Ocular Therapeutix (NasdaqGM:OCUL) Conference March 25, 2026 09:30 AM ET Company ParticipantsLisa Walter - VP of Biotech Equity ResearchPravin Dugel - Executive Chairman, President, and CEOLisa WalterGood morning, everyone. I'm Lisa Walter, Biotech Analyst here at RBC Capital Markets. Thanks for joining us at RBC's Ophthalmology Conference. This session, we have Pravin Dugel, Executive Chairman, President, and CEO of Ocular Therapeutix. Pravin, thanks so much for joining us today. How are you doing?Pravin D ...

EyePoint Pharmaceuticals (NasdaqGM:EYPT) Conference March 25, 2026 08:45 AM ET Company ParticipantsGeorge O. Elston - EVP and CFOJay S. Duker - President and CEOConference Call ParticipantsLisa Walter - Biotechnology AnalystLisa WalterGood morning, everyone. I'm Lisa Walter, biotech analyst here at RBC Capital Markets. Thanks for joining us at RBC's Ophthalmology Conference. This session, we have Jay Duker, Managing Director and Chief Executive Officer, and George Elston, EVP, and Chief Financial Officer fr ...

Hoth Therapeutics Reports Positive HT-001 PK, Safety, and Clinical Activity Data in Cancer Patients with EGFR Therapy-Associated Skin Toxicities Showing ~77% Increase in Drug Exposure and Minimal Systemic Absorption Accessibility StatementSkip Navigation NEW YORK, March 24, 2026 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH) today reported positive pharmacokinetic (PK), safety, and clinical activity data for HT-001, demonstrating a ~77% increase in systemic drug exposure following repeat dosing, min ...

Core Insights - Moleculin Biotech has enrolled the 45th subject in its pivotal Phase 2B/3 MIRACLE trial, evaluating Annamycin in combination with cytarabine for treating relapsed or refractory acute myeloid leukemia (R/R AML), marking a significant milestone for the company [1][2] - The upcoming interim data unblinding is expected in mid-2026 and is viewed as a potential inflection point for the company, with preliminary results indicating a 40% remission rate among the first 30 patients [2][3] Trial Progress - The MIRACLE trial is designed to evaluate AnnAraC across eight countries, with an initial dataset expected to include approximately 30 patients treated with AnnAraC and 15 patients in the control arm [2][4] - The trial's adaptive design aims to support a streamlined global registration pathway, integrating Phase 2B data into the Phase 3 portion, in line with regulatory guidance [4] Efficacy and Safety - Preliminary results from the trial show a composite complete remission rate of 40%, with 30% achieving complete remission and 10% achieving complete remission with partial hematologic recovery, despite many patients having previously failed venetoclax-based therapies [3][5] - The absence of cardiotoxicity in over 100 patients treated to date is a notable achievement for the company [2][5] Future Outlook - The company is advancing toward a total enrollment of 90 subjects, with the completion of Part A of the MIRACLE trial expected in Q3 2026 [2][4] - The successful outcomes from the trial could lead to a potential accelerated approval pathway based on the primary endpoint of complete remission [4][5]

Talphera Announces Fourth Quarter and Full Year 2025 Financial Results and Provides Corporate Update Accessibility StatementSkip Navigation Previously announced achievement of 50% enrollment of the NEPHRO CRRT clinical study in March 2026 and closed the associated financing tranche of $4.1 million All 12 clinical study sites now able to enroll patients to support an expected study completion in 2026 Cash and investments of $20.4 million at December 31, 2025 Fourth Quarter 2025 and Recent Highlights Fourth Q ...

Epilepsy DataOvid Therapeutics reported favorable topline safety and tolerability findings from a 7 mg dose cohort of OV329 for drug-resistant epilepsies.There were no treatment-related adverse events in the 7 mg cohort, and 19 unrelated adverse events, all of which were mild and transient.Additionally, the company plans to expand OV329’s development to include tuberous sclerosis complex seizures and infantile spasms, with a proof-of-concept study for TSC expected to begin in the fourth quarter of 2026.The ...

