Icon Bioscience, Inc.

FDA公布了其发给EyePoint 公司的一封警告信，信中主要针对EyePiont的Yutiq存在的生产问题。 FDA指出，在生产、加工、包装以及储存等环节不符合cGMP规定，要求EyePoint聘请第三方顾问在15个工作日内，针对其指出的生产问题给出解决方案。 多个cGMP生产缺陷 Yutiq是一种缓释氟轻松丙酮酯玻璃体内植入物，活性成分为—氟轻松丙酮酯，一类人工合成的皮质类固醇。Yutiq经单次植入后，在36个月时间内，持续释放共计0.18mg的氟轻松。 2018年10月，Yutiq获得FDA批准上市，用于治疗累及眼后段的慢性非感染性葡萄膜炎。2022年6月，Yutiq在国内获批上市，是国内首个完全基于"真实世界研究数据"获批上市的新药。 今年2月，FDA对EyePoint位于美国watertown的工厂进行了生产现场检查，并在今年7月发出了这份警告信。 FDA在信中指出，EyePoint未能对不同批次Yutiq之间差异的原因进行彻底调查，如对某些批次的药芯异常释放率未能进行调查，并采取适当的干预措施，公司也没有跟进调查，以确保其他批次不受类似影响。 EyePoint未能建立和遵守其生产和过程控制程序，FDA检查期间，生成了多个统计工艺控制图，发现了四个之前未被发现的不良趋势。 FDA在警告信中还指出人工目检中存在的问题，该公司缺乏对加工（包装)重大缺陷的识别和舍弃。 与国内企业深度合作 EyePoint是一家美国眼科制药公司，成立于2000年。 EyePoint拥有Yutiq和Duravyu两款上市产品，Duravyu是一种生物可降解的缓释抗炎药物，2018年被FDA批准用于治疗白内障手术相关炎症，是EyePoint通过收购Icon Bioscience公司获得。 在产品管线和研发管线上，EyePoint跟国内的贝达药业和欧康维视都有深度合作。 2018年，EyePoint便与欧康维视签订独家许可协议，欧康维视获得了Yutiq及Duravyu在大中华地区开发及商业化独家权益。2021年，欧康维视还对EyePoint进行了1570万美元的股权投资，成为其重要股东之一。 贝达与EyePoint渊源同样颇深。 2022年，贝达与EyePoint签订合作协议，贝达获得其主要管线EYP-1901大中华区（包括中国大陆、香港、澳门和台湾地区）独家开发和商业化权益。 EYP-1901是目前最重要的候选管线，其活性成分--伏罗尼布正是来自于贝达药业，2020年2月，贝达制药子公司Equinox Sciences将伏罗尼布在大中华地区以外开发所有局部给药眼科适应症的独家权益授权给EyePoint。 去年12月，EyePoint公布了EYP-1901治疗湿性年龄相关性黄斑变性（nAMD）Ⅱ期临床试验DAVIO 2结果，所有主要终点和关键次要终点全部达到，相比对照组（阿柏西普），两个剂量组的EYP-1901在最佳矫正视力（BCVA）上达到了非劣效性。受此利好消息影响，EyePoint股价昨日暴涨超200%以上。 EyePoint的财务状况也是十分紧张的，2023年5月公司以8250万美元将Yutiq的全球权益（不包括大中华区)卖给了Alimera，并且还关闭了商业团队，裁减了一半员工，以将现金跑道延长至2025年。 近期EyePoint公布了2024年上半年财报，收入也比较微薄，二季度净收入为950万美元，其中净产品收入为110万美元，特许权使用费和合作净收入为840万美元。 参考出处： https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/eyepoint-pharmaceuticals-inc-679747-07122024 https://www.fiercepharma.com/pharma/eyepoint-dinged-fda-warning-letter-over-manufacturing-shortfalls-tied-eye-implant https://investors.eyepointpharma.com/news-releases/news-release-details/eyepoint-pharmaceuticals-reports-second-quarter-2024-financial 本周好文推荐 如需转载请联系佰傲谷并在醒目位置注明出处 · · · · · · · ·

LAKE FOREST, Ill., March 06, 2023 (GLOBE NEWSWIRE) -- Assertio Holdings, Inc. (“Assertio” or the “Company”) (Nasdaq: ASRT), a specialty pharmaceutical company offering differentiated products to patients, today announced the appointment of Howard J. Franklin, MD, as Senior Vice President, Medical. “We see significant opportunities to expand the addressable market and label indications for key assets in our portfolio, in particular Indocin. We are excited to add Dr. Franklin to our team as we ready clinical studies related to these assets and expect to launch our first clinical investigation later in 2023,” said Dan Peisert, President and Chief Executive Officer of Assertio. “I am excited to join the team and create a best-in-class clinical development and medical affairs program that builds on the legacy of successful commercial innovation established here at Assertio,” said Dr. Franklin. “Assertio’s existing portfolio includes multiple assets with opportunities to open new or expand existing addressable markets through clinical studies and label expansion, deriving greater value from the application of those molecules. In addition, a robust medical program will support the acquisition of potential molecules that can fit Assertio’s unique, digital focused sales model.” Dr. Franklin was previously Chief Medical Officer at Finch Therapeutics, a microbiome-based biotechnology firm applying new technologies to the treatment of immuno-oncology, IBD and autism spectrum disorder. He was previously Chief Medical Officer of Salix Pharmaceuticals, a $2 billion division of Bausch Healthcare Corporation with a focus on gastrointestinal medicine, where he shaped and executed clinical, regulatory and medical affairs strategies for a suite of GI-related assets with a focus on lifecycle management. He previously held senior roles at Icon Bioscience, Oceana Therapeutics, The Medicines Company, Esprit Pharmaceuticals and Odyssey Pharmaceuticals. Dr. Franklin holds a Bachelor of Applied Science, Pre-Medical Studies, from Lehigh University, and a Doctor of Medicine from Drexel University College Medicine. He completed his medical residency in general surgery at Long Island Jewish Medical Center, followed by a fellowship in lapro-endoscopy and minimally invasive surgery at