Akcea Therapeutics appoints William Andrews as chief medical officer » 07:0507/0907/09/20
AKCA, IONS, ACER
Akcea Therapeutics (AKCA), a majority-owned affiliate of Ionis Pharmaceuticals (IONS), announced that William Andrews, MD, FACP, has joined the company as chief medical officer, effective immediately. Dr. Andrews will lead medical, clinical and regulatory functions in support of the company's two commercial-stage products TEGSEDI and WAYLIVRA and will also guide development of the multiple clinical-stage therapeutics in the pipeline. Former CMO Louis St. L. O'Dea, MB, BCh, BAO, FRCP, will serve as an advisor to the company to ensure a smooth transition. Most recently DR. Andrews served as chief medical officer at Acer Therapeutics (ACER).
Fly Intel: After-Hours Movers » 18:5907/0807/08/20
EXFO, SAR, ACER, OPTN, ANAB, VERI, PTC, SAP, CRNX, FTCH, COST, REGN, BBBY, OTIC, GLG, TPB, FIVE
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Acer Therapeutics announces data from food effect study of ACER-001 » 16:0707/0807/08/20
Acer Therapeutics announced data from a food effect study in healthy volunteers showing that administration of ACER-001 in a fasted state increased systemic exposure of phenylbutyrate, or PBA, phenylacetate, or PAA and phenylacetylglutamine, or PAGN, levels compared to fed state, and therefore based on modeling data may improve disease management in patients with urea cycle disorders, or UCDs, when compared to currently approved treatments requiring administration with food. Results from Part B of the ACER-001 bioequivalence, or BE, trial in healthy volunteers announced in February showed that ACER-001 was bioequivalent to Buphenyl and were within the parameters recommended by the FDA's Guidance for Industry. The BE trial included a food effect study, which evaluated the pharmacokinetics, or PK, of sodium phenylbutyrate showing that administration of ACER-001 in a fasted state achieved more than two times the maximum concentration of PBA compared to administration of the same dose of ACER-001 in a fed state. These results are consistent with previously published that evaluated PK of NaPBA in patients with progressive familial intrahepatic cholestasis, also demonstrating that administration of NaPBA in a fasted state significantly increased PBA peak plasma concentration compared to administration of NaPBA in a fed state. Based on the results from the food effect study within the ACER-001 BE trial, Acer commissioned Rosa & Co. to create a PhysioPD PK model to evaluate the potential food effect on exposure, tolerability and efficacy of ACER-001 in UCDs patients. Results from this in silico model suggest that administration of ACER-001 in a fasted state required approximately 30% less PBA to achieve comparable therapeutic benefit in a fed state. In addition, the model predicted that administration of ACER-001 in a fasted state compared to administration of Buphenyl or Ravicti in their required fed states is expected to result in higher peak blood PBA, PAA and PAGN concentrations, predicting a 43% increase in urinary PAGN levels.
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Acer jumps after Nature article on COVID therapy targets » 16:2505/1905/19/20
A late day surge in…
A late day surge in shares of Acer Therapeutics, that is carrying over to after-hours trading, is being attributed to the circulation of a Nature article regarding "Proteomics of SARS-CoV-2-infected host cells reveals therapy targets." The accelerated article preview, which was published online on May 14, stated that the clinical researchers "speculated that SARS-CoV-2 replication might be sensitive to translation inhibition. We tested two translation inhibitors - cycloheximide and emetine - for their ability to reduce SARS-CoV-2 replication. Both compounds significantly inhibited SARS-CoV-2 replication at non-toxic concentrations. Taken together, translatome analyses of cells infected with SARS-CoV-2 revealed the temporal profile of viral and host protein responses with prominent increases in the translation machinery. Translation inhibitors prevented SARS-CoV-2 replication in cells." On May 11, Acer Therapeutics announced it has entered into a research collaboration agreement with the National Center for Advancing Translational Sciences, or NCATS, one of the National Institutes of Health, or NIH, to develop emetine hydrochloride as a potential treatment for patients with COVID-19, the disease caused by infection with the SARS-CoV-2 virus. In after-hours trading, shares of Acer Therapeutics are up 83c, or 18%, to $5.36. Reference Link
Acer says cash position sufficient to fund operations into Q4 of 2020 » 16:0605/1405/14/20
Acer believes its cash…
Acer believes its cash position will be sufficient to fund its current operations into Q4 f 2020, excluding support for a planned emetine clinical trial and for EDSIVO development and precommercial activities.
Acer Therapeutics reports Q1 EPS (49c), consensus (40c) » 16:0505/1405/14/20
Cash and cash equivalents…
Cash and cash equivalents were $7.0M as of March 31, compared to $12.1M as of December 31, 2019.
Fly Intel: After-Hours Movers » 19:1405/1205/12/20
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Acer Therapeutics files to sell 1.64M shares of common stock for holders 16:1105/1205/12/20
Acer Therapeutics enters research pact with NCATS for emetine hydrochloride » 17:4105/1105/11/20
Acer Therapeutics announced it has entered into a research collaboration agreement with the National Center for Advancing Translational Sciences, or NCATS, one of the National Institutes of Health, or NIH, to develop emetine hydrochloride as a potential treatment for patients with COVID-19, the disease caused by infection with the SARS-CoV-2 virus. Under the terms of the agreement, Acer and NCATS will collaborate to accelerate the clinical development of emetine, a broad-acting and potent antiviral according to various preclinical and clinical studies. Acer is in ongoing discussion with the Division of Antivirals, or DAV, at the FDA after receiving its initial written responses to the company's pre-IND package. Acer is working toward an IND submission in mid-2020 and targeting clinical trial initiation in Q3, subject to additional capital. The company has proposed an adaptive design Phase 2/3 randomized, blinded, placebo-controlled multi-center trial to evaluate the safety and antiviral activity of emetine in high-risk, symptomatic adult patients with confirmed COVID-19 infection not requiring hospitalization. The trial objectives as planned are to determine the safety and efficacy of emetine via clinical status at a specific timepoint in addition to disease resolution. Acer is concurrently pursuing several financing options, including federally-funded research and grants, to support emetine development. For example, the Biomedical Advanced Research and Development Authority, or BARDA, invited the company to present the emetine development program at the BARDA CoronaWatch meeting on May 7. BARDA CoronaWatch is a funding program providing government support for selected coronavirus projects. While Acer plans to advance emetine through IND submission, initiation of the clinical trial of emetine is contingent on the timely availability of additional capital to fund this program. Emetine will be delivered as a sterile subcutaneous injection. Acer will oversee the contract synthesis and manufacturing of emetine for clinical development and potential commercialization.
Acer Therapeutics in $15M stock purchase pact with Lincoln Park » 16:5804/3004/30/20
Acer Therapeutics announced it has entered into a common stock purchase agreement for up to $15 million with Lincoln Park Capital Fund, a Chicago-based institutional investor. Under the terms of the purchase agreement and following the filing and effectiveness of a registration statement, Acer will have the right at its sole discretion, but not the obligation, to sell to LPC up to $15 million worth of shares over the 36-month term of the agreement, subject to various limitations including those under the Nasdaq listing rules. There are no upper limits to the price per share LPC may pay to purchase the shares, and the purchase price of the shares will be based on the then prevailing market prices at the time of each sale to LPC. Acer controls the timing and amount of any future sales of its stock to LPC. There are no warrants, derivatives, financial or business covenants associated with the agreements, and LPC has agreed not to cause or engage in any direct or indirect short selling or hedging of Acer's common stock. Acer may terminate the purchase agreement at any time, at its discretion, without any cost or penalty.