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.
Health Canada approves Roche’s (OTCQX:RHHBY) Rozlytrek (entrectinib) for the treatment of adults with unresectable locally advanced or metastatic extracranial solid tumours, including brain metastases, that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation, who have no satisfactory treatment options.
Roche acquired the rights to the kinase inhibitor via its $1.7B acquisition of Ignyta in 2018. It is a “tumor agnostic” drug that works by targeting the NTRK mutation which plays a key role in growth of cancer cells.
The FDA approved Rozlytrek in August 2019 for certain lung cancer patients and NTRK-positive solid tumors.
Sarepta Therapeutics (NASDAQ:SRPT) and the United States Army Medical Research Institute of Infectious Diseases (USAMRIID) have entered into a Cooperative Research and Development Agreement (CRADA) to jointly identify antisense oligonucleotides using Sarepta’s phosphorodiamidate morpholino oligomer (PMO) platform with activity against SARS-CoV-2 for the potential treatment of COVID-19.
Pursuant to the CRADA, Sarepta will design, synthesize, manufacture and provide multiple peptide-conjugated PMO constructs based on genetic sequencing of SARS-CoV-2 for COVID-19.
USAMRIID will evaluate the constructs for their potential to inhibit viral infection. Based on the results, funding proposals will be considered to advance the development of treatments for COVID-19.
Shares are up 5% premarket.
Inovio Pharmaceuticals (NASDAQ:INO) announces the full enrollment of 40 healthy volunteers in a Phase 1 clinical trial of INO-4800, its COVID-19 DNA vaccine candidate.
All participants have received their first dose. Preliminary immune response and safety data should be available in late June. They will receive a second dose four weeks after the first.
Shares up 5% premarket on robust volume.
Moderna (NASDAQ:MRNA) (+7%) and iBio (NYSEMKT:IBIO) (+32%) are leading other COVID-19 vaccine players in premarket action. The former is poised to launch a Phase 2 study while the latter announced that it has the capacity to make 500M doses of its product, if approved.
Selected tickers: (NASDAQ:NVAX) (+2%), GlaxoSmithKline (NYSE:GSK) (+1%), Soligenix (NASDAQ:SNGX) (+6%), Dynavax (NASDAQ:DVAX) (+9%), Applied DNA Sciences (NASDAQ:APDN) (+1%)
Merck (MRK) Q1 results:
Revenues: $12,057M (+11.5%).
Net Income: $3,219M (+10.4%); EPS: $1.26 (+12.5%); non-GAAP Net Income: $3,822M (+20.4%); non-GAAP EPS: $1.50 (+23.0%).
Key Product Sales: Keytruda: $3,284M (+45%); Januvia / Janumet: $1,277M (-6%); Gardasil / Gardasil 9: $1,097M (+31%); Proquad, M-M-R II and Varivax: $435M (-12%); Bridion: $299M (+17%); Pneumovax 23: $256M (+39%); Isentress / Isentress HD: $245M (-4%); Rotateq: $222M (+5%); Simponi: $215M (+3%); Zetia / Vytorin: $198M (-17%); Implanon/Nexplanon: $195M (-2%).
2020 Guidance: Revenues: $46.1B – 48.1B from $48.8B – 50.3B; GAAP EPS: $4.12 – 4.32 from $4.57 – 4.72; Non-GAAP EPS: $5.17 – 5.37 from $5.62 – 5.77.
BioXcel Therapeutics (BTAI +2.6%) initiates the second portion of its Phase 1b/2 clinical trial evaluating BCXL701, combined with Merck’s Keytruda (pembrolizumab), in patients with treatment-emergent neuroendocrine prostate cancer (an aggressive form).
Preliminary data should be available in Q4.
The company says small molecule BXCL701 is designed to stimulate both the innate and acquired immune systems by inhibiting an enzyme called dipeptidyl peptidase (DPP) 8/9 and blocking immune invasion by targeting fibroblast activation protein (FAP).
