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Rani Therapeutics Receives Feedback from Pre-IND Meeting with FDA; Provides Pipeline Update

Retrieved on: 
Thursday, January 5, 2023
Ustekinumab, PTH, Part, Food, Therapy, Drug discovery, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Osteoporosis, SAN, Initiation, Safety, Feedback, FDA, Biosimilar, IND, Psoriasis, Ulcerative colitis, Pharmaceutical industry

SAN JOSE, Calif., Jan. 05, 2023 (GLOBE NEWSWIRE) -- Rani Therapeutics Holdings, Inc. (“Rani Therapeutics” or “Rani”) (Nasdaq: RANI), a clinical-stage biotherapeutics company focused on the oral delivery of biologics and drugs, today announced that it completed a pre-Investigational New Drug (IND) meeting with the U.S. Food and Drug Administration (“FDA”) with respect to RT-102, the RaniPill™ GO containing a proprietary formulation of human parathyroid hormone (1-34) analog (PTH) for the potential treatment of osteoporosis, and provided a corporate update.

Key Points: 
  • Preliminary feedback received from the FDA on future development of RT-102.
  • Following feedback from a pre-IND meeting with the FDA, Rani believes that a 505(b)(2) pathway is suitable for the development of RT-102 in the U.S.
  • In December 2022, Rani announced positive topline results from Part 2 (repeat-dose portion) of the Phase 1 study of RT-102.
  • Rani Therapeutics is a clinical-stage biotherapeutics company focused on advancing technologies to enable the development of orally administered biologics and drugs.

NXP’s New i.MX 95 Family of Applications Processors Delivers Safe, Secure and Scalable AI-enabled Edge Platforms

Retrieved on: 
Sunday, January 22, 2023
Neutron, Cortex, NXP Semiconductors, Acceleration, Ecosystem, Software, ISO, Part, SOC, Bluetooth Low Energy, Original equipment manufacturer, USB, Ethernet, CES, LPDDR4X, Security, LAS, HMI, OTA, Rest, PCI Express, NXP, Family, Secure, AI, Wi-Fi, Safety, NXPI, Machine learning, Arm, NPU, LPDDR5, Radio, ISP, TSN, Human, HDR, IOT, MX, Robotics, Environment, Semiconductor, CPU, Video game console, Mobile phone

Additionally, the i.MX 95 family delivers high performance safety and security features, developed in compliance with automotive ASIL-B and industrial SIL-2 functional safety standards and including an integrated EdgeLock® secure enclave.

Key Points: 
  • Additionally, the i.MX 95 family delivers high performance safety and security features, developed in compliance with automotive ASIL-B and industrial SIL-2 functional safety standards and including an integrated EdgeLock® secure enclave.
  • The i.MX 95 family is the first i.MX applications processor family to integrate NXP’s eIQ Neutron neural processing unit (NPU) and a new image signal processor (ISP) developed by NXP to help developers to build these powerful, next-generation edge platforms.
  • The i.MX 95 family integrates a secure enclave to simplify implementation of security critical functions like secure boot, cryptography, trust provisioning, and run-time attestation.
  • The i.MX 95 applications processors are expected to begin sampling for lead customers in 2H 2023.

Inventiva announces changes to the clinical development of lanifibranor, including plans for a new Phase III trial in patients with NASH and compensated cirrhosis

Retrieved on: 
Wednesday, January 4, 2023
Fibrosis, Virginia Commonwealth University, Part, Cirrhosis, Fatty liver disease, Food, Part Two, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, F3, Euronext Paris, Histology, NASH, NDA, Risk, Thought, F2, Disease, Patient, Mortality, Liver disease, FDA, Mucopolysaccharidosis, Enrollment, Phase, Scan (company), Fast Track, Part 1, Caregiver, Pharmaceutical industry, EU

Inventiva’s request for a consultation with the FDA followed a public communication by the FDA1 suggesting that an alternative approach to seek full approval in patients with NASH could be considered upon submission of positive results of a Phase III trial using a histology surrogate endpoint in patients with NASH and a Phase III clinical outcome trial in patients with NASH and compensated cirrhosis.

