Stockwinners Market Radar for September 04, 2023 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

ALGM...

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20:00 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. The United Auto Workers union and the three Detroit automakers have less than two weeks to negotiate a new labor contract, and a strike of some sort seems increasingly likely, The New York Times' Neal E. Boudette reports. A strike against one of the companies, especially a prolonged stoppage, could send an economic jolt through several Midwestern states and crimp the profits of General Motors (GM), Ford Motor (F) or Stellantis(STLA), the author adds. A strike against all three could have a noticeable impact on the broader U.S. economy, the publication notes. 2. Barclays (BCS) is exploring the sale of a stake in the unit that processes payments for U.K. merchants as the British bank seeks a partner to help grow the business, Reuters' Amy-Jo Crowley, Pablo Mayo Cerqueiro and Milana Vinn report, citing four people familiar with the matter. The bank is considering bringing in a partner with the strategic "know-how" to expand the business, as well as raising capital, but has yet to decide how big a stake it might sell, said the people. The business could be valued at least $2.5B, sources added. 3. Wall Street seems of two minds about Allegro MicroSystems (ALGM), a New England-based chip maker whose sales to the auto industry have risen fast, Bill Alpert writes in this week's edition of Barron's. Allegro stock shot up 150% to a July peak above $50, before easing back to a recent $38. Even after its retreat, the company's stock fetches 37 times its operating earnings in the latest fiscal year-about twice the multiple of the S&P 500. All but one of the half dozen brokerage firms covering the stock rate it a Buy, arguing that Allegro's lead in magnetic sensor chips will lift the stock by 45%. But a number of buyside investors aren't convinced Allegro's growth and exceptional profit margins can last. They've joined the 8% of Allegro's float that's short, in a bet that the stock will drop, the author says. 4. Sony's (SONY) "The Equalizer 3" won the Labor weekend at the North American box office with a $42.3M debut for the four days. The movie starring Denzel Washington received an A CinemaScore. Overseas, "The Equalizer 3" opened to $26.1M for a global tally of $68.4M through Monday. 5. On Holding's (ONON) saw a positive mention in this week's edition of Barron's, while Coinbase (COIN) was mentioned cautiously.
AZN

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16:22 EDT AstraZeneca's Calquence approved in China for chronic lymphocytic leukaemia - AstraZeneca's Calquence, a next generation, selective Bruton's tyrosine kinase inhibitor, has been approved in China for the treatment of adult patients with chronic lymphocytic leukaemia or small lymphocytic lymphoma who have received at least one prior therapy. The approval by the National Medical Products Administration was based on positive results from two clinical trials, including the ASCEND Phase III trial of Calquence versus investigator's choice of idelalisib plus rituximab or bendamustine plus rituximab for patients with relapsed or refractory CLL and an open-label, single-arm Phase I/II trial in China for patients with R/R CLL. In the ASCEND Phase III trial, 88% of patients with R/R CLL treated with Calquence were alive and free from disease progression after 12 months compared with 68% of patients treated with IdR/BR.1 Longer-term follow-up data showed 62% of patients treated with Calquence were alive and had not progressed at 42 months versus 19% of patients treated with IdR/BR. Additionally, results from a Phase I/II trial in Chinese adults with R/R CLL showed Calquence achieved an overall response rate of 83.3%. At a median follow-up of 20.2 months, median progression-free survival was not reached and the 12-month and 18-month PFS rates were 90.7% and 78.8%, respectively. The safety and tolerability of Calquence in these trials were consistent with that observed in previous clinical trials. Calquence is approved for the treatment of CLL and SLL in the U.S. and Japan and is approved for the treatment of CLL in the EU and in several other countries worldwide in the treatment-naive and R/R settings. Calquence is also approved in the U.S., China and several other countries for the treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy. Calquence is not currently approved for the treatment of MCL in Japan or the EU.
SGEN GMAB

