SI-BONE Announces Preliminary Revenue for the Fourth Quarter and Full Year 2022
Fourth Quarter revenue of $31.7 - $31.9 million representing growth of approximately 26%Fiscal Year 2022 revenue of $106.1 - $106.3...
COVID-19
NGM Bio Outlines Corporate Strategy and Provides Guidance on Key Priorities
NGM Bio’s three-pronged corporate strategy includes the following components:Focus internal clinical development efforts on solid tumor oncology portfolioGenerate next-generation biologics...
Biora Therapeutics Receives Pre-IND Feedback from FDA and Provides Update on Key Programs for 2023
Company is on track to move into the clinic with its lead targeted therapeutics programSAN DIEGO, Jan. 09, 2023 (GLOBE...
Annexon Highlights Strategic Focus to Advance Four Flagship Complement Programs through Late-Stage Development and Progress Across Three Therapeutic Franchises
Mid-stage and Pivotal Trials of ANX005, ANX007 and ANX1502 Poised to Achieve Numerous Catalysts in Multiple Disease Indications Well-Capitalized with...
Merus Provides 2023 Outlook
- As of year-end 2022, more than 150 patients with NRG1 gene fusion positive (“NRG1+”) cancer have been treated with...
Viridian Announces Positive Data from Ongoing Phase 1/2 Trial Evaluating Low Dose VRDN-001 in Patients with Thyroid Eye Disease (TED)
- Significant and rapid improvement in both signs and symptoms of TED after two infusions of 3 mg/kg, generally consistent...
OpGen Announces Pricing of $7.5 Million Public Offering
ROCKVILLE, Md., Jan. 06, 2023 (GLOBE NEWSWIRE) -- OpGen, Inc. (Nasdaq: OPGN, “OpGen” or “the Company”), a precision medicine company...
Assure Holdings Announces Acquisition of NervePro
DENVER, Jan. 06, 2023 (GLOBE NEWSWIRE) -- Assure Holdings Corp. (the “Company” or “Assure”) (NASDAQ: IONM), a provider of intraoperative...
Madrigal Announces Additional Positive Results from the Pivotal Phase 3 MAESTRO-NASH Clinical Trial of Resmetirom for the Treatment of NASH with Liver Fibrosis
As previously reported, resmetirom demonstrated improvements in NASH and liver fibrosis on liver biopsies, the primary endpoints of the MAESTRO-NASH...
Novan Submits New Drug Application to the U.S. FDA for Berdazimer Gel, 10.3% (SB206) for the Treatment of Molluscum Contagiosum
– Potential FDA approval anticipated in first quarter 2024, assuming the filing is accepted by the FDA and under standard...
Icosavax Provides Corporate Update and Anticipated Milestones for 2023
- Recently reported positive six-month immunogenicity data for IVX-121 against RSV; first clinical evidence of potential differentiation on durability with...
Aquestive Therapeutics Provides Business Update and Outlines Key 2023 Objectives
Anticipates commencing pivotal pharmacokinetic (PK) trial for AQST-109 (epinephrine sublingual film) in second half of 2023 Anticipates receipt in the...
Ocular Therapeutix™ Provides 2022 Year End Corporate Update and Reviews Expected 2023 Milestones
Dextenza® Net Product Revenue in the Fourth Quarter of 2022 is Estimated to be $13.6 million, Growing Approximately 14% Over...
BiondVax’s Innovative Inhaled COVID-19 Therapy Virtually Eliminated SARS-COV-2 Virus in Preclinical In Vivo Study
Hamsters infected with SARS-COV-2 and then treated with BiondVax’s inhaled anti-COVID-19 nanosized antibodies (NanoAbs) had over 30-times lower lung viral...
Aclaris Therapeutics Provides 2023 Outlook
WAYNE, Pa., Jan. 06, 2023 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing...
Nabriva Therapeutics Provides Corporate Update
-Company To Focus on Preserving Cash to Fund Orderly Wind Down of Operations- -Company To Continue Work With Torreya Capital...
Mersana Therapeutics Provides Business Update and Announces Strategic Objectives and Expected Milestones
Report top-line data from UPLIFT registrational trial in mid-2023, submit potential BLA around year end 2023, and prepare for potential...
Microbot Medical Announces MedTech Industry Veteran Joe Mullings will Moderate the Next ‘Access-Ability Live by MBOT’ Webinar
Panel of Proven Medical Device Entrepreneurs and Surgical Robotics Pioneers Will Share Their Personal Experiences of Taking Innovative New Technologies...
atai Life Sciences Announces Results from Phase 2a Trial of PCN-101 (R-ketamine) for Treatment-Resistant Depression
NEW YORK and BERLIN, Jan. 06, 2023 (GLOBE NEWSWIRE) -- atai Life Sciences (NASDAQ: ATAI) (“atai” or “the Company”), a...
Alvotech and Teva Announce Acceptance of U.S. Biologics License Application for AVT04, a Proposed Biosimilar to Stelara® (ustekinumab)
The U.S. Food and Drug Administration’s (FDA) regulatory review is anticipated to be completed in the second half of 2023Stelara®...