The month of May saw investors grow increasingly cautious. This resulted in a dip in the biotech indices. The Nasdaq Biotechnology Index (NBI) declined by 3.73 percent, closing at 4,079.13. The SPDR S&P Biotech ETF dropped 4.53 percent to 79.19, while the S&P Biotechnology Select Industry Index (SPSIBI) slid by 4.61 percent, finishing the month at 6,170.44.
Amid this investor edginess, the pace of innovation, deal-making, and investment remained strong. Despite the volatile and uncertain political environment, multiple companies continued to unveil large-scale investment plans aimed at strengthening their US capabilities.
After
Eli Lilly in February, Johnson & Johnson in March, Novartis, AbbVie, AstraZeneca, Thermo Fisher and Roche in April, Bristol Myers Squibb (BMS), Takeda, Sanofi and Gilead Sciences announced major investments in the US in May. These investments will help them avoid the ‘imminent’ import tariffs indicated by the US President Donald Trump.
BMS
announced a US$ 40 billion investment over the next
five years to boost US manufacturing, research, and AI-enabled drug
development. Takeda pledged US$ 30 billion for its American operations,
and Sanofi committed to investing at least US$ 20 billion in the US through
2030. Similarly, Gilead Sciences expanded its prior commitments by adding US$ 11 billion in new US investments, bringing its total planned spend to US$ 32 billion.
Access the Pipeline Prospector Dashboard for May 2025 Newsmakers (Free Excel)Pfizer inks US$ 6 bn oncology deal with China’s 3SBio; Lilly ties up with Rznomics
Several
high-value deals made headlines in May. Pfizer announced a major licensing agreement with China’s 3SBio, committing about US$ 6
billion for an experimental cancer drug known as SSGJ-707. Similarly, Eli Lilly announced a US$ 1.3 billion RNA-based therapeutic collaboration with South Korea’s Rznomics, focused on hearing loss. Lilly also acquired SiteOne Therapeutics in a deal valued at up to US$ 1 billion, marking a strategic expansion into the non-opioid pain treatment market.
Roche
subsidiary Genentech struck a second deal with Orionis Biosciences, expanding their partnership
to discover novel oncology targets in a deal worth up to US$ 2.1 billion. Novo Nordisk entered into a collaboration with Septerna to develop oral small molecule drugs for diabetes, obesity, and cardiometabolic conditions, a deal potentially worth US$ 2.2 billion.
GSK acquired a late-stage
investigational therapy (efimosfermin) for steatotic liver disease from Boston Pharmaceuticals for up to US$ 2 billion. Biogen entered into a US$ 1 billion collaboration
with City Therapeutics to develop RNA interference
therapies for central nervous system disorders. And Astellas Pharma entered into an exclusive licensing agreement with Evopoint Biosciences for a novel antibody-drug
conjugate (ADC), which is currently in clinical trials for advanced solid
tumors. The deal could be worth up to US$ 1.5 billion.
Access the Pipeline Prospector Dashboard for May 2025 Newsmakers (Free Excel)GSK wins FDA nod for Nucala in eosinophilic COPD; Amneal’s autoinjector for migraines okayed
In
terms of regulatory approvals, the month saw a series of greenlights from the
US Food and Drug Administration (FDA). GSK saw an expansion
of its respiratory drug portfolio with the approval of Nucala (mepolizumab) for eosinophilic chronic
obstructive pulmonary disease (COPD), further establishing its presence in
inflammatory airway diseases.
Amneal Pharmaceuticals received approval
for Brekiya,
the first and only autoinjector formulation of dihydroergotamine mesylate. This self-administered treatment is aimed at adults suffering from migraines and cluster headaches, providing a new level of convenience and speed for those managing these debilitating conditions.
Meanwhile,
Incyte secured a long-awaited approval for Zynyz (retifanlimab), an
immunotherapy for advanced squamous cell carcinoma of the anal canal. The
approval comes four years after the drug was initially
rejected.
In
oncology, Verastem Oncology earned accelerated approval for Avmapki Fakzynja (avutometinib/defactinib), a dual oral therapy for KRAS-mutated, low-grade
serous ovarian cancer (the most common type of epithelial ovarian cancer). AbbVie also achieved an accelerated approval for
Emrelis (telisotuzumab vedotin), which will be used to treat certain patients
with advanced non-small cell lung cancer. Merck enhanced its oncology
portfolio as the FDA expanded the use of Welireg (belzutifan) to include treatment for
two rare types of adrenal gland tumors.
In
vaccines, Sanofi received FDA approval for MenQuadfi, a meningococcal vaccine now cleared for use in infants as young as six
weeks. This is the first such vaccine to be approved for that age group, and it
addresses the four most common strains of the bacteria that causes meningitis.
In
ophthalmology, Alcon gained FDA clearance for Tryptyr (acoltremon ophthalmic solution), a new
therapy for dry eye disease that aims to improve comfort and ocular health for
millions of Americans.
In
the obesity space, FDA accepted Novo Nordisk’s application for an oral version of Wegovy (semaglutide), a GLP-1 receptor agonist. If approved, it would be the first oral therapy of its kind for chronic weight management. This could potentially reshape the obesity drug landscape.
Access the Pipeline Prospector Dashboard for May 2025 Newsmakers (Free Excel)
J&J’s psoriasis drug clears skin in late-stage trial; gene therapy sees more setbacks
In
news from other clinical trials, Johnson & Johnson’s investigational psoriasis drug, icotrokinra (JNJ-2113), showed promising phase 3
results by
helping patients with moderate-to-severe plaque psoriasis achieve clear skin. Gilead Sciences announced strong topline data for Trodelvy (sacituzumab govitecan) in metastatic triple-negative breast cancer, where it demonstrated a significant improvement in progression-free survival for patients who are not candidates for PD-1/PD-L1 inhibitors.
Roche announced the progression of its investigational
antibiotic, zosurabalpin, into phase 3 clinical
trials, marking a significant advancement in the fight against antimicrobial
resistance. This development is noteworthy as zosurabalpin represents the first new
class of antibiotics targeting Gram-negative bacteria in over five decades. AstraZeneca also scored a clinical win as its triple-combination
COPD inhaler Breztri Aerosphere (budesonide/glycopyrrolate/formoterol fumarate) met all primary endpoints
in two phase 3 studies for uncontrolled asthma.
In
trial failures, GSK and iTeos Therapeutics discontinued the development of belrestotug for lung
cancer after phase 2 trials failed to meet efficacy benchmarks. Johnson & Johnson’s gene therapy, botaretigene sparoparvovec, intended for X-linked retinitis pigmentosa (a genetic disease that causes blindness in men), also fell short in phase 3 trials. Vertex Pharmaceuticals announced it
would abandon its AAV vector research and pause development on a partnered
cystic fibrosis therapy with Moderna, marking a strategic shift
away from certain gene therapy approaches.
Access the Pipeline Prospector Dashboard for May 2025 Newsmakers (Free Excel)
Our view
The volatile, uncertain, complex and ambiguous political climate has created chaos across the world. This has undoubtedly impacted market sentiment.
However, on the plus side, the pharmaceutical industry appears resilient, and looks determined to take on challenges with its strong focus on research and innovation. Let’s hope the indices start reflecting this strength soon. Access the Pipeline Prospector Dashboard for May 2025 Newsmakers (Free Excel)
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