The terms of the agreement with Royalty Pharma suggest the market potential of Zealand Pharma’s polycythemia vera drug candidate may be undervalued, according to Jefferies analysts.
PTC Therapeutics emerged as the winning bidder over Astellas for Sangamo Therapeutics’ Fabry disease gene therapy, while Eli Lilly is purchasing the biotech’s prion disease program and several platforms.
In this episode of Denatured, you’ll hear from Diana Saraceni, founder and managing partner at Panakès Partners and Fabrizio Calisti, medical director at Angelini Ventures. We explore how Italy’s life sciences ecosystem has evolved over the last decade—from stronger tech transfer and growing venture capital to the gaps that still keep it from matching the UK, Germany or France in company creation and scale.
Reports of seven deaths in patients who had taken Neurocrine Biosciences’ Vykat and the official termination of Aardvark Therapeutics’ Phase 3 trial after cardiac complications marked a tough day for the Prader-Willi syndrome community.
It’s smooth sailing for Definium Therapeutics as the psychedelic biotech charts another win for its LSD candidate, this time in anxiety. The psychedelic previously notched a late-stage victory in depression.
Beyond the legal action, Eli Lilly is calling on healthcare providers, regulatory authorities, online platforms and even logistics companies to help stem the illegal sale of its next-generation asset for weight loss.
BridgeBio Pharma’s transthyretin amyloidosis medicine Attruby is off to a strong launch, while Alnylam lowered full-year sales guidance for competitor Amvuttra.
After two rejections, Replimune has made it across the regulatory finish line with its advanced melanoma therapy. Meanwhile, the last of the major pharmas, including Eli Lilly and Novo Nordisk, reported second quarter earnings, and psychedelics made headlines once again.
A missed promotion can feel like a verdict on your potential. But people and organizations do not always develop at the same pace. Executive coach Angela Justice breaks down what a missed promotion is actually telling you—and what it isn’t.
Despite earlier claims of improvement at the fill-finish plant, the FDA has classified the facility as Official Action Indicated based on inspection findings.
Insilico Medicine CEO Alex Zhavoronkov’s mad dash across the BIO International Convention in June attracted plenty of eyes. But the executive would prefer industry watchers gawk at the billions of dollars’ worth of deals his company has struck.
Epicrispr Biotechnologies is working on an epigenetic medicine for facioscapulohumeral muscular dystrophy, while Infinimmune will advance a pair of antibodies for atopic dermatitis.
AbCellera Biologics’ reduction in hot flashes sets it apart from currently commercial oral drugs, including Astellas’ Veozah and Bayer’s Lynkuet, according to BMO Capital Markets.
The mid-stage win of Silence Therapeutics’ siRNA drug in polycythemia vera validates the therapeutic approach of similar assets in development—but also sets a high standard for therapies from Takeda, Agios and Disc Medicine.
Vaderis is hoping that engasertib will become the first approved medicine for hereditary hemorrhagic telangiectasia, a rare condition that can cause spontaneous bleeding.
The national growth vehicle isn’t biotech‑dedicated, but channeling capital toward life sciences would amplify Austria’s strong research hubs, nondilutive funding landscape and reputation as a champion in science and technology.
Bristol Myers Squibb’s $2.3 billion Houston manufacturing campus is part of the company’s larger $40 billion investment designed to bolster American innovation and manufacturing.
A surprise flop in Phase 2a cystic fibrosis trial sent Sionna’s shares plummeting, but for Vertex, the news reinforced its standard-of-care standing with highly successful drugs like Trikafta.
Jazz Pharmaceuticals is reaching into its wallet once again, this time buying Actio Biosciences and an experimental therapy for KCNT1+ epilepsy, a form of the disease with no FDA-approved treatments.
Definium Therapeutics’ closely watched anxiety readout could further validate its single-dose LSD candidate, while Compass Pathways advances a psilocybin program through a rolling FDA filing.
