The drug, known as Trodelvy, was developed by the biotech Immunomedics, which Gilead acquired in September for approximately $21 billion.
The FDA grants orphan drug designation to Syndax's (SNDX) axatilimab for the treatment of patients with idiopathic pulmonary fibrosis. Shares up.
- KGO – San Francisco
Economy flyers may be shut out of the best deals.
- Motley Fool
Immutep Limited reported that the U.S. Food and Drug Administration (FDA) granted the Fast Track designation to eftilagimod alpha in the treatment of recurring or metastatic head and neck squamous cell carcinoma (HNSCC). The Fast Track designation is given to drugs that fill an unmet medical need to expedite their development and approval. It ensures that the company in question and the FDA will work closely together at every step of the process.
Provention Bio Stock Craters After FDA Flags Deficiencies In PK Profiles From Teplizumab Trials For Diabetes
Provention Bio Inc (NASDAQ: PRVB) revealed it had received a notification on April 2 from the FDA stating that the agency has identified deficiencies that preclude discussion of labeling and post-marketing requirements/commitments at this time. Notably, the FDA expressed concerns over teplizumab pharmacokinetics data and comparability when Lilly first put teplizumab into clinical trials. Regulators assert the PK profiles from Provention’s studies and Lilly’s trials are not the same and asked for more data on April 2. According to the regulators, such concerns mean that the candidate cannot start post-marketing and label discussions. Investors responded sourly to the news after Thursday’s bell, with the stock crashing almost 40%. Provention responded, noting it is “willing to discuss these issues.” Regulators had scheduled a May 27 AdCom to discuss the experimental drug, which will continue as planned. The drug has a long history. In 2007, Eli Lilly And Co’s (NYSE: LLY) and MacroGenics Inc (NASDAQ: MGNX) partnered to develop and commercialize teplizumab. In 2010, teplizumab failed a pivotal late-stage diabetes study undertaken by Eli Lilly, and it handed the rights back to MacroGenics. In 2018, Provention Bio stepped in and in-licensed the drug from MacroGenics, hoping to bring the experimental drug back from the dead. PRVB used teplizumab as their lead drug for a $56 million IPO filing. Teplizumab is an investigational anti-CD3 monoclonal antibody for the delay or prevention of clinical type 1 diabetes (T1D) in at-risk individuals. Price Action: PRVB shares plunged 40.7% at $5.77 in the premarket session on the last check Friday. See more from BenzingaClick here for options trades from BenzingaEli Lilly-Incyte's Baricitinib Study In Hospitalized COVID-19 Patients Fails To Meet Main GoalFortress Biotech's Partner Firm Expands Footprint In Dermatology With Qbrexza Acquisition© 2021 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
SHAREHOLDER ALERT: Levi & Korsinsky, LLP Notifies Shareholders of Ehang Holdings Limited of a Class Action Lawsuit and a Lead Plaintiff Deadline of April 19, 2021 - EH
New York, New York--(Newsfile Corp. - April 8, 2021) - The following statement is being issued by Levi & Korsinsky, LLP:To: All persons or entities who purchased or otherwise acquired securities of Ehang Holdings Limited ("Ehang Holdings") (NASDAQ: EH) between December 12, 2019 and February 16, 2021. You are hereby notified that a securities class action lawsuit has been commenced in the United States District Court for the Southern District of New York. To ...
- KFSN – Fresno
Fresno County health officials are waiting for the green light to start vaccinating younger residents against COVID-19.
J&J is attracting investor scrutiny because it partially shields Gorsky from some $9 billion in costs over two years that have arisen from lawsuits claiming the healthcare company fueled the U.S. opioid crisis and allegations of asbestos in its talc baby powder. In a note to shareholders on Thursday, ISS said "...investors may nonetheless expect an explanation from the company of how the compensation committee considered the extraordinarily large litigation charges when making compensation decisions."
- Investor's Business Daily
Celcuity broke out and soared to a nearly two-year high Friday after striking a licensing deal with Pfizer for a breast cancer treatment. Celcuity paid Pfizer $10 million in cash and stock.
