Ovarian Cancer Data Give Corcept’s Shares a Bounce After Year-End CRL Drop
Corcept Therapeutics reported positive Phase III results for relacorilant in platinum‑resistant ovarian cancer, meeting the overall survival endpoint. The data lifted the stock after a steep decline following a complete response letter that had cut the company's market value by half at year‑end 2025. Relacorilant had previously driven the share price to an all‑time high of $117.33 in March 2025. The rebound suggests renewed investor confidence but the firm still faces challenges from the prior regulatory setback.
Corxel Draws $287M Round to Drive Global Development of Oral GLP-1
Corxel Pharmaceuticals announced a $287 million Series D‑1 financing round aimed at advancing its oral GLP‑1 therapy into late‑stage clinical trials. The capital will enable the company to move beyond its China‑only data and pursue a global development strategy. Existing backers RTW...
Astellas’ Okamura: The Bottleneck Isn’t Money — It’s Translation
Astellas CEO Naoki Okamura argues that Japan’s biotech sector is constrained more by the ability to translate scientific discoveries into market‑ready products than by a lack of capital. He outlines Astellas’ strategic focus on cell and gene therapies, a menopause...
FDA Takes Step Toward Innovation-Supporting Endpoints with MRD Negativity Guidance
The FDA released draft guidance endorsing measurable residual disease (MRD) negativity as a surrogate endpoint for accelerated approval in multiple myeloma. The guidance implements the unanimous 2024 recommendation from the Oncologic Drugs Advisory Committee. By formalizing MRD negativity, the agency...
Biotech’s Bull Is Back — and Investors Think It Can Stick
After more than four years of a biotech bear market, investors are now seeing a genuine bullish turn. Lower interest rates, clearer policy signals and strengthening fundamentals are aligning to revive capital flows. BioCentury’s survey of 15 buyside investors and...
TAC to the Future. Plus: GSK’s Rapt Deal, Codifying MFN — a BioCentury Podcast
Next‑generation targeting chimeras (TACs) are moving from research labs to early clinical programs, signaling a new wave of induced‑proximity therapeutics beyond PROTACs. GSK’s $2.2 billion acquisition of Rapt Therapeutics adds a China‑origin allergy platform to its pipeline, highlighting strategic biotech buyouts....
4Q25 Wrap: Megacaps Surge in 4Q as All Boats Rise for the Year
In the fourth quarter of 2025, biotech megacap companies—those valued at $10 billion or more—delivered a median stock price increase of 10%, adding $138.4 billion in market value. Over the full year, these megacaps posted the strongest performance, with a median gain...
Parabilis’ Path From POC to New Indications and Challenging Targets
Parabilis Medicines has secured a $305 million crossover financing round after demonstrating proof of concept for its lead candidate, zolucatetide, in desmoid tumors. The company now targets a Phase III trial while evaluating broader indications and combination‑first strategies. CEO Mathai Mammen highlighted...
Congress Advances PRV Reauthorization, NIH Funding, Multi-Cancer Detection Coverage
Congress is moving a bipartisan spending package that would reauthorize pediatric priority review vouchers, safeguard NIH funding, and extend Medicare coverage to multi‑cancer early‑detection tests. The House Appropriations Committee released a bill to fund the government through September and avoid...
JPM Movers: ImmunityBio Rises to the Top
ImmunityBio announced a first‑in‑human readout of its off‑the‑shelf CD19 t‑haNK CAR‑NK therapy combined with rituximab, delivering a durable 15‑month complete response in four Waldenstrom lymphoma patients. The data propelled the stock to $5.52, up 137% from the prior week and added...
Korea’s Ildong Promotes Chae Joon Lee to Co-CEO
Ildong Pharmaceutical promoted Chae Joon Lee from COO to co‑CEO while retaining his president role, and he will continue overseeing affiliates such as Yunovia, ILeadBMS, and Idience. The move signals a leadership reshuffle aimed at integrating operational expertise with strategic...
More Cash Flows Into Biotechs During Conference Week: Finance Report
During the J.P. Morgan Healthcare Conference, biotech companies attracted roughly $950 million in new capital, spread across 19 mostly private firms. The influx followed an early‑2026 surge of venture deals that pushed total private biotech funding to about $3 billion. Most of...
JPM Momentum and Asia’s Hotbeds of Innovation — a BioCentury Podcast
The J.P. Morgan Healthcare Conference ignited a surge of financing, the strongest in years for biotech. In a special BioCentury This Week podcast recorded at the conference, analysts and investors examined Asia’s burgeoning biotech ecosystems. Discussions covered deal pricing in China, the...
2026 U.S. Drug Pricing Outlook: ‘MFN’ Is the Future
The article forecasts that the United States will adopt a most‑favored‑nation (MFN) drug‑pricing model, tying domestic prices to international reference benchmarks. Policymakers view MFN as a tool to curb soaring prescription costs, while industry groups warn it could compress profit...
PROTAC Bottleneck Breakthroughs
The latest generation of intracellular PROTACs now offers precise spatial activation, tunable persistence, and expanded ubiquitin‑ligase recruitment, addressing the pharmacokinetic and toxicity hurdles of earlier candidates. Chinese research groups have pioneered formulations that release the degrader only within target cells...
