Latest news with #VY1706
Business Insider
3 days ago
- Business
- Business Insider
Oppenheimer Predicts Up to ~550% Jump for These 2 ‘Strong Buy' Stocks
After a rocky start to the spring, Wall Street came roaring back in May. President Trump's softened tariff stance reignited demand for risk assets, triggering the market's biggest monthly rally since November 2023. The S&P 500 rose ~6%, nudging back into positive territory for the year. Confident Investing Starts Here: Encouraged by this rebound, John Stoltzfus, chief investment strategist at Oppenheimer, has taken the measure of the markets and holds a positive outlook for the near- to mid-term. 'The effects of the stock market rally from the lows seen on April 8 appear to us to augur positively for investors practicing diversification and patience notwithstanding near-term uncertainties… We remain overweight US equities and do not ascribe to the view that US exceptionalism is fading,' Stoltzfus noted. Against this backdrop, Oppenheimer analyst Jay Olson has picked out his winners for the months ahead, zeroing in on two stocks in particular – including one with the potential to jump ~550% by this time next year. We checked in with the TipRanks database to see how the rest of Wall Street views these names. The verdict? Both picks carry Strong Buy consensus ratings across the board, with substantial upside potential. Let's take a closer look at the details. Voyager Therapeutics (VYGR) One company Oppenheimer is especially bullish on is Voyager Therapeutics, a clinical-stage biotech developing treatments for serious neurological diseases, including Alzheimer's disease and Friedreich's ataxia – both of which have limited therapeutic options. Voyager's lead clinical candidate is VY7523, a monoclonal antibody designed to target pathological tau (pTAU), a protein closely associated with the progression of Alzheimer's disease. Intended for early-stage intervention, the therapy has shown encouraging preclinical results. In mouse models, its murine surrogate demonstrated high selectivity for abnormal tau while sparing healthy tau and delivered strong efficacy in the P301S seeding model, a benchmark in Alzheimer's research. Voyager recently completed a Phase 1 single ascending dose (SAD) trial in healthy volunteers and has since launched a multiple ascending dose (MAD) trial in patients with early-stage AD. Topline SAD results were positive, showing that VY7523 was well tolerated across dose levels and achieved expected central nervous system exposure. Alongside its antibody-based approach, Voyager is also advancing a gene therapy pipeline powered by its proprietary TRACER capsid technology. These engineered capsids are designed to deliver therapeutic payloads directly to brain cells while minimizing off-target exposure in tissues such as the liver. Among these programs is VY1706, a tau-silencing gene therapy intended to suppress pTAU production in neurons for the treatment of Alzheimer's. At the 2025 AD/PD conference, Voyager presented encouraging non-human primate data showing that a single intravenous dose of VY1706 achieved dose-dependent, robust reductions in MAPT mRNA and tau protein across critical brain regions. An Investigational New Drug (IND) filing remains on track for 2026. The promise of Voyager's TRACER platform has attracted major pharmaceutical partners. Through deals with Neurocrine Biosciences, Novartis, and Alexion (a subsidiary of AstraZeneca), the company could earn up to $7.4 billion in milestone payments. The Neurocrine collaboration is already advancing gene therapy programs for Friedreich's ataxia and GBA1-related disorders, with IND filings expected in 2025 and clinical trials slated to begin in 2026. Voyager could receive up to $35 million in milestone payments tied to these near-term milestones. Currently trading at $2.74 per share, VYGR may be flying under the radar – but Oppenheimer's Jay Olson sees it as a compelling entry point. 'We remain enthusiastic about VYGR's unique platform and optionality, and believe VYGR is well-positioned to pursue tau-targeting with different approaches. VYGR's strong balance sheet with a cash runway into mid-2027 should offer stability… Additionally, we are encouraged by the positive preclinical data, external validation of the platform technology through multiple collaborations with industry leaders, a strong management team, and our optimistic long-term view on the gene therapy and CNS therapeutic area,' Olson said. To this end, Olson rates VYGR an Outperform (i.e., Buy), and his $18 price target implies room for a stunning 556% upside potential in the next 12 months. (To watch Olson's track record, click here) Tvardi Therapeutics (TVRD) The second name catching Oppenheimer's attention is Tvardi Therapeutics, another biopharmaceutical firm – but a newcomer to the public markets. The TVRD ticker began trading on the NASDAQ on April 16 of this year, following the completion of a merger between Tvardi Therapeutics and Cara Therapeutics. Following its public debut, Tvardi is now focused on developing