BioSpace

00:20:43

Gilead’s Ouro Buy, J&J/Protagonist’s Approval,...

BioSpace ·

2026/03/25

Immunology & inflammation stole the show this week, as Gilead dropped up to $2.1 billion for Ouro Medicines and its T cell engager OM336—an investment it hopes to split with longtime partner Galapagos. Meanwhile, Sanofi also added a T cell engager in a licensing deal with Kali Therapeutics worth $180 million upfront.One I&I partnership that bore fruit last week was that of Johnson & Johnson and Protagonist Therapeutics which got their IL-23 receptor blocker Icotyde across the FDA finish

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00:20:05

Inside the Race to Build the Next Generation of AI...

BioSpace ·

2026/03/19

In this episode, you'll be listening to Akshay Rai, principal, Healthcare & Biotech Investments at Premji Invest and Viswa Colluru, CEO and founder, Enveda. They discuss how AI platforms must now prove themselves through data, focused pipelines and clinical readouts and that promises of faster, cheaper drug discovery are not enough to entice strong investor engagement. HostJennifer Smith-Parker, Director of Insights, BioSpaceGuestsViswa Colluru, CEO & Founder, EnvedaAkshay Rai, Principal,

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00:20:08

Kennedy’s Vaccine Agenda Stalled, Structure’s...

BioSpace ·

2026/03/18

Biopharma’s weight loss warriors have led the news this week, with Structure Therapeutics and Rhythm Pharmaceuticals announcing new data. Structure delivered a “competitive profile” for its investigational GLP-1 pill compared to Eli Lilly’s orforglipron and Novo Nordisk’s oral Wegovy, BMO Capital Markets wrote to investors, after the candidate elicited 16.3% weight loss after 44 weeks in a Phase 2 trial. Rhythm was not as successful, announcing that Imcivree failed in a Phase 3 basket trial of

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00:21:20

From Two Trials to One, Sponsors Face a Higher Standard

BioSpace ·

2026/03/12

In this episode of Denatured, you'll listen to Oxana Iliach, senior director of regulatory strategy at Certara and Vera Pomerantseva, director of product management for risk-based quality management at eClinical Solutions. We speak about how the FDA's latest decision to have one, rather than two pivotal studies, for new drug applications raises the bar for data collection and risk-based management.Host⁠Jennifer C. Smith-Parker⁠, Director of Insights, BioSpaceGuestsOxana Iliach, Senior Director of

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00:28:12

Prasad Out at FDA, Lawmaker Takes Action on Rare...

BioSpace ·

2026/03/11

After Friday’s news that Center for Biologics Evaluation & Research Chief Vinay Prasad will leave the FDA—again—at the end of April, stocks for several rare disease drug developers popped. UniQure, in particular, was up 51% in premarket trading on Monday. Prasad in a meeting last Thursday with select journalists called the biotech’s Huntington’s treatment AMT-130 a “failed” therapy, according to STAT News. Shares of Replimune and REGENXBIO—which have suffered rejections during the past year—also

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00:21:18

Rising Amid Flurry of CAR T Deals, Stylus Proves Cell...

BioSpace ·

2026/03/10

Stylus Medicine CEO Emile Nuwaysir and Chief Scientific Officer Jason Fontenot speak with BioSpace about the biotech's work on next-generation genetic medicines—and why they think it’s the perfect time to be in the cell therapy game. Stylus Medicine is featured in BioSpace's list, the top startups to watch in the U.S.HostAnnalee Armstrong, Senior Editor, BioSpaceGuestsEmile Nuwaysir, CEO, Stylus MedicineJason Fontenot, Chief Scientific Officer, Stylus MedicineDisclaimer: The views expressed in this

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00:22:47

From Grants to Family Offices: Building a Unified...

