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The Daily Biotech Pulse: Novavax Advances Vaccine, Marinus Gets Nod For Late-Stage Study, 3 IPOs

The Daily Biotech Pulse: Novavax Advances Vaccine, Marinus Gets Nod For Late-Stage Study, 3 IPOs

每日生物技術脈搏:Novavax 推進疫苗,馬里努斯為後期研究點頭,3 首次公開募股
Benzinga Real-time News ·  2020/09/25 19:37

Here's a roundup of top developments in the biotech space over the last 24 hours.

以下是過去24小時生物技術領域的最新進展綜述。

Scaling The Peaks

攀登高峯

(Biotech Stocks Hitting 52-week Highs Sept. 24)

(生物科技股9月1日觸及52周高點。24)

  • Beigene Ltd (NASDAQ:BGNE))
  • Forte Biosciences Inc (NASDAQ:FBRX)
  • Pacific Biosciences of California Inc (NASDAQ:PACB)
  • 百濟神州有限公司(納斯達克:BGNE))
  • Forte生物科學公司(納斯達克:FBRX)
  • 加州太平洋生物科學公司(納斯達克:PACB)

Down In The Dumps

情緒低落

(Biotech Stocks Hitting 52-week Lows Sept. 24)

(生物科技股9月1日觸及52周低點。24)

  • ADiTx Therapeutics Inc (NASDAQ:ADTX)
  • AEterna Zentaris Inc. (NASDAQ:AEZS)
  • Akebia Therapeutics Inc (NASDAQ:AKBA)
  • Alector Inc (NASDAQ:ALEC)
  • AnPac Bio-Medical Science Co Ltd – ADR (NASDAQ:ANPC)
  • Amarin Corporation plc (NASDAQ:AMRN)
  • Athira Pharma Inc (NASDAQ:ATHA)
  • BELLUS Health Inc (NASDAQ:BLU)
  • Corbus Pharmaceuticals Holdings Inc (NASDAQ:CRBP)
  • Cyclacel Pharmaceuticals Inc (NASDAQ:CYCC)
  • DBV Technologies ADR Representing 0.5 Ord Shs (NASDAQ:DBVT)
  • Evofem Biosciences Inc (NASDAQ:EVFM)
  • Fusion Pharmaceuticals Inc (NASDAQ:FUSN)
  • Genetron Holdings Ltd – ADR (NASDAQ:GTH)
  • Genfit SA (NASDAQ:GNFT)
  • Gritstone Oncology Inc (NASDAQ:GRTS)
  • Happiness Biotech Group Ltd (NASDAQ:HAPP)
  • Histogen Inc (NASDAQ:HSTO)
  • Hoth Therapeutics Inc (NASDAQ:HOTH)
  • Intercept Pharmaceuticals Inc (NASDAQ:ICPT)
  • Jaguar Health Inc (NASDAQ:JAGX)
  • Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX)
  • Natus Medical Inc (NASDAQ:NTUS)
  • Neos Therapeutics Inc (NASDAQ:NEOS)
  • Neurobo Pharmaceuticals Inc (NASDAQ:NRBO)
  • NextCure Inc (NASDAQ:NXTC)
  • Odonate Therapeutics Inc (NASDAQ:ODT)
  • Oncternal Therapeutics Inc (NASDAQ:ONCT)
  • PainReform Ltd (NASDAQ:PRFX)
  • Pandion Therapeutics Inc (NASDAQ:PAND)
  • Pliant Therapeutics Inc (NASDAQ:PLRX)
  • Psychemedics Corp. (NASDAQ:PMD)
  • RA Medical Systems Inc (NYSE:RMED)
  • Renalytix AI PLC (NASDAQ:RNLX)
  • Rockwell Medical Inc (NASDAQ:RMTI)
  • Satsuma Pharmaceuticals Inc (NASDAQ:STSA)
  • SCYNEXIS Inc (NASDAQ:SCYX)
  • Solid Biosciences Inc (NASDAQ:SLDB)
  • Sonnet BioTherapeutics Holdings, Inc. (NASDAQ:SONN)
  • Teligent Inc (NEW JERSEY) (NASDAQ:TLGT)
  • Theravance Biopharma Inc (NASDAQ:TBPH)
  • Tricida Inc (NASDAQ:TCDA)
  • Vaccinex Inc (NASDAQ:VCNX)
  • Viveve Medical Inc (NASDAQ:VIVE)
  • Taro Pharmaceutical Industries Ltd. (NYSE:TARO)
  • ADiTx治療公司(納斯達克:ADTX)
  • Aeterna Zentaris Inc.(納斯達克:AEZS)
  • 木通治療公司(納斯達克:阿卡巴)
  • Alector Inc.(納斯達克:亞歷克)
  • 安派科股份有限公司-美國存託憑證(納斯達克:ANPC)
  • Amarin Corporation Plc(納斯達克:AMRN)
  • Athera Pharma Inc.(納斯達克:阿莎)
  • 貝盧斯健康公司(納斯達克:藍色)
  • Corbus製藥控股公司(納斯達克:CRBP)
  • Cyclacel製藥公司(納斯達克:中青旅)
  • 代表0.5個訂單SHS的DBV Technologies ADR(納斯達克:DBVT)
  • Evofem生物科學公司(納斯達克:EVFM)
  • Fusion製藥公司(納斯達克:FUSN)
  • 泛生子控股有限公司-美國存託憑證(納斯達克:GTH)
  • Genfit SA(納斯達克:GNFT)
  • Gritstone Oncology Inc.(納斯達克:GRTS)
  • 幸福來集團有限公司(納斯達克:哈普)
  • 組織原公司(納斯達克:HSTO)
  • 霍斯治療公司(納斯達克:霍斯)
  • Intercept製藥公司(納斯達克:ICPT)
  • 捷豹健康公司(納斯達克:JAGX)
  • Licion製藥公司。(納斯達克:LXRX)
  • Natus醫療公司(納斯達克:美國非政府組織)
  • 近地天體治療公司(納斯達克:近地天體)
  • Neurobo製藥公司(納斯達克:NRBO)
  • NextCure Inc.(納斯達克:NXTC)
  • 奧多納特治療公司(納斯達克:ODT)
  • Onctal Treeutics Inc.(納斯達克:ONCT)
  • 畫廊改革有限公司(納斯達克:PRFX)
  • 潘迪翁治療公司(納斯達克:Pand)
  • 柔韌治療公司(納斯達克:PLRX)
  • 精神化學公司(納斯達克:偏振模色散)
  • RA醫療系統公司(紐約證券交易所:RMED)
  • Renalytix AI PLC(納斯達克:RNLX)
  • 羅克韋爾醫療公司(納斯達克:RMTI)
  • 薩蘇瑪製藥公司(納斯達克:STSA)
  • Scynexis Inc.(納斯達克:SCYX)
  • 固體生物科學公司(納斯達克:SLDB)
  • 十四行詩生物治療控股公司(納斯達克:宋氏)
  • 泰利格特公司(新澤西州)(納斯達克:TLGT)
  • Theravance Biophma Inc.(納斯達克:TBPH)
  • Tricida Inc.(納斯達克:TCDA)
  • Vaccinex公司(納斯達克:VCNX)
  • Viveve醫療公司(納斯達克:萬歲)
  • 太郎藥業有限公司(紐約證券交易所:太郎)

