Latest news with #Axsome
Yahoo
11-04-2025
- Business
- Yahoo
Seeking Recession-Proof Stocks? RBC Suggests 2 Healthcare Stocks to Buy
President Trump's newly announced tariff policy has done more than just push the stock markets deeper into correction territory — the sudden panic on Wall Street has increased worries about a full-blown recession hitting in the near future. According to USA Today, several big banks are putting the chance of a recession at 40% or higher. Discover outperforming stocks and invest smarter with Top Smart Score Stocks. Filter, analyze, and streamline your search for investment opportunities using Tipranks' Stock Screener. Only time will tell if we dip into recession. For now, worried investors are seeking 'recession-proof' stocks to shore up their portfolios. The biopharma team at RBC has some concrete suggestions on this front. 'With recently-announced tariffs and other macro developments, we have been receiving more questions from investors on how to position for a potential recession, and whether biopharma is in fact a defensive sector,' RBC's biotech team noted. RBC crunched over three decades of data and found that large-cap biotech stocks have consistently held up during economic downturns — with a median downside of just 1% across major negative economic events. Even more encouraging, they believe selective mid-cap biotech names offer real upside potential when the market rebounds. To back up their thesis, RBC followed up with actionable recommendations — pinpointing specific healthcare stocks that could offer both protection and potential. We've used the TipRanks database to look up the broader Wall Street view on two of them. Let's take a closer look. Axsome Therapeutics (AXSM) We'll start with Axsome Therapeutics, a biotech research company that is developing new therapeutic agents for central nervous system (CNS) conditions. Diseases of the CNS are difficult on both patients and caregivers; they frequently resist treatment, and many CNS diseases lack any effective therapies. While this makes research into the field difficult, it also makes for a rich field of research targets. And Axsome has proven adept at hitting those targets. For research-oriented biopharma companies, getting a new drug approved and on the market is akin to the Holy Grail – and Axsome has three of these on the market. The company's first product to receive FDA approval was Sunosi, a prescription medication used in the treatment of excessive daytime sleepiness. In May 2022, Axsome bought the rights to Sunosi from Jazz Pharmaceuticals, after Sunosi had already been approved by the FDA in drug has been found useful in the treatment of narcolepsy and obstructive sleep apnea, and is described as an orally dosed wakefulness-promoting therapeutic agent. Next on the list is Auvelity, which was approved by the FDA in August of 2022 as a treatment for major depressive disorder (MDD) in adults. The drug, which is the first oral NMDA receptor agonist approved as an MDD treatment, is notable as the first depression therapy in 60 years to introduce a new mode of action. Finally, in January, Axsome announced that the FDA had approved Symbravo, a new treatment for migraine headaches. The drug was launched in February as a treatment for migraines, with or without an aura, in adults. Symbravo is a combination tablet, taken once daily. On the financial side, Axsome's three marketable products are its prime revenue generators. It's still too early for quarterly sales numbers on Symbravo – but both Auvelity and Sunosi showed strong revenue growth in 2024, per Axsome's 4Q24 earnings report. Auvelity's full-year revenue came to $291.4 million, up an impressive 124% year-over-year, while Sunosi's $94.3 million in revenue represented sound y/y growth of 26%. Overall, Axsome saw net product revenue of $385.7 million last year, up 88% from 2023. In addition to its stable of marketable products, Axsome has a solid pipeline of drug candidates. Notable among these is the company's Alzheimer's Disease program. Drug candidate AXS-05 is at the late clinical stages, and earlier this month the company announced positive results from the Phase 3 ACCORD-2 trial of AXS-05 in the treatment of agitation due to Alzheimer's. Last month, on March 3, the company announced that it had received from the FDA the formal pre-New Drug Application meeting minutes, an important step on the path to submitting the supplemental NDA. The sNDA submission for AXS-05 is planned for 3Q25. Despite the market losses of recent trading sessions, Axsome's stock has gained 34% over the past 12 months, and is up 15% for the year-to-date while AXSM still boasts a market cap of $4.8 billion. That market cap, along with several other factors, informs RBC's Leonid Timashev's bullish take here. He writes of Axsome, 'We believe AXSM's profile suggests the company should recover well in the event of a recession given their market cap, three commercial products, and a growing revenue base. Further, with their lead drug