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BRISBANE, Calif.--(BUSINESS WIRE)-- Aimmune Therapeutics, Inc. (Nasdaq: AIMT), a biopharmaceutical company developing and commercializing treatments for potentially life-threatening food allergies, today announced that the first patients in the United States are being treated with PALFORZIA™ [Peanut (Arachis hypogaea) Allergen Powder-dnfp], the first approved treatment for peanut allergy. Following the release of the medication lots by the U.S. Food and Drug Administration (FDA), specialty pharmacies are shipping PALFORZIA initial dosing kits to allergists for in-office administration to their peanut-allergic patients aged 4 through 17 years with a confirmed diagnosis of peanut allergy. “We are pleased that peanut-allergic children are being treated with PALFORZIA just six weeks after its FDA approval. Our anticipation of and preparedness for the REMS program allowed for a swift and smooth implementation of those requirements. In addition, our U.S.-based supply chain remains fully operational and commercial supply is available,” said Jayson Dallas, M.D., President and CEO of Aimmune. “Since our REMS website went live on February 21, well over 600 allergists are certified and ready to prescribe PALFORZIA to their patients. Our field team is continuing to meet with allergists to provide direction and information on the REMS process to help additional physicians and practices become certified and provide training on how to safely incorporate PALFORZIA into their practices.”

— Additional Data Highlight PALISADE Study Patient Baseline Characteristics and Associated Treatment Response — and Improvements in Self-Reported Quality of Life Following Long-Term Treatment with PALFORZIA

— Survey Results Reinforce Immunotherapy Practice Patterns for Food Allergy in Real-World Setting and Daily Impact of Peanut Allergy on Quality of Life Among Patients and Caregivers

BRISBANE, Calif.--(BUSINESS WIRE)-- Aimmune Therapeutics, Inc. (Nasdaq: AIMT), a biopharmaceutical company developing and bringing new treatments to people with potentially life-threatening food allergies, today announced new data from the clinical development program for PALFORZIA™ [Peanut (Arachis hypogaea) Allergen Powder-dnfp], the first peanut allergy treatment approved by the U.S. Food and Drug Administration (FDA). An analysis from ARC004, the open-label follow-on trial to the 52-week PALISADE trial, showed that patients tolerated more peanut protein, experienced fewer adverse events and continued immunomodulation – changes in the body's immune system – as evidenced by reductions in peanut-specific immunoglobulin (IgE) blood levels after an additional 56 weeks of daily treatment with PALFORZIA.

AVR-RD-04 is the third AVROBIO investigational gene therapy to receive orphan status

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- AVROBIO, Inc. (Nasdaq: AVRO), a leading clinical-stage gene therapy company with a mission to free people from a lifetime of genetic disease, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to the company’s investigational gene therapy, AVR-RD-04, for the treatment of cystinosis. The gene therapy consists of the patient’s own hematopoietic stem cells, which are genetically modified to express cystinosin, the protein that is functionally deficient in people with cystinosis. A Phase 1/2 clinical trial to evaluate the safety and efficacy of the investigational gene therapy in patients with cystinosis is ongoing, sponsored by AVROBIO’s academic collaborator at the University of California, San Diego (UCSD).

FREMONT, Calif., March 04, 2020 (GLOBE NEWSWIRE) -- Zosano Pharma Corporation (Nasdaq: ZSAN), a biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) for Qtrypta™ for filing and substantive review.

The Prescription Drug User Fee Act goal date for the completion of the FDA’s review of Qtrypta™ is set for October 20, 2020. This date reflects a standard 10-month review period and is consistent with the review timeline for a 505(b)(2) NDA submission.

Taiho’s in-licensing facilitates global development and commercialization of zimberelimab as a monotherapy and as a combination backbone for Arcus’s and Taiho’s oncology portfolios

Zimberelimab exhibits clinical activity and a safety profile consistent with those of currently approved anti-PD-1 therapies

Broad development program delivering randomized data in 2020 for zimberelimab in multiple novel combinations, including with AB154, Arcus’s anti-TIGIT antibody, and with AB928, the first and only dual A_2a/A_2b adenosine receptor antagonist in the clinic

HAYWARD, Calif.--(BUSINESS WIRE)-- Arcus Biosciences, Inc. (NYSE:RCUS), an oncology-focused biopharmaceutical company working to create best-in-class cancer therapies, and Taiho Pharmaceutical Co. Ltd., (“Taiho”), today announced Taiho’s exercise of its option to exclusively license zimberelimab, an anti-PD-1 monoclonal antibody, from Arcus Biosciences for commercialization in Japan and certain other territories in Asia (excluding China). This is Taiho’s second exercise of an Arcus program and follows their 2018 decision to license AB928, the first and only dual A_2a/A_2b adenosine receptor antagonist in the clinic.

