Stockwinners Market Radar for March 21, 2021 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

19:56 EDT Fly Intel: Top five weekend stock stories - Catch up on the weekend's top five stories with this list compiled by The Fly: 1. Canadian Pacific Railway (CP) and Kansas City Southern (KSU) announced they have entered into a merger agreement, under which CP has agreed to acquire KCS in a stock and cash transaction representing an enterprise value of approximately $29B, which includes the assumption of $3.8B of outstanding KCS debt. The transaction, which has the unanimous support of both boards of directors, values KCS at $275 per share, representing a 23% premium, based on the CP and KCS closing prices on March 19, 2021. Following the closing into a voting trust, common shareholders of KCS will receive 0.489 of a CP share and $90 in cash for each KCS common share held. 2. ironSource has entered into a definitive agreement to merge with Thoma Bravo Advantage (TBA), a publicly-traded special purpose acquisition company. The transaction values ironSource at a pro forma equity value of $11.1B, and is supported by a $1.3B oversubscribed Class A ordinary share PIPE led by an affiliate of Thoma Bravo, as well as investments from Tiger Global Management, Counterpoint Global, Nuveen, Hedosophia, Wellington Management, The Baupost Group, and certain funds managed by Fidelity Investments Canada ULC and other institutional investors. Upon closing of the transaction, the combined company will operate under the ironSource name. 3. The market capitalization of pure-play space companies now totals roughly $25B, up from essentially nothing a few years ago, and that figure doesn't include SpaceX, the giant founded by Tesla (TSLA) CEO Elon Musk, or Blue Origin, the passion project of Amazon.com (AMZN) founder Jeff Bezos, Al Root wrote in this week's edition of Barron's. Lockheed Martin (LMT) might be the safest way to play space, the author contended. The company owns 50% of ULA, which has more than 130 successful missions under its belt, and has recently agreed to purchase rocket-parts maker Aerojet Rocketdyne (AJRD) for about $4.4B. Lockheed can make satellites, too, and is an investor in Rocket Lab. It may be one of the largest, most complete space franchises, Root added. 4. Disney's (DIS) "Raya and the Last Dragon" stayed atop the domestic box office chart with $5.2M in its third weekend, falling only 5% as Los Angeles theaters reopen. The movie's domestic total is now at $23.4M for a global cume of $71.2M. "Raya and the Last Dragon" sports an A CinemaScore. 5. Splunk (SPLK), e.l.f. Beauty (ELF), Eli Lilly (LLY), Biogen (BIIB), Roche (RHHBY) and Flutter Entertainment (PDYPY) saw positive mentions in this week's edition of Barron's.

16:02 EDT ironSource announces combination with Thoma Bravo Advantage SPAC - ironSource has entered into a definitive agreement to merge with Thoma Bravo Advantage, a publicly-traded special purpose acquisition company. The transaction values ironSource at a pro forma equity value of $11.1B, and is supported by a $1.3B oversubscribed Class A ordinary share PIPE led by an affiliate of Thoma Bravo, as well as investments from Tiger Global Management, Counterpoint Global, Nuveen, Hedosophia, Wellington Management, The Baupost Group, and certain funds managed by Fidelity Investments Canada ULC and other institutional investors. Upon closing of the transaction, the combined company will operate under the ironSource name.

