| Today | ||||
Veru shares are up 117%… Veru shares are up 117% from January 12, 2019, but the stock "is in the early innings of reflecting the true value that could be unlocked in the company's pipeline this year," Cantor Fitzgerald analyst Brandon Folkes tells investors in a research note. He believes the shares are likely to "continue to reward investors this year." Upside for the stock will be driven by a positive Phase 1b data readout from VERU-111 in prostate cancer, a full dataset from Zuclomiphene citrate, interim looks on the three Phase 2 VERU-111 cancer trials, submission of IND on VERU-100, NDA submission of Tadfin, and continued growth of the company's base business, Folkes contends. He keeps an Overweight rating on Veru with a $6 price target. | ||||
| Yesterday | ||||
H.C. Wainwright analyst… H.C. Wainwright analyst Yi Chen raised Veru's price target to $6 from $4.50 after VERU-944 reduced the frequency of hot flashes in a Phase 2 study. The data demonstrate that 50mg zuclomiphene could effectively reduce the frequency of ADT-induced hot flashes, which has no FDA-approved therapy, Chen tells investors in a research note. The analyst reiterates a Buy rating on the shares. | ||||
| Over a week ago | ||||
Veru announced positive… Veru announced positive top line data interim results from its Phase 2 clinical study of Zuclomiphene citrate, a nonsteroidal oral estrogen receptor agonist, for the treatment of androgen deprivation hormone therapy induced hot flashes, also known as vasomotor symptoms, in men who have advanced prostate cancer. The Phase 2 clinical study is a double-blind randomized placebo-controlled dose finding study evaluating daily oral doses of Zuclomiphene in men with advanced prostate cancer who have ADT induced moderate to severe hot flashes. The clinical study has a treatment duration of 12 weeks and is being conducted in 24 clinical centers in the United States. A topline interim analysis was performed in which 93 men with ADT-induced hot flashes were enrolled. The objectives of the study were to evaluate the estrogenic activity of Zuclomiphene on hot flashes, to confirm a no-effect dose and to evaluate the effect of a higher dose of Zuclomiphene on the frequency of moderate to severe hot flashes at Day 42. The topline interim clinical results demonstrate that a statistically significant decrease in moderate to severe hot flashes from baseline was observed in the 50mg treatment group. The 10mg treatment group, as expected, did not show a statistically significant reduction in hot flashes from baseline. Based on this result, the 10mg dose group is established as a no-effect dose as was planned for in the study. Furthermore, when comparing the 50mg treatment group versus the 10mg treatment group, a statistically significant reduction in the frequency of moderate to severe hot flashes at Day 42 is observed. Moreover, the observed estrogenic activity of the 50mg group was statistically different from 10mg and placebo group. Zuclomiphene appears to be well tolerated as there have been no reports of drug related serious adverse events nor drug related severe adverse events and no observations of adverse events of special interest, such as breast enlargement or pain, or venothromboembolic events in the safety database for the Phase 2 clinical study. Adverse events of special interest are side effects commonly seen with off label use of steroidal estrogens and progestins for hot flashes. The 50mg treatment group shows statistical and clinically meaningful reductions in moderate to severe hot flashes from baseline without any clinically relevant safety findings. The Company plans to meet with FDA for an End of Phase 2 meeting and following this discussion with FDA, advance Zuclomiphene into a pivotal Phase 3 clinical trial for the treatment of ADT-induced moderate to severe hot flashes in men with prostate cancer in the first half of 2020. | ||||
| Over a month ago | ||||
HIGHER: Delta Air Lines… HIGHER: Delta Air Lines (DAL), up 2% after announcing FY20 guidance at its annual investor day... General Electric (GE), up 2% after UBS analyst Markus Mittermaier assumed coverage of GE from prior analyst Damian Karas and upgraded the shares to Buy from Neutral with a price target of $14, up from $11.50. The shares are at a "positive inflection point" into 2020 given GE's successful de-levering, "strong" estimated earnings growth in 2020 and 2021, and a tripling of free cash flow to $2.3B next year led by Aviation and Healthcare, Mittermaier tells investors... Lumber Liquidators (LL), up 6% after raising FY19 adjusted operating margin expectations. UP AFTER EARNINGS: FormFactor (FORM), up 5%. DOWN AFTER EARNINGS: Ciena (CIEN), down 2%... Veru (VERU), down 12%... Lovesac (LOVE), down 11%... Lululemon (LULU), down 3%. ALSO LOWER: Akoustis (AKTS), down 13% after its 4.8M share spot secondary priced at $6.25. | ||||
Reports Q4 revenue $8.7M,… Reports Q4 revenue $8.7M, consensus $9.17M. The company believes that it has sufficient resources to execute our clinical drug trial programs through year end 2021. CEO Mitchell Steiner stated, "The robust ramp up of prescription as well as global public sector sales of FC2(R) and increased consumer demand for our PREBOOST(R)/Roman(R) Swipes product drove the significantly improved financial performance. I would like to highlight on the clinical development front, VERU-111 -- our proprietary, oral, next generation, first-in-class, selective antitubulin - as it continues to show antitumor activity and no dose related toxicity in men with metastatic castration resistant prostate cancer (...) Growing strong revenues from our base business will continue to support not only the current Phase 1b/2 VERU-111 oral selective antitubulin clinical trial and other VERU-111 Phase 2 clinical trials for different tumor types, but also the completion of the Phase 2 zuclomiphene citrate trial, and the planned Phase 2 VERU-100 3-month depot GnRH antagonist clinical trial in 2020. We are very pleased with the significant clinical progress we are making in advancing our entire product development program." | ||||
Notable companies… Notable companies reporting before tomorrow's open, with earnings consensus, include Ciena (CIEN), consensus 63c... Lovesac (LOVE), consensus (43c)... Veru (VERU), consensus (5c). | |
Notable companies… Notable companies reporting before tomorrow's open, with earnings consensus, include Ciena (CIEN), consensus 63c... Lovesac (LOVE), consensus (43c)... Veru (VERU), consensus (5c). | |
Meetings to be held in… Meetings to be held in the West Coast area on November 13-14 hosted by Oppenheimer. | |
Meetings to be held in… Meetings to be held in the West Coast area on November 13-14 hosted by Oppenheimer. |
| Over a quarter ago | ||||
Global Healthcare… Global Healthcare Conference will be held in New York on October 2-4. | ||||