FSD Pharma launches mid-stage study of FSD201 in COVID-19

• Nano cap FSD Pharma (NASDAQ:HUGE) perks up 7% premarket on average volume in response to the initiation of a 352-subject Phase 2 clinical trial evaluating orally available FSD201 (ultramicronized palmitoylethanolamide, or ultramicronized PEA), along with standard-of-care (SOC) treatment, in hospitalized COVID-19 patients. Dosing should commence this month.
• The primary objective is to determine if FSD201 improves clinical status compared to SOC alone.
• Palmitoylethanolamide is a chemical made from fat. It is found naturally in foods like egg yolks and peanuts. It is used to treat pain, fibromyalgia, multiple sclerosis, carpal tunnel syndrome, infections of the airway and other disorders but scientific data demonstrating efficacy is lacking.
• https://seekingalpha.com/news/3619774-fsd-pharma-launches-mid-stage-study-of-fsd201-in-covidminus-19-shares-up-7
  

Shattuck Labs expects to price 10M shares in IPO at $14-$16

• Oncology biotech, Shattuck Labs (STTK) to issue 10M shares at an initial offering price range of $14-$16.
• Underwriters' over-allotment is an additional 1.5M common shares.
• With 38.1M shares outstanding, the pricing values the company at up to $609.3M.
• The company is currently conducting a Phase 1 trial of SL-172154 for ovarian cancer, with initial data expected in the 2H21. 
• The company intends to use the net proceeds together with existing cash and cash equivalents and short term investments: to advance SL-172154 through the completion of ongoing and planned Phase 1 clinical trials and to commence a Phase 2 clinical program; to advance SL-279252 through the completion of ongoing Phase 1 clinical trial; and to develop and advance additional product candidates derived from platforms through IND-enabling studies and to commence Phase 1 clinical trials.
• The company has booked $11M in collaboration revenue for the 12 months ended June 30, 2020.
• The following table highlights company's two clinical-stage assets that have been derived from ARC platform: 
• Source
• https://seekingalpha.com/news/3619768-shattuck-labs-expects-to-price-10m-shares-in-ipo-14-16
  

Durect to present additional Phase 1b DUR-928 data in NASH at AASLD meeting

• DURECT (NASDAQ:DRRX) will present a poster at The AASLD Liver Meeting Digital Experience (TLMdX) 2020, to be held virtually on November 13-16, 2020.
• Topline results from the 4-week Phase 1b clinical study of orally administered DUR-928 in nonalcoholic steatohepatitis (NASH) patients were released previously, showing an overall improvement from baseline in liver enzymes, liver stiffness, and serum lipid profiles.
• DUR-928, is an endogenous sulfated oxysterol and an epigenetic regulator.
• https://seekingalpha.com/news/3619762-durect-to-present-additional-phase-1b-durminus-928-data-in-nash-aasld-liver-meeting
  

Biocept's cerebrospinal fluid test improves cancer detection vs standard cytology

• Provider of cancer molecular tests, Biocept (NASDAQ:BIOC) has announced results from a prospective study comparing its Target Selector cerebrospinal fluid testing to conventional cytology in with non-small cell lung cancer and leptomeningeal metastasis. The results were presented at the International Association for the Study of Lung Cancer. Have a look at the presentation here.
• In this study, 28 cerebrospinal fluid samples from 15 patients obtained sequentially before and during treatment were compared. Target Selector improved detection of circulating tumor cells (CTC), finding CTCs in 78% of the samples, whereas cytology detected tumor cells in 55% of samples.
• Target Selector also provided sensitive quantitative identification of actionable EGFR mutations in cerebrospinal fluid.
• Also, alterations in CTC density as well as in EGFR mutant copy numbers were observed weeks before a treatment response was measured via traditional clinical evaluations.
• https://seekingalpha.com/news/3619752-study-shows-biocepts-cerebrospinal-fluid-test-improves-cancer-detection-compared-to-standard
  

Corvus Pharma rallies 40% on promising CPI-006 data in COVID-19

• Corvus Pharmaceuticals (NASDAQ:CRVS) announces encouraging data from its ongoing Phase 1 study investigating CPI-006 in COVID-19 patients.
• Updated data include 56-day follow-up results from the first two cohorts (0.3 mg/kg and 1.0mg/kg dose) and initial results from the third cohort (3.0 mg/kg) of the study.
• Day 56 results showed a dose-response, with higher and more prolonged titers of anti-SARS-CoV-2 antibodies in the 1.0 mg/kg cohort compared to the 0.3 mg/kg cohort.
• In addition, the results showed increased levels of memory B cells and memory T cells, and there have been no reports of any drug-related safety issues in any of the 15 patients treated as of September 17.
• As of September 28, 14 of 15 patients were discharged from the hospital with clinical improvement after a median of 4.5 days. One patient remains in the hospital with improvement of symptoms.
• Corvus expects to complete the study and report results this quarter, including a presentation at the Society for Immunotherapy of Cancer (SITC) meeting next month.
• A double blind study in hospitalized COVID-19 patients is next up.
• https://seekingalpha.com/news/3619747-corvus-pharma-rallies-40-on-promising-cpiminus-006-data-in-covidminus-19
  
  

Bristol Myers Squibb to acquire Myokardia for $13.1B in cash

• Bristol Myers Squibb (NYSE:BMY) accelerates the expansion of its cardiovascular portfolio by acquiring MyoKardia (NASDAQ:MYOK) for $13.1B, or $225/share in cash.
• The company expects to finance the acquisition with a combination of cash and debt and anticipates its closing during 4Q20.
• “The acquisition of MyoKardia further strengthens our portfolio, pipeline and scientific capabilities, and is expected to add a meaningful medium- and long-term growth driver,” said Giovanni Caforio, M.D., Board Chair and Chief Executive Officer of Bristol Myers Squibb. “We are further strengthening our outstanding cardiovascular franchise through the addition of mavacamten, a promising medicine with the potential to address a significant unmet medical need in patients with cardiovascular disease.”
• The transaction is expected to be minimally dilutive to company’s non-GAAP EPS in 2021 and 2022 and accretive beginning in 2023. Bristol Myers Squibb reaffirms its existing 2021 non-GAAP EPS guidance range.
• https://seekingalpha.com/news/3619698-bristol-myers-squibb-to-acquire-myokardia-for-13_1b-in-cash
  

Zai Lab commences late-stage study of retifanlimab in lung cancer

• The first participant has been dosed in a China-based Phase 3 clinical trial, PODIUM-304, evaluating Zai Lab Limited (NASDAQ:ZLAB) and Incyte's (NASDAQ:INCY) PD-1 inhibitor retifanlimab, combined with platinum-based chemo, in treatment-naïve patients with metastatic non-small cell lung cancer (NSCLC).
• The primary endpoints of the 530-subject study are overall survival and progression-free survival. The estimated primary completion date is August 2024.
• https://seekingalpha.com/news/3619737-zai-lab-commences-late-stage-study-of-retifanlimab-in-lung-cancer