INVESTOR ACTION ALERT: The Schall Law Firm Reminds Investors of Class Action Lawsuit Against Velodyne Lidar, Inc. and Encourages Investors with Losses in Excess of $100,000 to Contact the Firm
Los Angeles, California--(Newsfile Corp. - April 9, 2021) - The Schall Law Firm, a national shareholder rights litigation firm, reminds investors of a class action lawsuit against Velodyne Lidar, Inc. ("Velodyne" or "the Company") (NASDAQ: VLDR) for violations of §§10(b) and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5 promulgated thereunder by the U.S. Securities and Exchange Commission.Investors who purchased the Company's securities between July 2, 2020 and March 17, 2021, ...
Louisiana-Pacific (LPX) is well positioned to outperform the market, as it exhibits above-average growth in financials.
Yamaha Motor Co., Ltd. (YAMHF) possesses solid growth attributes, which could help it handily outperform the market.
Beneficiaries must juggle many considerations when they inherit a home, especially if they’re sharing that gift with siblings or others.
- Consumer Reports
After announcing on Tuesday that it’s pulling the plug on its struggling smartphone business, LG revealed today that it will provide three more annual Android operating system updates to many con...
MPLN ALERT: The Klein Law Firm Announces a Lead Plaintiff Deadline of April 26, 2021 in the Class Action Filed on Behalf of Multiplan Corporation F/K/A Churchill Capital Corp. Iii Limited Shareholders
New York, New York--(Newsfile Corp. - April 8, 2021) - The Klein Law Firm announces that a class action complaint has been filed on behalf of shareholders of Multiplan Corporation F/K/A Churchill Capital Corp. Iii (NYSE: MPLN) alleging that the Company violated federal securities laws.Class Period: July 12, 2020 and November 10, 2020Lead Plaintiff Deadline: April 26, 2021Learn more about your recoverable losses in MPLN:http://www.kleinstocklaw.com/pslra-1/multiplan-corporation-f-k-a-churchill-capital-corp-iii-loss-submission-form?id=14498&from=5The filed complaint alleges that Multiplan Corporation F/K/A Churchill Capital ...
APRIL 19, 2021, FUBO CLASS ACTION DEADLINE: Bernstein Liebhard LLP Reminds Investors of the Deadline to File a Lead Plaintiff Motion in a Securities Class Action Lawsuit Filed Against FuboTV, Inc.
New York, New York--(Newsfile Corp. - April 9, 2021) - Bernstein Liebhard, a nationally acclaimed investor rights law firm, reminds investors of the deadline to file a lead plaintiff motion in a securities class action lawsuit that has been filed on behalf of investors who purchased or acquired the securities of FuboTV, Inc. ("Fubo" or the "Company") (NYSE: FUBO) from March 23, 2020 through January 4, 2021 (the "Class Period"). The lawsuit filed in ...
- FOX News Videos
FOX News correspondent Alex Hogan has the story from Mission, Texas on 'Special Report'
U.S. and Iranian officials clashed on Friday over what sanctions the United States should lift to resume compliance with the 2015 nuclear deal, with Washington predicting an impasse if Tehran sticks to a demand that all sanctions since 2017 be removed. The two nations laid out tough stances as indirect talks in Vienna on how to bring both back into full compliance with the agreement wound up for the week, with some delegates citing progress. The talks, in which European Union officials are shuttling between the remaining parties to the deal and the United States, aim to restore the bargain at the core of the agreement - restrictions on Iran's nuclear activities in exchange for the lifting of U.S. and other international sanctions.
- The Independent
Biden gun control: Don Jr and Cruz lead GOP outrage as President declares ‘no amendment is absolute’
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- Associated Press
Nascent talks aimed at bringing the United States back into the 2015 nuclear deal with Iran broke Friday without any immediate signs of progress on the thorny issues dividing Washington and Tehran, but with delegates talking of a constructive atmosphere and resolving to continue the discussions. Two working groups that have been meeting in Vienna since Tuesday to brainstorm ways to secure the lifting of American sanctions and Iran's return to compliance with the deal reported their initial progress to a joint commission of diplomats from the world powers that remain in the deal — France, Germany, Britain, China and Russia. Russian delegate Mikhail Ulyanov tweeted that participants had “noted with satisfaction the initial progress made.”
- Associated Press
Wholesale prices jumped again in March pushed by another big increase in energy prices, the government reported Friday. The Labor Department’s producer price index, which measures inflation before it reaches consumers, rose 1% in March, follows last month’s 0.5% gain and a record jump of 1.3% in January. Energy prices jumped 5.9%, the Labor Department said Friday.