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  • Biotech & Pharma Updates | April 27 - 28, 2025

Biotech & Pharma Updates | April 27 - 28, 2025

Merck KGaA to acquire SpringWorks Therapeutics for $3.9bn, Novavax believes its COVID-19 vaccine application is approvable despite FDA request for postmarketing clinical trial commitment, Biohaven $600M strategic investment from Oberland Capital, HSBC downgrades Eli Lilly stock due to high valuation and competition from Novo Nordisk + 31 more stories

All the top Biotech & Pharma news in one daily newsletter.

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✅ The Good News ✅ 

THE GOOD
Approvals & Labels

Novavax believes its COVID-19 vaccine application is approvable despite FDA request for postmarketing clinical trial commitment
Vaccine, COVID-19, drug approval process - Read more

Vertex's ALYFTREK (deutivacaftor/tezacaftor/vanzacaftor) receives CHMP positive opinion to treat cystic fibrosis in patients 6+ with non-class I CFTR mutations
Small molecule, cystic fibrosis - Read more

THE GOOD
Business Development

Ferrer pays €80M upfront for European rights to Prilenia's Huntington's disease candidate (an oral S1R agonist), with total deal value upwards of €500M
Small molecule, Huntington's disease - Read more

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 More Good News 

THE GOOD
Clinical Trials

Boehringer Ingelheim's zongertinib, a tyrosine kinase inhibitor, shows durable efficacy for HER2-mutant non-small cell lung cancer in Ph1b trial
Small molecule, lung cancer - Read more

GSK's Jemperli, a checkpoint inhibitor, shows complete elimination of mismatch repair deficient rectal cancer in Ph2 trial
Monoclonal antibody, colorectal cancer - Read more

Protara Therapeutics' TARA-002 showed durable responses in Ph2 trial for non-muscle invasive bladder cancer, with strong efficacy in BCG-naïve and BCG-unresponsive patients
Cell therapy, inactivated streptococcus pyogenes cells, bladder cancer - Read more

CG Oncology's Cretostimogene Grenadenorepvec shows 75.5% complete response in Ph3 BOND-003 for high-risk non-muscle invasive bladder cancer unresponsive to BCG
Oncolytic virus, bladder cancer, adenovirus - Read more

UroGen Pharma's Ph2b study shows UGN-102 (mitomycin) achieves two-year response in patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer
Small molecule, antibiotic, bladder cancer - Read more

UroGen Pharma's Ph3 trial of UGN-102 (mitomycin) shows 80.6% duration of response at 18 months for recurrent low-grade non-muscle invasive bladder cancer.
Small molecule, antibiotic, bladder cancer - Read more

Levicept's LEVI-04, a neurotrophin-3 inhibitor, met Ph2 trial endpoints showing significant pain relief for osteoarthritis patients with good safety profile
Fusion protein, osteoarthritis - Read more

Roche's RO7589831, a Werner helicase inhibitor, shows promise in Ph1 trial for microsatellite instability-high solid tumors, including colorectal, ovarian, and endometrial cancers.
Small molecule, cancer, solid tumor - Read more

ImmVira's MVR-C5252, an oncolytic Herpes Simplex Virus targeting PD-1 and IL-12, shows promising Ph1 results for malignant glioma via convection-enhanced delivery.
Oncolytic virus, herpes simplex virus (HSV), glioma, brain cancer - Read more

YolTech's YOLT-101, a PCSK9-targeting base editing therapy, showed 50% LDL-C reduction in familial hypercholesterolemia patients in clinical trial.
Gene-editing, base-editing, in-vivo gene-editing therapy, hypercortisolemia, lipid nanoparticle (LNP) - Read more

Senti Biosciences' SENTI-202, an off-the-shelf Logic Gated CD33/FLT3/EMCN CAR-NK therapy, shows promising Ph1 results for relapsed/refractory acute myeloid leukemia
Cell therapy, CAR-NK (natural killer) cell, myeloid leukemia - Read more

MD Anderson researchers found LUT014, a topical BRAF inhibitor gel, reduced severity of EGFR inhibitor-induced skin rash in colorectal cancer patients during Ph2 trial
Small molecule, EGFR inhibitor side effect reduction, topical - Read more

National Cancer Institute study confirms single-dose HPV vaccine is effective against cervical, anal, penile, and head-and-neck cancers
Vaccine, human papillomavirus (HPV) infection - Read more [Paywall]