14:24 EDT Canadian Pacific to buy Kansas City Southern in $29B deal - Canadian Pacific Railway (CP) and Kansas City Southern (KSU) announced they have entered into a merger agreement, under which CP has agreed to acquire KCS in a stock and cash transaction representing an enterprise value of approximately $29B, which includes the assumption of $3.8B of outstanding KCS debt. The transaction, which has the unanimous support of both boards of directors, values KCS at $275 per share, representing a 23% premium, based on the CP and KCS closing prices on March 19, 2021. Following the closing into a voting trust, common shareholders of KCS will receive 0.489 of a CP share and $90 in cash for each KCS common share held. Following final approval from the Surface Transportation Board, the transaction will combine the two railroads to create the first rail network connecting the U.S., Mexico, and Canada. Joining seamlessly in Kansas City, Mo., in America's heartland, CP and KCS together will connect customers via single-network transportation offerings between points on CP's system throughout Canada, the U.S. Midwest, and the U.S. Northeast and points on KCS' system throughout Mexico and the South Central U.S. While remaining the smallest of six U.S. Class 1 railroads by revenue, the combined company will be a much larger and more competitive network, operating approximately 20,000 miles of rail, employing close to 20,000 people and generating total revenues of approximately $8.7 billion based on 2020 actual revenues. The combination is expected to be accretive to CP's adjusted diluted EPS6 in the first full year following CP's acquisition of control of KCS, and is expected to generate double-digit accretion upon the full realization of synergies thereafter. To fund the stock consideration of the merger, CP will issue 44.5 million new shares. The cash portion will be funded through a combination of cash-on-hand and raising approximately $8.6B in debt, for which financing has been committed. As part of the merger, CP will assume approximately $3.8B of KCS' outstanding debt. Following the closing into trust, CP expects that its outstanding debt will be approximately $20.2B. Pro forma for the transaction, CP estimates its leverage ratio against 2021E street consensus EBITDA to be approximately 4.0-times with the assumption of KCS debt and issuance of new acquisition-related debt. In order to manage this leverage effectively, CP will be temporarily suspending its normal course issuer bid program, and expects to produce approximately $7B of levered free cash flow over the next three years. CP estimates its long-term leverage target of approximately 2.5x to be achieved within 36 months after closing into trust. The combined company will remain committed to maintaining strong investment grade credit ratings while continuing to return capital for the benefit of shareholders.

14:12 EDT Rhythm Pharmaceuticals presents new data from Phase 2 basket study - Rhythm Pharmaceuticals announced that three late-breaking data presentations from Phase 2 and Phase 3 studies of setmelanotide were presented during the 103rd Annual Meeting and Expo of the Endocrine Society held virtually March 20-23. Proof-of-concept data was presented from Rhythm's Phase 2 study evaluating setmelanotide in individuals living with heterozygous obesity due to genetic variants in one of two alleles of the POMC, PCSK1 or LEPR gene. The oral presentation included new weight loss data that showed patients with HET obesity who were classified as setmelanotide-responsive at three months continued to lose weight as they remained on treatment, with a mean weight loss of 12.3 percent at nine months on therapy. In addition, two on-demand posters on setmelanotide were presented. Topline data from Rhythm's Phase 3 trial evaluating setmelanotide in patients with Bardet-Biedl syndrome or Alstrom syndrome were presented by Robert Haws, M.D., of the Marshfield Clinic Research Institute. Safety data from three trials evaluating setmelanotide in a total of 35 patients with severe obesity due to leptin receptor, proopiomelanocortin, or proprotein convertase subtilisin/kexin type 1 deficiency was also presented. The open-label, single-arm Phase 2 study included patients 6 years old or older with HET obesity. Participants received once daily setmelanotide at the therapeutic dose for 12 weeks. A total of 35 patients, whose mean baseline BMI was 50.3 kg/m2, were included in the analysis, which was previously reported by Rhythm in January 2021. The primary endpoint was mean percent change from baseline in body weight, and 34.3 percent of all patients in the study responded with 5 percent or greater weight loss at three months. Mean weight loss among responders was -10.1 percent at three months. New data presented at ENDO 2021 included an analysis that showed that, among people who responded to treatment with setmelanotide at three months, response was maintained for up to nine months with a mean percent change in body weight from baseline of -12.3 percent, as of Feb. 23, 2021. The adverse event profile for setmelanotide continued to be consistent with what has been previously reported including skin hyperpigmentation, nausea, and injection site pruritis. As previously disclosed, data from Phase 3 trial in Bardet-Biedl and Alstrom syndromes showed that treatment with setmelanotide was associated with significant body weight and hunger reduction in obesity due to BBS or Alstrom syndrome. The study met its primary and all key secondary endpoints, demonstrating statistically significant and clinically meaningful reductions in weight and hunger scores, with patients with BBS comprising all primary endpoint responders. No patients with Alstrom syndrome met the primary endpoint. The study included 31 patients 12 years old or older who were evaluable for the primary endpoint, including 28 patients with BBS and three patients with Alstrom syndrome. This presentation included new weight-loss data specific to adults that showed that patients 18 years old and older with BBS had a mean weight loss from baseline of 9.4 percent. Additionally, the presentation included previously disclosed data specific to adolescents and children, which showed that patients younger than 18 years of age with BBS had a mean reduction in BMI-Z scores of 0.8. The BMI-Z score, or BMI standard deviation score, represents the number of standard deviations from median BMI by child age and sex. The presentation of Setmelanotide safety results from Phase 2 and Phase 3 studies in obesity due to POMC, PCSK1, or LEPR deficiency provided data from analyses of three studies that evaluated setmelanotide in obesity due to POMC, PCSK1 or LEPR deficiency. The analysis included 35 patients across three trials. Consistent with prior clinical experience, AEs of special interest included hyperpigmentation disorders, disturbances in sexual arousal, nausea, vomiting, and injection site reactions. The onset of AEs of special interest was generally highest during the first month of treatment, with fewer events occurring during subsequent months. Apart from hyperpigmentation, all AEs resolved quickly after onset.

