Drug Application for lorundrostat and set a PDUFA target date of December 22, 2026. The company highlighted a surge in cash to $656.6 million, extending its financial runway to 2028, while net...
Galectin Therapeutics Inc (GALT) Q4 2025 Earnings Call Transcript
Altimmune reported a strengthened cash position of roughly $340 million, extending its runway through 2028 to fund a pivotal Phase III NASH trial. The company disclosed that the trial will enroll about 1,800 patients globally, testing 1.8 mg and 2.4 mg doses of its...
Mink Therapeutics Inc (INKT) Q4 2025 Earnings Call Transcript
MiNK Therapeutics reported a cash position of $14.3 million, extended through 2026 after a $1.2 million raise, while posting a $2.9 million net loss for Q4. Clinical data showed AGENT‑797 combined with PD‑1 achieved a median overall survival of roughly 23 months in heavily...
The BioPharm Brief: Talking Lifecycle Optimization, Strategic Investment, and Collaboration Shaping Growth Trajectory
The FDA has approved a higher-dose regimen of nusinersen (Spinraza) for spinal muscular atrophy, aiming to boost drug exposure and improve long‑term motor function. The approval underscores a broader industry shift toward lifecycle optimization of RNA‑targeted therapies. Simultaneously, biopharma firms...
Copper-Loaded Starch Nanoparticles Can Target Bacteria in Microbial Communities
University of Michigan researchers have engineered copper‑loaded starch nanoparticles that release antibacterial copper ions when specific bacteria degrade the starch carrier. The positively charged particles preferentially bind to bacterial surfaces and demonstrated potent activity against Staphylococcus aureus and Bacillus subtilis...
Scaling Certainty
Precision medicine is shifting pharma from a volume‑driven model to one focused on early patient identification and diagnostic certainty. Real‑world studies show genomic profiling yields actionable insights in about 61% of advanced solid‑tumor cases, yet only a fraction of patients...
HealthcareWATCH
Within3 unveiled Dataverse, a unified real‑world data ecosystem that merges electronic health records, claims, and specialty analytics to sharpen pharmaceutical launch decisions. Avalere Health released a global framework to broaden genomic profiling in cancer care, while Emota’s report highlighted rising...
Inventiva Reports 2025 Full Year Results and Provides a Business Update
Inventiva posted 2025 revenues of €4.5 million (≈ $4.9 million) and ended the year with €99.3 million ($108 million) in cash and €131.6 million ($143 million) in short‑term deposits. The company raised $172.5 million (≈ €149 million) in a U.S. public offering and expects its cash runway to last until...
RFK Jr.’s Peptide Deregulation Threatens the Foundations of Drug Safety
HHS Secretary Robert F. Kennedy Jr announced on a podcast that the federal government will lift restrictions on 14 injectable peptides, allowing compounding pharmacies to produce and sell them without the usual FDA review. The move bypasses the scientific advisory...
SCOUT-HCM: Mavacamten Can Benefit Teens With Obstructive HCM, Too
The phase III SCOUT‑HCM trial showed that mavacamten (Camzyos) significantly reduced left ventricular outflow tract (LVOT) gradients in adolescents with obstructive hypertrophic cardiomyopathy (HCM) compared with placebo. Forty‑four patients aged 12‑17 were randomized to weight‑based doses of 2 or 5 mg daily, achieving a...
STAT+: Doctors Without Borders Calls Gilead ‘Unconscionable’ for Refusing to Sell HIV Prevention Drug to the Organization
Doctors Without Borders has condemned Gilead Sciences for refusing to sell its long‑acting HIV prevention drug lenacapavir directly to the humanitarian organization. The company had previously negotiated a limited‑supply request, while a separate deal with the Global Fund aims to...
Drug Trials Snapshots: INLURIYO
Eli Lilly’s oral selective estrogen receptor degrader INLURIYO (imlunestrant) received FDA approval on September 25 2025 for adults with advanced ER‑positive, HER2‑negative breast cancer harboring an ESR1 mutation after endocrine therapy failure. The decision rests on the EMBER‑3 trial, which enrolled 874...