THE GOOD
Company Launches

Axiom launches with $15M to build AI models predicting drug toxicity, aiming to replace animal testing
Non-animal models, AI - Read more

THE GOOD
Earnings & Finances

WuXi AppTec reports 21% revenue growth in early 2025, rebounding from pressures caused by the proposed Biosecure Act
CDMO (Contract Development & Manufacturing Organization), BIOSECURE Act - Read more

THE GOOD
Fundraises

Biohaven $600M strategic investment from Oberland Capital, advancing clinical trials and potential commercialization of troriluzole for spinocerebellar ataxia
Small molecule, spinocerebellar ataxia - Read more

Cycuria Therapeutics receives undisclosed public grant to expand operations, developing targeted therapies for AML.
Protein, cancer, myeloid leukemia - Read more

Craif $22M Series C, developing AI-powered miRNA early cancer detection software for U.S. expansion.
miRNA, cancer detection/screening, AI, software - Read more

THE GOOD
Investments

Daiichi Sankyo's $350 million US manufacturing expansion (planned before tariff announcments) will mitigate effects of potential Trump pharma tariffs
Antibody-drug conjugate (ADC), ADC Manufacturing, domestic manufacturing, tariffs - Read more [Paywall]

THE GOOD
Lawsuit

Lawsuit challenges Kennedy-led HHS for cutting $11B disease prevention grants amid measles surge, claiming harm to public health
US Department of Health & Human Services (HHS), infectious disease, federal research funding - Read more

THE GOOD
Mergers & Acquistions

Merck KGaA acquires SpringWorks Therapeutics for $3.9bn, acquiring Ogsiveo (targeting gamma secretase) and Gomekli (MEK inhibitor) franchises
Small molecule, desmoid tumor, cancer, neurofibromatosis type 1-associated plexiform neurofibromas - Read more

THE GOOD
Partnerships

LIfT BioSciences, University of Galway, Hooke Bio, collaborating on clinical trial for IMANs cell therapy targeting resistant solid tumors
Cell therapy, immunomodulatory alpha neutrophils, solid tumor, cancer, allogeneic cell therapy - Read more

Scribe Therapeutics, Prevail Therapeutics, collaboration milestone on CRISPR therapeutics for neurological and neuromuscular disorders
Gene therapy, adeno-associated virus (AAV), CRISPR, neurology, neuromuscular disorder, drug development - Read more

THE GOOD
Regulatory

HHS lifts stop order, resumes funding for Vaxart's 10,000-person COVID-19 vaccine pill trial after February suspension
Vaccine, COVID-19, US Department of Health & Human Services (HHS) - Read more

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❌ The Bad News

THE BAD
Clinical Trials

Roche reveals Ph3 trial data for anti-TIGIT tiragolumab plus Tecentriq versus Tecentriq alone, having missed its overall survival endpoint in non-small-cell lung cancer
Monoclonal antibody, lung cancer - Read more

THE BAD
Earnings & Finances

HSBC downgrades Eli Lilly stock due to high valuation, economic concerns, and competition from Novo Nordisk in weight loss drugs
Big pharma earnings - Read more

THE BAD
Layoffs

Spruce Biosciences cuts 55% of staff to focus on rare disease treatment acquired from BioMarin for Sanfilippo syndrome type B.
Enzyme, Sanfilippo syndrome type B - Read more

Ono Pharma, Japanese company's US subsidiary, to lay off 83 Boston-area employees by June 30
Big pharma layoffs - Read more

THE BAD
Politics & Policy

Bipartisan bill aims to eliminate tax deductions for pharmaceutical companies' direct-to-consumer drug advertisements
Drug marketing - Read more

THE BAD
Strategic Plans

Novo Holdings slows investments amid uncertainty caused by Trump's tariff policies and economic outlook
Biotech ecosystem, tariffs, investment strategy, life science investment, biotech investing - Read more

Tonix Pharmaceuticals terminates midstage trial for cocaine intoxication treatment due to slow enrollment, not safety concerns
Recombinant enzyme, cocaine-use disorder, pipeline strategy, clinical trial enrolment - Read more

👹 The Ugly News 👹

THE UGLY
Adverse Events

France suspends Valneva's chikungunya vaccine in seniors after hospitalization of elderly patients and one death
Vaccine, chikungunya virus, adverse effects - Read more

You’re all caught up on the latest Pharma & Biotech News!

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