breakthrough therapies for fibrosis-driven diseases. Its approach centers on targeting STAT3 (signal transducer and activator of transcription 3), a key protein in the STAT family, known for its pivotal role in numerous cellular processes. At the center of Tvardi's clinical efforts is TTI-101, an oral small-molecule STAT3 inhibitor that selectively targets pY-STAT3 within the SH2 domain. Tvardi is advancing TTI-101 as a treatment for both hepatocellular carcinoma (HCC) and idiopathic pulmonary fibrosis (IPF), two diseases marked by high unmet need and limited effective therapies. Early clinical results have been encouraging. In a first-in-human Phase 1 trial involving patients with advanced solid tumors, including HCC, TTI-101 was well tolerated with no dose-limiting toxicities. Pharmacodynamic data confirmed target engagement, with biopsies showing reduced levels of activated STAT3. Tvardi expects topline data from its ongoing Phase 1b/2 REVERT Liver Cancer clinical trial in HCC to be available in the first half of 2026. Meanwhile, building on insights from the same trial, Tvardi is also advancing the REVERT IPF Phase 2 study – a randomized, double-blind, placebo-controlled trial evaluating TTI-101, both as a monotherapy and in combination with nintedanib, in patients diagnosed with IPF within the past seven years. On May 27, 2025, the company announced that enrollment was complete, with topline results expected in the fourth quarter of this year. The potential of TTI-101, based on its earlier clinical trial results and optimistic forecasts for the current trials, has not gone unnoticed by Oppenheimer's Olson. The analyst is encouraged by the possible long-term returns, assuming success in both the trial and regulatory process. 'We see an underappreciated opportunity for lead asset TTI-101 as we forecast ~$1.2B peak risk-adjusted sales in 2040. Blinded Ph2a interim data suggest that TTI-101 could reverse IPF progression, thus supporting favorable differentiation from key competitors, with detailed Ph2a results expected in 2H25 serving as a potential valuable inflection point. In HCC, we believe TTI-101 offers a novel, mechanistically distinct approach, with interim Ph1b/2 data suggesting synergy in combination with SoC ahead of topline results in 1H26. We leverage our expertise in IPF and HCC to inform our analysis, and view TVRD as well-capitalized through key catalysts… Based on our DCF valuation of TVRD, we believe that its shares remain underappreciated,' Olson stated. With that backdrop, Olson rates TVRD an Outperform (i.e., Buy), alongside a $65 price target, suggesting a potential upside of 129% from current levels. Overall, this new stock has picked up 4 analyst reviews since it went public, and all are positive – making the Strong Buy consensus rating unanimous. TVRD is currently trading for $28.34, and its $50.75 average price target suggests that the shares have a 79% upside lying in wait for the year ahead. (See TVRD 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.
Yahoo
11-03-2025
- Business
- Yahoo
Voyager Reports Fourth Quarter and Full Year 2024 Financial and Operating Results
- Tau silencing gene therapy VY1706 robustly reduced tau mRNA levels, with broad distribution, and was well-tolerated in NHP study; IND filing anticipated in 2026 - - Anti-tau antibody VY7523 was well tolerated in healthy volunteers and showed dose-proportional pharmacokinetics; initial tau PET imaging data in Alzheimer's patients expected H2 2026 - LEXINGTON, Mass., March 11, 2025 (GLOBE NEWSWIRE) -- Voyager Therapeutics, Inc. (Nasdaq: VYGR), a biotechnology company dedicated to leveraging genetics to treat neurological diseases, today reported fourth quarter and full year 2024 financial and operating results. 'Over the past year, Voyager has significantly advanced our two wholly-owned programs targeting tau, which we view as the most important target in Alzheimer's disease. Our anti-tau antibody VY7523 is now in a clinical trial in Alzheimer's disease patients, and our tau silencing gene therapy VY1706 is now in IND-enabling studies,' said Alfred W. Sandrock, Jr., M.D., Ph.D., Chief Executive Officer of Voyager. 'At the same time, we made significant progress across our partnered portfolio of IV gene therapy programs in 2024, generating approximately $80 million in non-dilutive funding last year alone. Our strong cash position is expected to provide runway through multiple value-creating milestones and into mid-2027, and this does not include potential milestone payments from existing partnerships.' Fourth Quarter 2024 and Recent Highlights Development candidate selected for tau silencing gene therapy program VY1706: In a three-month non-human primate (NHP) study, a single 1.3E13 vg/kg dose of VY1706 delivered intravenously (IV) resulted in reductions in tau mRNA levels of 50% to 73% across the cerebral cortex, including in areas of the brain where tau accumulates during progression of Alzheimer's disease (AD). Voyager expects to present additional data from the NHP study of VY1706 at the International