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Soleno Therapeutics Provides Corporate Update and Reports First Quarter 2024 Financial Results

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Giovedì, Maggio 9, 2024

FDA, Prader–Willi syndrome, Tablet, Investment, PATH, NDA, Food, Human resources, Research, PWS, Natural history, Behavior, Exercise, Neurodevelopmental disorder, Therapy, CMC, Polyphagia, Journal, Pharmaceutical industry

REDWOOD CITY, Calif., May 09, 2024 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (Soleno) (NASDAQ: SLNO), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today provided a corporate update, and reported financial results for the first quarter ended March 31, 2024.

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REDWOOD CITY, Calif., May 09, 2024 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (Soleno) (NASDAQ: SLNO), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today provided a corporate update, and reported financial results for the first quarter ended March 31, 2024.
Planned submission of a New Drug Application (NDA) for DCCR in PWS remains on track for mid-2024.
“Soleno’s top priority remains NDA submission for DCCR in PWS,” said Anish Bhatnagar, M.D., Chief Executive Officer of Soleno Therapeutics.
First Quarter Ended March 31, 2024 Financial Results
As of March 31, 2024, Soleno had $42.8 million of cash and cash equivalents, $106.8 million of short-term investments, and $8.8 million of long-term investments.

Soleno Therapeutics Announces Pricing of Approximately $138 Million Public Offering Of Common Stock

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Venerdì, Maggio 3, 2024

Sale, Prospectus, Prader–Willi syndrome, Equity, Guggenheim Partners, PWS, Research, Nicollet Mall, Madison Avenue, Oppenheimer Holdings, Public expenditure, Form, Therapy, Tablet, Attention, Telephone, Security (finance)

REDWOOD CITY, Calif., May 02, 2024 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (Nasdaq: SLNO), (“Soleno” or the “Company”), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, announced today the pricing of the underwritten public offering of 3,000,000 shares of its common stock at a public offering price of $46.00 per share.

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REDWOOD CITY, Calif., May 02, 2024 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (Nasdaq: SLNO), (“Soleno” or the “Company”), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, announced today the pricing of the underwritten public offering of 3,000,000 shares of its common stock at a public offering price of $46.00 per share.
The gross proceeds of the public offering are expected to be approximately $138.0 million, before deducting underwriting discounts and commissions and other estimated offering expenses.
Soleno has also granted the underwriters a 30-day option to purchase up to 450,000 shares of common stock at the public offering price, less underwriting discounts and commissions.
Piper Sandler, Guggenheim Securities, Cantor Fitzgerald & Co. and Oppenheimer & Co. are acting as joint book-running managers for the public offering.

Soleno Therapeutics Announces Proposed Public Offering of Common Stock

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Giovedì, Maggio 2, 2024

Guggenheim, Sale, Prospectus, Prader–Willi syndrome, Equity, Guggenheim Partners, PWS, Research, Nicollet Mall, Madison Avenue, Floor, Public expenditure, Form, Therapy, Tablet, Attention, Telephone, Pharmaceutical industry

REDWOOD CITY, Calif., May 02, 2024 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (Nasdaq:SLNO), ("Soleno" or the "Company"), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, announced today that it intends to offer and sell shares of its common stock in an underwritten public offering.

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REDWOOD CITY, Calif., May 02, 2024 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (Nasdaq:SLNO), ("Soleno" or the "Company"), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, announced today that it intends to offer and sell shares of its common stock in an underwritten public offering.
In addition, Soleno intends to grant the underwriters a 30-day option to purchase an additional number of shares of common stock equal to 15% of the aggregate number of shares of its common stock sold in the public offering.
The public offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.
The securities described above relating to the public offering are being offered by Soleno pursuant to a registration statement on Form S-3ASR (File No.

Rhode Island Partners With 120Water™ to Support Digital Lead Service Line Database

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Mercoledì, Aprile 17, 2024

Leading U.S. digital water testing and data management platform 120Water announced today that the state of Rhode Island selected it to manage the lead service line inventories for all water systems across the state.

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Leading U.S. digital water testing and data management platform 120Water announced today that the state of Rhode Island selected it to manage the lead service line inventories for all water systems across the state.
“Ensuring Rhode Island residents have access to safe, clean drinking water is a top priority for the state.
120Water is working closely with the Rhode Island Department of Health to distribute licenses, communications, and training to onboard all eligible systems.
Additional training support will be provided through 120Water’s recent partnership with the Rhode Island Rural Water Association.

Genasys Partners in European Union-Funded Project to Revolutionize Public Warning

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Martedì, Marzo 26, 2024

Civil service commission, Grant, Galileo Galilei, Republic, Disaster, Genasys, Satellite navigation, SAN, EWSS, University, European Commission, JCDecaux, CNES, Telecommunications, FDC, European, PWS, GNSS, Mobile phone

101082555) that goes beyond smartphone-based alerting by developing a solution that will extend the reception and processing of Galileo Emergency Warning Satellite Service (EWSS) public safety warnings into display panels, indoor warning systems, and acoustic devices.

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101082555) that goes beyond smartphone-based alerting by developing a solution that will extend the reception and processing of Galileo Emergency Warning Satellite Service (EWSS) public safety warnings into display panels, indoor warning systems, and acoustic devices.
Genasys’ experience in innovating satellite-connected speaker systems that broadcast audible voice messages with exceptional clarity qualified us to partner in this consortium.
Genasys Protect ALERT will be used to conduct an end-to-end Project AWARE demonstration with the Republic of Slovenia Administration for Civil Protection and Disaster Relief, a customer and consortium member.
The Republic of Slovenia Administration for Civil Protection and Disaster Relief will host one of the demonstrations planned at the end of the project.

