Sanofi Extends $180M to California T Cell Engager Startup Kali
Sanofi announced a $180 million upfront investment in California‑based T‑cell engager startup Kali, reviving its presence in the bispecific antibody space after a period of strategic uncertainty. The agreement also includes up to $1 billion in milestone payments tied to clinical and regulatory achievements. Kali, founded in 2020, will receive Sanofi’s development expertise and global commercialization network. The partnership positions Sanofi to compete directly with industry leaders such as Roche and Amgen in next‑generation immuno‑oncology therapies.
Top HHS Official Tamps Down Expectations on Scope of TrumpRx
The White House’s top drug‑pricing negotiator, Chris Klomp, clarified that the TrumpRx initiative is intended primarily to increase price transparency rather than serve as a broad marketplace for discounted drugs. He emphasized that the program will provide data tools and...
China-Rooted AI Biotech Earendil Labs Raises $787M Ahead of Possible IPO
US‑headquartered, China‑rooted biotech Earendil Labs announced a $787 million private financing round, the largest to date for an AI‑driven drug discovery company. The capital will accelerate its AI platform, which has already produced a pipeline of more than 40 preclinical drug...
UK’s NICE Revisits Lilly, Eisai Alzheimer's Drugs Under New Pricing Threshold
The UK’s National Institute for Health and Care Excellence (NICE) has reopened its evaluation of Eli Lilly’s donanemab and Eisai’s lecanemab after initially rejecting them on cost grounds. A newly‑introduced cost‑effectiveness threshold of roughly £20,000 per quality‑adjusted life year (QALY)...
Genentech Culls Muscle-Preserving Drug in Genetic Diseases, Raising Questions About Obesity Trial
Roche’s Genentech has halted the Phase III development of its muscle‑preserving therapy for spinal muscular atrophy (SMA) and facioscapulohumeral muscular dystrophy (FSHD). The decision follows disappointing efficacy signals and safety concerns that emerged in late‑stage trials. The program also included an...
Turmoil at ACIP Continues After Claim Committee ‘Disbanded’ Is Quickly Refuted
An outspoken CDC Advisory Committee on Immunization Practices (ACIP) member claimed Thursday that the vaccine advisory group had been disbanded. The CDC quickly refuted the allegation, confirming that ACIP remains fully operational and continues its role in shaping U.S. immunization...
FDA Seeks to Encourage Fewer Animal Studies with New Draft Guidance
The FDA released a draft guidance that details how biopharma firms can validate non‑animal approaches for early‑phase toxicology and safety studies. The document encourages the use of in‑vitro assays, computational modeling, and other modern methods to replace traditional animal testing....
AI Startup Basecamp Research Announces Trillion-Gene Project
Basecamp Research, an AI‑focused biotech startup backed by Microsoft and Nvidia, announced a trillion‑gene sequencing initiative. The company aims to collect genetic sequences for over a trillion proteins within the next two years. Leveraging high‑performance cloud computing and advanced generative‑AI...
Ionis Delays Prion Disease Readout; Arvinas' Parkinson's Biomarker Data
Ionis Therapeutics announced that the primary completion date for its Phase 1/2a prion disease trial has been pushed to February 2027, extending the study timeline by more than two years. In parallel, Arvinas reported new biomarker data from its Parkinson’s disease program,...
Briggs Morrison's Crossbow Unveils $77M Series B for T Cell Engagers
Crossbow Therapeutics, founded by biotech veteran Briggs Morrison, announced a $77 million Series B round to accelerate its off‑the‑shelf T‑cell engager platform. The funding, led by a mix of venture capital and strategic investors, will support the advancement of three preclinical candidates...
Aspen's Personalized Parkinson's Therapy Shows Early Promise
Aspen Neuroscience reported encouraging early data from a small autologous cell therapy trial for Parkinson's disease. The treatment, derived from each patient's own skin cells and reprogrammed into dopaminergic neurons, was safely implanted in twelve participants, showing graft survival and...
Xaira Unveils AI Model X-Cell for Predicting Virtual Cells
Xaira, the biotech AI startup with the deepest funding round, launched its first model, X‑Cell, on Tuesday. The platform uses deep learning to generate virtual cell representations from multi‑omics data, enabling researchers to simulate cellular responses without physical experiments. Early...
