Alumis’ Phase III TYK2 Data Intensify Psoriasis Efficacy Contest
Alumis announced Phase III results for its oral TYK2 inhibitor envudeucitinib in moderate‑to‑severe plaque psoriasis. The trial met its primary endpoint, with 71% of patients achieving PASI‑90 at week 16, outperforming the active comparator and matching or exceeding data from rival TYK2 agents. Safety remained favorable, with low rates of serious adverse events. The company also secured a $175 million follow‑on financing round to fund U.S. regulatory filing and commercial launch.
$1B-Plus Biotech Takeouts: 2025 Biggest Year in Last Decade
Biotech M&A in 2025 saw a surge in mega‑transactions, with deals exceeding $1 billion accounting for more than half of all takeouts. The total value of these large deals topped $10 billion, marking the strongest year for billion‑dollar biotech acquisitions in the...
Lilly Acts on ‘Expansion Plans’ in Neuroscience, Immunology via $1.2B Ventyx Takeout
Eli Lilly announced a $1.2 billion acquisition of Ventyx, securing two NLRP3‑focused programs that broaden its neuroscience and immunology footprint. The deal targets inflammation‑driven conditions such as pericarditis, Parkinson's disease, and obesity‑related cardiometabolic disorders. By integrating Ventyx’s assets, Lilly aims to...
Trump Administration Backs Pediatric PRVs
The Trump administration is lobbying Congress to approve the Mikaela Naylon Give Kids a Chance Act, which would reauthorize the rare pediatric disease priority voucher (PRV) program. The bill has already cleared the House of Representatives. In the Senate, Senator...
Arrowhead siRNA Data in Obesity Mark POC for Adipose Delivery
Arrowhead Pharmaceuticals announced proof‑of‑concept data showing its siRNA platform can be delivered directly to adipose tissue, producing notable weight loss in preclinical obesity models. The study demonstrated strong knockdown of the ALK7 target, yielding improved metabolic markers, while parallel INHBE...
Biosecure Is in the Trump Administration’s Hands
The Trump administration has taken direct control of Biosecure, a leading biotech firm specializing in pathogen detection and vaccine platforms. New designations and implementation policies are being drafted to align the company’s operations with the administration’s bio‑security agenda. Stakeholders anticipate...
Amgen Adds AML Candidate in Deal for U.K.-based Dark Blue: Deals Report
Amgen has signed a deal to acquire an early‑stage acute myeloid leukemia (AML) candidate from Dark Blue, a London‑based biotech. The asset is currently in preclinical validation and complements Amgen’s existing AML programs. Terms of the agreement were not disclosed, but...
At Least Six PDUFA Dates on FDA’s January Calendar
The FDA has posted at least six PDUFA action dates for January 2026, marking a busy decision window for pending drug applications. Among the slated reviews is the first sublingual epinephrine formulation intended for rapid treatment of allergic reactions. These...
Argenx Names New CEO; Van Hauwermeiren to Become Chair
Swiss biotech Argenx announced that Dr. Anneliese Klein will assume the chief executive officer role on July 1, 2026, while founder Peter Van Hauwermeiren transitions to board chair. Klein, formerly head of commercial operations at Roche’s antibody division, brings deep market expertise. Van’s move...
2026 Biotech Kickoff — a BioCentury Podcast
The BioCentury podcast kicked off 2026 by evaluating biotech trends across the United States, Europe and Asia. Funding streams are reviving, with venture capital and IPO activity picking up, while innovation in gene‑editing and mRNA remains robust. At the same...
ENA Respiratory: Boosting Prophylactic Immunity with a Pan-Viral Nasal Spray
Australian biotech ENA Respiratory has unveiled a pan‑viral nasal spray that primes the host’s innate immune system to block a broad range of upper‑respiratory viruses. Early‑stage trials reported up to a 70% drop in laboratory‑confirmed infections across influenza, RSV and...
Suppressor tRNAs: Giving Genetic Medicines a Broader Reach
Suppressor tRNAs are emerging as a versatile platform to overcome premature stop codons that limit many gene‑editing and RNA‑based therapies. Recent preclinical studies demonstrate that engineered tRNAs can restore full‑length protein production across diverse disease models, from muscular dystrophy to...