positioned to treat depression (we note economic decline is often also associated with increased rates of mental health issues in the population), we believe demand should continue to grow in the near-term. We believe Auvelity can deliver $500M in 2025 sales, and regulatory catalysts in 2H25 (AD agitation filing) and 2026 (potential AD agitation approval) can provide an opportunity for shares to inflect.' Timashev goes on to rate AXSM as Outperform (i.e., Buy), with a $190 price target that points toward a one-year upside potential of 95%. (To watch Timashev's track record, click here) There are 18 recent analyst reviews on record for Axsome, and they are unanimously positive for a Strong Buy consensus rating. The stock's $97.55 trading price and $175.87 average target price together imply a gain of 80% in the next 12 months. (See AXSM stock forecast) Alnylam Pharma (ALNY) The second stock we'll look at here is another biotech/biopharma, Alnylam. This company is focused on RNAi therapeutics, that is, RNA interference drugs used in the treatment of genetically-based diseases. Alnylam was a pioneer in the field of RNAi, and has used the approach to develop a new class of medications that treat diseases by silencing the causative genes. RNAi selectively targets and prevents specific proteins, the physical form of gene expression, from being made, effectively stopping disease conditions where they begin. Like Axsome above, Alnylam has several approved drugs on the market. The first of these to reach commercialization was Onpattro, which received its FDA approval in 2018, . This drug was designated as 'first-in-class,' and is used as a treatment for polyneuropathy caused by hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) in adult patients. Alnylam followed this in 2019, with the approval of Givlaari for the treatment of acute hepatic porphyria, also in adult patients. This condition affects the production of heme, which helps to bind oxygen in the blood. Patients suffer from the buildup of porphyrin molecules, which are a toxic byproduct of heme production. Givlaari targets the delta-aminolevulinate synthase 1 (ALAS1) enzyme, which is involved in producing heme. In 2020, Alnylam received FDA approval of Oxlumo, the first therapy on the market to lower urinary oxalate levels as a treatment for primary hyperoxaluria type 1 (PH1). The drug is a subcutaneous injection, and is available for both adult and pediatric patients. Next, in 2022, the Alnylam drug Amvuttra was approved. This drug is an RNAi therapeutic agent designed for the treatment of the polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis. This condition prevents the proper expression of the transthyretin (TTR) gene, resulting in TTR buildup that causes nerve damage. In addition, Alnylam announced this past March that its supplemental NDA for Amvuttra, in the treatment of cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults, has also received FDA approval. This approval gives Amvuttra an expanded indication, and makes it the only approved drug on the market to treat both ATTR-CM and the polyneuropathy of hereditary transthyretin-mediated amyloidosis (hATTR-PN) in adult patients. The most recent approved drug in Alnylam's lineup is Qfitlia, the approval of which was announced this past March 28. This drug is the first RNAi treatment approved for the treatment of hemophilia A or B. The approved indication of the drug is described as 'routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with hemophilia A or B, with or without factor VIII or IX inhibitors.' Alnylam has been developing and commercializing Qfitlia in partnership with Sanofi. Qfitlia is Alnylam's second partnership project. The company previously developed Leqvio, a treatment for high cholesterol, as a partnership project with Novartis. On the financial side, Alnylam's 4Q24 report showed that the company generated $593.17 million in total revenue during the quarter, for a 35% gain year-over-year – and beat the forecast by $12.55 million. At the bottom line, Alnylam recorded a quarterly net loss in Q4 of 65 cents per share, missing the estimates by 6 cents per share. A biotech with a solid line-up of approved products will always get attention from the analysts, and RBC's Luca Issi has been following Alnylam. Issi is impressed by the approved drugs, the partnership programs, and the recently expanded indication on Amvuttra. He also sees potential in the firm's development pipeline, and writes of the company, 'We believe ALNY's profile suggests the company could both act as a safe haven and recover well in the event of a recession given their market cap ($30 billion), four commercial products (plus two approved partnered products), and a $2.5b revenue stream anticipated to almost double over the next 3 years. Further, with their lead drug recently approved to treat TTR-CM (a relatively large prevalence pool of ~350k patients, but only 20% on treatment today) we believe demand should continue to grow in the near-term. We