Stocks In Focus

關注的股票

Novavax Commences Phase 3 Study of Coronavirus Vaccine Candidate

Novavax開始第三階段冠狀病毒候選疫苗研究

Novavax, Inc. (NASDAQ:NVAX) said it has initiated its first Phase 3 study to evaluate the efficacy, safety and immunogenicity of NVX-CoV2373, its COVID-19 vaccine candidate.

Novavax,Inc.(納斯達克:NVAX)表示,已經啟動了第一階段的第三階段研究,以評估該藥物的有效性、安全性和免疫原性NVX-CoV2373,它的新冠肺炎候選疫苗。

The trial is being conducted in the U.K. in partnership with the UK Government's Vaccines Taskforce, and is expected to enroll and immunize up to 10,000 individuals, ages 18-84 years, with and without relevant comorbidities, over the next four to six weeks, Novavax said.

Novavax表示,這項試驗是在英國與英國政府的疫苗工作組合作進行的,預計將在未來4至6周內招募1萬名年齡在18歲至84歲之間、有或沒有相關合並症的人進行免疫接種。

Separately, Endo International PLC (NASDAQ:ENDP) announced a non-exclusive agreement with Novavax to provide fill-finish manufacturing services at its plant in Rochester, Michigan for NVX-CoV2373.

