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.
Inovio Pharmaceuticals (INO -28.4%) finished deep in the red today after the company announced that the FDA placed a partial clinical hold on its planned Phase 2/3 trial evaluating COVID-19 vaccine candidate INO-4800.
Following the news, Roth Capital lowered its price target on Inovio’s shares to $8 (34% downside risk) from $11 with a Sell rating. “Even if lifted during the estimated mid-November timeframe, this will amount to the “wasting of precious time given the intense competition in this disease setting,” says analyst Jonathan Aschoff.
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Cantor Fitzgerald’s Charles Duncan downgraded the stock to Neutral from Overweight and slashed the value value target to $12 from $31.
RBC Capital analyst Gregory Renza reiterated a Sector Perform rating and $12 price target and said the hold a “disappointing but correctable” setback for the program.
Piper Sandler is ‘incrementally cautious‘ and says “It’s not guaranteed that Inovio will have the all-clear from FDA to start the trial once it hears back from the agency in November”. Keeps a Neutral rating with an $8 price target.
Maxim’s Jason McCarthy upgraded the stock to Buy, with PT at $20, as he believes the shares have been oversold on the announcement. He expects the issues to be resolved some in October or November and with the opportunity in COVID-19 ” intact, but with slight delay.
SA authors are Bullish while both Wall Street and Quant ratings are Neutral.
Despite the down day, shares are still up almost four-fold this year.
JD.com (NASDAQ:JD) to spin off its subsidiary JD Health and list it in Hong Kong to raise at least $1B and up to $3B
JD Health provides a wide range of services from drug delivery to online medical consultation.
In August, it raised more than $830M from Hillhouse Capital in its series B preference share financing.
JD Digits also filed on September 11 to join Shanghai’s Nasdaq-style Star Market, with the aim of raising RMB20.4B.
‘JD.com: Tremendous Value To Be Unlocked Soon‘, says ALT Perspective on Seeking Alpha.
Shares up 0.7% premarket.
The FDA has signed off Phase 2 trial of FSD Pharma’s (NASDAQ:HUGE) FSD201 (ultramicronized palmitoylethanolamide, or ultramicronized PEA) for the treatment of hospitalized COVID-19 patients. Patient dosing is expected to commence in October.
The 352-subject study will assess the efficacy and safety of FSD201 dosed at 600mg or 1200mg twice-daily, together with standard of care ((SoC)), with treatment period of 14 days.
The primary objective of the trial is to determine whether FSD201 plus SOC provides a significant improvement in the clinical status of patients (e.g., shorter time to symptom relief), at 28 days.
Shares up 16% premarket.
The FDA has placed a partial clinical hold on Inovio Pharmaceuticals’ (NASDAQ:INO) Phase 2/3 clinical trial of COVID-19 vaccine candidate INO-4800 and the Cellectra 2000 delivery device.
The agency cites the need to address additional questions about the study. The company says it plans to submit its response next month.
A partial clinical hold suspends enrollment but allows current participants to continue treatment.
The company’s Phase 1 trial is not affected.
CloudMD (OTCPK:DOCRF) to acquire 87.5% of Benchmark Systems from Antworks (parent company) for $4.375M in cash.
Benchmark System is a proprietary cloud-based practice management, billing and telehealth-enabled electronic health record provider.
The acquisition is immediately accretive as it provides CloudMD with expansion, distribution and optimization opportunities throughout the U.S. in supporting a patient- centric model.
Benchmark generates revenue of ~$4.9M and over 13% EBITDA annually from SAAS-based, recurring revenue.
AntWorks will retain a 12.5% equity stake and remain a strategic partner for CloudMD both in the U.S. and globally.