Massachusetts General Hospital, Harvard Medical School. He competed a Master of Business Administration degree at LaSalle University. About Assertio Assertio is a specialty pharmaceutical company offering differentiated products to patients utilizing a non-personal promotional model. We have built and continue to build our commercial portfolio by identifying new opportunities within our existing products as well as acquisitions or licensing of additional approved products. To learn more about Assertio, visit www.assertiotx.com. Forward Looking StatementsStatements in this communication that are not historical facts are forward-looking statements that reflect Assertio's current expectations, assumptions and estimates of future performance and economic conditions. These forward-looking statements are made in reliance on the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements relate to, among other things, the preliminary, unaudited financial results included in this press release, future events or the future performance or operations of Assertio, including our ability to realize the benefits from our operating model, successfully acquire and integrate new assets and explore new business development initiatives. All statements other than historical facts may be forward-looking statements and can be identified by words such as "anticipate," "believe," "could," "design," "estimate," "expect," "forecast," "goal," "guidance," "imply," "intend," "may", "objective," "opportunity," "outlook," "plan," "position," "potential," "predict," "project," "prospective," "pursue," "seek," "should," "strategy," "target," "would," "will," "aim" or other similar expressions that convey the uncertainty of future events or outcomes and are used to identify forward-looking statements. Such forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties and other factors, some of which are beyond the control of Assertio, including the risks described in Assertio's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the U.S. Securities and Exchange Commission ("SEC") and in other filings Assertio makes with the SEC from time to time. Investors and potential investors are urged not to place undue reliance on forward-looking statements in this communication, which speak only as of this date. While Assertio may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to update or revise any forward-looking-statements contained in this press release whether as a result of new information or future events, except as may be required by applicable law. Investor Contact Matt KrepsDarrow AssociatesM: 214-597-8200mkreps@darrowir.com

Patient dosing underway in PRISM4 Phase 3 trial of CP101 in recurrent CDITopline PRISM4 data anticipated in H1 2024 Anticipated cash runway into Q2 2024 SOMERVILLE, Mass., Nov. 10, 2022 (GLOBE NEWSWIRE) -- Finch Therapeutics Group, Inc. (“Finch” or “Finch Therapeutics”) (Nasdaq: FNCH), a clinical-stage microbiome therapeutics company leveraging its Human-First Discovery® platform to develop a novel class of orally administered biological drugs, today provided corporate updates and reported financial results for the third quarter ended September 30, 2022. “We are pleased with the tremendous progress our team has made recently to advance the development of our lead program, with patient dosing now underway in our PRISM4 Phase 3 trial of CP101, a product candidate that we believe holds the potential to fulfill the need for a convenient, one-time oral therapy to prevent recurrent C. difficile infection,” said Mark Smith, PhD, Chief Executive Officer of Finch Therapeutics. “In an effort to accelerate our timeline to topline PRISM4 data and conserve capital, we are evaluating possible modifications to PRISM4 for future discussion with FDA, such as a reduction in the size of the randomized portion of the trial, an approach that may be informed in part by regulatory insights from the recent FDA advisory committee meeting for an enema-based microbiome product candidate. We look forward to providing additional updates as we continue to advance this important program.” Recent Program Highlights Proceeded with Patient Dosing in PRISM4 