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Axcella Health Inc. (AXLA)

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3.6700-0.0400 (-1.08%)
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Previous Close3.7100
Bid3.5500 x 2200
Ask3.8200 x 1100
Day's Range3.5990 - 3.8200
52 Week Range3.1400 - 7.7300
Avg. Volume78,045
Market Cap138.324M
Beta (5Y Monthly)N/A
PE Ratio (TTM)N/A
Earnings DateN/A
Forward Dividend & YieldN/A (N/A)
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  • FDA Approves New Drug Application For Axcella’s AXA1125; Shares Pop 10%

    FDA Approves New Drug Application For Axcella’s AXA1125; Shares Pop 10%

    Shares of Axcella Health jumped 10.2% on April 13 after the clinical-stage biotechnology company announced that the US Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for AXA1125, the multi-targeted oral product candidate designed for the treatment of non-alcoholic steatohepatitis (NASH). Axcella (AXLA) CEO Bill Hinshaw said, “This IND follows close on the heels of AXA1665’s IND clearance earlier this year, ushering in an exciting new era for Axcella as we seek to tackle a variety of complex diseases and address important unmet needs for patients utilizing multi-targeted EMM compositions.” Following the FDA clearance, Axcella is likely to enter directly into a Phase 2b clinical trial in the second quarter of 2021. These clinical trials will evaluate the efficacy of AXA1125 in adult patients with biopsy-confirmed F2/F3 NASH. NASH is the most severe form of non-alcoholic fatty liver disease (NAFLD) related to significant morbidity and mortality globally. This disease is expected to impact up to 40 million Americans, including 10% of children. Notably, this chronic and progressive liver disease currently has no approved therapies in the United States. (See Axcella stock analysis on TipRanks) Following the development, Wedbush analyst Liana Moussatos reiterated a Buy rating and a price target of $11 (136% upside potential) on the stock. According to Moussatos, “the positive AXA1125-003 results, coupled with the oral route of administration and favorable tolerability profile to date, reinforce AXA1125’s competitive position among future NASH treatments.” The consensus rating among analysts is a Strong Buy based on 4 unanimous Buys. The average analyst price target stands at $12.75 and implies upside potential of 173.6% to current levels. Shares have gained 35.5% over the past year. Furthermore, TipRanks data shows that financial blogger opinions are 100% Bullish on Axcella, compared to a sector average of 69%. Related News: Hologic To Snap Up Mobidiag For $795M, Provide Growth Platform PAR Technology Buys Punchh For $500M; Shares Pop 25.5% Orbcomm To Be Acquired By GI Partners For $1.1B; Shares Pop 52% More recent articles from Smarter Analyst: Wall Street Roundup: Bullish & Bearish Calls Of The Day Score Media And Gaming's 2Q Revenue Misses Estimates; Shares Plunge 3% good natured Products Announces Preliminary Results For 1Q Galiano Gold Reports Preliminary Results For 1Q

  • Axcella's Multi-Targeted Approach To Treat Complex Diseases Holds Transformational Potential

    Axcella's Multi-Targeted Approach To Treat Complex Diseases Holds Transformational Potential

