JPM26: KalVista’s HAE Win Is a ‘Tale of Two Markets’
KalVista secured FDA approval for its oral on‑demand hereditary angioedema drug Ekterly after a delayed PDUFA review and reported political pressure. The pill is positioned as the only oral option in a market dominated by injectable therapies, targeting the $3.8‑6.5 billion global HAE space. CEO Benjamin Palleiko highlighted ongoing business‑development deals and a push into pediatric indications. KalVista sees Ekterly as a “better mousetrap” that could shift treatment habits from injections to tablets.
Roche Raises NC Manufacturing Investment to $2B To Support Obesity Challenge
Roche, through Genentech, is boosting its North Carolina manufacturing commitment from $700 million to roughly $2 billion to expand a 700,000‑square‑foot facility in Holly Springs. The plant, slated to be operational by 2029, will add about 100 jobs, bringing total staffing to over...
GSK Joins Growing PD-1 SubQ Push With Alteogen Alliance Worth up to $285M+
GSK has committed $20 million upfront and up to $265 million in milestones to partner with South Korea’s Alteogen, aiming to create a subcutaneous version of its PD‑1 cancer drug Jemperli. Alteogen will supply its Hybrozyme recombinant hyaluronidase (ALT‑B4) to enable under‑skin...
JPM26 Recap, Novo’s Oral Wegovy Soars as Lilly’s Orforglipron Is Delayed, IPOs Return
At the JPMorgan Healthcare Conference, Novo Nordisk’s oral Wegovy quickly reached roughly 3,100 patients within its first week, underscoring strong demand for oral obesity therapies. Eli Lilly’s competing oral candidate, orforglipron, saw its FDA decision pushed back to April 10, despite...
Going With the Flow: Finding Success in Academic and Biotech Research Cultures
The piece contrasts academic and biotech research cultures, highlighting how each handles uncertainty. Academic labs prioritize deep exploration and iterative validation, treating ambiguous results as opportunities for further inquiry. Biotech startups focus on data that can drive decisions quickly, balancing...
Pfizer Makes $530M Vaccine Play With Novavax Deal After Rumors of BioNTech Pullback
Pfizer has committed $30 million upfront and up to $500 million in milestone payments to partner with Novavax, gaining a non‑exclusive license to the Matrix‑M adjuvant technology. The agreement allows Pfizer to apply the adjuvant to up to two disease areas, though...
Moderna, Merck Show Long-Term Survival For mRNA-Keytruda Combo
Moderna and Merck reported that their mRNA neoantigen vaccine intismeran autogene combined with Keytruda cut the risk of melanoma recurrence or death by 49% at the five‑year mark, matching the three‑year result. The data come from the Phase IIb KEYNOTE‑942 trial...
JPM26: Galapagos' New CEO Is Here to Finally Turn The Ship Around
Galapagos appointed Henry Gosebruch as CEO, inheriting a €3 billion cash war chest and a mandate to reset the biotech’s direction after a series of clinical setbacks and a failed cell‑therapy push. Gosebruch has halted the cell‑therapy program and is reassessing...
Bonus Episode: Q3 2025 Job Market Update
BioSpace released a bonus podcast episode featuring Vice President of Marketing Chantal Dresner and Careers Editor Angela Gabriel, reviewing Q4 2025 job‑market performance in the life‑sciences sector. The hosts highlighted a modest hiring uptick, rising salaries, and stronger diversity hiring,...
2026 IPO Train Keeps Chugging as AgomAb, SpyGlass Eye Nasdaq Debut
California‑based SpyGlass Pharma and New York‑based AgomAb Therapeutics filed IPOs this week, targeting Nasdaq listings under the symbols SGP and AGMB respectively. SpyGlass’s lead candidate is a Phase III bimatoprost‑eluting intraocular lens aimed at treating ocular hypertension and open‑angle glaucoma, with enrollment...
AbbVie, Genmab’s Bispecific Misses Key Overall Survival Endpoint in Phase III Lymphoma Study
AbbVie and Genmab reported that their bispecific antibody Epkinly failed to achieve a statistically significant overall survival benefit in the Phase III EPCORE DLBCL‑1 trial, showing only a 4% OS gain versus standard chemotherapy. The study, which enrolled 483 relapsed/refractory DLBCL patients...
LOTTE Biologics Tightens Global Quality as Syracuse ADC Hub Ramps for 2026
LOTTE Biologics is ramping its Syracuse ADC hub for 2026 while extending a unified global quality culture across its organization. The company emphasizes a proactive contamination‑control strategy that relies on closed, functionally closed and single‑use systems, validated cleaning, and rigorous...