Recurrent CDI Trial, with Topline PRISM4 Data Anticipated in H1 2024: In October 2022, Finch announced that it had proceeded with patient dosing in PRISM4, a Phase 3 trial of CP101 for the prevention of recurrent C. difficile infection (CDI). The PRISM4 trial has two parts: a randomized, double-blind, placebo-controlled portion and an open-label portion for eligible participants who experience a recurrence during the randomized portion of PRISM4. Topline data from the randomized portion of PRISM4 is anticipated in the first half of 2024. To expand the safety database for CP101 in support of a potential Biologics License Application (BLA), Finch plans to allow direct entry into the open-label portion of PRISM4 following the completion of enrollment in the randomized portion of PRISM4.Presented CP101 PRISM-EXT Biomarker Data at ACG 2022: In October 2022, Finch announced the presentation of biomarker data from the PRISM-EXT open-label trial of CP101 in recurrent CDI at the American College of Gastroenterology (ACG) 2022 Annual Scientific Meeting. Following open-label administration of CP101 after standard-of-care (SOC) CDI antibiotics, there was a significant increase in microbiome diversity from baseline through week 8 and week 24 in PRISM-EXT participants. Higher engraftment of CP101-associated taxa and improvement in diversity were both associated with prevention of CDI recurrence through week 8 in PRISM-EXT participants. As previously reported, 80.3% and 78.8% of participants who received CP101 following SOC antibiotics in PRISM-EXT were without CDI recurrence through week 8 and week 24, respectively (n=132).Conducted Strategic Portfolio Review: Following a recent strategic review of its portfolio, which includes wholly-owned microbiome product candidates for recurrent CDI, inflammatory bowel disease (IBD) and autism spectrum disorder (ASD), Finch is prioritizing the development of CP101 in recurrent CDI and exploring opportunities to potentially advance the development of its pre-clinical candidates for IBD through strategic partnerships. In connection with the strategic review, Finch has suspended efforts to initiate a Phase 1 trial of FIN-211 in ASD while the Company explores opportunities to leverage clinical data generated by ongoing third-party studies to inform its autism program strategy going forward, as previously announced. Recent Corporate Highlights Appointed Howard Franklin, MD, MBA, as Chief Medical Officer: Dr. Franklin, a general surgeon and biopharmaceutical executive with more than 20 years of experience spanning clinical practice, clinical development, medical affairs, regulatory strategy, and product commercialization, previously served as Interim Chief Medical Officer for Finch. Prior to Finch, Dr. Franklin served as Chief Medical Officer at Salix Pharmaceuticals, where he provided leadership and expertise to program teams focused on the development of GI therapeutics. Prior to Salix, he held leadership roles within early-stage biotechnology companies as well as large pharmaceutical companies, including Icon Bioscience, Oceana Therapeutics, The Medicines Company, and Esprit Pharma. Third Quarter 2022 Financial Results Finch reported a net loss of $40.4 million for the third quarter of 2022, compared to a net loss of $10.0 million for the same period in 2021. The net loss was driven by a charge of $18.1 million for the full impairment of the Company’s goodwill during the current quarter. Additionally, there was a decrease in revenue of $11.2 million due to changes under Finch’s collaboration agreement with Takeda, including Takeda’s election in August 2022 to terminate the agreement. Finch also reported an increase in restructuring expenses of $1.3 million quarter-over-quarter.Research and development (R&D) expenses were $11.9 million for the third quarter of 2022, compared to $15.5 million for the same period in 2021. The decrease in R&D expense was driven by a decrease in expenses related to the CP101 program, primarily due to a decrease in external clinical research organization costs, in addition to a decrease in IBD program expenses due to Takeda’s election in August 2022 to terminate