Category - Developments

Developments

Palisade Bio flunks Phase 2 study in post-surgical abdominal adhesions

Palisade Bio’s (NASDAQ:PALI) U.S. Phase 2 PROFILE study evaluating LB1148 for reduction in intra-abdominal adhesions in subjects following elective bowel resection did not achieve its primary endpoint. Of the patients...

August 9, 2023

Developments

Precigen Phase 1/2 AdenoVerse study confirmed as pivotal

The FDA has agreed that the ongoing Phase 1/2 single-arm study of Precigen’s (NASDAQ:PGEN) investigational PRGN-2012 AdenoVerse immunotherapy for the treatment of recurrent respiratory papillomatosis will serve as...

August 9, 2023

Developments

Anixa opens enrollment for Keytruda arm in breast cancer vaccine trial

Anixa Biosciences’ (NASDAQ:ANIX) partner, Cleveland Clinic, has begun enrolling subjects in a treatment arm evaluating the combination of the company’s breast cancer vaccine with Keytruda. The treatment arm is an...

August 7, 2023

Developments

Vistagen posts positive Phase 3 results for nasal spray in social anxiety disorder

Vistagen (NASDAQ:VTGN) announced positive top-line results from its Phase 3 PALISADE-2 trial evaluating the efficacy, safety, and tolerability of fasedienol nasal spray in adults diagnosed with social anxiety disorder...

August 7, 2023

Developments

LENZ partner cleared for Phase 3 presbyopia trial in China

LENZ Therapeutics’ China partner, Ji Xing Pharmaceuticals, was cleared by the Center for Drug Evaluation of the National Medical Products Administration of the PRC to conduct a Phase 3 clinical trial of LNZ100...

August 7, 2023

Developments

Mesoblast receives FDA complete response for BLA in GvHD

Mesoblast (NASDAQ:MESO, ASX:MSB) received a complete response letter to its biologics license application resubmission for remestemcel-L for the treatment of pediatric steroid-refractory acute graft versus host disease...

August 4, 2023

Developments

Femasys begins pivotal trial of non-surgical permanent birth control candidate

Femasys (NASDAQ:FEMY) initiated enrollment in a prospective multi-center pivotal trial to investigate the safety and efficacy of its investigational permanent birth control candidate, FemBloc. The trial is designed to...

August 3, 2023

Developments

Aravive flunks Phase 3 in platinum-resistant ovarian cancer

Aravive’s (NASDAQ:ARAV) Phase 3 AXLerate-OC trial evaluating the safety and efficacy of batiraxcept in platinum-resistant ovarian cancer did not meet its primary endpoint of progression-free survival (PFS) in the pre...

August 3, 2023

Developments

Oramed, Hefei Tianhui in JV to advance oral drug delivery technology

Oramed Pharmaceuticals (NASDAQ, TASE:ORMP) signed a non-binding term sheet with Hefei Tianhui Biotech to establish a joint venture based on Oramed’s oral drug delivery technology. The proposed JV would focus on...

August 2, 2023

Developments

NeuroBo in out-licensing with MThera Pharma

NeuroBo Pharmaceuticals (NASDAQ:NRBO) entered into a term sheet with MThera Pharma detailing terms that NeuroBo will out-license the worldwide rights, outside of Korea, for NB-01 for the treatment of painful diabetic...

August 2, 2023

Category - Developments

Palisade Bio flunks Phase 2 study in post-surgical abdominal adhesions

Precigen Phase 1/2 AdenoVerse study confirmed as pivotal

Anixa opens enrollment for Keytruda arm in breast cancer vaccine trial

Vistagen posts positive Phase 3 results for nasal spray in social anxiety disorder

LENZ partner cleared for Phase 3 presbyopia trial in China

Mesoblast receives FDA complete response for BLA in GvHD

Femasys begins pivotal trial of non-surgical permanent birth control candidate

Aravive flunks Phase 3 in platinum-resistant ovarian cancer

Oramed, Hefei Tianhui in JV to advance oral drug delivery technology

NeuroBo in out-licensing with MThera Pharma

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