BioSpace

On the sidelines of this year’s J.P. Morgan Healthcare Conference in San Francisco, BioSpace Senior Editor Annalee Armstrong sat down with Kevin Marks, CEO of Delphia Therapeutics, a member of BioSpace’s ⁠NextGen Class of 2025⁠. Their discussion here focused on the company’s novel science of activation lethality, which involves forcing cancer cells to overactivate and thereby overload cell stress pathways, as well as Delphia's relatively smooth path to a $67 million series A raise thanks to contributions from Google Ventures (GV), where Marks was previously employed.

This is the second episode in a special series of The Weekly focused on how NextGen companies are navigating the current business environment.

Host

⁠Annalee Armstrong⁠, Senior Editor, BioSpace

Guest

⁠Kevin Marks⁠, President and CEO, Delphia Therapeutics

For a complete list of NextGen 2025 companies, ⁠click here⁠.

Miruna Sasu, CEO of COTA, has been labeled as a disrupter in the industry. In this discussion, she highlights the challenges of investing in the life sciences industry. She also suggests how the investor mindset needs to change as well as offer solutions that benefit both investors and developers seeking investment.

Host

⁠⁠Lori Ellis⁠⁠, Head of Insights, BioSpace

Guests

Miruna Sasu, President and CEO, COTA

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

There was a high point this week for employees riding the rollercoaster that is currently the FDA, as 300 recently fired employees are reportedly being asked to return. This could serve to boost spirits at the agency, which is reeling from unpredictable and seemingly ‘indiscriminate’ layoffs—and low morale as a result.   

Trump made additional waves over the weekend, threatening to enact tariffs on the largest pharmaceutical companies—unless they relocate their manufacturing operations to the U.S. And the early impacts of the new administration continue to be felt, as the CDC’s vaccine advisory board postponed its first meeting of 2025—just a week after RFK Jr.’s confirmation as HHS secretary.   

In weight loss news, the Outsourcing Facilities Association (OFA), which represents compounders, is suing the FDA after the agency declared an end to the shortage of semaglutide, marketed by Novo Nordisk as Ozempic and Wegovy. This followed a similar OFA lawsuit last fall, filed after the FDA removed Eli Lilly’s tirzepatide— Zepbound and Mounjaro—from its shortage list. In a possible attempt to protect Zepbound from compounder competition, Lilly announced Tuesday that it will expand single dose vials options of the blockbuster weight loss drug at a reduced price. This all comes as a new study compares physician wishlists with investment in the obesity space—and reveals key indicators for drug developers.  

And it’s been a good news/bad news kind of week in gene therapy, as Pfizer discontinued hemophilia B drug Beqvez worldwide, Regeneron reported more positive data from its gene therapy for genetic deafness and, facing a cash crunch, bluebird bio elected to go private in an acquisition by global investment firms Carlyle and SK Capital Partners.   

Finally, let us leave you with a ghost story—the story of so-called “ghost assets” that have found a new home, and a new purpose.  

At the 2025 National Biotechnology Conference, gene therapies, bispecific antibodies and other novel modalities—relative newcomers to medicine—will be much discussed. In this curtain raiser, BioSpace speaks with conference chair Prathap Nagaraja Shastri of J&J about these highly anticipated topics. 

Host

Jef Akst, Managing Editor, BioSpace

Guest

Prathap Nagaraja Shastri, Scientific Director and Group Leader, Clinical Pharmacology and Pharmacometrics, Johnson and JohnsonBioSpace is a media partner of the National Biotechnology Conference.

President Trump has been on a staff cutting rampage since taking office, and this weekend, the hammer came down on an undisclosed number of FDA employees. The firings—which reportedly affected staffers within the FDA’s centers for food, medical devices and tobacco products—came days after Robert F. Kennedy Jr. was confirmed as HHS secretary.

One space that could have an ally in RFK Jr. is psychedelic therapies, which the new HHS boss has accused the FDA of “suppressing,” along with stem cell therapies. On the flip side, Kennedy is a well-known vaccine critic, though his confirmation didn’t affect the approvals of a pair of vaccines—one for GSK’s meningococcal shot and another for Bavarian Nordic’s chikungunya jab.

One notable vaccine maker, however, is struggling. Moderna reported Q4 and 2024 earnings last week, revealing full-year revenue of just over $3 billion—less than half of the nearly $7 billion the company brought in the year before. Adding insult to financial injury, Moderna is also laying off around 50 employees on its digital team.

Moderna isn’t the only company facing challenges. Several biopharmas, including Merck, Regeneron and Bristol Myers Squibb are facing patent headwinds that, according to William Blair, are the strongest they’ve been in nearly 15 years. It’s also a difficult climate in which to stay alive as a biotech, to which the 13 bankruptcies in 2024 can attest.

Finally, BioSpace launched a new NextGen podcast series this week, in which senior editor Annalee Armstrong speaks with execs from four of our NextGen Class of 2025 companies—starting with COUR Pharmaceuticals.

