Here's a roundup of top developments in the biotech space over the last 24 hours.
Scaling The Peaks
(Biotech Stocks Hitting 52-week Highs Oct. 20)
- Aileron Therapeutics Inc (NASDAQ:ALRN)
- Anchiano Therapeutics Ltd – ADR (NASDAQ:ANCN)
- Athira Pharma Inc (NASDAQ:ATHA)
- Bio-Rad Laboratories, Inc. Class B Common Stock (NYSE:BIO)
- BioSpecifics Technologies Corp. (NASDAQ:BSTC)
- Blueprint Medicines Corp (NASDAQ:BPMC)
- Cleveland BioLabs, Inc. (NASDAQ:CBLI)(announced a reverse merger with Cytocom)
- Halozyme Therapeutics, Inc. (NASDAQ:HALO)
- Immunomedics, Inc. (NASDAQ:IMMU)
- Insmed Incorporated (NASDAQ:INSM)
- Laboratory Corp. of America Holdings (NYSE:LH)
- Pacific Biosciences of California Inc (NASDAQ:PACB)
- X T L Biopharmaceuticals Ltd (NASDAQ:XTLB)
Down In The Dumps
(Biotech Stocks Hitting 52-week Lows Oct. 19)
- Aerie Pharmaceuticals Inc (NASDAQ:AERI)
- Alector Inc (NASDAQ:ALEC)
- Aligos Therapeutics Inc (NASDAQ:ALGS)
- Avenue Therapeutics Inc (NASDAQ:ATXI)
- Baudax Bio Inc (NASDAQ:BXRX) (issued a corporate update)
- Codiak BioSciences Inc (NASDAQ:CDAK) (listed on Nasdaq on Oct. 14)
- Corbus Pharmaceuticals Holdings Inc (NASDAQ:CRBP)
- FSD Pharma Inc (NASDAQ:HUGE)
- Gilead Sciences, Inc. (NASDAQ:GILD)
- Intercept Pharmaceuticals Inc (NASDAQ:ICPT)
- ProQR Therapeutics NV (NASDAQ:PRQR)
- Titan Pharmaceuticals, Inc (NASDAQ:TTNP)
Stocks In Focus
Prothena to Advance Parkinson's Disease Drug Into Large-scale Confirmatory Study
Prothena Corporation PLC (NASDAQ:PRTA) said, based on positive signals of efficacy consistent with disease modification in the PASADENA study, it along with Roche Holdings AG Basel ADR Common Stock (OTC:RHHBY) plans to advance prasinezumab into a Phase 2b study in patients with early Parkinson's disease. The study is likely to be initiated in 2021, it added.
The study will further assess the efficacy of prasinezumab by expanding upon the patient population enrolled in PASADENA to include patients with early Parkinson's disease on stable levodopa therapy, Prothena said.
Prothena added that it will earn a $60 million clinical milestone payment upon first patient dosed in this study.
"Prasinezumab is the first anti-alpha-synuclein antibody to advance into confirmatory large study in patients with early Parkinson's disease," Prothena said.
The stock gained 11.01% to $12.50 in after-hours trading.
Xeris' Investigational Drug Gets Fast Track Designation For Treating Acute Repetitive Seizures
Xeris Pharmaceuticals Inc (NASDAQ:XERS) said the FDA granted fast track designation for the investigation of XP-0863 (diazepam non-aqueous injection) for the treatment of acute repetitive seizures.
In after-hours trading, the stock was up 9.52% to $5.75.
OncoCyte Rallies On Strong Adoption of its Lung Cancer Diagnostic Test
Molecular diagnostic company OncoCyte Corp (NYSE:OCX) said testing volume of DetermaRx, its lung cancer diagnostic test launched in January, more than doubled quarter-over-quarter to 175 billable samples in the third quarter. The company also noted that it maintained a re-order rate of about 60% and onboard hospitals increased to 67.
The stock added 7.38% to $1.60 in after-hours trading.
Crispr Reports Positive Results For Cell Therapy In Early-stage Study In B-cell Malignancies
Crispr Therapeutics AG (NASDAQ:CRSP) announced positive top-line results from its Phase 1 CARBON trial evaluating the safety and efficacy of CTX110, its wholly-owned allogeneic CAR-T cell therapy targeting CD19+ B-cell malignancies.