另外,遠藤國際公司(納斯達克:ENDP)宣佈與Novavax達成一項非獨家協議,在其位於密歇根州羅切斯特的工廠為NVX-CoV2373提供填充劑製造服務。

In pre-market trading Friday, Novavax shares were up 7.48% to $110.10, and Endo was gaining 9.27% to $3.30.

在上週五的盤前交易中,諾華的股價上漲了7.48%,至110.10美元,遠藤的股價上漲了9.27%,至3.3美元。

Altimmune Rallies On Institutional Buying

Altimmune因機構買入而上漲

Altimmune Inc (NASDAQ:ALT) shares moved after a filing by the company revealed D.E. Shaw and D.E. Shaw & Co. each beneficially own 1,634,730 shares, or 5% stake in the company.

Altimmune Inc.(納斯達克:谷丙轉氨酶)在該公司提交的一份文件顯示,D.E.Shaw和D.E.Shaw&Co.各自實益持有該公司1,634,730股,即5%的股份後,該公司的股票出現了變動。

The stock rallied 8.89% to $13.10 in after-hours trading.

該股在盤後交易中大漲8.89%,報13.10美元。

Clover Biopharma Announces Positive Preliminary Phase 1 Results From Coronavirus Vaccine Program

三葉草生物製藥公司宣佈冠狀病毒疫苗計劃第一階段結果呈陽性

Clover Biopharma, which is developing a protein-based COVID-19 S-Trimer vaccine candidate in combination with adjuvants from GlaxoSmithKline plc (NYSE:GSK) or Dynavax Technologies Corporation (NASDAQ:DVAX) said the investigational vaccine induced a strong immune response and protection against SARS-CoV-2 in animal models.

三葉草生物製藥公司正在開發一種基於蛋白質的新冠肺炎S-三聚體疫苗候選疫苗,該公司正在與來自葛蘭素史克(紐約證券交易所:葛蘭素史克)或戴納瓦克斯技術公司(納斯達克:DVAX)説,研究中的疫苗在動物模型中誘導了對SARS-CoV-2的強烈免疫反應和保護。

Clover also announced preliminary results from a Phase 1 study showing that the vaccine is likely to be safe and well-tolerated, with high levels of neutralizing antibodies.

克洛弗還宣佈了一項第一階段研究的初步結果,該疫苗可能是安全的,耐受性良好,具有高水平的中和抗體。

Based on these preliminary results, an additional 200 participants will be enrolled in a Phase 1 dose-expansion study at the selected S-Trimer dose-level and adjuvanted with either GSK's pandemic adjuvant or Dynavax's advanced adjuvant CpG 1018 plus alum, the company said.

該公司表示,根據這些初步結果,另外200名參與者將在選定的S-三聚體劑量水平上參加第一階段劑量擴展研究,並使用GSK的大流行佐劑或Dyavax的高級佐劑CpG 1018加明礬。

Clover also said it plans to initiate a Phase 2/3 efficacy study before the end of 2020.

三葉草還表示,計劃在2020年底之前啟動2/3期療效研究。

Genfit Announces First Patient Visit In Pivotal Phase 3 Study of Elafibranor In Primary Biliary Cholangitis

Genfit宣佈Elafibror治療原發性膽管炎的關鍵3期研究首次患者就診

Genfit announced the first patient first visit for ELATIVE, its global, pivotal, Phase 3 study evaluating the efficacy and safety of elafibranor in primary biliary cholangitis, or PBC.

Genfit宣佈了ELATIVE的第一次患者首次就診,這是其評估Elafibror治療原發性膽管炎(PBC)的有效性和安全性的全球性、關鍵的3期研究。

"This is a significant milestone and it means that we are now a step closer to hopefully bringing patients and caregivers a promising option to treat this debilitating disease and its symptoms. We see an important potential for elafibranor in PBC and will provide further information at the upcoming Corporate Update on September 30" said Pascal Prigent, CEO at GENFIT.

Genfit公司首席執行官帕斯卡·普里金特説:“這是一個重要的里程碑,這意味着我們現在離為患者和護理人員提供治療這種使人衰弱的疾病及其症狀的有希望的選擇又近了一步。我們看到了Elafibror在PBC中的重要潛力,並將在即將於9月30日舉行的公司更新中提供進一步的信息。”

In after-hours trading, the stock jumped 13.08% to $4.15.