Key Points: 
  • Inventiva’s request for a consultation with the FDA followed a public communication by the FDA1 suggesting that an alternative approach to seek full approval in patients with NASH could be considered upon submission of positive results of a Phase III trial using a histology surrogate endpoint in patients with NASH and a Phase III clinical outcome trial in patients with NASH and compensated cirrhosis.
  • A placebo-controlled exploratory cohort is anticipated to be added in parallel to Part 1 of the NATiV3 trial and will include approximately 200 patients with NASH and fibrosis who are not eligible for Part 1 (screen failures).
  • The Phase III outcome trial is expected to randomize approximately 800 patients with NASH and compensated cirrhosis.
  • Michael Cooreman, M.D., Chief Medical Officer of Inventiva, commented: “This is a promising evolution for our lanifibranor clinical development program.

atai Life Sciences Announces Results from the Kures Therapeutics Phase 1 Trial of KUR-101

Retrieved on: 
Friday, December 23, 2022
Hypoventilation, Part, Pharmacokinetics, Respiratory rate, Research, MOR, Oxycodone, CPT, Entrepreneurship, Safety, Kurash, Respiration, Pharmaceutical industry

NEW YORK and BERLIN, Dec. 23, 2022 (GLOBE NEWSWIRE) -- atai Life Sciences N.V. (Nasdaq: ATAI) (“atai” or “the Company”), a clinical stage biopharmaceutical company aiming to transform the treatment of mental health disorders, today announced additional clinical data from the Kures Therapeutics Phase 1 trial of KUR-101 in healthy volunteers. This two-part trial was designed to assess the safety, tolerability, pharmacokinetics, and analgesic activity of KUR-101.

Key Points: 
  • This two-part trial was designed to assess the safety, tolerability, pharmacokinetics, and analgesic activity of KUR-101.
  • Analgesic activity was assessed by the cold pressor test (CPT) and impact on respiration was evaluated by measuring respiration rate at multiple time points.
  • Part 2 consisted of a randomized, double-blind, crossover study to evaluate the safety and analgesic activity of KUR-101 compared to both oxycodone and placebo.
  • Further, both KUR-101 and oxycodone demonstrated effects on respiration comparable to placebo, thus precluding definitive conclusions of KUR-101’s respiratory impact.

Brunswick Exploration Closes Financings for Gross Proceeds of C$5.5 Million

Retrieved on: 
Thursday, December 22, 2022
Cloud, The Company, Private, Income Tax Act, Part, NI, BRW, Section 50C of the Isle of Man Income Tax Act 1970, Broker-dealer, Oil Taxation Act 1975, Mining, Minority, Warrant, Private placement, Initial public offering, Indian stock exchange, Exercise, National instrument, Agent, Prospectus, Offerings, Wainwright Securities Inc. v. Wall Street Transcript Corp., Sale, Security (finance), Real estate, Financial adviser, Regulation

MONTREAL, Dec. 22, 2022 (GLOBE NEWSWIRE) -- Brunswick Exploration Inc. (“BRW” or the "Company") is pleased to announce the closing of its previously announced private placements for aggregate gross proceeds of C$5,500,240.

Key Points: 
  • MONTREAL, Dec. 22, 2022 (GLOBE NEWSWIRE) -- Brunswick Exploration Inc. (“BRW” or the "Company") is pleased to announce the closing of its previously announced private placements for aggregate gross proceeds of C$5,500,240.
  • Mr. Killian Charles, President of BRW, commented: “With the closing of this financing, we are now fully financed to launch one of the largest grassroot lithium exploration programs globally.
  • The Company intends to use the proceeds raised from the Offerings for exploration of the Company’s projects in Quebec and Canada.
  • This press release does not constitute an offer to sell or a solicitation to buy any securities in any jurisdiction.

