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The Daily Biotech Pulse: Moderna Awaits Adcom Ruling On COVID-19 Booster Shot; Teligent Files For Chapter 11; CFO Transitions at Catalyst Biosciences, CRISPR; Lucid Diagnostics Debuts

The Daily Biotech Pulse: Moderna Awaits Adcom Ruling On COVID-19 Booster Shot; Teligent Files For Chapter 11; CFO Transitions at Catalyst Biosciences, CRISPR; Lucid Diagnostics Debuts

《每日生物技術脈搏》:Moderna 正在等待 Adcom 對 COVID-19 Booster Shot 的裁決;Teligent 申請第 11 章;CRISPR Catalyst Biosciences 的首席財務官轉職;Lucid Diagnostics
Benzinga Real-time News ·  2021/10/14 20:07

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

以下是過去 24 小時內生物技術領域的主要進展摘要:

Stocks In Focus

焦點股票

Catalyst Biosciences Announces Resignation Of CFO

Catalyst 生物科學公司宣佈首席財務官辭職

Catalyst Biosciences, Inc. (NASDAQ:CBIO) announced that its chief financial officer, Clinton Musil, has resigned for personal reasons effective Oct. 29. Seline Miller, the company's controller, has been promoted to senior vice president, finance and will serve as interim chief financial and principal accounting officer while the company initiates a search for a successor.

Catalyst 生物科學公司 納斯達克股票代碼:CBIO)宣佈,其首席財務官, 克林頓·穆西爾,已因個人原因辭職,自10月29日起生效。 賽琳·米勒,該公司的財務總監,已被提升爲財務高級副總裁,將在公司開始尋找繼任者期間擔任臨時首席財務官和首席會計官。

Orthopediatrics Preannounces Below-Consensus Q3 Revenues

Orthepediatrics 預先公佈了低於共識的第三季度收入

OrthoPediatrics Corp. (NASDAQ:KIDS) announced preliminary third-quarter revenue of about $25.1 million, up 13% year-over-year but trailing the consensus estimate of $26.48 million. The company clarified that quarterly revenue was impacted by increased COVID-19 delta variant cases as well as respiratory syncytial virus cases within the children's hospitals combined with hospital staff shortages.

整形外科公司 納斯達克股票代碼:KIDS)公佈的第三季度初步收入約爲2510萬美元,同比增長13%,但低於共識估計的2648萬美元。該公司澄清說,季度收入受到兒童醫院內 COVID-19 delta 變異病例以及呼吸道合胞病毒病例增加以及醫院人員短缺的影響。

Despite this impact, the company said it is reiterating its 2021 total revenue guidance range of $97 million to $101 million, surrounding the $98.74-million consensus estimate.

儘管有這種影響,但該公司表示將重申其2021年的總收入指導區間爲9700萬至1.01億美元,圍繞9,874萬美元的共識估計。

Turning Point Announces Clinical Collaboration For Studying Combo Therapy In Lung Cancer Patients With Certain Mutations

Turning Point宣佈開展臨床合作,研究具有某些突變的肺癌患者的組合療法

Turning Point Therapeutics, Inc. (NASDAQ:TPTX) announced a clinical collaboration to evaluate elzovantinib, its drug candidate targeting MET, SRC and CSF1R, in combination with aumolertinib, in patients with EGFR mutant MET-amplified advanced non-small cell lung cancer.

Turning Point Therapeu 納斯達克股票代碼:TPTX)宣佈了一項臨床合作,評估elzovantinib,這是其靶向MET、SRC和CSF1R 的候選藥物,與aumolertinib聯合用於治療表皮生長因子突變體MET擴增的晚期非小細胞肺癌患者。

Aumolertinib is EQRx's drug candidate targeting EGFR.

