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BioSpace

BioSpace

A Life Sciences and Science podcast

#11 in Life Sciences · 🇰🇷 #28 in Life Sciences · 🇬🇧
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About the show

Unravel the business of science with BioSpace. We dive into biopharma's top stories and biggest challenges, whether it’s layoffs, pipeline shake-ups, acquisitions, new FDA approvals or how to regulate AI in drug development.

Newest episodes

Can we finally get ahead of drug shortages?

20 min

In this episode of Denatured, you'll hear from Christina Smolke, co-founder & CEO at Antheia and Kyle Pudenz, senior vice president and head of data & AI product at Cencora. We explore why drug shortages are getting worse, and how combining predictive supply-chain analytics with agile, distributed manufacturing could finally make essential medicines more resilient and accessible. Host Jennifer C. Smith-Parker, Director of Insights, BioSpace Guests Christina Smolke, Co-founder & CEO, Antheia Kyle Pudenz, Senior Vice President, Head of Data & AI Product, Cencora Disclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

Novartis’ Zolgensma woes, BIO’s China plan, GLP-1s’ new safety warning, FDA’s stacked November

23 min

Novartis confirms that nine patients treated with its spinal muscular atrophy gene therapy Zolgensma have developed tumors; the FDA orders GLP-1 drugmakers to add a warning to their labels about the risk of a rare eye condition that can lead to vision loss; and the agency is set to decide on no fewer than 11 therapies this month, including closely watched applications from Summit Therapeutics, Vertex and Capricor Therapeutics.

Beyond the needle: The future of intratumoral therapy

21 min

In this episode of Denatured, you’ll hear from Lewis Bender, CEO at Intensity Therapeutics and Paul-Peter Tak, president, CEO and board director at Candel Therapeutics. We explore how intratumoral therapies trigger systemic anti-cancer immunity from a local injection, and redefine a foundational platform in immuno-oncology. Host Jennifer C. Smith-Parker, Director of Insights, BioSpace Guests Lewis Bender, President & CEO, Intensity Therapeutics Paul-Peter Tak, President, CEO and Board Director, Candel Therapeutics Disclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

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The newest 50 of 283 episodes

Can we finally get ahead of drug shortages?

20 min

In this episode of Denatured, you'll hear from Christina Smolke, co-founder & CEO at Antheia and Kyle Pudenz, senior vice president and head of data & AI product at Cencora. We explore why drug shortages are getting worse, and how combining predictive supply-chain analytics with agile, distributed manufacturing could finally make essential medicines more resilient and accessible. Host Jennifer C. Smith-Parker, Director of Insights, BioSpace Guests Christina Smolke, Co-founder & CEO, Antheia Kyle Pudenz, Senior Vice President, Head of Data & AI Product, Cencora Disclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

Novartis’ Zolgensma woes, BIO’s China plan, GLP-1s’ new safety warning, FDA’s stacked November

23 min

Novartis confirms that nine patients treated with its spinal muscular atrophy gene therapy Zolgensma have developed tumors; the FDA orders GLP-1 drugmakers to add a warning to their labels about the risk of a rare eye condition that can lead to vision loss; and the agency is set to decide on no fewer than 11 therapies this month, including closely watched applications from Summit Therapeutics, Vertex and Capricor Therapeutics.

Beyond the needle: The future of intratumoral therapy

21 min

In this episode of Denatured, you’ll hear from Lewis Bender, CEO at Intensity Therapeutics and Paul-Peter Tak, president, CEO and board director at Candel Therapeutics. We explore how intratumoral therapies trigger systemic anti-cancer immunity from a local injection, and redefine a foundational platform in immuno-oncology. Host Jennifer C. Smith-Parker, Director of Insights, BioSpace Guests Lewis Bender, President & CEO, Intensity Therapeutics Paul-Peter Tak, President, CEO and Board Director, Candel Therapeutics Disclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

Q3 earnings roll on, FDA pushes rare disease, uniQure’s Huntington’s therapy reaches review

23 min

The majority of the large pharmas have now reported third quarter earnings—spoiler alert: Eli Lilly made more money than anyone expected. Plus, the FDA dropped another initiative aimed at accelerating rare disease treatments; HHS greenlights the compounding of six unapproved peptides; and uniQure’s embattled gene therapy for Huntington’s disease has finally been accepted for review.

