Healthcare Industry Developments | BioTuesdays by Kilmer Lucas IR

Developments

Talaris Therapeutics to merge with Tourmaline Bio

Talaris Therapeutics (NASDAQ:TALS) and closely-held Tourmaline Bio agreed to merge in an all-stock transaction. The combined company will focus on advancing Tourmaline’s lead program, TOUR006, a potentially best-in...

June 22, 2023

Developments

FDA lifts clinical hold on DiaMedica ischemic stroke trial

The FDA has removed a clinical hold placed on DiaMedica’s (NASDAQ:DMAC) investigational new drug application for its ReMEDy2 Phase 2/3 clinical trial studying DM199 in the treatment of acute ischemic stroke (AIS) and...

June 21, 2023

Developments

Annovis Bio gets positive DSMB review of Phase 3 PD trial

A Data and Safety Monitoring Board (DSMB) recommended that Annovis Bio (NYSE:ANVS) continue its Phase 3 trial as originally designed of buntanetap, a drug for early Parkinson’s disease (PD) patients. The DSMB decision...

June 20, 2023

Developments

Precigen receives FDA breakthrough nod for AdenoVerse in RRP

The FDA granted breakthrough therapy designation for Precigen’s (NASDAQ:PGEN) investigational PRGN-2012 AdenoVerse immunotherapy for the treatment of recurrent respiratory papillomatosis (RRP). Standard-of-care for RRP...

June 20, 2023

Developments

Rhythm presents BMI reduction data in hypothalamic obesity

Rhythm Pharmaceuticals (NASDAQ:RYTM) presented data that showed meaningful weight loss was sustained and progressed in patients with hypothalamic obesity treated with its setmelanotide for six months as part of the long...

June 19, 2023

Developments

Hepion to present 2 posters at EASL International Liver Congress

Hepion Pharmaceuticals (NASDAQ:HEPA) will present two abstracts for poster presentations at the European Association for the Study of the Liver (EASL) International Liver Congress 2023 taking place June 21 – 24 in...

June 16, 2023

Developments

Hepion Phase 2b ASCEND-NASH trial passes key safety milestone

A data and safety monitoring board (DSMB) has reviewed the current data for Hepion Pharmaceuticals’ (NASDAQ:HEPA) ASCEND-NASH Phase 2b trial with rencofilstat and issued a “study may proceed without modification”...

June 15, 2023

Developments

2seventy’s CAR-T trial halted after pediatric death

2seventy bio’s (NASDAQ:TSVT) partner, Seattle Children’s Hospital, paused a Phase 1 CAR T-cell therapy trial for pediatric acute myeloid leukemia after a patient death. The child was the first to receive the second dose...

June 15, 2023

Developments

Zucara receives additional JDRF funding for Phase 2 study

Closely held Zucara Therapeutics received an additional $2-million in funding from JDRF (Juvenile Diabetes Research Foundation) to support Zucara’s planned Phase 2a study of the effect of its ZT-01 on nocturnal...

June 15, 2023

Developments

Confo, AbCellera in GPCR-targeting antibody discovery program

Confo Therapeutics of Belgium entered into a research collaboration with AbCellera Biologics (NASDAQ:ABCL) for the discovery of therapeutic antibody candidates targeting two undisclosed GPCR targets (G protein-coupled...

June 15, 2023

Developments

Blue Water acquires 6 FDA-approve drugs across various indication

Blue Water Biotech (NASDAQ:BWV) signed asset purchase agreements with WraSer and Xspire Pharma to acquire six FDA-approved assets across multiple indications, including cardiology, otic infections, and pain management...

June 14, 2023

Developments

Annovis Bio completes enrollment in Phase 3 Parkinson’s trial

Annovis Bio’s (NYSE:ANVS) Parkinson’s disease (PD) Phase 3 clinical trial of its lead compound, buntanetap, reached full enrollment in a record nine months after it began. Since the first patient was dosed in late...

June 8, 2023

Developments

FibroGen flunks Phase 3 in non-ambulatory DMD

FibroGen’s (NASDAQ: FGEN) Phase 3 LELANTOS-1 placebo-controlled trial of pamrevlumab for the treatment of non-ambulatory patients with Duchenne muscular dystrophy (DMD) on background corticosteroids did not meet the...

June 8, 2023

Developments

Vistagen posts positive Phase 2A study in women with menopausal hot flashes

Vistagen (NASDAQ:VTGN) reported that PH80, one of the company’s five investigational neuroactive nasal sprays, demonstrated statistically significant efficacy versus placebo in an exploratory Phase 2A study for the...

June 7, 2023

Developments

Check-Cap reviewing strategic alternatives

Check-Cap (NASDAQ:CHEK) is exploring strategic alternatives, such as the sale of all or part of the company, licensing, merger or reverse merger, and has retained Ladenburg Thalmann as an advisor to the company. Check...

June 6, 2023

Developments

Synlogic initiates pivotal study for phenylketonuria

Synlogic (NASDAQ:SYBX) initiated Synpheny-3, a global, Phase 3 study evaluating the efficacy and safety of SYNB1934 as a potential treatment for phenylketonuria (PKU), a rare inherited disorder that causes an amino...

June 5, 2023

Developments

Jazz, Zymeworks present positive pivotal data in BTC

Jazz Pharmaceuticals (NASDAQ:JAZZ) and Zymeworks (NASDAQ:ZYME) presented positive pivotal trial data, including new data on progression-free survival (PFS), from the Phase 2b HERIZON-BTC-01 trial of the bispecific...

June 5, 2023

Developments

AMA unveils new CPT Category 1 codes for Profound Medical’s TULSA-PRO

Profound Medical (NASDAQ:PROF; TSX:PRN) announced that, with sponsorship and support from multiple physician specialty societies, it has received from the American Medical Association (AMA) three new Current Procedural...

June 2, 2023

Developments

Vistagen presents Phase 3 data for SAD

Vistagen (NASDAQ:VTGN) presented positive safety and exploratory efficacy data at the American Society for Clinical Psychopharmacology annual meeting in Miami from its large Phase 3 open-label study of fasedienol nasal...

June 1, 2023

Developments

Ionis posts late-stage clinical progress in HAE

Ionis Pharmaceuticals (NASDAQ:IONS) reported positive clinical progress with donidalorsen, its late-stage investigational prophylactic therapy for hereditary angioedema (HAE). Topline two-year open-label extension (OLE)...

June 1, 2023

Developments

Glyscend posts positive topline Phase 2a results for Type 2 diabetes and obesity

Closely-held Glyscend Therapeutics reported that Phase 1 and Phase 2a clinical trials demonstrated that the novel mechanism of its lead candidate, GLY-200, offers significant and clinically relevant reductions in...

May 31, 2023

Developments

IntelGenx unveils short-term commercial objectives

IntelGenx (TSX:IGX; OTCQB:IGXT) unveiled a plan focussed on near-term revenue generation. “There is no question in my mind that IntelGenx has great science, services, assets, and people,”Dwight Gorham, the company’s...

May 31, 2023

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