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Scrip's Five Must-Know Things - Mar.16, 2026

14 min episode · 2 min read

Episode

14 min

Read time

2 min

Topics

Relationships, Startups, Leadership

AI-Generated Summary

Key Takeaways

  • Roche Pipeline Risk: Giadestrant failed the PERSEVERA trial's primary endpoint in first-line ER-positive, HER2-negative advanced breast cancer despite enrolling 992 patients. Jefferies flagged the trial as underpowered. FDA acceptance remains limited to the narrower ESR1-mutated population, constraining peak sales well below Roche's $10B target.
  • BioNTech Leadership Vacuum: Founders Ugur Sahin and Ozlem Tureci are departing to launch an mRNA spinoff, leaving BioNTech without its core visionaries as 15-plus phase three oncology trials approach readout. The company retains €17.2B in cash and a key BMS-partnered PDL1/VEGF bispecific, pemetimaig, as its lead asset.
  • Ipsen Safety-Driven Withdrawal: Tazverik, the only EZH2 inhibitor approved for follicular lymphoma and epithelioid sarcoma, is being voluntarily withdrawn globally after secondary hematologic malignancies emerged in the confirmatory SYMPHONY-1 trial. Sales had already declined 14% to €40.6M in 2025 before the safety signal surfaced.
  • UCB Competitive Positioning: Bimzelx demonstrated statistically significant superiority over AbbVie's Skyrizi at ACR50 week 16 in the 553-patient BE BOLD head-to-head psoriatic arthritis trial. This is UCB's fourth head-to-head superiority win, reinforcing Bimzelx's positioning across rheumatology and dermatology with €2.3B in 2025 annual sales.

What It Covers

Five biotech and pharma developments from the week of March 13, 2026: Roche's Giadestrant phase three failure, BioNTech's founders departing, Ipsen withdrawing Tazverik, Bayer's mixed earnings, and UCB's Bimzelx beating Skyrizi in psoriatic arthritis.

Key Questions Answered

  • Roche Pipeline Risk: Giadestrant failed the PERSEVERA trial's primary endpoint in first-line ER-positive, HER2-negative advanced breast cancer despite enrolling 992 patients. Jefferies flagged the trial as underpowered. FDA acceptance remains limited to the narrower ESR1-mutated population, constraining peak sales well below Roche's $10B target.
  • BioNTech Leadership Vacuum: Founders Ugur Sahin and Ozlem Tureci are departing to launch an mRNA spinoff, leaving BioNTech without its core visionaries as 15-plus phase three oncology trials approach readout. The company retains €17.2B in cash and a key BMS-partnered PDL1/VEGF bispecific, pemetimaig, as its lead asset.
  • Ipsen Safety-Driven Withdrawal: Tazverik, the only EZH2 inhibitor approved for follicular lymphoma and epithelioid sarcoma, is being voluntarily withdrawn globally after secondary hematologic malignancies emerged in the confirmatory SYMPHONY-1 trial. Sales had already declined 14% to €40.6M in 2025 before the safety signal surfaced.
  • UCB Competitive Positioning: Bimzelx demonstrated statistically significant superiority over AbbVie's Skyrizi at ACR50 week 16 in the 553-patient BE BOLD head-to-head psoriatic arthritis trial. This is UCB's fourth head-to-head superiority win, reinforcing Bimzelx's positioning across rheumatology and dermatology with €2.3B in 2025 annual sales.

Notable Moment

Bayer's two growth drugs, Nubeqa and Korindia, grew combined sales 67% year-on-year yet represent only 8% of group revenue, while loss-of-exclusivity products Xarelto and Eylea, comprising 11% of sales, fell 28%, mathematically overwhelming the growth story.

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Episode Transcript

Hello, and welcome to the podcast edition of Scripps five must know things, this time for the business week ended 03/13/2026. This is Ian Haydock. This episode was produced with the help of AI powered text to voice and voice emulation tools. This time, Roche faces Geodestrant phase three setback. Founders exit BioNTech, Ipsen to withdraw Tasviric, tough times for Bayer, and another boost for UCB's Beam Zelks. Roche's phase three, PERSEVERA trial of GIADESTRENT, a drug the Swiss farmer has predicted could become its best selling treatment, has failed to meet the primary endpoint in first line ER positive, HER two negative advanced breast cancer, Sushmita Panda reports. The oral selective estrogen receptor degrader candidate is the keystone to Roche's goal of building a dominant franchise in estrogen receptor positive breast cancer, having previously seen its breast cancer franchise restricted to the HER two positive field. CEO Thomas Schnecker had previously predicted that GIODESTRENT could become Roche's biggest selling medicine ever, which would require it to reach around $10,000,000,000 in peak annual sales. Analysts, however, have not been fully on board with these lofty expectations. The primary endpoint of the PERSEVERA study, which enrolled nine hundred ninety two patients globally, was investigator assessed progression free survival, and the secondary endpoints included overall survival, objective response rate, duration of response, and safety. Roche said that while the treatment in combination with palbociclib, Pfizer's c d k four slash six inhibitor, Ibrance, in ER positive, HER two negative advanced breast cancer did not meet the primary endpoint, a numerical improvement was observed. Jeffrey's analysts wrote in the March 9 note that Giardestrone's Persevera failure in first line breast cancer was not surprising, but said it was a meaningful setback for the program. We had previously flagged that the trial appeared underpowered, they noted. They said that AstraZeneca's Cambria two study of chamezestrant, which is expected to read out in 2027, had a better chance of showing positive results. Still, Roche's chief medical officer, Levi Garraway, expressed confidence in the potential of GIODestrant to become a new standard of care endocrine therapy in early and advanced ER positive breast cancer. In February, the US FDA accepted an NDA for geradextrant based on the data in later stages of ER positive slash HER two negative metastatic breast cancer, but this was restricted to the ESR one mutated population narrower than the all comer population Roche had hoped for. BioNTech has been gearing up for a potentially pivotal year for its oncology ambitions, so the announcement of its founder's departure has disappointed many investors, Andrew McConaughey writes. CEO Ugur Sahin and chief medical officer Ozlem Turetsky announced their plans to head up a new mRNA spin off firm on March 10. Praised for their skillful work on developing the iconic Pfizer partnered COVID nineteen vaccine, Comenati, and for subsequent investment and deal making in oncology, investors feared the founder's exit would rob BioNTech of strong leadership just as it approached key r and d …

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