Stability, speed and strategy: Inside Australia’s early‑stage edge

21 min

In this episode of Denatured, you’ll hear from Jerome Barley, commercial director at Avion Medical and Ryan Klein, vice president, business development, US and APAC at Resolian. We discuss why Australia has become a magnet for early clinical development, and whether its speed, regulatory clarity and tax incentives are pushing it toward a more integrated biotech role. Host Jennifer C. Smith-Parker, Director of Insights, BioSpace Guests Jerome Barley, Commercial Director, Avion Medical Ryan Klein, Vice President, Business Development, US and APAC, Resolian Disclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

Data leak kickstarts ESMO, BMS reports autoimmune CAR T death, pharma M&A outpaces 2025

23 min

Merck stole the show at the European Society for Medical Oncology (ESMO) annual conference, with new data on its Moderna-partnered personalized cancer vaccine leaking prior to the presentation and antibody-drug conjugate sac-TMT making a splash in endometrial cancer; Bristol Myers Squibb revealed the death of a patient with multiple sclerosis in an early-stage trial of zola-cel; and pharma is on track to easily surpass last year’s deal count.

Why investors are taking another look at kidney disease

18 min

In this episode of Denatured, you’ll hear from Bruce Culleton, CEO at ProKidney and Demetri Maxim, CEO at Nephrogen. We discuss why kidney disease has long been a hard target for cell and gene therapies, and what new delivery strategies, therapeutic approaches and regulatory clarity mean for commercially viable products. Host Jennifer C. Smith-Parker, Director of Insights, BioSpace Guests Bruce Culleton, CEO, ProKidney Demetri Maxim, CEO, Nephrogen Disclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

Disc’s redemption, China’s rise, Veradermics’ validation, ESMO’s headliners

17 min

China cracks down on some biotechnology ownership transfers—but will the new policy impact licensing deals?; Disc Medicine’s Phase 3 data sweep redeems rejected rare disease therapy, teeing up another FDA run; and the ESMO conference gets underway in Madrid this week, with much-anticipated data from Merck and Summit Therapeutics. 

Bonus: Q3 2026 Job Market Update

16 min

BioSpace Vice President Chantal Dresner and Angela Gabriel, content manager, life sciences careers, cover what happened in the biopharma job market during the third quarter. They discuss encouraging signs for those looking for their next opportunity, such as improved job postings live on the BioSpace website and a dramatic drop in layoffs.  Other topics include signs of industry health, news about job opportunities and advice for the Q4 job hunt. 

The decisions behind scientific progress

10 min

In this episode of Denatured, sponsored by Cytiva, Jennifer Smith-Parker speaks to Nicolas Pivet, VP & GM, Manufacturing & Digital Solutions at Cytiva. In this episode, we discuss how biopharma has long invested in more data and visibility, yet many programs still face delays and scale-up surprises. The real challenge isn’t information overload—it’s building confidence in the decisions that steer scientific progress from development through commercialization. This episode is presented in partnership with Cytiva. Host Jennifer Smith-Parker, Director of Insights, BioSpace Guest Nicolas Pivet, VP & GM, Manufacturing & Digital Solutions, Cytiva Disclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations

J&J’s disappointing Q3, RevMed’s subgroup data, BMS’ ‘mixed’ results, Caribou’s cutback

19 min

Johnson & Johnson beat analyst expectations in the third quarter but left Wall Street wanting more; BMS dominated the news cycle on Monday with a Phase 3 win validating its $4.1 billion RayzeBio buy and mixed data in a late-stage pulmonary fibrosis trial; Revolution Medicines’ newly approved pancreatic cancer drug works better for patients with certain mutations; and Caribou Biosciences may be on its way out.

Beyond equity: Why venture debt is reshaping European biotech

22 min

In this episode of Denatured, you’ll hear from Jennifer McMahon, partner at Seroba and Joey Mason, venture partner at Claret Capital. We dig into how venture debt buys time when equity can’t — and how Europe’s funding gaps, tranching habits and slower urgency shape who uses it well. Host Jennifer C. Smith-Parker, Director of Insights, BioSpace Guests Jennifer McMahon, Partner, Seroba Joey Mason, Venture Partner, Claret Capital Disclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

Genmab and AbbVie’s Epkinly win, a rush of deals, Sarepta’s turnaround hopes, more

24 min

New data for Genmab and AbbVie’s bispecific antibody Epkinly wowed analysts and could set the partners up for an expanded approval in diffuse large B cell lymphoma; deals have flowed steadily this week, including Novartis’ nearly $8 billion bet on mRNA drugs with China’s Abogen Biosciences; and could Sarepta Therapeutics turn things around from last year’s annus horribilis?