believe the TTR franchise can deliver $1.7b in 2025 sales, and the rest of the pipeline (AGT readout 2H25, next-gen TTR phase III start, initiation of obesity studies) can provide an opportunity for shares to inflect.' For Issi, this adds up to an Outperform (i.e., Buy) rating, which he supports with a $330 price target, implying an upside of 47% on the one-year horizon. (To watch Issi's track record, click here) Overall, this stock gets a Strong Buy consensus rating, based on 22 recent reviews that include 18 to Buy and 4 to Hold. The shares are priced at $224.32 and their $323.33 average target price suggests that the stock has a one-year upside potential of 44%. (See ALNY stock forecast) To find good ideas for stocks trading at attractive valuations, visit TipRanks' Best Stocks to Buy, a tool that unites all of TipRanks' equity insights. 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. Disclaimer & DisclosureReport an Issue Sign in to access your portfolio
Associated Press
08-04-2025
- Business
- Associated Press
ALERT: Grabar Law Office Investigates Claims on Behalf of Shareholders of Axsome Therapeutics, Inc. (NASDAQ: AXSM); BioVie Inc. (NASDAQ: BIVI); Maison Solutions Inc. (NASDAQ: MSS); and Virtu Financial Inc. (NASDAQ: VIRT), as Securities Fraud Class Actions Survive Motions to Dismiss
PHILADELPHIA, April 08, 2025 (GLOBE NEWSWIRE) -- Axsome Therapeutics Inc. (NASDAQ: AXSM) Class Action Survives Motion to Dismiss: Grabar Law Office is investigating claims on behalf of shareholders of Axsome Therapeutics, Inc. (NASDAQ: AXSM) as an underlying securities fraud class action has survived a motion to dismiss the complaint. The investigation concerns whether certain officers and directors breached the fiduciary duties they owed to the company. If you are a current Axsome (NASDAQ: AXSM) shareholder who purchased Axsome shares on prior to May 10, 2021 and still hold shares today, you may be able to seek corporate reforms, the return of money back to the company, and a court approved incentive award at no cost to you whatsoever. Please visit contact Joshua Grabar at [email protected], or call us at 267-507-6085 WHY?: An underlying securities fraud class action complaint alleges that Axsome Therapeutics (NASDAQ: AXSM), via certain of its officers, made false and/or misleading statements, as well as failed to disclose material adverse facts about the Company's business, operations, and prospects. Specifically, the Complaint alleges Defendants made false and/or misleading statements and/or failed to disclose that: (i) Axsome's chemistry, manufacturing, and control ('CMC') practices were deficient with respect to AXS-07 and its manufacturing process; (ii) as a result, Axsome was unlikely to submit the AXS-07 NDA on its initially represented timeline; (iii) the foregoing CMC issues remained unresolved at the time that the FDA reviewed the AXS-07 NDA; (iv) accordingly, the FDA was unlikely to approve the AXS-07 NDA; (v) as a result of all the foregoing, Axsome had overstated AXS-07's regulatory and commercial prospects; and (vi) as a result, the Company's public statements were materially false and misleading at all relevant times. On March 31, 2025, the Court issued an Order denying Axsome's Motion to Dismiss. In doing so the court determined that the operative complaint sufficiently pleads material misrepresentations or omissions regarding two categories of statements: (1) Defendants' statements that the manufacturing facility and suppliers for AXS-07 were not experiencing problems and (2) Defendants' statements about AXS-07's NDA. $AXSM #Axsome WHAT YOU CAN DO NOW: If you purchased Axsome Therapeutics (NASDAQ: AXSM) prior to May 10, 2021 and still hold shares today, you are encouraged to visit contact Joshua Grabar at [email protected], or call 267-507-6085. You may be able to seek corporate reforms, the return of funds back to the company, and a court approved incentive award at no cost to you whatsoever. BioVie Inc. (NASDAQ: BIVI) Class Action Survives Motion to Dismiss: Grabar Law Office is investigating claims on behalf of shareholders of BioVie Inc. (NASDAQ: BIVI) as an underlying securities fraud class action has survived a motion to dismiss the complaint. The investigation concerns whether certain officers and directors breached the fiduciary duties they owed to the company. If you are a current BioVie (NASDAQ: BIVI) shareholder who purchased BioVie shares on prior to December 7, 2022 and still hold shares today, you may be able to seek corporate reforms, the return of money back to the company, and a court approved incentive award at no cost to you whatsoever. Please visit contact Joshua Grabar at [email protected] or call us at 267-507-6085. Why? On August 5, 2021, BioVie announced in a Form 8-K filed with the SEC the enrollment of the first patient in its Phase 3 study of NE3107 in Alzheimer's Disease. An underlying securities fraud class action complaint has survived a motion to dismiss. According to that complaint, BioVie Inc. (NASDAQ: BIVI), through certain of its officers, made materially false and/or misleading statements and failed to disclose material adverse facts about the Company's business, operations, and prospects. Specifically, the Complaint alleges that Defendants misled investors by failing to disclose that (1) BioVie was not conducting proper oversight of its Phase 3 clinical trial; (2) that the COVID-19 pandemic significantly and negatively impacted the Company's ability to adequately conduct proper oversight of the Phase 3 clinical trial; (3) that due to lack of proper oversight and reliance on contract research organizations, the data from Defendants' Phase 3 clinical trial faced a greater risk of being unreliable and that the majority of patients would have to be excluded from the clinical trial; (4) that, as a result of the significant exclusions from the trial results, the Phase 3 clinical trial would fail to meet its primary endpoints; and (5) statements about BioVie's business, operations, prospects, and compliance with current good clinical practices were materially false and/or misleading and/or lacked a reasonable basis at all relevant times. On March 27, 2025, the Court issued an Order denying Defendants' Motion to Dismiss. In so doing, the Court noted that 'that a compelling inference that Individual Defendants acted with minimum deliberate recklessness is at least as strong as an opposing inference of good faith.' WHAT YOU CAN DO NOW: If you purchased BioVie (NASDAQ: BIVI) prior to December 7, 2022 and still hold shares today, you are encouraged to visit contact Joshua Grabar at [email protected], or call 267-507-6085. You may be able to seek corporate reforms, the return of funds back to the company, and a court approved incentive award at no cost to you whatsoever. #BioVie $BIVI Maison Solutions Inc. (NASDAQ: MSS) Class Action Survives Motion to Dismiss: Grabar Law Office is investigating claims on behalf of shareholders of Maison Solutions Inc. (NASDAQ: MSS) as an underlying securities fraud class action has survived a motion to dismiss the complaint. The investigation concerns whether certain officers and directors breached the fiduciary duties they owed to the company. If you are a current Maison Solutions Inc. (NASDAQ: MSS) shareholder who purchased Maison shares on or near its October 5, 2023 IPO and still hold shares today, you may be able to seek corporate reforms, the return of money back to the company, and a court approved incentive award at no cost to you whatsoever. Please visit contact Joshua Grabar at [email protected] or call us at 267-507-6085 WHY? On October 5, 2023, the Maison Solutions filed its prospectus on Form 424B4 with the SEC, which forms part of the Registration Statement. In the IPO, the Company sold 2,500,000 shares of Class A common stock at a price of $4.00 per share. The Company received net proceeds of approximately $10 million from the Offering. On December 15, 2023, at approximately 2:30 p.m. Eastern Standard Time, Hindenburg Research published a report about Maison, alleging a number of 'red flags' concerning potentially illegal activities. An underlying securities fraud class action complaint alleges that in the Registration Statement and throughout the Class Period (October 5, 2023 through December 15, 2023), Maison, through certain of its officers, made materially false and/or misleading statements, including failing to disclose to investors: (1) that the Company's vendor XHJC Holdings Inc., is a related party; (2) that the Company's CEO and related entities were alleged to have used supermarkets as a front to defraud the EB-5 visa program; and (3) that, as a result of the foregoing, Defendants' positive statements about the Company's business, operations, and prospects were materially misleading and/or lacked a reasonable basis. On March 31, 2025, material portions of the underlying complaint survived a motion to dismiss. WHAT YOU CAN DO NOW: If you purchased Maison Solutions Inc. (NASDAQ: MSS) on or near its October 5, 2023 IPO and still hold shares today, you are encouraged to visit contact Joshua Grabar at [email protected], or call 267-507-6085. You may be able to seek corporate reforms, the return of funds back to the company, and a court approved incentive award at no cost to you whatsoever. $MSS #MaisonSolutions Virtu Financial Inc. (NASDAQ: VIRT) Class Action Survives Motion to Dismiss: A federal securities fraud class action alleging that Virtu Financial Inc. (NASDAQ: VIRT), and certain of its officers failed to disclose to investors that it had improper safeguards in place and was not monitoring which of its employees were accessing the primary database containing sensitive trader information, has survived a motion to dismiss. Virtu shareholders who have continuously held Virtu shares since prior to November 7, 2018, can seek corporate reforms, the return of funds back to the company, and a court approved incentive award at no cost to them whatsoever. Learn more or join by clicking contact Joshua H. Grabar