Robert Barrow, MindMed CEO
Psychedelic therapy has emerged once again as a potentially promising path to treating neurological conditions, but one tiny biotech is now facing a holdup at the FDA in bringing its LSD program to more patients.
The FDA has slammed a clinical hold on MindMed’s IND application for a Phase IIb study testing LSD-assisted therapy in patients with generalized anxiety disorder, the biotech said Tuesday.
Details — as they usually are with this sort of thing — were slim in a release, with MindMed only saying it expects further action from the FDA within 30 days. The biotech didn’t dive into what issues the agency flagged before it made its decision.
‘Our team has a tremendous sense of urgency to bring new treatments, such as LSD, to the many patients in need, particularly given the growing mental health epidemic,’ CEO Robert Barrow said in a statement. ‘We remain highly confident in the therapeutic potential of LSD to usher in a new treatment paradigm for these disorders and we look forward to working closely with FDA to satisfy all outstanding concerns as rapidly as possible.’
Already far into microcap territory, shares in $MNMD were mostly trading flat on the news.
Not a whole lot is known about the New York biotech except that Barrow, formerly interim CEO and chief development officer, stepped into the full-time CEO role about a week ago, just in time to catch the bad news. His promotion came as the company’s former chairman Perry Dellelce stepped down from his role.
According to its website, the company is working on creating ‘experiential therapies’ to address neurological conditions, including its LSD-assisted therapy program for anxiety, dubbed ‘Project Lucy.’
CALQUENCE is a registered trademark of the AstraZeneca group of companies.
At the 2021 American Society of Hematology (ASH) Annual Meeting & Exposition, blood cancer researchers from around the world gathered virtually to discuss the progress that has been made in the field of hematology. Over the past decade, that progress has been tremendous. We’ve seen not only breakthrough approaches to care, but also significant improvement upon existing novel treatments and exploring combinations within those medicines.1 These advances have transformed expectations of what a blood cancer diagnosis now means for patients. While we’ve come a long way, I believe the most exciting scientific discovery is yet to come, and that future advances will truly transform patient care.
Alzheimer’s disease researchers along with medical professors from Harvard and Johns Hopkins issued a formal statement Monday asking the FDA to quickly pull Biogen’s Aduhelm from the market.
‘An accelerated withdrawal would mitigate some of the harm of its unwarranted accelerated approval,’ they wrote to FDA, explaining how Aduhelm ‘did not meet the FDA’s own criteria for accelerated approval based on surrogate markers because amyloid plaque does not correlate well with symptoms, severity of disease or progression.’
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Michel Vounatsos, Biogen CEO (Credit: World Economic Forum/Valeriano Di Domenico)
In a surprise move, Biogen announced Monday that it will cut the price of its controversial Alzheimer’s drug Aduhelm in half, slashing the cost from $56,000 to $28,000.
The sudden discount marks a sudden turnaround for the big biotech as it struggles to turn around a drug whose stuck-in-the-mud sales and political ramifications have sent the company into turmoil and triggered the ousting of its longtime chief scientist. Biogen’s leadership had resisted calls since June to reduce the price of the drug.
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Angie You and Volker Schellenberger, Amunix
Sanofi is crashing the year-end M&A party with a deal of its own.
Immuno-oncology is the name of the game as it swallows Mountain View, CA-based Amunix for $1 billion upfront and up to $225 million in biobucks, tagging a suite of T cell engagers and cytokine therapies as well as a tech platform for making ‘conditionally activated biologics.’
‘The Amunix technology platform utilizes a next generation smart biologics approach to precisely tailor-deliver medicines to become active only in tumor tissues while sparing normal tissues,’ said Sanofi R&D chief John Reed, ‘thus bringing the promise of more effective and safer treatment options for cancer patients.’
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New research from Johns Hopkins shows convalescent plasma may work in the outpatient space, which could be key as the Omicron variant has extinguished several monoclonal antibody treatments.
The results of this placebo-controlled, multicenter trial led by Hopkins researchers showed that convalescent plasma reduced the need for hospitalization among more than 1,000 outpatients with Covid-19 who participated.
David Ricks, Eli Lilly CEO (David Paul Morris/Bloomberg via Getty Images)
Just 6 days after Eli Lilly execs ID’d its $1.1 billion atopic dermatitis drug lebrikizumab as one of its top late-stage drug candidates, the pharma giant has followed up with another round of positive late-stage data as it paves the way to planned regulatory filings in 2022.
The Christmas week statement from Lilly included little by way of hard data — the big outfit typically reserves that for its science conferences — but researchers touted a clean sweep of the primary and all secondaries in its 3rd round of late-stage results.
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A young man with Duchenne muscular dystrophy has died in Pfizer’s Phase Ib trial of its mini-dystrophin gene therapy, triggering a halt in screening and dosing — and a clinical hold imposed by the FDA.
Pfizer informed the Parent Project Muscular Dystrophy of the death in a community letter. The patient was participating in the non-ambulatory cohort of the trial, the company wrote, adding:
At this time, we do not yet have complete information and are actively working with the trial siteinvestigator to understand what happened.
Graphic: Alexander Lefterov for Endpoints News
Drug pricing reform has been a political football for years, with both Donald Trump and Joe Biden championing changes during their presidencies. Little has moved the needle on Capitol Hill, however, thanks in part to the drug industry’s powerful lobbyists.
In the most recent example, Democrats tried to allow Medicare to negotiate drug prices — an immediate non-starter for biopharma proponents. After months of negotiation, the measure fell apart in favor of provisions on a small subset of drugs that passed the House but marked a far cry from Biden’s promises and what many activists had hoped for. The bill, included as part of Biden’s broad social policy agenda, now appears dead after Democrats failed to secure 50 votes in the Senate.
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Bob Duggan, Summit CEO (via Summit Investments)
Bob Duggan — the billionaire investor famous for turning Pharmacyclics from a penny stock to a $20 billion company — placed a handsome bet on the company’s new antibiotic for C. difficile infection last year, scooping up a majority stake and naming himself CEO in hopes of turning a profit in a field largely abandoned by Big Pharma.
But on Monday, a Phase III failure sent the company’s stock spiraling in premarket trading — and now, Duggan says he’s looking to raise more cash.
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https://endpts.com/fda-slams-clinical-hold-on-tiny-psychedelics-players-shot-at-bringing-lsd-assisted-therapy-to-more-patients/