The race for access: How the FAIR Act could reclaim U.S. biotech leadership

20 min

In this episode of Denatured, you’ll hear from Max Bronstein, CEO of Aviva Strategies and Teresa Barnes, Chief Executive Warrior of PF Warriors. We dig into why U.S. patients are losing access to rare disease trials happening abroad and how the FAIR Act’s accelerated, harmonized reviews could help the U.S. keep pace while getting lifesaving studies to patients faster. Host ⁠Jennifer C. Smith-Parker, Director of Insights, BioSpace Guests Max Bronstein, CEO, Aviva Strategies Teresa Barnes, Chief Executive Warrior, PF Warriors Disclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

AstraZeneca buys into Summit, UniQure drops on 4-year data, FDA on a roll

20 min

Summit Therapeutics scores a $2 billion equity investment from AstraZeneca to support ivonescimab’s late-stage development; uniQure crashes after four-year data from its Huntington’s disease gene therapy failed to impress; Kyverna Therapeutics brings new light to a struggling CAR T space in autoimmune disease.

How radioligand therapy is rewriting cancer care

15 min

In this episode of Denatured presented by Curium, Jennifer Smith-Parker speaks to Mike Patterson, CEO North America and Professor Sabine Brookman-May, vice president and head of Global Clinical Development. We examine radioligand therapy’s accelerating momentum and how its diagnostic and therapeutic reach could potentially reshape care for more than 14 million patients worldwide. We also discuss Curium's push to expand US capacity and scale up at pace, and critically what success could mean for patients with cancer in the years ahead. This episode is presented in partnership with Curium. Host Jennifer Smith-Parker, Director of Insights, BioSpace Guests Mike Patterson, CEO North America, Curium Sabine Brookman-May, VP and Head of Global Clinical Development, Curium Disclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

Novo’s turnaround plan, weight loss wins, Ultragenyx’s Sanfilippo approval, IPO blitz

21 min

Novo plans to hit $23B in revenue by 2035, has further reduced its workforce by 4,000 and is boosting manufacturing capacity for its Wegovy pill, but investors are unconvinced it will be enough to turn things around; Viking Therapeutics and Roche report positive results for their weight loss assets; Ultragenyx snags FDA approval for its Sanfilippo syndrome gene therapy; IPOs keep on coming.

When vision fades: Rethinking wet AMD and the durability gap

21 min

In this episode of Denatured, you’ll hear Philip Jacob Rosenfeld, professor of Ophthalmology at the University of Miami Health System and Bascom Palmer Eye Institute, and Wesley Jackson, chief science officer at Valitor. We talk about the eye condition call wet age-related macular degeneration (AMD), the limits of anti‑VEGF therapy and the push for true durability to change a patient’s life. Host Jennifer C. Smith-Parker, Director of Insights, BioSpace Guests Philip Jacob Rosenfeld, Professor of Ophthalmology, University of Miami Health System, Bascom Palmer Eye Institute Wesley Jackson, Chief Science Officer, Valitor   Disclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

FDA hears input on psychedelics, PDUFA, lung cancer’s next-gen therapies boost survival

22 min

The FDA held a public forum on Monday to discuss the future of psychedelic therapeutics, followed by a meeting on Wednesday regarding recommendations for reauthorizing the Prescription Drug User Fee Act the day after launching its TrialBlazer initiative. Meanwhile, Definium Therapeutics notched another late-stage trial win for its LSD drug, and Novartis continues to reel from the company’s triple asset stumble.

The supply chain fault lines of modern pharma

36 min

In this episode of Denatured, sponsored by SK Pharmteco, Jennifer Smith-Parker speaks to Arvind Singh, vice president and global head of supply chain. In this episode, we discuss how CDMOs are revamping supply‑chain strategy for a new generation of intricate modalities. Topics addressed include moving from smarter raw‑material sourcing and precision cold‑chain logistics to navigating geopolitical and regulatory uncertainty and deploying AI to building sustainable, scalable capabilities from clinical through commercial. This episode is presented in partnership with SK Pharmteco. Host Jennifer Smith-Parker, Director of Insights, BioSpace Guest Arvind Singh, VP & Global Head of Supply Chain Disclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

Novo’s canned heart disease trials, Novartis’ clinical fails, first approval for Alexander disease

20 min

September has been a rough month already for Novo Nordisk, which canned two more late-stage trials of its embattled IL-6 inhibitor, and Novartis, which took Phase 3 hits in both cardiovascular and muscular dystrophy indications; Ultragenyx’s big bet in Angelman syndrome failed to yield benefit in Phase 3 but Ionis’ Pharmaceuticals nabbed the first targeted approval for Alexander disease; and on the business side, biopharma investment is back in a big way. 

