Global Blood's (GBT) Candidates for SCD Get Two FDA Tags

03:23pm, Tuesday, 07'th Jun 2022 Zacks Investment Research
The FDA bestows both orphan drug and rare pediatric disease designations to Global Blood's (GBT) inclacumab and GBT021601 (GBT601) for the treatment of sickle cell disease.

GSK Gets FDA Nod for Measles, Mumps & Rubella Vaccine, Priorix

02:13pm, Monday, 06'th Jun 2022 Zacks Investment Research
The FDA approves GSK's Priorix vaccine for active immunization for the prevention of measles, mumps and rubella in individuals aged 12 months and older.

Immunocore (IMCR) Up on Deal With Sanofi for Skin Cancer Study

01:48pm, Monday, 06'th Jun 2022 Zacks Investment Research
Immunocore (IMCR) signs a collaboration agreement with Sanofi to study the combination of Kimmtrak with the latter's SAR444245 for treating metastatic cutaneous melanoma. Shares up.

Immunic (IMUX) Falls as Phase II Ulcerative Colitis Study Fails

02:51pm, Friday, 03'rd Jun 2022 Zacks Investment Research
Immunic's (IMUX) phase II CALDOSE-1 study, evaluating vidofludimus calcium in patients with moderate-to-severe ulcerative colitis, fails to meet primary endpoint. Stock down.

Aeglea (AGLE) Down on RTF Letter from FDA for Rare Disease Drug

02:49pm, Friday, 03'rd Jun 2022 Zacks Investment Research
Aeglea (AGLE) gets a Refusal to File letter from the FDA related to the biologics license application for pegzilarginase to treat arginase 1 deficiency. Stock down.

Apellis (APLS) Files NDA for Pegcetacoplan in Geographic Atrophy

04:09pm, Thursday, 02'nd Jun 2022 Zacks Investment Research
Apellis (APLS) submits a new drug application to the FDA for pegcetacoplan for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration.

Sanofi (SNY) Gets Breakthrough Therapy Tag for Hemophilia A Drug

03:24pm, Thursday, 02'nd Jun 2022 Zacks Investment Research
The FDA bestows a Breakthrough Therapy designation to Sanofi's (SNY) efanesoctocog alfa for the treatment of people with hemophilia A.

GSK to Boost Vaccine Portfolio With Affinivax Acquisition

03:26pm, Tuesday, 31'st May 2022 Zacks Investment Research
GSK signs an agreement to acquire Affinivax, Inc. for a $2.1 billion upfront payment. The company is looking to boost its vaccine pipeline with this acquisition.

Global Blood (GBT) Thrives on Oxbryta, Overdependence a Woe

03:18pm, Thursday, 26'th May 2022 Zacks Investment Research
Global Blood's (GBT) Oxbryta is approved for treating sickle cell disease. The recent label expansion nod to Oxbryta is a positive. However, sole dependence on Oxbryta for growth is a concern.

INmune Bio (INMB) Down on Clinical Hold for Alzheimer's Study

04:07pm, Wednesday, 25'th May 2022 Zacks Investment Research
The FDA places clinical hold on INmune Bio's (INMB) IND application to begin a phase II study on the investigational TNF inhibitor, XPro1595, for Alzheimer's disease.

SpringWorks (SWTX) Down Despite Desmoid Tumors Study Meeting Goal

04:05pm, Wednesday, 25'th May 2022 Zacks Investment Research
SpringWorks' (SWTX) phase III study evaluating its investigational candidate, nirogacestat, in adult patients with progressing desmoid tumors, meets primary and key secondary endpoints.

Seagen (SGEN) Posts Positive Data from New Study on Tukysa

02:58pm, Tuesday, 24'th May 2022 Zacks Investment Research
Seagen (SGEN) reports favorable data on the pivotal phase II MOUNTAINEER study evaluating Tukysa in combination with Herceptin for treating HER2-positive metastatic colorectal cancer.

AbbVie (ABBV) Files NDA for Parkinson's Disease Candidate

03:46pm, Monday, 23'rd May 2022 Zacks Investment Research
AbbVie (ABBV) submits a new drug application to the FDA for ABBV-951, which has been developed for treating advanced Parkinson's disease.

Lilly's (LLY) Olumiant Gets CHMP Nod for Alopecia Areata

03:33pm, Monday, 23'rd May 2022 Zacks Investment Research
The CHMP gives a positive opinion and recommends approval of Lilly's (LLY) Olumiant to treat adults with severe alopecia areata.
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