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The Daily Biotech Pulse: FDA Vaccine Committee Meeting, Roche In $350M Deal for COVID-19 Treatment, Edwards Lifesciences Reports Q3 Beat
Here's a roundup of top developments in the biotech space over the last 24 hours: Scaling The Peaks (Biotech Stocks Hitting 52-week Highs Oct. 21)
Benzinga · 5d ago
The Daily Biotech Pulse: Prothena Progress In Parkinson's Disease Pipeline, Fast Track For Xeris, Biogen Earnings
Here's a roundup of top developments in the biotech space over the last 24 hours. Scaling The Peaks (Biotech Stocks Hitting 52-week Highs Oct. 20)
Benzinga · 6d ago
Athira Pharma to Host Educational Webinar on the Predictive Nature of P300 to Determine Clinical Benefit of Alzheimer’s Disease Treatments
\- Expert neuropsychiatric clinician to discuss the testing method and its correlation to clinical results\- Event to feature an in-clinic demonstration of P300 testing \- Webcast to be held on Wednesday, Oct. 28, at 1 p.m. PT / 4 p.m. ET SEATTLE, Oct. 21, 2020 (GLOBE NEWSWIRE) -- Athira Pharma, Inc. (NASDAQ: ATHA), a late clinical-stage biopharmaceutical company focused on developing small molecules to restore neuronal health and stop neurodegeneration, today announced it will host a webinar exploring the use of a common clinical measure, Event-Related Potential P300 latency (P300), as an assessment of working memory processing speed. The webinar will be webcast live on Wednesday, Oct. 28, at 1 p.m. PT / 4 p.m.ET and will feature: * A discussion with Larry Ereshefsky, Pharm.D., BCPP, FCCP, a leader in the application of translational drug development tools for neurodegenerative and psychiatric disorders. Dr. Ereshefsky is Chief Scientific Officer at Apex Innovative Sciences and a member of Athira’s Scientific Advisory Board. * Leen Kawas, Ph.D., President and Chief Executive Officer at Athira, who will review the company’s completed and ongoing Phase 2/3 clinical trials of ATH-1017.Athira is measuring P300 in clinical trials of its investigational drug, ATH-1017, for treatment of mild-to-moderate Alzheimer’s disease to establish a connection between this functional measurement and improved cognition.The live webcast event can be accessed from the investors' section of the Athira website at https://investors.athira.com/news-and-events/events-and-presentations. An archived replay will also be available on the company website for at least 30 days following the event.About Athira Pharma, Inc. Athira, headquartered in Seattle, is a late clinical-stage biopharmaceutical company focused on developing small molecules to restore neuronal health and stop neurodegeneration. Athira aims to provide rapid cognitive improvement and alter the course of neurological diseases with our novel mechanism of action. Athira is currently advancing its lead therapeutic candidate, ATH-1017, a novel small molecule for Alzheimer’s and Parkinson’s dementia. For more information, visit www.athira.com. You can also follow Athira on Facebook, LinkedIn and @athirapharma on Twitter and Instagram.Forward-Looking Statements This release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as "may," "will," "should," "would," "expect," "plan," "believe," "intend," "pursue," and other similar expressions among others. Any forward-looking statements are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include the risks detailed in Athira’s filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof and Athira undertakes no obligation to update forward-looking statements. Athira may not actually achieve the plans, intentions, or expectations disclosed in its forward-looking statements, and you should not place undue reliance on the forward-looking statements.Investor & Media Contact: Julie Rathbun Athira Pharma Julie.rathbun@athira.com 206-769-9219
GlobeNewswire · 6d ago
The Daily Biotech Pulse: Aptinyx Jumps On Positive Readout, Cara Executes Korsuva Licensing Deal, Cleveland BioLabs Rallies On Reverse Merger
Here's a roundup of top developments in the biotech space over the last 24 hours: Scaling The Peaks (Biotech Stocks Hitting 52-week Highs Oct. 19)
Benzinga · 10/20 12:17
Goldman Sachs: 2 Stocks That Could Climb Over 90%