Conference on Alzheimer's and Parkinson's Diseases and Related Neurological Disorders (ADPD) April 1-5, 2025. Initiated multiple ascending dose (MAD) study of VY7523 anti-tau antibody for AD: VY7523 demonstrated an acceptable safety, tolerability, and immunogenicity profile as well as expected pharmacokinetic results in a Phase 1, single ascending dose (SAD) clinical trial in healthy volunteers. No serious adverse events (SAEs), severe adverse events, or infusion reactions were reported, and the cerebrospinal fluid (CSF)-to-serum ratio was 0.3%. Initial tau positron emission tomography (PET) data from the recently initiated MAD study are expected in the second half of 2026. Additionally, in the fourth quarter of 2024, third-party data demonstrated for the first time that an anti-tau antibody can impact tau accumulation in a human brain, and that this may correlate with clinical benefit, further increasing Voyager's confidence in this approach. Runway extended into mid-2027 as VY9323 no longer advancing: Voyager previously announced that it is assessing alternate payloads related to its gene therapy program for superoxide dismutase 1 (SOD1) amyotrophic lateral sclerosis (ALS) and is no longer advancing VY9323, its previous lead development candidate for the program. This resulted in an extension of Voyager's cash runway into mid-2027; this does not include any potential milestone payments from existing partnerships. Anticipated Upcoming Milestones April 2025: VY1706 tau silencing gene therapy and VY7523 anti-tau antibody data at ADPD conference 2025: IND filings anticipated with Neurocrine-partnered gene therapies for GBA1 Parkinson's and other GBA1-mediated diseases, as well as for Friedreich's ataxia 2025 and 2026: potentially informative anti-tau antibody and tau silencing antisense oligonucleotide data read-outs expected from multiple third parties 2026: U.S. IND and Canadian clinical trial application (CTA) filings anticipated with tau silencing gene therapy VY1706 for AD H2 2026: Initial tau PET imaging data expected in MAD clinical trial of VY7523 in AD Fourth Quarter and Full Year 2024 Financial Results Collaboration Revenues: Voyager had collaboration revenue of $6.3 million for the fourth quarter of 2024, compared to $90.1 million for the same period in 2023, and $80.0 million for the year ended December 31, 2024, compared to $250.0 million for the same period in 2023. The decrease was primarily due to decreased revenue recognized under our Neurocrine and Novartis collaboration agreements, including $80.0 million in collaboration revenue that was recognized during the fourth quarter of 2023 in connection with the Novartis collaboration announced in January 2024. Net Loss/Income: Net loss was $34.5 million for the fourth quarter of 2024, compared to net income of $56.4 million for the same period in 2023, and net loss was $65.0 million for the year ended December 31, 2024, compared to net income of $132.3 million for the same period in 2023. The differences are primarily due to the decreases in collaboration revenue discussed above. R&D Expenses: Research and development expenses were $35.6 million for the fourth quarter of 2024, compared to $25.8 million for the same period in 2023, and $127.4 million for the year ended December 31, 2024, compared to $92.2 million for the same period in 2023. The increase in R&D expenses was primarily due to increased program-related spending to support our advancing pipeline, along with increased facilities costs related to our lease for additional laboratory and office space. G&A Expenses: General and administrative expenses were $9.0 million for the fourth quarter of 2024, compared to $10.2 million for the same period in 2023, and $35.9 million for the year ended December 31, 2024, compared to $35.8 million for the same period in 2023. The consistent spend reflects continued disciplined expense management. Cash Position: Cash, cash equivalents and marketable securities as of December 31, 2024, were $332.4 million. Financial Guidance Voyager is committed to maintaining a strong balance sheet that supports the advancement and growth of its platform and pipeline. Voyager continues to assess its planned cash needs both during the current period and in future periods. We expect our cash, cash equivalents, and marketable securities, along with amounts expected to be received as reimbursement for development costs under the Neurocrine and Novartis collaborations and interest income, to be sufficient to meet Voyager's planned operating expenses and capital expenditure requirements into mid-2027. Conference Call Voyager will host a conference call and webcast today at 4:30 p.m. ET to discuss fourth quarter and full year 2024 financial and operating results. A live webcast of the call will be available on the Investors section of the Voyager website at and a replay of the call will be available at the same link approximately two hours after its completion. The replay will be available for at least 30 days following the conclusion of the call. About Voyager