Category - Developments

Developments

Tonix Pharmaceuticals enrolls first patient in Phase 3 fibromyalgia study

Tonix Pharmaceuticals (NASDAQ:TNXP) enrolled the first patient in its Phase 3 study of TNX-102 SL for the management of fibromyalgia. TNX-102 SL is a non-opioid analgesic, administered daily at bedtime. The trial will...

December 10, 2019

Developments

Dermira atopic dermatitis drug gets FDA fast track designation

Dermira’s (NASDAQ:DERM) lebrikizumab received FDA fast track designation for the treatment of moderate-to-severe atopic dermatitis. Lebrikizumab is a humanized monoclonal antibody that targets interleukin-13, which is...

December 10, 2019

Developments

Hepion to present CRV431 clinical and scientific updates at HEP DART 2019 meeting

Hepion Pharmaceuticals (NASDAQ:HEPA) is slated to present two posters at the HEP DART 2019, frontiers in drug development for hepatology, including viral hepatitis, NASH and co-infections meeting. The presentations...

December 9, 2019

Developments

ObsEva reports positive results from Phase 3 study of linzagolix

ObsEva’s (NASDAQ:OBSV) Phase 3 trial of linzagolix for the treatment of heavy menstrual bleeding (HMB) due to uterine fibroids met its primary and secondary endpoints. The U.S. trial enrolled 535 women to evaluate the...

December 9, 2019

Developments

FDA removes hold on Abeona’s pivotal gene therapy trial

The FDA removed its clinical hold on Abeona Therapeutics’ (NASDAQ:ABEO) Phase 3 clinical trial evaluating EB-101 for the treatment of recessive dystrophic epidermolysis bullosa (RDEB). The hold was removed following...

December 9, 2019

Developments

Musculoskeletal company Trainer Rx changes name to RecoveryOne

Closely-held RecoveryOne, formerly Trainer Rx, which is focused on enabling patient recovery from musculoskeletal (MSK) conditions, is raising $12-million in a round led by Cigna Ventures. The company says the financing...

December 9, 2019

Developments

Positive buzz on new prostate disease treatment, TULSA-PRO, coming out of RSNA annual meeting

According to a number of trade media reports, Profound Medical’s (NASDAQ:PROF; TSX:PRN) recently 510(k)-cleared TULSA-PRO system received high marks at the Radiology Society of North America (RSNA) annual meeting. TULSA...

December 6, 2019

Developments

Omeros reports positive data from pivotal narsoplimab trial

Omeros (NASDAQ:OMER) reported positive data from its pivotal clinical trial of narsoplimab for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA). HSCT-TMA occurs when...

December 5, 2019

Developments

Rhythm Pharma completes enrollment in Phase 3 setmelanotide trial

Rhythm Pharmaceuticals (NASDAQ:RYTM) completed enrollment of the pivotal cohort in its Phase 3 trial of setmelanotide for the treatment of insatiable hunger and severe obesity in Bardet-Biedl syndrome (BBS) or Alström...

December 5, 2019

Developments

Anavex presents two-year data from Phase 2a AD trial

Anavex Life Sciences (NASDAQ:AVXL) presented interim two-year data from its Phase 2a extension study of ANAVEX2-73 in Alzheimer’s disease (AD) patients at the 2019 clinical trials on AD conference. ANAVEX2-73 is...

December 5, 2019

Category - Developments

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