BioSpace ·

2026/03/05

In this Denatured episode, Jennifer C. Smith-Parker speaks to Ram May-Ron, managing partner at FreeMind Group, and Ravi Kiron, managing director at Biopharma Strategy Advisors. We'll discuss how best to tailor an investment approach of both nondilutive funding and family offices to overcome the drug development valley of death. Host⁠Jennifer Smith-Parker⁠, Director of Insights, BioSpaceGuestsRam May-Ron, Managing Partner, FreeMind GroupRavi Kiron, Managing Director, Biopharma Strategy

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00:23:37

UniQure’s Delay, REGENXBIO’s Rejection Explained,...

BioSpace ·

2026/03/04

The FDA is dominating the headlines once again thisweek. Days after FDA Commissioner Marty Makary appeared to question uniQure’s gene therapy candidate for Huntington’s disease, the company revealed that the agency will require it to conduct a randomized, double-blind, sham surgery–controlled Phase 3 study. The FDA also published anothercomplete response letter (CRL), this one for REGENXBIO’s gene therapy for Hunter syndrome. The rejection, sustained by the biotech early last month, was driven by

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00:20:45

ALS Advances Unite Patients and Pharma on Novel...

BioSpace ·

2026/02/26

In this episode, you'll be listening to Indu Navar, CEO and founder of EverythingALS and Dr. Olga Uspenskaya, chief medical officer at VectorY Therapeutics. We'll be speaking about patient-pharma collaborations accelerating trials and hope, advances in ALS biology understanding and biomarker-driven endpoints.HostJennifer Smith-Parker, Director of Insights, BioSpaceGuests⁠Indu Navar⁠, CEO and Founder, EverythingALSDr. Olga Uspenskaya, Chief Medical Officer, VectorY TherapeuticsDisclaimer: The

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00:24:37

Lilly Bests Novo Again, Rare Disease Week Goes...

BioSpace ·

2026/02/25

Eli Lilly notches another win over Novo Nordisk, as Zepbound bests CagriSema in a head-to-head trial sponsored by Novo; The FDA kicked off Rare Disease Week, providing draft guidance on its new plausible mechanism pathway, while a bipartisan senate hearing on Thursday will focus on the authorization process for rare conditions; Another leadership change shakes up CDC; and Gilead acquires CAR T partner Arcellx for nearly $8 billion. Everything is coming up Lilly. The Indianapolis-based pharma bested

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00:17:33

Corsera Eyes Two-Pronged Approach To Tackle Leading...

BioSpace ·

2026/02/24

Corsera Health’s Chief Operating Officer Rena Denoncourt and CFO Meredith Kaya speak with BioSpace about the biotech’s mission and vision for the next generation of cardiovascular care in this special bonus episode. Corsera Health is featured in BioSpace's NextGen: Class of 2026 list, the top startups to watch in the U.S.HostAnnalee Armstrong, Senior Editor, BioSpaceGuestsRena Denoncourt, Chief Operating Officer, Corsera HealthMeredith Kaya, Chief Financial Officer, Corsera HealthDisclaimer: The

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00:18:33

Redefining Obesity Treatment Beyond GLP-1 Limits

BioSpace ·

2026/02/19

In this episode, you'll be listening to Jane Hughes, President of R&D and Co Founder of Verdiva Bio, and Jon Rees, CEO and cofounder of MitoRx Therapeutics. We'll discuss next-generation obesity solutions tackling GLP-1's muscle loss and adherence challenges, through innovative muscle preservation, oral administration and combination therapy.HostJennifer Smith-Parker, Director of Insights, BioSpaceGuestsJane Hughes, President of R&D and Co-founder, Verdiva BioJon Rees, CEO and

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00:20:42

Modernagate Fallout, Disc’s Rejection, Compass’...

BioSpace ·

2026/02/18

Last week, the FDA declined to review Moderna’s mRNA-based flu vaccine, with Center for Biologics Evaluation and Research Director Vinay Prasad himself signing the refuse-to-file (RTF) letter. Prasad said Moderna’s comparator group “does notreflect the best-available standard of care,” while Moderna pushed back, saying CBER had previously found a standard-dose flu shot to be an “acceptable” comparator. Despite the shocking turn of events, HHS backed Prasad, saying Moderna didn’t “follow very clear

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00:15:36

As FDA Moves Away From Animal Testing, AI and...