Report: U.S. Life Sciences Job Market Report Q4 2025
BioSpace’s Q4 2025 U.S. Life Sciences Job Market Report shows early signs that biopharma hiring is stabilizing after a turbulent period. Job postings increased modestly, while layoffs slowed markedly, and hiring sentiment edged higher heading into 2026. The report highlights...
After the JPM Hype, a Reality Check: Why Your 2026 Strategy Hinges on Your Manufacturing Toolkit
After the J.P. Morgan Healthcare Conference, biotech firms face a reality check: manufacturing, not just discovery, will determine whether 2026 promises are fulfilled. The article argues that flexible CDMO toolkits, combining legacy platforms like AGC Biologics’ CHEF1 with high‑speed systems...
Vedanta ‘Significantly’ Reduces Staff, Focuses on Phase III Study of C. Diff Drug
Vedanta Biosciences announced a major headcount reduction, cutting roughly half of its workforce to preserve cash for a Phase III trial of its oral C. difficile candidate VE303. The layoffs follow earlier cuts after a failed Phase II study of VE202 and reflect...
JPM26: Protagonist Has a $400M Decision To Make. It’s a No-Brainer
Protagonist Therapeutics faces a pivotal choice on its rusfertide partnership with Takeda. The company is leaning toward opting out of the 50‑50 co‑development deal, which would trigger a $400 million opt‑out payment and tiered royalties up to 29% on sales exceeding...
JPM26: Deal Hungry Novo Moves With ‘Intention’ To Put Metsera in the Rearview
Novo Nordisk is revamping its business‑development approach under new CEO Mike Maziar Doustdar, emphasizing intentional M&A and licensing to accelerate its obesity and diabetes pipeline. The company recently closed a $5.2 billion acquisition of Akero Therapeutics and secured a China partnership...
Former Emergent CEO Hit With Insider Trading Lawsuit
The New York Attorney General sued former Emergent BioSolutions CEO Robert Kramer for alleged insider trading, claiming he sold stock based on nonpublic knowledge of vaccine contamination. Kramer reportedly profited over $10.1 million from trades executed between November 2020 and early 2021....
JPM26: Korro Bio Looks To Save Itself Despite Unenviable Position
Korro Bio’s lead RNA‑editing candidate KRRO‑110 failed its Phase I/IIa trial for alpha‑1 antitrypsin deficiency, prompting an 80% stock plunge and a one‑third staff layoff. A root‑cause analysis revealed the lipid nanoparticle delivery vehicle achieved only about 25% of the...
FDA Delays Decision for Lilly’s Obesity Pill Orforglipron, Other Priority Voucher Awardees: Report
The FDA announced it will postpone its action date for Eli Lilly’s oral obesity drug orforglipron to April 10, 2026, extending the review timeline for the medication. The agency also delayed decisions for three other Commissioner’s National Priority Voucher recipients—Sanofi’s Tzield, Disc Medicine’s...
Compounder Sues Lilly, Novo, Claims Coordinated Crackdown
Arizona‑based Strive Compounding Pharmacy has filed an antitrust lawsuit in Texas against Eli Lilly and Novo Nordisk, accusing the two giants of coordinating with telehealth firms to block compounders from filling GLP‑1 prescriptions. The complaint alleges that the pharma companies restrict payment...
Jazz Sells Priority Review Voucher for $200M as Program’s Renewal Languishes in Senate
Jazz Pharmaceuticals sold a priority review voucher for $200 million, the highest price in nearly a decade, during its J.P. Morgan Healthcare Conference presentation. The voucher stemmed from the FDA’s August 2025 approval of Modeyso, a rare‑brain‑tumor drug acquired through Chimerix. While...
JPM Day 3: Rare Disease in the Spotlight
Rare‑disease therapeutics dominated day three of J.P. Morgan Healthcare, with five companies outlining 2026 roadmaps. Rocket Pharmaceuticals announced it will resume dosing three Danon disease patients in the first half of 2026 after an FDA hold, while also awaiting a...
JPM26: As Capital Concentrates, VCs Scrutinize Founder Pedigree and CEO Fit in Early Biotech
At the J.P. Morgan Healthcare Conference, venture capitalists highlighted a tightening funding environment for early‑stage biotech firms, driven by a hyper‑concentration of capital among a few investors. VCs now scrutinize founder and CEO attributes, emphasizing regulatory know‑how, market insight, and...
11 Companies Hiring Manufacturing Professionals Now
Big Pharma is accelerating domestic manufacturing hiring as 2026 begins, highlighted by Johnson & Johnson’s plan to add 500 jobs at a new North Carolina plant and AbbVie’s $100 billion ten‑year commitment to U.S. R&D and capital projects. The surge creates...
