News

Dec 3 2019

BridgeBio Pharma’s Origin Biosciences Initiates Rolling Submission Of New Drug Application With The U.S. FDA For BBP-870 For The Treatment Of MoCD Type A

Dec 3 2019

BOSTON, December 3, 2019 – BridgeBio Pharma, Inc. (Nasdaq: BBIO) subsidiary Origin Biosciences has initiated a rolling submission of a New Drug Application (NDA) with the United States Food and Drug Administration (FDA) for fosdenopterin (BBP-870/ORGN001) for the treatment of patients with molybdenum cofactor deficiency (MoCD) Type A.

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Dec 2 2019

PellePharm Completes Enrollment Of Pivotal Phase 3 Clinical Trial Of Patidegib Topical Gel In Patients With Gorlin Syndrome

Dec 2 2019

– Trial rapidly enrolled in 8 months

– Trial size expanded to accommodate 24 more patients than planned

SAN FRANCISCO – December 2, 2019 – PellePharm, Inc., a BridgeBio Pharma, Inc. (Nasdaq: BBIO) company, today announced the completion of enrollment for its pivotal Phase 3 clinical trial of Patidegib Topical Gel 2% vs. vehicle gel in patients with Gorlin Syndrome. PellePharm is a late clinical-stage biopharmaceutical company committed to targeting rare forms of basal cell carcinoma.

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Nov 16 2019

BridgeBio And Eidos Present Data From Phase 2 Open Label Extension Suggesting Long-Term Tolerability Of AG10 And Stabilization Of Transthyretin Amyloid Cardiomyopathy Disease Measures

Nov 16 2019

AG10 was Well Tolerated with Median 65 Weeks Follow-up since Phase 2 Initiation

Rates of All-Cause Mortality (Including Either Death or Cardiac Transplantation, 8.5%) and Cardiovascular Hospitalization (25.5%) Observed in Exploratory Analysis Were Lower than Rates Observed in Placebo-treated Participants in the ATTR-ACT Study

Near-complete Stabilization of TTR Maintained in Participants Throughout Duration of Study

Serum TTR levels, a Prognostic Indicator of Survival in ATTR-CM Patients, Were Elevated and Maintained in the Normal Range Throughout the Study Duration

Cardiac Biomarkers and Echocardiographic Parameters Were Stable Throughout Trial Duration

Presentation from AHA 2019 Scientific Sessions Available on Company Websites (eidostx.com and bridgebio.com) 

San Francisco, November 16, 2019 — BridgeBio Pharma, Inc. (BridgeBio) (Nasdaq:BBIO) and Eidos Therapeutics, Inc. (Eidos) (Nasdaq:EIDX), today presented positive data from the companies’ ongoing Open Label Extension (OLE) of the Phase 2 clinical trial studying AG10 in patients with symptomatic transthyretin (TTR) amyloidosis cardiomyopathy (ATTR-CM). ATTR-CM is a progressive and fatal disease that is an under recognized cause of heart failure. The data were presented in a late-breaking featured science oral presentation at the American Heart Association (AHA) Scientific Sessions in Philadelphia, Pennsylvania.

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Oct 24 2019

Aclaris Therapeutics’ A-101 45% Topical Solution Meets Primary and All Secondary Efficacy Endpoints in Second Successful Pivotal Phase 3 Clinical Trial for the Treatment of Common Warts (THWART-1)

Oct 24 2019

If approved, A-101 45% Topical Solution would be the first FDA-approved prescription treatment for common warts

  • Highly statistically significant results for the primary efficacy endpoint
  • Highly statistically significant results for all secondary efficacy endpoints
  • Management to host conference call at 4:30 PM ET today

WAYNE, Pa., Oct. 24, 2019 (GLOBE NEWSWIRE) — Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a physician-led biopharmaceutical company focused on immuno-inflammatory diseases, today announced positive results from its second Phase 3 clinical trial, THWART-1 (WART-301), of A-101 45% Topical Solution (A-101 45%), an investigational new drug, for the potential treatment of common warts (verruca vulgaris). A-101 45% met the primary and all secondary efficacy endpoints, achieving clinically meaningful and statistically significant clearance of common warts. A-101 45% is a proprietary high-concentration hydrogen peroxide topical solution being developed as a potential prescription treatment for common warts.

