Here's a roundup of top developments in the biotech space over the last 24 hours:
Stocks In Focus
Connect Biopharma Atopic Dermatitis Treatment Aces Mid-stage Study But Lack of Efficacy Details Worries Investors
Connect Biopharma Holdings Limited CNTB announced positive topline results from the global Phase 2 clinical trial of CBP-201 administered subcutaneously to adult patients with moderate-to-severe atopic dermatitis.
The data showed that the trial met its primary efficacy endpoint, with statistically significant improvements in the percentage reduction in the Eczema Area and Severity Index score from baseline to Week 16. All three CBP-201 arms were statistically superior to placebo at Week 16. CBP-201 was also observed to have a favorable safety profile.
Lack of efficacy details limits comparison with existing treatments such as Sanofi SNY-Regeneron Pharmaceuticals, Inc.'s REGN Dupixent and other biologics, potentially polarizing investors, SVB Leerink analyst Thomas Smith said.
The stock was slumping 26.67% to $8.88 in premarket trading.
Merck Stalls Phase 2 HIV Combo Treatment Study Due to Decreases In Immune Cells In Treatment Arms
Merck & Co., Inc. MRK said decreases in total lymphocyte and CD4+ T-cell counts were observed in a Phase 2 study participants randomized to receive MK-8507 and islatravir as a once-weekly oral treatment for HIV-1 infection.
A review by the external Data Monitoring Committee determined that this effect was related to treatment with the combination of ISL+MK-8507. At the recommendation of the eDMC, Merck is stopping dosing in the trial, with continued monitoring of study participants.
The stock was down 1.20% at $82.05 in premarket trading.
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Reata's Omaveloxolone Gets Fast Track Designation For Treatment Of Friedreich's Ataxia
Reata Pharmaceuticals, Inc. RETA said the U.S. Food and Drug Administration has granted fast track designation for omaveloxolone for the treatment of Friedreich's ataxia.
The stock was advancing 1% to $88.98 in premarket trading.
Bristol-Myers Squibb Says FDA Announces 3-Month Extension to PDUFA Date For Drug To Treat Abnormal Thickening Of Heart Muscles
Bristol-Myers Squibb Company BMY announced that the FDA has extended the review of the new drug application for mavacamten for the treatment of patients with symptomatic obstructive hypertrophic cardiomyopathy to April 28, 2022.
The extension was to allow sufficient time to review information pertaining to updates to the proposed Risk Evaluation Mitigation Strategy. A REMS program was included in the initial application for mavacamten. No additional data or studies have been requested.
The stock was down 0.41% to $58.80 in premarket trading.
Ascendis Reports Positive Phase 2 Data For Hormone Replacement Therapy For Hypoparathyroidism
Ascendis Pharma A/S ASND announced top-line results from Week 84 of the Phase 2 PaTH Forward trial of its investigational TransCon PTH product candidate in adult patients with hypoparathyroidism.
The week 84 data showed that subjects treated with TransCon PTH had both mean serum calcium levels and urinary calcium excretion that remained stable and in the normal range and that most subjects continued to be free from taking active vitamin D and were taking less than 600 mg/day of calcium supplements.
Enanta Discontinues Development Of Phase 1 HBV Treatment Candidate Due To Safety Scare
Enanta Pharmaceuticals, Inc. ENTA announced it is discontinuing development of EDP-721, an oral HBV RNA destabilizer, based on emerging safety observations in the single ascending dose part of a Phase 1 study in healthy volunteers.
"We are committed to developing a functional cure for chronic hepatitis B patients, and remain confident in EDP-514, our HBV core inhibitor, which has demonstrated safe and robust antiviral activity in Phase 1b studies of viremic and NUC-suppressed patients with chronic HBV infection," said Jay Luly, CEO of Enanta.
The stock was slipping 1.71% to $91 in premarket trading.
Pfizer Reportedly Seeks to File For Authorization Of Oral COVID-19 Pill In Europe Friday
Pfizer, Inc. PFE, which announced Thursday a $5.29 billion deal to supply its yet-to-be authorized oral COVID-19 pill Paxlovid to the U.S. government, is planning to file for emergency use authorization with the European Medicines Agency Friday, German weekly Wirtschaftswoche said, citing sources close to the EMA.
The weekly also said the German government is in talks with Pfizer regarding procurement of the oral antiviral pill.
The stock was rising 1.11% to $51.98 in premarket trading.
Gracell's Multiple Myeloma Treatment Gets Orphan Drug Designation
Gracell Biotechnologies Inc. GRCLannounced that the FDA has granted orphan drug designation for GC012F, its CAR-T cell therapy for the treatment of multiple myeloma.
The stock was jumping 22.83% to $11.03 in premarket trading.
Related Link: Attention Biotech Investors: Mark Your Calendar For November PDUFA Dates
Offerings
RedHill Biopharma Ltd. RDHL announced an underwritten public offering of ADS, with each ADS represents ten ordinary shares. All of the ADSs to be sold in the offering will be offered by RedHill.
The stock was retreating 10.05% to $3.49 in premarket trading.
On The Radar
Clinical Readouts
Dermata Therapeutics, Inc. DRMA will present at the American Society For Dermatologic Surgery meeting, efficacy and safety results for its Phase 1b proof of concept study evaluating a single application of DMT410 to treat multiple aesthetic skin conditions.
Candel Therapeutics, Inc. CADL is scheduled to present at the 2021 Society For Neuro-Oncology meeting, initial safety data on CAN-2409 in combination with nivolumab from a phase 1 clinical trial in high-grade glioma
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