JPM26: Sanofi’s CEO Keen To Buy the Dip as Vaccine Rhetoric Impacts Short-Term Sales
Sanofi’s CEO Paul Hudson said the firm will acquire Dynavax for $2.2 billion, targeting its adult hepatitis B vaccine Heplisav‑B, as vaccine sentiment wanes under U.S. political rhetoric. Legacy vaccine sales fell 8 % in Q3 2025, prompting a long‑term focus on adult‑focused products...
JPM26: Gilead Captures Sunny JPM Mood With Yeztugo Numbers, HIV Vibes
Gilead’s new HIV therapy Yeztugo is gaining rapid market traction, achieving 85% payer coverage six months after its June 2025 approval and hitting the $150 million revenue target for the year. CEO Daniel O’Day highlighted voluntary licensing of the drug’s active ingredient,...
AstraZeneca’s Path to $80B by 2030 Paved With ADCs, Cell Therapies, Near-Term Product Launches
At the J.P. Morgan Healthcare Conference, AstraZeneca reaffirmed its ambition to generate $80 billion in revenue by 2030, a target now seen as attainable. The company highlighted three near‑term product launches—baxdrostat for hypertension, camizestrant for breast cancer, and gefurulimab for myasthenia...
Novartis Doesn’t Have a GLP-1. They Don’t Miss It In a World Of Me-Toos
Novartis chief strategy officer Ronny Gal told BioSpace at J.P. Morgan that the Swiss giant will not pursue a GLP‑1 acquisition, citing the high commercial risk of me‑too products. He emphasized that existing GLP‑1s such as Eli Lilly’s Zepbound and Novo Nordisk’s...
After Mortality-Marred Year, Sarepta Looks Ahead to Catalyst-Rich 2026
Sarepta Therapeutics is shifting focus from a troubled DMD gene‑therapy portfolio to a robust siRNA pipeline partnered with Arrowhead. Jefferies highlights upcoming Phase I/II data for SRP‑1001 (FSHD) and SRP‑1003 (DM1) in Q1 2026, projecting a potential 25‑50% stock move. The...
Lung Cancer Trial to Proceed After FDA Releases Hold on Merck, Daiichi’s ADC
The U.S. Food and Drug Administration has lifted the partial clinical hold on Merck and Daiichi Sankyo’s antibody‑drug conjugate ifinatamab deruxtecan (I‑DXd) in the Phase III IDeate‑Lung02 trial for relapsed small‑cell lung cancer. The companies can now resume enrollment and data...
AbbVie, Amgen, Lilly Lead Calls for FDA To Update Post-Approval Change Rules
Big‑pharma leaders including AbbVie, Amgen and Eli Lilly urged the FDA to decouple pre‑approval inspections from marketing applications and modernize its post‑approval change framework. They argue the 1990s SUPAC guidance treats all biologics as high‑risk, slowing domestic facility transfers. The coalition...
At JPM26, Experts Try To Look Past the Most Favored Nation ‘Distraction’
At JPM26, life‑science investors and policymakers dissected the Trump administration’s disruptive biotech agenda. Health Secretary Robert F. Kennedy Jr. ordered the CDC to drop several childhood‑vaccine recommendations, unsettling billion‑dollar vaccine revenues. The administration’s focus on Most Favored Nation (MFN) drug‑pricing leverage spurred a...
Moderna Hits 2025 Revenue Goal as Operating Costs Fall Faster than Forecast
Moderna announced a 2025 revenue outlook of $1.9 billion, aligning with the midpoint of its narrowed $1.6‑$2 billion range and matching Wall Street expectations. The biotech also trimmed its operating expense forecast to $5‑$5.2 billion, a $200 million reduction from the prior November guidance....
FDA Carves Out Manufacturing Exemptions for CGTs To Accelerate Development
The FDA announced new manufacturing exemptions for cell and gene therapies, allowing developers to bypass certain chemistry, manufacturing and controls (CMC) requirements as products move beyond Phase I. The agency will not enforce Chapter 600 specifications for later‑stage trials and will treat...
Flagship CEO Calls Out Attacks on Science, Warns of China Dominance
Flagship Pioneering CEO Noubar Afeyan warned that U.S. cuts to NIH, NSF, and BARDA are jeopardizing the country’s biotech “miracle machine.” He highlighted concrete examples such as the resurgence of measles and reduced vaccine recommendations, linking them to policy decisions....
To Broaden Access to CAR Ts, Mitigate Their Side Effects
The FDA has removed the Risk Evaluation and Mitigation Strategies (REMS) requirement for approved CAR‑T therapies, reflecting confidence in real‑world safety data. Yet only about 30% of eligible patients receive CAR‑T because severe toxicities—cytokine release syndrome (CRS) and immune effector...