Therapeutics Voyager Therapeutics, Inc. (Nasdaq: VYGR) is a biotechnology company dedicated to leveraging the power of human genetics to modify the course of – and ultimately cure – neurological diseases. Our pipeline includes programs for Alzheimer's disease, Friedreich's ataxia, Parkinson's disease, amyotrophic lateral sclerosis (ALS), and multiple other diseases of the central nervous system. Many of our programs are derived from our TRACER™ AAV capsid discovery platform, which we have used to generate novel capsids and identify associated receptors to potentially enable high brain penetration with genetic medicines following intravenous dosing. Some of our programs are wholly owned, and some are advancing with partners including Alexion, AstraZeneca Rare Disease; Novartis Pharma AG; and Neurocrine Biosciences, Inc. For more information, visit Voyager Therapeutics® is a registered trademark, and TRACER™ is a trademark, of Voyager Therapeutics, Inc. Forward-Looking Statements This press release contains forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws. The use of words such as 'expect,' 'believe,' 'anticipate,' 'potential,' 'may,' or 'continue,' and other similar expressions are intended to identify forward-looking statements. For example, all statements Voyager makes regarding Voyager's ability to advance its AAV-based gene therapy programs and tau antibody program, including expectations for Voyager's achievement of preclinical and clinical development milestones for its potential development candidates such as the identification of lead development candidates, IND and CTA filings, the initiation of clinical trials, clinical trial enrollment, and the generation of clinical data; the potential for an antibody targeting tau to impact the accumulation of tau in the brain of Alzheimer's patients and for this impact to offer a clinically significant benefit in some patients; the potential for third-party clinical data to inform Voyager's clinical development plans; Voyager's ability to advance gene therapy product candidates under the Neurocrine collaboration; Voyager's anticipated financial results, including the anticipated receipt by Voyager of revenues or reimbursement payments from collaboration partners; and Voyager's cash runway and ability to generate sufficient cash resources to enable it to continue its business and operations are forward looking. All forward-looking statements are based on estimates and assumptions by Voyager's management that, although Voyager believes such forward-looking statements to be reasonable, are inherently uncertain and subject to risks and uncertainties that may cause actual results to differ materially from those that Voyager expected. Such risks and uncertainties include, among others, the expectations and decisions of regulatory authorities; the timing, initiation, conduct and outcomes of Voyager's preclinical and clinical studies; the availability of data from clinical trials; the availability or commercial potential of product candidates under collaborations; the success of Voyager's product candidates; the willingness and ability of Voyager's collaboration partners to meet obligations under collaboration agreements with Voyager; the continued development of Voyager's technology platforms, including Voyager's TRACER platform and its antibody screening technology; Voyager's scientific approach and program development progress, and the restricted supply of critical research components; the development by third parties of capsid identification platforms that may be competitive to Voyager's TRACER capsid discovery platform; Voyager's ability to create and protect intellectual property rights associated with the TRACER capsid discovery platform, the capsids identified by the platform, and development candidates for Voyager's pipeline programs; the possibility or the timing of Voyager's receipt of program reimbursement, development or commercialization milestones, option exercise, and other payments under Voyager's existing licensing or collaboration agreements; the ability of Voyager to negotiate and complete licensing or collaboration agreements with other parties on terms acceptable to Voyager and the third parties; the success of programs controlled by third-party collaboration partners in which Voyager retains a financial interest; the ability to attract and retain talented directors, employees, and contractors; and the sufficiency of Voyager's cash resources to fund its operations and pursue its corporate objectives. These statements are also subject to a number of material risks and uncertainties that are described in Voyager's most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission. All information in the press release is as of the date of this press release, and any forward-looking statement speaks only as of the date on which it was made. Voyager undertakes no obligation to publicly update or revise this information or any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. Contacts Trista Morrison, tmorrison@ Media: Brooke Shenkin, brooke@ Selected Financial Information ($ amounts in thousands, except per share data) Three Months Ended Year Ended December 31, December 31, Statement of Operations Items: 2024 2023 2024 2023 Collaboration revenue $ 6,278 $ 90,061 $ 80,001 $ 250,008 Operating expenses: Research and development 35,583 25,576 127,368 92,172 General and administrative 8,994 10,242 35,920 35,822 Total operating expenses 44,577 35,998 163,288 127,994 Operating (loss) income (38,299 ) 54,063 (83,287 ) 122,014 Total other income 4,396 3,154 18,950 11,724 (Loss) income before income taxes (33,903 ) 57,127 (64,337 ) 133,738 Income tax provision 584 822 665 1,408 Net (loss) income $ (34,487 ) $ 56,395 $ (65,002 ) $ 132,330 Net (loss) income per share, basic $ (0.59 ) $ 1.28 $ (1.13 ) $ 3.08 Net (loss) income per share, diluted $ (0.59 ) $ 1.25 $ (1.13 ) $ 2.97 Weighted-average common shares outstanding, basic 57,974,688 43,983,990 57,667,543 43,020,747 Weighted-average common shares outstanding, diluted 57,974,688 45,078,511 57,667,543 44,569,334 December 31, December 31, Selected Balance Sheet Items: 2024 2023 Cash, cash equivalents, and marketable securities $ 332,388 $ 230,875 Total assets $ 393,050 $ 351,281 Accounts payable and accrued expenses $ 18,167 $ 18,427 Deferred revenue $ 30,397 $ 75,240 Total stockholders' equity $ 299,760 $ 236,320 GAAP vs. Non-GAAP Financial MeasuresVoyager's financial statements are prepared in accordance with generally accepted accounting principles in the United States, or GAAP, and represent revenue and expenses as reported to the Securities and Exchange Commission. Voyager has provided in this release certain financial information that has not been prepared in accordance with GAAP, including net collaboration revenue and net research and development expenses, which exclude the impact of reimbursement by Neurocrine Biosciences (Neurocrine) and Novartis Pharma AG (Novartis) for expenses we incur in conducting preclinical development activities under our collaboration agreements. Management uses these non-GAAP measures to evaluate the Company's operating performance in a manner that allows for meaningful period-to-period comparison and analysis of trends in its business. Management believes that such non-GAAP measures are important in comparing current results with prior period results and are useful to investors and financial analysts in assessing the Company's operating performance. Non-GAAP financial measures are not required to be uniformly applied, are not audited and should not be considered in isolation. The non-GAAP measures give investors and financial analysts a better understanding of our net revenue and net research and development expenses without the pass-through impact of Neurocrine costs. The non-GAAP financial information presented here should be considered in conjunction with, and not as a substitute for, the financial information presented in accordance with GAAP. Investors are encouraged to review the reconciliation of these non-GAAP measures to their most directly comparable GAAP financial measures set forth below. Reconciliation of GAAP to Non-GAAP Measures (in thousands) Three Months Ended Year Ended December 31, December 31, 2024 2023 2024 2023 GAAP collaboration revenue $ 6,278 $ 90,061 $ 80,001 $ 250,008 Revenue recognized for reimbursed research and development services (Note 1) $ 1,893 $ 3,052 $ 8,463 $ 10,095 Net collaboration revenue $ 4,385 $ 87,009 $ 71,538 $ 239,913 GAAP total research and development expenses $ 35,583 $ 25,576 $ 127,368 $ 92,172 Expenses incurred for reimbursed research and development services (Note 1) $ 1,893 $ 3,052 $ 8,463 $ 10,095 Net research and development expenses $ 33,690 $ 22,704 $ 118,905 $ 82,077 Note 1: Under the Company's existing collaboration agreements with Neurocrine and Novartis, Neurocrine and Novartis have agreed to be responsible for all costs the Company incurs in conducting preclinical development activities for certain collaboration programs, in accordance with joint steering committee agreed upon workplans and budgets. Reimbursable research and development services performed during the period are captured within collaboration revenue and research and development expenses in the Company's consolidated statements of operations. During the three months ended December 31, 2024, we incurred $1.9 million of reimbursable research and development services recorded within collaboration revenue and research and development expenses. During the three months ended December 31, 2023, we incurred $3.1 million of reimbursable research and development services recorded within collaboration revenue and research and development expenses. During the year ended December 31, 2024, we incurred $8.5 million of reimbursable research and development services recorded within collaboration revenue and research and development expenses. During the year ended December 31, 2023, we incurred $10.1 million of reimbursable research and development services recorded within collaboration revenue and research and development in to access your portfolio
