BioSpace

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.

In this episode of Denatured, BioSpace editorial team members, Senior Editor, Annalee Armstrong, and News Editor, Dan Samorodnitsky, discuss their post-JPM takeaways and 2026 forecasts after speaking to a range of pharma and biotech executives and investors last week.

Hosts⁠
Jennifer Smith-Parker⁠, Director of Insights, BioSpace⁠

Guests
⁠Annalee Armstrong, Senior Editor, BioSpace
⁠Dan Samorodnitsky, News Editor, BioSpace

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

The 2026 J.P. Morgan Healthcare Conference concludedlast week without a big M&A deal. But the meeting was anything but boring, with President Donald Trump’sMost Favored Nation drug pricing scheme and the perpetual battle for supremacyin the obesity space between Eli Lilly and Novo Nordisk prime topics of conversation. Meanwhile, other companies like Biohaven refuse tocede the entire weight loss market, stating their intention to carve out apiece of the massive pie.
 
On the competitive front, Novo took a step forwardMonday with the news that its Wegovy pill reached nearly 3,100 patients since its launch on Jan. 5. Meanwhile, an FDAdecision for Lilly’s own oral offering, orforglipron, has been delayed from March28 to April 10. Orforglipron is being reviewed under the FDA’s new Commissioner’sNational Priority Voucher (CNPV) program, which aims to shorten the reviewperiod from 10–12 months to 1–2 months. Other voucher recipients—includingSanofi and Disc Medicine—have also had their decisions delayed.
 
While the FDA wasn’t a primary focus at JPM, severalbiotechs sought to make clear during their investor presentations that they hadsecured alignment with the regulator on trial design or pathways to approval. This comesafter a year that has seen many of their peers experience regulatory whiplashas previous FDA guidance was seemingly reversed.
 
And on the business front, IPOs are back! This week, SpyGlass Pharma and AgomAb Therapeutics joined Veradermicsand Eikon Therapeutics on the rapidly accelerating IPO train. Aktis Oncology,which announced its bid in late 2025, debuted on the Nasdaq earlier this month.
 
And in BioPharm Executive this week, Annalee Armstrongand Dan Samorodnitsky catch up with execs from Novo Nordisk, Korro Bio, Biohaven and Galapagos.