PennyWorld
2年前
Acer Therapeutics (NASDAQ:ACER – Get Rating) will be announcing its earnings results on Tuesday, February 28th.
Acer Therapeutics Price Performance
ACER opened at $2.14 on Monday. The company’s 50 day moving average is $2.57 and its 200 day moving average is $1.85. Acer Therapeutics has a 12-month low of $1.11 and a 12-month high of $4.56.
Insider Buying and Selling at Acer Therapeutics
In related news, CEO Chris Schelling purchased 819,672 shares of the company’s stock in a transaction that occurred on Tuesday, November 29th. The stock was bought at an average price of $1.22 per share, for a total transaction of $999,999.84. Following the completion of the transaction, the chief executive officer now owns 2,712,529 shares in the company, valued at approximately $3,309,285.38. The purchase was disclosed in a legal filing with the Securities & Exchange Commission, which is accessible through this link. Insiders own 20.20% of the company’s stock.
Institutional Investors Weigh In On Acer Therapeutics
Several large investors have recently added to or reduced their stakes in ACER. Geode Capital Management LLC grew its stake in Acer Therapeutics by 6.1% during the 4th quarter. Geode Capital Management LLC now owns 96,330 shares of the biopharmaceutical company’s stock worth $241,000 after buying an additional 5,515 shares during the last quarter. Renaissance Technologies LLC raised its position in Acer Therapeutics by 216.8% during the second quarter. Renaissance Technologies LLC now owns 69,700 shares of the biopharmaceutical company’s stock worth $88,000 after acquiring an additional 47,700 shares during the period. Meridian Wealth Management LLC acquired a new position in shares of Acer Therapeutics during the fourth quarter valued at approximately $180,000. Finally, Vanguard Group Inc. boosted its stake in Acer Therapeutics by 55.5% during the 1st quarter. Vanguard Group Inc. now owns 278,215 shares of the biopharmaceutical company’s stock worth $807,000 after purchasing an additional 99,335 shares during the last quarter. 27.96% of the stock is owned by hedge funds and other institutional investors.
tw0122
2年前
Acer Therapeutics (ACER)
The next biopharma with an advanced drug candidate well into the regulatory process is Acer Therapeutics. The company’s research is focused on serious metabolic diseases that are also exceedingly rare, and lack effective medical treatments. The company’s pipeline currently features three research tracks, with the leading drug candidate, ACER-001, being the farthest along.
ACER-001 is underdevelopment as a treatment for serious ‘inborn errors of metabolism,’ including urea cycle disorders, UCDs, and maple syrup urine disease (MSUD). Acer resubmitted the new drug application (NDA) on -001 to the FDA in July of this year, and is looking at a PDUFA date from the regulatory agency of January 15, 2023.
In June 2022, the FDA already turned down Acer’s application to get ACER-001 approved for the treatment of UCDs. The Complete Response Letter (CRL) stated that the FDA field investigator “could not complete inspection” of ACER’s third party contract packaging manufacturing location because “the facility was not ready for inspection.” The FDA also had one comment in the CRL that was “not an approvability issue” pertaining to a request for additional nonclinical information.
On the insider front, we see a clear case of confidence ahead of the upcoming PDUFA date. First, CEO Steven Lisi laid down $1 million for a bloc of 819,672 shares in his company. The second large buy was from Chairman Steve Aselage who’s 409,836 share purchase cost $500,000.
5-star analyst Vernon Bernardino, covering Acer for H.C. Wainwright, doesn’t hide his optimism for the stock as well. Bernardino is clear on why Acer has sound prospects ahead, and lays it out in unambiguous prose.
“With no further approvability concerns, we are positive on ACER-001’s prospects for FDA approval on or before January 15, 2023. Thus, we look for ACER-001 to achieve commercial success, and estimate ACER-001 can achieve approximately $750M in annual sales as a treatment for UCDs by 2028. We believe Acer’s accomplishments in meeting the challenges of advancing its NDA, and the potential for ACER-001 to achieve near-term commercial success, are underappreciated,” Bernardino wrote.
