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Bio Roundup: Amyloid Angst, NASH News, Brammer Bagged & More

Xconomy National — 

A week after the failure of Biogen’s Alzheimer’s drug aducanumab, the ripple effects are still being felt—and not just by Biogen, which lost billions of dollars in market value in a flash.

We’ll kick off this week’s roundup with the aducanumab reaction, which includes plenty of thoughts about the future of the so-called “amyloid hypothesis” and what’s next for another Biogen Alzheimer’s drug that has had mixed results.

We’ll also check in on the gene therapy deal spree, the big week in national healthcare policy, and the preparations several companies are making for one of the year’s biggest medical meetings for liver disease. Let’s get to it!

WHITHER AMYLOID?

—In the wake of the crushing failure of Biogen’s (NASDAQ: BIIB) Alzheimer’s drug aducanumab, various stories emerged questioning whether the “amyloid hypothesis” commonly used to explain the origins of the disease is dead, what’s next for the field, and what other drugs are in development.

—Days after aducanumab’s failure eviscerated almost a third of its market value, the Cambridge, MA, firm responded with a plan to buy back $5 billion of its shares.

—Is there a “rough patch” in the Alzheimer’s drug partnership between Biogen and Eisai? Right after aducanumab failed, the Japanese pharma announced plans to plow ahead with a Phase 3 trial of BAN2401—another amyloid-busting drug that has shown mixed results in early testing. Biogen’s response to the decision included a carefully crafted statement, STAT reports.

BRISTOL-GENE

—The FDA approved siponimod (Mayzent), a pill to treat certain forms of multiple sclerosis. The Novartis (NYSE: NVS) drug gets the jump on a rival product from Celgene (NASDAQ: CELG), which botched its first attempt at an FDA review. However…

—Celgene said this week it has refiled its FDA application for the drug, ozanimod. The drug is a key component of Celgene’s pipeline and of the rationale that potential acquirer Bristol-Myers Squibb (NYSE: BMY) is touting for its $74 billion takeout proposal.

—Activist investor Starboard Value kept up its opposition to the deal, however. The firm sent a letter to Bristol shareholders asking them to vote against the buyout, calling it a “highly risky and likely value-destructive acquisition.”

—The Federal Trade Commission is scrutinizing the merger as well, keying in on the psoriasis treatments the two companies have. Reuters has more here.

POLITICS & POLICY

—The Trump administration shocked Democrats and Republicans alike by reviving hostilities against the Affordable Care Act, aka Obamacare, thereby renewing a rallying cry that worked well for Democrats in the midterm elections. Over the objections of HHS Secretary Alex Azar and Attorney General William Barr, the Justice Department will no longer defend parts of the law against GOP challenges, according to Politico.

—A federal judge struck down Medicaid rules in Arkansas and Kentucky that deny coverage to “able-bodied” recipients unless they work, study, or volunteer. Kentucky’s governor has said he would appeal.

—House Democrats unveiled this week a bill to bolster Obamacare that does not include “Medicare for All,” meaning the party now has two competing visions for healthcare reform.

—Purdue Pharma agreed to pay $270 million to settle Oklahoma’s lawsuit claiming that the company’s marketing of its painkiller Oxycontin helped fuel the nationwide opioid drug crisis. Meanwhile, New York filed suit pinning responsibility on eight members of the Sackler family, which owns Purdue. The Sacklers issued a statement calling the suit “a misguided attempt to place blame where it does not belong.”

NASH NEWS

—Genfit (NASDAQ: GNFT), a French company with one of the most advanced experimental treatments for the fatty liver disease nonalcoholic steatohepatitis, raised $135 million in a U.S. IPO. Genfit stock is already traded in Europe. Its lead drug elafibranor should produce Phase 3 results later this year.

—NASH competitor NGM Biopharmaceuticals set the terms for its IPO, which could price next week and raise $100 million. STAT has more.

—Madrigal Pharmaceuticals (NASDAQ: MDGL) started a Phase 3 trial of resmetiron in NASH patients with fibrosis.

—Abstracts, or, snippets of data dropped this week ahead of the European Association of the Study of the Liver’s annual meeting. Vantage previewed the conference, which should include data updates from closely watched studies in NASH, hepatitis B, acute hepatic porphyria and more.

—One of those abstracts featured data from Viking Therapeutics (NASDAQ: VKTX)—whose drug, VK2809, works the same way as Madrigal’s resmetiron. The abstract outlined … Next Page »

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