2026 Outlook: ‘Slow-Moving Catastrophe’ at FDA
The FDA is entering a ‘slow‑moving catastrophe’ as staffing cuts, politicization, and the erosion of scientific expertise undermine its regulatory capacity. Senior leadership turnover and a hiring freeze have reduced review staff by roughly 15 percent, while political pressure accelerates...
Nabla: Using AI to ‘Auto-Complete’ Biologics Design
Nabla Bio, a Harvard spin‑out founded in 2020, is developing an AI‑driven platform that automatically completes biologics designs while preserving manufacturability. The technology, created in George Church’s lab, targets the persistent bottleneck of translating complex protein candidates into scalable therapeutics....
2026 Policy Outlook: Reaping What Was Sown in 2025
The 2026 policy outlook warns that the turbulence of 2025 is giving way to a deeper, more systemic shift in U.S. biomedical policy. Political and ideological forces are increasingly dictating drug‑pricing rules and regulatory decisions, eroding the traditional science‑based framework....
TAC to the Future: Where Induced Proximity Is Pointing in 2026
The targeting chimera (TAC) platform is shifting from early‑stage proof‑of‑concept to broader industry adoption as 2026 approaches. Companies are deploying next‑generation E3 ligases, cell‑surface degrader formats, and non‑proteolytic proximity mechanisms to expand target space beyond intracellular proteins. These advances promise...
JPM Lineup: New Roles Across Industry
Dozens of biotech firms and investors announced senior‑level moves ahead of the J.P. Morgan Healthcare Conference, with several companies naming new CEOs. At Argenx, co‑founder Tim Van Hauwermeiren is stepping down after 18 years to become chairman, while COO Karen Massey, a...
Nine-Digit Venture Rounds for Mirador, Kinaset
Mirador Therapeutics announced a $120 million Series B round, while KinaseT secured $95 million in a Series A financing. Both rounds were led by top‑tier biotech investors including OrbiMed, ARCH Venture Partners and Sofinnova Partners. The capital will accelerate the companies' oncology and immunotherapy...
JPM Day 1: Big Bucks for Bispecific
AbbVie announced a $5.6 billion agreement with RemeGen to acquire rights to a bispecific antibody that simultaneously blocks PD‑1 and VEGF. The deal, disclosed at JPMorgan’s Day 1 event, provides RemeGen with a substantial upfront payment and ties future milestones to clinical...
New Early Stage VC Apuri Seeks to Seed China’s Academic Discoveries
Apuri, a new Shanghai‑based early‑stage venture firm, is launching its debut fund to commercialize biotech breakthroughs emerging from China’s academic labs. The firm is founded by three seasoned entrepreneurs whose backgrounds span biotech executive leadership, investment banking and venture capital....
Haisco Steps Onto Global Stage with Blue Chip NewCo Deal
Haisco announced the creation of AirNexis, a new company focused on chronic obstructive pulmonary disease (COPD) therapeutics. The venture secured a $200 million financing round led by Frazier Capital, marking a blue‑chip endorsement. AirNexis will develop a COPD asset designed to...
Early Proof of Concept for Krystal’s Cystic Fibrosis Gene Therapy: Clinical Report
Krystal Therapeutics reported early proof‑of‑concept data from its first‑in‑human cystic fibrosis (CF) gene‑editing trial. The single‑dose, lipid‑nanoparticle delivery of a CFTR‑correcting mRNA achieved measurable gene expression in airway epithelial cells of six patients, with no serious adverse events. Pulmonary function...
The Split-Screen Story of 2026: A Letter From the Editor
The editor’s January note highlights a resurgence in biotech capital markets, with investors returning to the sector and financing activity picking up. At the same time, a “split‑screen” narrative emerges as the FDA undergoes structural changes, longstanding public‑health policies are...
Deals Not Waiting for JPM
Dealmakers kicked off 2026 with a flurry of announcements, bypassing the J.P. Morgan Healthcare Conference. Since Jan 5, three acquisitions and more than two dozen partnerships have been disclosed. The headline deal is Eli Lilly’s $1.2 billion purchase of Ventyx Biosciences. The activity...
Warm Welcome for Aktis Could Open up IPO Queue: Public Equity Report
Aktis Therapeutics closed a $350 million private‑placement at a 30 % premium, drawing strong participation from top biotech investors. The financing bolsters its gene‑editing pipeline and is viewed by Public Equity Report as a potential catalyst for a dormant IPO pipeline. Investment...
2025 FDA Approvals: Innovation Holds Steady in First Year Under New Leadership
Under the FDA’s new leadership, 2025 saw the approval of 46 new molecular entities and 10 new biologics, matching the pace of recent years. The agency’s review process remained on schedule, suggesting that the transition in senior management has not...
Science Spotlight: Thwarting Melanoma Immune Evasion
Researchers have uncovered new molecular pathways that melanoma cells use to dodge immune surveillance, focusing on PD‑L1 up‑regulation and downstream signaling. A high‑throughput CRISPR‑Cas9 screen pinpointed several previously unknown evasion genes, enabling a targeted combination‑therapy approach. Early‑phase trials combining checkpoint...
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...
$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....