The Week Ahead In Biotech (April 17-April 23): J&J, Abbott Earnings, Adcom Test For TG Therapeutics And More
The Week Ahead In Biotech (April 17-April 23): J&J, Abbott Earnings, Adcom Test For TG Therapeutics And More
Regeneron Pharmaceuticals, Inc.'s (NASDAQ:REGN) communicated the Food and Drug Administration's decision to delay granting full approval of its antibody cocktail REGEN-COV as a prophylactic treatment for COVID-19.Biotech stocks retreated in the week ending April 14, lock-stepping with the broader market. The news flow was light during the holiday-shortened week and ahead of the imminent first-quarter reporting season.
生物科技股在截至4月14日的一週內回落，與大盤同步。在假期縮短的一週內，以及即將到來的第一季度報道季節之前，新聞流動清淡。
Lyra Therapeutics, Inc. (NASDAQ:LYRA) was among the biggest gainers of the week following the completion of a $100.5 million private placement. Sierra Oncology, Inc. (NASDAQ:SRRA) also advanced strongly after it announced a deal to be acquired by GlaxoSmithKline plc (NYSE:GSK) for $1.9 billion.
萊拉治療公司納斯達克(Sequoia Capital：LYRA)是本週漲幅最大的股票之一，此前該公司完成了1.05億美元的私募。塞拉腫瘤公司納斯達克(Sequoia Capital：SRRA)也強勁上漲，此前該公司宣佈將被葛蘭素史克(紐約證券交易所代碼：GSK)19億美元。
Meanwhile, Kaleido Biosciences, Inc. (NASDAQ:KLDO) plunged after disclosing in a filing that it is shuttering operations. The microbiome therapeutic-focused biopharma was facing a cash crunch and clinical setbacks.
同時，卡萊多生物科學公司納斯達克(Sequoia Capital：KLDO)在一份文件中披露將關閉業務後，股價暴跌。這家專注於微生物治療的生物製藥公司正面臨資金短缺和臨牀挫折。
Regeneron Pharmaceuticals, Inc.'s (NASDAQ:REGN) communicated the Food and Drug Administration's decision to delay granting full approval of its antibody cocktail REGEN-COV as a prophylactic treatment for COVID-19.
Regeneron製藥公司新浪納斯達克(新浪納斯達克：REGN)通報了美國食品和藥物管理局關於推遲完全批准其抗體雞尾酒REGEN-COV作為新冠肺炎預防性治療的決定。
Here are the key catalysts that could impact trading in biotech stocks in the unfolding week:
以下是可能影響未來一週生物科技股交易的關鍵催化劑：
Conferences
會議
2022 American Society of Cataract and Refractive Surgery, or ASCRS, Annual Meeting: April 23-26, in Washington, D.C.
2022年美國白內障與屈光手術學會年會：4月23-26日，華盛頓特區。
2022 Tandem Meetings – Transplantation & Cellular Therapy Meetings Of American Society for Transplantation and Cellular Therapy, or ASTCT, and Center for International Blood and Marrow Transplant Research, or CIBMTR: April 23-26, in Salt Lake City, Utah
2022年連續會議-美國移植和細胞治療學會(ASTCT)和國際血液和骨髓移植研究中心(CIBMTR)的移植和細胞治療會議：4月23-26日，在猶他州鹽湖城
Related Link: Attention Biotech Investors: Mark Your Calendar For April PDUFA Dates
相關鏈接：生物技術投資者請注意：在日曆上標記4月份的PDUFA日期
Adcom Calendar
Adcom日曆
FDA's Oncologic Drugs Advisory Committee is scheduled to meet on Friday, April 22 to discuss TG Therapeutics, Inc.'s (NASDAQ:TGTX) sNDA for Ukoniq (umbralisib) tablets, and BLA for ublituximab injection. The proposed indication for these two products is in combination for the treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma.
FDA的腫瘤藥物諮詢委員會定於4月22日星期五舉行會議，討論TG治療公司的(納斯達克代碼：TGTX)優康奈克片劑用sNDA，注射用烏比妥昔單抗用血乳酸。這兩種產品的建議適應症是聯合治療患有慢性淋巴細胞白血病或小淋巴細胞性淋巴瘤的成人患者。
The committee will also discuss the existing umbralisib indications in patients with relapsed or refractory follicular lymphoma and marginal zone lymphoma approved under accelerated approval regulations.
委員會還將討論根據加速批准條例批准的復發或難治性濾泡性淋巴瘤和邊緣帶淋巴瘤患者的現有umbralisib適應症。
Clinical Readouts/Presentations
臨牀讀數/演示
ASCRS Meeting Presentation(s)
ASCRS會議演示文稿
Ocular Therapeutix, Inc. (NASDAQ:OCUL): Phase 2 data for OTX-DED, an intracanalicular dexamethasone Insert, for the treatment of episodic dry eye disease (Saturday, 3:30-3:35 pm ET)
眼科治療公司(納斯達克：OCUL)：用於治療發作性乾眼病的OTX-DED的第二階段數據(美國東部時間星期六下午3：30-3：35)
Earnings
收益
Johnson & Johnson (NYSE:JNJ) (Tuesday, before the market open)
Abbott Laboratories (NYSE:ABT) (Wednesday, before the market open)
Plus Therapeutics, Inc. (NASDAQ:PSTV) (Thursday, after the close)
Intuitive Surgical, Inc. (NASDAQ:ISRG) (Thursday, after the close)
強生(紐約證券交易所代碼：JNJ)(週二，市場開盤前)
雅培(紐約證券交易所股票代碼：ABT)(週三，市場開盤前)
Plus Treateutics公司(納斯達克：PSTV)(週四收盤後)
直覺外科公司股份有限公司(納斯達克：ISRG)(週四收盤後)
IPOs
首次公開募股(IPO)
IPO Quiet Period Expiry
IPO靜默期到期
AN2 Therapeutics, Inc. (NASDAQ:ANTX)
AN2治療公司(納斯達克：螞蟻)
Related Link: Merck Continues to See Executive Exodus; Here's A Look At All Recent Departures
相關鏈接：默克公司繼續出現高管離職；以下是最近所有離職人員的情況
譯文內容由第三人軟體翻譯。