Breaking borders: Building biotech scale in Benelux

18 min

In this episode of Denatured, you’ll listen to Christina Takke, managing partner at V-Bio Ventures and Mariette van der Velden-Roesink, founding partner at Curie Capital. We examine why Benelux delivers world‑class science yet remains an investment patchwork, and what it will take to knit the region into a truly unified biotech investment corridor. Host ⁠Jennifer C. Smith-Parker, Director of Insights, BioSpace Guests Christina Takke, Managing Partner, V-Bio Ventures Mariette van der Velden-Roesink, Founding Partner, Curie Capital Disclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

Novartis’ and BMS’ paused CAR T trials, RevMed’s pancreatic cancer approval, more MFN deals

20 min

Novartis hits pause on several CAR T trials after three patient deaths, followed by Bristol Myers Squibb after separate safety signals; Revolution Medicines scores early FDA approval for groundbreaking pancreatic cancer drug; BioNTech suspends a mid-stage trial of its mRNA cancer immunotherapy after a futility analysis; and nine mid-sized biopharma companies join their big pharma peers in President Donald Trump’s Most Favored Nation drug pricing scheme.

Fragile X at a turning point: Breaking through the clinical bottleneck

19 min

In this episode of Denatured, you’ll hear from Hilary Rosselot, executive director at the National Fragile X Foundation and Jordi Fàbrega, co-founder & CEO at CONNECTA Therapeutics. From trial endpoints and placebo effects to neuroplasticity modulation, we explore what it will take to build a sustainable path to the first approved therapy. Host Jennifer C. Smith-Parker, Director of Insights, BioSpace Guests Hilary Rosselot, Executive Director, National Fragile X Foundation Jordi Fàbrega, Co-Founder & CEO, CONNECTA Therapeutics Disclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

Capricor’s DMD therapy still alive, Merck/Moderna’s cancer vax shines, FDA’s future revealed

23 min

FDA extends its review of Capricor Therapeutics’ Duchenne muscular dystrophy cell therapy as an unhappy shareholder advocates for change; Merck and Moderna tout positive data for their mRNA-based cancer vaccine; Trump nominates White House aide Heidi Overton as FDA commissioner; and the oral obesity market heats up with rivals Eli Lilly and Novo Nordisk going head-to-head.

Rewriting the rules of CMV prevention

19 min

In this episode of Denatured, you’ll hear from Ian McGowan, Chief Medical Officer at Synklino and James Hunter, associate professor of transplantation at Oxford University. We explore transplantation and antiviral innovation and why CMV remains one of the most persistent and consequential challenges facing transplant patients today. Host Jennifer C. Smith-Parker, Director of Insights, BioSpace Guests Ian McGowan, CMO, Synklino James Hunter, Associate Professor of Transplantation, Oxford University Disclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations. Custom Fields

Amylyx’s redemption story, Summit’s survival woes, Definium’s anxiety win, more

19 min

Amylyx shares good news for its investigational GLP-1 blocker; Definium announces positive data for its LSD-based therapy in anxiety; Summit/Akeso’s ivonescimab shows degrading survival benefits; patients treated with Neurocrine’s Prader-Willi drug experience serious adverse events; and Eli Lilly cracks down on the black market for next-gen obesity asset retatrutide.

The Italian inflection point: Clinical strength, culture and capital

18 min

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. Host Jennifer C. Smith-Parker, Director of Insights, BioSpace Guests Diana Saraceni, Founder and Managing Partner, Panakès Partners Fabrizio Calisti, Medical Director, Angelini Ventures Disclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

Rumors of biggest pharma merger ever drop amid Q2 earnings, contentious FDA adcomms

23 min

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.

