FDA Archives - Page 2 of 2

Developments

Theralase in pact for U.S. clinical sites for Phase 2 NMIBC trial

Theralase Technologies (TSXV:TLT; OTCQB:TLTFF) signed an agreement with a trial management organization (TMO) to provide four-to-six U.S.-based urology study sites that will be able to commence enrolling and treating...

July 24, 2019

Developments

Chiasma’s Mycapssa meets all endpoints in Phase 3 acromegaly trial

Chiasma (NASDAQ:CHMA) reported positive top-line Phase 3 data from a pivotal trial evaluating its octreotide candidate, conditionally trade-named Mycapssa, for the treatment of acromegaly. Acromegaly is caused by the...

July 23, 2019

Developments

Intec Parkinson’s disease candidate misses primary endpoint in Phase 3 trial

Intec Pharma (NASDAQ:NTEC) reported that its Accordion Pill carbidopa/levodopa (AP-CD/LD) failed to meet its primary endpoint in a Phase 3 trial for Parkinson’s disease (PD). Intec’s extended release AP-CD/LD failed to...

July 22, 2019

Developments

Aridis Pharma gets EMA orphan drug designation for CF drug

Aridis Pharmaceuticals (NASDAQ:ARDS) received European Medicines Agency (EMA) orphan drug designation for AR-501 for the treatment of lung infections in patients with cystic fibrosis (CF). AR-501 is an inhaled...

July 19, 2019

Markets

CIBC ups Theratechnologies PT to $15 from $10.30

CIBC World Markets raised its price target for Theratechnologies (TSX:TH) to $15 from $10.30 after the FDA approved Trogarzo for the treatment of multi-drug resistant HIV patients. The stock was quoted at $9.35 in...

March 7, 2018

Markets

BTIG cuts Obalon Therapeutics PT to $7 from $13

BTIG lowered its price target for Obalon Therapeutics (NASDAQ:OBLN) to $7 from $13 after the company reported in-line fourth quarter results and guidance for 2018. The stock finished at $4.01 on March 5. Obalon is...

March 6, 2018

Developments

FDA grants priority review to Theratechnologies’ ibalizumab

Theratechnologies (TSX:TH) has been notified by its partner, TaiMed Biologics, that the FDA has accepted for review the biologics license application for ibalizumab as a treatment for multidrug-resistant human...

June 30, 2017

Tag - FDA

Theralase in pact for U.S. clinical sites for Phase 2 NMIBC trial

Chiasma’s Mycapssa meets all endpoints in Phase 3 acromegaly trial

Intec Parkinson’s disease candidate misses primary endpoint in Phase 3 trial

Aridis Pharma gets EMA orphan drug designation for CF drug

CIBC ups Theratechnologies PT to $15 from $10.30

BTIG cuts Obalon Therapeutics PT to $7 from $13

FDA grants priority review to Theratechnologies’ ibalizumab

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