Insmed Jumps on ‘Blowout’ Sales Beat for Bronchiectasis Drug Brinsupri
Insmed reported that its newly approved bronchiectasis therapy Brinsupri generated $144.6 million in Q4 2025 sales, nearly three times analyst forecasts. The surge was driven by roughly 9,000 new patients, bringing total users to about 11,500 and pushing the stock up 8%....
Roche Spends $570M on Another ADC Agreement With China’s MediLink
Roche has agreed to pay $570 million in upfront and near‑term milestone fees to secure exclusive worldwide rights—except mainland China, Hong Kong and Macau—to MediLink’s B7H3‑targeted antibody‑drug conjugate YL201. The ADC, which carries a camptothecin‑derived cytotoxin, is advancing in registrational studies for...
Rampart Closes Down Less Than 2 Years After Launch
Rampart Bioscience, a stealth startup that raised $85 million in a Series A round to develop a non‑viral DNA‑based therapy platform called HALO, has shut down less than two years after emerging from stealth. The company’s website and LinkedIn page have been...
InflaRx Stanches Spending With 30% Staff Reduction, Priority Pivot
InflaRx announced a restructuring that will eliminate roughly 30% of its workforce and incur about $7 million in one‑time, largely non‑cash, costs. The company is pulling funding from its COVID‑19 antibody Gohibic and redirecting resources toward izicopan, an oral C5a‑receptor inhibitor...
Tessera Trimming 90 Employees as Part of Pipeline Prioritization
A wave of workforce reductions swept the biotech sector in early 2024, with Tessera Therapeutics cutting 90 employees (about 35% of its staff) to prioritize its AATD and sickle‑cell programs after a $275 million Regeneron partnership. Similar cuts hit companies ranging...
Vanda Slides After FDA Again Rejects Hetlioz For Jet Lag
Vanda Pharmaceuticals’ sleep‑aid Hetlioz was again rejected by the FDA for a jet‑lag indication, despite the agency acknowledging positive efficacy in trials. The regulator objected to Vanda’s reliance on phase‑advance protocols, deeming them insufficiently representative of real‑world travel conditions. The...
From Nuclear Winter to Renewal: Biotech Investing for 2026
The Denatured podcast episode "From Nuclear Winter to Renewal: Biotech Investing for 2026" features Sofinnova’s Maha Katabi and Ally Bridge’s Andrew Lam discussing a shift from a prolonged funding chill to a robust M&A environment. Guests highlight that 2026 will...
Parabilis Heads Biotech Fundraising Frenzy With $305M to Advance Cancer Drug
Parabilis Medicines announced an oversubscribed $305 million Series F financing, the largest of a busy Thursday for biotech fundraises. The capital will accelerate development of its lead peptide drug zolucatetide, which disrupts the β‑catenin/TCF transcription complex in rare and solid tumors. Parabilis...
VC Funding Uptick in Back Half of 2025 Has Analysts Hopeful for 2026
Venture capital into Massachusetts biopharma fell to $6.85 billion in 2025, the lowest level since 2019, as a cautious IPO market and investor reluctance dampened the first half. Despite the slump, 60% of the year’s funding arrived in the back half,...
Lilly Bulks Up Inflammatory Pipeline With $1.2B Ventyx Buy, InduPro Cancer Pact
Eli Lilly announced a $1.2 billion cash acquisition of Ventyx Biosciences, adding two mid‑stage oral NLRP3 inhibitors and a suite of inflammatory‑bowel‑disease candidates to its pipeline. The deal, slated to close in early 2026, broadens Lilly’s portfolio beyond its obesity flagship tirzepatide....
The Top 12 Companies Hiring in Biopharma Now
BioSpace’s December hiring report shows a 10 % month‑over‑month drop in active job postings and a 16 % year‑on‑year decline versus December 2024, reflecting typical holiday‑season slowdown. A noticeable surge in postings during the first week of January signals that hiring momentum is...
Biopharmas Axed 47% More Employees Year Over Year
Biopharma layoffs surged 47% year‑over‑year in 2025, affecting roughly 42,700 employees, as capital tightening forced both early‑stage and large firms to cut staff. The wave was driven by investor pull‑back after biotech failures, prompting leaner operations and accelerated M&A activity....
Crinetics Advances Potential Neurocrine Competitor With Fresh Data and Money
Crinetics Pharmaceuticals reported Phase II data showing its ACTH‑receptor antagonist atumelnant enabled 88% of patients with congenital adrenal hyperplasia (CAH) to reach physiologic glucocorticoid doses, outperforming Neurocrine’s approved therapy Crenessity, which achieved 63% in a Phase III trial. The results prompted Crinetics...