CMC

Outlook Therapeutics® Doses First Subject in NORSE EIGHT

Retrieved on: 
Wednesday, January 31, 2024

Outlook Therapeutics expects NORSE EIGHT topline results and resubmission of the ONS-5010 BLA by the end of calendar year 2024.

Key Points: 
  • Outlook Therapeutics expects NORSE EIGHT topline results and resubmission of the ONS-5010 BLA by the end of calendar year 2024.
  • The start of patient enrollment in NORSE EIGHT represents an important step toward potential FDA approval and launch of ONS-5010.
  • Earlier this month, Outlook Therapeutics announced that it received written agreement from the FDA under an SPA for NORSE EIGHT.
  • Outlook Therapeutics is working to address the open CMC items in the CRL and expects to resolve these comments prior to the expected completion of NORSE EIGHT.

Ashland reports financial results1 for first quarter fiscal 2024; issues outlook for second quarter and full-year fiscal 2024

Retrieved on: 
Tuesday, January 30, 2024

WILMINGTON, Del., Jan. 30, 2024 (GLOBE NEWSWIRE) -- Ashland Inc. (NYSE: ASH) today announced financial results1 for the first quarter of fiscal year 2024, which ended December 31, 2023, and issued its outlook for second quarter and full-year fiscal 2024. The global additives and specialty ingredients company holds leadership positions in high-quality, consumer-focused markets including pharmaceuticals, personal care and architectural coatings.

Key Points: 
  • Sales in the first quarter were $473 million, down 10 percent versus the prior-year quarter.
  • Ashland repurchased 1.2 million shares during the first quarter and now has $900 million remaining under the existing evergreen share repurchase authorization.
  • The first quarter of fiscal year 2024 cash flows provided by operating activities includes the favorable impact of the new Foreign Accounts Receivable Sales Program.
  • “Financial results in the December quarter yielded adjusted EBITDA above the outlook range we issued on November 8, 2023,” said Guillermo Novo, chair and chief executive officer, Ashland.

COMPANY STATEMENT OF ADVANCED MICRO-FABRICATION EQUIPMENT INC. CHINA

Retrieved on: 
Sunday, February 4, 2024

AMEC has always operated in a lawful and compliant manner and strictly complied with domestic and international laws and regulations relating to its business.

Key Points: 
  • AMEC has always operated in a lawful and compliant manner and strictly complied with domestic and international laws and regulations relating to its business.
  • At the same time, AMEC has no connection with the military and no military investment, nor does AMEC provide products and services for any military end-users.
  • The inclusion of AMEC in the CMC list by DOD is completely irrational, which is contrary to objective facts and lacks of evidence.
  • This time, AMEC will take effective measures to prove that AMEC is not a military-related company in order to protect the interests of AMEC, its partners and shareholders.

Gate.io Emerges as Dominant Player in Inscription Token Market, Averages 30% of Exchange Token Share

Retrieved on: 
Wednesday, January 31, 2024

PANAMA CITY, Jan. 31, 2024 /PRNewswire/ -- Gate.io, a leading cryptocurrency exchange and Web3 innovator, has established a dominant position in the Inscription token market.

Key Points: 
  • PANAMA CITY, Jan. 31, 2024 /PRNewswire/ -- Gate.io, a leading cryptocurrency exchange and Web3 innovator, has established a dominant position in the Inscription token market.
  • Gate.io has also exceeded 10% in exchange token share for 27 Inscription tokens and 30% for 14.
  • Moreover, the exchange held high positions in the CMC exchange volume ranking on 23 of 31 (74%) tokens it has listed.
  • The exchange has attributed its newfound Inscription market position to its comprehensive multi-chain and -protocol support for users and project creators in the Inscription ecosystem.

Gate.io Emerges as Dominant Player in Inscription Token Market, Averages 30% of Exchange Token Share

Retrieved on: 
Wednesday, January 31, 2024

PANAMA CITY, Jan. 31, 2024 /PRNewswire/ -- Gate.io, a leading cryptocurrency exchange and Web3 innovator, has established a dominant position in the Inscription token market.

Key Points: 
  • PANAMA CITY, Jan. 31, 2024 /PRNewswire/ -- Gate.io, a leading cryptocurrency exchange and Web3 innovator, has established a dominant position in the Inscription token market.
  • Gate.io has also exceeded 10% in exchange token share for 27 Inscription tokens and 30% for 14.
  • Moreover, the exchange held high positions in the CMC exchange volume ranking on 23 of 31 (74%) tokens it has listed.
  • The exchange has attributed its newfound Inscription market position to its comprehensive multi-chain and -protocol support for users and project creators in the Inscription ecosystem.

Cielo Announces Effective Date of Share Consolidation

Retrieved on: 
Friday, January 26, 2024

CALGARY, Alberta, Jan. 26, 2024 (GLOBE NEWSWIRE) -- Cielo Waste Solutions Corp. (TSXV:CMC; OTCQB:CWSFF) (“Cielo” or the “Company”), a waste-to-fuel environmental technology company, announces that, further to a news release dated January 16, 2024, the Company has received approval from the TSX Venture Exchange (the "Exchange") for its 1:15 share consolidation (the "Consolidation").

