Fast track (FDA)

Inventiva completes sale of $30 million through its ATM program to existing and new specialized institutional investors

Thursday, September 23, 2021 - 7:45am

The New Shares will represent 5.1% of the share capital of the Company upon completion of the transaction.

Key Points: 
  • The New Shares will represent 5.1% of the share capital of the Company upon completion of the transaction.
  • It is anticipated that the settlement and delivery of the New Shares will take place on September 27, 2021.
  • Prospective investors should read the base prospectus and the accompanying sales agreement prospectus, together with the documents incorporated by reference therein.
  • In parallel, Inventiva is in the process of selecting an oncology development candidate for its Hippo signalling pathway program.

BioVie to Present at Cantor Virtual Global Healthcare Conference

Wednesday, September 22, 2021 - 1:00pm

SANTA MONICA, Calif., Sept. 22, 2021 (GLOBE NEWSWIRE) -- BioVie Inc., (NASDAQ: BIVI) (BioVie or the Company) a clinical-stage company developing innovative drug therapies for the treatment of neurological and neurodegenerative disorders and advanced liver disease, today announced the participation of its management team at the Cantor Virtual Global Healthcare Conference to be held September 27-30, 2021.

Key Points: 
  • SANTA MONICA, Calif., Sept. 22, 2021 (GLOBE NEWSWIRE) -- BioVie Inc., (NASDAQ: BIVI) (BioVie or the Company) a clinical-stage company developing innovative drug therapies for the treatment of neurological and neurodegenerative disorders and advanced liver disease, today announced the participation of its management team at the Cantor Virtual Global Healthcare Conference to be held September 27-30, 2021.
  • BioVie Inc. (NASDAQ: BIVI) is a clinical-stage company developing transformative therapies to overcome unmet medical needs in chronic debilitating conditions.
  • The Company is also planning a pivotal Phase 3 study of BIV201 in the treatment of hepatorenal syndrome-acute kidney injury (HRS-AKI) in 2022.
  • In neurodegenerative disease, BioVie acquired the assets of NeurMedix Inc., including NE3107 that inhibits inflammatory activation of ERK and NFB (e.g.

Inventiva announces FDA decision that Fast Track designation granted to lanifibranor in NASH encompasses the treatment of NASH with compensated cirrhosis

Tuesday, September 21, 2021 - 9:00pm

This decision follows a Fast Track designation request for lanifibranor in NASH with compensated cirrhosis filed by Inventiva with the FDA in August 2021.

Key Points: 
  • This decision follows a Fast Track designation request for lanifibranor in NASH with compensated cirrhosis filed by Inventiva with the FDA in August 2021.
  • Previously, the FDA had granted both Fast Track and Breakthrough Therapy designations to lanifibranor for the treatment of NASH in September 2019 and October 2020, respectively.
  • The FDA decision does not only recognize this urgency but also the potential of lanifibranor to address this crucial unmet medical need.
  • In 2020, Inventiva announced positive topline data from its Phase IIb clinical trial evaluating lanifibranor for the treatment of patients with NASH and obtained both FDA Breakthrough Therapy and Fast Track designation for lanifibranor in the treatment of NASH.

Inventiva reports 2021 first half financial results and provides a corporate update

Monday, September 20, 2021 - 9:10pm

Revenues for the first half of 2021 reached 0.1 million, stable compared to the first half of 2020.

Key Points: 
  • Revenues for the first half of 2021 reached 0.1 million, stable compared to the first half of 2020.
  • Net financial income amounted to 0.8 million in the first half of 2021, mainly linked to exchange rate variation.
  • Net cash used in operating activities amounted to 19.8 million and 7.2 million in the first half of 2021 and 2020, respectively.
  • The financial statements of the first half of 2021 were approved by Inventivas Board of Directors on September 16, 2021.

Humacyte Announces Issuance of Three Additional U.S. Patents Covering its Proprietary Universally Implantable Bioengineered Human Tissue Platform

Monday, September 20, 2021 - 1:45pm

DURHAM, N.C., Sept. 20, 2021 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, today announced the issuance of three additional U.S. patents covering its proprietary technology platform.

Key Points: 
  • DURHAM, N.C., Sept. 20, 2021 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, today announced the issuance of three additional U.S. patents covering its proprietary technology platform.
  • For issued U.S. patents, the last patent expires in 2035 and additional U.S. patent applications pending, if issued, would extend coverage into 2040.
  • U.S. Patent 11,058,534 is jointly owned by Humacyte and Yale University, and Yale has exclusively licensed its rights to Humacyte.
  • Humacyte now owns or licenses a total of 14 U.S. patents and 105 international patents covering its proprietary platform.

Humacyte Leadership to Present at Five Scientific Events in September

Friday, September 17, 2021 - 12:51pm

DURHAM, N.C., Sept. 17, 2021 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA) , a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, today announced that senior leadership will present at five scientific and medical events in September 2021.

Key Points: 
  • DURHAM, N.C., Sept. 17, 2021 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA) , a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, today announced that senior leadership will present at five scientific and medical events in September 2021.
  • Our presentations at multiple scientific conferences this month highlight the robust body of data weve amassed on our HAV and the breadth of its potential.
  • The presentation will summarize Humacytes ongoing HAV development program in vascular repair, reconstruction and replacement and potential future applications.
  • We anticipate that subsequent events and developments will cause our views to change.