Nadia Care Raises $12M to Grow Medicaid Maternal Care
Nadia Care, a maternal‑care startup that blends virtual and in‑person services, announced a $12 million financing round. The company has recently exited commercial insurance contracts to concentrate exclusively on Medicaid beneficiaries. This capital infusion will fund expansion of its telehealth platform...
China Startup CirCode Gets Clearance for Trial of Circular RNA Therapy
Cir‑Code Bio‑med, a Chinese biotech focused on circular RNA medicines, has secured an Investigational New Drug (IND) approval from the U.S. Food and Drug Administration to commence its first human trial. The therapy targets a rare genetic disorder using a...
Structure Therapeutics Reports More Phase 2 Data for Oral GLP-1
Structure Therapeutics released Phase 2 data for its oral GLP‑1 agonist, positioning the candidate as a next‑generation alternative to injectable therapies from Eli Lilly and Novo Nordisk. The trial demonstrated a mean 30% reduction in HbA1c and 70% of participants achieving target...
After Novartis Pact, Macrocycle Shop Unnatural Products Gets $45M Series B
Santa Cruz‑based Unnatural Products secured a $45 million Series B round to accelerate its macrocycle drug platform. The financing follows a newly announced partnership with Novartis that will grant the pharma giant early access to the company’s pipeline and a co‑development option...
Gubra Plots Roivant-Like Model as Partnered Obesity Drugs Take Flight
Gubra, a 300‑employee Danish biotech known for its obesity drug partnerships, announced plans to adopt a Roivant‑style incubation model. The strategy will spin out a series of focused biotech companies, each targeting niche therapeutic areas beyond obesity, such as metabolic...
Immutep's LAG-3 Drug Fails Phase 3 Lung Cancer Study
Immutep’s LAG‑3 fusion protein eftilagimod‑alpha failed to improve overall survival in a Phase 3 randomized study in non‑small cell lung cancer. The trial, enrolling roughly 600 patients, did not meet its primary endpoint and showed no statistically significant benefit versus standard...
Ultragenyx’s Gene Therapy Hits Key Endpoint in Phase 3 Trial for Blood Ammonia Disease
Ultragenyx announced that its investigational gene therapy for ornithine transcarbamylase (OTC) deficiency met a primary endpoint in a Phase 3 trial involving 37 patients. The study demonstrated a statistically significant reduction in blood ammonia levels, the key marker of disease...
Flagship Startup Loses CEO to Ipsen; Ionis to Shed Nearly Six Decades of Board Experience
Alltrna's CEO Michelle Werner announced her resignation, moving to pharmaceutical giant Ipsen as its new chief executive. The biotech startup will rely on interim management while it searches for a permanent replacement. Simultaneously, Ionis Therapeutics disclosed that several long‑standing board...
Grail Names New CEO as Bob Ragusa Retires
Grail announced that long‑time CEO Bob Ragusa will retire, handing the role to current president Josh Ofman. The transition follows a multi‑year succession plan designed to ensure leadership continuity. Ofman, who has overseen product launches and regulatory milestones, will assume...
Pfizer to Close Ignite, Its R&D Services Unit for Small Biotechs
Pfizer announced the shutdown of its Ignite unit, a dedicated R&D services platform that partnered with early‑stage biotech companies. Ignite offered fee‑based scientific, regulatory, and strategic support, helping dozens of startups advance drug candidates. The closure aligns with Pfizer’s cost‑discipline...
A Simpler Form of DNA May Be Key to Non-Viral Gene Therapy, Study Suggests
Researchers have identified a streamlined DNA construct that could replace viral carriers in gene‑therapy applications. The study demonstrates that this minimalist DNA format delivers therapeutic genes with efficiency comparable to adeno‑associated viruses while eliciting a weaker immune response. Production of...
Biotech Startups Use Funding Extensions to Sidestep Full Capital Rounds
Biotech startups are increasingly opting to extend existing financing rounds instead of launching fresh fundraising campaigns. By adding capital to current rounds, companies can secure needed cash while avoiding the dilution and valuation pressure of a full round. This approach...
