Stockwinners Market Radar for November 14, 2021 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

18:35 EST 89bio presents new data from Phase 1b/2a NASH study - 89bio announced the presentation of new data from a post-hoc analysis of the Phase 1b/2a proof-of-concept study evaluating BIO89-100 in patients with nonalcoholic steatohepatitis at The Liver Meeting 2021 of the American Association for the Study of Liver Diseases. The sub-analysis, which assessed the correlation between liver fat and spleen volume, demonstrated that treatment with BIO89-100 reduced spleen volume by an average of 11.8% in patients with NASH. The post-hoc analysis of the Phase 1b/2a study assessed the effect of BIO89-100 on SV in NASH patients without advanced fibrosis. SV was evaluated in all eligible patients on BIO89-100 27mg every week dose, BIO89-100 36mg every two-week dose and 16 patients on placebo. These patients were assessed by MRI at baseline, on Day 50 and on Day 92. At baseline, it was observed that SV was correlated with liver volume, vibration-controlled transient elastography score and body mass index, and negatively correlated with platelet count. Findings at study Day 50 and Day 92 demonstrated that treatment with BIO89-100 led to a progressive and significant decrease in spleen volume compared to placebo. These preliminary observations suggest that increased fat in the liver and inflammation may lead to subclinical worsening of portal blood flow, which in turn leads to increased spleen volume in NASH patients without advanced fibrosis. Based on these study findings, portal flow may be improved with treatment that significantly reduces liver fat. In addition to being presented at the meeting, the abstract has been selected by members of the AASLD Scientific Program Committee as a key presentation in The Best of Liver Meeting 2021.

17:18 EST Elon Musk taunts Bernie Sanders, suggests sale of more Tesla stock - Responding to Senator Bernie Sanders tweet saying "We must demand that the extremely wealthy pay their fair share. Period," Tesla's Elon Musk said that, "I keep forgetting that you're still alive... Want me to sell more stock, Bernie? Just say the word..." Reference Link

16:05 EST Iovance announces data for Lifileucel in combination with Pembrolizumab - Iovance Biotherapeutics announced clinical data for lifileucel in combination with pembrolizumab in patients with advanced cancers were presented in an oral session at the Society for Immunotherapy of Cancer Annual Meeting. Clinical data in the presentation show encouraging response rates after lifileucel plus pembrolizumab in patients with immune checkpoint inhibitor-naive cervical cancer, advanced melanoma, and head and neck squamous cell carcinoma. The clinical data also demonstrated that lifileucel can be safely combined with pembrolizumab and warrant continued investigation of tumor infiltrating lymphocyte cell therapy combinations as early-line treatment in advanced solid tumor cancers. Early-line treatment with single-agent pembrolizumab achieves an overall response rate of 33% in patients with advanced melanoma and 17% in patients with HNSCC. Cervical cancer patients previously treated with standard-of-care systemic therapy achieve an ORR of 11%-14% with pembrolizumab monotherapy. Novel early-line combination therapies are needed to improve the rate and depth of responses with manageable long-term safety. Clinical data in the SITC oral presentation included cervical cancer patients who were ICI- and chemotherapy-naive as well as patients with ICI-naive advanced melanoma and HNSCC. Patients across all three cohorts had high tumor burden at baseline.

15:58 EST Outlook presents NORSE TWO Phase 3 safety, efficacy data for ONS-5010/LYTENAV - Outlook Therapeutics presented pivotal safety and efficacy data from the Phase 3 NORSE TWO trial for ONS-5010, an investigational ophthalmic formulation of bevacizumab for use in wet age-related macular degeneration and other retinal indications, at the Retinal Subspecialty Day, AAO 2021 Annual Conference. The NORSE TWO Phase 3 pivotal trial enrolled a total of 228 wet AMD patients at 39 clinical trial sites in the United States. NORSE TWO was a superiority trial comparing the safety and efficacy of ONS-5010 ophthalmic bevacizumab dosed monthly against ranibizumab dosed according to the PIER regimen in the Lucentis labeling. Participants in the trial were treated for 12 months, with the primary endpoint at Month 11 being the difference in proportion of patients who gained at least 15 letters in best corrected visual acuity. The key secondary endpoint was the mean change in BCVA from baseline to Month 11. NORSE TWO data showed a strong safety profile, results consistent with previously reported safety data for ONS-5010, and similar to safety levels reported in prior research for bevacizumab used off-label in ophthalmology. The NORSE TWO pivotal data met both primary and secondary endpoints with statistically significant and clinically relevant results, the company said. Results from NORSE TWO also demonstrated that ONS-5010 ophthalmic bevacizumab has a strong safety profile. In findings that are consistent with historical bevacizumab data reported in prior research, in all three ONS-5010 registration trials there was only one ocular inflammatory adverse event, which was treated topically and resolved without sequelae. The safety findings continue to support minimal ocular inflammation and safety signals consistent with what was previously reported in the 2011 CATT trial and other large bevacizumab-controlled ophthalmic studies. Outlook Therapeutics' clinical program investigating ONS-5010 ophthalmic bevacizumab to treat wet AMD consists of three clinical trials - NORSE ONE, NORSE TWO, and NORSE THREE - all of which have now been completed. Based on the strong data from this clinical program, Outlook Therapeutics plans to submit a new BLA under the Public Health Service Act 351(a) regulatory pathway in the first quarter of calendar 2022. If the BLA is approved, it is expected to result in 12 years of marketing exclusivity in the US for ONS-5010 as the first and only ophthalmic formulation of bevacizumab approved by the FDA to treat wet AMD.

15:44 EST Snap responds to 'mini-tender offer by TRC Capital Investment - Snap announced that it received notice of an unsolicited "mini-tender" offer by TRC Capital Investment, or TRC Capital, to purchase up to 2,000,000 shares of Snap Class A common stock at a price of $50.25 per share in cash. TRC Capital's offer price is 4.43% below than the $52.58 closing price per share of Snap's Class A common stock on October 29, 2021, the last trading day before TRC Capital commenced its mini-tender offer. If all shares are acquired, TRC Capital's ownership would represent approximately 0.15% of Snap's outstanding Class A common stock.