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16:10 EDT Seagen, Genmab announce Phase 3 innovaTV 301 trial met primary endpoint of OS - Seagen (SGEN) and Genmab A/S (GMAB) announced that the Phase 3 innovaTV 301 global trial in recurrent or metastatic cervical cancer patients with disease progression on or after front-line therapy who received TIVDAK, compared with chemotherapy alone, met its primary endpoint of overall survival, or OS. An Independent Data Monitoring Committee determined that OS crossed the pre-specified efficacy boundary at interim analysis. The key secondary endpoints of investigator-assessed progression-free survival and objective response rate also demonstrated statistical significance. The safety profile of TIVDAK in innovaTV 301 was consistent with the known safety profile of TIVDAK as presented in the U.S. prescribing information, and no new safety signals were observed. The results of innovaTV 301/ENGOT cx-12/GOG 3057, a global, randomized, open-label Phase 3 trial, add to the previous results of innovaTV 204, which served as the basis for the accelerated approval of TIVDAK in the U.S. Subject to discussions with regulatory authorities, the results from innovaTV 301 are intended to serve as the pivotal confirmatory trial for the U.S. accelerated approval and support global regulatory applications. The innovaTV 301 China extension study has been initiated and continues to enroll patients, in collaboration with Zai Lab Limited. Results of the Phase 3 innovaTV 301 clinical trial will be submitted for presentation at an upcoming medical congress and discussed with regulatory authorities.
XENE

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08:46 EDT Xenon Pharmaceuticals showcases XEN1101 epilepsy program at 35th IEC - Xenon Pharmaceuticals announced a summary of its oral and poster presentations at the 35th International Epilepsy Congress taking place in Dublin, Ireland from September 2-6, 2023. An interim analysis, with a cutoff date of September 22, 2022, of the ongoing X-TOLE open-label extension study demonstrated that treatment with XEN1101 resulted in sustained monthly reduction in seizure frequency from double-blind period baseline, with adverse events consistent with previous results and those seen with other antiseizure medications, and no new safety signals were identified. Newly compiled interim data from the X-TOLE OLE focused on quality-of-life measures as assessed using a validated tool called the Quality of Life in Epilepsy Inventory-31 in the overall OLE group as well as a subgroup that was seizure-free for at least 12 consecutive months at the time of the interim data analysis. The SFG consisted of 29 patients. The overall OLE patient group showed improvements in overall Quality of Life. Clinically important improvements in QOLIE-31 subscales of Seizure Worry, Social Functioning, and Medication Effects were seen across all patients, with even greater improvements in the SFG. The SFG achieved clinically important improvements in all QoL subscales assessed by the QOLIE-31. The improvements in Medication Effects across all patients is notable as this measures the patients' perception of drug tolerability as well as the benefit of long-term seizure reduction.
MVIR

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07:08 EDT Medivir reports interim safety, efficacy data from Phase 1b/2a HCC study - Medivir AB announced what it called "promising interim safety and efficacy data" from its ongoing phase 1b/2a study of first-in-class candidate drug fostrox in combination with Lenvima in advanced hepatocellular carcinoma patients for whom current first- or second-line treatment has proven ineffective or is not tolerable. The interim results confirmed the previously announced favorable safety and tolerability profile. No new or unexpected safety events and the combination continues to be tolerable. The phase 2a dose expansion part of the study is ongoing and is now fully recruited. Data from phase 1b/2a is planned to be presented at an upcoming scientific congress.
ALB

