Target to $6.50 from $9.50
Wednesday, November 8, 2023
Durect fails alcohol-associated hepatitis trial, plans phase 3 anyway
Durect and investors have reached radically different conclusions about its severe alcohol-associated hepatitis phase 2 data. The biotech hailed “remarkable” results—on a secondary goal, in a subpopulation—but failed to persuade investors to look past the failure of the primary endpoint, causing its stock to sink.
Investigators randomized around 300 patients to receive one of two doses of larsucosterol, an epigenetic modulator, or placebo. Durect had originally set out to show whether larsucosterol improved the 90-day mortality rate, before switching last year to a composite primary endpoint covering 90-day mortality and liver transplantation. Nothing good came from the change.
“We had some input from some thought leaders, and we made an adjustment midstream, changed horses in the middle of a stream, which one should never do,” Durect CEO James Brown said on a conference call with investors to discuss the data.
“We learnt the hard way here, unfortunately,” Brown added. “But it doesn't change … the outcome. The outcome here is we have really good mortality data.”
Neither dose of larsucosterol met the primary endpoint, with the proportions of patients who were alive and transplant-free at 90 days ranging from 71.6% in the placebo group to 78.8% in the low-dose arm. Durect pinned the failure on the transplant rates and data generated outside the U.S.
Narrowing the analysis to 90-day mortality at the U.S. sites, Durect linked the two larsucosterol doses to a relative risk reduction of 57% and 58% versus standard of care. The relative reduction in mortality in the entire study was 40.7% in the low-dose cohort and 34.9% in the high-dose arm, suggesting that the ex-U.S. sites, which enrolled around one-quarter of the patients, dragged on the results.
“We don't know for sure exactly what happened outside the United States. It could be just random bad luck, it could be something more than that,” Brown said. “We know some characteristics are slightly different—these patients had a higher level of cirrhosis, they were older, things like that. Is it enough to make a difference? We don't know.”
Durect is trying to figure out what happened while preparing to meet with the FDA in the first quarter of next year to discuss the results and the design of a planned phase 3 trial. The biotech plans to use 90-day mortality as the primary endpoint and may enroll all of the phase 3 patients in the U.S.
Shares in Durect fell 62% to below $1 in premarket trading.
Bayer weighs break-up options as management job cuts loom
Bayer is considering breaking apart from its consumer health or crop science divisions, it said on Wednesday, as new CEO Bill Anderson gave his initial thoughts on how to revive the diversified German company's battered share price.
Management is looking into separating either the non-prescription medicines business or the agriculture business from the rest of the group which includes pharmaceuticals, but not at the same time, Bayer said in a statement.
A sequential split into three companies is also an option, as is keeping all three divisions, said Anderson.
Initial public share offerings or spin-offs without raising cash were among the options, he said in a media call, but added further details would be withheld until a capital markets day next March.
"We are not wedded to one structure. We will pursue the best course to ensure maximum value creation," the CEO said, adding that all members of Bayer’s supervisory board backed the review.
The German maker of medicines, seeds and crop chemicals also unveiled plans to remove several layers of management to accelerate decision-making, resulting in a "significant reduction" in the workforce, confirming a Reuters report from September.
Anderson said that 12 layers of management between him and customers were "simply too much".
Bayer shares were down 1% at 1110 GMT, after rising as much as 1.2% in early trade as analysts weighed up the company's cautious guidance on business in 2024 against the prospect of an organisational turnaround.
Bayer said that it expects a "soft growth outlook and continued challenges" to profitability next year. It also expressed confidence in its 2023 financial guidance but said a strong fourth quarter was needed.
"A separation of Consumer Health would be the easiest way to generate value. For Bayer it would mean following an industry trend," said Markus Manns, a fund manager at Union Investment.
US FDA approves Otsuka's blood pressure treatment device for use
The U.S. Food and Drug Administration (FDA) approved the use of a device made by an Otsuka Holdings unit in a type of surgery to treat high blood pressure, the company said on Wednesday.
The approval for Paradise Ultrasound Renal Denervation comes after an FDA panel backed its use.
The device is made by Japanese company Otsuka's unit ReCor and is indicated for use in patients whose hypertension, or high blood pressure, cannot be controlled with drugs.
