CBAY News

CymaBay Therapeutics (CBAY) has seen solid earnings estimate revision activity over the past month, and belongs to a strong industry as well.

Q4 2019 Cymabay Therapeutics Inc Earnings Call

LOS ANGELES, CA / ACCESSWIRE / March 10, 2020 / The Schall Law Firm, a national shareholder rights litigation firm, announces that it is investigating claims on behalf of investors of CymaBay Therapeutics, Inc. ("CymaBay" or "the Company") (NASDAQ:CBAY) for violations of the securities laws. The investigation focuses on whether the Company issued false and/or misleading statements and/or failed to disclose information pertinent to investors. CymaBay released a letter from its President and CEO, Sujal Shah, to investors on January 29, 2020.

Generic Drugs Industry's Prospects Uncertain Amid Coronavirus

CymaBay Therapeutics, Inc. (NASDAQ: CBAY) (the "Company"), a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet need, today confirmed that Engine Capital Management ("Engine") has nominated three candidates to stand for election to the Company’s Board of Directors (the "Board") at the 2020 Annual Meeting. Shareholders are not required to take any action at this time. CymaBay issued the following statement:

CBAY earnings call for the period ending March 31, 2020.

NEW YORK, NY / ACCESSWIRE / March 12, 2020 / CymaBay Therapeutics, Inc. (NASDAQ:CBAY) will be discussing their earnings results in their 2019 Fourth Quarter Earnings call to be held on March 12, 2020 at ...

We can readily understand why investors are attracted to unprofitable companies. For example, although...

Looking into the current session, CymaBay Therapeutics Inc. (NASDAQ: CBAY) shares are trading at $4.21, after a 129% spike. Moreover, over the past month, the stock increased by 138.41%, but in the past year, decreased by 67.46%. Shareholders might be interested in knowing whether the stock is undervalued, even if the company is performing up to par in the current session.The stock is currently trading higher from its 52 week low by 248.35%. Assuming that all other factors are held constant, this could present itself as an opportunity for investors trying to diversify their portfolio with Biotechnology stocks, and capitalize on the lower share price observed over the year.The P/E ratio is used by long-term shareholders to assess the company's market performance against aggregate market data, historical earnings, and the industry at large. A lower P/E indicates that shareholders do not expect the stock to perform better in the future, and that the company is probably undervalued. It shows that shareholders are less than willing to pay a high share price, because they do not expect the company to exhibit growth, in terms of future earnings.Depending on the particular phase of a business cycle, some industries will perform better than others.Compared to the aggregate P/E ratio of the 6.99 in the biotechnology industry, CymaBay Therapeutics has a lower P/E ratio of 0.0. Shareholders might be inclined to think that they might perform worse than its industry peers. It's also possible that the stock is undervalued.price to earnings ratio is not always a great indicator of the company's performance. Depending on the earnings makeup of a company, investors may not be able to attain key insights from trailing earnings.See more from Benzinga * 20 Healthcare Stocks Moving In Tuesday's Pre-Market Session(C) 2020 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

CymaBay Therapeutics, Inc. (CBAY), a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet need, today announced corporate updates and financial results for the first quarter ended March 31, 2020. While we have not yet discussed full results from our investigation nor any of the panel’s conclusions with the FDA, we are planning to re-engage with the agency as quickly as possible.

Shares of CymaBay Therapeutics (NASDAQ: CBAY) have climbed nearly 143% since last week after it got great news about its orphan drug, seladelpar. A phase 2B trial for the drug to see how it did against nonalcoholic steatohepatitis (NASH, or liver inflammation not caused by alcohol) had been sidelined by the Newark, Calif., clinical-stage biopharmaceutical company since November due to safety concerns after study pathologists found tissue damage in the livers of participants. Last week, however, the company announced that a panel of independent experts unanimously overturned earlier findings that seladelpar caused liver damage.

