Healthcare Industry Developments | BioTuesdays by Kilmer Lucas IR

Developments

Reviva completes Phase 3 enrollment for brilaroxazine in schizophrenia

Reviva Pharmaceuticals (NASDAQ:RVPH) completed enrollment in the pivotal Phase 3 RECOVER study, evaluating brilaroxazine for schizophrenia, with 402 patients enrolled across 40 sites in the U.S., Europe, and Asia. “We...

August 17, 2023

Developments

Minghui enrolls first patient in Phase 3 trial for atopic dermatitis

Closely held Minghui Pharmaceutical enrolled the first patient in the Phase 3 clinical study for MH004 cream targeting mild-to-moderate atopic dermatitis, a prevalent skin condition. The randomized, double-blind, and...

August 17, 2023

Developments

Keystone Dental Holdings to combine with Check-Cap

Closely held Keystone Dental Holdings agreed to a definitive business combination with Check-Cap (NASDAQ:CHEK), with stockholders of Keystone becoming majority holders of the combined company. If completed, the business...

August 17, 2023

Developments

Eyenovia acquires U.S. rights for ocular asset from Formosa Pharmaceuticals

Eyenovia (NASDAQ:EYEN) entered an agreement with Taiwan-based Formosa Pharmaceuticals (TWO:6838) to acquire the exclusive U.S. rights to distribute and sell Formosa’s APP13007 (clobetasol propionate ophthalmic...

August 16, 2023

Developments

FDA clears Revance’s DAXXIFY injection for cervical dystonia

The FDA approved the first therapeutic indication for Revance Therapeutics’ (NASDAQ:RVNC) DAXXIFY for injection for the treatment of cervical dystonia in adults. Cervical dystonia is a chronic, debilitating disease in...

August 14, 2023

Developments

Anixa to present ovarian cancer CAR-T therapy at CAR-TCR Summit

Dr. Pamela Garzone, chief development officer of Anixa Biosciences (NASDAQ:ANIX) will present, “Developing a CAR-T for Ovarian Cancer and Other Solid Tumors,” at the 8th Annual CAR-TCR Summit in Boston...

August 14, 2023

Developments

Plus Therapeutics posts positive Phase 1 data in leptomeningeal metastases

Plus Therapeutics (NASDAQ:PSTV) reported positive data from the ReSPECT-LM clinical study evaluating the company’s lead radiotherapeutic, rhenium (Re-186) obisbemeda, for the treatment of leptomeningeal metastases (LM)...

August 11, 2023

Developments

IntelGenx first CDMO packaging accord to generate $9-million in revenue over 3 years

IntelGenx (TSX:IGX; OTCQB:IGXT) expects to generate $9-million in revenue over three years from an agreement for packaging a pharmaceutical oral film product that an undisclosed contract development and manufacturing...

August 11, 2023

Developments

Inversago Pharma accepts $1.1-billion offer from Novo Nordisk

Closely held Inversago Pharma of Montreal agreed to be acquired by Denmark’s Novo Nordisk for up to $1.1-billion (U.S.) in cash if certain development and commercial milestones are achieved. Inversago Pharma is a...

August 10, 2023

Developments

Absci, Caltech receive Gates grant to develop affordable HIV vaccines

Absci (NASDAQ:ABSI) and leading researchers at the California Institute of Technology received a grant from the Bill & Melinda Gates Foundation for a joint effort to discover affordable HIV therapeutic vaccinations...

August 10, 2023

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

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

Developments

Avenue Therapeutics achieves high potency and full efficacy in a model of generalized seizures

Avenue Therapeutics’ (NASDAQ:ATXI) BAER-101, its potentially best-in-class selective GABA-A alpha2,3 positive allosteric modulator significantly suppressed seizures in a translational animal model of absence epilepsy...

August 1, 2023

Developments

IntelGenx completes enrollment in Montelukast VersaFilm Phase 2a trial in AD

IntelGenx (TSX:IGX; OTCQB:IGXT) completed patient enrollment in the ongoing Montelukast VersaFilm Phase 2a BUENA clinical trial in patients with mild-to-moderate Alzheimer’s disease (AD). The company successfully...

August 1, 2023

Developments

Anixa Biosciences receives U.S. notice of additional ovarian cancer vaccine patent

The U.S. Patent and Trademark Office (USPTO) issued a notice of allowance broadening protection of Anixa Biosciences’ (NASDAQ:ANIX) novel ovarian cancer vaccine technology, which has been exclusively licensed from, and...

July 27, 2023

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