The next treatment-resistant depression paradigm

20 min

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. Host ⁠Jennifer C. Smith-Parker, Director of Insights, BioSpace Guests Hans Eriksson, Chief Medical Officer, FundaMental Pharma Steve Levine, Chief Patient Officer, Compass Pathways Disclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

Life after the lead asset: Advancing an early-stage pipeline

24 min

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 — an inflection point many biotech and pharma companies face, but few navigate effectively. This episode is presented in partnership with Arvinas. Host Jennifer Smith-Parker, Director of Insights, BioSpace Guest Randy Teel, President and CEO, Arvinas

Capricor and Replimune prep for FDA adcomms, Q2 earnings roll on, Sarepta’s new leader, more

17 min

The FDA published briefing documents ahead of advisory committee meetings for Capricor Therapeutics’ Duchenne muscular dystrophy therapy and Replimune’s advanced melanoma drug indicating an uphill battle for the biotechs; GSK and AstraZeneca outlined ambitious plans in second quarter presentations; Sarepta tapped Michael Severino as its new CEO; and Amgen launched its official defense of Tavneos.

Nordic biotech’s next act: From fragmentation to global force

20 min

In this episode of Denatured, you’ll hear from Ester Sklarsky, principal at Sound Bioventures and João Ribas, partner at Novo Holdings Seed Investments. In this episode, we explore the diverging trajectories of Nordic biotech and what it will take for the region, including Norway and Finland, to compete more cohesively on the global stage. Host Jennifer C. Smith-Parker, Director of Insights, BioSpace Guests Ester Sklarsky, Principal, Sound Bioventures João Ribas, Partner, Novo Holdings Seed Investments Disclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

Q2 earnings underway, FDA’s CRL kerfuffle, IPOs full speed ahead in H2

21 min

Second quarter earnings continue to roll with Novartis and Roche reporting this week; Eli Lilly’s AtaiBeckley buy for up to $3.8 billion offers clear “validation” for the fledgling psychedelics space; more drama unfolds at FDA as the agency goes back and forth on its policy of publishing complete response letters in real-time; and IPO fever continues.  

The future of pain relief: Exploring opioid alternatives

19 min

In this episode of Denatured, you’ll hear from Lance Alstodt, chairman and CEO at Biorestorative Therapies, and Paul Mieyal, chief business officer at South Rampart Pharma. We explore why pain has remained such a difficult therapeutic area to tackle and one of the biggest unmet needs today, and how non-opioid mechanisms to regenerative therapies could reshape the future of treatment. Host Jennifer C. Smith-Parker, Director of Insights, BioSpace Guests Lance Alstodt, Chairman & CEO, BioRestorative Therapies Paul Mieyal, Chief Business Officer, South Rampart Pharma Disclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

Biogen validates anti-tau approach at AAIC, psychedelics full speed ahead, ATTR-CM shakeup

21 min

Biogen’s new data, presented at the Alzheimer's Association International Conference, supports a tau-focused approach to the intractable neurodegenerative disease; psychedelics are back in the news with more positive data from Compass Pathways and final guidance from the FDA; and the ATTR-CM space got a major shakeup with the late-stage failure of AstraZeneca and Ionis’ antisense therapeutic.

Bonus: Q2 2026 Job Market Update

9 min

In this bonus episode, BioSpace Managing Editor Jef Akst and Angela Gabriel, content manager, life sciences careers, look at the Q2 job market and discuss encouraging signs for job seekers.

From sequence to scale: Gene editing’s new era in biologics manufacturing

20 min

In this episode of Denatured, you’ll hear from Jack Crawford, CEO of Demetra, and Magnus Gustavsson, chief commercial officer at NorthX Biologics. We unpack the evolution of cell line development — CHO cells, targeted integration, transposases and the collaboration models speeding biologics from sequence to GMP. Host Jennifer C. Smith-Parker, Director of Insights, BioSpace Guests Jack Crawford, CEO, Demeetra Magnus Gustafsson, Chief Commercial Officer, NorthX Biologics Disclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

The Golden Triangle and the gaps: Rethinking UK biotech

19 min

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.   Host   Jennifer C. Smith-Parker, Director of Insights, BioSpace   Guests   Hakan Goker, Managing Director, M Ventures Maina Bhaman, Partner, Sofinnova Partners   Disclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

AbbVie keeps M&A rolling, FDA’s reversal train chugs along, BIO 2026 dispatch, more