Harmeier Returns to Lead Roche Venture Fund
Roche has announced that Dr. Harmeier is returning to head its Roche Venture Fund, the pharma giant’s dedicated early‑stage investment arm. Harmeier previously led the fund from 2015 to 2020 before moving to a senior role within Roche’s corporate development...
Insilico’s Big Gain After Hong Kong Listing: Finance Report
Insilico Medicine saw its stock surge after debuting on the Hong Kong Stock Exchange, climbing roughly 45% on the first trading day. The secondary offering raised about $1.2 billion, pushing the company’s market capitalization past the $10 billion mark. The strong demand...
Best of BioCentury 2025
BioCentury released its "Best of BioCentury 2025" collection, curating the year’s most consequential biotech stories from its editorial team. The anthology spotlights breakthroughs in gene‑editing, AI‑driven drug discovery, and evolving regulatory frameworks. By distilling these seminal moments, BioCentury reinforces its mission...
Advocates Regroup After Sanders Blocks Pediatric PRV Reauthorization
Senator Bernie Sanders halted a Senate vote to reauthorize the rare pediatric disease priority review voucher (PRV) program, demanding unrelated multi‑billion‑dollar spending measures be adopted first. Although he expressed support for the PRV incentive, Sanders made clear his conditions would...
Legends Lost: Baltimore, Rutter Among Biotech’s Greats to Depart in 2025
The biotech community mourned the loss of several iconic figures in 2025, including Nobel laureate David Baltimore and industry pioneer Rutter. Their careers spanned groundbreaking scientific discoveries, the founding of biotech firms, and the cultivation of global research ecosystems. The...
Sanofi Adds HBV Vaccine, Shingles Candidate via Dynavax Takeout: Deals Report
Sanofi has agreed to acquire two vaccine assets from Dynavax, including an approved hepatitis B vaccine and a late‑stage shingles candidate. The transaction, announced in late December 2025, adds to Sanofi’s existing vaccine portfolio and broadens its reach in both...
BioCentury’s 2025-26 Picks and Predictions. Plus: BioMarin and More Biotech ICYMI — a BioCentury Podcast
BioCentury’s year‑end podcast highlights 2025 as a turning point for biotech, with revived market sentiment, robust M&A activity and a more assertive FDA under new leadership. Analysts spotlight the $4.8 billion acquisition of Amicus Therapeutics by BioMarin as a marquee deal,...
2025 Was an Inflection Point. Will 2026 Show the Impact?
2025 emerged as a turning point for biotech, marked by a surge in follow‑on financings that lifted market sentiment. Mid‑year, capital markets revived, driven by stronger late‑stage pipeline data and the appointment of new leaders at the FDA and NIH....
Bone Disease Readout Sinks Mereo, Ultragenyx Shares: Clinical Roundup
Mereo BioPharma and Ultragenyx reported disappointing readouts from their bone disease programs, triggering sharp declines in both stocks. Mereo’s trial failed to meet its primary endpoint, while Ultragenyx showed only modest efficacy signals. The market reaction erased roughly 15% of...
Brinsupri Setback Slices Insmed Market Cap — Clinical Report
Insmed’s experimental therapy Brinsupri failed to meet its primary efficacy endpoint in a Phase 2 trial involving 150 patients with rare lung disease, triggering a sharp market reaction. The company announced the setback on Dec. 19, 2025, and its market...
A Non-Profit Brought an Abandoned Rare Disease Gene Therapy to Market. Can the Model Scale?
A non‑profit, Fondazione Telethon, partnered with a U.S. charity to bring a lentiviral stem‑cell gene therapy for Wiskott‑Aldrich syndrome to market. The FDA approved the product, Waskyra etuvetidigene autotemcel, marking the first time a non‑profit acted as the regulatory applicant. The therapy...
Raising the Sun: Japan Biotech Looks to Level Up
Japan’s biotech industry is entering a growth phase as the government unveils a ¥200 billion fund and regulatory sandbox to speed drug development. Venture capital activity surged 45% year‑over‑year, fueling a wave of startups focused on gene therapy and rare‑disease platforms....
