Sage and its partners at Biogen can now mark a summer date for a go/no go marketing decision for their blockbuster depression candidate, zuranolone. The FDA has put the fast-acting anti-depressive on the inside regulatory track, offering a quick priority review and setting the PDUFA for Aug. 5.

That’s a solid piece of good news for the developers, but Brian Abrahams at RBC notes some major hurdles ahead. The biggest immediate one: the prospect of an expert panel review, which he thinks ought to be made clear in the next couple of weeks. And that raises the possibility of some nasty surprises, followed by a tough marketing challenge.

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 170,400+ biopharma pros reading Endpoints daily — and it's free.

SIGN UP LOG IN

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

As you come back to our website this weekend for ASCO news, don’t forget to check out our updated event lineup at BIO, which will cover everything from the current state of VC investing in biotech to top pharma R&D chiefs discussing how to make pipeline decisions.

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 170,400+ biopharma pros reading Endpoints daily — and it's free.

SIGN UP LOG IN

After lining up a string of partnerships over the years, Dutch antibody-drug conjugate specialist Synaffix has found a new home: Lonza, the contract development and manufacturing giant.

Lonza is paying about $107 million (€100 million) in cash to acquire Synaffix, with up to $64 million (€60 million) in “additional performance-based consideration” on the table. Synaffix’s ADC tech platform will now become part of Lonza’s offering for biopharma clients, lending its bioconjugate technologies to not just ADCs but also targeted gene therapy, immune cell engagers and other applications.

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 170,400+ biopharma pros reading Endpoints daily — and it's free.

SIGN UP LOG IN

CHICAGO — Gilead and Arcus unveiled a fuller snapshot of a Phase II study testing their experimental cancer immunotherapy combo that showed lower progression-free survival rates than its previous update, results that are likely to spark further debate over the closely-watched clinical trial.

Last December, the anti-TIGIT/anti-PD-L1 combo, positioned as a first-line treatment for non-small cell lung cancer, recorded data that drew mixed reactions. The latest analysis, presented Saturday afternoon at ASCO, included only a handful more patients than the previous update, but PFS rates fell — in one cohort by nearly three months.

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 170,400+ biopharma pros reading Endpoints daily — and it's free.

SIGN UP LOG IN

CHICAGO — In a study pitting Seagen’s Adcetris against Bristol Myers Squibb’s Opdivo in newly diagnosed patients with advanced classic Hodgkin lymphoma, a greater proportion of those who received Opdivo saw no cancer growth at one year compared to those who got Adcetris.

In addition, patients in the Opdivo arm of the Phase III trial reported reduced toxicities, according to lead investigator Alex Herrera, a hematologist-oncologist at City of Hope’s cancer cancer in Duarte, CA. Notably, the trial included more than 200 children across both arms. Generally, more than half of children with advanced Hodgkin lymphoma receive radiation therapy, but in this trial, dubbed SWOG S1826, only a handful of patients in the two arms received radiotherapy, sparing many children from long-term side effects of radiation.

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 170,400+ biopharma pros reading Endpoints daily — and it's free.

SIGN UP LOG IN

An experimental pill from Servier Pharmaceuticals showed potentially practice-changing results in a narrow group of brain cancer patients, cutting the risk of their cancers progressing by 61%, according to a late-stage clinical trial.

The drug, vorasidenib, is a precision medicine that only works in certain people whose cancer carries mutations in one of two genes called IDH1/2. Doctors hope that the therapy will delay the need for chemotherapy or radiation, which are often used to combat relapses in patients who’ve previously undergone surgery to remove brain tumors.

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 170,400+ biopharma pros reading Endpoints daily — and it's free.

SIGN UP LOG IN

CHICAGO — Adding AstraZeneca’s Imfinzi and Lynparza to the treatment regimen for patients with advanced ovarian cancer and no BRCA mutation extended progression-free survival (PFS) by five months, according to interim data released at the ASCO annual meeting Saturday morning.

However, the design of the Phase III study obscures how much Imfinzi is contributing to the PFS extension, doctors said, making it difficult to apply the findings to clinical practice.

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 170,400+ biopharma pros reading Endpoints daily — and it's free.

SIGN UP LOG IN

CHICAGO — Merck has found partial success with its latest effort to more aggressively treat earlier stages of lung cancer.

On Saturday the pharma giant announced results from a large trial in which patients received Merck’s immunotherapy Keytruda plus chemotherapy before surgeons removed their tumors, followed by another course of Keytruda afterward.

The Phase III study, called KEYNOTE-671, enrolled 800 people with the early stages of the most common kind of lung cancer: non-small cell lung cancer, or NSCLC. Everyone got chemo before surgery, and half also got Keytruda before and after. At two years, 62.4% of those who got Keytruda kept their cancer at bay, compared to 40.6% who got a placebo.

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 170,400+ biopharma pros reading Endpoints daily — and it's free.

SIGN UP LOG IN

The FDA approved Pfizer’s RSV vaccine called Abrysvo for older adults on Wednesday, placing another Big Pharma onto the commercial stage ahead of the next RSV season.

Pfizer’s approval comes weeks after GSK won approval for its rival shot, Arexvy. Those two vaccines are both approved for use in adults 60 years and older and will be reviewed by a CDC panel in June before they’re expected to commercially launch this fall. Wall Street analysts see RSV as the next multibillion-dollar vaccine market, with Jefferies analysts recently forecasting the RSV market will grow to $17 billion over the next decade.

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 170,400+ biopharma pros reading Endpoints daily — and it's free.

SIGN UP LOG IN