The development of the biotechnology and biopharmaceutical industry in recent years has attracted the attention of many investors, and it has also provided substantial potential profit returns. However, the risk of new drug development is extremely high, and if the critical clinical data is disappointing, the huge risk of investment is self-evident. The top Wall Street analysts recently made predictions based on the products under development and pointed out that the stock prices of the four biopharmaceutical companies are expected to double in the next 12 months.
TG Therapeutics is a biopharmaceutical company focused on the development and commercialization of novel therapeutic methods for B-cell malignancies and autoimmune diseases. After the announcement of strong fourth-quarter results, Edward White, a five-star analyst of HC Wainwright, raised the TG Therapeutics target price from $33 to $38 on March 8th, with the potential to rise above the same day’s 131%. Edward White’s reasoning for stock prices is a bit complicated, but it is ultimately based on the net present value of clinical success and potential revenues of the company’s two phase III clinical drugs ublituximab and umbralisib.
Ublituximab (TG-1101) is a novel chimeric monoclonal antibody that targets a unique epitope on the CD20 antigen; its affinity for the FcγRIIIa receptor is enhanced by glycosyltransferases, thereby demonstrating greater antibody than rituximab and ofatumumab Dependent cytotoxicity (ADCC) activity.
Ublituximab was developed to treat B-cell proliferative disorders including non-Hodgkin’s lymphoma (NHL) and chronic lymphocytic leukemia (CLL). Anti-CD20 antibodies have also been shown to be effective in the treatment of selective autoimmune diseases such as rheumatoid arthritis Inflammation (RA) and systemic lupus erythematosus (SLE), as well as multiple disorders of neurological disorders (MS), are currently in Phase 3 clinical stages of patients with hematological malignancies and multiple sclerosis.
To date, more than 800 patients with various B-cell malignancies have been treated with ublituximab, and two multi-center Phase III clinical trials have been completed or are ongoing, and were announced in February 2018 for a period of 6 months. Clinical IIa test results show that: Ublituximab exhibits strong anti-tumor activity with excellent safety and tolerability. Within 24 hours of receiving the first dose of ublituximab, most patients’ B cells could be effectively depleted, and all patients could achieve B cell depletion (>99%) at week 4 and at week 24 (6 months; N = 40) maintained significantly lower levels. 97.5% of the subjects (39/40) had no recurrence within 24 weeks and were well tolerated. The most common AEs were infusion-related reactions (IRRs), both grade 2 or lower, with a rapid infusion (450 mg below 1h) Good tolerability.
Umbralisib (TGR-1202) is a new generation PI3Kδ inhibitor with unique structure and activity characteristics that are different from other PI3Kδ inhibitors. It mainly includes: It has shown better liver toxicity and colitis than other PI3Kδ inhibitors. Safety features; long half-life, enabling once-daily dosing; high selectivity for PI3K[delta]; and protein casein kinase 1 epsilon (CK-l[epsilon]), which can suppress regulatory T cell function.
Umbralisib as a single agent showed better safety in patients who were intolerant of ibrutinib or idelalisib, with only 2 patients (6%) discontinued due to AE. As the number of discontinuations due to adverse events decreased, the patient’s tolerance was improved and the patient was able to maintain continuous administration to achieve and maintain a higher response rate: the ORR of the single drug Umbralisib in relapsed/refractory CLL was 85%. The ORR of monotherapy Umbralisib in relapsed/refractory FL was 53%. In the early triad combination ublituximab+umbralisib+ibutinib study, a total response rate of 100% was achieved in 19 treated CLL/SLL patients, and in 7 refractory refractory non-Hodgians who had been treated. The 86% response rate was achieved in gold lymphoma (follicular lymphoma and marginal zone lymphoma), achieving a 100% response rate in 4 patients treated with mantle cell lymphoma.
Therapeutics MD is a women’s health care innovative therapy company. It is developing therapy and research for the treatment of menopausal related diseases. They submitted NDA applications for TX-001HR and TX-004HR to the FDA in December and November 2017 respectively. The PDUFA dates are 2018 respectively. October 28 and May 29 of the year.
William Tanner, an analyst at Cantor Fitzgerald, believes that the stock will reach $28 with a 400% uptrend; in the past three months, Tipranks also released four analysts’ buying ratings for TXMD, with an average target price of $21.50. This is a 315% increase from the current $5.18 share price (minimum valuation of $15.0).
