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CG Oncology Reports First Quarter 2024 Financial Results and Provides Business Updates

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четверг, мая 9, 2024

Final Results from CORE-001 Phase 2 Clinical Trial of Cretostimogene in Combination with Pembrolizumab in BCG-Unresponsive HR-NMIBC to be presented at ASCO 2024.

Key Points: 
  • Final Results from CORE-001 Phase 2 Clinical Trial of Cretostimogene in Combination with Pembrolizumab in BCG-Unresponsive HR-NMIBC to be presented at ASCO 2024.
  • BOND-003 (BCG-Unresponsive, HR-NMIBC): Final results from the Phase 3 clinical trial of cretostimogene monotherapy by the end of 2024.
  • CORE-001 (BCG-Unresponsive, HR-NMIBC): Final results from the Phase 2 clinical trial of crestostimogene in combination with pembrolizumab in June 2024 at the 2024 ASCO Annual Meeting.
  • General and Administrative (G&A) Expenses: G&A expenses for the first quarter ended March 31, 2024 were $5.8 million compared with $2.1 million for the first quarter ended March 31, 2023.

Supernus Announces First Quarter 2024 Financial Results

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среда, мая 8, 2024

ROCKVILLE, Md., May 08, 2024 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced financial results for the first quarter of 2024 and associated Company developments.

Key Points: 
  • ROCKVILLE, Md., May 08, 2024 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced financial results for the first quarter of 2024 and associated Company developments.
  • "We are pleased to announce another strong quarter for Qelbree, which delivered robust growth of 75% in net sales compared to the same quarter in the prior year," said Jack Khattar, President and CEO of Supernus.
  • Total IQVIA prescriptions were 176,503 for first quarter 2024, an increase of 31% compared to the prior year period.
  • See “Non-GAAP Financial Information” section for information on non-GAAP financial measures.

BeiGene Reports First Quarter 2024 Financial Results and Business Updates

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среда, мая 8, 2024

Product Revenue for the three months ended March 31, 2024, was $747 million, compared to $410 million in the same period of 2023, representing an increase of 82%.

Key Points: 
  • Product Revenue for the three months ended March 31, 2024, was $747 million, compared to $410 million in the same period of 2023, representing an increase of 82%.
  • The increase in product revenue was attributable to increased sales of our internally developed products, BRUKINSA and tislelizumab.
  • Gross Margin as a percentage of global product revenue for the first quarter of 2024 was 83%, compared to 80% in the prior-year period.
  • The gross margin percentage increased primarily due to proportionally higher sales mix of global BRUKINSA compared to other products in the portfolio.

Glancy Prongay & Murray LLP, a Leading Securities Fraud Law Firm, Announces Investigation of Supernus Pharmaceuticals, Inc. (SUPN) on Behalf of Investors

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четверг, мая 2, 2024

Glancy Prongay & Murray LLP (“GPM”), a leading national shareholder rights law firm, today announced that it has commenced an investigation on behalf of Supernus Pharmaceuticals, Inc. (“Supernus” or the “Company”) (NASDAQ: SUPN ) investors concerning the Company’s possible violations of the federal securities laws.

Key Points: 
  • Glancy Prongay & Murray LLP (“GPM”), a leading national shareholder rights law firm, today announced that it has commenced an investigation on behalf of Supernus Pharmaceuticals, Inc. (“Supernus” or the “Company”) (NASDAQ: SUPN ) investors concerning the Company’s possible violations of the federal securities laws.
  • You can also contact Charles H. Linehan, of GPM at 310-201-9150, Toll-Free at 888-773-9224, or via email at [email protected] to learn more about your rights.
  • On this news, Supernus’s stock price fell $2.12, or 6.3%, to close at $31.43 per share on April 8, 2024, thereby injuring investors.
  • Whistleblower Notice: Persons with non-public information regarding Supernus should consider their options to aid the investigation or take advantage of the SEC Whistleblower Program.

Glancy Prongay & Murray LLP, a Leading Securities Fraud Law Firm, Announces Investigation of Abeona Therapeutics Inc. (ABEO) on Behalf of Investors

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четверг, мая 2, 2024

Glancy Prongay & Murray LLP (“GPM”), a leading national shareholder rights law firm, today announced that it has commenced an investigation on behalf of Abeona Therapeutics Inc. (“Abeona” or the “Company”) (NASDAQ: ABEO ) investors concerning the Company’s possible violations of the federal securities laws.