Aumolertinib 是 eqRx 的靶向 EGFR 的候選藥物。

Under the terms of the agreement, Turning Point will sponsor and conduct a Phase 1b/2 clinical trial to evaluate the safety, tolerability and preliminary efficacy of the combination regimen and will assume all costs associated with the trial. EQRx will provide aumolertinib at no cost. Turning Point is targeting initiation of the clinical trial in 2022, pending filing of an investigational new drug application with the Food and Drug Administration.

根據協議條款,Turning Point將贊助和進行一項1b/2期臨床試驗,以評估該聯合療法的安全性、耐受性和初步療效,並將承擔與該試驗相關的所有費用。eqRx 將免費提供奧莫替尼。Turning Point的目標是在2022年啓動臨床試驗,等待向美國食品藥品監督管理局提交研究性新藥申請。

The stock was adding 2.06% to $48 in premarket trading.

該股在盤前交易中上漲2.06%,至48美元。

CRISPR Announces Departure of CFO, Names Former Translate Bio Executive To The Post

CRISPR 宣佈首席財務官離職,任命前 Translate Bio 高管出任

CRISPR Therapeutics (NASDAQ:CRSP) announced the appointment of Brendan Smith as chief financial officer effective Thursday. Smith brings more than 20 years of financial, operational and strategic leadership experience, including as CFO of Translate Bio, the company said. He succeeds Michael Tomsicek, who is retiring after four years at the company.

CRISPR 療法 納斯達克股票代碼:CRSP)宣佈任命 布倫丹·史密斯 擔任首席財務官,自週四起生效。該公司表示,史密斯擁有超過20年的財務、運營和戰略領導經驗,包括擔任Translate Bio的首席財務官。他成功了 邁克爾·託姆西切克,他在公司工作四年後即將退休。

The stock was up 1.01% at $97.75 in premarket trading.

該股在盤前交易中上漲1.01%,至97.75美元。

Related Link: The Week Ahead In Biotech (Oct. 10-16): Avadel FDA Decision, Conference Presentations And IPOs Take Center Stage

相關鏈接:生物技術未來一週(10 月 10 日至 16 日):Avadel FDA 的決定、會議演講和首次公開募股佔據中心位置

Teligent Files For Chapter 11 Bankruptcy Protection

Teligent 申請第 11 章破產保護

Specialty generic pharma company Teligent, Inc. (NASDAQ:TLGT) announced that it has, together with certain of its affiliates, filed for voluntary protection under Chapter 11 of the U.S. Bankruptcy Code in the U.S. Bankruptcy Court for the District of Delaware to pursue a sale process that is intended to maximize the value of the company.

專業仿製藥公司 Teligent, Inc. 納斯達克股票代碼:TLGT)宣佈,它已與其某些關聯公司一起根據美國破產法第11章向美國特拉華特區破產法院申請自願保護,以進行旨在實現公司價值最大化的出售程序。

The company began a marketing process ahead of the Chapter 11 filing to determine the level of market interest and is in ongoing discussions with several interested parties. It expects to consummate a sale of the entire business or its core assets by early 2022. Meanwhile, Teligent's Canadian affiliate, Teligent Canada, will be pursuing an out-of-court sale process.

該公司在提交第11章申請之前開始了營銷程序,以確定市場興趣水平,並且正在與多個利益相關方進行討論。它預計將在2022年初完成整個業務或其核心資產的出售。同時,Teligent的加拿大子公司Teligent Canada將進行庭外出售。

The stock was retreating 37.12% to 20.95 cents in premarket trading.

該股在盤前交易中下跌了37.12%,至20.95美分。

Roche Announces European Regulatory Nod For Shorter Infusion Gazyvaro In Advanced Follicular Lymphoma Patients

羅氏宣佈歐洲監管部門同意縮短對晚期濾泡性淋巴瘤患者的輸液時間 Gazyvaro

Roche Holding AG (OTC:RHHBY) announced European Medicines Agency approval of a new, shorter 90-minute Gazyvaro infusion time, administered in combination with chemotherapy in patients with previously treated or untreated advanced follicular lymphoma.

