News

Nov 22 2021

Obseva Announces U.S. FDA Acceptance of New Drug Application for Linzagolix

Nov 22 2021
  • FDA Accepts NDA for Linzagolix for the Management of Heavy Menstrual Bleeding Associated with Uterine Fibroids
  • Ad hoc announcement pursuant to Art. 53 LR of the SIX Swiss Exchange

GENEVA, Switzerland – November 22, 2021 – Obseva SA (NASDAQ: OBSV; SIX: OBSN), a biopharmaceutical company developing and commercializing novel therapies to improve women’s reproductive health,today announced that the New Drug Application (NDA) for linzagolix for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women has been accepted for review by the United States Food and Drug Administration (FDA). The submission is based on data from the two Phase 3 PRIMROSE trials. Linzagolix has a differentiated profile and if approved, would be the first and only GnRH receptor antagonist with flexible dosing options for uterine fibroids, including a low dose option to address the needs of women who cannot or do not want to take hormones.1,4 The FDA set a target action date of September 13, 2022 for this NDA under the Prescription Drug User Fee Act (PDUFA).

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Nov 22 2021

Prolacta Bioscience Appoints Dr. Anne Beal to Board of Directors

Nov 22 2021

DUARTE, CA – November 22, 2021 — Prolacta Bioscience®, the world’s leading hospital provider of 100% human milk-based nutritional products for premature and critically ill infants, today announced that Dr. Anne Beal, founder and CEO of AbsoluteJOI Skincare, has been appointed as a member of its board of directors.

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Nov 19 2021

BridgeBio Pharma and Helsinn Group Announce Strategic Collaboration to Co-Develop and Co-Commercialize BridgeBio’s Novel GPX4 Inhibitor in Multiple Cancer Tumor Types

Nov 19 2021

Palo Alto, CA, and Lugano, Switzerland – November 19, 2021 – BridgeBio Pharma, Inc. (Nasdaq: BBIO), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, and Helsinn Group, a fully integrated, global biopharma company with a diversified pipeline of innovative oncology assets and strong track record of commercial execution, announced they have entered into a strategic collaboration to codevelop and co-commercialize a potentially first-in-class inhibitor designed to target glutathione peroxidase 4 (GPX4) with the hope of providing an effective new therapy for patients with difficult-to-treat tumors.

The joint collaboration for BridgeBio’s GPX4 inhibitor was established as part of a new non-exclusive collaboration framework between BridgeBio and Helsinn that allows the companies to propose co-development and co-commercialization opportunities for preclinical precision oncology programs.

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Nov 15 2021

ews Antios Therapeutics Announces Agreement with IRBM, INGM and OSR to Acquire Fourth-Generation HBV Capsid Assembly Modulators (CAMs)

Nov 15 2021

MENDHAM, NJ and ROME, ITALY – November 15, 2021 – Antios Therapeutics, Inc. (“Antios”), a clinical-stage biopharmaceutical company developing innovative therapies to treat and cure chronic hepatitis B virus (HBV), and IRBM, a drug discovery and early development research institute and global contract research organization, announced today they entered into an agreement for Antios to purchase the IP rights to a novel series of fourth-generation capsid assembly modulators (CAMs) being developed for the treatment of HBV. The CAMs were originated and developed at IRBM in conjunction with Promidis/CNCCS (a subsidiary of IRBM), Istituto Nazionale Genetica Molecolare (INGM) and San Raffaele Hospital (OSR). These CAMs enable the selection of a new pipeline candidate, which will be the second molecule in Antios’ HBV portfolio. The total potential value of the deal to the Italian sellers/parties is up to $50 million, in addition to royalties.

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Nov 10 2021

Monte Rosa Therapeutics Announces First Development Candidate and Reports Third Quarter 2021 Financial Results and Business Updates

Nov 10 2021

BOSTON, MA – November 10, 2021 — Monte Rosa Therapeutics, Inc. (NASDAQ: GLUE), a biotechnology company developing novel molecular glue-based precision medicines, today reported business highlights and financial results for the third quarter, ended Sept. 30, 2021.

“This year has been marked by several exciting and significant milestones for Monte Rosa, culminating in the naming of our first development candidate, MRT-2359, selectively targeting GSPT1 for the treatment of cancers driven by one of the Myc family genes,” said Markus Warmuth, M.D., CEO of Monte Rosa. “Preclinical data recently presented at AACR-NCI-EORTC underscores the potential of our molecular glue degraders to differentially induce cell death in Myc-addicted tumors. With the selection of MRT-2359 as our lead candidate, we are now positioned to rapidly advance our clinical development plan in both solid tumors and hematological malignancies. We have initiated IND-enabling studies and look forward to submitting our first IND to the FDA in mid-2022.”

