Biotechnology

Bristol Myers Squibb Presents Late-Breaking Phase 3 Data Demonstrating Health Status Benefits of Mavacamten in Patients with Obstructive Hypertrophic Cardiomyopathy at American College of Cardiology’s 70th Annual Scientific Session

Saturday, May 15, 2021 - 5:15pm

At 30 weeks, the change in Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ OSS) was greater in mavacamten patients than placebo, with similar benefits across all KCCQ subscales.

Key Points: 
  • At 30 weeks, the change in Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ OSS) was greater in mavacamten patients than placebo, with similar benefits across all KCCQ subscales.
  • Moreover, a greater proportion of mavacamten patients achieved a very large, clinically meaningful improvement (\xe2\x89\xa520 points) in the KCCQ OSS, compared to placebo, 36% [33/92] vs. 15% [13/88].
  • A change of at least 5 points is required to be considered clinically significant.
  • Mavacamten reduces cardiac muscle contractility by inhibiting excessive myosin-actin cross-bridge formation that results in hypercontractility, left ventricular hypertrophy and reduced compliance.

Kinos Medical Merges with restor3d

Saturday, May 15, 2021 - 1:42am

b'restor3d is pleased to announce an exciting merger with Kinos Medical, a leading total ankle replacement company.\nrestor3d (Durham, NC), a leader in patient-specific 3D printed implants, is pleased to announce an exciting merger with Kinos Medical, a leading total ankle replacement company.

Key Points: 
  • b'restor3d is pleased to announce an exciting merger with Kinos Medical, a leading total ankle replacement company.\nrestor3d (Durham, NC), a leader in patient-specific 3D printed implants, is pleased to announce an exciting merger with Kinos Medical, a leading total ankle replacement company.
  • restor3d (Durham, NC), was founded with a mission to enable surgeons to repair and reconstruct the human body using 3D printing technologies, advanced biomaterials, and artificial intelligence.
  • The Axiom total ankle is the first biomechanically accurate implant on the market, offering motion in all three anatomic planes, as is seen in the natural ankle,\xe2\x80\x9d said Brian Garvey, CEO of Kinos Medical.
  • Leveraging expertise and experience in 3D printing of key biomedical materials spanning a wide range of properties, restor3d seeks to improve medical device solutions.\nView source version on businesswire.com: https://www.businesswire.com/news/home/20210514005572/en/\n'

Greenbrook TMS Reports First Quarter Operational and Financial Results

Friday, May 14, 2021 - 10:01pm

TMS therapy provides local electromagnetic stimulation to specific brain regions known to be directly associated with mood regulation.

Key Points: 
  • TMS therapy provides local electromagnetic stimulation to specific brain regions known to be directly associated with mood regulation.
  • In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances contain forward-looking information.
  • Rather, these measures are provided as additional information to complement those IFRS measures by providing further understanding of our results of operations from management\xe2\x80\x99s perspective.
  • In addition to our results determined in accordance with IFRS, we use non-IFRS measures including, \xe2\x80\x9cEBITDA\xe2\x80\x9d and \xe2\x80\x9cAdjusted EBITDA\xe2\x80\x9d.

Veracyte Announces Data Reinforcing the Diagnostic Performance and Utility of the Envisia Genomic Classifier in ILD Diagnosis

Friday, May 14, 2021 - 9:35pm

(Nasdaq: VCYT) announced that data reinforcing the diagnostic performance and utility of the Envisia\xc2\xae Genomic Classifier are being shared at the American Thoracic Society (ATS) 2021 International Conference, taking place today through May 18.

Key Points: 
  • (Nasdaq: VCYT) announced that data reinforcing the diagnostic performance and utility of the Envisia\xc2\xae Genomic Classifier are being shared at the American Thoracic Society (ATS) 2021 International Conference, taking place today through May 18.
  • The Envisia Genomic Classifier detects a genomic pattern of usual interstitial pneumonia (UIP) to improve ILD diagnostic and prognostic confidence.
  • Researchers retrospectively analyzed 144 samples from ILD patients enrolled in two prior, independent clinical validation cohorts.
  • \xe2\x80\x9cWe are excited to execute on this plan, beginning with the Envisia classifier.\xe2\x80\x9d\nMultiple abstracts relating to the Envisia Genomic Classifier can be viewed at the links below.

Gilead Sciences to Present at Upcoming Investor Conferences

Friday, May 14, 2021 - 9:05pm

b'Gilead Sciences, Inc. (Nasdaq: GILD) announced today that its executives will be speaking at the following investor conferences:\nCowen Annual Virtual Oncology Innovation Summit on Friday, May 21 at 12:00pm ET\nJefferies Virtual Healthcare Conference on Tuesday, June 1 at 1:30pm ET\nBernstein Annual Strategic Decisions Conference on Wednesday, June 2 at 4:30pm ET\nGoldman Sachs Annual Global Healthcare Conference on Wednesday, June 9 at 2:10pm ET\nThe live webcasts can be accessed at the company\xe2\x80\x99s investors page at investors.gilead.com.

Key Points: 
  • b'Gilead Sciences, Inc. (Nasdaq: GILD) announced today that its executives will be speaking at the following investor conferences:\nCowen Annual Virtual Oncology Innovation Summit on Friday, May 21 at 12:00pm ET\nJefferies Virtual Healthcare Conference on Tuesday, June 1 at 1:30pm ET\nBernstein Annual Strategic Decisions Conference on Wednesday, June 2 at 4:30pm ET\nGoldman Sachs Annual Global Healthcare Conference on Wednesday, June 9 at 2:10pm ET\nThe live webcasts can be accessed at the company\xe2\x80\x99s investors page at investors.gilead.com.
  • The replays will be available for at least 30 days following the presentation.\nGilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people.
  • The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer.
  • Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.\nFor more information on Gilead Sciences, please visit the company\xe2\x80\x99s website at www.gilead.com , follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.\nView source version on businesswire.com: https://www.businesswire.com/news/home/20210514005524/en/\n'

Atara Biotherapeutics Reports Inducement Grants Under Nasdaq Listing Rule 5635(C)(4)

Friday, May 14, 2021 - 9:01pm

With our lead program in Phase 3 clinical development, Atara is the most advanced allogeneic T-cell immunotherapy company and intends to rapidly deliver off-the-shelf treatments to patients with high unmet medical need.