Core Insights - Keros Therapeutics (KROS) is entering 2026 with a clearer focus on operational execution and a defined catalyst stack, primarily driven by rinvatercept [1][2] - The company has shifted costs related to elritercept to Takeda, allowing for a leaner R&D base and a longer operational runway [2] Rinvatercept as a Central Value Driver - Rinvatercept is positioned as the key value driver in Keros' pipeline, designed to inhibit negative regulators of muscle and bone mass [3] - The drug aims to promote muscle regeneration, increase muscle size and strength, reduce body fat, and improve bone strength [4] Upcoming Milestones - A pivotal milestone is the expected start of a Phase II study of rinvatercept in Duchenne muscular dystrophy (DMD) in Q2 2026, which is crucial for Keros as it is their lead program [5][10] - The Phase II trial is significant as it aims to test the drug's clinical benefits against the current standard of care, glucocorticoids, which have long-term side effects [6] Regulatory Engagement for ALS - Keros plans to engage with regulatory authorities in the second half of 2026 to discuss a Phase II study for rinvatercept in amyotrophic lateral sclerosis (ALS) [7][8] Data Support and Clinical Profile - A March 2023 update indicated that rinvatercept was well tolerated with no serious adverse events, supporting its mechanism and potential benefits [9][11] - The update also highlighted increases in muscle mass, reduced fat, and higher bone density, reinforcing the drug's target engagement [11] Competitive Landscape in DMD - The DMD therapeutic area is competitive, with established players like Sarepta Therapeutics and PTC Therapeutics, necessitating Keros to demonstrate a clear clinical profile [12][14] - Sarepta has multiple therapies and recent approvals, while PTC markets Emflaza, underscoring the need for differentiation [13][14] Financial Considerations - Keros has not recorded product sales and relies on licensing and transition-service revenue, leading to potential volatility in financials until a commercial engine is defined [15] - The company ended 2025 with $287.4 million in cash, expected to fund operations into the first half of 2028, contingent on current assumptions [16]

Core Insights - Avoro Capital Advisors LLC reduced its holdings in Alkermes plc by 22.8% during the 3rd quarter, now owning 2,240,000 shares after selling 660,000 shares [2] - Alkermes has seen significant changes in institutional investor positions, with Norges Bank purchasing approximately $53.33 million in the second quarter and Arrowstreet Capital increasing its position by 1,070.6% in the third quarter [3] - Alkermes' stock opened at $27.76, with a market capitalization of $4.63 billion and a PE ratio of 19.41, while the company reported a quarterly revenue of $384.55 million, down 10.6% year-over-year [4] Institutional Holdings - Avoro Capital Advisors LLC's stake in Alkermes is now 0.9% of its total holdings, making it the 23rd largest position [2] - Other institutional investors, such as American Century Companies Inc., increased their stake by 20.2% in the 3rd quarter, now owning shares worth $131.92 million [3] - Institutional investors and hedge funds collectively own 95.21% of Alkermes' stock [3] Stock Performance - Alkermes shares have a 52-week low of $25.17 and a high of $36.32, with a 50-day simple moving average of $31.58 [4] - The company reported earnings per share (EPS) of $0.29 for the last quarter, missing the consensus estimate of $0.43 by $0.14 [4] Insider Activity - Director Shane Cooke sold 61,200 shares at an average price of $34.57, resulting in a 37.10% decrease in ownership [5] - Insiders sold a total of 157,434 shares valued at $5.31 million over the last three months, with insiders owning 4.40% of the company [5] Analyst Ratings - Zacks Research downgraded Alkermes from a "strong-buy" to a "hold" rating, while Truist Financial raised its target price from $50.00 to $55.00 [6] - The consensus rating for Alkermes is "Moderate Buy" with a target price of $44.07 [7] Company Overview - Alkermes plc is a biopharmaceutical company focused on developing innovative medicines for central nervous system disorders, including addiction and depression [8]