What’s more critical for the stock market’s health than the outcome of the presidential election? A COVID-19 vaccine, so says Goldman Sachs. With Q3 earnings season kicking into gear this week, the firm believes the virus’ effect on fundamentals should be the focus, as opposed to the race to the White House. “The vaccine represents a more important factor than the election result for the path of equities... The consequences of the semi-frozen economy on an uneven road to recovery will be in Q3 results,” Goldman Sachs’ U.S. equity strategist David Kostin commented. Even though elections are a source of uncertainty, research analysts from Goldman Sachs found just a 4% difference in EPS if President Trump is re-elected or the Democrats come out on top. Based on the firm’s analysis, an increase in fiscal spending that is partly funded by increased tax revenue would “boost economic growth, and help offset the earnings headwind from high tax rates.” Taking this into consideration, our attention turned to two stocks that Goldman Sachs thinks have outsized growth prospects, with the firm’s analysts forecasting at least 90% upside potential for each. Using TipRanks’ database, we found out both tickers also sport a “Strong Buy” consensus rating from the rest of the Street. Athira Pharma (ATHA) Applying cutting-edge approaches to neurodegenerative diseases, Athira Pharma wants to improve the lives of patients from all over the world. Given the potential of its asset in Alzheimer’s disease (AD), Goldman Sachs is pounding the table. ATHA made its public market debut on September 18, with the first trade coming in at 17.4% above the IPO price. Raising $204 million, the company sold 12 million shares instead of the 10 million that was originally expected. Writing for Goldman Sachs, analyst Graig Suvannavejh points to its lead candidate, ATH-1017, which is a small molecule activator of HGF/MET currently being evaluated in a Phase 2/3 trial as a treatment for mild-to-moderate AD, as a key component of his bullish thesis. The analyst doesn’t dispute that AD is a difficult indication to address, but tells clients he has high hopes for ATHA. “We’re fully cognizant of the history of AD drug development, and its well documented past of high failure rates. As such, AD-focused companies like ATHA should be considered as having high risk. However, as there still remains a significant lack of effective drugs for AD, we believe alternative approaches to treating AD have merit,” he explained. In the past, the most common therapeutic approaches to AD have been those focused on the belief that the accumulation of disease-causing proteins in the brain leads to AD. However, AD therapeutics based on targeting amyloid have all failed in clinical trials to demonstrate efficacy, with monoclonal antibody (mAb) approaches that target tau, another protein that aggregates in the brains of AD patients, also failing. So, ATHA’s differentiated approach makes it a stand-out, in Suvannavejh’s opinion. Looking at the therapy’s mechanism of action (MOA), it is based on HGF/MET agonism, a strategy that hasn’t been studied in AD before. Additionally, Suvannavejh argues the FDA’s recent decision to review Biogen’s aducanumab for approval even though it was prematurely discontinued in two large Phase 3 studies due to futility is a “sign of a positive regulatory backdrop.” On top of this, the company is applying a new thinking to AD clinical trials. It will use a non-traditional technique (EEG) in order to measure improvements in the brains of AD subjects, and a novel clinical trial end point (Global Statistical Test/GST) that will evaluate the efficacy. It is based on both the ERP biomarker and more traditional efficacy measures (e.g., ADAS-Cog). Weighing in on this, Suvannavejh stated, “With this entirely innovative way of thinking in mind, we think it’s critical to acknowledge that FDA has already provided its sign off to ATHA’s novel clinical trial plan — which importantly also reduces overall time and costs typically associated with AD drug development. Further, given our view that FDA may be experiencing a sense of urgency to get new AD therapeutics in the hands of patients, their caregivers and physicians, we believe the time is right for a candidate like ATH-1017.” When it comes to the revenue potential for ATH-1017, according to Suvannavejh, neurodegenerative diseases represent one of the highest areas of unmet medical need, with it estimated that more than 5 million people over the age of 65 in the U.S. have AD. This number is expected to nearly triple by 2050, based on research from the Alzheimer’s Association. To this end, the analyst projects risk-unadjusted peak 2035 sales of $10.8 billion. Everything that ATHA has going for it convinced Suvannavejh to initiate coverage with a Buy rating. In addition to the call, he set a $53 price target, suggesting 189% upside potential. (To watch Suvannavejh’s track record, click here) Judging by the consensus breakdown, opinions are anything but mixed. With 4 Buys and no Holds or Sells assigned in the last three months, the word on the Street is that ATHA is a Strong Buy. At $42.50, the average price target implies 132% upside potential. (See Athira Pharma stock analysis on TipRanks) Denali Therapeutics (DNLI) Dedicated to defeating neurodegenerative diseases through rigorous therapeutic development, Denali Therapeutics is attracting significant attention from Wall Street. Ahead of a key data readout, Goldman Sachs has high hopes. As the