Friday, May 15, 2026
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Policy•Fierce Biotech•May 15, 2026
Chutes & Ladders—AC Immune CEO bids adieu
background ▾
- •AC Immune co-founder and CEO Andrea Pfeifer is retiring; interim replacement by board chair Martin Zügel while permanent successor is sought
AC ImmuneBicara TherapeuticsReplimuneficerafusp alfaIFX-101IFX-201
→ Read original articlePolicy•Fierce Pharma•May 15, 2026
Eli Lilly delivers $50M boost to UNICEF’s pediatric health push
background ▾
- •Eli Lilly commits $50M over six years to UNICEF for pediatric noncommunicable disease initiatives
Eli LillyUNICEF USA
→ Read original articlePolicy•Fierce Pharma•May 15, 2026
Biopharma leaders rally behind Pazdur for FDA commissioner pick. But does he want the role?
background ▾
- •FDA Commissioner Marty Makary is stepping down, creating a leadership vacuum at a critical regulatory agency
- •Biopharma industry leaders are coalescing around Richard Pazdur as the preferred successor, signaling desire for a scientifically rigorous, experienced regulator
- •Pazdur's willingness to accept the role remains uncertain, which could reshape the trajectory of FDA leadership and drug approval policies
Policy•Fierce Pharma•May 15, 2026
FDA floats possible approach to repurpose approved drugs under new uses
background ▾
- •FDA is developing a formal framework to streamline drug repurposing by utilizing existing safety and efficacy data from prior approvals, potentially reducing time-to-market for new indications
- •The initiative could redirect development resources toward unmet medical needs while reducing clinical trial burdens and associated costs for sponsors
- •Critical details on regulatory pathway requirements, evidence standards, and eligible drug classes need further FDA guidance before industry-wide adoption
Policy•Fierce Pharma•May 15, 2026
Sun recalls US chemotherapy batch, citing glass particle contamination concerns
background ▾
- •Sun Pharma recalled a single lot of chemotherapy drug due to glass particle contamination, signaling quality control lapses in generic manufacturing
- •The recall highlights recurring particulate contamination issues across the generics industry and potential reputational/compliance risks for major manufacturers
Sun Pharma
→ Read original articleMarket Access
Market Access•Fierce Biotech•May 15, 2026
Alumis pulls back from would-be rival to Amgen’s Tepezza after assessing prospects
background ▾
- •Alumis is abandoning internal development of lonigutamab despite acquiring it for $51 million just one year ago, now seeking external partners or alternative arrangements for the asset
- •Competitive landscape shift: Amgen's successful phase 3 data for subcutaneous Tepezza and Viridian's dual phase 3 wins have eroded lonigutamab's differentiation on convenience, the original value proposition
- •Watch for: Whether Alumis successfully partners lonigutamab out-of-house, any write-down impact on company financials, and continued consolidation in the TED space as the market becomes increasingly crowded
AlumisAcelyrinAmgenlonigutamabTepezzaenvudeucitinib
→ Read original articleMarket Access•Fierce Pharma•May 15, 2026
Johnson & Johnson bladder cancer survey reveals toll of surgery, BCG treatment
background ▾
- •Survey data demonstrates significant emotional and quality-of-life burden from standard bladder cancer treatments (surgery and BCG), creating a potential market access narrative for alternative therapies
- •J&J is building a patient-centered evidence foundation ahead of likely commercial launches or label expansions for bladder cancer candidates
- •Monitor whether J&J uses this data to support reimbursement arguments, payer negotiations, or regulatory submissions for emerging bladder cancer assets
Johnson & JohnsonBCG
→ Read original articleMarket Access•Fierce Pharma•May 15, 2026
Bora snaps up MacroGenics’ manufacturing, CDMO operations for up to $127.5M
background ▾
- •Bora Group's acquisition of MacroGenics' CDMO operations signals consolidation in the outsourced manufacturing sector and expands Bora's service portfolio in North America
- •MacroGenics' divestiture of manufacturing assets allows the company to de-risk its balance sheet and concentrate resources on advancing its clinical pipeline
- •Monitor whether this transaction closes successfully and whether Bora integrates MacroGenics' manufacturing capabilities into its global CDMO network
Bora GroupMacroGenics
→ Read original articleMarket Access•Fierce Biotech•May 14, 2026
Create Medicines fashions $122M fundraise for in vivo CAR-T dreams
background ▾
- •Create has the largest clinical dataset in in vivo CAR-T (50+ patients dosed) compared to recent acquisitions like Kelonia (Eli Lilly) and Interius (Gilead) with minimal clinical data, providing a competitive advantage in validation and risk mitigation.