at [email protected], or call 267-507-6085. WHAT IS HAPPENING: Grabar Law Office is investigating claims on behalf of long-term Virtu (NASDAQ: VIRT) shareholders. The investigation concerns whether certain officers of the company have breached their fiduciary duties owed to the company. This investigation comes as a shareholder securities fraud class action has survived a motion to dismiss. WHY: A securities fraud class action complaint alleges that Virtu Financial, via certain of its officers and directors, made false and/or misleading statements and/or failed to disclose that: (i) the Company maintained deficient policies and procedures with respect to its information access barriers; (ii) accordingly, Virtu had overstated the Company's operational and technological efficacy as well as its capacity to block the exchange of confidential information between departments or individuals within the Company; (iii) the foregoing deficiencies increased the likelihood that the Company would be subject to enhanced regulatory scrutiny; and (iv) as a result, Defendants' public statements were materially false and/or misleading at all relevant times. On March 17, 2025, a federal Court determined that key allegations were sufficiently pled to survive defendants' motion to dismiss. According to the Court's Order, 'essentially anyone at Virtu, including its proprietary traders' could directly access this material non-public information from at least January 2018 through April 2019, and to do so, Virtu traders only needed to use a 'widely known and frequently shared username and password.' 'The court concludes that plaintiff's 'inference of scienter,' [inference that defendants knew their statements or omissions were false or misleading or acted with reckless disregard for the truth] supported by circumstantial evidence of defendants' reckless failure to inform its investors about the FS Database issue, is 'cogent and at least as compelling as' defendants' opposing inference that they identified the FS Database issue, rectified it, and self-reported it to the SEC, while continuously updating the market on the fact of and substance of the resultant SEC investigation.' WHAT YOU SHOULD DO NOW: If you are a current Virtu shareholder who has held Virtu stock since on or before November 7, 2018, you can seek corporate reforms, the return of funds spent defending litigation back to the company, and a court approved incentive award, at no cost to you. Contact: Joshua H. Grabar, Esq. Grabar Law Office One Liberty Place 1650 Market Street, Suite 3600 Philadelphia, PA 19103 Tel: 267-507-6085
Reuters
01-04-2025
- Health
- Reuters
Axsome to narrow focus of depression drug trial after limited success in initial run
April 1 (Reuters) - Axsome Therapeutics (AXSM.O), opens new tab said on Tuesday it will narrow the focus of a late-stage study of its depression drug after an initial run of the trial showed improvement only in a small subgroup of patients. The drug, solriamfetol, did not show statistically significant improvement in the overall group of patients. Keep up with the latest medical breakthroughs and healthcare trends with the Reuters Health Rounds newsletter. Sign up here. However, it helped reduce symptoms in some patients with major depressive disorder who also suffered from excessive daytime sleepiness (EDS), a common symptom of MDD. "The study missing in the overall MDD population limits the market opportunity significantly, and is disappointing given the company's expertise in the space," RBC Capital Markets analyst Leonid Timashev said in a client note. Axsome said it plans to start a larger late-stage study of the drug in MDD patients with EDS this year. The initial late-stage study that served as a proof of concept for the larger trial had enrolled 346 participants with MDD, of which 51 patients had severe EDS, the company said. The drug was well-tolerated in the study with no new safety concerns, Axsome said. Each year, around 21 million adults in the U.S. are affected by MDD, according to the company. Solriamfetol has already been approved in the U.S. to improve wakefulness in adults with excessive sleepiness from sleep disorders, narcolepsy and sleep apnea, and is sold under the brand Sunosi.
Reuters
25-03-2025
- Health
- Reuters
Axsome Therapeutics' ADHD drug meets main goal in late-stage study
March 25 (Reuters) - Axsome Therapeutics (AXSM.O), opens new tab said on Tuesday its experimental drug to treat attention deficit hyperactivity disorder (ADHD) met its main goal in a late-stage study. The drug, solriamfetol, helped ease symptoms which include difficulty paying attention, restlessness, and impulsivity in adults as measured using a common scale, the company said. Keep up with the latest medical breakthroughs and healthcare trends with the Reuters Health Rounds newsletter. Sign up here. The drug was found to be safe and well tolerated in the study with no serious side-effects, Axsome said. The company plans to begin a trial in pediatric patients this year.