14:01 EDT Neurocrine presents data analyses for Crinecerfont in adults with classic CAH - Neurocrine Biosciences announced the presentation of additional data from its Phase II CAHlibrate study of crinecerfont, an investigational, oral, non-steroidal corticotropin-releasing factor type 1 receptor antagonist for the potential treatment of classic congenital adrenal hyperplasia due to 21-hydroxylase deficiency, at ENDO 2021, the Endocrine Society's annual meeting, on March 20-23, 2021. The new analyses, based on data from seven male subjects with classic CAH receiving crinecerfont, demonstrate dose-dependent decreases in androstenedione, a key marker of CAH control and precursor to testosterone, with similar dose-dependent decreases in the A4 to testosterone ratio. Testosterone levels were preserved despite the marked reductions in A4, suggesting a positive effect on reproductive hormones and providing early indications of improved testicular function.

13:53 EDT 89bio presents additional analysis of Phase 1b/2a NASH study - 89bio announced additional data from its Phase 1b/2a study of BIO89-100, a long-acting glycoPEGylated FGF21 analog, in patients with nonalcoholic steatohepatitis. The data will be presented in an on-demand poster presentation at ENDO 2021, the Endocrine Society's annual meeting taking place virtually from March 20-23, 2021. New analyses of the Phase 1b/2a study data showed BIO89-100 treatment resulted in significant reductions in liver volume of up to 15% and liver fat volume of up to 65% in treated patients at 13 weeks compared to baseline, as measured by magnetic resonance imaging-proton density fat fraction. These data extend the previously reported MRI-PDFF data in which BIO89-100 treatment resulted in up to 70% relative reduction in liver fat fraction relative to placebo treatment. Additionally, BIO89-100, as previously reported, demonstrated a favorable safety and tolerability profile, with rates of gastrointestinal side effects such as nausea, diarrhea and vomiting similar to placebo.