Key Points: 
  • Glancy Prongay & Murray LLP (“GPM”), a leading national shareholder rights law firm, today announced that it has commenced an investigation on behalf of Abeona Therapeutics Inc. (“Abeona” or the “Company”) (NASDAQ: ABEO ) investors concerning the Company’s possible violations of the federal securities laws.
  • If you suffered a loss on your Abeona investments or would like to inquire about potentially pursuing claims to recover your loss under the federal securities laws, you can submit your contact information at www.glancylaw.com/cases/Abeona-Therapeutics-Inc/ .
  • You can also contact Charles H. Linehan, of GPM at 310-201-9150, Toll-Free at 888-773-9224, or via email at [email protected] to learn more about your rights.
  • Whistleblower Notice: Persons with non-public information regarding Abeona should consider their options to aid the investigation or take advantage of the SEC Whistleblower Program.

SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims on Behalf of Investors of Supernus Pharmaceuticals, Inc. - SUPN

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четверг, мая 2, 2024

NEW YORK, May 02, 2024 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Supernus Pharmaceuticals, Inc. (“Supernus” or the “Company”) (NASDAQ: SUPN).

Key Points: 
  • NEW YORK, May 02, 2024 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Supernus Pharmaceuticals, Inc. (“Supernus” or the “Company”) (NASDAQ: SUPN).
  • The investigation concerns whether Supernus 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.

SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims on Behalf of Investors of Abeona Therapeutics Inc. - ABEO

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четверг, апреля 25, 2024

NEW YORK, April 25, 2024 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Abeona Therapeutics Inc. (“Abeona” or the “Company”) (NASDAQ: ABEO).

Key Points: 
  • NEW YORK, April 25, 2024 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Abeona Therapeutics Inc. (“Abeona” or the “Company”) (NASDAQ: ABEO).
  • The investigation concerns whether Abeona 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.

SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims on Behalf of Investors of Supernus Pharmaceuticals, Inc. - SUPN

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среда, апреля 24, 2024

NEW YORK, April 24, 2024 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Supernus Pharmaceuticals, Inc. (“Supernus” or the “Company”) (NASDAQ: SUPN).

Key Points: 
  • NEW YORK, April 24, 2024 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Supernus Pharmaceuticals, Inc. (“Supernus” or the “Company”) (NASDAQ: SUPN).
  • The investigation concerns whether Supernus 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.

SHAREHOLDER ALERT: Abeona Therapeutics Investigated by Block & Leviton For Potential Securities Law Violations; Investors Who Have Lost Money Are Encouraged to Contact the Firm

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вторник, апреля 23, 2024

BOSTON, April 23, 2024 (GLOBE NEWSWIRE) -- Block & Leviton is investigating Abeona Therapeutics, Inc. (NASDAQ: ABEO) for potential securities law violations.

Key Points: 
  • BOSTON, April 23, 2024 (GLOBE NEWSWIRE) -- Block & Leviton is investigating Abeona Therapeutics, Inc. (NASDAQ: ABEO) for potential securities law violations.
  • Investors who have lost money in their Abeona Therapeutics, Inc. investment should contact the firm to learn more about how they might recover those losses.
  • Block & Leviton is investigating whether the Company committed securities law violations and may file an action to attempt to recover losses on behalf of investors who have lost money.
  • If you've lost money on your investment, you should contact Block & Leviton to learn more via our case website , by email at [email protected] , or by phone at (617) 398-5600.

Abeona Therapeutics Provides Regulatory Update on Pz-cel

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понедельник, апреля 22, 2024

CLEVELAND, April 22, 2024 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced a regulatory update for prademagene zamikeracel (pz-cel). The U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) in response to the Company’s Biologics License Application (BLA) for pz-cel for the treatment of patients with recessive dystrophic epidermolysis bullosa (RDEB). The CRL follows the completion of Abeona’s Late Cycle Review Meeting with the FDA in March 2024. At the Late Cycle Review Meeting and in a subsequent information request, the FDA noted that certain additional information needed to satisfy Chemistry Manufacturing and Controls (CMC) requirements must be satisfactorily resolved before the application can be approved. In response, the Company submitted plans to the FDA with the commitment to provide CMC data prior to BLA approval, and full validation reports after approval in mid-2024. In addition, the Company discussed these plans with the FDA in a subsequent informal meeting. In the CRL, the FDA indicated that the proposed timing of the data submission by Abeona would not allow sufficient time for the FDA to complete its review by the May 25, 2024 PDUFA date.

Key Points: 
  • ET to provide details on the requested CMC information
    CLEVELAND, April 22, 2024 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced a regulatory update for prademagene zamikeracel (pz-cel).
  • The CRL follows the completion of Abeona’s Late Cycle Review Meeting with the FDA in March 2024.
  • Abeona believes that both studies demonstrate that a single application of pz-cel on large and chronic wounds will deliver sustained wound healing and pain reduction.
  • Abeona Therapeutics will host a conference call and webcast to provide details on the requested CMC information on Tuesday, April 23, 2024, at 8:30 a.m.