Validating ruxolitinib for graft vs. host

A new Phase 3 NEJM study confirms what many oncologists have suspected for years: that the JAK inhibitor drug ruxolitinib can improve the odds of patients who develop graft-versus-host disease after undergoing a bone marrow transplant.

There have been few treatments available for GVHD, outside of steroids — which only work about half the time. Ruxolitinib emerged as a potential medication about five years ago, and oncologists began using it off-label, based on early studies and anecdotal evidence. The FDA approved the drug — which is sold in the U.S. by Incyte Corporation as Jakafi — in May 2019 based on Phase 2 data alone. This larger NEJM study validates that decision, one oncologist told STAT — adding that he thinks this study “will rapidly change the standard of care for patients.”

Biogen won't file for aducanumab til Q3

Biogen will delay its U.S. marketing application for its Alzheimer’s drug, aducanumab, until the summer, the company said in an investor call. The company’s shares fell 7% on the news and closed down for the day more than 9%.

Analysts pressed the company to explain the delay. Al Sandrock, Biogen’s R&D chief, said part of the reason was that many employees fell ill with the novel coronavirus: “It’s hard to work when you get Covid-19; some people were affected by the disease, so that’s part of it,” he said.

Compiling more data and analyses is another reason for the holdup, per Biogen CEO Michel Vounatsos.

Biotech valuations may suffer

Biotech startups could see a marked dip in their valuations. A company’s appraisal leans heavily on estimations on how and when it can complete clinical trials, and when it might achieve regulatory approval. Covid-19 has tossed this all up in the air, which means some biotechs may be worth less on paper than they were before, STAT’s Kate Sheridan writes.

“In some situations, people have been pulling term sheets or going back and revising valuations,” one venture capitalist told STAT.

Lower valuations might encourage larger pharma players to start gobbling up biotechs. But this might, in turn, make raising funds more difficult for startups.

A new breast cancer drug to hit the market

After being held up for more than a year thanks to manufacturing woes, Immunomedics has finally achieved regulatory approval for its metastatic breast cancer drug, Trodelvy. It’s a monoclonal antibody that homes in on a protein found on the surface of many solid tumors, and kills cancer cells by damaging their DNA.

The drug is targeted toward a particularly aggressive form of the disease: It’s for women with triple-negative breast cancer, who have tumors that don’t carry receptors for hormones like estrogen and progesterone — and therefore don’t respond to drugs like Herceptin or tamoxifen.