13:45 EDT BridgeBio announces proof-of-concept data of Encaleret in ADH1 - BridgeBio Pharma announced early results from an ongoing Phase 2b proof-of-concept, open-label study of encaleret for the treatment of Autosomal Dominant Hypocalcemia Type 1. The data were featured in an ePoster presentation at the Endocrine Society's 2021 Annual Meeting. In the data from the ongoing Phase 2b open-label, dose-ranging study, six adults with ADH1 with four distinct CASR genotypes were administered encaleret. Calcitriol therapy was discontinued prior to and throughout the study. Non-dietary calcium supplements were withheld in five participants with adequate dietary calcium intake. Participants received sequential, increasing daily doses of encaleret starting at 30 mg while undergoing intensive safety monitoring and frequent blood and urine sampling for biochemical measures. Following five days of dosing with encaleret, blood calcium, parathyroid hormone, phosphorus and magnesium were within the normal range on average. Urinary calcium excretion was normal or undetectable in all participants. Throughout this initial period of dose escalation, encaleret was well-tolerated with no serious adverse events and no adverse events of moderate or severe intensity reported. Two participants experienced transient, asymptomatic hypophosphatemia which was the only treatment-related adverse event. The tolerability and consistent mineral responses following encaleret administration in all six ADH1 trial participants demonstrates proof of concept that encaleret may be an efficacious therapy option for ADH1. The company intends to meet with regulatory health authorities in 2021 to discuss potential paths to registration prior to initiation of a Phase 3 registrational study in patients with ADH1. If the development program is successful, encaleret could be the first approved therapy option indicated specifically for the treatment of ADH1. At ENDO 2021, BridgeBio also presented clinical study designs for the Phase 2b study of encaleret in ADH1; for its Phase 2 study of low-dose infigratinib, an FGFR1-3 inhibitor, for children with achondroplasia, the most common form of genetic short stature; and for its Phase 1/2 study of its investigational AAV5 gene therapy candidate for congenital adrenal hyperplasia. CAH is one of the most prevalent genetic diseases that could potentially be addressable with AAV gene therapy.

13:36 EDT Strongbridge presents results from Pivotal Phase 3 LOGICS Study of RECORLEV - Strongbridge Biopharma announced that detailed results from the previously reported Phase 3 LOGICS study of RECORLEV in patients with endogenous Cushing's syndrome were presented in a poster session at the Annual Meeting of the Endocrine Society, being held virtually from March 20 - 23, 2021. The poster presentation, which further evaluated the safety and efficacy of RECORLEV by comparing the effect of withdrawing RECORLEV treatment to placebo versus continuing treatment with RECORLEV on the cortisol therapeutic response established during open-label RECORLEV therapy, highlighted the following that as previously reported, LOGICS met its primary endpoint with statistical significance. At the end of the double-blind randomized-withdrawal phase, 54.5% more patients who were withdrawn to placebo had a loss of mean urinary free cortisol response as compared with those who remained on RECORLEV. Sensitivity analyses supported the primary endpoint inference. The key secondary endpoint of mUFC normalization at the end of the RW phase was also statistically significant with 45.5% more patients treated with RECORLEV maintaining mUFC normalization in the active arm than the placebo arm. In the RW phase, median time on RECORLEV was 55.5 days and on placebo was 23.0 days, indicating rapid loss of cortisol control upon RECORLEV cessation. The secondary endpoints of mean changes from the RW baseline to the end of the RW phase for total and LDL-cholesterol were significantly different between treatment groups, with mean treatment differences of 37.1 and 25.1 mg/dL, respectively. During the titration-maintenance phase, mean change in body mass index was -1.13 kg/m2. Mean change in BMI from RW baseline to end of RW phase was -0.65 kg/m2 in the RECORLEV group, and +0.59 kg/m2 in the placebo group. Among 80 subjects treated with RECORLEV in both phases combined, the most commonly reported adverse events were nausea, hypokalemia, headache, hypertension, and diarrhea. Five percent of subjects had a serious adverse event considered to be drug related. Nineteen percent had an adverse event that contributed to drug discontinuation; no subjects discontinued due to adverse event in the RW phase. On March 2, 2021, the company announced it had submitted an NDA for RECORLEV for the treatment of endogenous Cushing's syndrome to the FDA. The submission is supported by previously reported positive and statistically significant results of the SONICS and LOGICS trials: two Phase 3 multinational studies designed to evaluate the safety and efficacy of RECORLEV when used to treat adults with endogenous Cushing's syndrome.