Tvardi Therapeutics Inc. stock lost 83.9% of its value as investors took in poor preliminary results of the phase II study of its lead candidate for idiopathic pulmonary fibrosis (IPF). The company’s shares (NASDAQ:TVRD) closed at $6.69 each on Oct. 13.
The U.S. FDA has approved the priority sNDA for a new first-line maintenance therapy in extensive-stage small-cell lung cancer from Jazz Pharmaceuticals plc. Zepzelca (lurbinectedin) can now be combined with Tecentriq (atezolizumab, Roche AG) or atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza, Roche) as a maintenance therapy for adults who haven’t progressed after first-line induction therapy with atezolizumab, carboplatin and etoposide.
The dash for MASH is gaining momentum, with Roche AG acquiring 89bio Inc. and its phase III FGF21 analogue, pegozafermin, for treating metabolic dysfunction-associated steatohepatitis, in a deal worth up to $3.5 billion. The Swiss pharma is to pay $14.50 per share, valuing San Francisco-based 89Bio at $2.4 billion, a premium of approximately 52% to 89bio’s 60-day average price on Sept. 17, 2025. Shares of 89bio (NASDAQ:ETNB) gained $6.88, or 85%, to close Sept. 18 at $14.96.
The fate of IL-33-targeting astegolimab will be determined by talks with regulators, after Roche AG’s Genentech unit rolled out mixed results from a pair of studies testing the compound vs. placebo on top of standard-of-care (SOC) maintenance therapy in subjects with moderate to very severe chronic obstructive pulmonary disease (COPD).
How the U.S. FDA might respond became a serious question for Wall Street as Sarepta Therapeutics Inc. made known a second death due to acute liver failure with gene therapy Elevidys (delandistrogene moxeparvovec), cleared for Duchenne muscular dystrophy (DMD). Shares of Cambridge, Mass.-based Sarepta (NASDAQ:SRPT) closed June 16 at $20.94, down $15.24, or 42%, as Wall Street digested the news.
Biopharma deal value declined in the first three months of 2025 compared to the previous quarter, but remained above the 2024 quarterly average of $57.63 billion. In the first quarter (Q1), biopharma deals totaled $66.86 billion across 330 transactions, a decrease from $80.65 billion in Q4 2024, which saw 372 deals. However, this was a significant value increase from Q1 2024, when deals amounted to $44.32 billion across 376 transactions.
Roche AG has become the latest pharmaceutical company to respond to the Trump administration’s threat to impose tariffs, saying it will invest $50 billion in drug and diagnostics manufacturing in the U.S. over the next five years. That figure matches a similar commitment by its Basel, Switzerland-based neighbor, Novartis AG, which on April 11 said it would be investing almost $50 billion in the U.S., also over the next five years.
Biopharma deal value declined in the first three months of 2025 compared to the previous quarter, but remained above the 2024 quarterly average of $57.63 billion. In the first quarter (Q1), biopharma deals totaled $66.86 billion across 330 transactions, a decrease from $80.65 billion in Q4 2024, which saw 372 deals. However, this was a significant value increase from Q1 2024, when deals amounted to $44.32 billion across 376 transactions.
Oxford Biotherapeutics Ltd. is partnering with Roche AG to expand the current field of tumor antigens that can be drugged with antibodies, as part of a potential $1 billion-plus agreement. The agreement will see Oxford Biotherapeutics apply its membrane protein discovery platform to search for novel cancer cell antigens, which will be validated through the research collaboration, with Roche then taking the lead in advancing any resulting antibody programs.
In what it says is the biggest obesity deal to date, Zealand Pharma A/S has signed up Roche AG to a potential $5.3 billion global collaboration and license agreement to develop petrelintide, an amylin analog that is currently in phase IIb development. The two companies will co-develop and co-commercialize petrelintide and combination products, including a fixed-dose combination of petrelintide and CT-388, Roche’s dual GLP-1/GIP receptor agonist.
