Allogene Therapeutics Receives IND Clearance from the U.S. Food and Drug Administration for ALLO-715 in Combination with Nirogacestat in…

SOUTH SAN FRANCISCO, Calif., Dec. 23, 2020 (GLOBE NEWSWIRE) -- Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T™) therapies for cancer today announced that the U.S. Food & Drug Administration (FDA) has cleared an Investigational New Drug (IND) application to study ALLO-715, Allogene’s investigational BCMA AlloCAR T therapy, in combination with nirogacestat, SpringWorks Therapeutics’ investigational gamma secretase inhibitor (GSI), in patients with relapsed or refractory multiple myeloma. This combination is part of the company’s multi-pronged strategy to develop a treatment for multiple myeloma and will be deployed in the ongoing UNIVERSAL trial. Enrollment in this cohort is expected to begin in the first quarter of 2021.

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Allogene Therapeutics Receives IND Clearance from the U.S. Food and Drug Administration for ALLO-715 in Combination with Nirogacestat in...

Galapagos’ CEO makes donation of €10 million in the form of personal shares to African Parks

Mechelen, Belgium; 23 December 2020, 18.00 CET – Galapagos NV (Euronext & NASDAQ: GLPG) today announces that Onno van de Stolpe, CEO of Galapagos, has committed to make a personal €10 million donation to African Parks, a non-profit organization that serves at the front lines of wildlife conservation, ecosystem restoration, and community development. The €10 million donation will be in the form of ordinary shares of Galapagos, donated by Mr. van de Stolpe to African Parks and spread over the coming five years. The first €2 million (25,150 ordinary shares held by Mr. van de Stolpe) have been transferred on 22 December 2020.

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Galapagos’ CEO makes donation of €10 million in the form of personal shares to African Parks

Altimmune Provides an Update on its Investigational New Drug Application for a Phase 1 AdCOVID™ Clinical Trial

GAITHERSBURG, Md., Dec. 23, 2020 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has issued a clinical hold on the Company’s Investigational New Drug (IND) application for AdCOVID, a single-dose intranasal COVID-19 vaccine candidate. The Agency requested certain protocol modifications and the submission of additional Chemistry, Manufacturing and Controls (CMC) data. Altimmune has responded to the Agency’s clinical hold letter received on December 22, 2020 and, at this time, does not anticipate a significant impact on the overall clinical development timeline as the Company has agreed to each of the FDA’s requests.

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Altimmune Provides an Update on its Investigational New Drug Application for a Phase 1 AdCOVID™ Clinical Trial

Verrica Pharmaceuticals Announces Resubmission of New Drug Application for VP-102 for the Treatment of Molluscum Contagiosum

WEST CHESTER, Pa., Dec. 23, 2020 (GLOBE NEWSWIRE) -- Verrica Pharmaceuticals Inc. (“Verrica”) (Nasdaq: VRCA), a dermatology therapeutics company developing medications for skin diseases requiring medical interventions, today announced that it has resubmitted the New Drug Application (NDA) for VP-102 for the treatment of molluscum contagiosum (molluscum) to the U.S. Food and Drug Administration (FDA). The NDA for VP-102 was resubmitted based on the outcome and final minutes of a Type A meeting with the FDA, which was conducted to obtain clarity on the Complete Response Letter (CRL) issued by the FDA in July 2020.

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Verrica Pharmaceuticals Announces Resubmission of New Drug Application for VP-102 for the Treatment of Molluscum Contagiosum