ReCor's device, which is a balloon-like structure inside a catheter, is inserted through a small cut into the kidney's arteries and sends ultrasound energy to burn nerves that are believed to control blood pressure.
The surgery has been previously approved in Europe and other parts of the world.
https://finance.yahoo.com/news/us-fda-approves-otsukas-blood-002009918.html
Akebia Results and Recent Business Highlights
Akebia to host conference call at 8:00 a.m. ET
Akebia will host a conference call and webcast on Wednesday, November 8 at 8:00 a.m. ET to discuss its financial results and recent business highlights. To access the call, please register by clicking on this Registration Link, and you will be provided with dial in details. To avoid delays and ensure timely connection, we encourage dialing into the conference call 15 minutes ahead of the scheduled start time. A live webcast of the conference call will be available via the "Investors" section of Akebia's website at: https://ir.akebia.com/. An online archive of the webcast can be accessed via the Investors section of Akebia's website at https://ir.akebia.com approximately two hours after the event. |
BioXcel Positive Overall Survival in Phase 2 Prostate Cancer
Median overall survival of 15.5 months with BXCL701 + KEYTRUDA® (pembrolizumab), compared to 9.6 months with checkpoint inhibitor monotherapy in late-line refractory patients in separate Phase 2 trial1
59% of studied patients alive at one year following treatment with BXCL701 + KEYTRUDA
Median progression-free survival of 4.2 months with BXCL701 + KEYTRUDA compared to 2.1 months with checkpoint inhibitor monotherapy in late-line refractory patients in separate Phase 2 trial1
Company plans to determine program development path following end of Phase 2 meeting with FDA scheduled for December
Eisai Sees ‘Dramatic’ Increase in Leqembi Uptake Following Full FDA Approval
In its second-quarter earnings report for fiscal year 2023, Eisai touted a sharp increase in the number of patients being treated with its Alzheimer’s disease therapy Leqembi (lecanemab).
Leqembi is an anti-amyloid antibody that won accelerated approval in January 2023. It works by binding to the pathologic amyloid aggregates in the brain and tags them for clearance. Following evidence of clinical benefit from the confirmatory Phase III Clarity-AD trial, the FDA converted Leqembi’s authorization into full approval in July 2023.
Traditional approval meant that the Centers for Medicare and Medicaid Services would offer coverage for Leqembi, making the therapy more accessible for a broader population of patients.
“Compared to the level at the time of accelerated approval, the number of patients treated is increasing dramatically,” Eisai CEO Haruo Naito said in an investor call Monday morning, adding that as of Oct. 27, around 800 Alzheimer’s disease (AD) patients had received Leqembi in the U.S.
Between April and September 2023, Leqembi earned Eisai approximately $2.7 million in sales. This was a modest contributor to the company’s approximately $2.4 billion earnings in the same period. “I understand that there are some voices of disappointment in the market,” Naito said, adding that this may reflect in the company’s share price.
However, he reiterated that this is within the company’s expectations. “Please do not see this as a negative surprise,” Naito said. In terms of weekly average revenue, Leqembi is 11 times higher than it was before earning full FDA approval.
Eisai contends it is prepared for Leqembi’s further expansion. From June to October 2023, the number of specialists ready to diagnose, treat and monitor AD patients grew from approximately 1,400 to 2,500. In addition, Leqembi has now been approved by 60% of the top 100 Integrated Delivery Networks in the U.S.
The company’s target is to reach around 10,000 patients by March 2024 with revenue of $66 million.
To aid in the expansion, Eisai is developing a subcutaneous formulation of Leqembi. Last month, at the 2023 Clinical Trials on Alzheimer’s Disease (CTAD) conference, the company posted data from the open-label extension phase of Clarity-AD, demonstrating that a weekly subcutaneous injection of Leqembi had a better pharmacokinetic profile and a slightly higher amyloid clearance rate than biweekly intravenous infusions.
Nevertheless, the subcutaneous injection still came with safety issues called amyloid-related imaging abnormalities, indicative of bleeding and swelling in the brain.
Subscribe to:
Comments (Atom)