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07:02 EDT Albemarle confirms non-binding agreement to acquire Liontown - Albemarle confirmed that it will be working toward the execution of a binding agreement to acquire Liontown Resources Limited Albemarle notes the announcement to the ASX by Liontown and confirms that it submitted a best and final non-binding proposal, in the absence of a superior proposal, to acquire all outstanding shares of Liontown by way of scheme of arrangement for A$3.001 cash per share. The Revised Proposal values Liontown at A$6.6B or $4.32B on an equity value basis. The Liontown Board has confirmed to Albemarle that, subject to entry into a mutually acceptable non-disclosure and exclusivity agreement, it intends to grant Albemarle an opportunity to conduct a limited period of exclusive due diligence, subject to customary fiduciary exceptions, to enable it to put forward a binding proposal. Should Albemarle make a binding proposal at $3.00 per share, the Liontown Board intends to unanimously recommend that Liontown shareholders vote in favor of the Revised Proposal, in the absence of a superior proposal, and subject to the parties entering into a mutually acceptable binding SID, the completion of Albemarle's due diligence to Albemarle's satisfaction, and an independent expert concluding that the Revised Proposal is in the best interests of Liontown shareholders. Albemarle and Liontown will enter into a mutually acceptable non-disclosure and exclusivity agreement granting Albemarle with an exclusivity period to undertake confirmatory due diligence and negotiate a binding SID.
CCJ

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06:59 EDT Cameco provides production, market update - Cameco provided a market update regarding challenges at the Cigar Lake mine and Key Lake mill that are expected to impact its 2023 production forecast. At the Cigar Lake mine, the company now expects to produce up to 16.3M pounds of uranium concentrate this year, a reduction from the previous forecast of 18M pounds U3O8. Production from the McArthur River/Key Lake operations for 2023 is anticipated to be 14M pounds U3O8, down from the previous forecast of 15M pounds U3O8. As previously reported, mining activities at the Cigar Lake operation were initiated from a new zone in the orebody in the second quarter of this year, which impacted productivity. As mining activities continued in the west pod during the third quarter, equipment reliability issues emerged which further affected performance. The mine is scheduled to enter its planned annual maintenance shutdown that will run through most of September. At the Key Lake mill, ramp up activities remain ongoing. However, as noted in our second quarter MD&A, there is continued uncertainty regarding planned production in 2023 at Key Lake due to the length of time the facility was in care and maintenance, the operational changes that were implemented, availability of personnel with the necessary skills and experience, and the impact of supply chain challenges on the availability of materials and reagents. These factors have combined to impact production at Key Lake, leading to the reduced forecast. The McArthur River mine continues to operate well and is expected to achieve its planned production for the year. Any ore from McArthur River that is not immediately processed at Key Lake will be stored in inventory for future milling. Cameco says the company's strategy of full-cycle value capture. Any pounds it does not produce this year will remain available and, with increasing supply pressures, potentially become more valuable when delivered in the future. Cameco has exposure to higher prices under the market-related contracts in our long-term portfolio and a pipeline of contracting discussions underway, which it expects will also benefit from the increased focus on securing access to scarce supplies and generate long-term value for Cameco. "This expected production shortfall further highlights the growing security of supply risk at a time when we believe the demand outlook is stronger and more durable than ever and where the risk has shifted from producers to utilities. Uncertainty about where nuclear fuel supplies will come from to satisfy growing demand continues to drive long-term contracting, with clear evidence that the broader uranium market is moving toward replacement rate contracting for the first time in over a decade. This is the type of contracting necessary to promote the price discovery already seen in the enrichment and conversion markets and that is expected to incentivize investments in the supply needed to satisfy the growing long-term requirements," the company adds. This unplanned event may lead to variability in the other outlook provided in its second quarter MD&A for 2023; however, it is too soon to quantify what the impact might be.
RLYB

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06:55 EDT Rallybio presents Phase 1 single ascending dose data for RLYB116 - Rallybio presented clinical data in a poster from the Phase 1 first-in-human single ascending dose clinical study in healthy participants of RLYB116. RLYB116 is an innovative potentially long-acting, subcutaneously injected inhibitor of C5 in development for the treatment of patients with complement-mediated diseases. The poster presentation took place at the 29th International Complement Workshop, in Newcastle, U.K. The data demonstrated that single-dose administration of RLYB116 at the two higher doses of 100 mg and 300 mg resulted in maximum exposures of greater than 1 microM and 3 microM, respectively, and greater than 99% reductions in free C5 concentrations. Subcutaneously administered RLYB116 was observed to be generally well-tolerated as a single 100 mg or 300 mg dose, with mild to moderate adverse events and no drug-related serious adverse events.