Healthcare Industry Developments | BioTuesdays by Kilmer Lucas IR

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

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

Developments

Titan Pharma to sell certain ProNeura assets

Titan Pharmaceuticals (NASDAQ:TTNP) entered into an asset purchase agreement with Fedson for the sale of certain ProNeura assets, including Titan’s portfolio of drug addiction products, in addition to other early...

July 27, 2023

Developments

Carmell to merge with Axoloti Biologix

Carmell Therapeutics (NASDAQ:CTCX) signed a definitive agreement and plan of merger with Axoloti Biologix, a profitable regenerative medicine company developing products for active soft tissue repair, aesthetics and...

July 27, 2023

Developments

Humacyte completes Phase 2/3 enrollment in vascular trauma repair

Humacyte (NASDAQ:HUMA) completed enrollment of its Phase 2/3 vascular trauma trial that is expected to support a BLA filing for Humacyte’s human acellular vessel (HAV) in vascular trauma repair planned for the fourth...

July 26, 2023

Developments

Symetryx ups offer for Check-Cap to $4.60 a share

Closely-held Symetryx increased its non-binding proposal to acquire Check-Cap (NASDAQ:CHEK) to $4.60 a share from $4.35 when it announced its offer on July 18. At last report, Check-Cap had 5.8 million shares...

July 25, 2023

Developments

Enzo sells clinical laboratory to Labcorp for $113.25-million

Enzo Biochem (NYSE:ENZ) closed a transaction to sell certain assets of Enzo’s clinical laboratory division (Enzo Clinical Labs) to Laboratory Corp. of America Holdings (NYSE:LH) for $113.25-million. In accordance with...

July 25, 2023

Developments

IntelGenx updates Montelukast VersaFilm collaboration for Parkinson’s

IntelGenx (TSX:IGX; OTCQB:IGXT) finalized a research grant agreement with Sweden’s Karolinska University Hospital and that the manufacturing of both active and placebo films are underway for a planned multicentre...

July 25, 2023

Developments

Infinity terminates merger accord with MEI Pharma

Infinity Pharmaceuticals (NASDAQ:INFI) terminated its merger agreement to merge with MEI Pharma (NASDAQ:MEIP). At a special meeting of MEI stockholders on July 23, MEI did not obtain stockholder approval for the merger...

July 24, 2023

Developments

Axxess acquires Complia Health

Axxess, a home healthcare technology provider, acquired Complia Health in move that adds more clients, more talent and even greater engagement with leading care providers among the Axxess family. Complia’s roster of...

July 24, 2023

Developments

Advent nabs rare pediatric disease designation for bronchopulmonary dysplasia in preemies

Advent Therapeutics received FDA rare pediatric disease designation for its vitamin A metabolic and reparative respiratory drugs for the prevention of bronchopulmonary dysplasia (BPD) in premature infants. BPD is a rare...

July 20, 2023

Developments

Eliem Therapeutics to explore strategic alternatives

Eliem Therapeutics (NASDAQ:ELYM) completed a review of its business, including the status of its programs, resources, and capabilities, and has decided to halt further development of its Kv7 program and to conduct a...

July 20, 2023

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

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

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

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

Titan Pharma to sell certain ProNeura assets

Carmell to merge with Axoloti Biologix

Humacyte completes Phase 2/3 enrollment in vascular trauma repair

Symetryx ups offer for Check-Cap to $4.60 a share

Enzo sells clinical laboratory to Labcorp for $113.25-million

IntelGenx updates Montelukast VersaFilm collaboration for Parkinson’s

Infinity terminates merger accord with MEI Pharma

Axxess acquires Complia Health

Advent nabs rare pediatric disease designation for bronchopulmonary dysplasia in preemies

Eliem Therapeutics to explore strategic alternatives

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