IONS, MRK Lead FDA Approvals; ACHV Gets CRL; ADCT Cuts Jobs; TECH Acquired

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Summary · why it matters

This week brought a mix of FDA and EU approvals, layoffs, acquisitions, and clinical trial updates across the biotech sector. Ionis Pharmaceuticals secured FDA approval for TRYNGOLZA as an adjunct therapy for severe hypertriglyceridemia, while Merck received European Commission approval for Keytruda in combination with Padcev as a neoadjuvant treatment for muscle-invasive bladder cancer. Gilead's Trodelvy was cleared by the FDA for first-line metastatic triple-negative breast cancer, and Pfizer's IBRANCE won expanded approval for HR+/HER2+ metastatic breast cancer. Natera gained Japanese approval for its Signatera MRD test in colorectal cancer, and AbbVie's MAVIRET was approved in the EU for both acute and chronic Hepatitis C. Achieve Life Sciences received an FDA Complete Response Letter for its Cytisinicline NDA due to manufacturing deficiencies, though no efficacy or safety issues were raised. ADC Therapeutics announced a 17% workforce reduction as part of a strategic reorganization to focus on its ZYNLONTA lymphoma franchise. In dealmaking, Merck KGaA agreed to acquire Bio-Techne for $73 per share in cash, representing an enterprise value of $11.3 billion, while Ionis inked a licensing deal with Recordati for Zilganersen, an investigational therapy for Alexander disease. Passage Bio and Remix Therapeutics entered an all-stock merger agreement, and Boundless Bio and Serapha Bio also announced an all-stock merger. On the clinical front, IMUNON's Phase 3 OVATION 3 trial passed a safety review, Takeda's Zasocitinib showed superiority over Deucravacitinib in a Phase 3 psoriasis study, and Eledon reported positive long-term kidney transplant data for Tegoprubart. However, Pfizer's Sigvotatug vedotin missed its primary overall survival endpoint in a Phase 3 non-small cell lung cancer study, and MapLight's ML-004 failed to meet its primary endpoint in autism spectrum disorder, though it showed an irritability signal in adolescents. Definium Therapeutics reported positive Phase 3 results for DT120 ODT in major depressive disorder.

Impact on stocks 18

Biotech & Genomic Medicine± Mixed · 15 stocks
ADC Therapeutics SA
ADCT
▼ NegativeCapitalrelevance

Announced 17% workforce reduction as part of strategic reorganization.

Bio-Techne Corp
TECH
▲ PositiveCapitalrelevance

Merck KGaA agreed to acquire Bio-Techne for $73/share in cash, representing a premium.

Gilead Sciences Inc
GILD
▲ PositiveRegulationrelevance

FDA approval for Trodelvy in first-line metastatic triple-negative breast cancer.

Merck & Company Inc
MRK
▲ PositiveRegulationrelevance

European Commission approval for Keytruda combination in bladder cancer.

Imunon Inc
IMNN
▲ PositiveRegulationrelevance

Phase 3 OVATION 3 trial passed safety review.

Natera Inc
NTRA
▲ PositiveRegulationrelevance

Japanese approval for Signatera MRD test in colorectal cancer.

Pfizer Inc
PFE
▼ NegativeTechnologyrelevance

Pfizer's Sigvotatug vedotin missed primary overall survival endpoint in Phase 3 NSCLC trial.

Recordati
0KBS
▲ PositiveDemandrelevance

Recordati licensed Zilganersen from Ionis for Alexander disease, expanding pipeline.

AbbVie Inc
ABBV
▲ PositiveRegulationrelevance

AbbVie's MAVIRET approved in EU for Hepatitis C.

Passage Bio Inc
PASG
± MixedCapitalrelevance

Passage Bio announced an all-stock merger with Remix Therapeutics; impact unclear until details emerge.

Health Care▼ · 1 stocks
Critical Materials & Supply Chain▲ · 1 stocks
Merck KGaA
MRK
▲ PositiveCapitalrelevance

Merck KGaA agreed to acquire Bio-Techne for $11.3B enterprise value, a strategic acquisition.

Psychedelic Medicine▲ · 1 stocks

Off-coverage companies 2

Remix TherapeuticsPrivate± Mixed
Capitalrelevance

Remix Therapeutics entered an all-stock merger agreement with Passage Bio.

Serapha BioPrivate± Mixed
relevance

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