CubCrafters Acquires Summit Aircraft Skis

Retrieved on: 
Wednesday, December 21, 2022
Aircraft, Carbon, Cub Crafters, Part, Trinidad and Tobago Securities and Exchange Commission, Regulation A, Bangladesh Securities and Exchange Commission, Summit, Security (finance), Acquisition, Growth, Family, Experiment, Regulation, Intellectual property, Super Cub, Summit Ski Area, CubCrafters Carbon Cub EX, Airline, Transport

YAKIMA, Wash., Dec. 21, 2022 (GLOBE NEWSWIRE) -- via InvestorWire – CubCrafters, the leading designer and manufacturer of Part 23 Certified, Light-Sport, and Experimental backcountry aircraft, announced today the acquisition of Summit Aircraft Skis, including the company's design and manufacturing assets, unique patents and related intellectual property, from the Summit Aircraft Corporation of Sandpoint, Idaho.

Key Points: 
  • YAKIMA, Wash., Dec. 21, 2022 (GLOBE NEWSWIRE) -- via InvestorWire – CubCrafters, the leading designer and manufacturer of Part 23 Certified, Light-Sport, and Experimental backcountry aircraft, announced today the acquisition of Summit Aircraft Skis, including the company's design and manufacturing assets, unique patents and related intellectual property, from the Summit Aircraft Corporation of Sandpoint, Idaho.
  • Summit Aircraft Skis are favored by Carbon Cub aircraft owners and preferred by the owners of many other types of non-CubCrafters manufactured backcountry capable aircraft.
  • Adding Summit Skis to the CubCrafters product lineup allows us to better meet our customers’ needs and adds a new profit center.
  • Manufacturing of skis has already begun in Yakima and going forward Summit Skis will continue to be available on both CubCrafters aircraft and competing aircraft from other manufacturers as well.

Summa Silver Announces $10 Million Brokered Financing

Retrieved on: 
Monday, December 19, 2022
Part, Person, NI, TSX Venture Exchange, News, Unit, Indian stock exchange, Regulation, National instrument, Offering, Agent, NOT, FOR, Sale, Security (finance)

VANCOUVER, British Columbia, Dec. 19, 2022 (GLOBE NEWSWIRE) -- Summa Silver Corp. (“Summa” or the “Company”) (TSXV:SSVR) (OTCQB: SSVRF) (Frankfurt:48X) is pleased to announce that it has entered into an agreement with Research Capital Corporation and Eventus Capital Corp., as co-lead agents and joint bookrunners, on behalf of a syndicate of agents (collectively, the "Agents") in connection with a brokered private placement financing (the "Offering") of up to 12,500,000 units (each, a “Unit”) at a price of $0.80 per Unit, for aggregate gross proceeds of up to $10 million.

Key Points: 
  • Galen McNamara, CEO of the Company, stated: “I would like to thank our shareholders and welcome new shareholders for their support and endorsement of the Company.
  • In less than three years since inception, we have come a long way on both of our landmark American high-grade silver projects.
  • The Offering is anticipated to close on or about December 29, 2022, or such later date as the Company may determine.
  • The Company has agreed to pay to the Agents a cash commission equal to 6% of the gross proceeds of the Offering.

XORTX Announces Completion of Dosing in XRX-OXY-101 Clinical Study

Retrieved on: 
Monday, December 19, 2022
Clinical, Autosome, Part, ADPKD, Pharmacokinetics, Therapy, Polycystic kidney disease, Kidney disease, Control, FDA, XRX, 2013 Bendigo Women's International (2) – Singles, Marketing, Regulation, Pharmaceutical industry, Chemistry, EU

CALGARY, Alberta, Dec. 19, 2022 (GLOBE NEWSWIRE) -- XORTX Therapeutics Inc. ("XORTX" or the “Company”) (NASDAQ: XRTX | TSXV: XRTX | Frankfurt: ANU), a late stage clinical pharmaceutical company focused on developing innovative therapies to treat progressive kidney disease, is pleased to announce the completion of dosing in the XRX-OXY-101 pharmacokinetics bridging study (the “Study”).