21 min

This year has been partly defined by a return to M&A. In the first quarter of 2026, biopharma spent nearly $47 billion in acquisitions across 19 deals, and this week, AbbVie notched another one for the second quarter, scooping up Apogee Therapeutics and its IL-23 blocker for atopic dermatitis for around $10.9 billion. The deal follows GSK’s $10.6 billion Nuvalent Bio acquisition earlier this month.   These deals come as several big pharmas face patent cliffs. Sanofi, for example, will lose patent protection on Dupixent in 2031. New CEO Belén Garijo made a major play to build out Sanofi’s pipeline this week, announcing that Xaira veteran Paulo Fontoura will step in as R&D chief as Houman Ashrafian exits.    Another key trend over the past 18 months has been regulatory uncertainty. This trend continues, with both uniQure and REGENXBIO announcing FDA reversals for their gene therapies for Huntington’s disease and Hunter syndrome, respectively. Both companies will submit for approval of their products—a first submission for uniQure and a resubmission for REGENXBIO—in the third quarter, after the agency, under the leadership of acting commissioner Kyle Diamantas, deemed their current data sufficient.   Also at the FDA, a policy memo on the agency’s consideration of Sanofi’s Commissioner’s Priority Review Voucher for type 1 diabetes drug Tzield threw more fire on the CNPV program, which has already been mired in controversy. And the agency debuted an investigational new drug pilot program that would leverage collaborations with U.S. research institutions to reduce early trial timelines by as much as 12 months.   For a special treat, we heard from BioSpace Managing Editor Jef Akst and Senior Editor Annalee Armstrong who are currently in San Diego enjoying BIO 2026.   And finally, on the Eli Lilly front, a new report from Evaluate projects that the company’s weight loss franchise will account for nearly half of the total sales of the top 10 drugs in 2032. But Lilly isn’t re...

From fragile skin to living medicine: Lessons from RDEB

21 min

In this episode of Denatured, you'll hear from Mark Lowdell, CSO & co-founder at INmuneBio Inc. and Vishwas Seshadri, CEO & director at Abeona Therapeutics. We examine how recessive dystrophic epidermolysis bullosa serves as a model for cell and gene therapy, and what this ultra-rare disease teaches us about scaling advanced treatments for the future.   Host   Jennifer C. Smith-Parker, Director of Insights, BioSpace   Guests   Mark Lowdell, CSO & Co-Founder, INmuneBio Inc   Vishwas Seshadri, CEO & Director, Abeona Therapeutics   Disclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

Moderna’s FDA adcomm, IPO mania, biopharma layoffs, more

25 min

Moderna’s mRNA-based flu vaccine made headlines in February when the FDA declined to even review the application. Days later, the agency reversed course, setting a decision date for August and later scheduling an advisory committee meeting for June 18. In documents released ahead of that meeting, the FDA and Moderna seem to have reached alignment, though the agency did flag certain data gaps for advisors to review. Biotech IPOs are off the charts—literally. This past month has seen not one but two record-setting public debuts. First there was Kailera Therapeutics, which hit the market with $625 million in April, outpacing Moderna’s 2018 IPO of $600 million. And now we have Parabilis Medicines, which last week dethroned Kailera as the largest biotech IPO of all time, with $670 million. Meanwhile, the number of employees laid off spiked by almost 50% year-over-year in May, though that jump is mostly due to significant cuts at Takeda and BioNTech. Genentech also made a big change last week. Eli Lilly continued its dealmaking spree with AlzeCure, striking a licensing agreement worth up to $1 billion centering on a small-molecule asset for Alzheimer’s disease. But the bigger Lilly news in the past week was clinical results that show promise for the pharma’s $2.3 billion acquisition of Ajax Therapeutics in April. Earlier this month, the FDA held a public session to glean feedback regarding the Commissioner’s National Priority Voucher program, in which several groups called for a temporary pause to the pilot, citing concerns about transparency and political involvement. While the future of that program hangs in the balance, two voucher holders got updates this week. First, Sanofi’s diabetes drug Tzield was greenlit for older kids and teenagers, though it’s unclear whether a voucher was associated with the approval. Meanwhile, Disc Medicine’s rejected rare disease drug bitopertin appears to be back on track, with the biotech announcing last week that the FDA will allow...