在盤後交易中,該股躍升13.08%,至4.15美元。

Radius Health, Partner Say Enrollment Into Phase 3 Study of Breast Cancer Drug Completed

RADIUS Health,合作伙伴稱乳腺癌藥物第三階段研究已完成

Radius Health Inc (NASDAQ:RDUS) and partner Menarini Group said the target enrollment milestone has been reached in the Phase 3 EMERALD clinical trial of elacestrant that is being studied in postmenopausal women and men with ER+/HER2- advanced or metastatic breast cancer.

RADIUS健康公司(納斯達克:RDUS)和合作夥伴Menarini Group表示,elacestrant的Emerald 3期臨牀試驗已經達到了目標登記里程碑,該試驗正在對患有ER+/HER2晚期或轉移性乳腺癌的絕經後女性和男性進行研究。

The companies expect to conduct primary analysis of data from the study in the second half of 2021. An independent data monitoring committee that reviewed results of futility analysis conducted after the completion of 70% of targeted enrollment recommended that the study proceed without modification, the companies said.

兩家公司預計將在2021年下半年對研究數據進行初步分析。兩家公司表示,一個獨立的數據監測委員會審查了在完成70%的定向登記後進行的無效性分析的結果,建議這項研究在不進行修改的情況下繼續進行。

Marinus Cleared to Initiate Registrational Phase 3 Study of Ganaxolone In Refractory Status Epilepticus

Marinus獲準啟動Ganaxolone治療難治性癲癇持續狀態的註冊3期研究

Marinus Pharmaceuticals Inc (NASDAQ:MRNS) said it has satisfied the FDA's protocol-specific questions for the registrational Phase 3 trial of intravenous ganaxolone in refractory status epilepticus, allowing enrollment to begin in this clinical trial. The company expects the first patient to be enrolled in October and release topline data in the first half of 2022.

Marinus製藥公司(納斯達克:MRNS)表示,它已經滿足了FDA關於靜脈注射甘納鬆酮治療難治性癲癇持續狀態的註冊第三階段試驗的特定方案問題,允許開始登記參加這項臨牀試驗。該公司預計第一名患者將於10月份入選,並在2022年上半年發佈背線數據。

Marinus recently reported positive Phase 3 results for ganaxolone in CDKL5 deficiency disorder

最近的馬利納斯已報告CDKL5缺乏症患者Ganaxolone三期試驗陽性結果

In pre-market trading, the stock was adding 5.61% to $11.30.

在盤前交易中,該股上漲5.61%,至11.30美元。

On The Radar

在雷達上

IPOs

首次公開募股

Prelude Therapeutics, a clinical-stage precision oncology company, priced its initial public offering, or IPO, of 8.325 million shares at $19 per share, the upper end of the estimated price range of $17-$19. Gross proceeds from the offering are expected at $158.2 million. The shares will begin trading on the Nasdaq under the ticker symbol PRLD.

前奏治療學,一家臨牀階段的精確腫瘤學公司,將其832.5萬股的首次公開募股(IPO)定價為每股19美元,這是預估價格區間17-19美元的上限。此次發行的總收益預計為1.582億美元。該股將在納斯達克市場開始交易,股票代碼為PRLD。

Greenwich LifeSciences Inc., a clinical-stage biopharma focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery, priced its IPO of 1.261 million shares at $5.75 apiece, for raising gross proceeds of $7.25 million. The shares will begin trading on the Nasdaq under the symbol GLSI.

格林威治生命科學公司,一家專注於開發GP2的臨牀階段生物製藥公司,將其126.1萬股IPO定價為每股5.75美元,以籌集725萬美元的毛收入。GP2是一種免疫療法,旨在防止以前接受過手術的患者的乳腺癌復發。該股將在納斯達克市場開始交易,交易代碼為GLSI。

MV Pharmaceuticals, Inc., a precision oncology company, priced its IPO of 11.765 million shares at $18 per share. The shares are expected to begin trading on the Nasdaq under the ticker symbol PMVP.

MV製藥公司一家精密腫瘤學公司,將其1176.5萬股的IPO定價為每股18美元。該股預計將在納斯達克市場開始交易,股票代碼為PMVP。

譯文內容由第三人軟體翻譯。


以上內容僅用作資訊或教育之目的,不構成與富途相關的任何投資建議。富途竭力但無法保證上述全部內容的真實性、準確性和原創性。
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