Here's a roundup of top developments in the biotech space over the last 24 hours:
Stocks In Focus
Anaptys Discontinues Phase 2 Study Of Imsidolimab In Acne
Anaptys Bio, Inc. ANAB said the Phase 2 clinical trial of imsidolimab for the treatment of moderate-to-severe acne did not demonstrate efficacy over placebo on primary or secondary endpoints. The study will be discontinued.
"Although the results of this ACORN trial are disappointing, I would like to thank all of the patients, investigators, staff and our employees involved in conducting this trial," said Hamza Suria, AnaptysBio's CEO.
"We look forward to further advancement of imsidolimab for the treatment of GPP and hidradenitis suppurativa. AnaptysBio continues to utilize its strong cash position in a capital-efficient manner to advance three wholly-owned clinical-stage programs with $90 to $100 million anticipated net cash burn in 2022."
The stock was declining 10.48% to $25.46 in premarket trading.
Biogen, Eisai Amend Economic Agreement Related To Aduhelm
Biogen, Inc. BIIB and Eisai Co. Ltd. ESALY announced an amendment to the economic agreement between the companies. According to the amendment, Eisai will receive a tiered royalty on net sales of Aduhelm, rather than sharing global profits and losses.
The companies clarified that the economic agreements for 2022 will remain unchanged, with Eisai's share of expenses capped at $335 million for the costs related to development, commercialization and manufacturing for calendar year 2022.
Merck, AstraZeneca To Discontinue Combo Treatment Study In Prostate Cancer Patients
Merck & Co. Ltd. MRK said it will stop the Phase 3 KEYLYNK-010 trial investigating Keytruda in combination with Lynparza, co-developed by Merck and AstraZeneca plc AZN, for the treatment of patients with metastatic castration-resistant prostate cancer who progressed after treatment with chemotherapy and either abiraterone acetate or enzalutamide.
The discontinuation follows the recommendation of an independent Data Monitoring Committee, which found the combo did not demonstrate a benefit in overall survival, one of the study's dual primary endpoints, compared to the control arm of either abiraterone acetate or enzalutamide. The trial's other dual primary endpoint, radiographic progression free survival, was evaluated at an earlier interim analysis and did not demonstrate improvement compared to the control arm.
The companies announced Monday FDA approval of Lynparza in early stage breast cancer.
Exelixis Declines To File For Regulatory Approval Of Cabometyx-Tecentriq Combo In Liver Cancer Following Failed Phase 3 Study
Exelixis, Inc. EXEL said a final analysis of the secondary endpoint of OS from the Phase 3 study of Cabometyx, in combination with Roche Holdings AG's RHHBY Tecentriq compared to Bayer AG's BAYRY Nexavar in patients with previously untreated advanced hepatocellular carcinoma (HCC) showed neither improvement nor detriment.
Based on this outcome for OS and the rapidly evolving treatment landscape for previously untreated advanced HCC, Exelixis said it does not intend to submit a supplemental new drug application to the U.S. Food and Drug Administration.
The stock was down 3.4% at $19.89 in premarket trading.
Better Therapeutics Announces Positive Data From Pivotal Type 2 Diabetes Treatment Study
Better Therapeutics, Inc. BTTX said data from its pivotal trial of BT-001, an investigational PDT platform that is designed to use digitally delivered nCBT to treat type 2 diabetes, demonstrated clinically meaningful and statistically significant results in improving glycemic control by reducing A1c 0.4% versus the control group receiving standard of care.
The stock was adding 7.9% to $4.37 in premarket trading.
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Offerings
China SXT Pharmaceuticals, Inc. SXTC said it entered a securities purchase agreement to issue a convertible promissory note in the original principal amount of $2.805 million to Streeterville Capital, a Utah limited liability company. The 12-month note shall bear interest at the rate of 6% per annum.
The stock was rising 6.65% to 18 cents in premarket trading.
On The Radar
Clinical Readouts/Presentations
IDEAYA Biosciences, Inc. IDYA is scheduled to announce interim clinical data for IDE397 in patients having tumors with MTAP deletion.
Cognition Therapeutics, Inc. CGTX will present at the International Conference On Alzheimer's And Parkinson's Diseases And Related Neurological Disorders with data from the Phase 1b SNAP study and an interim analysis from the Phase 2 SHINE study in two posters.
Earnings
Precision BioSciences, Inc. DTIL (before the market open)
Gamida Cell Ltd. GMDA (before the market open)
IMARA Inc. IMRA (before the market open)
Brickell Biotech, Inc. BBI (before the market open)
Syros Pharmaceuticals, Inc. SYRS (before the market open)
Altimmune, Inc. ALT (before the market open)
Athenex, Inc. ATNX (before the market open)
ANI Pharmaceuticals, Inc. ANIP (before the market open)
Athersys, Inc. ATHX (after the close) (after the close)
TRACON Pharmaceuticals, Inc. TCON (after the close)
Related Link: Attention Biotech Investors: Mark Your Calendar For March PDUFA Dates
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