Ayala Pharmaceuticals Presents Preliminary Clinical Data from the Ongoing Phase 2 ACCURACY Trial and Announces Pre-Clinical Proof of Concept Data for Enhanced Activity of AL101 in Combination with Approved Cancer Therapies in ACC

Thursday, September 16, 2021 - 1:00pm

REHOVOT, Israel and WILMINGTON, Del., Sept. 16, 2021 (GLOBE NEWSWIRE) -- Ayala Pharmaceuticals, Inc. (NASDAQ: AYLA), a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare and aggressive cancers, today announced new preliminary clinical data from the 6mg cohort of its ongoing Phase 2 ACCURACY trial of AL101 for the treatment of recurrent/metastatic (R/M) adenoid cystic carcinoma (ACC) harboring Notch-activating mutations. The data is being presented at the 2021 ESMO Virtual Congress as an ePoster. In a separate ePoster presentation, Ayala presented new preclinical results evaluating the potential of AL101 in combination with approved cancer therapies for dual targeting of ACC tumours.

Key Points: 
  • In a separate ePoster presentation, Ayala presented new preclinical results evaluating the potential of AL101 in combination with approved cancer therapies for dual targeting of ACC tumours.
  • R/M ACC remains a significant area of unmet need, and I am encouraged by the preliminary results that AL101 monotherapy has demonstrated to-date.
  • The preliminary safety and efficacy data from the 6mg cohort of our ongoing ACCURACY trial of AL101 highlights a favourable profile.
  • Preliminary Safety and Efficacy Data from 6mg Cohort of ACCURACY Phase 2 Trial:
    Ayala presented new preliminary 6mg data from its ongoing ACCURACY Phase 2 clinical trial evaluating the safety and efficacy of AL101 monotherapy for the treatment of patients with R/M ACC harboring Notch-activating mutations.

BioVie to Present at Oppenheimer Fall Healthcare Life Sciences & MedTech Virtual Summit

Wednesday, September 15, 2021 - 9:01pm

SANTA MONICA, Calif., Sept. 15, 2021 (GLOBE NEWSWIRE) -- BioVie Inc., (NASDAQ: BIVI) (BioVie or the Company) a clinical-stage company developing innovative drug therapies for the treatment of neurodegenerative disorders and advanced liver disease, today announced the participation of its management team in the Oppenheimer Fall Healthcare Life Sciences & MedTech Virtual Summit September 22, 2021.

Key Points: 
  • SANTA MONICA, Calif., Sept. 15, 2021 (GLOBE NEWSWIRE) -- BioVie Inc., (NASDAQ: BIVI) (BioVie or the Company) a clinical-stage company developing innovative drug therapies for the treatment of neurodegenerative disorders and advanced liver disease, today announced the participation of its management team in the Oppenheimer Fall Healthcare Life Sciences & MedTech Virtual Summit September 22, 2021.
  • BioVie Inc. (NASDAQ: BIVI) is a clinical-stage company developing transformative therapies to overcome unmet medical needs in chronic debilitating conditions.
  • The Company is also planning a pivotal Phase 3 study of BIV201 in the treatment of hepatorenal syndrome-acute kidney injury (HRS-AKI) in 2022.
  • In neurodegenerative disease, BioVie acquired the assets of NeurMedix Inc., including NE3107 that inhibits inflammatory activation of ERK and NFB (e.g.

Sage Therapeutics Receives Fast Track Designation for SAGE-718 for the Treatment of Huntington’s Disease

Wednesday, September 15, 2021 - 11:30am

Fast Track is a process designed to facilitate the development and review of new treatments for serious conditions with unmet medical need such as HD.

Key Points: 
  • Fast Track is a process designed to facilitate the development and review of new treatments for serious conditions with unmet medical need such as HD.
  • In studies to date, treatment with SAGE-718 has been associated with improved cognitive performance, particularly in the domain of executive functioning.
  • The FDA Fast Track Designation is an important milestone in the development of SAGE-718, as it provides opportunities to engage collaboratively with the FDA to further clinical development and future regulatory review of SAGE-718 for the treatment of HD.
  • Drugs with Fast Track Designation may also qualify for priority review to expedite the FDA review process, if relevant criteria are met.

DNAtrix Announces the Appointment of David Liebowitz, M.D., Ph.D., as Chief Medical Officer

Tuesday, September 14, 2021 - 1:00pm

"We are thrilled to welcome Dave to the executive leadership team at DNAtrix," said Jeffrey Knapp, chief executive officer of DNAtrix. "Dave has expertise in developing products that elicit immune responses against targets of interest through various therapeutic modalities, including viral-based vaccines. His deep experience leading oncology drug development programs for innovative, young, as well as established biopharmaceutical companies ­­-- such as Amgen -- will prove invaluable as we advance our pipeline with multiple product candidates being studied in several tumor types and two programs in pivotal stage development."

Key Points: 
  • "We are thrilled to welcome Dave to the executive leadership team at DNAtrix," said Jeffrey Knapp, chief executive officer of DNAtrix.
  • "Dave has expertise in developing products that elicit immune responses against targets of interest through various therapeutic modalities, including viral-based vaccines.
  • Prior to joining DNAtrix, Dr. Liebowitz was most recently vice president of Clinical Oncology at Xencor, Inc. From 2012 to 2018, he served as the chief medical officer for Vaxart, Inc., a novel vaccine development company.
  • He was previously the Chief Scientific and Medical Officer for Vivaldi Biosciences, an influenza vaccine and therapeutics biotechnology company.