Healthcare Industry Developments | BioTuesdays by Kilmer Lucas IR

Developments

Opus Genetics doses first patient with gene therapy in LCAS

Closely-held Opus Genetics dosed the first patient in its Phase 1/2, first-in-human clinical trial of OPGx-LCA5, an adeno-associated virus 8 vector designed to precisely deliver a functional LCA5 gene to the outer...

September 7, 2023

Developments

Arcutis posts positive long-term roflumilast cream results in AD

Arcutis Biotherapeutics (NASDAQ:ARQT) reported positive interim results from the INTEGUMENT-OLE long-term, open-label study of roflumilast cream 0.15% in adults and children ages six years and older with atopic...

September 7, 2023

Developments

Cantor boosts biotech research with Josh Schimmer, Eric Schmidt

Cantor Fitzgerald bolstered its healthcare and biotech equity research team with the addition of Josh Schimmer, M.D., and Eric Schmidt, Ph.D. “Having two of the most highly regarded analysts in the biotechnology...

September 6, 2023

Developments

Palisade Bio in GI-licensing deal with Giliant Pharma

Palisade Bio (NASDAQ:PALI) entered into a licensing agreement with closely-held Giliant Pharma for the exclusive worldwide rights to develop, manufacture and commercialize Giiant’s proprietary targeted prodrug platform...

September 6, 2023

Developments

Tonix fails Phase 2 pain study; holds out hope in fatigue

Tonix Pharmaceuticals Holding’s (NASDAQ:TNXP) TNX-102 SL did not achieve the pre-specified primary endpoint of improving Long COVID pain intensity scores at week 14 in the Phase 2 PREVAIL study. However, TNX-102 showed...

September 5, 2023

Developments

Plus Therapeutics initiates Part B of ReSPECT-LM Phase 1/2a trial for LM

Plus Therapeutics (NASDAQ:PSTV) treated the first patient in Part B (Cohort 4) of the ReSPECT-LM Phase 1/2a dose escalation clinical trial of rhenium obisbemeda for the treatment of leptomeningeal metastases (LM) from...

September 5, 2023

Developments

Sage in reorganization to support launch of ZURZUVAE, advance pipeline

Sage Therapeutics (NASDAQ:SAGE) plans to reorganize its business operations and pipeline priorities to support goals for long-term business growth, including the planned commercial launch of ZURZUVAE for women with...

August 31, 2023

Developments

Ampio Pharmaceuticals unveils reverse stock split

The board of Ampio Pharmaceuticals (NYSEA:AMPE) approved a 20-to-1 reverse stock split of the company’s common stock, to be effective at close on Sept. 11. Ampio’s common stock is expected to begin trading on a...

August 31, 2023

Developments

NRx Pharmaceuticals submits IND for chronic pain

NRx Pharmaceuticals (NASDAQ:NRXP) submitted an investigational new drug (IND) application to the FDA for the use of NRX-101 to treat chronic pain. The IND application leverages pioneering research on the use of D...

August 30, 2023

Developments

Outlook Therapeutics receives CRL in wet AMD

Outlook Therapeutics (NASDAQ:OTLK) received a complete response letter (CRL) to the company’s biologics license application (BLA) for ONS-5010, an investigational ophthalmic formulation of bevacizumab under development...

August 30, 2023

Developments

Zealand Pharma gets FDA priority review in congenital hyperinsulinism

The FDA granted priority review designation for Zealand Pharma’s (NASDAQ:ZEAL; CVR-no. 20045078) dasiglucagon for the prevention and treatment of hypoglycemia in pediatric patients seven days of age and older with...

August 30, 2023

Developments

AEON presents positive Phase results in cervical dystonia

AEON Biopharma (NYSE:AEON) presented positive results from its Phase 2 clinical study of ABP-450 for the treatment of cervical dystonia (CD), a chronic and debilitating neurologic condition affecting the muscles of the...

August 29, 2023

Developments

Anixa Biosciences treats third patient in ovarian cancer CAR-T clinical trial

Anixa Biosciences (NASDAQ:ANIX), in partnership with Moffitt Cancer Center, commenced treatment of the third patient in the ongoing clinical trial of Anixa’s novel chimeric antigen receptor T-cell (CAR-T) therapy...

