MAA

DGAP-News: Tetra Bio-Pharma Provides Update on Clinical Development Program for QIXLEEF(TM)

Thursday, October 14, 2021 - 2:29pm

Since the beginning of the clinical development program in late-2016, QIXLEEF(TM) strictly adhered to and complied with the regulatory requirements of a prescription drug.

Key Points: 
  • Since the beginning of the clinical development program in late-2016, QIXLEEF(TM) strictly adhered to and complied with the regulatory requirements of a prescription drug.
  • Having a global drug development strategy ensures economy of scale and lower cost of drug development to shareholders.
  • The REBORN(c) clinical strategy provides the fastest and lowest cost development program to bring QIXLEEF(TM) to the market.
  • Guy Chamberland, CEO and CRO commented, "Our team has made significant progress in bringing QIXLEEF(TM) to a late clinical development stage.

Tetra Bio-Pharma Provides Update on Clinical Development Program for QIXLEEF™

Thursday, October 14, 2021 - 11:30am

Since the beginning of the clinical development program in late-2016, QIXLEEF strictly adhered to and complied with the regulatory requirements of a prescription drug.

Key Points: 
  • Since the beginning of the clinical development program in late-2016, QIXLEEF strictly adhered to and complied with the regulatory requirements of a prescription drug.
  • The Company completed two Phase 1 clinical trials in healthy volunteers to assess the safety profile, including cardiovascular, pharmacodynamics and pharmacokinetics, of smoked and vaporized QIXLEEF.
  • The REBORN clinical strategy provides the fastest and lowest cost development program to bring QIXLEEF to the market.
  • Guy Chamberland, CEO and CRO commented, "Our team has made significant progress in bringing QIXLEEF to a late clinical development stage.

Travere Therapeutics Announces Transition of Chief Medical Officer

Tuesday, October 12, 2021 - 10:00pm

SAN DIEGO, Oct. 12, 2021 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc. (NASDAQ: TVTX) today announced that its chief medical officer, Noah Rosenberg, M.D., has chosen to transition for personal reasons to an executive advisor role at the end of 2021.

Key Points: 
  • SAN DIEGO, Oct. 12, 2021 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc. (NASDAQ: TVTX) today announced that its chief medical officer, Noah Rosenberg, M.D., has chosen to transition for personal reasons to an executive advisor role at the end of 2021.
  • On behalf of the Board and our Travere employees, I would like to thank Noah for his many contributions to the advancement of our pipeline, said Eric Dube, Ph.D., chief executive officer of Travere Therapeutics.
  • It has been a privilege working alongside the talented and patient-inspired team at Travere.
  • At Travere Therapeutics we are in rare for life.

Sesen Bio Expands CMC and Clinical Teams

Tuesday, October 12, 2021 - 1:00pm

Sesen Bio (Nasdaq: SESN ), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, today announced the expansion of its chemistry, manufacturing, and control (CMC) and clinical development teams with the hiring of Eun Jang as Senior Director, Analytical Sciences, and Chrie Kaefring as Director, Clinical Operations.

Key Points: 
  • Sesen Bio (Nasdaq: SESN ), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, today announced the expansion of its chemistry, manufacturing, and control (CMC) and clinical development teams with the hiring of Eun Jang as Senior Director, Analytical Sciences, and Chrie Kaefring as Director, Clinical Operations.
  • I am delighted to welcome Eun and Chrie to Sesen Bio to further strengthen our capabilities across our CMC and clinical teams, said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio.
  • These hirings come as Sesen Bio is preparing for CMC and clinical Type A meetings with the US Food and Drug Administration (FDA) for Vicineum.
  • Sesen Bio, Inc. is a late-stage clinical company advancing targeted fusion protein therapeutics for the treatment of patients with cancer.

Humanigen Signs Contract With Clinigen for Lenzilumab Managed Access Program in Europe

Friday, October 8, 2021 - 7:00am

We are working with Clinigen to provide access to lenzilumab on a patient-by-patient basis in specific European countries, said Timothy E. Morris, COO and CFO of Humanigen.

Key Points: 
  • We are working with Clinigen to provide access to lenzilumab on a patient-by-patient basis in specific European countries, said Timothy E. Morris, COO and CFO of Humanigen.
  • Under the terms of the agreement, Clinigen will manage key elements of the program including regulatory oversight, logistics and access management.
  • Humanigen will rely on Clinigens expertise working with regulatory authorities in the relevant countries to make access to lenzilumab possible in each of the 16 nations identified above.
  • Clinigen currently oversees more than 161 similar managed access programs for other companies.

Modified long-term share-based incentive program for 2021

Thursday, October 7, 2021 - 7:40am

Copenhagen, Denmark, October 7, 2021 Orphazyme A/S (ORPHA.CO (DK); ORPH (US)), a late-stage biopharmaceutical company, has today introduced a modified long-term incentive program for 2021 (the LTIP) with the view to retaining members of the Executive Management and other employees of the Group, while also creating an incentive for a positive share price development and corporate performance for the benefit of the Companys shareholders.