After Missing Kezar Buyout in 2024, Tang Returns as CEO of Aurinia With $50M Offer
Kevin Tang, newly installed CEO of Aurinia Pharmaceuticals, has revived his bid for Kezar Life Sciences with a $50 million offer of $6.95 per share, roughly matching Kezar’s $47 million market cap. The proposal follows Tang’s earlier, unsuccessful $1.10‑per‑share attempt made through...
#ACC26: Merck Touts Comparator Data for Oral Cholesterol Drug
Merck reported that its experimental oral PCSK9 inhibitor, enlici‑tide, outperformed a range of commonly prescribed cholesterol‑lowering medicines in a head‑to‑head comparator trial. The data bring the drug a step closer to becoming the first oral PCSK9 therapy on the market....
Centivax Closes $37 Million Financing
Centivax, a clinical‑stage biotech focused on universal vaccines, closed an oversubscribed $37 million financing round led by Structure Fund. The round also attracted Meiji Seika Pharma, Sigmas Group, Kendall Capital Partners, and Stripe co‑founder Patrick Collison. The capital will fund pre‑clinical...
#AAD26 Roundup: Takeda, Alumis, Priovant and Incyte Take the Stage
At the American Academy of Dermatology (AAD) meeting in Denver, Takeda, Alumis, Priovant and Incyte each unveiled late‑stage dermatology data, ranging from novel biologics to targeted small molecules. Sanofi and Biogen also presented, highlighting mixed results in eczema and lupus...
Accord, Intas, and Bio-Thera File Four IPRs Against Janssen Golimumab Patents
Accord BioPharma, Intas Pharmaceuticals and Bio‑Thera have filed four Inter Partes Review petitions challenging four Janssen patents covering golimumab treatment methods for ankylosing spondylitis and psoriatic arthritis. The petitioners contend that the claims are anticipated or obvious based on publicly...
Gene Therapy Reduces Geographic Atrophy Lesion Growth
Ocugen’s phase‑2 ArMaDa trial of the modifier gene therapy OCU410 showed a 31% reduction in geographic atrophy lesion growth and a 27% slower rate of ellipsoid zone loss at the medium dose, with 55% of treated eyes achieving at least...
Depression Improves with Mebufotenin
A phase‑2b trial of inhaled mebufotenin (GH001) in 81 adults with treatment‑resistant depression showed rapid symptom relief, with 57.5% of the active‑treatment group achieving remission by day 8 versus none on placebo. The mean MADRS score fell by 15.2 points compared...
US Stocks: Viridian Shares Plunge 34% as Eye Disease Drug Disappoints on Efficacy Despite Trial Success
Viridian Therapeutics’ shares tumbled 34% to $18.66 after its late‑stage trial of elegrobart for thyroid eye disease (TED) fell short of investor efficacy expectations, despite meeting the primary endpoint of reducing eye bulging. The four‑week regimen showed a 54% improvement...
Discontinuing Beta-Blockers After MI Reasonable in some Patients
The SMART‑DECISION trial showed that stopping beta‑blockers one year after a myocardial infarction is non‑inferior to continuing them in stable, low‑risk patients without heart failure or reduced ejection fraction. Among 2,540 participants followed for a median of 3.1 years, the...
The Crucial Role of Payload Linker Innovation in the Growth of ADCs
Antibody‑drug conjugates (ADCs) are becoming a cornerstone of oncology, with the global market expected to reach $65.2 billion by 2031. The number of ADC programs has more than tripled, rising from 557 in 2020 to 1,643 in 2025, driven by advances...
The Dosing Problem That Precision Medicine Has Yet to Solve
Only about 45% of cancer patients receive a dose within the optimal therapeutic window, leaving many under‑dosed or over‑dosed. True Dose is introducing an at‑home capillary blood‑spot kit that lets patients collect finger‑prick samples for therapeutic drug monitoring, with results...