News

Jun 14 2022

Dren Bio Announces $65 Million Series B Financing to Advance its Lead Asset into the Clinic and to Accelerate Development of New Product Candidates from its Targeted Myeloid Engager and Phagocytosis Platform

Jun 14 2022

– Momentum continues to build for Dren Bio after successfully forming highly experienced senior leadership team and earlier this year announcing research collaboration and license deal with Pfizer 

– The financing round was co-led by Aisling Capital and HBM Healthcare Investments with participation from new investors Pfizer, ArrowMark Partners and Revelation Partners, along with all current insiders

FOSTER CITY, CA – June 14, 2022 – Dren Bio, Inc. (“Dren Bio” or the “Company”) today announced the completion of their $65 million Series B financing, pushing the Company’s total capital received to date over $156 million. Following the financing, Dren Bio is well-capitalized to reach multiple key inflection points across both its drug discovery programs over the coming years.

“We are truly grateful for all the support we continue to receive from such an outstanding syndicate of investors,” said Nenad Tomasevic, Ph.D., Chief Executive Officer of Dren Bio. “This financing comes at the perfect time as we prepare to initiate the first clinical trial evaluating DR-01, our lead asset, in patients with Large Granular Lymphocytic leukemia or cytotoxic lymphomas in mid-2022. In addition to advancing DR-01, the proceeds from this latest round will also enable us to further expand the development of our internal pipeline using our proprietary Targeted Myeloid Engager and Phagocytosis Platform.”

The Series B financing was co-led by Aisling Capital and HBM Healthcare Investments, with participation by new marquee investors Pfizer, ArrowMark Partners and Revelation Partners. There was also significant participation in the round by Dren Bio’s existing insiders SR One, 8VC, Taiho Ventures, BVF PartneOKrs, Mission BioCapital and Alexandria Venture Investments, amongst others. In connection with the closing of the financing, the Company announced that Andrew Schiff, M.D., of Aisling Capital, and Chandra P. Leo, M.D., of HBM Partners, will join its Board of Directors.

“We were thoroughly impressed by Dren Bio’s diversified R&D portfolio that encompasses two distinct therapeutic antibody programs including their attractive proprietary platform,” said Dr. Schiff, Managing Partner at Aisling Capital. “We are excited by the opportunity to support Dren Bio in progressing on their mission to deliver revolutionary therapies to patients with severe unmet needs, starting with difficult-to-treat cancers.”

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Jun 13 2022

BridgeBio Pharma Shares Positive Phase 2b Data and Announces Pivotal Study Design for Phase 3 Trial of Encaleret in Autosomal Dominant Hypocalcemia Type 1 (ADH1)

Jun 13 2022

-Treatment with encaleret resulted in rapid and sustained restoration of normal mineral homeostasis, with mean values of blood calcium, urinary calcium, and blood PTH within the normal range by day 5 of therapy and sustained at 24 weeks, and was well-tolerated without any reported serious adverse events

– At week 24 of encaleret treatment, 92% (12/13) of participants had achieved normal trough blood calcium levels in the absence of extra-dietary calcium supplements and active vitamin D, and 77% (10/13) of participants had normal urinary calcium excretion

– The Company completed its end of Phase 2 interaction with the US FDA; the Phase 3 pivotal study is anticipated to begin in 2022 and will evaluate a primary composite endpoint of blood and urinary calcium within target ranges in participants treated with encaleret compared to standard of care

– Phase 2b data are featured in an oral presentation at the Endocrine Society (ENDO) 2022 Annual Conference

– BridgeBio will host an investor call on June 13, 2022, at 4:30 pm ET to discuss the Phase 2b study results and the planned pivotal Phase 3 study design

PALO ALTO, CA – June 13, 2022 — BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, today announced positive Phase 2b data of encaleret in patients with autosomal dominant hypocalcemia type 1 (ADH1). The results are featured in an oral presentation at the Endocrine Society (ENDO) 2022 Annual Conference in Atlanta, GA. BridgeBio will also host an investor call on June 13, 2022, at 4:30 pm ET to discuss the results from the Phase 2b study.