its collaboration agreement with Finch. Additionally, there was a decrease in expenses associated with both the hepatitis B (HBV) and ASD programs, due to the Company's decision to suspend its HBV program, announced on March 31, 2022, and its subsequent decision, announced on September 1, 2022, to suspend its Phase 1 clinical trial in ASD.General and administrative (G&A) expenses were $9.6 million for the third quarter of 2022, compared to $5.7 million for the same period in 2021. The increase in G&A expense was primarily due to an increase in professional fees, in addition to an increase in facility-related costs and stock-based compensation expense. This increase was partially offset by a decrease in employee-related expenses due to reduced headcount.Finch’s cash and cash equivalents as of September 30, 2022 were $85.3 million, compared to $133.5 million as of December 31, 2021. Finch believes its cash and cash equivalents on hand as of September 30, 2022, together with anticipated cash inflows from executed subleases for one of the Company’s office and lab facilities, will fund its operations into Q2 2024. About the PRISM4 Phase 3 Trial PRISM4 is a randomized, double-blind, placebo-controlled, multi-center Phase 3 trial evaluating the efficacy and safety of a one-time oral administration of CP101 for the prevention of recurrent C. difficile infection (CDI). After completing standard-of-care CDI antibiotics for their most recent CDI recurrence, eligible participants will be randomized in a 2:1 ratio to receive either CP101 or placebo. Participants will be evaluated for CDI recurrence and safety through week 8, the primary endpoint, as well as through week 24. Participants who qualify may enroll in the optional open label arm and receive CP101 if they experience a CDI recurrence through week 8 of the trial. To learn more about the trial, visit clinicaltrials.gov (Identifier: NCT05153499) or the study website at https://prism4trial.com/. About Finch Therapeutics Finch Therapeutics is a clinical-stage microbiome therapeutics company leveraging its Human-First Discovery® platform to develop a novel class of orally administered biological drugs. Finch’s lead candidate, CP101, is in late-stage clinical development for the prevention of recurrent C. difficile infection and has received Breakthrough Therapy and Fast Track designations from the U.S. Food and Drug Administration. Finch is exploring strategic options to potentially advance the development of its pre-clinical candidates FIN-524 for ulcerative colitis and FIN-525 for Crohn's disease and its pre-clinical program in autism spectrum disorder. Finch routinely posts information that may be important to its investors on its website at www.finchtherapeutics.com. Finch encourages investors to consult the “Investors & News” section of its website regularly. Human-First Discovery® is a registered trademark of Finch Therapeutics Group, Inc. Forward-Looking Statements This press release includes “forward-looking statements.” Words such as “will,” "anticipates," "believes," "expects," "intends," “plans,” “potential,” "projects,” “would” and "future" or similar expressions are intended to identify forward-looking statements. These forward-looking statements include, but are not limited to, statements regarding: the therapeutic potential of Finch’s product candidates, including the potential of CP101 to fulfill the need for a convenient, one-time oral therapy for the prevention of recurrent CDI; possible modifications to PRISM4 and Finch’s ability to leverage regulatory insights from a recent FDA advisory committee meeting; Finch’s ability to accelerate its timeline to topline PRISM4 data and conserve capital; the anticipated timing for topline data from PRISM4; Finch’s plans to allow direct entry in the open-label portion of PRISM4 to expand the safety database for CP101; potential strategic partnerships to advance Finch’s product candidates; opportunities to leverage clinical data generated by third-party studies to inform Finch’s ASD program strategy; Finch’s cash runway; and Finch’s ability to develop a novel class of orally administered biological drugs. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, among others, those related to: Finch’s limited operating history and historical losses; Finch’s ability to raise additional funding to complete the development and any commercialization of its product candidates; Finch’s dependence on the success of its lead product candidate, CP101; the possibility that Finch may be delayed in initiating, enrolling or completing any clinical trials, including PRISM4; results of clinical trials may not be indicative of final or future results from later stage or larger clinical trials (or in broader patient populations once the product is approved for use by regulatory agencies) or may not be favorable or may not support further development; Finch’s product candidates may not generate the benefits to patients that are anticipated; results of clinical trials may not be sufficient to satisfy regulatory authorities to approve Finch’s product candidates in their targeted or other indications (or such authorities may request additional trials or additional information); Finch’s ability to comply with regulatory requirements; ongoing regulatory obligations and continued regulatory review may result in significant additional expense to Finch and Finch could be subject to penalties for failure to comply; competition from third parties that are developing products for similar uses; Finch’s ability to maintain patent and other intellectual property protection and the possibility that Finch’s intellectual property rights may be infringed, invalid or unenforceable or will be threatened by third parties; Finch’s ability to qualify and scale its manufacturing capabilities; Finch’s lack of experience in selling, marketing and distributing its product candidates; Finch’s dependence on third parties in connection with manufacturing, clinical trials and preclinical studies; and risks relating to the impact and duration of the COVID-19 pandemic on Finch’s business. These and other risks are described more fully in Finch’s filings with the Securities and Exchange Commission (“SEC”), including the section titled “Risk Factors” in Finch’s Annual Report on Form 10-K for the year ended December 31, 2021 filed with the SEC on March 31, 2022, as supplemented by Finch’s Quarterly Reports on Form 10-Q filed with the SEC on May 16, 2022 and August 11, 2022, as well as discussions of potential risks, uncertainties, and other important factors in Finch’s other filings with the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except to the extent required by law, Finch undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. Investor Contact: Stephen Jasper Gilmartin Group (858) 525-2047 stephen@gilmartinir.com Media Contact: Jenna Urban Berry & Company Public Relations (212) 253-8881 jurban@berrypr.com Finch Therapeutics Group, Inc.Condensed Consolidated Statements of Operations (Unaudited)(in thousands, except share and per share data) FOR THE THREE MONTHSENDED SEPTEMBER 30, FOR THE NINE MONTHSENDED SEPTEMBER 30, 2022 2021 2022 2021 Revenue: Collaboration revenue $138 $11,343 $853 $17,726 Total revenue 138 11,343 853 17,726 Operating expenses: Research and development 11,859 15,537 41,312 42,476 General and administrative 9,584 5,739 27,152 16,173 Impairment of goodwill 18,057 — 18,057 — Restructuring expense 1,270 — 2,173 — Total operating expenses 40,770 21,276 88,694 58,649 Loss from operations (40,632) (9,933) (87,841) (40,923)Other income (expense) 261 (22) 203 1,818 Net loss $(40,371) $(9,955) $(87,638) $(39,105)Net loss per share attributable to common stockholders—basic and diluted $(0.85) $(0.21) $(1.84) $(1.07)Weighted-average common stock outstanding—basic and diluted 47,728,130 47,445,195 47,611,872 36,408,506 Finch Therapeutics Group, Inc.Condensed Consolidated Balance Sheet Data (Unaudited)(in thousands) SEPTEMBER 30,2022 DECEMBER 31,2021 Assets: Cash and cash equivalents $85,292 $133,481 Other assets 102,676 91,888 Total assets $187,968 $225,369 Liabilities, redeemable convertible preferred stock and stockholders' equity Liabilities 67,102 23,145 Stockholders' equity 120,866 202,224 Total liabilities and stockholders' equity $187,968 $225,369