Fulcrum Therapeutics announces topline results from Phase 3 REACH clinical trial of losmapimod in facioscapulohumeral muscular dystrophy (FSHD)
- Losmapimod did not achieve the primary endpoint of change from baseline in Reachable Workspace (RWS) compared to placebo at week 48.
- Secondary endpoints, including Muscle Fat Infiltration (MFI) and shoulder abductor strength, also did not achieve nominal statistical significance.
- Fulcrum Therapeutics plans to suspend future development of losmapimod for FSHD.
- The company will complete a full evaluation of the data and share the results at an upcoming medical meeting.
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Aura Biosciences reports positive phase 2 end of study results evaluating bel-sar as a first-line treatment for early-stage choroidal melanoma
- Bel-sar demonstrated an 80% tumor control rate and 90% visual acuity preservation.
- The Phase 2 study included 22 patients with early-stage choroidal melanoma.
- No treatment-related serious adverse events were reported, and the safety profile was highly favorable.
- Aura Biosciences is currently enrolling patients in the global Phase 3 CoMpass trial.
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Seres Therapeutics reports SER-155 Phase 1b placebo-controlled cohort 2 study safety and clinical results in patients undergoing allogeneic hematopoietic stem cell transplant
- SER-155 administration significantly reduced bacterial bloodstream infections (BSIs) and systemic antibiotic exposure compared to placebo through day 100 post HSCT.
- The treatment was generally well tolerated with no treatment-related serious adverse events observed.
- Seres Therapeutics plans to seek Breakthrough Therapy designation from the FDA due to the high unmet medical need associated with BSIs.
- The company aims to advance the development of SER-155 in allo-HSCT and evaluate its use in other high-risk patient populations.
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ProMIS Neurosciences to showcase PMN310’s ability to target toxic oligomers in preclinical studies
- ProMIS Neurosciences will present preclinical data on PMN310 at the 4th International Conference on Cognitive & Behavioral Neurosciences.
- PMN310 is designed to selectively target toxic amyloid-beta oligomers, potentially offering greater efficacy in treating Alzheimer's disease.
- Studies show PMN310 has minimal interaction with monomers and does not bind to amyloid plaques or vascular deposits.
- ProMIS plans to advance PMN310 into a Phase 1b study in Q4 2024 following positive Phase 1a trial results.
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Bright Minds Biosciences initiates the BREAKTHROUGH study: a phase 2 trial of BMB-101 in absence epilepsy and developmental epileptic encephalopathy
- Bright Minds Biosciences has launched the BREAKTHROUGH Study, a Phase 2 clinical trial for BMB-101.
- The trial targets adult patients with Absence Epilepsy and Developmental Epileptic Encephalopathy (DEE).
- The study will monitor seizure activity over a 4-week baseline period, followed by an 8-12 week treatment phase.
- Primary endpoints include changes in seizure frequency and generalized spike-wave discharges (GSWD) on EEG.
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Syra Health announces pricing of $2.1 million public offering
- Syra Health Corp. has priced a public offering of 3,203,125 shares of Class A common stock and Series Warrants at $0.64 per share.
- The Series Warrants include Series A and Series B, with exercise prices of $0.64 per share, expiring in 18 months and 5 years, respectively.
- The offering is expected to close around September 13, 2024, subject to customary conditions.
- Gross proceeds are anticipated to be approximately $2.1 million, with potential additional proceeds of $4.1 million if all Series Warrants are exercised.
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Santhera announces half-year 2024 financial results and provides corporate update
- Revenue from contracts with customers increased to CHF 14.1 million (H1-2023: CHF 3.9 million).
- AGAMREE launched in Germany and Austria; approved in the UK for DMD treatment.
- Priority review for AGAMREE NDA in DMD granted by China’s regulatory authority.
- Cash and cash equivalents of CHF 16.5 million bolstered by financing of up to CHF 69 million.
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Ryvu Therapeutics reports 2024 half-year financial results and provides corporate update
- H1 2024 operating revenues reached USD 12.1 million, a USD 4.2 million increase from H1 2023.
- Cash position as of September 5, 2024, was USD 65.3 million, ensuring a runway through Q1 2026.
- Received the final EUR 6 million tranche from the European Investment Bank.
- Advancing PRMT5 inhibitor RVU305 to preclinical development, targeting IND/CTA filing in H2 2025.
- Progressing with RVU120 Phase II studies, with initial data expected at ASH 2024 conference.
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Viridian Therapeutics announces pricing of upsized public offering of shares
- Viridian Therapeutics is offering 10,666,600 shares of common stock at $18.75 per share.
- The company is also offering 20,000 shares of Series B non-voting convertible preferred stock at $1,250.06250 per share.
- Gross proceeds from the offering are expected to be approximately $225 million.
- Proceeds will be used for clinical development programs, working capital, and general corporate purposes.
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ITM obtains exclusive worldwide license from Debiopharm for CA IX-targeted peptide-based radiopharmaceutical programs targeting solid tumors
- ITM gains exclusive global license for the clinical and commercial development of ITM-91/ITM-94D, targeting the CA IX surface protein.
- The theranostic pair is being investigated in the phase 1/2 GaLuCiâ„¢ clinical trial for patients with locally advanced ccRCC, PDAC, and CRC.
- ITM-91 is a Lutetium-177-labeled radioligand therapeutic compound, and ITM-94D is a Gallium-68-labeled imaging agent.
- The GaLuCiâ„¢ trial is a multicenter, non-randomized phase 1/2 clinical trial assessing safety, tolerability, imaging characteristics, and efficacy.
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