IPO
Kalohexis is working on peptide therapies, including one for obesity that could offer an alternative approach to the GLP-1s that currently dominate the weight loss space.
Vera Therapeutics’ atacicept, to be marketed as Trutakna, will go up against Novartis, Otsuka and possibly Vertex in the kidney disease primary IgA nephropathy after receiving an accelerated FDA approval.
New data on Hengrui Pharma and Kailera Therapeutics’ investigational oral GLP-1 have validated the late-stage weight loss asset and paved the road for a regulatory submission in China, but analysts pointed to high rates of nausea and vomiting that could challenge the ongoing U.S. study.
With the latest layoffs, Novartis expects to let go of around 800 employees by the end of 2028. More than half of the cuts have been at the company’s East Hanover, New Jersey, location.
New data from a Phase 3 trial will further support a rolling submission for Compass Pathways’ psilocybin treatment COMP360. Patients who saw a clinically meaningful benefit on depression severity maintained response through week 26.
Vertex Pharmaceuticals’ acquisition of Crinetics Pharmaceuticals is the largest pickup in the company’s history, according to analysts at BMO Capital Markets.
Patients treated with Bristol Myers Squibb’s Krazati in combination with cetuximab saw shorter median overall and progression-free survival than comparators on chemotherapy.
FEATURED STORIES
Merck’s Keytruda holds on to the top spot while AbbVie’s Humira—once the world’s top-selling drug—continues to cede its market share to biosimilar competitors.
Congress did not reauthorize the rare pediatric disease priority review program at the end of 2024. Advocates say the ripple effect is already being felt across biopharma.
In the current legal and political landscape, it is all about survival for DEI initiatives.
More than a decade after Merck’s Keytruda and BMS’ Yervoy ushered in the immuno-oncology revolution, the space is at a crossroads, with experts highlighting novel targets, combinations and pre-emptive immunization as the next wave for IO.
Two recent documents—one from the FDA, the other from a commission organized by The Lancet Diabetes & Endocrinology—indicate an evolving mindset toward treating obesity as a chronic disease.
While at SCOPE 2025, Sam Srivastava, CEO at WCG Clinical discusses the challenges and responsibilities of the life sciences industry in building public trust amidst growing anger towards healthcare.
FROM BIOSPACE INSIGHTS
The U.K.’s core biotech cluster continues to produce world‑class science, but investors say limited talent mobility, uneven regional growth and tightening early‑ and mid‑stage capital are slowing the country’s ability to scale new companies.
UPCOMING EVENTS
LATEST PODCASTS
A surprising deal from Vertex Pharmaceuticals adds to Big Pharma’s acquisitive streak as Crinetics folds into the cystic fibrosis drugmaker. Meanwhile, IPOs and venture capital raises trend upward, but mostly for derisked companies. Plus, FDA decisions slow only slightly as the hunt for a permanent leader drags on.
The vibe at BIO 2026 in San Diego last week was overwhelmingly positive, with attendees observing noticeable changes at the FDA and an uptick in dealmaking and IPOs. Plus, a top medical journal this week retracted a pivotal study for Amgen’s rare disease drug Tavneos, which has been in the FDA’s crosshairs since January.
In this episode of Denatured, as part of our series on the European life sciences investment ecosystem, you’ll hear from Hakan Goker, managing director at M Ventures and Maina Bhaman, partner at Sofinnova Partners. We explore the UK biotech ecosystem: from the Golden Triangle’s evolving role to the challenges of scaling companies, unlocking pension capital and staying globally competitive.
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SPECIAL EDITIONS
Who is the highest paid CEO in all of pharma? In this special edition, BioSpace examines top paid CEOs and their pay packages.
BioSpace examines how the FDA approval of Eli Lilly’s oral obesity drug Foundayo has ignited a key race with Novo Nordisk.
Opportunities increased by the end of the first quarter, according to BioSpace data.
DEALS
  1. A mostly black box since emerging with more than a billion dollars in hand, Xaira Therapeutics is slowly pulling back the curtain, revealing plans to find partners and validate its pipeline.
  2. IPO
    After debuting on the public markets with $256.3 million and raking in an additional $472 million, Veradermics has emerged as one of biotech’s biggest post-IPO standouts. CEO Reid Waldman credits the weight loss craze for establishing consumer-driven channels.
  3. The centerpiece of the acquisition is Myricx Bio’s novel N-myristoyltransferase inhibitor payload platform, which could help Novartis develop antibody-drug conjugates that can overcome the limitations of existing therapies.
  4. AstraZeneca and CSPC Pharmaceutical Group have already inked two other agreements this year, including an obesity-focused deal in January and one focused on chronic diseases in June.
  5. Ipsen is penning its second acquisition of the week, this time securing Memo Therapeutics and its midstage monoclonal antibody in a deal that could approach $800 million.
WEIGHT LOSS
  1. Eli Lilly’s weight-loss franchise—including the tirzepatide products Mounjaro and Zepbound, and the weight-loss pill Foundayo—is projected to account for nearly half of the total sales of the top 10 drugs in 2032.
  2. Rhythm Pharmaceuticals’ Imcivree reduced fat—while boosting muscle—in patients with Prader-Willi syndrome.
  3. After suffering the market withdrawal of its only product, Amylyx is gearing up for a pivotal Phase 3 readout in post-bariatric hypoglycemia. But the company’s driving ethos is still to treat “debilitating, devastating” neurodegenerative diseases, co-CEO Justin Klee told BioSpace.