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Oct 22 2019

ADMA Biologics Named Company of the Year by BioFlorida

Oct 22 2019

RAMSEY, N.J. and BOCA RATON, Fla., Oct. 22, 2019 (GLOBE NEWSWIRE) — ADMA Biologics, Inc. (NASDAQ: ADMA) (“ADMA” or the “Company”), a commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics for the treatment of immunodeficient patients at risk for infection and the prevention of certain infectious diseases, today announced that it has been named Company of the Year by BioFlorida, in recognition of ADMA’s significant achievements over the past year.

“We are honored to receive this award from BioFlorida and to be recognized for the recent achievements at our Boca Raton, Florida biologics manufacturing and laboratory campus,” stated Adam Grossman, President and Chief Executive Officer. “Over the past year, we were granted two U.S. Food and Drug Administration (“FDA”) biologic product approvals for ASCENIV™ and BIVIGAM®, improved our current good manufacturing practice (“cGMP”) compliance classification with FDA, and secured funding that will support our ongoing commercial product launches and operations. We are extremely proud of these accomplishments and attribute our success to our passionate and dedicated team who worked so hard to revitalize our biologics manufacturing business. We look forward to continuing to contribute to the growing pharma and biotech community in Florida and to continue to expand our operations and grow our workforce to support the increasing demand of our therapeutic products.”

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Oct 21 2019

ADMA Biologics Announces First Commercial Sales of ASCENIV

Oct 21 2019

RAMSEY, N.J. and BOCA RATON, Fla., Oct. 21, 2019 (GLOBE NEWSWIRE) — ADMA Biologics, Inc. (NASDAQ: ADMA) (“ADMA” or the “Company”), a commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics for the treatment of immunodeficient patients at risk for infection and the prevention of certain infectious diseases, today announced the first commercial sales of ASCENIV (formerly known as RI-002).  ASCENIV received approval from the U.S. Food and Drug Administration (“FDA”) on April 1, 2019.

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Oct 10 2019

Aclaris Therapeutics Announces Divestiture of RHOFADE®

Oct 10 2019

WAYNE, Pa., Oct. 10, 2019 (GLOBE NEWSWIRE) — Aclaris Therapeutics, Inc. (Nasdaq: ACRS), a physician-led biopharmaceutical company focused on immuno-inflammatory diseases, today announced it has divested RHOFADE® (oxymetazoline hydrochloride) cream, 1% (RHOFADE) and related intellectual property assets to EPI Health, LLC (EPI Health). The divestiture of RHOFADE is a key component of Aclaris’ recently announced strategic plan to refocus resources on the development of its immuno-inflammatory development programs.

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Oct 9 2019

Zosano Pharma Announces CEO Transition

Oct 9 2019

FREMONT, Calif., Oct. 08, 2019 (GLOBE NEWSWIRE) — Zosano Pharma Corporation (NASDAQ:ZSAN), a clinical-stage biopharmaceutical company, today announced that Steven Lo, veteran biotechnology and pharmaceutical executive, will become president and chief executive officer of Zosano effective October 21, 2019. He will also serve on the company’s board of directors. Upon retiring after 48 years in the healthcare industry, John Walker will continue as the chairman of the company’s board of directors.

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Oct 8 2019

AVROBIO Announces First Patient Dosed in Phase 1/2 Trial of Gene Therapy for Cystinosis

Oct 8 2019

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Oct. 8, 2019– AVROBIO, Inc. (NASDAQ: AVRO) (the “Company”) today announced that the first patient has been dosed in the Company’s AVR-RD-04 investigational gene therapy program for cystinosis, a devastating lysosomal storage disease, in an ongoing Phase 1/2 clinical trial sponsored by academic collaborators at the University of California San Diego. The gene therapy is derived from the patient’s own hematopoietic stem cells, which are genetically modified to produce functional cystinosin, a crucial protein that patients with cystinosis lack.

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Oct 7 2019

ADMA Biologics Announces Data Presented At IDWeek 2019

Oct 7 2019

RAMSEY, N.J. and BOCA RATON, Fla., Oct. 07, 2019 (GLOBE NEWSWIRE) — ADMA Biologics, Inc. (NASDAQ: ADMA) (“ADMA” or the “Company”), a vertically integrated commercial biopharmaceutical and specialty immunoglobulin company that manufactures, markets and develops specialty plasma-derived biologics for the treatment of immune deficiencies and the prevention of certain infectious diseases, announces that a poster presentation was given at IDWeek 2019, the combined annual meeting of IDSA, SHEA, HVMA and PIDS in Washington, D.C. The poster detailed data obtained from the compassionate use of ASCENIV™ (formerly referred to as RI-002) in the treatment of Respiratory Syncytial Virus (“RSV”) infection in two immunocompromised children.

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