“ADH1 is a rare genetic form of hypoparathyroidism associated with lifelong abnormally high urine calcium and low blood calcium levels, sometimes leading to severe consequences such as seizures, heart rhythm abnormalities, muscle cramping, and breathing difficulties,” said Rachel Gafni, M.D., senior research physician and head of the Mineral Homeostasis Studies Group of the National Institute of Dental and Craniofacial Research of the National Institutes of Health (NIH). “Current management with calcium and vitamin D supplements is inadequate and may exacerbate high urine calcium levels, which can cause kidney complications. These 24-week outpatient data, evaluating an investigational calcilytic in a precision-medicine approach, demonstrate that encaleret has the potential to restore normal calcium and phosphate metabolism in individuals with ADH1.”

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Apr 5 2022

Atreca Announces Expansion of Preclinical Pipeline

Apr 5 2022

SAN CARLOS, CA – April 05, 2022 — Atreca, Inc. (Atreca) (NASDAQ: BCEL), a clinical-stage biotechnology company focused on developing novel therapeutics generated through a unique discovery platform based on interrogation of the active human immune response, today announced a licensing agreement with Zymeworks Inc. (Zymeworks) (NYSE: ZYME) to utilize their ZymeLink™ technology to develop novel antibody-drug conjugates (ADCs) and declared ATRC-301, an ADC targeting a novel epitope on EphA2, as the Company’s next clinical candidate. Atreca management will discuss the agreement, ATRC-301, and its earlier stage pipeline programs during today’s R&D Day beginning at 4:15pm EDT.

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Apr 3 2022

BridgeBio Pharma Presents Updated Results from Phase 2 Open-label Extension Study of Acoramidis in Transthyretin Amyloid Cardiomyopathy (ATTR-CM)

Apr 3 2022

PALO ALTO, CA – April 3, 2022 — BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, today announced updated data from its ongoing Phase 2 open-label extension (OLE) study of acoramidis (AG10) in patients with symptomatic transthyretin (TTR) amyloid cardiomyopathy (ATTR-CM). The results were featured in an oral presentation at the American College of Cardiology (ACC) Annual Scientific Session & Expo, taking place in Washington, D.C. on April 2 – 4, 2022.

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May 13 2022

BridgeBio Pharma Sells Rare Pediatric Disease Priority Review Voucher for $110 Million and Defers Principal Payment on Senior Debt by Two Years

May 13 2022

Entered into a definitive agreement to sell the rare pediatric disease Priority Review Voucher (PRV) it obtained in February 2021 for $110 million

Secured a two-year extension of interest-only period on its existing senior secured credit facility

PALO ALTO, CA – May 13, 2022 — BridgeBio Pharma, Inc. (Nasdaq: BBIO) (BridgeBio), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, announced today that it has entered into a definitive agreement with an undisclosed purchaser to sell its PRV for $110 million.

The Company received the voucher in February 2021 under a U.S. Food and Drug Administration (FDA) program intended to encourage the development of treatments for rare pediatric diseases. BridgeBio was awarded the voucher when its affiliate, Origin Biosciences Inc., received approval of NULIBRY™ (fosdenopterin) for injection as the first therapy to reduce the risk of mortality in patients with molybdenum cofactor deficiency (MoCD) Type A. The sale is subject to customary closing conditions and is expected to occur following the expiration of applicable U.S. antitrust clearance requirements.

In connection with the PRV sale, BridgeBio has executed an amendment to its existing senior secured credit facility, extending the interest-only period by two years and principal repayment to November 17, 2026. The Company received consent for the PRV sale from its lenders with all proceeds retained by BridgeBio.  BridgeBio retains access to up to $100 million in delayed debt draws through year end 2022, subject to certain conditions.  The amendment was approved unanimously by existing lenders in the syndicate without adjusting pricing and without imposing financial covenants.

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Mar 31 2022

CIDARA THERAPEUTICS ANNOUNCES THE COMPLETION OF DOSING THE FIRST COHORT OF HEALTHY VOLUNTEERS IN THE PHASE 1 TRIAL OF CD388 IN DEVELOPMENT FOR UNIVERSAL PREVENTION AND TREATMENT OF SEASONAL AND PANDEMIC INFLUENZA

Mar 31 2022

SAN DIEGO, CA – March 31, 2022 — Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company developing long-acting therapeutics designed to help improve the standard of care for patients facing serious diseases, today announced that the first cohort of healthy volunteers has been dosed in its Phase 1 trial of CD388, a highly potent long-acting antiviral immunotherapy designed to deliver universal prevention of seasonal and pandemic influenza. The study is being conducted under an exclusive worldwide license and collaboration agreement with Janssen Pharmaceuticals, Inc. (Janssen), one of the Janssen Pharmaceutical Companies of Johnson & Johnson, to develop and commercialize Cidara’s Cloudbreak drug-Fc conjugates (DFCs) for the prevention and treatment of seasonal and pandemic influenza.