"While longer follow-up is required, these early data support the potential for CTX110 to become an effective off-the-shelf CAR-T therapy for patients with relapsed or refractory B-cell malignancies," said Joseph McGuirk, an investigator in the study.
The stock was slipping 3% to $103.50 in pre-market trading.
Actinium Announces NIH Grant For Study of its CD45-targeting Antibody Radio-conjugate
Actinium Pharmaceuticals Inc (NYSE:ATNM) said the National Institutes of Health has awarded it a Small Business Technology Transfer grant to support a clinical collaboration with Memorial Sloan Kettering Cancer Center to study Iomab-ACT, Actinium's CD45-targeting antibody radio-conjugate, for targeted conditioning to achieve lymphodepletion prior to administration of a CD19-targeted CAR T-cell therapy developed at MSK.
The CD19 CAR-T has been previously studied by MSK in a Phase 2 trial with chemotherapy conditioning in patients with relapsed or refractory B-cell acute lymphoblastic leukemia or diffuse large B-cell lymphoma.
In pre-market trading, the stock was up 6.67% to $11.68.
Offerings
Replimune Group Inc (NASDAQ:REPL) announced a proposed public offering of $125 million of shares of its common stock. All shares of common stock in the offering will be offered by the company.
The stock was down 8.06% to $39 in after-hours trading.
Aptinyx Inc (NASDAQ:APTX), which announced a positive mid-stage clinical readout late Tuesday, said it intends to offer and sell 12 million shares of its common stock in an underwritten public offering. All of the shares sold in the offering will be sold by the company.
In after-hours trading, the stock shed 4.54% to $4.10.
On The Radar
Clinical Readouts
Pfizer Inc. (NYSE:PFE) is scheduled to present at the ID Week 2020 full results of a pediatric Phase 2 proof-of-concept study of 20vPNC and detailed results from a Phase 2 proof-of-concept study of its potential first-in-class pentavalent meningococcal vaccine candidate.
Earnings
Abbott Laboratories (NYSE:ABT) (before the market open)
Biogen Inc (NASDAQ:BIIB) (before the market open)
Edwards Lifesciences Corp (NYSE:EW) (after the close)
以下是过去24小时生物技术领域的最新进展综述。
攀登高峰
(生物科技股10月20日触及52周高点)
- 副翼治疗公司(纳斯达克:ALRN)
- Anchiano治疗有限公司-ADR(纳斯达克:ANCN)