Going forward from these comments, Bernardino gives ACER shares a Buy rating, and his $12 price target implies a hefty upside of 664% for the coming year. (To watch Bernardino’s track record, click here)
Turning now to the rest of the Street, other analysts are on the same page. With 3 Buys and no Holds or Sells, the word on the Street is that ACER is a Strong Buy. The stock has a $9.67 average price target and a share price of $1.57, for a one-year upside potential of ~516%. (See ACER stock forecast on TipRanks)
PennyWorld
2年前
Acer wins FDA OK for Olpruva to treat urea cycle disorders
Dec. 23, 2022 2:30 PM ETAcer Therapeutics Inc. (ACER), RLFTF, RLFTYBy: Dulan Lokuwithana, SA News Editor
Headquarters of US Food and Drug Administration (FDA)
Grandbrothers/iStock Editorial via Getty Images
The U.S. Food and Drug Administration (FDA) has greenlighted Olpruva, being developed by Acer Therapeutics (NASDAQ:ACER) and Swiss biotech Relief Therapeutics (OTCQB:RLFTF) (OTCQB:RLFTY) as a treatment for patients with urea cycle disorders (UCD).
The oral treatment, also known as sodium phenylbutyrate, will therefore be indicated in the U.S. as an adjunctive therapy to the standard of care for chronic management of adults and children with UCDs.
UCDs are a genetically-driven group of diseases that impact the urea cycle, leading to excess accumulation of blood ammonia, which can result in lethargy, coma, multi-organ failure, seizures, and psychiatric symptoms.
In June 2022, the FDA rejected the therapy citing the need for an adequate review of Acer's (ACER) third-party contract manufacturer for the drug, then known as ACER-001.
However, the following month, FDA accepted the company's resubmitted New Drug Application for ACER-001, issuing Jan. 15, 2023, as the target action date.
In August, Acer (ACER) and Relief (OTCQB:RLFTF) announced the European orphan medicinal product designation for ACER-001 as a treatment for the rare metabolic disorder Maple Syrup Urine Disease.
PennyWorld
2年前
Acer wins FDA OK for Olpruva to treat urea cycle disorders
Dec. 23, 2022 2:30 PM ETAcer Therapeutics Inc. (ACER), RLFTF, RLFTYBy: Dulan Lokuwithana, SA News Editor
Headquarters of US Food and Drug Administration (FDA)
Grandbrothers/iStock Editorial via Getty Images
The U.S. Food and Drug Administration (FDA) has greenlighted Olpruva, being developed by Acer Therapeutics (NASDAQ:ACER) and Swiss biotech Relief Therapeutics (OTCQB:RLFTF) (OTCQB:RLFTY) as a treatment for patients with urea cycle disorders (UCD).
The oral treatment, also known as sodium phenylbutyrate, will therefore be indicated in the U.S. as an adjunctive therapy to the standard of care for chronic management of adults and children with UCDs.
UCDs are a genetically-driven group of diseases that impact the urea cycle, leading to excess accumulation of blood ammonia, which can result in lethargy, coma, multi-organ failure, seizures, and psychiatric symptoms.
In June 2022, the FDA rejected the therapy citing the need for an adequate review of Acer's (ACER) third-party contract manufacturer for the drug, then known as ACER-001.
However, the following month, FDA accepted the company's resubmitted New Drug Application for ACER-001, issuing Jan. 15, 2023, as the target action date.
In August, Acer (ACER) and Relief (OTCQB:RLFTF) announced the European orphan medicinal product designation for ACER-001 as a treatment for the rare metabolic disorder Maple Syrup Urine Disease.