羅氏控股股份公司 (OTC: RHHBY) 宣佈歐洲藥品管理局批准一項新的、更短的90分鐘Gazyvaro輸液時間,該輸液時間與化療聯合使用,適用於以前接受過治療或未經治療的晚期濾泡淋巴瘤患者。

Fortress Biotech Partner Company Announces Positive Results From Pivotal Studies of Menkes Disease Treatment

Fortress Biotech合作伙伴公司宣佈門克斯病治療關鍵研究取得積極結果

Fortress Biotech, Inc. (NASDAQ:FBIO) partner company Cyprium Therapeutics and its licensing partner Sentynl Therapeutics announced positive results from an efficacy and safety analysis of data integrated from two completed pivotal studies in patients with Menkes disease treated with CUTX-101.

豐澤生物技術有限公司 (納斯達克股票代碼:FBIO)合作伙伴公司Cyprium Therapeutics及其許可合作伙伴Sentynl Therapeutics宣佈,對兩項針對接受 CUTX-101 治療的門克斯病患者的已完成關鍵研究的數據的療效和安全性分析得出了積極的結果。

The stock was up 5.48% to $3.27 in premarket trading.

該股在盤前交易中上漲5.48%,至3.27美元。

In both pre-specified primary and secondary efficacy analysis, treatment with CUTX-101 demonstrated a significantly greater median overall survival compared to untreated historical control patients.

在預先指定的主要和次要療效分析中,與未接受治療的歷史對照患者相比,CUTX-101 治療的總存活率中位數明顯更高。

These data will be presented as a virtual poster at the 2021 American Academy of Pediatrics National Conference & Exhibition.

這些數據將在2021年美國兒科學會全國會議和展覽上以虛擬海報的形式呈現。

Click here to access Benzinga's FDA Calendar.

點擊此處訪問 Benzinga 的 FDA 日曆。

On The Radar

在雷達上

Adcom Meetings

Adcom 會議

FDA's Vaccines and Related Biological Products Advisory Committee is meeting Thursday to discuss a booster dose of the Moderna, Inc. (NASDAQ:MRNA) COVID-19 vaccine.

美國食品藥品管理局的疫苗及相關生物製品諮詢委員會將於週四開會,討論該疫苗的加強劑量 Moderna, Inc. (納斯達克股票代碼:MRNA)COVID-19 疫苗。

IPOs

首次公開招股

Medical device maker PAVmed Inc. (NASDAQ:PAVM)'s spin-off unit Lucid Diagnostics Inc. (NASDAQ:LUCD) has priced its initial public offering of 5 million shares at $14 compared to the estimated price range of $14-$16. The New York-based company's shares will begin trading on the Nasdaq under the ticker symbol "LUCD."

醫療設備製造商 PavMed Inc. (納斯達克股票代碼:PAVM)的分拆部門 Lucid Diagnost納斯達克股票代碼:LUCD)已將其500萬股股票的首次公開募股定價爲14美元,而估計的價格區間爲14-16美元。這家總部位於紐約的公司的股票將在納斯達克開始交易,股票代碼爲 “LUCD”。

Lucid is a commercial-stage medical diagnostics technology company focused on treating patients with gastroesophageal reflux disease, also known as chronic heartburn, acid reflux or simply reflux, who are at risk of developing esophageal precancer and cancer, specifically highly lethal esophageal adenocarcinoma.

Lucid 是一家處於商業階段的醫療診斷技術公司,專注於治療胃食管反流病(也稱爲慢性胃灼熱、胃酸反流或簡稱反流)的患者,這些患者有患食管癌前期和癌症,特別是高致命性的食管腺癌的風險。

Related Link: Attention Biotech Investors: Mark Your Calendar For October PDUFA Dates

相關鏈接:生物技術投資者注意:在日曆上標出十月的PDUFA日期

譯文內容由第三人軟體翻譯。


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