Ruthigen IPO Set To Soar; Tetraphase To Find Lower Floor
Wall Street Advisors • 13 Comments
Wall Street Advisors • 13 Comments
Fri, May 13, 12:45 PM
Fri, May 13, 9:17 AM
Fri, May 13, 9:01 AM
- Micro cap Tetraphase Pharmaceuticals (NASDAQ:TTPH) slumps 24% premarket on increased volume in response to the announcement that the FDA requires another Phase 3 clinical trial to support a New Drug Application (NDA) for lead product candidate IV eravacycline.
- The company is working on a protocol for twice-daily IV eravacycline in patients with complicated intra-abdominal infections and expects to initiate the study in Q4. If all goes well, top-line data will be available in Q4 2017. It also intends to conduct another Phase 3 assessing once-daily IV eravacycline in patients with complicated urinary tract infections. Data from this study will support a supplemental NDA.
- Last September, IV eravacycline flunked a Phase 3 non-inferiority study compared to levofloxacin.
- Previously: Tetraphase Pharma's IV eravacycline flunks late stage study; shares plummet 80% AH (Sept. 8, 2015)
Thu, May 12, 5:37 PM
Fri, Apr. 8, 12:45 PM
Dec. 30, 2015, 5:38 PM
Nov. 19, 2015, 9:14 AM
Sep. 9, 2015, 12:44 PM
Sep. 9, 2015, 9:17 AM
Sep. 8, 2015, 5:36 PM
Sep. 8, 2015, 4:24 PM
- A Phase 3 clinical trial, IGNITE2, evaluating Tetraphase Pharmaceuticals' (NASDAQ:TTPH) eravacycline administered intravenously as a transition to oral therapy in patients with complicated urinary tract infections (cUTI) failed to achieve its primary endpoint of non-inferiority (no worse than) compared to levofloxacin.
- The pivotal portion of IGNITE2 enrolled 908 subjects randomized 1:1 to receive eravacycline (1.5 mg/kg IV every 24 hours followed by 200 mg orally every 12 hours) or levofloxacin (750 mg IV every 24 hours followed by 750 mg orally every 24 hours). Each patient received a minimum of thee days of IV therapy before transitioning to oral for a total treatment period of seven days.
- The study failed to achieve the primary endpoint per FDA criteria and EMA criteria.
- The company will host a conference call at 4:30 pm ET to discuss the results.
- Shares are down 80% after hours on robust volume.
Jun. 4, 2015, 5:35 PM
May 15, 2015, 5:38 PM
Feb. 19, 2015, 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%)
Feb. 19, 2015, 9:12 AM
Feb. 19, 2015, 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.
Tetraphase Pharmaceuticals, Inc. is a clinical stage biopharmaceutical company, which discovers and develops next-generation tetracycline antibiotics that address unmet needs such as the treatment of serious drug-resistant and gram-negative infections. The company's lead product candidate,... More
Industry: Drug Manufacturers - Other
Country: United States
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