BioSpace ·

2026/02/17

Last year, the FDA announced it would be phasingout animal testing requirements for some therapies. The NIHfollowed suit. According to Thomas Hartung, professor and chair at Johns Hopkins Bloomberg School of Public Health, these policy shifts are an “overdue adaptation to scientific progress.” In this special edition of The Weekly, Hartung discusses howartificial intelligence (AI) and various non-animal models such as human organoids will transform drug development and delivery, especially now that

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00:23:11

Digital Pathology, AI and the Future of ADCs and HER2...

BioSpace ·

2026/02/12

In this episode of Denatured, Jennifer C. Smith-Parker speaks with Dr. Rob Monroe, Vice President and Chief Scientific Officer of Oncology at Danaher Corporation and Chief Medical Officer at Leica Biosystems, and Jennifer Fakish, Vice President and Franchise Head of Oncology at Danaher Corporation. We'll be discussing how antibody drug conjugates (ADCs) are transforming cancer care and with AI-powered pathology, doctors can now measure her HER2 more precisely to match patients with the best

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00:24:49

Weight Loss Drama Compounds on Heels of Novo, Lilly...

BioSpace ·

2026/02/11

Last Thursday, Hims & Hers launched a compounded versionof Novo’s oral Wegovy, approved just before Christmas and launched in early January. Novo was, not surprisingly, none too pleased. FDA Commissioner Marty Makary denounced“illegal copycat drugs” in an X post the same day without naming Hims, which then said it would notsell the oral weight loss drug. Novo sued the consumer healthcare company for patent infringement, seeking potentially hundreds of millions in damages. Thenit emerged that FDA

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00:24:36

Programmable RNA 2.0: Beyond the First mRNA Revolution

BioSpace ·

2026/02/05

In this episode of Denatured, Jennifer C. Smith-Parker speaks to Erik Digman Wiklud, CEO of Circio and Jacob Becraft, CO-founder and CEO of Strand Therapeutics. Since the mRNA vaccine breakthroughs of the COVID-19 era, attention has turned to what's next for programmable medicines. While first- generation mRNA prove the power of transient genetic instruction, its instability, immune reactivity, and short-lived expression have limited its use mainly to vaccines. Emerging platforms like circular

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00:17:35

Pfizer’s Metsera Data, 2025 Earnings, the FDA and...

BioSpace ·

2026/02/04

Pfizer reported the first data from its new obesity pipeline, picked up in the nearly $10 billion acquisition of Metsera last fall. While BMO Capital Markets said in a Tuesday note that the data “look competitive,” analysts clamored for more details on Pfizer’s earnings call the same morning—and were left wanting more. Meawhile, Merck batted away accusations of “modest growth” from analysts on its own earnings call, as CEO Robert Davis touted “probably the broadest and widest pipelinewe’ve had in

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00:19:41

Biotech’s New Cycle, JPM Deal Hype and Where Alpha...

BioSpace ·

2026/01/29

In this episode of Denatured, Jennifer C. Smith-Parker speaks with RTW’s Rod Wong and Stephanie Sirota how shifting JPM deal timing masks record M&A potential; why oncology, obesity, psychedelics, and neuroscience are attracting fresh capital; and how “alphastacking” shapes their investment edge in an age of chronic uncertainty. They cover topics discussed in RTW's new book, "Innovation is the Best Medicine."Hosts⁠⁠⁠⁠Jennifer Smith-Parker⁠⁠, Director of Insights,

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00:17:00

Roche Makes Obesity Splash, Moderna Cans Vaccine...

BioSpace ·

2026/01/28

Roche made the biggest splash this week so far, announcing on Tuesday that GLP-1/GIP injectable CT-388 led to 22.5%weight loss in a Phase II trial. These numbers appear to put CT-388, which Roche acquired in its $2.7 billion Carmot buy, in line with Eli Lilly’s Zepbound, according to William Blair analysts. Roche plans to start a Phase III study of CT-388 in the first half of this year and is also pairing the drug with a therapy from Zealand Pharma, with the aim of offering a weight lossoption with

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