Latest news with #INDs
Yahoo
24-06-2025
- Business
- Yahoo
BofA Remains Bullish on Sana Biotechnology (SANA)
Sana Biotechnology, Inc. (NASDAQ:SANA) is one of the 13 Best Long-Term Penny Stocks to Buy According to Analysts. On May 14, Bank of America Securities analyst Alec Stranahan maintained a Buy rating on Sana Biotechnology, Inc. (NASDAQ:SANA) and set a price target of $6.00. The rating update came after the company announced on May 12 plans to present at the BofA Securities 2025 Healthcare Conference. A scientist working with a microscope in a laboratory, focusing on a cell of a medical experiment. In addition, Sana Biotechnology, Inc. (NASDAQ:SANA) presented positive 4- and 12-week clinical results for its ongoing type 1 diabetes study. The company plans to file Investigational New Drug applications (INDs) for SG299 in B-cell-related diseases and for SC451 in type 1 diabetes as early as 2026. As of fiscal Q1 2025, Sana Biotechnology, Inc. (NASDAQ:SANA) has a cash position of $104.7 million, with an expected cash runway into 2026. Sana Biotechnology (NASDAQ:SANA) is a biotechnology company that specializes in using engineering cells as medicines. It develops cell engineering programs that transform treatment across several therapeutic areas with treatment gaps, including diabetes, oncology, the central nervous system, and B-cell-mediated autoimmune disorders. While we acknowledge the potential of SANA as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: The Best and Worst Dow Stocks for the Next 12 Months and 10 Unstoppable Stocks That Could Double Your Money. Disclosure: None.
Yahoo
24-06-2025
- Business
- Yahoo
BofA Remains Bullish on Sana Biotechnology (SANA)
Sana Biotechnology, Inc. (NASDAQ:SANA) is one of the 13 Best Long-Term Penny Stocks to Buy According to Analysts. On May 14, Bank of America Securities analyst Alec Stranahan maintained a Buy rating on Sana Biotechnology, Inc. (NASDAQ:SANA) and set a price target of $6.00. The rating update came after the company announced on May 12 plans to present at the BofA Securities 2025 Healthcare Conference. A scientist working with a microscope in a laboratory, focusing on a cell of a medical experiment. In addition, Sana Biotechnology, Inc. (NASDAQ:SANA) presented positive 4- and 12-week clinical results for its ongoing type 1 diabetes study. The company plans to file Investigational New Drug applications (INDs) for SG299 in B-cell-related diseases and for SC451 in type 1 diabetes as early as 2026. As of fiscal Q1 2025, Sana Biotechnology, Inc. (NASDAQ:SANA) has a cash position of $104.7 million, with an expected cash runway into 2026. Sana Biotechnology (NASDAQ:SANA) is a biotechnology company that specializes in using engineering cells as medicines. It develops cell engineering programs that transform treatment across several therapeutic areas with treatment gaps, including diabetes, oncology, the central nervous system, and B-cell-mediated autoimmune disorders. While we acknowledge the potential of SANA as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: The Best and Worst Dow Stocks for the Next 12 Months and 10 Unstoppable Stocks That Could Double Your Money. Disclosure: None. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
06-06-2025
- Business
- Yahoo
BofA Hikes Exelixis, Inc. (EXEL) Target Amid CRC Caution
On Thursday, analysts at BofA Securities raised the price target for Exelixis, Inc. (NASDAQ:EXEL) to $46 from $45, with a Neutral rating. This minor change in the price target, reflecting an upside of nearly 8% from the current stock price, signals the company's revised evaluation of the Zanza pipeline asset. The company is all set to begin the STELLAR-311 trial of Zanza in NET, aiming for as many as three new INDs within this year. During the latest earnings call, the management expressed optimism around its Zanza pipeline asset. As the CEO of Exelixis, Inc. (NASDAQ:EXEL), Michael Morrissey, mentioned: "We're excited to advance Zanza to the center stage in 2025 as our next oncology franchise opportunity." White medicinal tablets. Photo by The analysts noted the significance of the upcoming readouts for the Zanza asset, renal cell carcinoma (RCC), and colorectal cancer (CRC). Despite the excitement for Zanza, analysts remain cautious about the prospects of the CRC population, which is considered the most critical. They substantially discount its chances of success here, citing that the recent updates to the statistical analysis cast a shadow over the stock's potential. Without a breakthrough in the CRC intent-to-treat group, analysts believe that Zanza's peak sales will be between $500 million and $1 billion in the years ahead. Exelixis, Inc. (NASDAQ:EXEL) is a California-based biopharmaceutical company that discovers, develops, and markets new cancer solutions. With a focus on oncology, the company has a leading network of drug development, clinical trials, and commercialization of drugs for difficult-to-treat cancer types. While we acknowledge the potential of EXEL as an investment, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and have limited downside risk. If you are looking for an extremely cheap AI stock that is also a major beneficiary of Trump tariffs and onshoring, see our free report on the best short-term AI stock. READ NEXT: 20 Best AI Stocks To Buy Now and 30 Best Stocks to Buy Now According to Billionaires. Disclosure. None.
