Monday: FDA wins, deal tape pops

Upfront Briefing

Tape Action

Instrument Last close 1D % YTD % S&P 500 6,834.5 0.9% 16.2% Nasdaq 100 25,346.2 1.3% 20.6% Russell 2000 2,529.4 0.9% 13.4% XBI 123.4 2.8% 37.1% Nasdaq Biotech Index 5,738.0 2.4% 33.1% BioShares Biotechnology 39.5 2.3% 64.8%

• Biotech led the risk-on tape: XBI (+2.8%) outpaced the S&P 500 (+0.9%).
• One-day standout was XBI (+2.8%), edging the Nasdaq Biotech Index (+2.4%).
• Market data: U.S. close Fri 19 Dec 2025.

The Big 3

1 FDA approves Cytokinetics' heart drug Myqorzo Cytokinetics has received FDA approval for Myqorzo, its first drug, setting the stage for competition with Bristol Myers Squibb in the hypertrophic cardiomyopathy market. Why it matters: Cytokinetics just flipped from “pipeline story” to commercial story—and it’s entering oHCM with a differentiated profile vs BMS’s Camzyos, making label + monitoring burden the first real battleground, not efficacy hype. Source: BioPharma Dive More: Endpoints; STAT; BioSpace

2 BioMarin acquires Amicus Therapeutics for $4.8 billion BioMarin has announced its largest acquisition to date, purchasing Amicus Therapeutics for $4.8 billion to expand its rare disease portfolio with new therapies and a late-stage asset. Why it matters: This is BioMarin’s biggest swing yet: it adds two marketed rare-disease franchises (Fabry + Pompe) plus a late-stage/clinical asset angle, and it’s sized to matter—financed with cash + new debt and aimed at near-term revenue lift (with a Q2 2026 expected close). Source: BioPharma Dive More: BioCentury; STAT; Endpoints

3 White House announces new drug pricing agreements The White House has finalized its largest set of drug pricing agreements to date, impacting several major pharmaceutical companies and aiming to reduce medicine costs. Why it matters: Nine new MFN-style agreements expand the footprint of U.S. price-setting pressure—raising policy overhang across big pharma portfolios and increasing the odds that “one-off” pricing deals become a repeatable template investors have to model. Source: STAT More: PR; PR; Endpoints

Everything Else that broke

• Alvotech launched Gobivaz, billed as the first global biosimilar to Simponi, in Europe. — PR
• FDA granted accelerated approval to Roche’s Lunsumio VELO for subcutaneous use in relapsed/refractory follicular lymphoma. — PR
• AstraZeneca’s ceralasertib missed its primary endpoint in a Phase 3 lung cancer study. — Fierce Biotech
• Merck and Daiichi Sankyo’s ADC trial was put on partial clinical hold after patient deaths. — BioPharma Dive
• Galapagos’ TYK2 program hit in dermatomyositis but missed in lupus, putting its path forward back under the microscope. — Endpoints
• Insmed’s Brinsupri failed a mid-stage rhinosinusitis study, blamed on a strong placebo response. — BioCentury
• Takeda’s zasocitinib posted positive Phase III plaque psoriasis data, teeing up competition with BMS’s Sotyktu. — BioSpace
• Catalent’s gene therapy manufacturing sites received FDA Form 483s, including a facility tied to Sarepta’s Elevidys. — Endpoints
• AstraZeneca said it will pull Andexxa after the FDA flagged concerns about the product’s risk-benefit profile. — Fierce Pharma
• European Commission approved TREMFYA for pediatric plaque psoriasis, described as the first IL-23 inhibitor for that population. — PR
• STAT profiled a biotech VC calling for a wave of IPOs in 2026. — STAT
• Three FDA issues to watch as Commissioner Makary works to stabilize the agency, including vaccine policy and deregulation. — STAT
• BioSpace recapped FDA policy initiatives in 2025, flagging shifts in guidances for rare diseases and vaccines, plus efficiency and reshoring pushes. — BioSpace
• Endpoints covered senators debating who blocked reauthorization of the rare pediatric priority review voucher program. — Endpoints
• A strict new U.S. vaccine approval process could slow development and access, per Labiotech. — Labiotech
• J&J’s Trufill n-BCA liquid embolic system won FDA approval for subdural hematoma treatment. — Fierce Biotech
• EMA’s executive director highlighted 2025 achievements, emphasizing innovation support and earlier development engagement. — EMA

Deal Flow

M&A / BD&L

• AstraZeneca licensed Jacobio’s clinical-stage pan-KRAS inhibitor for $100M upfront. — Fierce Biotech
• Ipsen signed an exclusive licensing agreement for Simcere Zaiming’s ADC, SIM0613. — PR
• Aditum Bio partnered with Fosun in a collaboration that includes forming a new company. — Endpoints
• Samsung Biologics to buy GSK’s Rockville, Maryland drug substance facility for $280M (its first U.S. manufacturing site); deal expected to close by end of Q1 2026. — Reuters

VC / Private Financings

• No notable VC / Private Financings since the last edition.

IPOs / Follow-Ons

• IN8bio priced a private placement of up to $40.2M to advance a gamma-delta T cell engager program. — PR