August 28, 2023

Developments

ANI Pharma announces FDA approval and launch of Estradiol Gel, 0.1%

ANI Pharmaceuticals (NASDAQ:ANIP) received FDA approval for the abbreviated new drug application for Estradiol Gel, 0.1%, to treat and prevent hot flashes. ANI’s Estradiol Gel, 0.1%, is the generic version of the...

August 28, 2023

Developments

XyloCor presents positive Phase 2 data for refractory angina

XyloCor Therapeutics presented positive results from the Phase 2 portion of its Phase 1/2 EXACT clinical trial of its lead gene therapy candidate, XC001, for the treatment of refractory angina at the European Society of...

August 25, 2023

Developments

SK bioscience, Vaxxas in pact for needle-free patch delivery of typhoid vaccine

SK bioscience of South Korea entered into a collaboration agreement with Australia’s Vaxxas to develop a second-generation typhoid conjugate vaccine with support from Wellcome, a global charitable foundation supporting...

August 24, 2023

Developments

EMA accepts Novaliq’s CyclASol for regulatory review in DED

The European Medicines Agency (EMA) has accepted the marketing authorization application (MAA) from Novaliq GmbH for CyclASol (ciclosporin ophthalmic solution) for regulatory review. CyclASol is an investigational new...

August 24, 2023

Developments

Tarsier Pharma misses endpoint in Phase 3 uveitis trial

Closely-held Tarsier Pharma of Israel did not reach the primary endpoint in the non-infectious anterior uveitis TRS4VISION trial with its TRS01 eye drops. However, a post hoc analysis of the data demonstrates the much...

August 23, 2023

Developments

Relmada doses first patient in Phase 3 trial for MDD

Relmada Therapeutics (NASDAQ:RLMD) announced dosing the first patient in the Relight Phase 3, randomized, double-blind, placebo-controlled trial evaluating REL-1017 as an adjunctive treatment of major depressive...

August 23, 2023

Developments

LEO Pharma to acquire Timber Pharmaceuticals

LEO US Holding, a wholly-owned subsidiary of LEO Pharma A/S, entered into a definitive agreement to acquire Timber Pharmaceuticals (NYSEA:TMBR) in a total transaction value of up to $36-million. Timber is eligible to...

August 21, 2023

Developments

Anebulo gets FDA nod for Phase 3 in acute cannabinoid intoxication

The FDA provided positive feedback to Anebulo Pharmaceuticals (NASDAQ:ANEB) for its Phase 3 program of ANEB-001 in patients suffering from acute cannabinoid intoxication (ACI) and substance abuse.

August 21, 2023

Developments

MindBio receives first LSD batch for home psychedelic clinical trials

MindBio Therapeutics (CSE:MBIO; Frankfurt:WF6) received its first batch of MB22001 ready for take-home use in Phase 2 psychedelic microdosing clinical trials. MB22001 is a proprietary titratable form of lysergic acid...

August 18, 2023

Opus Genetics doses first patient with gene therapy in LCAS

Arcutis posts positive long-term roflumilast cream results in AD

Cantor boosts biotech research with Josh Schimmer, Eric Schmidt

Palisade Bio in GI-licensing deal with Giliant Pharma

Tonix fails Phase 2 pain study; holds out hope in fatigue

Plus Therapeutics initiates Part B of ReSPECT-LM Phase 1/2a trial for LM

Sage in reorganization to support launch of ZURZUVAE, advance pipeline

Ampio Pharmaceuticals unveils reverse stock split

NRx Pharmaceuticals submits IND for chronic pain

Outlook Therapeutics receives CRL in wet AMD

Zealand Pharma gets FDA priority review in congenital hyperinsulinism

AEON presents positive Phase results in cervical dystonia

Anixa Biosciences treats third patient in ovarian cancer CAR-T clinical trial

ANI Pharma announces FDA approval and launch of Estradiol Gel, 0.1%

XyloCor presents positive Phase 2 data for refractory angina

SK bioscience, Vaxxas in pact for needle-free patch delivery of typhoid vaccine

EMA accepts Novaliq’s CyclASol for regulatory review in DED

Tarsier Pharma misses endpoint in Phase 3 uveitis trial

Relmada doses first patient in Phase 3 trial for MDD

LEO Pharma to acquire Timber Pharmaceuticals

Anebulo gets FDA nod for Phase 3 in acute cannabinoid intoxication

MindBio receives first LSD batch for home psychedelic clinical trials

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