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Nov 3 2021

Antios Therapeutics Raises $75 Million in a Series B-1 Funding to Advance Clinical Programs for HBV

Nov 3 2021
  • Financing round was co-led by GordonMD Global Investment LP
  • Funding will support the Phase 2b clinical program of ATI-2173 in HBV

MENDHAM, NJ – Nov. 3, 2021 – Antios Therapeutics, Inc. (“Antios”), a clinical-stage biopharmaceutical company developing innovative therapies to treat and cure chronic hepatitis B virus (HBV), today announced the successful closing of a $75 million Series B-1 financing. The financing round was co-led by GordonMD Global Investments, a firm focused on investments in private and publicly traded global growth and innovative biopharma companies primarily located in the United StatesJapan, and Europe.

The proceeds from this financing will be used to advance the clinical development of ATI-2173, Antios’ lead Phase 2b clinical candidate. ATI-2173 is the only Active Site Polymerase Inhibitor Nucleotide (ASPIN) in clinical development and has the potential, if approved, to become the cornerstone of a curative, once-daily HBV therapy. Pre-clinical data to date for ATI-2173, alone or combined with tenofovir disoproxil fumarate (TDF), indicate the potential for sustained HBV DNA suppression off treatment, unique among approved nucleosides and investigational anti-HBV therapies.

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Nov 3 2021

Antios Therapeutics Raises $75 Million in a Series B-1 Funding to Advance Clinical Programs for HBV

Nov 3 2021

MENDHAM, NJ – November  03, 2021 — Antios Therapeutics, Inc. (“Antios”), a clinical-stage biopharmaceutical company developing innovative therapies to treat and cure chronic hepatitis B virus (HBV), today announced the successful closing of a $75 million Series B-1 financing. The financing round was co-led by GordonMD Global Investments, a firm focused on investments in private and publicly traded global growth and innovative biopharma companies primarily located in the United StatesJapan, and Europe.

The proceeds from this financing will be used to advance the clinical development of ATI-2173, Antios’ lead Phase 2b clinical candidate. ATI-2173 is the only Active Site Polymerase Inhibitor Nucleotide (ASPIN) in clinical development and has the potential, if approved, to become the cornerstone of a curative, once-daily HBV therapy. Pre-clinical data to date for ATI-2173, alone or combined with tenofovir disoproxil fumarate (TDF), indicate the potential for sustained HBV DNA suppression off treatment, unique among approved nucleosides and investigational anti-HBV therapies.

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Oct 29 2021

Prolacta Bioscience Develops World’s First Test to Directly Detect Bacteria and Viruses, Including SARS-CoV-2, in Donor Breast Milk

Oct 29 2021

DUARTE, CA –  October 29, 2021 – Prolacta Bioscience®, the world’s leading hospital provider of 100% human milk-based nutritional products, announced today that it has developed the first nucleic acid amplification test (NAAT) capable of directly detecting the presence of infectious disease-causing pathogens in donated breast milk, including bacteria and viruses such as SARS-CoV-2, the virus that causes COVID-19. Prolacta is the first and only company in the human milk industry to apply NAAT to all donor milk received through its milk banks, leading the industry with unmatched quality, safety, and bioactivity.

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Oct 21 2021

Harmony Biosciences to be Added to the S&P SmallCap 600® Index

Oct 21 2021

PLYMOUTH MEETING, PA – Oct. 21, 2021 – Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY)(“Harmony” or the “Company”), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases, today announced that it will be added to the S&P SmallCap 600® Index, effective prior to the open of trading on Friday, October 22, 2021.

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Oct 12 2021

Poseida Therapeutics Announces Research Collaboration with Takeda for Novel Non-Viral In Vivo Gene Therapies

Oct 12 2021
  • Collaboration to leverage Poseida’s non-viral piggyBac® DNA Modification System, Cas-CLOVER™ Site-Specific Gene Editing System, biodegradable DNA and RNA nanoparticle delivery technology and other proprietary genetic engineering platforms
  • Collaboration to initially include up to six liver- and hematopoietic stem cell (HSC)- directed indications with an option to add two additional programs
  • In addition to an upfront payment, Poseida is eligible to receive preclinical, development and commercial milestone payments plus tiered royalties into the double digits

SAN DIEGO, CA – Oct. 12, 2021 – Poseida Therapeutics, Inc. (Nasdaq: PSTX), a clinical-stage biopharmaceutical company utilizing proprietary genetic engineering platform technologies to create cell and gene therapeutics with the capacity to cure, today announced that it has entered into a research collaboration and exclusive license agreement with Takeda Pharmaceutical Company Limited (“Takeda”) to utilize Poseida’s piggyBac, Cas-CLOVER, biodegradable DNA and RNA nanoparticle delivery technology and other proprietary genetic engineering platforms for the research and development of up to eight gene therapies. The collaboration will focus on developing non-viral in vivo gene therapy programs, including Poseida’s Hemophilia A program.

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