Kala Pharmaceuticals Announces FDA Acceptance of IND Application for KPI-012 for the Treatment of PCED
-- On-track to initiate Phase 2b trial in 1Q 2023; Topline data expected in 1Q 2024 -- -- Received remaining $25...
Clinical Trial
Acer Therapeutics and Relief Therapeutics Announce U.S. FDA Approval of OLPRUVA™ for Patients with Urea Cycle Disorders
New FDA-approved formulation for patients living with urea cycle disorders $42.5 million of non-dilutive debt funding available to Acer that,...
TRACON Pharmaceuticals Announces up to $30M Non-Recourse Non-Dilutive Financing Related to Arbitration Award Decision Expected in Q1 2023
Initial $3.5M Funding Maintains Cash Runway of Mid-2023SAN DIEGO, Dec. 27, 2022 (GLOBE NEWSWIRE) -- TRACON Pharmaceuticals (Nasdaq: TCON), a...
Junshi Biosciences and Hikma Sign Exclusive Licensing Agreement for Cancer Treatment Drug Toripalimab for the Middle East and North Africa Region
SHANGHAI, China, Dec. 26, 2022 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences”, HKEX: 1877; SSE: 688180), a...
Junshi Biosciences and Coherus Share Update on the FDA Review of the Biologics License Application (BLA) for Toripalimab as Treatment for Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC)
- FDA has been unable to travel to China to conduct the required site inspection resulting in delayed action on...
Coherus and Junshi Biosciences Share Update on the FDA Review of the Biologics License Application (BLA) for Toripalimab as Treatment for Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC)
- FDA has been unable to travel to China to conduct the required site inspection resulting in delayed action on...
Outlook Therapeutics® Enters Definitive Agreement for $31.8 Million Unsecured Convertible Promissory Note
ISELIN, N.J., Dec. 23, 2022 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK) (the “Company”), a biopharmaceutical company working to...
MediWound Expands NexoBrid’s Global Presence with Marketing Approval in Japan
Japan is the first country in the world to approve NexoBrid for people of all ages; pediatric and adult populations Exclusive...
CytoDyn to Hold Webcast to Discuss the Performance of Leronlimab in Clinical Trials and Recent Charges Against Former CEO
VANCOUVER, Washington, Dec. 23, 2022 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a biotechnology company developing...
180 Life Sciences Corp. Announces Closing of $6 Million Registered Direct Offering Priced At-The-Market Under Nasdaq Rules
PALO ALTO, Calif., Dec. 23, 2022 (GLOBE NEWSWIRE) -- 180 Life Sciences Corp. (NASDAQ: ATNF, “180 Life Sciences” or the...
Immutep Announces Successful Meeting with the FDA on Eftilagimod Alpha plus Chemotherapy for the Treatment of Metastatic Breast Cancer
Agreement with FDA on Phase II/III trial design positions the Company to exploit eftilagimod alpha’s potential to address high unmet...
atai Life Sciences Announces Results from the Kures Therapeutics Phase 1 Trial of KUR-101
- This two-part phase 1 trial in healthy volunteers was designed to assess the safety, pharmacokinetics, and analgesic activity of...
Immuron Receives FDA Approval for Travelan IND Application
Highlights: Immuron receives U.S. Food and Drug administration (FDA) approval for Travelan Investigational New Drug (IND) application IND to evaluate...
Outlook Therapeutics Announces $25 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules
ISELIN, N.J., Dec. 23, 2022 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to develop and...
BioNTech Initiates Phase 1 Clinical Trial for Malaria Vaccine Program BNT165
BioNTech aims to develop the first mRNA-based vaccine for Malaria prevention based on a novel multi-antigen vaccine approachFirst evaluated candidate...
Bavarian Nordic Enters Agreement Valued up to USD 83 Million with the U.S. Department of Defense to Further Advance the Development of Equine Encephalitis Virus Vaccine
Total considerations of up to USD 83 million with the majority secured for Phase 2 development of the multivalent MVA-BN®...
DBV Technologies Announces FDA Has Lifted Partial Clinical Hold on VITESSE Phase 3 Pivotal Trial
Montrouge, France, December 23, 2022 DBV Technologies Announces FDA Has Lifted Partial Clinical Hold on VITESSE Phase 3 Pivotal Trial ...
Valneva Completes BLA Submission to U.S. FDA for its Single-Shot Chikungunya Vaccine Candidate
Saint-Herblain (France), December 23, 2022 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announces that...
Mesoblast and Oaktree Extend Availability Period of Undrawn Tranches of Financing Facility
NEW YORK, Dec. 22, 2022 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory...
Applied Molecular Transport Announces Top-line Phase 2 Results from LOMBARD Monotherapy Trial of Oral AMT-101 in Patients with Moderate-to-Severe Ulcerative Colitis
– Similar clinical remission rates observed in patients receiving AMT-101 monotherapy compared to placebo at week 12 – AMT-101 was...