    Axcella Health (NASDAQ: AXLA) was one of the sponsors for the Benzinga Biotech Global Small Cap Conference that took place on March 24-25, 2021. The information contained in this article in no way represents investment advice or opinion on the part of Benzinga or its writers and is intended for informational purposes only. Precision medicine — providing the right treatment, for the right patient, at the right time — is saving lives. To battle diseases that are tough to treat, biotech companies typically use a small molecule or a biological drug to target one pathway within the body. Though, traditional single-target mechanisms may only address an individual metabolic or disease node. There is another class of important and promising candidates that are overlooked: multi-target drugs powered by endogenous metabolic modulators (EMMs). Axcella Health, a Massachusetts-based clinical-stage biotechnology company, is pioneering a multi-targeted approach using EMM compositions to treat complex diseases. What Are EMMs? Endogenous metabolic modulators, or EMMs, are a critical set of naturally occurring molecules that have a fundamental role in biology. EMMs include a broad set of molecular families, including Axcella’s current focus: amino acids and their derivatives. Amino acids serve as master regulators and signaling agents for metabolic pathways throughout the body while also having a well-established track record for clinical safety and tolerability. They can help provide the ability for cells and organs to: Select fuel sources. Create biomolecules such as nucleic acids, proteins, lipids and carbohydrates. Sense the availability of nutrients. Eliminate waste products. Produce immune responses. Activate signaling pathways. Unique Approach Leveraging these master regulators and signaling agents, Axcella has compiled a portfolio of multi-targeted product candidates that hold transformational potential, working with the body’s systems to tackle complex diseases such as nonalcoholic steatohepatitis (NASH) and overt hepatic encephalopathy (OHE). Photo: Axcella Health Drug Candidate To Treat NASH AXA1125 is Axcella’s drug candidate to treat NASH. Nonalcoholic steatohepatitis (NASH) is a severe form of nonalcoholic fatty liver disease that is caused by the accumulation of liver fat, which can lead to complications such as cirrhosis and liver cancer. Between 3% to 12% of adults in the U.S. (up to 40 million) suffer from NASH. While there are currently no FDA-approved drugs to combat this chronic and deadly disease, virtually all analysts expect NASH to become a multi-billion-dollar market over the next decade. Designed just four years ago, AXA1125 is now set to enter a Phase 2b clinical trial. Axcella believes the trial’s initiation will demonstrate distinct advantages of the company’s differentiated approach. For instance, while it normally would take seven or more years to reach Phase 2 development with a drug candidate, Axcella is accomplishing this in roughly half of the time. The company also is armed with more data entering this phase of development than many companies. Drug Candidate To Target The Reduction In Risk Of Recurrent OHE AXA1665 is Axcella’s product candidate for the prevention of recurring OHE. OHE is a manifestation of cirrhosis in which patients are severely and cognitively impaired to where they are unable to care for themselves and may ultimately become comatose. It is estimated that about one-third of cirrhotic patients experience at least one OHE event during the course of their disease, leading to roughly $1 billion being spent annually on OHE treatments in the U.S. Additionally, many of these patients experience repeated events even while on today’s approved medicines, namely lactulose and rifaximin. Axcella believes this is because these agents focus on only one of the disease drivers, namely elevated ammonia, and because tolerability is a challenge and thus compliance is limited. AXA1665 holds the potential to improve the standard of care by addressing this disease more comprehensively and safely. The drug candidate is currently entering a Phase 2 clinical trial. Financials As of December 31, 2020, cash, cash equivalents and marketable securities totaled $107.3 million, compared to $92.1 million on December 31, 2019. The increase is primarily the result of net proceeds from the company’s follow-on stock offering that was completed in May 2020. Axcella expects that its cash balance will be sufficient to meet the company’s operating needs into the third quarter of 2022. To learn more about Axcella Health, you can visit its website here. Photo by National Cancer Institute on Unsplash See more from BenzingaClick here for options trades from BenzingaHow Status Money Is Rewriting the Fintech Playbook© 2021 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

  • Axcella Health Tanks 4% On Wider-Than-Feared Quarterly Loss

    Axcella Health Tanks 4% On Wider-Than-Feared Quarterly Loss

    Axcella Health dipped 3.8% to close at $5.57 on March 17 after the clinical-stage biotechnology company posted a larger-than-expected loss in the fourth quarter. Axcella Health (AXLA) incurred a loss of $0.40 per share in 4Q, compared to the $0.36 loss per share estimated by analysts. The company reported a loss of $0.68 per share in the prior-year quarter. The company’s research and development expenses decreased 1.9% year-over-year to $10.6 million, while general and administrative expenses declined 15.2% to $3.9 million. (See Axcella Health stock analysis on TipRanks) Axcella Health CEO Bill Hinshaw said, “We were pleased to advance our preparations in the fourth quarter with a successful Type B pre-IND meeting with the U.S. Food and Drug Administration (FDA) regarding our non-alcoholic steatohepatitis (NASH) candidate, AXA1125, and began 2021 with our first investigational new drug (IND) clearance for AXA1665, our candidate for the reduction in risk of recurrent overt hepatic encephalopathy (OHE).” Following the 4Q results, B.Riley Financial analyst Mayank Mamtani maintained a Buy rating and a price target of $14 (151.4% upside potential). Mamtani said, “AXA1665 IND clearance marks an important milestone, validating AXLA’s capital efficient, accelerated drug development model to rapidly advance molecules to late-stage programs.” Axcella Health shares have exploded 147.6% over the past year, while the stock still scores a Strong Buy consensus rating based on 4 unanimous Buys. That’s alongside an average analyst price target of $14.75, which implies 164.8% upside potential to current levels. Related News: Lennar’s 1Q Results Top Analysts’ Expectations As Housing Market Picks Up Southwest Airlines Provides Operational And Financial Business Update; Shares Gain Johnson & Johnson’s Single-Dose COVID-19 Vaccine Granted Emergency Use Listing By WHO More recent articles from Smarter Analyst: Signet Jewelers’ Sales Outlook Tops Estimates After 4Q Beat; Shares Jump Pre-Market Gilead, Novo Nordisk Expand NASH Collaboration Black Knight Expands Offerings With Acquisition Of Mortgage Broker LOS Accenture Boosts Sustainability Services With Investment In Arabesque S-Ray