Patients treated with Tenax Therapeutics’ heart failure drug TNX-103 did not show significantly better functional performance—though Leerink analysts found biomarker improvements and subgroup analyses in elderly and more severe patients “very encouraging.”
After launching in April, Hunter syndrome drug Avlayah surprised analysts with a strong first quarter, as patients rush to get access to Denali Therapeutics’ new option.
The shift from ex vivo to in vivo gene delivery is rewriting the rules of viral vector manufacturing, forcing developers to rethink scale, purity, cell lines and analytics as vectors themselves become the drug. AGC Biologics is betting on stable producer lines, next‑gen purification and deeper characterization to meet the far stricter demands of in vivo therapies.
Three years after Qalsody was approved by the FDA as the first drug to target a genetic cause of ALS, some patients are reporting not only disease stabilization but also improvement of symptoms.
The Phase 2 study was small and was not designed to establish the statistical difference between Vistagen’s drug candidate and placebo, according to Vistagen. The biotech plans to meet with the FDA to determine a registrational path for the asset.
Replimune’s immunotherapy for advanced melanoma faced a perilous regulatory road with two previous rejections, but the drug—to be marketed as Tudriqev—prevailed with strong support from oncologists and a 10-3 advisory committee vote in its favor.
BioVie’s stock fell by nearly 50% as the biotech claimed victory in a mid-stage Parkinson’s disease trial using an alternative endpoint to the primary clinical goal.
Braveheart Bio has emerged on the Nasdaq with an upsized expected initial public offering—marking the public entrance of the twenty-second biotech this year.
Orzeyful is the first orexin agonist cleared by the FDA, and is the first narcolepsy therapy that addresses the full host of disease symptoms. It is "likely to reshape the treatment paradigm” for the condition, Jefferies told investors.
Since stepping in as Sanofi’s CEO in April, Belén Garijo has launched a deep look at the pharma’s pipeline, reassessing assets based on “scientific merit” and potential for long-term value in the quest for a Dupixent follow-up.
The FDA in February slapped Moderna’s vaccine with a refusal-to-file letter—though the agency backtracked a few days later and accepted a revised submission for review. An advisory committee in June unanimously backed mFLUVISA’s approval.
Patients who receive an organ transplant must take difficult immuno-suppressive medicines for the rest of their lives. LifeMine Therapeutics wants to offer a safer alternative.
In this episode of Denatured, you’ll hear from Hans Eriksson, chief medical officer at FundaMental Pharma and Steve Levine, chief patient officer at Compass Pathways. We explore why treatment-resistant depression remains so difficult to address, and how new approaches—from rapid-acting antidepressants to psychedelic therapy—may reshape the treatment paradigm.
While biotechs and contract research organizations each have their advantages, that doesn’t mean both options work for everyone. Two experts discuss the differing environments and how to pick between them.
A legal dispute between the FDA and Eli Lilly over whether the highly anticipated obesity candidate retatrutide is indeed a biologic has come to a head as the company prepares to submit the medicine for approval.
Reuters has deflated rumors that AstraZeneca and Bristol Myers Squibb are discussing a possible merger, letting the air out of industry-wide speculation over what could have been the largest deal in pharma history.
Seven months after launching with $16 million in seed financing, Jennifer Doudna’s Aurora Therapeutics is pivoting away from its lead indication, phenylketonuria, owing to growing competition in the field.
The FDA has been trying to mend fences with rare disease drug developers and patient groups since the departure of former Commissioner Marty Makary three months ago. But advisory committee meetings last week for Replimune and Capricor Therapeutics only created more confusion and frustration.
HIV remained Gilead’s strongest franchise in the second quarter, but the pharma is building out its pipeline beyond virology, particularly focusing on inflammation and oncology.
Eli Lilly’s shares rose nearly 5% to $1,170 apiece in premarket trading as the company reported $23 billion in revenue for the second quarter. The company’s market cap is $1.02 trillion as of the end of July.