Lilly Warns of Impurity Risk in Certain Compounded Forms of Mounjaro and Zepbound
Eli Lilly warned that compounded versions of its GLP‑1 drugs Mounjaro and Zepbound, when mixed with vitamin B12, may contain unsafe impurities. The alert follows growing off‑label compounding as demand outpaces supply. Lilly’s notice urges clinicians and patients to verify product sources...
FDA Merges Adverse Event Trackers Into One Database
The FDA announced a unified adverse‑event database that will eventually incorporate all of its existing reporting systems, including the vaccine‑side‑effect tracker jointly operated with the CDC. The new platform, called the Adverse Event Monitoring System, centralizes data from drugs, biologics,...
Eli Lilly CEO David Ricks Seeks 'Exit Velocity' For Pharma's Future
Eli Lilly’s chief executive David Ricks announced a strategic push to sustain the company’s recent $1 trillion revenue milestone by accelerating AI‑driven drug discovery and manufacturing. He highlighted a new partnership with Nvidia to embed generative‑AI models across the R&D pipeline, aiming...
RA Capital, Forbion and Canaan Appear to Back Harbour's CTLA-4 Partner Solstice
RA Capital, Forbion, and Canaan have collectively invested in Solstice Therapeutics, the CTLA-4 antibody partner of Harbour Therapeutics. The funding round, reportedly a multi‑million dollar Series B, will support Solstice's pre‑clinical and early clinical programs. By backing Solstice, the investors...
Study Suggests Long Non-Coding RNA Has Potential as New Class of Genetic Medicine
Researchers at the University of Toronto have engineered synthetic long non‑coding RNA (lncRNA) molecules that can dampen inflammatory responses. The study, led by PhD student Janice Pang and biologist Omar Khan, demonstrates that these engineered lncRNAs reduce cytokine release in...
Lundbeck CEO Talks Drug Pricing, Protecting Biotech and European Needs
Lundbeck chief executive Charl van Zyl warned that Europe’s fragmented drug‑pricing regime threatens biotech sustainability and patient access. He cited recent remarks by HHS Secretary Robert F. Kennedy Jr. suggesting Europeans already pay higher prices than Americans. Van Zyl called...
China Is Going After the World's Most Expensive Drugs: Endpoints Signal
China is actively targeting ultra‑expensive gene therapies, challenging the notion that these treatments are immune to price competition. Recent regulatory approvals and centralized procurement initiatives have forced manufacturers to negotiate steep discounts on therapies that once commanded multi‑million‑dollar price tags....
FDA Widens Use of Leucovorin without New Trial Data
The U.S. Food and Drug Administration has approved the generic form of leucovorin, also known as folinic acid, for treating cerebral folate deficiency (CFD). The decision widens the drug’s label despite the absence of new clinical trial data, relying on...
Breakout Ventures Closes $114M Fund, Plans 20 Investments
Breakout Ventures announced the close of a new $114 million venture fund, its first dedicated vehicle, aimed at backing roughly 20 early‑stage companies. The capital raise underscores the firm’s confidence in high‑growth sectors such as SaaS, fintech and artificial intelligence. Breakout...
BioNTech Co-Founders to Exit Company and Start a New One
Uğur Şahin and Özlem Türeci announced they will leave BioNTech by the end of 2026 to launch a new company focused on next‑generation mRNA technologies. BioNTech will concurrently narrow its portfolio, concentrating on late‑stage therapeutic candidates and its existing vaccine...
Universal Health Services Buys Talkspace for $835M
Universal Health Services (UHS) announced the acquisition of digital therapy platform Talkspace for $835 million, marking a major entry into virtual mental‑health care. The deal occurs as tele‑health valuations soften despite sustained demand for remote counseling. Talkspace’s subscription model and clinician...
AbbVie, Gubra Post Obesity Data; Regeneron Obesity Drug Succeeds in China
AbbVie and its partner Gubra released Phase 2 data on a long‑acting amylin analogue that produced significant weight loss in obese participants, with reductions approaching double‑digit percentages and a clean safety signal. The study highlighted dose‑responsive efficacy and tolerability, positioning the...