Tonix Pharmaceuticals Receives Rare Pediatric Disease Designation from the FDA for TNX-2900 for the Treatment of Prader-Willi Syndrome

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Lunedì, Marzo 25, 2024

Eating, Prader–Willi syndrome, Obesity, Orphan drug, Appetite, Ageing, Tonix Pharmaceuticals, IND, Polyphagia, Priority review, Oxytocin, Marketing, FDA, Genetic disorder, PWS, Food, Pharmaceutical industry

CHATHAM, N.J., March 25, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation to TNX-2900* (intranasal potentiated oxytocin), a proprietary magnesium (Mg2+)-potentiated formulation of intranasal oxytocin, to treat Prader-Willi syndrome (PWS) in children and adolescents. TNX-2900 was previously granted Orphan Drug designation by the FDA in 2022 for the treatment of PWS and the investigational new drug (IND) application was cleared by the FDA in 2023. The Company may be eligible to receive a transferable Priority Review Voucher if TNX-2900 for PWS is approved for marketing. Recently, vouchers have sold for approximately $100 million.

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TNX-2900 was previously granted Orphan Drug designation by the FDA in 2022 for the treatment of PWS and the investigational new drug (IND) application was cleared by the FDA in 2023.
The Company may be eligible to receive a transferable Priority Review Voucher if TNX-2900 for PWS is approved for marketing.
Recently, vouchers have sold for approximately $100 million.
“The Rare Pediatric Disease Designation is an important regulatory milestone in the development of TNX-2900.

HARMONY BIOSCIENCES INITIATES GLOBAL PHASE 3 REGISTRATIONAL TRIAL (TEMPO STUDY) OF PITOLISANT IN PATIENTS WITH PRADER-WILLI SYNDROME

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Mercoledì, Aprile 3, 2024

ODD, Narcolepsy, Prader–Willi syndrome, TEMPO, Cataplexy, Patient, Ageing, EDS, Safety, Harmony, Plasma protein binding, FDA, PWS, Pitolisant, Pharmaceutical industry

Approximately 15,000 – 20,000 people in the U.S. are living with PWS, the majority experiencing behavioral symptoms and more than half with EDS.

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Approximately 15,000 – 20,000 people in the U.S. are living with PWS, the majority experiencing behavioral symptoms and more than half with EDS.
"Our progress in expanding the clinical applications of pitolisant in PWS and in other rare diseases, remains promising.
Pitolisant is marketed as WAKIX® in the U.S. and is FDA approved to treat EDS or cataplexy in adult patients with narcolepsy.
Pitolisant is not approved for use in patients with PWS and is currently being evaluated as an investigational agent in this patient population.

3M Settlement with Public Water Suppliers to Address PFAS in Drinking Water Receives Final Court Approval

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Lunedì, Aprile 1, 2024

Insurance, Risk, District court, Uncertainty, Drinking water, PFAS, PWS, Pharmaceutical industry

The now-finalized agreement will support PWS that detect PFAS at any level or may do so in the future and will benefit U.S.-based PWS that provide drinking water to Americans across the country.

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The now-finalized agreement will support PWS that detect PFAS at any level or may do so in the future and will benefit U.S.-based PWS that provide drinking water to Americans across the country.
The agreement received overwhelming support and participation from U.S. PWS, and the court resolved the small number of objections that were raised in favor of the settlement.
Payments under the agreement are scheduled to begin in the third quarter of 2024, provided there are no pending appeals of the final approval order.
The table below sets forth the expected pre-tax payments that 3M would make assuming the nominal $12.5B settlement cap is reached.

Soleno Therapeutics Provides Corporate Update and Reports Fourth Quarter and Full-Year 2023 Financial Results

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Mercoledì, Marzo 6, 2024

Therapy, Quarter, Research, FDA, Food, HQ, Sale, Prader–Willi syndrome, Exercise, PWS, Human resources, Patient, NDA, Pharmaceutical industry

REDWOOD CITY, Calif., March 06, 2024 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (Soleno) (NASDAQ: SLNO), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today provided a corporate update, and reported financial results for the fourth quarter and full-year ended December 31, 2023.

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REDWOOD CITY, Calif., March 06, 2024 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (Soleno) (NASDAQ: SLNO), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today provided a corporate update, and reported financial results for the fourth quarter and full-year ended December 31, 2023.
DCCR continued to be generally well-tolerated in the randomized withdrawal period with no new or unexpected safety signals.
“Following recent feedback from the FDA, Soleno remains focused on preparing an NDA submission for DCCR in PWS mid-2024,” said Anish Bhatnagar, M.D., Chief Executive Officer of Soleno Therapeutics.
Total other income (expense), net, was $2.6 million for the quarter ended December 31, 2023, and $0.1 million in the same period of 2022.

PRISM MarketView Highlights Work of Emerging Companies on Rare Disease Day

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Giovedì, Febbraio 29, 2024

All areas of medicine, and all organs and body systems, are impacted by rare diseases, including rare neurological and neuromuscular diseases, metabolic, skin and bone diseases, and chromosomal disorders.

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All areas of medicine, and all organs and body systems, are impacted by rare diseases, including rare neurological and neuromuscular diseases, metabolic, skin and bone diseases, and chromosomal disorders.
Today on Rare Disease Day, PRISM MarketView highlights emerging companies working to deliver life changing treatments for those living with rare diseases.
RDEB is a severe rare disease characterized by extremely fragile, and extensive blistering and wounds.
Capricor is a biotechnology company dedicated to advancing transformative cell and exosome-based therapeutics to redefine the treatment landscape for rare diseases.