Cantor Fitzgerald analyst Louise Chen believes it is a good time to take another look at Theravance Biopharma given its “inexpensive valuation” and “important catalysts” this year. The company’s cash and equivalents totaled $517.1M at the end of 2018 and it appears well positioned to receive over $1B in milestones and payments, Chen tells investors in a research note. However, its market capitalization is only $1.3B, says the analyst. She thinks the peak sales potential of Theravance’s organ-selective JAKs, Ampreloxetine, Yupelri and Trelegy, are all underappreciated and keeps an Overweight rating on the shares with a $55 price target.
Monday, April 8, 2019
Evolus announces publication of Jeuveau, Botox head-to-head trial
Evolus announced the publication of the European and Canadian Phase III head-to-head pivotal trial results in the April issue of Aesthetic Surgery Journal. “The results of this study are compelling and reinforce the clinical performance of Jeuveau, which is the first 900 kDa product to enter the U.S. market in nearly 30 years,” said David Moatazedi, president and CEO. “We look forward to launching Jeuveau in the coming weeks in the United States.
Cantor positive on HTG Molecular after hosting management meetings
Cantor Fitzgerald analyst Jordan Abrams reiterates an Overweight rating on HTG Molecular Diagnostics with a $6 price target. After hosting investor meetings with management, the analyst is positive on “increased visibility into the business” with a focus on longer-term product development. Product investment positions HTG well to be the leader in RNA molecular profiling, Abrams tells investors in a research note. Meanwhile, the analyst believes the company’s base profiling business “remains strong.” Although biopharma partnership data readouts are the most visible potential catalysts to the shares, consistent execution in the base profiling business “will also propel the shares higher,” Abrams writes.
Applied Genetic reaches enrollment milestones in two clinical trials
Applied Genetic announced that it has achieved enrollment milestones in two of its Phase 1/2 clinical trials. The company completed enrollment of the dose escalation portion of the achromatopsia, or ACHM, CNGB3 trial, which is evaluating the safety and efficacy of its product candidate, rAAV2tYF-PR1.7-hCNGB3, for the treatment of ACHM caused by mutations in the CNGB3 gene. The company also completed enrollment in the expansion group, which includes pediatric patients, of its product candidate, rAAV2tYF-GRK1-RPGR, for the treatment of X-linked retinitis pigmentosa, or XLRP, caused by mutations in the RPGR gene. Both investigational therapies utilize the company’s proprietary AAV delivery technology and are administered by subretinal injection. The company is enrolling patients in two parallel Phase 1/2 clinical trials of its product candidates for ACHM caused by mutations in the two most common ACHM genes, CNGB3 and CNGA3. To date, AGTC has enrolled 12 patients in the ACHM CNGB3 trial and six patients in the ACHM CNGA3 trial. AGTC plans to provide topline interim six-month data for the dose escalation portion of the CNGB3 study in the second half of the year. To date, AGTC has completed enrollment of 10 and six patients in the dose escalation and expansion portions of the XLRP trial, respectively. The company plans to provide topline interim six-month data for the dose escalation portion of the trial in Q3 and the expansion portion in Q4.
Axsome Therapeutics initiated at SVB Leerink
Axsome Therapeutics initiated with an Outperform at SVB Leerink. SVB Leerink analyst Marc Goodman initiated Axsome Therapeutics with an Outperform and $25 price target.
Invitae price target raised to $30 from $21 at Oppenheimer
Oppenheimer analyst Kevin DeGeeter raised his price target for Invitae to $30 from $21 based on improved long-term competitive positioning for the company’s patient-initiated testing given data presented at the ACMG meeting demonstrating poor performance for a leading DTC genetic test and potential consolidation in DTC market as industry matures and economies of scale, quality/clinical data and regulatory oversight drive market share. The analyst reiterates an Outperform rating on the shares.
Tyme Technologies says SM-88 first in-human study published in IND
Tyme Technologies announced that the results of its first human study, completed as of September 15, 2017 and designed to evaluate the safety, tolerability and efficacy of SM-88 in patients with advanced metastatic cancers, was published online on March 30th 2019 in the peer-reviewed journal Investigational New Drugs. The article, titled “A first-in-human study of the novel metabolism-based anti-cancer agent SM-88 in subjects with advanced metastatic cancer,” is available online. Based on these proof-of-concept clinical findings, TYME is developing new approaches, including SM-88, that target cancer metabolism. As metabolic changes in tumor cells are nearly universal, TYME believes that targeting these mechanisms creates the possibility of delivering potent therapeutic benefit across a broad spectrum of solid tumors and blood cancers. The SM-88 first human study was a TYME-sponsored, open-label, single-center first in human study of 30 patients with metastatic cancers who had failed or refused all available therapeutic options. In this study, SM-88 was used with low doses of melanin, melanotan 2, phenytoin, and sirolimus. Based on results from the study, clinical researchers observed that patients reached a median overall survival of 29.8 months and 13 months of progression free survival without additional therapy. 33% of patients achieved RECIST complete response and partial response with median time to best response of greater than 3 months. 57% of patients achieved RECIST stable disease with a median duration of 11 months.
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