- Athera Pharma Inc.(纳斯达克:阿莎)
- Bio-Rad实验室公司B类普通股(纽约证券交易所:生物)
- BioSpecifics Technologies Corp.(纳斯达克:BSTC)
- 蓝图医药公司(纳斯达克:BPMC)
- 克利夫兰生物实验室公司(纳斯达克:CBLI)(宣布与Cytocom的反向合并)
- Halozyme治疗公司(纳斯达克:光晕)
- 免疫医学公司(纳斯达克:伊玛目)
- Insmed Inc.(纳斯达克:INSM)
- 美国实验室控股公司(纽约证券交易所:黄体素)
- 加州太平洋生物科学公司(纳斯达克:PACB)
- XT L生物制药有限公司(纳斯达克:XTLB)
情绪低落
(生物科技股10月19日触及52周低点)
- 艾瑞制药公司(纳斯达克:AIR)
- Alector Inc.(纳斯达克:亚历克)
- Aligos治疗公司(纳斯达克:ALGS)
- 大道治疗公司(纳斯达克:ATXI)
- 博达克斯生物公司(纳斯达克:BXRX)(发布了企业最新消息)
- Codiak BioSciences Inc.(纳斯达克:CDAK)(10月14日在纳斯达克挂牌)
- Corbus制药控股公司(纳斯达克:CRBP)
- FSD制药公司(纳斯达克:巨大的)
- 吉利德科学公司(纳斯达克:镀金)
- Intercept制药公司(纳斯达克:ICPT)
- ProQR治疗公司(纳斯达克:PRQR)
- 泰坦制药公司:(纳斯达克:TTNP)
关注的股票
Prothena将推进帕金森病药物进入大规模验证性研究
普罗塞纳公司PLC(纳斯达克:PRTA)说,基于帕萨迪纳研究中与疾病修改一致的疗效的积极信号,它与罗氏控股公司巴塞尔美国存托凭证普通股(场外交易:RHHBY)计划将prasinezumab推进到早期帕金森病患者的2b期研究中。它补充说,这项研究可能会在2021年启动。
Prothena说,这项研究将进一步评估prasinezumab的疗效,方法是扩大在帕萨迪纳登记的患者群体,包括接受稳定左旋多巴治疗的早期帕金森病患者。
Prothena补充说,在这项研究中使用第一个患者时,它将获得6000万美元的临床里程碑付款。
“Prasinezumab是第一个在早期帕金森氏病患者中进入验证性大型研究的抗α-突触核蛋白抗体,”Prothena说。
该股在盘后交易中上涨11.01%,至12.50美元。
Xeris的研究药物获得治疗急性反复发作的快车道称号
Xeris制药公司(纳斯达克:Xers)表示,FDA批准了XP-0863(安定非水注射液)治疗急性反复发作的研究的快速通道指定。
在盘后交易中,该股上涨9.52%,至5.75美元。
OncoCyte因其肺癌诊断测试的强劲采用而上涨
分子诊断公司OncoCyte公司(纽约证券交易所:OCX)表示,其于1月份推出的肺癌诊断测试DetermaRx的检测量在第三季度环比增加了一倍多,达到175个可收费样本。该公司还指出,它保持了约60%的再订购率,机上医院增加到67家。
该股在盘后交易中上涨7.38%,至1.60美元。
CRISPR报告B细胞恶性肿瘤早期研究中细胞治疗的积极结果
CRISPR治疗公司(纳斯达克:CRSP)宣布了其第一阶段碳试验的正面顶线结果,评估了CTX110的安全性和有效性,CTX110是其全资拥有的针对CD19+B细胞恶性肿瘤的同种异体CAR-T细胞疗法。
该研究的研究员约瑟夫·麦吉克说:“虽然需要更长时间的随访,但这些早期数据支持CTX110有可能成为复发性或难治性B细胞恶性肿瘤患者的一种有效的现成CAR-T疗法。”
在盘前交易中,该股下跌3%,至103.50美元。
Actdium公司宣布为其CD45靶向抗体放射性结合物的研究提供NIH赠款
Actdium制药公司(纽约证券交易所:ATNM)说,美国国立卫生研究院已经向其提供了一笔小企业技术转让赠款,以支持与纪念斯隆·凯特琳癌症中心的临床合作,研究Actdium的CD45靶向抗体放射性结合物Iomab-ACT,用于在MSK开发的CD19靶向CAR T细胞疗法之前进行靶向调节,以实现淋巴枯竭。
CD19 CAR-T此前曾由MSK在复发或难治性B细胞急性淋巴细胞性白血病或弥漫性大B细胞淋巴瘤患者的化疗条件的第二阶段试验中进行研究。
在盘前交易中,该股上涨6.67%,至11.68美元。
产品和服务
Replimune集团公司(纳斯达克:REPL)宣布拟公开发行1.25亿美元的普通股。此次发行的所有普通股将由该公司提供。
该股在盘后交易中下跌8.06%,至39美元。
Aptinyx Inc.(纳斯达克:APTX),这是宣布在周二晚间公布积极的中期临床读数后,该公司表示,打算在承销的公开募股中发行和出售1200万股普通股。此次发行中出售的所有股票都将由该公司出售。
在盘后交易中,该股下跌4.54%,至4.10美元。
在雷达上
临床读数
辉瑞。(纽约证券交易所:PFE)计划在2020年ID周上公布对20vPNC进行的儿科第二阶段概念验证研究的全部结果,以及对其潜在的一流五价脑膜炎球菌候选疫苗进行第二阶段概念验证研究的详细结果。
收益
雅培(纽约证券交易所:ABT(开市前)
生物遗传公司(纳斯达克:BIIB(开市前)
爱德华兹(纽约证券交易所:电子战)(收市后)