Monthly Archives: May 2024

Has the potential to Enhance the visibility of Scilex’s Non-Opioid Pain Management Therapeutics In Global Financial Markets Has the potential to Enhance the visibility of Scilex’s Non-Opioid Pain Management Therapeutics In Global Financial Markets

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Scilex Holding Company Announces it has been Added to the MSCI Global Microcap Index

WALTHAM, Mass., May 24, 2024 (GLOBE NEWSWIRE) -- Sobi North America, the North American affiliate of Swedish Orphan Biovitrum AB (Sobi®), today announced that the US Food and Drug Administration (FDA) has granted Fast Track designation to emapalumab-lzsg being investigated as a potential therapeutic option in patients with Macrophage Activation Syndrome (MAS). Emapalumab is a fully human, anti-IFN? monoclonal antibody that binds free and receptor-bound IFN?, neutralizing its biological activity. Emapalumab is currently in Phase lll development for MAS.

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Sobi Receives US FDA Fast Track Designation for Emapalumab-lzsg being investigated in Macrophage Activation Syndrome

SAN CARLOS, Calif., May 24, 2024 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, today announced that senior leadership plans to present at the following conferences and events:

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Iovance Biotherapeutics to Present at Upcoming Conferences and Events

ROCKVILLE, Md., May 24, 2024 (GLOBE NEWSWIRE) -- OpGen, Inc. (Nasdaq: OPGN, “OpGen” or “the Company”) announced today that it received a notice from The Nasdaq Stock Market LLC (“Nasdaq”) indicating that the Company was not in compliance with Nasdaq Listing Rule 5250(c)(1) due to the Company not filing its Quarterly Report on Form 10-Q for the period ended March 31, 2024 (the “Form 10-Q”), which serves as an additional basis for delisting the Company’s securities from Nasdaq, and that the Nasdaq Hearings Panel will consider this matter in connection with the continued listing of the Company’s securities on Nasdaq. Nasdaq Listing Rule 5250(c)(1) requires listed companies to timely file all periodic reports with the Securities and Exchange Commission (the “SEC”).

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OpGen Receives Expected Nasdaq Notice Regarding Delayed Form 10-Q

WALTHAM, Mass., May 24, 2024 (GLOBE NEWSWIRE) -- Sobi North America, the North American affiliate of Swedish Orphan Biovitrum AB (Sobi®), today announced the presentation of three abstracts that highlights data from its myelofibrosis treatment option at the American Society of Clinical Oncology (ASCO) Annual Meeting taking place in Chicago from May 31 – June 4, 2024.

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Sobi to present new myelofibrosis data at the ASCO 2024 Annual Meeting

All monetary figures listed in Canadian Dollars.

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Rakovina Therapeutics Announces Debentureholder Election to Receive Shares in Partial Satisfaction of Debenture Interest Payment Obligations

FLORHAM PARK, N.J., May 24, 2024 (GLOBE NEWSWIRE) -- Celularity Inc. (Nasdaq: CELU) (the “Company”), a regenerative medicine company developing placental-derived allogeneic cell therapies and advanced biomaterial products, announced today that on May 21, 2024, the Company received notification from the Listing Qualifications department of the Nasdaq Stock Market LLC (“Nasdaq”) stating that because the Company has not yet filed its Form 10-Q for the quarter ended March 31, 2024 (“Q1 2024 Form 10-Q”), and because the Company remains delinquent in filing its Annual Report on Form 10-K for the year ended December 31, 2023 (“2023 Form 10-K”), does not comply with the Nasdaq continued listing requirements which require listed companies to timely file all required periodic financial reports with the Securities and Exchange Commission. Nasdaq’s notice has no immediate effect on the listing of Celularity’s common stock and warrants, which continue to trade on the Nasdaq Capital Market under the symbols “CELU” and “CELUW”, respectively.

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Celularity Inc. Announces Receipt of Nasdaq Notice Regarding Late Form 10-Q Filing

Basel, May 25, 2024 – Novartis today presented results from the 6-month, double-blind period of the Phase III APPEAR-C3G study of Fabhalta® (iptacopan) at the late-breaking clinical trials session of the European Renal Association (ERA) Congress1. Patients treated with Fabhalta in addition to supportive care achieved a 35.1% (p=0.0014) reduction in proteinuria (as measured by 24-hour urine protein to creatinine ratio [UPCR]) at 6 months when compared to placebo on top of supportive care1. In many kidney diseases, proteinuria reduction is an increasingly recognized surrogate marker correlating with delaying progression to kidney failure14,15.

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Novartis presents latest Phase III Fabhalta® (iptacopan) data in C3 glomerulopathy (C3G) showing clinically meaningful and statistically...

Basel, May 25, 2024 – Novartis today presented results from a pre-specified interim analysis of the Phase III ALIGN study of atrasentan, an investigational oral selective endothelin A (ETA) receptor antagonist, in patients with IgA nephropathy (IgAN)1. Patients treated with atrasentan, in addition to supportive care (maximally tolerated and stable dose of a renin-angiotensin system [RAS] inhibitor), achieved a 36.1% (p<0.0001) reduction in proteinuria (as measured by 24-hour urine protein to creatinine ratio [UPCR]) at 36 weeks when compared to placebo on top of supportive care1. The results were presented during a late-breaking clinical trials session at the European Renal Association (ERA) Congress1. The study also showed atrasentan has a favorable safety profile consistent with previously reported data1,9.

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Novartis atrasentan Phase III data show clinically meaningful proteinuria reduction further advancing company's IgA nephropathy (IgAN) portfolio

Basel, 27 May 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that James Sabry (1958), Head of Roche Pharma Partnering, will be retiring after fourteen years with the company.

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Changes to the Roche Enlarged Corporate Executive Committee