company gears up to report first proof-of-concept biomarker data for DNL310 in Hunter syndrome by YE20, the firm’s Salveen Richter likes what she’s seeing. DNL310 is a recombinant form of the iduronate 2-sulfatase (IDS) enzyme engineered to cross the blood-brain barrier (BBB) using Denali’s enzyme transport vehicle (ETV) technology, which enables the trafficking of large molecules into the brain. DNLI is set to publish initial data from Cohort A, and management expects the starting dose of 3mg/kg to reduce CSF GAGs by 50% at eight weeks. A second Cohort B will evaluate DNL310 in a broader range of patients, with dose escalation levels based on findings from Cohort A. Richter points out a 50% reduction in CSF GAGs was associated with a decrease in lipid lysosome and neurofilament light (NfL) chain accumulations that are associated with neuronal degeneration and injury. “While this is the first in-human trial for DNL310, we see the pre-clinical data as strongly supportive of the anticipated therapeutic benefit and potential for GAG reduction in the CSF to drive downstream changes in lysosomal lipid and NfL accumulation (i.e. prevent neuronal dysfunction and injury) for improved cognition and function,” Richter commented. It should be noted that the preclinical and early clinical data for JCR Pharmaceuticals’ JR-141, a BBB-penetrant fusion protein that also leverages receptor-mediated transcytosis to traffic iduronate-2-sulfatase (I2S) to the brain, de-risks the approach, in Richter’s opinion. To this end, the five-star analyst believes positive DNL310 biomarker data could serve as proof-of-concept for DNLI’s transport vehicle (TV) technology. The platform’s modularity could allow for various large molecules to be transported across the BBB, for a range of other neurodegenerative indications like Parkinson’s disease (PD) and frontotemporal dementia (FTD). On top of this, DNLI could leverage this delivery platform for antibodies, proteins or enzymes not currently in its own portfolio, with increasing interest on assets from Biogen, according to Richter. In line with her optimistic approach, Richter stayed with the bulls, reiterating a Buy rating. She also bumped up the price target from $41 to $60. Investors could be pocketing a gain of 36%, should this target be met in the twelve months ahead. (To watch Richter’s track record, click here) Looking at the consensus breakdown, 6 Buys and 2 Holds have been issued in the last three months. Therefore, DNLI gets a Strong Buy consensus rating. Based on the $51.17 average price target, shares could surge 16% in the next year. (See Denali Therapeutics stock analysis on TipRanks) Disclaimer: The opinions expressed in this article are solely those of the featured analysts. The content is intended to be used for informational purposes only. It is very important to do your own analysis before making any investment.
TipRanks · 10/18 16:00
Goldman Sachs Initiates Coverage On Athira Pharma with Buy Rating, Announces Price Target of $53
Goldman Sachs initiates coverage on Athira Pharma (NASDAQ:ATHA) with a Buy rating and announces Price Target of $53.
Benzinga · 10/13 08:59
U.S. IPO Week Ahead: Healthcare, Solar Panels, And Chinese Retail In A 9 IPO Week
Five biotechs, two medical device makers, a solar panel mounting manufacturer, and a Chinese retailer are scheduled to raise $2.0 billion in the week ahead.Several companies could join the IPO calendar early in the week, including McAfee and Datto Holding.Street research is expected for 15 companies.The lock-up for Renalytix AI will be expiring on Thursday, 10/15.
Seekingalpha · 10/11 20:55
The Week Ahead In Biotech: J&J Earnings Kickstarts Pharma Earnings, More IPOs In The Pipeline
Biotech stocks advanced along with the broader market in the week ended Oct. 9, although the news flow was quite light.
Benzinga · 10/11 17:29
Insiders Not Scared By Upcoming Risks - September 2020 Insider Update
Tracking insider purchases is an overlooked but very informative strategy. It can provide undervalued stocks in the market and can make assumptions for future market returns.September's number of insider purchases was close to the historical average, indicating that insiders are not scared from upcoming risks such as the election and COVID-19.Insiders are particularly buying stocks in the industrials sector recently.This monthly update also provides a list of the top 10 insider purchases by market cap and the top 10 insider purchases by value purchased.
Seekingalpha · 10/11 13:00
Lumen Bioscience Announces Appointment of Dr. Mark Litton to Board of Directors
Lumen Bioscience, a clinical-stage biopharmaceutical company developing biologic drugs for highly prevalent diseases, today announced the appointment of Mark Litton, PhD, MBA, Chief Operating Officer of Athira Pharma (NASDAQ: ATHA), to the company's Board of Directors.