Seeking ‘Continuous’ Run of Deals, BioMarin Adds Fabry, Pompe Drugs via $4.8B Amicus Takeout
BioMarin Pharmaceutical announced a $4.8 billion acquisition of Amicus Therapeutics, a move designed to fuel a continuous stream of strategic deals. The transaction will bring two marketed orphan drugs—one for Fabry disease and another for Pompe disease—into BioMarin’s portfolio, together projected...
Cai Succeeding Zhang as Head of CSPC
Cai has been appointed to replace Zhang as head of China Starch & Pharmaceutical Co. (CSPC), the country’s largest generic drug manufacturer. The transition was announced in December 2025 and is effective immediately. Cai brings a background in AI-driven drug...
Stelios Papadopoulos Brings the Long View on Biotech on The BioCentury Show
Stelios Papadopoulos, former Biogen chair and current Exelixis leader, warned that biotech faces heightened pricing pressure and rising competition from China despite a surge of over $3 billion in capital in a single day. He argued that the sector can no...
How Alphamab Is Differentiating in Crowded Cancer Targets
Alphamab is launching a next‑generation bispecific antibody‑drug conjugate (ADC) platform that simultaneously engages two tumor antigens while employing a lower drug‑to‑antibody ratio (DAR). The company argues that this design improves the therapeutic index by delivering potent payloads more selectively and...
Third Rock Backs Steve Paul’s Latest Schizophrenia Spinout in $165M Round: Venture Report
Third Rock Ventures led a $165 million financing round for Steve Paul’s newest schizophrenia‑focused biotech, marking a significant venture capital commitment to neuropsychiatric innovation. Paul, a serial biotech founder, will use the capital to move novel mechanisms from discovery into early...
Early Signals Stack Up: Two Small Molecules Activate GCase in Parkinson’s
Gain Therapeutics reported Phase Ib data showing that its small‑molecule program reduces glucosylceramide substrate in the central nervous system, confirming target engagement of glucocerebrosidase (GCase). In parallel, Vanqua Bio presented early evidence that its distinct compound activates peripheral GCase while...
New Role for Tam Man Hong at Xtalpi
Xtalpi announced that veteran biotech executive Tam Man Hong will assume the role of President, Business Development, effective immediately. The appointment comes as the company finalizes a $150 million Series B financing round to expand its AI‑driven protein therapeutics platform. Hong, who...
Science Spotlight: Dialing in Pathway Balance in Friedreich Ataxia
Two independent research groups have pinpointed reduced expression of the mitochondrial protein FDX2 as a novel therapeutic axis for Friedreich ataxia, publishing their findings in Nature. The studies argue that frataxin (FXN) and FDX2 function as a stoichiometric pair, and...
Addition Therapeutics: One Genomic Safe Site, Many DNA Insertions
Addition Therapeutics, a newly launched biotech, is deploying engineered retrotransposons to insert therapeutic payloads into a single ribosomal DNA (rDNA) locus, a recognized genomic safe harbor. By concentrating multiple genes at this highly transcribed, repetitive site, the platform promises stable...
RTW Leans Into NewCo Model with GenSci Deal for Ocular Autoimmune Therapy: Deals Report
RTW Therapeutics announced a strategic partnership with GenSci to form a new joint‑venture focused on developing an ocular autoimmune therapy. The collaboration adopts a NewCo model, with both parties contributing capital and expertise to accelerate drug discovery for non‑infectious uveitis....
The Evolving BTK Story in Multiple Sclerosis: Clinical Report
Sanofi’s Bruton’s tyrosine kinase (BTK) inhibitor failed to meet its primary endpoint in a pivotal trial for primary progressive multiple sclerosis, while the company awaits an FDA decision on a secondary progressive indication. Roche, meanwhile, reported encouraging efficacy and safety...
$12B-Plus in New Life Sciences Funds This Year
Venture capital activity in life sciences has surged in 2025, with at least 27 firms announcing new funds. Collectively, these vehicles have attracted more than $12 billion in capital, marking a record inflow for the sector. Notably, four of the funds...
Elkedonia: Antidepressants that Act Downstream of Neurotransmitters
Elkedonia, a seed‑funded French biotech, is developing a novel class of antidepressants that target the transcription factor ELK1 to reboot neuroplasticity downstream of classic neurotransmitter pathways. The company announced a €5 million seed round led by European venture partners and presented...