- •The company's mRNA-based transient cell engineering approach differs fundamentally from permanent viral-based alternatives, offering potential advantages in safety and manufacturing scalability.
- •Watch for MT-304 phase 1/2 data readout in solid tumors (HER2+ cancers) and advancement of the lead autoimmune program targeting CD19+ B cells; also monitor manufacturing scale-up success as a key differentiator versus competitors.
Create MedicinesNewpath PartnersARCH Venture PartnersMT-304
→ Read original articleMarket Access•Endpoints News•May 14, 2026
Degron, CREATE, TenNor raise capital; Cabaletta posts CAR-T data
background ▾
- •Degron Therapeutics secured $40 million Series A extension for molecular glue degrader platform, signaling sustained venture funding in the PROTAC/degrader space
Degron TherapeuticsCabaletta BioCREATE
→ Read original articleClinical Trials
Clinical Trials•Fierce Pharma•May 15, 2026
AstraZeneca scores with Imfinzi in another bladder cancer trial, rivaling Merck's Keytruda
background ▾
- •Imfinzi + Padcev demonstrated positive phase 3 efficacy in cisplatin-ineligible MIBC patients, a population lacking adequate treatment options and representing significant commercial opportunity
- •Results directly challenge Merck's Keytruda dominance in bladder cancer and could establish a dual-agent combination as standard-of-care in an understudied patient segment
- •Regulatory pathway and specific trial endpoints (progression-free survival, overall survival data maturity) should be monitored as AstraZeneca moves toward submission
AstraZenecaMerckImfinziPadcevKeytruda
→ Read original articleClinical Trials•Fierce Biotech•May 15, 2026
Aardvark to dig into phase 3 data early after FDA imposes hold
background ▾
- •FDA issued a full clinical hold on ARD-101 following cardiac QRS prolongation safety signals in healthy volunteer studies, halting the company's lead phase 3 PWS program and forcing early data unblinding
- •Aardvark now faces critical execution pressure: 68 patients dosed in phase 3, cash runway to mid-2027, and 11+ weeks already lost—unblinding is a high-risk gambit to maintain investor confidence and attract partnership/funding
- •Watch for: unblinded efficacy/safety data readout and FDA's response; whether early data supports dose optimization or program termination; and Aardvark's ability to secure financing or partnership before cash depletion
Aardvark TherapeuticsARD-101ARD-201
→ Read original articleClinical Trials•Fierce Biotech•May 14, 2026
Signant Health buys Ametris to unite data streams in clinical trials
background ▾
- •Signant Health acquired Ametris to merge eCOA and wearable-derived digital biomarkers into a single platform, reducing integration complexity for trial sponsors.
- •This is part of a broader industry consolidation trend among clinical trial technology providers, following Signant's 2023 acquisition of DSG.
- •The success of this integrated approach will depend on adoption rates among sponsors and whether combined patient-reported and objective measures actually improve regulatory decision-making and trial outcomes.
Signant HealthAmetris
→ Read original articleClinical Trials•Endpoints News•May 14, 2026
Regenxbio hits Duchenne gene therapy milestone, eyes 2027 FDA approval
background ▾
- •Regenxbio's DMD gene therapy met primary efficacy endpoint in pivotal trial, de-risking the regulatory path forward
- •FDA approval target of 2027 suggests timeline for commercial launch of a potentially transformative therapy for a monogenic disease with high unmet need
- •Watch for full data presentation at scientific conferences and regulatory interactions that will confirm feasibility of 2027 submission and approval
RegenxbioRegenxbio DMD gene therapy
→ Read original articleClinical Trials•Fierce Biotech•May 14, 2026
Biogen advances Alzheimer’s tau program despite midphase miss
background ▾
- •Primary endpoint miss on dose-response but prespecified secondary analyses showed cognitive slowdown across all diranersen doses with robust tau pathology reductions, persuading Biogen to advance to phase 3 despite unclear clinical magnitude
- •Critical data gap: companies have not yet disclosed absolute magnitude of cognitive benefit versus placebo on CDR-SB scale, which will determine whether the 0.6-point threshold (supporting 50% upside) or lower thresholds (0.4-0.5 points) are achieved
- •Watch for full dataset presentation at Alzheimer's Association International Conference in July 2024—this will be the inflection point for accurate valuation of diranersen and validate or challenge the broader tau-targeting paradigm in Alzheimer's drug development
BiogenIonis PharmaceuticalsGuggenheim SecuritiesdiranersenVY1706
→ Read original article