FDA

APPH, PTE & HYZN, HYZNW, DCRC, DCRCW, DCRCU - Bronstein, Gewirtz & Grossman, LLC Reminds Shareholders of Class Actions and Lead Plaintiff Deadlines

Monday, October 25, 2021 - 3:00pm

You can review a copy of the Complaints by visiting the links belowor you may contact Peretz Bronstein, Esq.

Key Points: 
  • You can review a copy of the Complaints by visiting the links belowor you may contact Peretz Bronstein, Esq.
  • or his Investor Relations Analyst, Yael Nathanson of Bronstein, Gewirtz & Grossman, LLC at212-697-6484.
  • If you suffered a loss, you can request that the Court appoint you as lead plaintiff.
  • A lead plaintiff acts on behalf of all other class members in directing the litigation.

Qiutang Li, Neurophth CSO, Named Top 25 Women Leaders in Biotechnology 2021

Monday, October 25, 2021 - 2:30pm

SAN DIEGO, Oct. 25, 2021 /PRNewswire/ -- Neurophth Therapeutics Ltd.,("Neurophth") a fully-integrated genomic medicines company seekingto improve lives through the curative potential ofgene therapies, today announced that Qiutang Li, Ph.

Key Points: 
  • SAN DIEGO, Oct. 25, 2021 /PRNewswire/ -- Neurophth Therapeutics Ltd.,("Neurophth") a fully-integrated genomic medicines company seekingto improve lives through the curative potential ofgene therapies, today announced that Qiutang Li, Ph.
  • D., Neurophth's Chief Scientific Officer, has been listed as one of The Top 25 Women Leaders in Biotechnology of 2021 by The Healthcare Technology Report.
  • Neurophth congratulates its very own Dr. Qiutang Li as well as all the other award winners who have been recognized by The Healthcare Technology Report in their Top 25 Women Leaders in Biotechnology 2021.
  • "I amhumbled andhonoredto be included among this list of outstanding women leaders who are boldly changing the future of life science industry, " saidDr.

Moon Rabbit Named Agency of Record by Opiant Pharmaceuticals

Monday, October 25, 2021 - 2:05pm

NEW YORK, Oct. 25, 2021 /PRNewswire-PRWeb/ -- Moon Rabbit , an independent advertising and marketing agency focused on the consumer and healthcare sectors, today announced it has been named agency of record for OPNT003, nasal nalmefene, by Opiant Pharmaceuticals .

Key Points: 
  • NEW YORK, Oct. 25, 2021 /PRNewswire-PRWeb/ -- Moon Rabbit , an independent advertising and marketing agency focused on the consumer and healthcare sectors, today announced it has been named agency of record for OPNT003, nasal nalmefene, by Opiant Pharmaceuticals .
  • Moon Rabbit will be responsible for supporting commercial preparations and, if approved by the FDA, launch of OPNT003 in the U.S.
    "We look forward to being an integral part of the Opiant team," noted Moon Rabbit managing partner John Tenaglia.
  • Focused on the healthcare and consumer sectors, Moon Rabbit is an award-winning advertising agency created to build brands that make their customers feel something.
  • As self-described "proudly misfit," Moon Rabbit challenges tired conventions and always pushes to create brave and powerful work that speaks to people.

Biomerics Advances Metals Capabilities And Capacities

Monday, October 25, 2021 - 2:05pm

SALT LAKE CITY, Oct. 25, 2021 /PRNewswire/ --Biomerics LLC, a leading mid-market contract manufacturer for the interventional medical device market, announced that it is doubling its micromachining capacity, as well as adding additional metals capabilities.

Key Points: 
  • SALT LAKE CITY, Oct. 25, 2021 /PRNewswire/ --Biomerics LLC, a leading mid-market contract manufacturer for the interventional medical device market, announced that it is doubling its micromachining capacity, as well as adding additional metals capabilities.
  • "This increase in demand is exactly what we expected to occur when we started to build out the metals portion of Biomerics over two years ago.
  • Founded in 1993, Biomerics is a mid-market medical device contract manufacturer serving the Interventional Cardiovascular, Gastrointestinal, and Advanced Surgical markets.
  • Biomerics is a leader in biomaterials, injection molding, extrusion, micro metals processing, medical balloons, catheter assembly, and finished packaging.

Ideal Image Appoints Celeste Ortiz to Board of Directors

Monday, October 25, 2021 - 2:00pm

TAMPA, Fla., Oct. 25, 2021 (GLOBE NEWSWIRE) -- Ideal Image , North Americas leading aesthetics brand that is making personal aesthetic and wellness services more affordable, accessible, and effective than ever before, today announced that Celeste Ortiz has joined its Board of Directors.