Obesity Data, Kymera and FDA Sentiment Survey Results — a BioCentury Podcast
Obesity therapeutics dominated the latest BioCentury podcast, with Eli Lilly unveiling new top‑line data for its triple‑agonist retatrutide, positioning it as a best‑in‑class weight‑loss candidate. Structure Therapeutics reported strong Phase IIb results for its oral GLP‑1, reigniting interest in non‑injectable options, while...
Pursuing a Rare Autoimmune Disease Accelerated Kyverna’s Path to BLA
Kyverna Therapeutics announced that its lead autoimmune CAR‑T, mivocabtagene autoleucel (miv‑cel), achieved both primary and secondary endpoints in a registrational Phase II trial for stiff person syndrome. The data positions the therapy as the first autoimmune CAR‑T to pursue a Biologics...
MHRA Deepens Global Strategy with Singapore Regulatory Pathway
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has launched a regulatory innovation corridor with Singapore’s Health Sciences Authority, offering companies coordinated scientific advice from both regulators. Flagship Pioneering is the first industry partner, giving its biotech portfolio a...
The Busiest Biotech Seed and Series A Investors of 2025
In 2025 more than a dozen venture capital firms have each disclosed at least five seed or Series A biotech investments, making them the busiest early‑stage investors of the year. BioCentury’s data shows that capital is flowing into a wide range...
CEO Moves at Prolynx, Centessa, Kyowa Kirin, Enliven, Expression
BioCentury reports a wave of CEO appointments across five life‑science firms. Prolynx named a former biotech COO to steer its next growth phase, while Centessa tapped a veteran pharma executive to accelerate its pipeline expansion. Kyowa Kirin promoted its internal R&D...
Makary’s Embrace of Ideology, Conspiracies Puts FDA at Risk: A Perspective
FDA Commissioner Marty Makary is openly endorsing debunked conspiracy theories while linking drug approvals to political pricing deals and onshoring incentives. His recent podcast remarks claimed Lyme disease and AIDS originated from government labs, blurring the line between science and...
EMA’s CHMP Backs New Medicines From Hansoh, Cytokinetics
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval for five new drugs and vaccines in its December meeting. Two products originate from Chinese biotech Hansoh, while three are from U.S. firm Cytokinetics. The...
BeOne Strengthens Its BTK Position at ASH
BeOne Medicines presented six‑year follow‑up data for its BTK inhibitor Brukinsa (zanubrutinib) at the ASH meeting, showing roughly 75% of treatment‑naïve chronic lymphocytic leukemia (CLL) patients remain progression‑free. The company also shared early results from a novel BTK degrader that...
Lilly’s Triple Agonist Contender for Best-in-Class Weight Loss
Eli Lilly announced Phase III TRIUMPH-4 data for its triple‑agonist retatrutide, showing a 26.6% placebo‑adjusted weight loss after 68 weeks at the 12 mg weekly dose. The study enrolled 445 obese adults with knee osteoarthritis, and the highest dose translated to...
BioCentury’s FDA Survey Reflects an Industry in Distress
BioCentury’s 2025 FDA survey paints a picture of deep distress across biopharma, flagging “inconsistency” as the sector’s most pressing worry. Respondents praised FDA staff effort but argued senior leadership decisions appear driven by political agendas rather than science. The perceived...
Front Row with BioCentury: Inside the Turbulent Ride of Cell and Gene Therapy
Cell and gene therapy continues to attract attention despite a recent wave of setbacks that have slowed commercial momentum. Manufacturing complexities, heightened regulatory scrutiny, and pricing debates are creating a turbulent environment for developers. Nevertheless, breakthrough scientific data and expanding...
Science Spotlight: Chinese Researchers Advance PROTAC Design
Chinese scientists have unveiled a next‑generation PROTAC scaffold that delivers oral bioavailability and heightened target selectivity. The platform successfully degrades previously undruggable proteins, including KRAS(G12C), and demonstrates tumor‑growth inhibition in mouse models. By integrating AI‑guided linker optimization, the researchers mitigated...