Key Points: 
  • CALGARY, Alberta, Dec. 19, 2022 (GLOBE NEWSWIRE) -- XORTX Therapeutics Inc. ("XORTX" or the “Company”) (NASDAQ: XRTX | TSXV: XRTX | Frankfurt: ANU), a late stage clinical pharmaceutical company focused on developing innovative therapies to treat progressive kidney disease, is pleased to announce the completion of dosing in the XRX-OXY-101 pharmacokinetics bridging study (the “Study”).
  • Previously topline results from Part 1 and 2 have been reported in the Company’s press releases of July 13 and August 22, 2022.
  • Plasma sample analysis and topline results from both part 3 and part 4 are expected within the next several weeks.
  • Consolidated topline results from each part are anticipated to be reported in January 2023.

MAIA Biotechnology to Participate in Four Upcoming Investor Conferences

Retrieved on: 
Thursday, January 5, 2023
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, JPM, Part, Baozou Big News Events, News, Biotechnology, Patient, Innovation, BIO, NYSE, Safety, Conference, NSCLC, MAIA, Pharmaceutical industry, Nightclub

MAIA Biotechnology, Inc. (NYSE American: MAIA ) (“MAIA,” “the Company”) announced today that the management team will participate in the four upcoming investor conferences as follows:

Key Points: 
  • MAIA Biotechnology, Inc. (NYSE American: MAIA ) (“MAIA,” “the Company”) announced today that the management team will participate in the four upcoming investor conferences as follows:
    Biotech Showcase: The Investor Conference for Innovators will be held in-person in San Francisco from January 9-11, and virtually from January 18-19.
  • The MAIA team will host investor meetings and is scheduled to present on Monday, January 9 at 4:00 pm PT.
  • The MAIA team will conduct investor meetings at this event.
  • BIO CEO & Investor Conference will be held in-person in New York City from February 6-7 and virtually from February 8-9.

Nostromo Energy Reaches Key Application Milestone for $189 Million Loan Guarantee from the U.S. Department of Energy to Deploy 275 MWh of Distributed Energy Storage Systems

Retrieved on: 
Wednesday, January 4, 2023
Building Systems, Semiconductor, Commercial Building & Real Estate, White House, Federal Government, Alternative Energy, Construction & Property, Energy, Sustainability, Alternative Vehicles, Fuels, Technology, EV, Electric Vehicles, Environmental Policy, Environment, Public Policy, Government, Automotive, Utilities, U.S. Department of Energy, Office of Inspector General, Part, DOE, C&I, EV, LPO, Multimedia, Energy, Electricity, Weather, Title, Carbon, GHG, Renewable energy

The proposed $189 million loan guarantee from the DOE would support Nostromo’s “energy storage-as-a-service” (ESaaS) offering, designed to accelerate the deployment of its large-scale, behind-the-meter, modular and highly-efficient cold energy storage technology.

Key Points: 
  • The proposed $189 million loan guarantee from the DOE would support Nostromo’s “energy storage-as-a-service” (ESaaS) offering, designed to accelerate the deployment of its large-scale, behind-the-meter, modular and highly-efficient cold energy storage technology.
  • The loan guarantee is subject to completion of an equity capital raise for an amount yet to be determined.
  • Concurrently, Nostromo appointed investment bank Independence Point Securities as an exclusive advisor for raising the equity capital for the project.
  • To date, LPO’s Title XVII Innovative Clean Energy Loan Guarantee Program has provided more than $35 billion in loan guarantees to a variety of energy projects.