– Proceeds to advance development of Tildacerfont in Congenital Adrenal Hyperplasia and other indications – Existing Investors Novo Holdings and RiverVest Venture Partners support the deal with new Investors HealthCap, Rock Springs Capital, Aisling Capital, Surveyor Capital (a Citadel company) and Sands Capital joining the syndicate San Francisco, California — February 19, 2020 – Spruce Biosciences today announced it has raised $88 million in Series B financing co-led by Omega Funds and Abingworth and supported by existing investors Novo Holdings and RiverVest Venture Partners, as well as new investors HealthCap, Rock Springs Capital, Surveyor Capital (a Citadel company), Aisling Capital and Sands Capital. Spruce is a clinical stage biopharmaceutical company developing therapeutics for rare endocrine diseases. The proceeds will be used to further fund the clinical development of the company’s lead product, tildacerfont, in classic congenital adrenal hyperplasia (CAH) and other conditions. Tildacerfont, a second generation CRF-1 receptor antagonist, is the first non-steroidal molecule to demonstrate an ability to normalize elevated androgens in patients with CAH in clinical studies. With the closing of the financing, Spruce will evaluate the ability of tildacerfont to reduce glucocorticoid (GC) steroid usage and improve clinical outcomes in a late-stage clinical program in adults with CAH. In addition, the company plans to complete proof-of-concept trials in the pediatric population.

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Feb. 10, 2020-- AVROBIO, Inc. (NASDAQ: AVRO), a leading clinical-stage gene therapy company with a mission to free people from a lifetime of genetic disease, today announced new initial data from the first patient dosed in the investigational gene therapy program for cystinosis, showing improvements in early measures at three months compared to baseline. The company also unveiled new clinical data showcasing a sustained biomarker response in patients for up to 32 months after receiving the company’s investigational gene therapy for Fabry disease across metrics including vector copy number (VCN), substrate levels and enzyme activity. Additionally, the company reported on the clinical debut of its plato^TM gene therapy platform. These data showed improved enzyme activity, transduction efficiency and VCN in drug product manufactured using plato compared with drug product produced using the academic platform, as well as higher in vivo enzyme activity at one month in the first patient treated with plato, as compared to other patients treated using the academic platform. All these data will be presented today, during the 16^th Annual WORLDSymposium^TM in Orlando, Fla.

Early data trends from first patient dosed in the AVR-RD-04 investigational gene therapy program for cystinosis show improvements across multiple measures

Data from the Phase 1 and Phase 2 trials of AVR-RD-01 support potential long-term engraftment and durable, endogenous production of functional enzyme in patients with Fabry disease

First Phase 2 Fabry patient treated using plato gene therapy platform shows plasma enzyme activity at one month 4.0 times higher than mean activity of other Phase 2 patients treated using academic platform at same timepoint

BRISBANE, Calif.--(BUSINESS WIRE)--Feb. 5, 2020-- Aimmune Therapeutics, Inc. (Nasdaq: AIMT), a biopharmaceutical company developing treatments for potentially life-threatening food allergies, today announced it has obtained an exclusive worldwide license to develop and commercialize the investigational humanized monoclonal antibody XmAb^®7195 from Xencor, Inc. XmAb7195, which has been renamed AIMab7195, was originally developed by Xencor for the treatment of allergic asthma. It uses three distinct mechanisms of action to reduce blood serum IgE and suppress IgE-producing cells. Aimmune initially plans to develop AIMab7195 as an adjunctive treatment with select Characterized Oral Desensitized ImmunoTherapy (CODIT™) programs, including PALFORZIA^™, to explore treatment outcomes in patients with food allergies.

BRISBANE, Calif.--(BUSINESS WIRE)--Jan. 31, 2020-- Aimmune Therapeutics, Inc. (Nasdaq: AIMT), a biopharmaceutical company developing and commercializing treatments for potentially life-threatening food allergies, today announced that the U.S. Food and Drug Administration (FDA) approved PALFORZIA™ [Peanut (Arachis hypogaea) Allergen Powder-dnfp]. PALFORZIA is the first approved treatment for patients with peanut allergy. It is an oral immunotherapy indicated for the mitigation of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut. PALFORZIA is approved for use in patients with a confirmed diagnosis of peanut allergy. Initial dose escalation may be administered to patients aged 4 through 17 years. Up-dosing and maintenance may be continued in patients 4 years of age and older. PALFORZIA is to be used in conjunction with a peanut-avoidant diet. PALFORZIA is not indicated for the emergency treatment of allergic reactions, including anaphylaxis.

- Offering led by premier life sciences investors including BVF, Boxer Capital and AI Life Sciences -- Shares offered at $8, a 20% premium to the January 30, 2020 market close -- Agreement with Hercules would provide Company with additional, non-dilutive capital to advance its innovative pipeline of cancer therapies -