RepliCel Life Sciences Inc (TSXV:RP)
RepliCel is a regenerative medicine company developing autologous cell therapies that address diseases caused by a deficit of healthy cells required for normal healing and function.
In an open letter, Gilead Sciences (NASDAQ:GILD) Chairman & CEO Dan O’Day announces the price of antiviral remdesivir, still the only drug approved by the FDA for emergency use in COVID-19.
Aimed at “broad and equitable” access at a time of urgent global need, the company has priced it at $390 per vial or $2,340 per five-day course (six vials), the most common treatment regimen for COVID-19 patients, substantially below what some analysts have been projecting.
It is ramping up production and expects its investment in the development and manufacture of remdesivir to exceed $1B by year-end.
In the developing world, Gilead has deals with generic manufacturers to allow treatment at substantially lower costs.
Shares up 1% premarket on light volume.
RedHill Biopharma (RDHL -6.5%) announces that the UK Medicines & Healthcare products Regulatory Agency (MHRA) has signed off on a Phase 2/3 clinical trial evaluating opaganib in hospitalized patients with severe COVID-19 pneumonia.
The multi-center, randomized, double-blind, parallel-arm, placebo-controlled study will enroll up to 270 patients. The primary endpoint will be the proportion of patients requiring intubation and mechanical ventilation by Day 14.
Futility only interim analysis will be conducted by an independent data safety monitoring board when ~100 subjects have been evaluated for the primary endpoint.
In parallel, RedHill has commenced enrollment in a U.S.-based randomized, double-blind, placebo-controlled Phase 2a trial testing opaganib in up to 40 patients with severe COVID-19 pneumonia requiring hospitalization and supplemental oxygen.
Opaginib, branded as Yeliva, inhibits an enzyme called sphingosine kinase-2 (SK2) which blocks the synthesis of a lipid-signaling molecule called sphingosine 1-phosphate (S1P) that promotes cancer cell growth and pathological inflammation.
Sell-side analysts are busy updating their spreadsheets and investor notes after Gilead Sciences (GILD +0.7%) announced its government price of $390/vial price for antiviral remdesivir, implying a typical cost per treatment course of $2,340 (six vials). Commercially insured patients will pay a bit more, $520 per vial or $3,120 per course.
Analysts expected a U.S. cost/course in the neighborhood of $5,000 after drug cost watchdog ICER published a cost/benefit analysis that determined a price of $4,500 to be cost-effective.
In his open letter, CEO Dan O’Day stated that earlier hospital discharge would save ~$12K per patient.
SunTrust’s Robyn Karnauskas (HOLD/$73) has trimmed her fair value target on the company by $3 saying it is “unclear” how Gilead will recoup its $1B investment in the near term since cost of goods sold (COGS) is unknown as is the number of patients who will be treated in H2.
RBC’s Brian Abrahams (OUTPERFORM/$88) remains a cheerleader, projecting that remdesivir will generate $2.3B in sales this year which should add $1/share in valuation and ~$1 to 2020 EPS.
SVB Leerink’s Geoffrey Porges (OUTPERFORM/$94) is revisiting his sales forecast although he believes the pricing is “reasonable.”
Piper Sandler’s Tyler Van Buren (OVERWEIGHT/$90) believes the pricing is “in line” with ICER’s assessment based on the mortality benefit.
Jefferies’ Michael Yee (BUY/$97) also regards the pricing as “in line” although the company could certainly charge more considering the $12,000 savings for early discharge. He would not be surprised if the company conservatively guides 2020 sales of ~$1B although investors are most likely expecting sales as high as $2B this year.
Heron Therapeutics (NASDAQ:HRTX) is down 11% premarkket in reaction to its announcement that it received a Complete Response Letter (CRL) from the FDA regarding its NDA for HTX-011 for the management of postoperative pain.
The CRL stated that the FDA is unable to approve the NDA in its present form based on the need for additional non-clinical information.
The Agency did not identify any clinical safety or efficacy issues or chemistry, manufacturing and controls issues. There are four non-clinical issues in the CRL, none of which relate to any observed toxicity.
The Company will request a Type A meeting to obtain agreement with the Agency and resubmit the application as quickly as possible.
CytoDyn (OTCQB:CYDY) has entered into a Memorandum of Understanding (MoU) with the Coordinating Commission of the National Institutes of Health and High Specialty Hospitals of Mexico (NIH) to conduct a COVID-19 clinical trial with leronlimab for severe and critically ill patients, with the potential to collaborate on additional COVID-19 trials.
Under MoU, CytoDyn will supply leronlimab at its expense, and both parties will proceed expeditiously to complete the mutually agreed protocol for this clinical trial.
The Phase 3 trial is expected to enroll only 25 patients.