PR Newswire · 10/08 11:30
Dosing underway in Athira Pharma's mid-stage Alzheimer's study with ATH-1017
Athira Pharma (ATHA) has commenced patient dosing in Phase 2/3 trial (LIFT-AD) evaluating ATH-1017 for the treatment of mild-to-moderate Alzheimer's disease.The 300-subject trial conducted in the U.S. and Australia, will evaluate
Seekingalpha · 10/01 11:58
Athira Pharma Announces Initiation of Patient Dosing for the LIFT-AD Study, a Phase 2/3 Clinical Trial to Evaluate ATH-1017 for Treatment of Mild-to-Moderate Alzheimer's Disease
Athira Pharma, Inc. (NASDAQ: ATHA), a late clinical-stage biopharmaceutical company focused on developing small molecules to restore neuronal health and stop neurodegeneration, today announced that patient dosing has begun in the company’s Phase 2/3 clinical trial evaluating ATH-1017, a once-daily investigational
GlobeNewswire · 10/01 11:30
The Daily Biotech Pulse: Novavax Advances Vaccine, Marinus Gets Nod For Late-Stage Study, 3 IPOs
Here's a roundup of top developments in the biotech space over the last 24 hours. Scaling The Peaks (Biotech Stocks Hitting 52-week Highs Sept. 24)
Benzinga · 09/25 11:37
The Daily Biotech Pulse: Gilead's $7.25B Debt Offering, Lexicon Deleverages, Taysha Gene Therapies Prices IPO
Here's a roundup of top developments in the biotech space over the last 24 hours: Scaling The Peaks (Biotech Stocks Hitting 52-week Highs Sept. 23)
Benzinga · 09/24 12:15
Athira Pharma Announces Closing of Initial Public Offering
SEATTLE, Sept. 22, 2020 (GLOBE NEWSWIRE) -- Athira Pharma, Inc., (Nasdaq: ATHA) (“Athira”), a late clinical-stage biopharmaceutical company focused on developing small molecules to restore neuronal health and stop neurodegeneration, today announced the closing of its initial public offering of 12,000,000
GlobeNewswire · 09/22 20:05
The Daily Biotech Pulse: Legal Relief For Evolus, Fulgent to Join S&P SmallCap 600, AIM ImmunoTech's Positive Cancer Drug Readout
Here's a roundup of top developments in the biotech space over the last 24 hours: Scaling The Peaks (Biotech Stocks Hitting 52-week Highs Sept. 21)
Benzinga · 09/22 11:59
U.S. IPO Weekly Recap: Snowflake's IPO Breaks Records In A Diverse 15-IPO Week
In the busiest week yet for the 2020 IPO market, 15 IPOs raised $8.7 billion.Snowflake took the spotlight, completing the largest software IPO ever and bagging the biggest billion-dollar pop in two decades.Eight SPACs joined the week's diverse group of IPOs.
Seekingalpha · 09/19 13:54
Athira Pharma estimated to open +29% above IPO
Athira Pharma (ATHA) hints to open at $22 vs. IPO price of $17.Pricing was at the high end of the target range of $15-$17.Offering was upsized from 10M shares to
Seekingalpha · 09/18 15:00
Athira Upsizes IPO, Looks To Raise Over $204M
Athira Pharma Inc. (NASDAQ: ATHA) on Thursday upsized its initial public offering plans over what it earlier reported in a filing with the Securities and Exchange Commission.
Benzinga · 09/18 08:17
Athira Pharma prices upsized IPO at $17
Athira Pharma (ATHA) has priced its upsised IPO of 12M (from 10M) common shares at $17.00/share, for expected gross proceeds of $204M.Athira is a biopharmaceutical company focused on developing small
Seekingalpha · 09/18 05:28
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About ATHA
Athira Pharma, Inc. is a clinical-stage biopharmaceutical company focused on developing small molecules to restore neuronal health and stop neurodegeneration. The Company’s pipeline is built from its drug discovery platform (ATH) platform, and consists of a series of small molecules that are designed to target either the central nervous system (CNS), by crossing the blood brain barrier (BBB), or the peripheral nervous system. The ATH platform utilizes proprietary technology to target and enhance the activity of a vital neuronal growth factor that promotes neuronal health and regeneration. The Company is developing ATH-1017, for the treatment of neurodegenerative disorders, with an initial focus on Alzheimer’s disease (AD). ATH-1017 is designed to enhance neuronal health and promote regeneration, thereby improving symptoms in cognitively impaired subjects.
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