Amgen has discontinued Phase 1 obesity candidate AMG 513, leaving MariTide as its sole weight loss asset. Meanwhile, executives said the company’s late-stage pipeline is largely full and future business development will focus on earlier-stage opportunities.
Novo Nordisk CEO Maziar Mike Doustdar on a second quarter earnings call argued that failure is par for the course in the drug development business. The Danish pharma is focused on building out its pipeline to move past recent clinical roadblocks.
The industry has been abuzz since the weekend when talks of a potential mega-merger between Bristol Myers Squibb and AstraZeneca were reported. Meanwhile, Pfizer, Merck and others release second quarter earnings, with some disclosing pipeline discontinuations and cost-cutting measures. Finally, all eyes turn to the FDA in the wake of heated advisory committee meetings for Capricor Therapeutics and Replimune.
BioSpace NextGen honorees made up one-third of the U.S. biotechs that have publicly debuted in 2026. Most are looking for biopharma professionals to join their teams.
Pharma is definitely interested in making more deals. But what biotechs will come under the magnifying glass? BioSpace takes a look at companies that analysts see as near-term targets for buyouts.
In addition to laying off employees, including a member of its management team, Lisata Therapeutics is also suing Kuva Labs, alleging the company breached a merger agreement.
Asked on a second quarter earnings call if Pfizer could direct more money to M&A amid a feeding frenzy across the pharma industry, CEO Albert Bourla defended his strategy.
The anti-TL1A antibody from Merck's 2023 Prometheus buy delivered positive mid-stage results in a skin condition but failed in a certain type of lung disease, the Big Pharma revealed alongside second-quarter earnings.
Supernus Pharmaceuticals and Indivior Pharmaceuticals are outlining a combined expected $2.2 billion in annual revenue, plus $125 million in cost savings that will include “natural redundancies.”
BioNTech’s leadership transition was announced earlier this year, with CEO Ugur Sahin and CMO Özlem Türeci leaving to start a new mRNA company. Guido Oelkers of Swedish Orphan Biovitrum AB will take over as CEO in early 2027.
Novo Nordisk was banking on the inflammatory benefits of its investigational therapy ziltivekimab to improve cardiovascular outcomes. Last week’s Phase 3 failure dashed not just the Danish pharma’s hopes but that of other drugmakers working on the same pathway.
If AstraZeneca and Bristol Myers Squibb were to successfully become one company, analysts say it could reset the current deal environment, which has picked up greatly in the first half of the year.
The hack is unlikely to affect Amgen’s financial reporting and other operations, nor does the pharma expect its ability to meet patient needs will be compromised.
As biologics, biosimilars and GLP-1s drive demand for sterile drug products, CMOs and CDMOs are investing in fill-finish, lyophilization, inspection and packaging capacity to keep pace with a dynamic injectable market.
The FDA’s new investigational new drug pilot program—one part of HHS’s broader clinical trial modernization initiatives—has lofty goals to expedite first-in-human trials of novel drugs, but experts say it won’t tip the scales much on its own.
The Phase 3 failure of AstraZeneca and Ionis Pharmaceuticals’ antisense therapy in transthyretin amyloid cardiomyopathy last month left the space reeling—and readjusting. BioSpace looks at five contenders and where they currently stand.
After an FDA advisory committee voted 9-3 on Wednesday against recommending Capricor Therapeutics’ Duchenne muscular dystrophy cardiomyopathy drug for approval, stakeholders allege an “ulterior motive” and “biased intentions.”
The investment will expand Resilience’s U.S. capacity to make the KwikPen device Eli Lilly uses to deliver its injectable diabetes and obesity medicines.
Novo Nordisk's IL-6 inhibitor ziltivekimab failed to reduce the risk of cardiovascular events in the late-stage trial, dashing hopes for an edge in the hyper-competitive cardiometabolic space.