Portugal, Spain and the new biotech frontier

20 min

In this episode of Denatured, as part of our series on the European life sciences investment ecosystem, you'll hear from Hannah Franklin, associate at Biovance Capital and Pablo Gabriel Cironi Lopez, director of life science investment at Caixa Capital Risc. We examine the rise of Southern Europe’s biotech ecosystem—from Portugal’s efforts to turn strong science into startups to Spain’s growing depth of capital and talent—and what it will take for the region to compete globally. Host ⁠Jennifer C. Smith-Parker, Director of Insights, BioSpace Guests Hannah Franklin, Associate, Biovance Capital Pablo Gabriel Cironi Lopez, Director, Life Science Investment, Caixa Capital Risc Disclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

Lilly tees off with Novo at ADA, GSK’s $10.6B deal, FDA reform continues in Makary’s absence

25 min

Everything came up roses for Eli Lilly at the American Diabetes Association, as the pharma boasted positive results for its new pill Foundayo and next-gen asset retatrutide—not just for weight loss but also for other indications. Obesity rival Novo Nordisk, meanwhile, held a dinner, during which executives may have convinced analysts that the company is turning a corner after a rough couple of years. Also check out ADA updates from Roche and partner Zealand Pharma, Boehringer Ingleheim, Pfizer (touting results from its Metsera buy), AstraZeneca, Kailera Therapeutics and more. Outside of ADA, the biggest news of the past week came on Tuesday with GSK striking the biggest traditional pharma/biotech M&A of the year so far with its $10.6 billion acquisition of oncology focused Nuvalent Bio. And on Monday, J&J notched a smaller deal, buying out Firefly Bio for $1B. These deals add to continued uptick in M&A seen in biopharma this year, with much of that momentum being driven by Eli Lilly and its GLP-1 cash. At an FDA listening meeting last week on the Commissioner’s National Priority Voucher program, the agency heard multiple calls to pause it. Confusion also still persists around all of the new rare disease pathways, including the new plausible mechanism framework.

Rethinking hair loss treatment

21 min

In this episode of Denatured, you'll be hearing from Daniel Gil, CEO of Pelage Pharmaceuticals and Francisco Ramírez-Valle, senior vice president of immunology discovery at Eli Lilly. We dive into the long-overlooked hair loss space, exploring why true innovation has lagged, how a regenerative approach aims to reactivate dormant follicles and what early proof-of-concept means for patients. Host Jennifer C. Smith-Parker, Director of Insights, BioSpace Guests Daniel Gil, CEO, Pelage Pharmaceuticals Francisco Ramírez-Valle, Senior Vice President, Immunology Discovery, Eli Lilly Disclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

ASCO wins from RevMed, Akeso/Summit, more; plus more Lilly and more China; ADA on deck

27 min

At the American Society of Clinical Oncology (ASCO) annual meeting in Chicago this past weekend, packed plenary sessions from Revolution Medicines and Summit Therapeutics’ Chinese partner Akeso stole the show. For RevMed, analysts anticipate a potential approval in pancreatic cancer as early as this year, while Summit still has a tough road ahead showing that the survival benefit seen in Akeso’s clinical trial in China will hold up in a global population. Immuneering, BMS/BioNTech, Merck, Pfizer and many more also scored oncology wins at the annual meeting, as did Moderna, with “encouraging” 5-year survival for its mRNA-based personalized melanoma vaccine. Outside of ASCO, the past week saw Pfizer strike an unusual pact with China’s Innovent Biologics as it seeks to bolster its oncology pipeline. Reminiscent of another recent deal from BMS and Hengrui Pharma, it could signal a more collaborative approach to working with Chinese companies. We’ll also cover the latest deals from Eli Lilly, which continues to rack up partners with its GLP-1 windfall. Finally, learn about how BrainStorm is planning another FDA bid for its experimental ALS therapy NurOwn with former regulator Peter Pitts now on the board, and check out a preview of the 2026 American Diabetes Association, or ADA, which kicks off this weekend in New Orleans.

France’s biotech ecosystem: science, capital and scale

21 min

In this episode of Denatured, as part of our series on the European life sciences investment ecosystem, you'll be hearing from Ksenija Pavletic, partner and chief commercial officer at Jeito Capital and Thierry Laugel, managing partner at Kurma Partners. We dive into France’s biotech ecosystem and what still needs to happen for more early innovation to translate into investable, scalable biotech. Host ⁠Jennifer C. Smith-Parker, Director of Insights, BioSpace Guests Ksenija Pavletic, Partner and Chief Commercial Officer, Jeito Capital Thierry Laugel, Managing Partner, Kurma Partners Disclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

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