In the world of biotechs, all it takes is a single piece of good news to change the narrative. This has been exemplified by none other than CymaBay Therapeutics (CBAY), which is focused on developing cutting-edge therapies for patients with liver and other chronic diseases.This month, an independent panel featuring eight expert liver pathologists and hepatologists unanimously determined that there wasn’t any clinical, biochemical or histological evidence of drug-induced liver injury (DILI) in the Phase 2b NASH study of CBAY’s seladelpar drug, which had been suspended based on atypical findings. Adding to the good news, the panel also recommended that the clinical hold put on seladelpar be removed, freeing the company up to resume its clinical development. In response, shares have skyrocketed 123% in the last month alone.Representing H.C. Wainwright, 5-star analyst Ed Arce notes that the next step for CBAY will be to “seek a meeting with the FDA to present its full findings and analysis within the next few months to discuss a pathway to remove seladelpar’s clinical hold.”Arce added, “Assuming a successful meeting with the FDA by year-end 2020, we foresee one or more new clinical trials of seladelpar to initiate in 1Q21 (recall, there were three active seladelpar programs in PBC, NASH, and PSC as of November 2019).”While this development is exciting, Arce acknowledges that the PBC Phase 3 trial may need to start over from the beginning. “Given the trial’s enrollment initiation in October 2018, we do not believe a meaningful number of patients had completed 52 weeks of seladelpar treatment when the trial was suspended in November 2019. Although we expect a new Phase 3 trial to possibly start from scratch upon the removal of seladelpar’s clinical hold, we believe the original trial’s rapid pace of enrollment reflected trial investigators’ positive experience with seladelpar in PBC, which could carry over to the new Phase 3 trial,” he explained.It should be noted that it could be possible for the company to use some of the safety and efficacy data from the suspended Phase 2b NASH trial as the candidate’s clinical hold was spurred by the abnormal findings witnessed during the analysis of the first tranche of biopsy data. However, Arce believes that CBAY will still kick off a new 52-week Phase 2b trial to support seladelpar’s future Phase 3/4 pivotal program.Based on all of the above, Arce gave CBAY his stamp of approval. In addition to upgrading his rating from Neutral to Buy, he put a $9 price target on the stock. Given this target, shares could soar 133% in the next year. (To watch Arce’s track record, click here)Turning now to the rest of the Street, other analysts also like what they’re seeing. 7 Buys and no Holds or Sells have been assigned in the last three months, making the consensus rating a Strong Buy. While less aggressive than Arce’s, the $7 average price target still leaves room for 81% upside potential. (See CymaBay stock analysis on TipRanks)To find good ideas for healthcare stocks trading at attractive valuations, visit TipRanks’ Best Stocks to Buy, a newly launched tool that unites all of TipRanks’ equity insights. More recent articles from Smarter Analyst: * Data Center Set to Send Nvidia Stock Soaring Even Higher * Google Pay App May Face Anti-Trust Probe In India – Report * 3 “Strong Buy” Biotech Stocks Under $5 With Explosive Upside Potential * Gilead & Arcus Join Forces For 10-Year Cancer Deal, Arcus Down 15% In Pre-Market

Shares in CymaBay Therapeutics (CBAY) exploded over 105% in after-hours trading Monday after the company revealed a positive update for its seladelpar liver disease drug, which has been on clinical hold since November.Sujal Shah, President and CEO of CymaBay, stated, “Last week a panel of some of the most experienced and distinguished liver pathologists and hepatologists in the world completed an independent review analyzing findings from our Phase 2b study of seladelpar in patients with NASH.”“I am pleased to report that the panel unanimously concluded there was no clinical, biochemical or histological evidence of seladelpar-induced liver injury in the study, and as a result they also unanimously supported the lifting of the clinical hold and re-initiation of clinical development.”CymaBay now intends to reach out to the FDA to discuss all of the data it has collected to date and the results of the panel review meetings. Once initial feedback is gathered, CymaBay wants to submit a complete response to the seladelpar clinical hold to the FDA.At the same time the company announced Q1 GAAP EPS of -$0.19, which beat the Street consensus by $0.11. Research and development expenses for the three months ended March 31, 2020 were $9.5 million, compared to $18.6 million for the three months ended March 31, 2019.Meanwhile cash, equivalents and marketable securities came in at $176.23M (down 7.7% from the previous quarter). “We remain focused on cost containment and will look at additional steps we can take into fiscal year 2020 in order to closely control the Company’s operating expenses and associated cash burn” commented Shah.The Street gives CBAY a cautiously optimistic Moderate Buy analyst consensus with 3 recent buy ratings and 2 hold ratings. The average analyst price target stands at $2.78 (51% upside potential). (See CymaBay stock analysis on TipRanks).Related News: GW Pharma Pops 9% After-Hours As Epidiolex Smokes Expectations 3 Stocks Needham’s Top Analysts Are Raving About Solid Biosciences: Keep Your Eyes On The Prize Says Top Analyst More recent articles from Smarter Analyst: * Roku Under Investigation By ITC For Universal Electronics Patent Infringement * Microsoft Buys Softomotive To Boost Its Robotic Automation Offerings * Spotify Surges 8.4%, Joe Rogan Brings More Than Experience Says Top Analyst * Microsoft Launches Cloud-Based Platform For Healthcare Organizations

