The late-stage miss is “surprising,” Stifel analysts said, given that Wainua’s mechanism of silencing transthyretin protein expression has previously proven effective.
GSK and Alector first partnered in 2021 to advance two antibodies for neurodegenerative diseases. Both assets have since failed to show significant clinical benefit.
An unnamed pharma filed a citizen petition in April seeking reforms to the way the FDA publicly releases rejection letters, alleging that the policy “contravenes decades of agency practice.”
After being bought by Bain for $3.3 billion, Tanabe has reached a deal to sell its manufacturing unit and 17 products.
The discovery of a foreign substance prompted Amgen to voluntarily recall batches of the medicine Corlanor made in Italy.
Follow along as BioSpace tracks job cuts and restructuring initiatives.
FEATURED STORIES
Eli Lilly topped the list of the 20 biggest pharmas by market cap with a more than 39% improvement year-to-date in its share price. Other companies have not been so lucky.
Currently, Eli Lilly’s GLP-1 drugs Mounjaro and Zepbound (tirzepatide) are not on the FDA’s shortage list but compounded pharmacies are still making them. That’s unprecedented.
Sage Therapeutics discontinued development of its lead candidate dalzanemdor after a third clinical failure, leading analysts to question the biotech’s future profitability.
ADC Therapeutics, Sutro Biopharma and Zai Lab are among those developing antibody-drug conjugates to address payload and toxicity challenges of current ADCs—and rapidly grow the multibillion-dollar market.
With two decisions originally scheduled for this week already announced, including BridgeBio’s approval in ATTR-CM, the regulator has just one PDUFA on its plate this holiday week.
RFK Jr. as HHS head is perhaps President-elect Donald Trump’s most controversial Cabinet pick now that Matt Gaetz has withdrawn as nominee for Attorney General. With Dr. Oz tapped to lead CMS and maybe Marty Makary at the FDA, it’s going to be quite the show.
UPCOMING EVENTS
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Friday, July 10, 2026 12–2pm EDT·Cambridge, Mass
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Developing Efficient Downstream Purification for Bispecific Antibodies: Challenges and BreakthroughsWednesday, July 22, 2026 11am EDT·Virtual
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Wednesday, July 22, 2026 2–3pm EDT·Virtual
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Thursday, July 23, 2026 9–10am PDT·Virtual
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Tuesday, July 28, 2026 10–11am EDT·Virtual
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
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In AstraZeneca’s third trip to Asia this year, the pharma secured ex-China rights to a dual inhibitor of PDE3 and PDE4, which in a Phase 2b study significantly improved lung function and lowered symptom burden in patients with chronic obstructive pulmonary disorder. -
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. -
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. -
Vertex Pharmaceuticals’ acquisition of Crinetics Pharmaceuticals is the largest pickup in the company’s history, according to analysts at BMO Capital Markets. -
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.
WEIGHT LOSS
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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. -
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. -
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. -
Rhythm Pharmaceuticals’ Imcivree reduced fat—while boosting muscle—in patients with Prader-Willi syndrome. -
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.
POLICY
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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. -
Teams at facilities being developed by Eli Lilly, Regeneron and other companies will receive early technical guidance and additional perks from the 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. -
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. -
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.
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
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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Patients treated with Bristol Myers Squibb’s Krazati in combination with cetuximab saw shorter median overall and progression-free survival than comparators on chemotherapy. -
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. -
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. -
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. -
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.
NEUROSCIENCE
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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. -
The mid-stage disappointment in Alzheimer’s disease delivers another blow to Neuphoria Therapeutics, which in November last year was forced to launch a strategic business review after a Phase 3 trial in social anxiety disorder failed. -
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. -
The delay is largely “benign” for Praxis Precision Medicines, according to Jefferies, which emphasized that the FDA did not flag safety or manufacturing issues. -
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.
CELL AND GENE THERAPY
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The FDA approved the expansion of Casgevy, which had previously been greenlit for patients 12 and up, into a younger pediatric population under the agency’s Commissioner’s National Priority Voucher program. -
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. -
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. -
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. -
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.
