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Roche / Genentech

Roche / Genentech

Pharmaceutical and diagnostics company

Appears in 19 stories · Last updated Oct 31, 2026

Stories

Roche launches BAP1 test to streamline mesothelioma diagnosis

New Capabilities

Developer and global distributor of the VENTANA BAP1 (SP527) assay

A biopsy from the lining of a lung can look like several diseases under a microscope: mesothelioma, non-small cell lung cancer, or a benign scar. Roche's new BAP1 test uses a single marker with near-perfect specificity to isolate the deadliest possibility, malignant mesothelioma, from the rest.

Updated Oct 31

Roche bets $15 billion on Chinese antibody-drug conjugates

Money Moves

Licensor and payer in the Hansoh deal; expanding ADC pipeline via China partnerships

Roche agreed on Oct. 19 to pay Hansoh Pharmaceutical $400 million upfront, plus $110 million a year later, for a portfolio of antibody-drug conjugates: cancer drugs that carry a toxin straight to tumor cells. Hansoh could collect more than $15 billion in milestones if the programs clear development, regulatory and sales hurdles.

Updated Oct 30

FDA approves first-of-its-kind hepatitis B drug from GSK and Ionis

New Capabilities

Provider of companion diagnostic for Hibsago

The Food and Drug Administration approved Hibsago on October 20 for adults with chronic hepatitis B who have no cirrhosis and have taken antiviral pills for at least six months. In two late-stage trials, 19% of patients who took it had no detectable virus 24 weeks after ending all treatment; none of the 614 placebo recipients did.

Updated Oct 29

Henlius reports positive U.S. bridging trial results for lung cancer drug serplulimab

New Capabilities

Maker of atezolizumab, the active comparator in ASTRIDE

A randomized U.S. trial in extensive-stage small cell lung cancer (ES-SCLC) found patients on Henlius' serplulimab lived a median 12.4 months, versus 10.2 months for Genentech's atezolizumab. The 201-patient study was a bridging trial meant to test whether global evidence for serplulimab holds in American patients.

Updated Oct 29

Merck's remigromig meets main goal in pivotal eye disease trial

New Capabilities

Markets ranibizumab (Lucentis), the active control in BRUNELLO

Jefferies cut its risk-adjusted peak sales estimate for remigromig by 60%, to $300 million. The change followed Merck's presentation of full one-year BRUNELLO results at the American Academy of Ophthalmology meeting in October. In the 984-patient trial, the drug matched ranibizumab on vision but produced smaller gains and higher rates of proliferative diabetic retinopathy.

Updated Oct 26

Disc Medicine's rejected sun-sensitivity drug clears Phase 3, reopening FDA path

New Capabilities

Licensor of bitopertin

People with erythropoietic protoporphyria feel stabbing pain in strong light, and no oral drug is approved to help them. Disc Medicine's bitopertin passed a 183-patient Phase 3 trial called APOLLO, the company said on Oct. 19, 2026, reopening a path to the FDA after a rejection in February.

Updated Oct 25

Epcoritamab plus R-CHOP halves progression risk in first-line lymphoma trial

New Capabilities

Competitor; markets Polivy, the only approved first-line alternative to R-CHOP, and is developing Columvi and glofitamab

AbbVie and Genmab reported on October 5 that adding epcoritamab to the R-CHOP chemotherapy combination cut the risk of disease progression or death by 51% in newly diagnosed diffuse large B-cell lymphoma. It is the first phase 3 trial of a bispecific antibody, a drug that steers the body's T cells onto cancer cells, to beat the 20-year-old R-CHOP backbone.

Updated Oct 24

FDA approves Roche's Enspryng as first at-home thyroid eye disease treatment

New Capabilities

Markets Enspryng for TED and NMOSD; FDA decision on MOGAD expected January 2027

The FDA approved Roche's Enspryng for thyroid eye disease on October 15, the first and only at-home subcutaneous treatment for the condition. Patients or caregivers inject the drug with a prefilled syringe or pen after a healthcare provider's training, with no infusion clinic visits.

Updated Oct 17

Giredestrant–everolimus combination improves progression-free survival in advanced breast cancer

New Capabilities

As of October 2026: Parent company of Genentech; co-announced evERA results

Patients with estrogen receptor (ER)-positive advanced breast cancer who progress on a CDK4/6 inhibitor have few options left. The Phase III evERA trial found that giredestrant, a pill that degrades the estrogen receptor, plus everolimus cut the risk of progression or death by 44% overall and 62% in ESR1-mutated tumors.

Updated Oct 2

Roche's sefaxersen meets phase 3 goal, joining IgAN market battle with Novartis

New Capabilities

As of September 2026: Sponsor of the IMAgINATION study and sefaxersen licensee

Roche's experimental IgA nephropathy drug sefaxersen met its phase 3 primary endpoint on September 23, cutting proteinuria versus placebo at 37 weeks in the IMAgINATION study. The result, from a prespecified interim look, was strong enough that Roche is taking it to health authorities and planning a medical meeting presentation.