Bristol Myers Says Second CELMoD Succeeds in Phase 3
Bristol Myers Squibb announced that its oral CELMoD candidate mezigdomide met primary endpoints in the Phase 3 SUCCESSOR‑2 trial for relapsed or refractory multiple myeloma. The open‑label study showed a statistically significant improvement in progression‑free survival compared with the current standard...
RNA Editing Startup Tacit Therapeutics Launches with $19M for Brain Diseases
Tacit Therapeutics, an RNA‑editing startup focused on neurological disorders, announced its launch backed by a $19 million financing round. The capital, led by Andreessen Horowitz and DCVC, will fund the development of ADAR‑based therapeutics targeting diseases such as ALS, Huntington’s, and...
Roche’s Big-Hope Breast Cancer Drug Fails in Crucial First-Line Trial
Roche’s oral breast‑cancer therapy, touted as a potential blockbuster, missed its primary endpoint in the pivotal Phase 3 persevERA trial. The study evaluated the drug as a first‑line treatment for hormone‑receptor‑positive, HER2‑negative metastatic breast cancer and enrolled more than 1,200 patients...
GLP-1 News Galore; Top 100 Venture Investors; Doug Ingram to Step Down; and More
This week’s Endpoints Weekly highlighted a surge of GLP‑1 developments, including new trial data and expanded indications that reinforce the class’s dominance in obesity and diabetes treatment. The newsletter also released its annual Top 100 venture investors list, showing a notable...
Hims Reports 2025 Earnings, Shares Details on GLP-1 Pill Decisions
Hims & Hers disclosed its fourth‑quarter earnings and announced that it has withdrawn the controversial GLP‑1 weight‑loss pill it briefly launched. The decision followed conversations with key ecosystem stakeholders, including regulators and partner pharmacies. The company highlighted modest revenue growth...
Novartis to Divest India Unit to Private Equity-Led Consortium for $159M
Novartis announced the sale of its majority stake in its Indian generics and prescription business to a private‑equity‑led consortium for $159 million. The transaction transfers control of a portfolio that includes both off‑patent generics and branded medicines to the buyers. The...
Sanofi Appoints Specialty Care Head; Biogen Chair to Retire in June
Sanofi announced the appointment of a new head of specialty care, effective March 1, as the company prepares for the transition to CEO Belén Garijo. The new executive will oversee oncology, immunology and rare‑disease portfolios, aiming to accelerate pipeline launches....
Grail's Cancer Test Misses Primary Study Goal in UK Study
Grail announced that its Galleri multi‑cancer blood test failed to achieve the primary endpoint in a large United Kingdom clinical trial. The study, which evaluated the test’s ability to detect early‑stage cancers across dozens of tumor types, showed promising signals...
AbbVie, PhRMA Can Proceed with 340B Case in Hawaii
A federal judge has ruled that AbbVie and the Pharmaceutical Research and Manufacturers of America (PhRMA) may move forward with most of their claims challenging Hawaii's 340B law. The state statute limits how discounted 340B drugs are distributed, and the...
Teva Beats Corcept in Appeals Fight over Generic Cushing's Syndrome Drug
Teva Pharmaceutical secured a legal victory as the U.S. Court of Appeals for the Federal Circuit ruled that its generic version of a Cushing’s syndrome treatment does not infringe Corcept Therapeutics’ patents. The decision clears the path for Teva to...
Obesity Biotech Verdiva Plans Big Year of Data, Explores Deals
Verdiva Bio, an obesity‑focused biotech, is gearing up for a data‑heavy 2026, with Phase 2 results for its lead long‑acting peptide slated for the third quarter. The company is also courting strategic partnerships, eyeing potential deals with major pharma players after...
Biogen Stops Part of an MS Trial; Merck Reports More Enflonsia Data
Biogen announced it is halting the combination‑therapy arm of its multiple sclerosis (MS) trial after interim data showed insufficient efficacy and safety concerns. The decision pauses enrollment in the experimental regimen while the company continues evaluating its monotherapy components. Meanwhile,...
Altesa Raises $75M for Oral Respiratory Med