Associated Press
20-05-2025
- Business
- Associated Press
The FDA (Food and Drug Administration) Drug Approval Process Training Course: Procedures for Submission of INDs, NDAs, ANDAs and 505(b)(2) (ONLINE EVENT: June 11-12, 2025)
DUBLIN--(BUSINESS WIRE)--May 20, 2025-- The 'The FDA (Food and Drug Administration) Drug Approval Process Training Course' training has been added to offering. This programme will be especially beneficial to those responsible for preparing US registration documents (INDs,NDAs, Biologics License Applications, etc), regulatory affairs personnel, lawyers and others responsible for advising companies on strategies for developing new drugs for the US market. The US is the largest market globally for pharmaceutical sales, so having a good understanding of FDA procedures is vital for those submitting in this challenging region. This course will help clarify the US regulatory process, giving you a practical insight into FDA requirements and ensuring that you are fully up to date with all the latest developments. The comprehensive programme will cover procedures for submission of INDs, NDAs, ANDAs and 505(b)(2), provide a useful insight into the organisation and structure of the FDA and its review processes, and highlight recent changes. The course will emphasise areas of interest to innovative manufacturers, but will also deal with issues relating to generic and over-the-counter drugs. There will be ample opportunity for discussion with our expert trainer as well as other delegates and a practical workshop session to optimise learning. Benefits of attending: Certifications: Key Topics Covered: Day 1 Pharmaceutical Medicine and Documents FDA History and Organisation Legal Basis (Patent Exclusivity PDUFA, GDUFA, BsUFA) Legal Basis Continued Application and Submissions Types Refusal to File Investigational New Drug (IND) Applications Getting Products to the Market Faster FDA Meetings and Documentation CTD Content - Setting the Scene CTD Content - M1 Day 2 CTD Content - M3 and Corresponding M2 CTD Content - M4 and Corresponding M2 CTD Content - M5 and Corresponding M2 Submission Format and Methods US Amendment Procedures High Level Comparison US vs EU Case Study For more information about this training visit About is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. View source version on CONTACT: Laura Wood, Senior Press Manager [email protected] For E.S.T Office Hours Call 1-917-300-0470 For U.S./ CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 KEYWORD: INDUSTRY KEYWORD: FDA PHARMACEUTICAL HEALTH SOURCE: Research and Markets Copyright Business Wire 2025. PUB: 05/20/2025 08:25 AM/DISC: 05/20/2025 08:24 AM
Fox News
05-03-2025
- Politics
- Fox News
Republican, independent voters react positively to Trump declaring US ‘woke no longer'
A Fox News Digital focus group of Democrats, Republicans, and independents gave reactions to President Donald Trump's condemnation of wokeness and declaration that there are "only two genders" during his speech to a joint session of Congress. In two separate dial tests administered by maslansky + partners' Lee Carter for Fox News Digital on Tuesday night, the three sets of voters indicated how they felt about the two prominent moments from the address as they happened. The two most notable results showed that both Republican and independent voters reacted very favorably to Trump's proclamation that the U.S. will be "woke no longer," while Democratic voters revealed their negative feelings towards his statement on there being two genders. During the first test, a clip was shown of Trump saying, "We've ended the tyranny of so-called diversity, equity and inclusion policies all across the entire federal government and, indeed, the private sector and our military. And our country will be woke no longer." As he said those words, the red line representing Republican voters shot up and stayed well above the neutral position. He continued, saying, "We believe that whether you are a doctor, an accountant, a lawyer or an air traffic controller, you should be hired and promoted based on skill and competence, not race or gender. Very important." The red line stayed high, and even climbed slightly. Meanwhile, the yellow line representing independents – though it shot up somewhat slower – eventually climbed to a highly positive point where it met the red line and remained there for the rest of Trump's statement. Democrats, however, remained neutral and only slightly negative towards Trump's comments on wokeness. Their blue line dipped just below the neutral mark on the chart and stayed there throughout the president's point. Carter gave her analysis of this test, stating, "Republicans and independents celebrated this moment. So many said it's about time. Many called back his line about common sense rulings, saying things like, 'Welcome Back... Common Sense!'" For the second test, the group listened as Trump said, "I signed an order making it the official policy of the United States government that there are only two genders, male and female." The red line climbed to a high point quickly and remained there, showing that Republicans favored the words. A similar dynamic could be seen among independent voters, as the yellow line started climbing slowly but eventually shot up almost to the red when Trump said "two genders." The blue Democratic line stayed neutral for a moment and then dipped a bit into the negative zone in response to the president's words. "AGAIN, [Republicans] and INDs celebrated while their Dem counterparts scowled, saying things like, 'Good gawd. Trump is bringing this country back to the dark ages,'" Carter said, giving her analysis. She did offer a couple of observations about the dial tests overall, saying, "Dems barely reacted – wasn't dialing on the floor like we usually see. They were just neutral. It's like they weren't willing to listen to him at all. Independents behaved much more like Republicans than Democrats."