Core Insights - Axsome Therapeutics (AXSM) is experiencing significant growth driven by its lead drug, Auvelity (AXS-05), which is approved for major depressive disorder and has contributed substantially to the company's revenue since its U.S. launch in 2022 [1][9]. Sales Performance - In 2025, Auvelity achieved sales of $507.1 million in the U.S., reflecting a year-over-year increase of approximately 74% [2][9]. - The sales growth is attributed to an increase in unit sales volume, with expectations for continued momentum into 2026 [2]. - Sunosi, another drug in Axsome's portfolio, generated $124.8 million in sales in 2025, marking a 32% increase year-over-year [5][9]. - Axsome's newest product, Symbravo, launched in June 2025, recorded $6.6 million in sales in its first year [5]. Regulatory Developments - The FDA has accepted Axsome's supplemental new drug application (sNDA) for AXS-05 to treat Alzheimer's disease agitation, with a priority review and a decision expected by April 30, 2026 [3]. Clinical Development - Axsome plans to initiate a pivotal phase II/III study of AXS-05 for smoking cessation in the second quarter of 2026 [4]. Competitive Landscape - The CNS market remains competitive, with Acadia Pharmaceuticals' Nuplazid generating $691.9 million in sales in 2025, up 14.7% year-over-year [7]. - Sunosi may face competition from Jazz Pharmaceuticals' sleep disorder drugs, while Symbravo is expected to compete with established migraine treatments from Pfizer and AbbVie [8]. Valuation and Market Performance - Year-to-date, Axsome's shares have declined by 15.6%, contrasting with a 5.7% increase in the industry [10]. - Axsome's price-to-sales (P/S) ratio stands at 12.22, significantly higher than the industry average of 2.45, although below its five-year mean of 14.41 [11]. Earnings Estimates - The Zacks Consensus Estimate for 2026 has shifted from earnings of $0.34 per share to a projected loss of $1.29 per share, with 2027 estimates also decreasing from $5.85 to $5.12 [12].

Core Insights - Tonix Pharmaceuticals achieved FDA approval and launched TONMYA, the first new medicine for fibromyalgia in over 15 years, with over 1,500 healthcare providers prescribing it to approximately 2,500 patients by February 27, 2026 [2][4] - The company reported a net product revenue of approximately $13.1 million for the full year 2025, an increase from $10.1 million in 2024, with TONMYA contributing approximately $1.4 million from its launch until year-end [17][19] - Tonix has a robust clinical pipeline, including TNX-4800 for Lyme disease prevention and TNX-102 SL for major depressive disorder, with plans for further development and FDA discussions in 2026 [2][6][9] Commercial Updates - TONMYA was launched on November 17, 2025, and has shown favorable early prescription trends, with cumulative prescriptions totaling approximately 4,200 by February 27, 2026 [4][3] - The company has deployed a salesforce of approximately 90 members to support the commercialization of TONMYA and enhance awareness among healthcare providers and patients [2][4] Financial Highlights - As of December 31, 2025, Tonix had approximately $207.6 million in cash and cash equivalents, a significant increase from $98.8 million in 2024 [13][30] - The company completed a $20.0 million registered direct offering with Point72 in December 2025 to fund commercialization and pipeline development [14] - Research and development expenses for 2025 were approximately $44.5 million, reflecting increased investment in pipeline projects [18] Product Pipeline - TNX-4800, a long-acting monoclonal antibody for Lyme disease prevention, is set for FDA discussions regarding Phase 2/3 development in 2026 [6][9] - TNX-102 SL has received IND clearance for a Phase 2 study in major depressive disorder, with enrollment expected to begin in mid-2026 [9][12] - TNX-2900, targeting Prader-Willi syndrome, is planned for a Phase 2 trial initiation in Q1 2027 [11] Operational Highlights - The company has established partnerships for distribution and patient access programs to facilitate the commercialization of TONMYA [8] - Tonix is focusing on expanding payer engagement and establishing contracts with commercial payers while progressing discussions with Medicare and Medicaid [8]