PennyWorld
2年前
Bernardino gives ACER shares a Buy rating, and his $12 price target implies a hefty upside of 664% for the coming year. (To watch Bernardino’s track record, click here)
Turning now to the rest of the Street, other analysts are on the same page. With 3 Buys and no Holds or Sells, the word on the Street is that ACER is a Strong Buy. The stock has a $9.67 average price target and a share price of $1.57, for a one-year upside potential of ~516%
PennyWorld
2年前
Institutional Inflows and Outflows
Several large investors have recently modified their holdings of the business. Vanguard Group Inc. increased its position in shares of Acer Therapeutics by 55.5% during the first quarter. Vanguard Group Inc. now owns 278,215 shares of the biopharmaceutical company’s stock worth $807,000 after purchasing an additional 99,335 shares in the last quarter. Renaissance Technologies LLC raised its position in shares of Acer Therapeutics by 216.8% during the 2nd quarter. Renaissance Technologies LLC now owns 69,700 shares of the biopharmaceutical company’s stock worth $88,000 after purchasing an additional 47,700 shares during the last quarter. Finally, Copperwynd Financial LLC acquired a new stake in Acer Therapeutics in the 2nd quarter valued at about $29,000. Hedge funds and other institutional investors own 9.76% of the company’s stock.
https://reporter.am/2022/11/22/acer-therapeutics-nasdaqacer-shares-cross-below-200-day-moving-average-of-1-54.html
PennyWorld
3年前
On October 8, 2021 Dr Joey posted this........
3. Add ACER deal - this is going to happen! Next June, ACER-001 has a 90% chance of approval rating right now. It has been accepted (big deal and 2month process alone from submission to announcement of official acceptance). It is going in under section b (505) meaning it's applying for an ALREADY APPROVED DRUG with modifications to it (that do not affect its effectiveness). In other words, the drug is already approved as safe, effective, beneficial for the conditions for which they are submitting the application. The bar is very low here for these types of drugs under section b (505). You only have to prove by bioequivalence. Basically, the hard part is over. In layman's terms, ACER put a hard candy shell on the outside of the same nasty drug that patients have been refusing and spitting out for years because of the taste. They hard part to get this ACER-001 drug approved was just proving that once the pill passes the palate and into the stomach, and the hard candy shell dissolves, does the drug amount available to be delivered equal the same amount of available drug as did the original nasty stuff once it made it to the same stage of digestion. Also, does their manufacturing processes to make the drug yield pure bioequivalent substance of the same sanitary quality as the original already approved drug. Obviously, they are past out of this. Now they will meet to discuss marketing and aftermarketing observation methods for the drug before user fees are applied (for which they won't have to pay these either because MSUD has already received ODD status! That means a $2.9mil amt that stays in the pocket!).
PennyWorld
3年前
https://seekingalpha.com/news/3822571-acer-relief-report-data-showing-bioequivalence-of-acer-001-versus-reference-drug
Acer, Relief report data showing bioequivalence of ACER-001 versus reference drug
Apr. 12, 2022 5:56 AM ETAcer Therapeutics Inc. (ACER), RLFTFBy: Ravikash, SA News Editor
Medical Science Laboratory with Diverse Multi-Ethnic Team of Microbiology Scientists Have Meeting on Developing Drugs, Medicine, Doing Biotechnology Research. Working on Computers, Analyzing Samples
gorodenkoff/iStock via Getty Images
Acer Therapeutics (NASDAQ:ACER) and Relief Therapeutics (OTCQB:RLFTF) said data from two phase 1 studies showed that taste-masked sodium phenylbutyrate (ACER-001) was bioequivalent to sodium phenylbutyrate (BUPHENYL(R)) powder under both fed and fasting conditions.
The company has filed an application with the U.S. FDA seeking approval of ACER-001 for Urea Cycle Disorders (UCDs). The FDA is expected to make a decision by June 5.
The companies presented the data — which evaluated the bioavailability, bioequivalence and taste attributes of taste-masked ACER-001 compared to sodium phenylbutyrate (BUPHENYL(R)) — at the Society for Inherited Metabolic Disorders Annual Meeting.
The companies added that higher levels of phenylbutyrate (PBA) and phenylacetate (PAA), a conjugate base of phenylacetic acid, were seen when taste-masked ACER-001 was administered under fasting versus fed conditions. A similar reduction in the PK of sodium phenylbutyrate (BUPHENYL(R)) powder under fed conditions was seen between the fasted and fed studies.
Adverse events in the studies showed no major safety signals.
In addition, the companies noted that results from two phase 1 taste assessment studies concluded that taste-masked ACER-001 was shown to have overall lower flavor intensity scores than sodium phenylbutyrate (BUPHENYL(R)) powder when administered within five minutes of preparation.
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