Yahoo
05-03-2025
- Business
- Yahoo
Axsome Therapeutics Settles Sunosi® (solriamfetol) Patent Litigation with Hikma Pharmaceuticals USA
NEW YORK, March 05, 2025 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM) (Axsome), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced that it has entered into a settlement agreement with Hikma Pharmaceuticals USA, Inc. (Hikma) resolving patent litigation related to Axsome's product Sunosi® (solriamfetol). The litigation, which is pending in the United States District Court for the District of New Jersey, resulted from submission by Hikma of an Abbreviated New Drug Application to the U.S. Food and Drug Administration seeking approval to market a generic equivalent of Sunosi in the United States. Under the terms of the settlement agreement, Axsome will grant Hikma a license to sell its generic version of Sunosi beginning on or after September 1, 2040, if pediatric exclusivity is granted for Sunosi, or on or after March 1, 2040, if no pediatric exclusivity is granted, subject to FDA approval and conditions and exceptions customary for agreements of this type. As required by law, Axsome and Hikma will submit the settlement agreement to the U.S. Federal Trade Commission and the U.S. Department of Justice for review. Similar patent litigation brought by Axsome against other parties related to Sunosi remains pending in the U.S. District Court for the District of New Jersey. About Axsome Therapeutics Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes. Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, and multiple late-stage development programs addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Together, we are on a mission to solve some of the brain's biggest problems so patients and their loved ones can flourish. For more information, please visit the Company's website at Forward Looking Statements Certain matters discussed in this press release are 'forward-looking statements'. The Company may, in some cases, use terms such as 'predicts,' 'believes,' 'potential,' 'continue,' 'estimates,' 'anticipates,' 'expects,' 'plans,' 'intends,' 'may,' 'could,' 'might,' 'will,' 'should' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. In particular, the Company's statements regarding trends and potential future results are examples of such forward-looking statements. The forward-looking statements include risks and uncertainties, including, but not limited to, the commercial success of the Company's Sunosi®, Auvelity®, and Symbravo® products and the success of the Company's efforts to obtain any additional indication(s) with respect to solriamfetol and/or AXS-05; the Company's ability to maintain and expand payer coverage; the success, timing and cost of the Company's ongoing clinical trials and anticipated clinical trials for the Company's current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company's ability to fully fund the Company's disclosed clinical trials, which assumes no material changes to the Company's currently projected revenues or expenses), futility analyses and receipt of interim results, which are not necessarily indicative of the final results of the Company's ongoing clinical trials, and/or data readouts, and the number or type of studies or nature of results necessary to support the filing of a new drug application ('NDA') for any of the Company's current product candidates; the Company's ability to fund additional clinical trials to continue the advancement of the Company's product candidates; the timing of and the Company's ability to obtain and maintain U.S. Food and Drug Administration ('FDA') or other regulatory authority approval of, or other action with respect to, the Company's product candidates, including statements regarding the timing of any NDA submission; the Company's ability to successfully defend its intellectual property or obtain the necessary licenses at a cost acceptable to the Company, if at all; the Company's ability to successfully resolve any intellectual property litigation, and even if such disputes are settled, whether the applicable federal agencies will approve of such settlements; the successful implementation of the Company's research and development programs and collaborations; the success of the Company's license agreements; the acceptance by the market of the Company's products and product candidates, if approved; the Company's anticipated capital requirements, including the amount of capital required for the commercialization of Sunosi, Auvelity, and Symbravo and for the Company's commercial launch of its other product candidates, if approved, and the potential impact on the Company's anticipated cash runway; the Company's ability to convert sales to recognized revenue and maintain a favorable gross to net sales; unforeseen circumstances or other disruptions to normal business operations arising from or related to domestic political climate, geo-political conflicts or a global pandemic and other factors, including general economic conditions and regulatory developments, not within the Company's control. The factors discussed herein could cause actual results and developments to be materially different from those expressed in or implied by such statements. The forward-looking statements are made only as of the date of this press release and the Company undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstance. Investors:Mark JacobsonChief Operating Officer(212) 332-3243mjacobson@ Media:Darren OplandDirector, Corporate Communications(929) 837-1065dopland@ in to access your portfolio