Key Points: 
  • With our lead program in Phase 3 clinical development, Atara is the most advanced allogeneic T-cell immunotherapy company and intends to rapidly deliver off-the-shelf treatments to patients with high unmet medical need.
  • Improving patients\xe2\x80\x99 lives is our mission and we will never stop working to bring transformative therapies to those in need.
  • Atara is headquartered in South San Francisco and our leading-edge research, development and manufacturing facility is based in Thousand Oaks, California.
  • For additional information about the company, please visit atarabio.com and follow us on Twitter and LinkedIn .\nView source version on businesswire.com: https://www.businesswire.com/news/home/20210514005502/en/\n'

Quidel’s QuickVue® At-Home OTC COVID-19 Test Now Available for Sale Through Amazon

Friday, May 14, 2021 - 9:10pm

The QuickVue\xc2\xae At-Home OTC COVID-19 Test has not been FDA cleared or approved.

Key Points: 
  • The QuickVue\xc2\xae At-Home OTC COVID-19 Test has not been FDA cleared or approved.
  • An innovator for over 40 years in the medical device industry, Quidel pioneered the first FDA-cleared point-of-care test for influenza in 1999 and was the first to market a rapid SARS-CoV-2 antigen test in the U.S.
  • For more information about Quidel, visit quidel.com .\nThis press release contains forward-looking statements within the meaning of the federal securities laws that involve material risks, assumptions and uncertainties.
  • You are cautioned not to place undue reliance on these forward-looking statements, which reflect management\xe2\x80\x99s analysis only as of the date of this press release.

Axonics® Announces Closing of Public Stock Offering and Full Exercise of Underwriters’ Option to Purchase Additional Stock

Friday, May 14, 2021 - 9:05pm

b'Axonics, Inc. (Nasdaq: AXNX), (\xe2\x80\x9cAxonics\xe2\x80\x9d), a global medical technology company that is developing and commercializing novel products for the treatment of bladder and bowel dysfunction, today announced the closing of its public offering of 4,025,000 shares of common stock at the public offering price of $50.00 per share, which includes the exercise in full by the underwriters of the underwriters\xe2\x80\x99 option to purchase 525,000 additional shares at the public offering price.

Key Points: 
  • b'Axonics, Inc. (Nasdaq: AXNX), (\xe2\x80\x9cAxonics\xe2\x80\x9d), a global medical technology company that is developing and commercializing novel products for the treatment of bladder and bowel dysfunction, today announced the closing of its public offering of 4,025,000 shares of common stock at the public offering price of $50.00 per share, which includes the exercise in full by the underwriters of the underwriters\xe2\x80\x99 option to purchase 525,000 additional shares at the public offering price.
  • The gross proceeds from the offering to Axonics, before deducting underwriting discounts and commissions and estimated offering expenses, were approximately $201.3 million.\nBofA Securities, Piper Sandler and SVB Leerink acted as the joint book-running managers for the offering and representatives of the underwriters.
  • A final prospectus supplement and accompanying prospectus relating to the offering have been filed with the SEC and are available on the SEC\xe2\x80\x99s website located at http://www.sec.gov .
  • 6105 or by email at syndicate@svbleerink.com .

NeuBase Therapeutics to Participate in Upcoming Investor Conferences in May 2021

Friday, May 14, 2021 - 5:30pm

b'NeuBase is accelerating the genetic revolution by developing a new class of precision genetic medicines which can be designed to increase, decrease, or change gene function, as appropriate, to resolve genetic defects that drive disease.

Key Points: 
  • b'NeuBase is accelerating the genetic revolution by developing a new class of precision genetic medicines which can be designed to increase, decrease, or change gene function, as appropriate, to resolve genetic defects that drive disease.
  • NeuBase\xe2\x80\x99s targeted PATrOL\xe2\x84\xa2 therapies are centered around its proprietary drug scaffold to address genetic diseases at the DNA or RNA level by combining the highly targeted approach of traditional genetic therapies with the broad organ distribution capabilities of small molecules.
  • With an initial focus on silencing disease-causing mutations in debilitating neurological, neuromuscular, and oncologic disorders, NeuBase is committed to redefining medicine for the millions of patients with both common and rare conditions.
  • To learn more, visit www.neubasetherapeutics.com .\n'

Outlook on the Medical Enzyme Technology Global Market to 2028 - Rising Production of Biopharmaceutical Products Presents Opportunities - ResearchAndMarkets.com

Friday, May 14, 2021 - 6:00pm

Abnormalities in enzyme metabolism system leads to many metabolic diseases.

Key Points: 
  • Abnormalities in enzyme metabolism system leads to many metabolic diseases.
  • Many enzymes are being widely used in the clinical examination as a specific disease marker.
  • Enzymes are the preferred markers in various disease states such as myocardial infarction, jaundice, pancreatitis, cancer, and neurodegenerative disorders.
  • However, the market for normothermic machine perfusion is estimated to grow at a higher CAGR of 4.4% during the forecast period.\nThe medical enzyme technology market, by application, is segmented into disease treatment, diagnostic tools, biomedical research, and others.