Key Points: 
  • Copenhagen, Denmark, October 7, 2021 Orphazyme A/S (ORPHA.CO (DK); ORPH (US)), a late-stage biopharmaceutical company, has today introduced a modified long-term incentive program for 2021 (the LTIP) with the view to retaining members of the Executive Management and other employees of the Group, while also creating an incentive for a positive share price development and corporate performance for the benefit of the Companys shareholders.
  • The exercise of the RSUs and PSUs to be granted under the modified LTIP is conditional upon the participant not exercising his or her RSUs or PSUs granted in April 2021, which will subsequently lapse and no longer be exercisable.
  • The modified LTIP including the other share-based retention grants to the Executive Management are expected to comprise up to 675,000 shares in total.
  • On June 17, 2021, Orphazyme received a Complete Response Letter from the FDA regarding its New Drug Application for arimoclomol for the treatment of NPC.

Marinus Pharmaceuticals Provides Strategic Update at Virtual R&D Event

Tuesday, October 5, 2021 - 12:30pm

Ganaxolone exhibits anti-seizure and anti-anxiety activity via its effects on synaptic and extrasynaptic GABAA receptors.

Key Points: 
  • Ganaxolone exhibits anti-seizure and anti-anxiety activity via its effects on synaptic and extrasynaptic GABAA receptors.
  • Marinus Pharmaceuticals, Inc. is a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders.
  • Ganaxolone is a positive allosteric modulator of GABAA receptors that acts on a well-characterized target in the brain known to have anti-seizure, antidepressant and anti-anxiety effects.
  • Any forward-looking statements that we make in this press release speak only as of the date of this press release.

Orphazyme provides regulatory and financial updates

Tuesday, October 5, 2021 - 7:55am

Copenhagen October 5, 2021 Orphazyme A/S (ORPHA.CO; ORPH), a late-stage biopharmaceutical company, today announces regulatory updates for its investigational drug candidate, arimoclomol, for which it is seeking marketing authorization in both Europe and the United States for the treatment of Niemann-Pick disease Type C (NPC).

Key Points: 
  • Copenhagen October 5, 2021 Orphazyme A/S (ORPHA.CO; ORPH), a late-stage biopharmaceutical company, today announces regulatory updates for its investigational drug candidate, arimoclomol, for which it is seeking marketing authorization in both Europe and the United States for the treatment of Niemann-Pick disease Type C (NPC).
  • In the United States, Orphazyme requested and has been granted a Post-Action Type A meeting with the U.S. Food and Drug Administration (FDA), which has been scheduled for mid-October.
  • On June 17, 2021, Orphazyme received a Complete Response Letter from the FDA regarding its New Drug Application for arimoclomol for the treatment of NPC.
  • Orphazyme is a late-stage biopharmaceutical company developing arimoclomol for Niemann-Pick disease type C (NPC).

The first treatment for sickle cell disease in over 20 years, Novartis' Adakveo®▼ (crizanlizumab) receives NICE recommendation for preventing recurrent vaso-occlusive crises

Tuesday, October 5, 2021 - 7:00am

LONDON, Oct. 5, 2021 /PRNewswire/ -- Novartis is pleased to announce that eligible patients in England and Wales will soon have routine access to Adakveo®▼ (crizanlizumab) under a Managed Access Agreement (MAA). The news comes as the National Institute for Health and Care Excellence (NICE), published the Final Appraisal Determination (FAD) recommending crizanlizumab as an option for preventing recurrent sickle cell crises (two or more vaso-occlusive crises, VOCs, in a year, managed at home or in hospital) in people aged 16 or older with sickle cell disease (SCD).[2] Access to this innovative treatment not only helps with SCD but also demonstrates a commitment to supporting health equity for a community that has been historically underserved, without any new treatment options for more than 20 years, and disproportionately impacted by COVID-19.

Key Points: 
  • [4],[5] Sickle cell pain crises disrupt patients' lives physically, socially, and emotionally and can worsen into acute and long-term complications.
  • [3] While sickle cell disease mainly affects people of African or African-Caribbean origin, the sickle gene is found in all ethnic groups.
  • Kenny T and Tidy C. Sickle Cell Disease and Sickle Cell Anaemia patient information leaflet.
  • Management Strategies and Satisfaction Levels in Patients With Sickle Cell Disease: Interim Results From the International Sickle Cell World Assessment Survey (SWAY).

MAA Announces Date of Third Quarter 2021 Earnings Release, Conference Call

Monday, October 4, 2021 - 9:15pm

GERMANTOWN, Tenn., Oct. 4, 2021 /PRNewswire/ -- MAA (NYSE: MAA)announced today that the company expects to release its third quarter 2021 results on Wednesday, October 27, 2021 after market close and will hold its third quarter conference call on Thursday, October 28, 2021 at 9:00 a.m. Central Time.

Key Points: 
  • GERMANTOWN, Tenn., Oct. 4, 2021 /PRNewswire/ -- MAA (NYSE: MAA)announced today that the company expects to release its third quarter 2021 results on Wednesday, October 27, 2021 after market close and will hold its third quarter conference call on Thursday, October 28, 2021 at 9:00 a.m. Central Time.
  • During the conference call, company officers will review third quarter performance and conduct a question-and-answer period.
  • The conference call-in number is (877) 830-2598 (Domestic) or +1 (785) 424-1877 (International).
  • A replay of the conference call will be available from October 28, 2021 through November 11, 2021 by dialing (800) 723-5154 (Domestic) or +1 (402) 220-2661 (International).