On the sidelines of this year’s J.P. Morgan Healthcare Conference in San Francisco, BioSpace Senior Editor Annalee Armstrong sat down with Dannielle Appelhans, CEO of COUR, a member of BioSpace’s NextGen Class of 2025. Their discussion here, focused on the company’s long history leading up to its $105 million in series A funding at the start of 2024 and the possibility of an initial public offering in the future, among other things, represents the first of a special series of The Weekly focused on how NextGen companies are navigating the current business environment.

Host

Annalee Armstrong, Senior Editor, BioSpace

Guest

Dannielle Appelhans, CEO, COUR

For a complete list of NextGen 2025 companies, click here.

The NextGen Class of 2025 is brought to you by Pliancy.

BioSpace’s Head of Insights Lori Ellis and Tom Whitehead, co-founder of the Emily Whitehead Foundation discuss the challenges navigated by cancer patients, weaving in their personal experiences with treatment and how they would encourage those undergoing treatment to speak up and advocate for themselves.

This episode is presented by the ⁠Genscript Biotech Global Forum 2025.⁠

Host

⁠⁠Lori Ellis⁠⁠, Head of Insights, BioSpace

Guests

⁠⁠Tom Whitehead,⁠⁠ Author, Keynote speaker; Co-Founder, Emily Whitehead Foundation

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

We saw more action on the M&A front this week as Novartisbought back its blood thinner abelacimab and the rest of Anthos Therapeutics for up to $3.1 billion and still ahead, a potential buyout of SpringWorks Therapeutics by Merck KGaA, which confirmed it’s in “advanced discussions” with the biotech. Meanwhile, Eli Lilly signed aglobal licensing deal for a MASH asset with South Korea’s OliX Pharmaceuticals.

As Q4 and full-year 2024 earnings continue to roll in, BMS, Eli Lilly,Novo Nordisk, AstraZeneca, Eisai, Vertex and Gilead all reported their results in the past week. Notably, BMS continues to reorganize, now targeting an additional $2 billion in savings through 2027, and AstraZeneca axed two rare disease drugs from its $39 billion acquisition of Alexion. When it comes to revenue growth, Novo’s Wegovy and Lilly’s Zepbound continue to climb at a striking pace—a phenomenon that has at times driven the weight loss drugs into shortage and spawning a controversialshadow market of off-brand versions.

Speaking of controversy, Regeneron is suing its Dupixent partner Sanofi, claiming the French pharma has failed to provide it with adequate information regarding sales of the blockbuster anti-inflammatory drug—which missed analyst expectations in Q4.

On the clinical side, the pulmonary fibrosis space continues to see positive results, with Boehringer Ingelheim notching its second Phase III win in six months for nerandomilast. It wasn’t all good news, however, as Pliant Therapeutics suspended dosing and enrollment in a Phase IIb/III study of its idiopathic pulmonary fibrosis candidate, causing its stock to crash.

Finally, BioSpace released a special edition of ClinicaSpace this week focused on the resurgent cardiovascular space—just in time for Valentine’s Day! Sign uphere to receive your copy.

U.S. political maneuverings are keeping biopharma on its toes. Tuesday, Robert F. Kennedy, Jr. passed a major hurdle as the Senate Finance Committee voted to advance his nomination for HHS secretary to a floor vote of the entire Senate. If confirmed, RFK Jr. could have an impact on myriad regulatory issues, including PDUFA negotiations.

In other political news, Donald Trump announced his promised tariffs on Canada, Mexico and China—the last of which could have particular implications for biopharma companies looking to China for promising new drug candidates.

Both were subjects of conversation as leading pharma companies—including Pfizer, Merck and Regeneron—reported their Q4 and full-year 2024 earnings. Notably, Pfizer is eyeing deals between $10 billion and $15 billion, while Merck took a 12% stock hit on Gardasil challenges in China and Regeneron issued its first-ever dividends.

On the regulatory front, the FDA greenlit Vertex’s Jounavx last week as the first new drug for acute pain in more than two decades. Journavx leads a non-opioid pain space that is seeing significant momentum this year, with Tris Pharma, Algiax Pharamceuticals and SiteOne Therapeutics all announcing positive data in the past month.

Meanwhile, in obesity news, the U.K.’s pharmacies regulator rolled out stricter guidelines for online pharmacies selling medicines including Novo Nordisk’s Wegovy and Eli Lilly’s Mounjaro, and an obesity-focused deal inked with Novo last year wasn’t enough to keep Omega Therapeutics afloat as the Massachusetts-based biotech revealed it is heading toward bankruptcy.

Finally, a new CEO will be taking the reins at Takeda in 2026—but the selection of Julie Kim is an exception in an industry still struggling for gender parity at the top leadership ranks.

BioSpace's Head of Insights Lori Ellis and Tom Whitehead sit down and discuss cell and gene therapies from the perspectives of patients. What do caregivers and patients consider to be risks when lives are on the line?

This episode is presented by the Genscript Biotech Global Forum 2025.

Host

⁠Lori Ellis⁠, Head of Insights, BioSpace

Guests

⁠Tom Whitehead,⁠ Author, Keynote speaker; Co-Founder, Emily Whitehead Foundation

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