Fri, May 15, 5:38 PM
Wed, May 6, 5:15 PM| Comment!
Mon, Apr. 27, 3:30 PM
- Two Phase 3 clinical trials evaluating Tetraphase Pharmaceuticals' (TTPH -5.1%) lead product candidate, eravacycline, show positive results for the treatment of complicated intra-abdominal infections (cIAI) and complicated urinary tract infections (cUTI).
- The first study, IGNITE-1, compared eravacycline to Merck's (MRK -1.1%) Invanz (ertapenem) for the treatment of cIAI. It achieved the primary endpoint of statistical non-inferiority (no worse than) of clinical response at the test-of-cure (TOC) visit. In the microbiological intent-to-treat (micro-ITT) population (n=446) 86.8% of patients receiving eravacycline achieved a clinical cure compared to 87.6% of patients receiving ertapenem (FDA criteria). In the clinically evaluable population (n=477) 92.9% of patients receiving eravacycline achieved a clinical cure versus 94.5% of patients receiving ertapenem (EMA criteria). These results were first reported in December.
- In the lead-in portion of the second study, IGNITE-2, both IV-to-oral dosing regimens of eravacycline (1.5 mg/kg followed by 200 mg or 250 mg) compared favorably with levofloxacin, a broad spectrum antibiotic, for the treatment of cUTI. The primary endpoint, per the FDA's criteria, was the responder rate (defined as both clinical cure and successful microbiological outcome) in the micro-ITT population. The responder rates for 200 mg (n=24), 250 mg (n=28) and levofloxacin (n=23) were 75.0%, 64.3% and 56.4%, respectively. In the microbiologically evaluable population, the primary endpoint was the microbiological response per the EMA's criteria. The respective responses for levofloxacin isolates (n=24) were: 83.3%, 72.7% and 42.9%. Based on these data, the 200 mg dose will be used for the pivotal portion of the Phase 3 that is currently underway.
- The company expects to submit its regulatory applications by the end of the year.
- The data were presented at this week's 25th European Congress of Clinical Microbiology and Infectious Diseases in Copenhagen, Denmark.
- Previously: Tetraphase antibiotic non-inferior to ertapenem in Phase 3 study (Dec. 17, 2014)
Tue, Mar. 17, 1:22 PM
Wed, Mar. 11, 10:14 PM
- Tetraphase Pharmaceuticals (NASDAQ:TTPH) prices its public offering of 4.3M shares of common stock at $35 per share. Underwriters over-allotment is an additional 645K shares. Closing date is March 17.
- Today's price at the close was $36.14.
- Previously: Tetraphase Pharma initiates equity offering (March 9)
Mon, Mar. 9, 5:44 PM
Thu, Mar. 5, 5:06 PM| Comment!
Thu, Feb. 19, 10:44 AM
- "Small is better" appears to be the recent investment theme in healthcare stocks. Thinly-traded nano cap MELA Sciences (MELA +42.4%) jumps on a 12x surge in volume on no particular news. Shares are up 63% since Tuesday.
- Other recent nano/micro cap bullish moves: (CLRX +102.6%)(TTPH +8.2%)(AKAO +3.7%)(ROSG +1.8%)(HTBX -3.7%)(EGRX +3.7%)(ONCY -12%)(GENE -5%)(WGBS -5.6%)(SGNL -4.2%)
Thu, Feb. 19, 9:12 AM
Thu, Feb. 19, 8:37 AM
- Tetraphase Pharmaceuticals (NASDAQ:TTPH) is up 14% premarket on light volume in apparent response to the exposure of up to 181 patients at UCLA Medical Center to carbapenem-resistant enterobacteriaceae (CRE), a drug-resistant superbug.
- The patients, two who have died, were potentially exposed during endoscopic procedures, although the two scopes in question were sterilized according to the manufacturer's instructions.
- Tetraphase develops antibiotics targeting multi-drug-resistant (MDR) bacterial infections. Its lead product is eravacycline, a broad-spectrum intravenous and oral antibiotic for the treatment of MDR infections, including MDR Gram-negative bacteria like CRE.
- Thinly-traded nano cap Achaogen (NASDAQ:AKAO), also developing antibiotics for MDR Gram-negative infections, is up 8% premarket as well.
Dec. 18, 2014, 12:47 PM
Dec. 18, 2014, 9:14 AM| 9 Comments
Dec. 17, 2014, 5:40 PM
Dec. 17, 2014, 4:44 PM
- In a Phase 3 clinical trial, Tetraphase Pharmaceuticals' (NASDAQ:TTPH) investigational antibiotic, eravacycline, was found to be non-inferior (no worse than) compared to ertapenem (Merck's Invanz) for the treatment of complicated intra-abdominal infection. The study's primary endpoint was the clinical response at the test-of-cure visit in the two treatment arms.
- The company is developing eravacycline as a broad spectrum intravenous and oral antibiotic. It expects to submit its regulatory applications by the end of 2015.
Dec. 15, 2014, 12:36 PM
- Added to the Nasdaq Biotechnology Index, effective Dec. 22: AAVL, AERI, AKBA, ALDR, ALIM, AMPH, ANIP, ASPX, CARA, CGEN, CLDN, CNCE, ENTA, FLML, FMI, FOLD, FPRX, GWPH, HPTX, ICPT, INO, INSM, KITE, KPTI, MGNX, OPHT, PCYC, PETX, POZN, PTX, QLTI, RARE, RCPT, RDUS, RLYP, RTRX, RVNC, SAGE, TBPH, TTPH, VSAR, XLRN, ZFGN, ZSPH.
- Deleted: AMRN, AUXL, CRIS, EXPR, ICEL, ONTX, RIGL, ZGNX.
- Source: Press Release
Nov. 24, 2014, 12:46 PM
TTPH vs. ETF Alternatives
Tetraphase Pharmaceuticals Inc is a clinical stage biopharmaceutical company engaged in creating antibiotics for serious and life-threatening multidrug-resistant infections. Its product candidate eravacycline is a fully synthetic tetracycline derivative.
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