Key Points: 
  • TAMPA, Fla., Oct. 25, 2021 (GLOBE NEWSWIRE) -- Ideal Image , North Americas leading aesthetics brand that is making personal aesthetic and wellness services more affordable, accessible, and effective than ever before, today announced that Celeste Ortiz has joined its Board of Directors.
  • People are at the core of what we do at Ideal Image, and we are thrilled to welcome Ms. Ortiz to the Board to strengthen our culture and advance our mission of helping people look and feel their best, said Ideal Image CEO David Prokupek.
  • Ideal Image is North Americas #1 aesthetics brand, making personal aesthetic and wellness services more affordable, accessible and effective than ever before.
  • Ideal Image believes confidence changes everything, and that the only opinion that matters when it comes to your appearance and well-being is your own.

Cellectar Announces Innovative Concierge Service for Patients Participating in Its Clinical Studies

Monday, October 25, 2021 - 2:00pm

These services are designed to improve patients and their caregiver's access to high quality care and innovative treatments for their cancer.

Key Points: 
  • These services are designed to improve patients and their caregiver's access to high quality care and innovative treatments for their cancer.
  • Cellectars new concierge services program underscores our focus on patients and our commitment to providing them with best-in-class treatments and support.
  • We recognize the challenges facing patients and their families as they battle cancer and navigate the clinical study process and are honored to support them through this journey.
  • Their tools inspire study communities and alleviate site administrative burdens, enabling doctors and nurses to spend more time with patients.

Aquestive Therapeutics Reports Positive Topline Data from Phase 1 Pharmacokinetic Trial of AQST-109 (epinephrine prodrug sublingual film) Supporting its Development as an Oral Alternative to Epinephrine Autoinjectors for the Emergency Treatment of Allergi

Monday, October 25, 2021 - 1:31pm

Based on the study results, Aquestive plans on continuing development of the target formulation to take forward into a pivotal PK study.

Key Points: 
  • Based on the study results, Aquestive plans on continuing development of the target formulation to take forward into a pivotal PK study.
  • All treatment-emergent adverse events (TEAEs) deemed at least possibly related were mild to moderate in nature across cohorts.
  • The changes observed suggest a comparable effect for AQST-109 when compared to autoinjectors in healthy volunteers.
  • Aquestive Therapeutics is developing a sublingual (SL) film containing a prodrug of epinephrine as an alternative dosage form to epinephrine injection (1 mg/mL).

Akari Therapeutics Announces New Data with Nomacopan from its Surface of the Eye Program

Monday, October 25, 2021 - 1:30pm

The article in Allergy summarizes a large body of work undertaken with University College of London and Moorfields Eye Hospital.

Key Points: 
  • The article in Allergy summarizes a large body of work undertaken with University College of London and Moorfields Eye Hospital.
  • MMP shares a similar pathology with bullous pemphigoid where Akari has initiated a Phase III study with nomacopan.
  • Clive Richardson, Chief Executive Officer of Akari, commented, The new surface of the eye data is an important step forward in our program and highlights the potential benefits of nomacopans differentiated bi-specific mode of action.
  • Taken together with prior data this collectively points to the more severe form of these diseases as important clinical targets for nomacopan within the $6bn+ surface of the eye market.

Better For You Wellness Signs LOI to Acquire Ironwood Clay Co. and NENA Skincare

Monday, October 25, 2021 - 1:30pm

Ironwoods NENA Skincare brand (NENA) is a rapidly growing natural skincare brand whose core ingredient is glacial oceanic clay.

Key Points: 
  • Ironwoods NENA Skincare brand (NENA) is a rapidly growing natural skincare brand whose core ingredient is glacial oceanic clay.
  • Beyond Canada, Ironwood distributes its products, ingredients and raw materials globally to the United States, China, Korea, and more.
  • Closing of the transaction contemplated in the LOI will be subject to multiple closing conditions and completion of due diligence.
  • Better For You Wellness is actively exploring and evaluating numerous additional business opportunities including, but not limited to, mergers, acquisitions, or business combination transactions.

Panbela Schedules Conference Call on November 10, 2021, to Report 2021 Third Quarter Financial Results

Monday, October 25, 2021 - 2:00pm

The safety data and PMI profile observed in the current Panbela sponsored clinical trial provides support for continued evaluation of SBP-101 in a randomized clinical trial.

Key Points: 
  • The safety data and PMI profile observed in the current Panbela sponsored clinical trial provides support for continued evaluation of SBP-101 in a randomized clinical trial.
  • Panbela Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing disruptive therapeutics for patients with urgent unmet medical needs.
  • Examples of forward-looking statements include statements we make regarding our intention to continue to innovate and build our patent portfolio.
  • Our actual results and financial condition may differ materially and adversely from the forward-looking statements.