Updated Sep 23

Roche's dual GLP-1/GIP drug posts strong phase 2 diabetes results

New Capabilities

As of September 2026: Running phase 3 obesity trials, planning phase 3 diabetes trials

Roche's experimental once-weekly diabetes injectable cut blood sugar and body weight in a 48-week phase 2 trial announced September 22. Patients on the highest 24 mg dose saw HbA1c drop 2.65 percentage points and weight fall 15.5%.

Updated Sep 22

Roche-backed lung cancer drug clears phase 3 but trails GSK rival on survival

New Capabilities

As of September 2026: Holds ex-China rights to Tam-Peli

Two rival antibody-drug conjugates just beat the standard of care in relapsed small-cell lung cancer. Roche-partnered Tam-Peli held median survival at 13.3 months; GSK's competitor got 18.5. Both faced the same decades-old chemotherapy — and that five-month gap is the story.

Updated Sep 14

FDA delays decision on Exelixis' colorectal cancer drug zanzalintinib

Rule Changes

As of September 2026: Supplies atezolizumab (Tecentriq) for the zanzalintinib combination

Exelixis learned on September 10 that the FDA would delay its decision on zanzalintinib, its experimental colorectal cancer drug, by three months. The new deadline is March 3, 2027, after the agency deemed updated safety and efficacy data a major amendment to the application.

Updated Sep 11

Novo Nordisk advances denecimig toward the hemophilia A market

New Capabilities

As of August 2026: Incumbent competitor via Hemlibra

People with hemophilia A can bleed for hours from a small cut and bleed inside their joints for no clear reason. Novo Nordisk says its experimental injection, denecimig, kept most patients bleed-free in a long-term trial: about 71% of adults and teens and about 89% of children had zero treated bleeds.

Updated Aug 11

Pharma giants absorb AI pathology firms

Money Moves

As of May 2026: Acquirer

For a century, the cancer diagnosis that decides a patient's treatment has come from a pathologist staring at a tumor slide through a microscope. Software is now doing that reading—and the pharmaceutical companies that sell the drugs are buying the companies that built the software. On May 7, Roche agreed to pay up to $1.05 billion for PathAI, the largest independent AI pathology firm in the United States.

Updated May 31

First drug engineered to cross the blood-brain barrier wins FDA approval

New Capabilities

As of May 2026: Advancing competing BBB-crossing platform for Alzheimer's disease

For decades, the blood-brain barrier has blocked nearly all large-molecule drugs from reaching the brain — a biological wall that left most neurological diseases effectively untreatable with modern biologics. On March 25, 2026, the FDA approved Denali Therapeutics' AVLAYAH. It's the first drug specifically engineered to cross the blood-brain barrier and deliver a therapeutic enzyme to the central nervous system after a simple intravenous infusion.

Updated May 30

New antibiotics reach advanced trials as drug-resistant infections kill over a million per year

New Capabilities

As of May 2026: Running parallel Phase 3 trial of zosurabalpin for CRAB

No genuinely new class of antibiotic has reached patients since 1987, and in the nearly four decades since, bacteria have steadily evolved resistance to existing drugs. Carbapenem-resistant Acinetobacter baumannii—a hospital-acquired pathogen that kills up to 60 percent of ventilated pneumonia patients—is at the top of the WHO's list of critical-priority threats. On March 16, 2026, Swiss biotech BioVersys received FDA clearance to enroll American patients in a Phase 3 pivotal trial of BV100, which reduced 28-day mortality by half in earlier testing.

Updated May 30

The race to protect 27 million Americans from accidental food allergen exposure

Money Moves

As of May 2026: Incumbent; markets Xolair (with Novartis) for food allergy

For decades, the 27 million American adults and children with food allergies had one option: avoid the allergen and carry an EpiPen. That changed in February 2024 when the FDA approved Xolair as the first drug to reduce allergic reactions—including anaphylaxis—from accidental exposure to multiple foods.

Updated May 22

The BTK inhibitor race for multiple sclerosis

New Capabilities

As of May 2026: Leading the BTK inhibitor race, awaiting final trial data

The FDA rejected Sanofi's tolebrutinib for progressive MS on December 28, 2025—a crushing blow for a drug that had won Breakthrough Therapy status and became the first BTK inhibitor approved anywhere in the world. Meanwhile, Roche's rival drug fenebrutinib is racing toward approval after strong Phase 3 results, and Merck's evobrutinib crashed out entirely. Three pharma giants bet billions that brain-penetrating BTK inhibitors could finally slow the relentless neurodegeneration that leaves MS patients in wheelchairs, and only one looks likely to reach the finish line first.

Updated May 16