  4. Novo Nordisk said that the information affected by the breach shouldn’t allow third parties to “identify participants in our clinical trials” despite “unauthorized access” to patients’ personal data.
  5. Eli Lilly and obesity rival Novo Nordisk stole the show at the American Diabetes Association conference, though plenty of other companies also had data to show for their own weight loss assets; GSK strikes the biggest traditional pharma buyout of 2026; and FDA initiatives still lack clarity.
POLICY
  1. Congressional letters sent to the CEOs of Eli Lilly, Pfizer, Merck, BMS and AbbVie this week voicing concerns about the pharmas’ clinical trials in China highlight an ongoing discrepancy in how government and industry think about the rise of the Asian country’s biotech industry.
  2. Teams at facilities being developed by Eli Lilly, Regeneron and other companies will receive early technical guidance and additional perks from the FDA.
  3. FDA
    Policymaking at FDA has been anything but business as usual under the Trump administration, but former regulators cite the agency’s new investigational new drug pilot program as a sign of normalcy.
  4. A few short days after announcing an FDA pivot on a separate asset, REGENXBIO is planning to test the agency’s apparent newfound rare disease outlook on another late-stage gene therapy.
  5. Former FDA, CDC and NIH leaders convene at the BIO International Convention to discuss the dismantling of the Department of Health and Human Services under the Trump administration—and where we go from here.
CAREER HUB
The 2022 search approach is no longer working. Companies need to think critically about how they are acquiring top regulatory, clinical and commercial executives or risk their programs in this new regulatory and market reality.
Even something as simple as “Tell me about yourself” can trip up biopharma professionals during job interviews. Two recruiting experts discuss what candidates should and shouldn’t say when answering five specific questions.
Rather than getting hung up on what to call DEI in the workplace, leaders should take three specific actions to help their employees embrace and engage with it. Companies and the patients they serve will benefit.
Three experts discuss whether biotech and pharma professionals should try to convince employers to adjust employment offers, mistakes people make during the process and tips for getting it right.
The people most trusted to deliver are not always the ones invited to shape direction. Executive coach Angela Justice examines why the habits that build a career can eventually limit advancement.
Scientists who focus only on generating data risk missing their role in shaping strategy and driving innovation.
Panel interviews can play a major role in getting jobs. Two career coaches discuss what to do before and during the interview, including identifying how to differentiate yourself, engaging in true conversations and not overlooking a key panel member.
HOTBEDS
Where are the Best Places to Work in life sciences? BioSpace’s annual Best Places to Work list demonstrates a company’s desirability in the recruitment marketplace - find out who made the list this year.
IN CASE YOU MISSED IT
FDA
Many of the FDA’s decisions this quarter involve applications that have previously been delayed, declined or outright rejected, including one for an mRNA vaccine that became the center of controversy earlier this year.
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
  1. The approval of Tregzi—the first regulatory greenlight for Orca Bio—was based on a Phase 3 study in which patients on the therapy were twice as likely to survive without cancer relapse and without chronic GVHD compared with conventional allogeneic transplant.
  2. The star of Ipsen’s acquisition is an MDM2 blocker being proposed as an add-on therapy to ruxolitinib for myelofibrosis. The drug could be available to patients “as early as 2028,” according to Ipsen CEO David Loew.
  3. Recent approvals for Corcept Therapeutics and Merck have injected momentum into the space, where GSK, Allarity Therapeutics, OSE Immunotherapies and others are advancing their own candidates.
  4. Replimune’s resubmission for RP1 for melanoma comes after the departures of FDA leaders in place at the time of the drug’s first two rejections. The FDA expects to hold an advisory committee meeting in late July.
  5. Encouraging data for combination regimens of Revolution Medicines’ zoldonrasib “reinforce the path to leadership in PDAC” for the biotech, according to Truist Securities.
NEUROSCIENCE
  1. Despite the late-stage fail, Vistagen will nevertheless continue to push its drug candidate forward and meet with the FDA to align on a potential registrational path.
  2. The delay is largely “benign” for Praxis Precision Medicines, according to Jefferies, which emphasized that the FDA did not flag safety or manufacturing issues.
  3. A recent FDA reversal sparked new hope for patients with Huntington’s disease. Flying under the radar, Skyhawk Therapeutics revealed 12-month functional data from a midstage trial of its own candidate showing improvements on a key disease measurement scale.
  4. The positive ADHD data for Otsuka Pharmaceutical’s centanafadine is good news in what has of late been a mixed bag for the neuropsychiatric space.
  5. Results for Definium Therapeutics psychedelic candidate for major depressive disorder “exceeded expectations,” according to Stifel, while Jefferies called the efficacy data “profound.”
CELL AND GENE THERAPY
  1. If cell and gene therapy makers are going to achieve their mission to improve patients’ lives, the industry must come together to share information across stakeholders, from regulators to manufacturers to payers.
  2. Be Biopharma’s terminated trial is the latest setback in the hemophilia space, where companies like Pfizer and BioMarin have opted to pull their respective products from the market after weak traction.
  3. Instead of using viral vectors, SonoThera’s genetic medicines are delivered through an ultrasound-mediated technology that could help sidestep key safety issues with conventional delivery methods.
  4. All six non-Hodgkin lymphoma patients on Legend Biotech’s CAR T therapy responded to treatment—findings that could make the biotech an attractive takeover target, according to analysts at Oppenheimer.
  5. ALS
    For Peter Pitts, a former associate commissioner at the FDA, the appointment to the board of BrainStorm Cell Therapeutics is an opportunity to fulfill a promise he made long ago to a patient with ALS.