TNKase is the first stroke drug to win FDA approval in nearly three decades.
Last week, Eli Lilly also responded to the President’s tariff warnings by investing $27 billion to construct four manufacturing facilities across the U.S. in five years.
The partners are pushing to expand Enhertu’s list of indications beyond its standing uses in breast, lung and gastric cancers.
Biohaven in recent months has reported a clinical stumble in spinal muscular atrophy, alongside a Phase I readout for its protein degrader candidate that investors found underwhelming.
In the second podcast in a special series focused on BioSpace’s NextGen Class of 2025, Senior Editor Annalee Armstrong speaks with Kevin Marks, CEO of Delphia Therapeutics.
Delphia launched in May 2024 with the goal of forcing malignant cells to overactivate and die.
FEATURED STORIES
After the FDA declined to approve Lykos Therapeutics’ MDMA-assisted therapy for post-traumatic stress disorder, companies are pivoting away from or delaying similar therapeutics targeting the psychiatric disease.
Women are already underrepresented in clinical trials; the new abortion and IVF laws could make it worse.
Pfizer’s sudden market withdrawal of sickle cell therapy Oxbryta, which some analysts predicted would reach $750 million in sales by the end of the decade, has left patients and healthcare providers with few options, while investors question the pharma giant’s dealmaking prowess.
FROM BIOSPACE INSIGHTS
In a year when eradicated diseases are on the uptick in America, how will American children survive RFK Jr.’s vaccine scrutiny and inconsistency? Two experts call on pharma and regulatory bodies to rebuild trust.
LATEST PODCASTS
HHS Secretary Robert F. Kennedy Jr. made waves this week, firing the remaining members of the CDC’s Advisory Committee on Immunization Practices; Metsera’s amylin drug produced weight loss of 8.4% at 36 days; and FDA leaders gathered last week to discuss the future of cell and gene therapy, a sector that has been in turmoil since the ousting of CBER Chief Peter Marks.
In this episode of Denatured, presented by IQVIA, BioSpace’s head of insights Lori Ellis discusses how AI transformation can help organizations navigate a rapidly evolving regulatory environment with senior director of regulatory innovation and technology, Michelle Gyzen.
Sanofi and BMS paid big money for rare disease and cancer assets, while Regeneron got in the obesity game; AstraZeneca, Gilead and Amgen shone at ASCO; RFK Jr. and the CDC appeared to disagree over COVID-19 vaccine recommendations and several news outlets are questioning the validity of the White House’s Make America Healthy Again report.
Job Trends
Intellia Therapeutics, Inc. announced that interim results from the Phase 1 portion of the Phase 1/2 study of NTLA-2002 were published online in the New England Journal of Medicine.
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SPECIAL EDITIONS
BioSpace did a deep dive into executive pay, examining the highest compensation packages, pay ratios and golden parachutes—what a CEO would get paid to leave.
A new generation of checkpoint inhibitors is emerging, with some showing more promise than others. From recent TIGIT failures to high-potential targets like VEGF, BioSpace explores what’s on the horizon in immuno-oncology.
Peter Marks, the venerable head of the FDA’s Center for Biologics Evaluation and Research, has been forced out. In this special edition of BioPharm Executive, BioSpace takes a deep dive into the instability of the HHS.
DEALS
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Acrivon Therapeutics announced the pricing of its initial public offering Tuesday, putting all of its 7,550,000 shares of common stock up for sale for $12.50 apiece. -
Indivior PLC announced it will acquire Opiant Pharmaceuticals and its lead candidate OPNT003, an intranasal-delivered opioid overdose recovery product. -
Bankruptcy might be looming for embattled Clovis Oncology, the company warned Wednesday in a 10-Q filing. Clovis also revealed it has taken action to reduce its workforce by 115 employees. -
Eye specialist Oyster Point Pharma announced is being acquired by Viatris Inc. after Oyster’s board of directors unanimously signed off on the deal, Oyster Point announced Monday. -
San Diego-based Arcturus Therapeutics signed a strategic collaboration and licensing deal with CSL Seqirus to help develop and commercialize vaccines.
WEIGHT LOSS
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For $812 million, Novo Nordisk will enlist Deep Apple to discover and develop a non-incretin therapy for obesity, months after the Danish pharma’s amylin efforts underwhelmed investors. -
The deal is Lilly’s second obesity tie-up in a week, after sinking up to $870 million into an agreement with Camurus to develop long-acting versions of molecules against GLP-1 and other incretins. -
HHS Secretary Robert F. Kennedy Jr. made waves this week, firing the remaining members of the CDC’s Advisory Committee on Immunization Practices; Metsera’s amylin drug produced weight loss of 8.4% at 36 days; and FDA leaders gathered last week to discuss the future of cell and gene therapy, a sector that has been in turmoil since the ousting of CBER Chief Peter Marks. -
In what Guggenheim Partners called one of Metsera’s “critical program milestones” this year, its ultra-long-acting amylin injection MET-233i showed promising weight-loss after a little more than a month of treatment. -
Given the evidence, the committee has recommended that the labels for Novo Nordisk’s Wegovy and Ozempic be updated to include the “very rare” risk of non-arteritic anterior ischemic optic neuropathy.
