Here's a roundup of top developments in the biotech space over the last 24 hours.
Kezar Life Sciences Inc (NASDAQ:KZR) announced topline results from the PRESIDIO Phase 2 trial of zetomipzomib (KZR-616) in patients with dermatomyositis (DM) and polymyositis (PM), chronic inflammatory diseases of muscle.
Topline results showed that most DM and PM patients saw clinically meaningful improvements in Total Improvement Score, but zetomipzomib demonstrated no significant differentiation from placebo.
Zetomipzomib was well tolerated.
There were three Grade 3 serious adverse events in the zetomipzomib arms. All deemed unrelated to zetomipzomib.
The FDA has accepted AstraZeneca plc's (NASDAQ) supplemental marketing application seeking approval for Imfinzi (durvalumab), in combination with standard-of-care chemotherapy, for locally advanced or metastatic biliary tract cancer.
Under the Priority Review status, the FDA action date is in the third quarter of 2022.
Click here to access Benzinga's FDA Calendar
Brickell Biotech Inc (NASDAQ:BBI) agreed to sell sofpironium bromide rights to Australia-based Botanix Pharmaceuticals Limited.
Brickell will receive upfront and potential near-term regulatory milestone payments over the next 18 months of up to $9 million.
Brickell also is eligible to receive additional milestone payments of up to $168 million and tiered earn-out payments.
Sofpironium bromide gel, 15% recently completed a U.S. Phase 3 program for primary axillary hyperhidrosis or excessive underarm sweating.
Shares are trading 30.3% higher at 0.30 cents during the premarket session.
Connect Biopharma Holdings Limited (NASDAQ:CNTB) announced topline results at 12 weeks from its Phase 2 trial for CBP-307 (CBP-307CN002) for ulcerative colitis.
CBP-307 0.2 mg demonstrated a numerical reduction for the primary endpoint of least squares mean change from baseline in adapted Mayo Score at Week 12 that did not meet statistical significance.
The Mayo Score (stool frequency, rectal bleeding, and endoscopy scores) at Week 12 for CBP-307 0.2 mg and placebo were -2.65 and -2.01, respectively (p=0.103).
The company intends to engage in partnership discussions for the future development of CBP-307 to focus on the lead program CBP-201.
Shares closed 33.5% lower at $1.29 during after-hours trading.
The FDA has approved Phathom Pharmaceuticals Inc's (NASDAQ:PHAT) Voquezna (vonoprazan) regimens for Helicobacter pylori infection in adults.
The approval covers Voquezna Triple Pak (vonoprazan tablets, amoxicillin capsules, clarithromycin tablets) and Voquezna Dual Pak (vonoprazan tablets, amoxicillin capsules).
Voquezna triple and dual paks are expected to be available in the U.S. in Q3 of 2022 and marketed exclusively by Phathom.
The European Commission has approved Novartis AG's (NYSE:NVS) Kymriah (tisagenlecleucel), CAR-T cell therapy for follicular lymphoma (FL).
The approval covers adult patients with relapsed or refractory (r/r) FL after two or more lines of systemic therapy.
This approval marks the third indication for Kymriah and makes it the first CAR-T cell therapy approved in the EU for these patients.
Also Read: Attention Biotech Investors: Mark Your Calendar For May PDUFA Dates.
Novartis AG (NYSE:NVS) has announced updated median overall survival (OS) results for Kisqali (ribociclib) combined with fulvestrant for postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor-2 negative advanced or metastatic breast cancer.
The analysis of patients treated in first-line with Kisqali plus fulvestrant demonstrated a significant OS benefit of nearly 16 months compared to those treated with fulvestrant alone.
The final analysis demonstrated a statistically significant OS benefit for Kisqali combined with fulvestrant and a relative reduction in the risk of death by 28% compared to fulvestrant alone.
The FDA has granted Fast Track designation to Aptose Biosciences Inc's (NASDAQ:APTO) HM43239 for relapsed or refractory acute myeloid leukemia (AML) with FLT3 mutation.
HM43239 received orphan drug designation from the FDA for acute myeloid leukemia in 2018.
Association for Research in Vision and Ophthalmology (ARVO)
Applied Genetic Technologies Corporation (NASDAQ:AGTC), Multiple presentations related to ongoing X-linked retinitis pigmentosa and achromatopsia trials.
UNITY Biotechnology Inc (NASDAQ:UBX): 24-week results of a Phase 1 study of UBX1325 in advanced DME or wet AMD patients.
ProQR Therapeutics N.V. (NASDAQ:PRQR): Efficacy and safety of sepofarsen for CEP290-associated Leber congenital amaurosis.
Tempest Therapeutics Inc (NASDAQ:TPST): Director Thomas Woiwode reported the purchase of 2.12 million shares at $2.36/share.
Allena Pharmaceuticals Inc (NASDAQ:ALNA) has announced a registered direct offering of 1,436.0688 shares of its Series D Convertible Preferred Stock and 1,436.0688 shares of its Series E Convertible Preferred Stock for gross proceeds of approximately $2.8 million.
Deciphera Pharmaceuticals Inc (NASDAQ:DCPH): (Before Market Open).
Amneal Pharmaceuticals Inc (NYSE:AMRX): (Before Market Open).
Amarin Corporation plc (NASDAQ:AMRN): (Before Market Open).
Regeneron Pharmaceuticals Inc (NASDAQ:REGN): (Before Market Open).
G1 Therapeutics Inc (NASDAQ:GTHX): (Before Market Open).
Moderna Inc (NASDAQ:MRNA): (Before Market Open).
Seres Therapeutics Inc (NASDAQ:MCRB): (Before Market Open).
United Therapeutics Corporation (NASDAQ:UTHR): (Before Market Open).
Ionis Pharmaceuticals Inc (NASDAQ:IONS): (Before Market Open).
Apellis Pharmaceuticals Inc (NASDAQ:APLS): (Before Market Open).
Regenxbio Inc (NASDAQ:RGNX): (After Market Close)
Kura Oncology Inc (NASDAQ:KURA): (After Market Close)
Rain Therapeutics Inc (NASDAQ:RAIN): (After Market Close)
Fate Therapeutics Inc (NASDAQ:FATE): (After Market Close)
Zymeworks Inc (NYSE:ZYME): (After Market Close)
Allogene Therapeutics Inc (NASDAQ:ALLO): (After Market Close)
AxoGen Inc (NASDAQ:AXGN): (After Market Close)
Mirati Therapeutics Inc (NASDAQ:MRTX): (After Market Close)
Sarepta Therapeutics Inc (NASDAQ:SRPT): (After Market Close)
Jazz Pharmaceuticals PLC (NASDAQ:JAZZ): (After Market Close)
免责声明:投资有风险,本文并非投资建议,以上内容不应被视为任何金融产品的购买或出售要约、建议或邀请,作者或其他用户的任何相关讨论、评论或帖子也不应被视为此类内容。本文仅供一般参考,不考虑您的个人投资目标、财务状况或需求。TTM对信息的准确性和完整性不承担任何责任或保证,投资者应自行研究并在投资前寻求专业建议。