Key Points: 
  • CALGARY, Alberta, Jan. 26, 2024 (GLOBE NEWSWIRE) -- Cielo Waste Solutions Corp. (TSXV:CMC; OTCQB:CWSFF) (“Cielo” or the “Company”), a waste-to-fuel environmental technology company, announces that, further to a news release dated January 16, 2024, the Company has received approval from the TSX Venture Exchange (the "Exchange") for its 1:15 share consolidation (the "Consolidation").
  • The Consolidation will be effective at market open on January 29, 2024.
  • In the case of fractional shares resulting from the Consolidation, fractions of a share will be rounded down to the next whole share.
  • Common shares held in uncertificated form by non-registered shareholders will be converted through brokerage accounts at the consolidation ratio.

SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims on Behalf of Investors of Theratechnologies Inc. - THTX

Retrieved on: 
Friday, January 26, 2024

NEW YORK, Jan. 26, 2024 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Theratechnologies Inc. (“Theratechnologies” or the “Company”) (NASDAQ: THTX).

Key Points: 
  • NEW YORK, Jan. 26, 2024 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Theratechnologies Inc. (“Theratechnologies” or the “Company”) (NASDAQ: THTX).
  • The investigation concerns whether Theratechnologies and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.
  • Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions.
  • The Firm has recovered billions of dollars in damages awards on behalf of class members.

Theratechnologies Receives Complete Response Letter (CRL) from the FDA for the F8 Formulation of Tesamorelin sBLA

Retrieved on: 
Wednesday, January 24, 2024

The Company will address the FDA’s request and intends to pursue approval of this newer formulation of tesamorelin.

Key Points: 
  • The Company will address the FDA’s request and intends to pursue approval of this newer formulation of tesamorelin.
  • The questions outlined in the CRL are largely related to chemistry, manufacturing and controls (CMC) concerning the microbiology, assays, impurities and stability for both the lyophilized product and the final reconstituted drug product.
  • In addition, the FDA requested further information to understand the potential impact of the proposed formulation on immunogenicity risk.
  • “While we are disappointed to receive a Complete Response Letter from the FDA for the F8 formulation of tesamorelin containing questions that were not raised during the review process, we plan to address these new comments as swiftly as possible,” said Christian Marsolais, Ph.D., Senior Vice President and Chief Medical Officer at Theratechnologies.

Unicycive Therapeutics Issues Shareholder Letter to Highlight Corporate Progress and Key Upcoming Milestones

Retrieved on: 
Tuesday, January 23, 2024

LOS ALTOS, Calif., Jan. 23, 2024 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the “Company or “Unicycive”), today issued a letter to shareholders.

Key Points: 
  • As I sit down to write this letter, I am filled with a profound sense of gratitude and excitement, energized for the year ahead.
  • In this letter, I am pleased to recap for you another year of great accomplishments.
  • We’ve made significant advancements in our clinical programs which will propel us to new heights in 2024.
  • I would like to express my deep appreciation to the physician investigators, study participants, and especially to our dedicated Unicycive employees.

Cielo Provides Update on Purchase of Land in Dunmore

Retrieved on: 
Thursday, January 18, 2024

CALGARY, Alberta, Jan. 18, 2024 (GLOBE NEWSWIRE) -- Cielo Waste Solutions Corp. (TSXV:CMC; OTCQB:CWSFF) (“Cielo” or the “Company”), a waste-to-fuel environmental technology company, announces today that it has executed an amendment (the “Amendment”) to the agreement of purchase and sale (the “PSA”) with Renewable U Energy Inc. (“Renewable U”) regarding the purchase by Cielo of land in Dunmore, Alberta (the “Dunmore Land”) for the purposes of building a full-scale, waste-to-fuel facility (the “Dunmore Facility”).

Key Points: 
  • CALGARY, Alberta, Jan. 18, 2024 (GLOBE NEWSWIRE) -- Cielo Waste Solutions Corp. (TSXV:CMC; OTCQB:CWSFF) (“Cielo” or the “Company”), a waste-to-fuel environmental technology company, announces today that it has executed an amendment (the “Amendment”) to the agreement of purchase and sale (the “PSA”) with Renewable U Energy Inc. (“Renewable U”) regarding the purchase by Cielo of land in Dunmore, Alberta (the “Dunmore Land”) for the purposes of building a full-scale, waste-to-fuel facility (the “Dunmore Facility”).
  • On May 1st, 2023, Cielo announced its agreement with Renewable U to acquire the Dunmore Land, which provided for a condition deadline as well as a tentative closing date, both of which have been amended since the date of the initial agreement, as previously disclosed.
  • The Payment Shares, if approved and once issued, will be subject to a hold period of four months and one day from the date of issuance.
  • On January 16, 2024, the Company had announced that it is proceeding with a share consolidation (the “Consolidation”) on the basis of one pre-Consolidation common share of Cielo for every fifteen post-Consolidation common shares of Cielo, which should read “…one post-Consolidation common share of Cielo for every fifteen pre-Consolidation common shares of Cielo”.