POLICY
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Less than half of cancer drugs approved via the FDA’s accelerated approval pathway between 2013 and 2017 showed clinical benefit in confirmatory trials in terms of overall survival or quality of life, according to the paper. -
Many promising small molecules have lost significant investment appeal as a result of lopsided incentives favoring biologics in 2022’s Inflation Reduction Act. -
After BrainStorm Cell Therapeutics withdrew its BLA in October 2023 for NurOwn, the company announced Tuesday that the FDA has agreed to the design of a Phase IIIb trial for its amyotrophic lateral sclerosis candidate under a Special Protocol Assessment. -
As part of its ongoing review, the European Medicines Agency this week is slated to examine the potential risks of suicidal ideation and self-harm associated with diabetes and weight-loss treatments. -
Federal funding and legislation spotlight women’s health opportunities and challenges.
There is something of a recurring theme among the life science, healthcare and biopharma industries: shortage of skilled employees will lead to a decrease in innovation.
Is your dream job with a large organization or a small company? It’s common for life sciences professionals to have a preference one way or the other when considering employment opportunities.
Have you ever considered relocating for your career? If you have, you aren’t alone. According to a recent BioSpace Community Survey, 78% of life science professionals would be open to relocation for the right job opportunity.
To navigate each step along the way from an interview to a final offer, you should have a clear understanding of a timeline of events. These job search tips can help you with that.
Have you thought about what benefits are important to you? Would you request certain benefits from your current employer, or during an interview for a new job?
Most people avoid networking connections due to uncomfortable situations. In contrast, strategic networking can be extremely beneficial for your career.
HOTBEDS
REPORTS
In this Employment Outlook report, BioSpace explores current workforce sentiment, job activity trends and the prospective job and hiring outlook for 2025, particularly as it compares to the previous year.
BioSpace’s third report on diversity, equity, inclusion and belonging in life sciences examines dramatic shifts in attitude around diversity initiatives.
CANCER
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BioNTech will get CureVac’s early-stage cancer assets, including its mRNA-based glioblastoma therapy currently in Phase I development. CureVac had previously sued BioNTech for copyright infringement related to mRNA vaccine technology. -
Nuvation Bio’s first approved product is Ibtrozi, a CNS-active ROS1 inhibitor that in pivotal studies showed high rates of treatment response in patients with non-small cell lung cancer. -
Instead of homing in on PSMA—currently the most validated target in prostate cancer—BMS and Philochem will instead collaborate on an early-stage molecule that binds to a novel marker called ACP3. -
The Seattle-based company came to ASCO25 with new data on its neuroendocrine tumor–treating lead therapy, with big vibes and speedy speech. -
Analysts at Truist Securities called the mid-stage data a “mixed bag,” also flagging gastrointestinal adverse events. However, the readout is unlikely to be “incremental” to Corcept’s overall stock narrative.
NEUROSCIENCE
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Although there are many mechanisms proposed that contribute to neuroinflammation and damage caused by inflammaging in the brain, INmune Bio has focused on tumor necrosis factor (TNF). -
A blood test to diagnose Alzheimer’s disease launched in April by Quest Diagnostics has the potential to screen patients for risk years before symptoms appear. -
Eisai and Biogen have completed the rolling submission of a Biologics License Application for lecanemab drug to the U.S. Food and Drug Administration. -
A recent study describes how researchers at the UK Research Institute at the University of Cambridge stumbled upon a potential target of dementia research. -
Athira Pharma announced the duration of its open-label study of fosgonimeton for the treatment of mild-to-moderate Alzheimer’s Disease (AD) has been increased from six months to eighteen months.
CELL AND GENE THERAPY
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The company’s intein-based technology is initially aimed at Stargardt disease, a type of macular degeneration. -
The layoffs will heavily affect Vertex’s operations in Rhode Island, where the biotech will consolidate three facilities into one. -
Gene therapies have ridden investor mania to huge valuations but commercialization challenges have pushed market caps to the floor. At an FDA roundtable last week, FDA leaders promised faster approvals and broad support to the industry. -
Avidity has been given the go-ahead by the FDA to request accelerated approval of delpacibart braxlosiran—potentially the first disease-modifying treatment for facioscapulohumeral muscular dystrophy—with an application in the second half of 2026. -
In a roundtable event on Thursday, HHS Secretary Robert F. Kennedy Jr. said his office will work to eliminate barriers that keep cell and gene therapies from the market.
