BioSpace

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.

Host

Annalee Armstrong, Senior Editor, BioSpace

Guests

Rena Denoncourt, Chief Operating Officer, Corsera Health

Meredith Kaya, Chief Financial Officer, Corsera Health

Disclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

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.

Host

Jennifer Smith-Parker, Director of Insights, BioSpace

Guests

Jane Hughes, President of R&D and Co-founder, Verdiva Bio

Jon Rees, CEO and Co-founder, MitoRx Therapeutics

Disclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

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 FDA guidance from 2024.”

Regardless of the reasons, the development imperilsModerna’s breakeven plans, affecting not just the company’s investigational flu vaccine but also a flu-COVID combo shot and other parts of the company’s pipeline. And for the broader industry, it highlights the regulatory uncertainty that persists into 2026, even as other countries move full speed ahead with novel modalities.

That regulatory uncertainty extended this week to DiscMedicine, whose rare disease drug bitopertin was rejectedby the FDA. The company tried to convince investors that its planned Phase 3 trial would pave the way toward a refiling, but analysts raised concerns that the study was developed with oldFDA leadership. Disc’s situation also raises questions about the FDA’s Commissioner’s National Priority Voucher, which bitopertin had received.

Meanwhile, Compass Pathways dropped long-awaited data from two Phase 3 trials of its psilocybin-based COMP360, showing strong durability data that “clearly met the Street’s bar for success,” according to Stifel analysts. The company plans to complete a rolling new drug application by the end of the year.

Finally, the CDC has been left leaderless, again, with the departure of Jim O’Neill, who had been servingas acting director after the ouster of Susan Monarez last summer. And Sanofi’s Paul Hudson was removed as CEO last week. He’ll be replaced by Merck KGaA’s Belén Garijo, who becomes just the second woman in charge of a Big pharmacompany.

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 the regulatory side is catching up. The FDA Modernization Act, now making its way through Congress, codifies the FDA’s stated goal of starting to move away from animal testing. And in making that announcement last year, the FDA put out a roadmap for how to do this.

In May, Hartung will attend the National Biotechnology Conference in San Diego as a keynote speaker. BioSpace is a media partner of the meeting, and Managing Editor Jef Akst will also attend to moderate the executive track.

The 2026 National Biotechnology Conference runs May 11–14.You can find the agenda here.

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 treatments.

Host

Jennifer Smith-Parker, Director of Insights, BioSpace

Guests

Dr. Rob Monroe, Vice President and Chief Scientific Officer, Oncology, Danaher Corporation; Chief Medical Officer, Leica Biosystems

Jennifer Faikish, Vice President and Franchise Head, Oncology, Danaher Corporation

Disclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

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 hit Hims with a warning letter last year about infestations of vermin at a facility it owns, including rodents, birds and insects, as well as a live spider in a production area.

The timing of all the Hims drama is interesting, because BioSpace was already covering Novo, Lilly and their blockbuster GLP weight loss drugs as both companies—and others—reported 2025 fourth quarter and full year earnings. EliLilly and Novo both reported last Wednesday, and both spoke of Novo’s oral Wegovy launch positively. But the calls had two very different tones, as Lilly beat Q4 2025 analyst consensus by more than a billion dollars while Novo projected sales to decline by 5% in 2026.

In other recent earnings calls, AbbVie touted strong Skyriziand Rinvoq sales, and the company continues to follow Johnson & Johnson’s lead into the psychedelics space. And Biogen discussed the highly anticipated readout of its tau-targetingtherapy for Alzheimer’s.

Finally, in gene therapy, Sarepta struggles to recover from last year’s patient deaths as other DMD contenders near the market; uniQure pauses two arms of a clinical trial for Fabry disease; and Ultragenyx resubmits its in vivo gene therapy UX111 for the treatment of Sanfilippo syndrome type A.

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 and logic circuit RNA are expanding the field's therapeutic horizons.

Host

Jennifer Smith-Parker, Director of Insights, BioSpace

Guests

Erik Digman Wiklund⁠, CEO, Circio

Jacob Becraft, Co-founder and CEO, Strand Therapeutics

Disclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

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 years.”

These calls followed Roche last week and Johnson & Johnson before that, but earnings season is just getting started. On the docket today is Eli Lilly, which has been acquisitive of late, plus Novo Nordisk, Novartis, AbbVie and more.

On the regulatory front, the FDA is expected to decideon eight products this month, including REGENXBIO’s Hunter syndrome gene therapy RGX-121. The biotech ran into a regulatory snag last week, however, as the FDA placed a clinical hold on two of its programs, including RGX-121. The agency also launched its much-anticipated PreCheck pilot program, which aims to make it easier for companies to build manufacturing plants in the U.S. And President Donald Trump’s TrumpRx platform is delayed, potentially amid anti-kickback concerns.

In ClinicaSpace this week, we took a deep dive intothe resurgent psychedelics space, which could see two companies—Compass Pathways and Definium—submit FDAapplications this year. H.C. Wainwright analyst Patrick Trucchio told BioSpace 2026 is set to be “the biggest year from a clinical data standpoint,” since the firm began covering Compass in 2018.

And check your inboxes Wednesday for BioPharmExecutive, where we take a look back at the banner IPO year that was 2021: Where are these companies now?

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 “alpha stacking” shapes their investment edge in an age of chronic uncertainty. They cover topics discussed in RTW's new book, "Innovation is the Best Medicine."

Hosts⁠⁠⁠

⁠Jennifer Smith-Parker⁠⁠, Director of Insights, BioSpace

Guests

Roderick Wong, Managing Partner, Chief Investment Officer, RTW Investments

Stephanie Sirota, Partner, Chief Business Officer, RTW Investments

Disclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

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 fewer gastrointestinal side effects.

Meanwhile, Baseline Therapeutics debuted to challenge Lilly with a Phase III–ready GLP-1 for alcohol use disorder.

In the vaccines sector, Moderna took perhaps the biggest action to date amid Health Secretary Robert F. Kennedy’s anti-vaccine policies and rhetoric, last week announcing that the company will no longer run late-stage vaccine trials for infectious diseases. “You cannot make a return on investment if you don’t have access to the U.S. market,” CEO Stéphane Bancel saidthe World Economic Forum at Davos, Switzerland. Pfizer CEO Albert Bourla, also speaking at Davos, called RFK Jr.’s rhetoric and policies on vaccines “anti-science.”

Finally, Sarepta released new data on Monday for Elevidys, the company’s embattled gene therapy for neuromuscular disease Duchenne muscular dystrophy. Plus, check out up-and-coming treatments for Alzheimer’s and Parkinson’s.