Healthcare Industry Developments | BioTuesdays by Kilmer Lucas IR

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

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

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