Six months ago, disturbing liver biopsies suggesting some patients in an FDA Phase 2b study of CymaBay Therapeutics (CBAY) suffered inflamed and destroyed liver cells forced the company to suspend nonalcoholic steatohepatitis (NASH) treatment trials of its seladelpar liver treatment drug -- and cost CymaBay stock 75% of its market cap. Six months later, a new study just showed no evidence that seladelpar causes liver damage, giving CymaBay the all-clear to proceed with its trials, and more than doubling the stock's share price on Tuesday.Analysts rushed to hail the results, and as of today, every one of the six analysts tracked by TipRanks, who have voiced an opinion on CymaBay stock in the last two months, rate the stock a "buy" -- with an average target price of $5.15 on the shares (23% upside from Tuesday's closing price).Some analysts think it could be worth even more than that -- Oppenheimer's Jay Olson for example. In a note out Tuesday, Olson explained the importance of the new results:An "independent expert panel review of seladelpar" has determined "unanimously" that there is "no evidence" of "seladelpar-induced liver injury." The panel furthermore unanimously recommends that the CymaBay resume developing its drug pending the FDA's analysis of the results, which is not expected until 30 days after CymaBay officially submits its findings in Q3 2020.Olson expects the FDA's response to be positive, leading to the drug's progression to Phase 3 trials in early 2021, and concluding in 2023. Based on this timeline, and his estimate of the chance of the drug ultimately winning FDA approval rising to 35%, Olson rates CymaBay stock "outperform," and assigns the shares a $6 price target -- up from $4 previously. Based on Olson's recommendation, Oppenheimer's price target on CymaBay is now 9% above the consensus target -- but it's still far from the most optimistic price being posited. That honor now goes to Stifel Nicolaus, which on Tuesday doubled its price target on the shares. Previously valuing the company at no more than Oppenheimer did ($4 a share), Stifel now thinks the stock could be worth $8 within the next 12 months.Why? As analyst Derek Archila explains, you don't even have to accept Oppenheimer's 35% probability of success (POS) to assign an $8 price target to CymaBay shares. 15% POS suffices, even assuming it takes two or more years for seladelpar to win FDA approval, especially given the unequivocal nature of the expert panel's endorsement. ("No clinical or biochemical/serological evidence of drug-induced liver injury," whatsoever, was discovered).Archila furthermore notes that CymaBay has $176 million in cash currently, or about $3 a share. Thus, most of CymaBay's current $4-a-share valuation is already backed up by cash. And that cash, says the analyst, "at current burn rates should be more than enough to make it through a decision from the FDA" -- meaning there's little risk of stock dilution from CymaBay needing to raise more cash to complete its clinical work.Flush with cash and with solid clinical results underlying its new drug, Archila sees CymaBay as a "highly favorable" stock offering much more reward than risk to investors.To find good ideas for healthcare stocks trading at attractive valuations, visit TipRanks’ Best Stocks to Buy, a newly launched tool that unites all of TipRanks’ equity insights.

Q1 2020 Cymabay Therapeutics Inc Earnings Call

Investors need to pay close attention to CymaBay Therapeutics (CBAY) stock based on the movements in the options market lately.

Shares of CymaBay Therapeutics Inc. rocketed on in very active morning trading Tuesday, after an upbeat report on results of a study of its treatment of liver disease prompted a wave of upgrades by Wall Street analysts, who are now unanimously bullish on the biopharmaceutical company. The company said late Monday that a panel reviewing a Phase 2b study of seladelpar in patients with nonalcoholic steatohepatitis (NASH) concluded there was no evidence that seladelpar resulted in liver injury, and therefore unanimously supported the lifting of the clinical hold placed on the studies by the Food and Drug Administration. The stock soared 124% toward a 6-month high on volume of 17.5 million shares, which compares with the full-day average of 1.4 million shares. After a number of upgrades, all 8 of the analysts surveyed by FactSet have the equivalent of buy ratings. Stifel Nicolaus's Derek Archila raised his rating to buy from hold and doubled his price target to $8, saying the risk-versus-reward scenario is now "highly favorable" given the panel's findings. Raymond James's Steven Seedhouse lifted his rating to outperform from market perform, saying the seladelpar development is "stunning," while SVB Leerink's Thomas Smith upgraded CymaBay to outperform from market perform and lifted his price target to $6.00 from $2.50. Separately, CymaBay reported late Monday a narrower-than-expected first-quarter loss, according to FactSet. The stock has more than doubled (up 110%) year to date, while the S&P 500 has slipped 9.1%.

SAN FRANCISCO, CA / ACCESSWIRE / March 11, 2020 / Hagens Berman urges investors in CymaBay Therapeutics, Inc. (NASDAQ:CBAY) who have suffered significant losses to submit their losses now . The firm is ...

NEWARK, Calif., May 04, 2020 -- CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a clinical-stage biopharmaceutical company focused on developing therapies for liver and other.

Investigating unexpected findings from Phase 2b study of seladelpar in NASH In parallel, board and management evaluating all potential strategic alternatives to maximize.