TX-001HR is a novel therapeutic agent combining 17β-estradiol with progesterone using the SYMBODA technology for the treatment of moderate to severe vasomotor symptoms (VMS) due to menopause. TX-001HR is considered to be the first and only combination drug candidate to replace the 17β-estradiol and progesterone hormones that the ovaries almost cease to produce.
At ENDO2017, Dr. Rogerio Lobo, professor of obstetrics and gynecology at Columbia University and director of the reproductive endocrinology program, reviewed the detailed results of the supplemental trial. In clinical phase III studies, the safety and efficacy of four doses of TX-001HR were evaluated. Supplementary trials showed that two doses of TX-001HR (estradiol 1 mg/progesterone 100 mg and estradiol 0.5 mg/progesterone 100 mg) were compared to placebo at the fourth and twelfth week respectively for flushing Significant statistical significance and clinical significance were achieved in terms of frequency reduction and severity reduction, satisfying the primary efficacy end point. In addition, Dr. David Archer, professor of obstetrics and gynecology and director of clinical research at the Jones Institute of the East Virginia School of Medicine, published a supplemental trial that provided data on the safety of the endometrium. Data showed that TX-001HR did not cause endometrial hyperplasia or malignancy (0%) in all treatment groups, consistent with the recommendations of the FDA draft guidelines.
Clearsidebio is a late-stage clinical biopharmaceutical company that develops First-in-class drugs for blinding eye diseases. It uses the method of injecting drugs through the suprachoroidal space to treat visually impaired diseases such as uveitis and retinal vein occlusion ( RVO), diabetic macular edema (DME) and wet age-related macular degeneration (wet AMD) patients provide clinical benefit.
The company’s share price rose from 6.46 US dollars at the end of February to 14.82 US dollars, the highest point in March, an increase of 121%. Although stocks have fallen in recent days, it is not too late to profit from the sharp rise in share prices. Wedbush analyst Liana Moussatos raised its target price for the next 12 months to 29 U.S. dollars; in the past 3 months, 6 analysts have announced a buy rating, and their average target price is 22.8 U.S. dollars, compared with 6.46 U.S. dollars at the end of February. The stock price will rise by 253%.
Moussatos commented: “Besides several phase II clinical trials of ME-NIU, ME-RVO and DME, the PEACHTREE trial results represent the success of CLS-TA clinical phase 3. Given the advantages of the clinical phase 3 results, we believe that the Clinical risk will be reduced.”
According to Clearsidebio’s published Phase 3 clinical data from Clearsidebio in March, 47% received Clearside’s proprietary corticosteroid triamcinolone acetonide suspension (CLS-TA) via the suprachoroidal or SCSTM posterior eye. Patients treated with CLS-TA in the suprachoroidal space could see at least 15 letters compared with only 16% of placebo patients (p < 0.001). There were no treatment-related serious adverse events reported in the trial. Within 24 weeks, approximately 11.5% of patients in the CLS-TA group reported an adverse event with elevated corticosteroid-associated intraocular pressure (IOP), whereas the control group did not. In addition, Clearside continues to recruit patients with SAPPHIRE for a Phase 3 clinical trial to assess the safety and efficacy of the combination of the suprachoroidal CLS-TA and Eylea® (Aflibercept) in RVO patients. Compared with the simple vitreous Eylea control group, BCVA improved at least 15 letters after 8 weeks of initial treatment.
Flex Pharma is a biotechnology company dedicated to the development of innovative and exclusive therapies for muscle cramps, spasms and severe neurological diseases, and sports-related muscle spasms. HC Wainwright analyst Andrew Fein reiterated his Flex buy rating in March with a target price of $40. Given that the stock’s trading price on the date of Andrew Fein’s release of the Buy rating is only $5, this indicates a huge upside potential of up to 680%, which shows its confidence in the company’s clinical drug FLX-787. In the past three months, a total of five analysts have issued a purchase rating for them, with an average valuation of US$ 17.5, an increase of 326% from the end of February.
FLX-787 is a clinical drug of Flex Pharma developed for amyotrophic lateral sclerosis (ALS), Charcot-Marie Tooth (CMT), multiple sclerosis (MS), etc. An exploratory clinical phase 2 trial of multiple sclerosis is underway in Australia, two clinical phase 2 trials including ALS and CMT in the United States, and FDA accredited ALS fast track certification.
“At the end of last year, we achieved an important milestone. A small positive ALS study data provided the first clinical evidence that FLX-787 could provide benefits to patients with underlying neurological disease,” said Dr. Bill McVicar, President and CEO of the company. Mentioned. The company expects to report the top-line results of FLX-787 in Phase 2 of MS patients at the end of the first quarter of 18 years.