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Mar 30 2022

Antios Therapeutics’ ATI-2173 Demonstrates Suppression of Hepatitis B Virus in Phase 1b and 2a Studies

Mar 30 2022

DOYLESTOWN, PA – March 30, 2022 – Antios Therapeutics, Inc. (Antios), a clinical-stage biopharmaceutical company developing innovative therapies to treat and cure chronic hepatitis B virus (HBV), today announced new data from the Phase 1b and 2a clinical trials of ATI-2173, its investigational proprietary drug candidate and the only Active Site Polymerase Inhibitor Nucleotide (ASPIN) in clinical development for HBV. These data showed that ATI-2173 alone, or in combination with tenofovir disoproxil fumarate (TDF), was generally well-tolerated among the cohorts, and ATI-2173 and TDF suppressed HBV DNA and induced declines in biomarkers of cccDNA activity. Data from these trials will be presented in two poster sessions during the 31st Conference of the Asian Pacific Association for the Study of Liver (APASL), taking place in Seoul, South Korea on March 30, 2022 – April 3, 2022.

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Mar 29 2022

Prolacta - Independent, head-to-head study shows significant health benefits of early fortification associated with Prolacta Bioscience’s 100% human milk-based fortifiers compared to cow milk-based fortifiers for premature infants

Mar 29 2022

DUARTE, CA- March 29, 2022 – An independent, head-to-head study from Neuburg, Germany, shows extremely low birth weight preterm infants fed Prolacta Bioscience® 100% human milk-based fortifiers (HMBF) as part of an Exclusive Human Milk Diet (EHMD) had reduced incidences of life-threatening comorbidities and experienced shorter stays in the neonatal intensive care unit (NICU), compared to those fed cow/bovine milk-based fortifiers (CMBF), offsetting the higher therapeutic costs of HMBF.1

The study, “Nutrition of Infants with Very Low Birth Weight Using Human and Bovine Based Milk Fortifier: Benefits and Costs,” was published in Neonatal and Pediatric Medicine and is the first head-to-head clinical trial of nutritional fortifiers conducted within Germany’s national health care system. The findings corroborate the results from more than 20 peer-reviewed studies demonstrating the benefits of Prolacta’s 100% human milk-based fortifiers, compared to cow-milk based fortifiers.2-15

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Mar 25 2022

ADMA Biologics Announces FDA Approval of Extended Shelf Life for ASCENIV™ & BIVIGAM® from 24 to 36 Months

Mar 25 2022

RAMSEY, NJ and BOCA RATON, FL – March 25, 2022 — ADMA Biologics, Inc. (NASDAQ: ADMA) (“ADMA”), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics, announced the United States Food and Drug Administration’s (“FDA”) approval to extend the expiration dating from 24 to 36 months for both its ASCENIV and BIVIGAM immune globulin (“IG”) drug product stored at 2-8°C. The expiration date extension applies to all existing ASCENIV and BIVIGAM lots currently in the commercial supply chain as well as to future production of ASCENIV and BIVIGAM in all vial sizes, production scales as well as internal and external fill-finished drug product.

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Mar 24 2022

ADMA Biologics Announces Fourth Quarter and Full Year 2021 Financial Results and Provides Business Update, Including $175M Debt Refinance with Hayfin Capital Management

Mar 24 2022

RAMSEY, NJ and BOCA RATON, FL – March 24, 2022 — ADMA Biologics, Inc. (Nasdaq: ADMA) (“ADMA” or the “Company”), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics, today announced its fourth quarter and full year 2021 financial results. Additionally, ADMA today announced the closing of a debt refinancing with Hayfin Capital Management (“Hayfin”) of $150 million, and up to an additional $25 million tied to the achievement of certain revenue targets during 2022.   The first tranche of the newly issued loan from Hayfin was fully drawn and used to completely repay the obligations under the Perceptive Advisors (“Perceptive”) senior secured notes, including all associated prepayment fees.

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