Moderna’s norovirus vaccine failed in a Phase 3 trial, but the company still has faith in an ambitious revenue growth target thanks to ex-U.S. vaccine sales and a unanimous FDA adcomm win for mFLUSIVA.
Alnylam’s revenue cut “may create a near term credibility overhang and could “raise questions on peak sales potential, even if there’s tailwinds in the competitive landscape,” according to Stifel.
UniQure is ready to put its Huntington’s disease gene therapy through an advisory committee meeting—even as the broader rare disease space has been put on edge by recent FDA scrutiny of assets by Replimune and Capricor.
The FDA’s Cellular, Tissue and Gene Therapies advisory committee voted 10 to 3 in favor of Replimune’s immunotherapy for advanced melanoma in combination with Bristol Myers Squibb’s Opdivo, but trial design was a major sticking point as the panel deliberated.
Strong quarterly results are prompting Bristol Myers Squibb to lift its 2026 outlook, though the company is facing another delay for key Cobenfy Alzheimer’s data and a pushed-back readout for milvexian.
Calls for Regeneron to step up dealmaking have intensified as the company has established an $18 billion cash pile and suffered clinical trial setbacks.
With Enhertu and Datroway hitting their peak revenue and rivals flowing into the antibody-drug conjugate space, Jefferies cuts expectations for Daiichi Sankyo.
Sanofi is going to "look very deeply" at its late-stage pipeline as part of a portfolio prioritization initiative, though new CEO Belén Garijo didn’t commit to shelving a specific number of assets.
In this episode of Denatured presented by Arvinas, Jennifer Smith-Parker speaks to Arvinas President and CEO Randy Teel about the strategic discipline and leadership required to successfully refocus a company on an early-stage pipeline after a lead asset is outlicensed, discontinued or otherwise falls away.
Biotechs that announced series B financing this year and are looking for employees as they grow include one that received over $100 million and another that has a partnership with a Big Pharma company.
So far in 2026, over 50 biopharmas have cut or plan to cut their workforces. If they didn’t take a careful, thoughtful approach to telling people they were being laid off, they likely left a negative impression on employees, based on stories shared with BioSpace.
With so many unknowns, Biogen is carefully eyeing its next-gen Alzheimer’s treatment diranersen as a high-risk, high-reward project with the potential for a major payout around 2030.
During a perplexing advisory committee meeting in which FDA reviewers focused largely on the Phase 3 HOPE-3 trial’s secondary endpoint of cardiac function, experts pointed to “very fragile” data. The committee voted 9-3 against approval of deramiocel.
Reverse mergers and acquisitions remain a viable path to the public market for venture-backed biotechs, with Caldera Therapeutics and Vidya Therapeutics announcing separate deals on Wednesday to advance immunology and inflammation assets.
Biogen officially began reporting revenue from the $5.6 billion acquisition of Apellis in the second quarter, shaking up analysts’ consensus estimates and leading to a beat.
Business stage is just one factor in whether biopharmas want job candidates to have oncology experience for oncology roles. Two recruiters explain when oncology expertise matters most, the mistakes job seekers make and how to make a good impression.
Shareholders allege that Novo Nordisk withheld information about crucial protocol changes in a Phase 3 study of the weight loss drug CagriSema, which led investors to buy company shares “at artificially inflated prices.”
The FDA published briefing documents ahead of advisory committee meetings for therapies from Capricor Therapeutics and Replimune indicate an uphill battle for the biotechs; GSK and AstraZeneca outline ambitious plans in second quarter presentations; Sarepta taps Michael Severino as its new CEO; and Amgen launches its official defense of Tavneos.
As GSK records $2.4 billion in impairment charges for the second quarter, the U.K. pharma has announced a sweeping restructure designed to save about the same amount of money over the next few years.
The FDA's rebuff of Replimune comes a day after the agency similarly called into question the Phase 3 trial for Capricor’s Duchenne muscular dystrophy cell therapy.
