Here's a roundup of top developments in the biotech space over the last 24 hours.
Stocks In Focus
Protagonist to Discontinue Development Of Early-Stage Inflammatory Diseases Drug And Focus On PN-235
Protagonist Therapeutics PTGX said it has selected PN-235 as the final candidate for all clinical studies in multiple indications based on intervention of the Interleukin-23 pathway, under its collaboration with Johnson & Johnson, Inc.'s JNJ Janssen unit.
In addition to the previously announced Phase 2 clinical study of PN-235 in psoriasis, new Phase 2 clinical studies of PN-235 in inflammatory bowel diseases are expected to commence in late 2022. Further development of PN-232 will be discontinued in favor of PN-235 based on its superior potency, and overall pharmacokinetic and pharmacodynamic profile, the company added.
The stock was down 3.64% to $31.50 in premarket trading.
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Bristol-Myers Squibb Says Application For Expanding Label For Reblozyl Accepted For Priority Review
Bristol-Myers Squibb Company BMY announced that the U.S. Food and Drug Administration has accepted for priority review the supplemental Biologics License Application for Reblozyl for the treatment of anemia in adults with non-transfusion dependent beta thalassemia.
The FDA has set a PDUFA goal date of March 27, 2022.
In addition, the European Medicines Agency has validated the Type II variation for Reblozyl in NTD beta thalassemia. Reblozyl is being co-developed and co-commercialized with Merck & Co., Inc., MRK following Merck's recent acquisition of Acceleron Pharma, Inc.
Xenon Announces Additional Positive Data From Mid-Stage Focal Epilepsy Study
Xenon Pharmaceuticals Inc. XENE announced additional positive data from new sub-analyses of the Phase 2b X-TOLE clinical trial evaluating efficacy and safety of XEN1101 in adults with focal epilepsy. The company noted that topline data showed all primary and secondary seizure reduction endpoints were met with statistically significance across all dose groups.
The stock was jumping 24.77% to $32.29 in premarket trading.
Bayer's Nubeqa Combo Therapy Aces Late-stage Prostate Cancer Study
Bayer Aktiengesellschaft BAYRY announced the Phase 3 ARASENS trial investigating the use of the oral androgen receptor inhibitor Nubeqa in metastatic hormone-sensitive prostate cancer has met its primary endpoint.
The investigational asset, in combination with docetaxel and androgen deprivation therapy, significantly increased overall survival compared to docetaxel and ADT. The overall incidence of reported adverse events was similar between treatment arms.
Eli Lilly's Partnered Cancer Drug, BeiGene's 3 Drugs Included In China's National Reimbursement Drug List
Hong Kong-based Innovent Biologics and Eli Lilly & Co, Inc. LLY announced that their jointly developed cancer drug sintilimab has been successfully included in the China's updated National Reimbursement Drug List for all approved indications, according to the latest announcement from the China National Healthcare Security Administration The updated NRDL will officially take effect on January 1, 2022
A total of four approved indications for sintilimab are now included in the updated NRDL, the companies said.
BeiGene Ltd. BGNE said three of its medicines have been added to the NRDL. The recently added drugs include tislelizumab in three new indications, including in lung and liver cancers, Brukinsa in one new indication, and the initial listing for pamiparib.
Separately, BeiGene and EUSA Pharma (announced that the China National Medical Products Administration has approved siltuximab for the treatment of adult patients with multicentric Castleman disease, who are HIV-negative and human herpes virus-8 negative.
Related Link: Arbutus Shares Are Soaring As Moderna Loses Appeal Of Board Ruling On COVID-19 Vaccine Delivery Technology Patent
Offerings
Esperion Therapeutics, Inc. ESPR priced its previously announced underwritten public offering of 32.14 million shares of its common stock and short-term warrants to purchase up to an aggregate of 32.14 million shares.
Each share is being sold together with one short-term warrant to purchase one share at a combined public offering price of $7 per share and accompanying warrant. The short-term warrants have an exercise price of $9 per share, are exercisable immediately, and will expire two years following the date of issuance.
The gross proceeds from the offering to Esperion are expected to be approximately $225 million.
The shares were sliding 30.88% to $6.20.
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