CymaBay Therapeutics

CymaBay Therapeutics, Inc. engages in the provision and development of access to therapies for patients with liver and other chronic diseases with high unmet medical needs. Its products pipeline includes Seladelpar, MBX-2982, CB-0406, and CB-001. The company was founded on October 5, 1988 and is headquartered in Newark, CA.

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CymaBay Therapeutics progresses in Phase 3 program, eyes commercial readiness

CymaBay Therapeutics is well-positioned with strong financials, a robust team, and a comprehensive approach to product launch and market access.
While facing challenges in regulatory engagement and competitive landscape, the company's focus on research, patient preferences, and global expansion provides opportunities for growth.
Anticipation for top-line data in Q3 2023 and a busy year ahead signal exciting prospects for CymaBay as they navigate towards potential commercial transformation.
Overall, CymaBay's strategic advancements, partnerships, and focus on patient outcomes position them favorably in the competitive landscape of PBC treatments.

CymaBay Therapeutics reports strong Phase 3 progress and financial stability

CymaBay Therapeutics showcased positive Phase 3 progress for seladelpar, backed by a strong financial position and a patient-centric approach to treatment advancement.
The company faces challenges in competitive positioning, resource allocation for post-marketing commitments, and meeting regulatory and patient expectations.
Opportunities lie in market expansion through partnerships, differentiation through clinical data, and enhancing treatment outcomes through ongoing studies.
Overall, CymaBay Therapeutics is poised for growth with a focus on advancing treatment guidelines, leveraging real-world data, and addressing unmet medical needs.

CymaBay reports strong Q2 earnings, faces reimbursement challenges ahead

CymaBay's Q2 2023 performance reflects financial strength and progress in seladelpar development, with upcoming milestone results expected.
While seladelpar shows promise in improving PBC patient quality of life, challenges in reimbursement criteria and rising expenses persist.
Opportunities lie in expanding patient reach through IDEAL study, exploring combination therapies, and transitioning patients into commercial use.

CymaBay excels in Q3 with seladelpar breakthrough therapy designation

CymaBay's Q3 2023 was marked by success in pivotal trials and financial strength, positioning seladelpar as a promising PBC treatment.
While facing challenges in expenses and regulatory concerns, CymaBay is leveraging opportunities in market expansion and differentiation.
The company's commitment to generating data and strategic pre-commercialization efforts underpin its confidence in seladelpar's potential.

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CymaBay Therapeutics is a clinical-stage biopharmaceutical company located in the San Francisco Bay Area focused on the development and commercialization of proprietary new medicines for important human diseases. We are committed to developing breakthrough medicines that improve the lives of patients and their families. CymaBay was seeded with the assets from an earlier metabolic disease company in which more than $120M was invested to produce a robust pipeline.  Arhalofenate is a novel oral small molecule being developed to treat the approximately 1 million gout patients that flare three or more times per year. Gout flares are painful inflammatory episodes caused by crystals of monosodium urate (MSU) that result from excess serum uric acid (sUA). In three Phase 2 studies in gout patients arhalofenate was shown to reduce the incidence and duration of flares while simultaneously lowering sUA. If confirmed in additional clinical studies, arhalofenate’s dual acting profile would be unique since all other urate lowering therapies paradoxically increase flares as they lower sUA over the first 6 to 12 months of treatment. Increased flares lead many patients to stop or avoid treatment leading to progression of disease with pain and suffering, erosion of joint structure and functionality, lost time from work, and increased healthcare costs.

The average of price targets set by Wall Street analysts indicates a potential upside of 46% in CymaBay Therapeutics Inc. (CBAY). While the effectiveness of this highly sought-after metric is questionable, the positive trend in earnings estimate revisions might translate into an upside in the stock.

Does CymaBay Therapeutics Inc. (CBAY) Have the Potential to Rally 45.99% as Wall Street Analysts Expect?

CymaBay Therapeutics, Inc. (CBAY) Q3 2023 Earnings Call Transcript

Announced top-line results from RESPONSE Phase 3 study in PBC where seladelpar met the primary and two key secondary endpoints with high statistical significance.

CymaBay Reports Third Quarter and Nine Months Ended September 30, 2023 Financial Results and Provides Corporate Update

NEWARK, Calif., Nov. 06, 2023 (GLOBE NEWSWIRE) -- CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a biopharmaceutical company focused on innovative therapies for patients with liver and other chronic diseases, today announced that members of its management team will participate in the UBS Biopharma Conference, November 8-9t h in Miami Beach, FL, the Piper Sandler 35th Annual Healthcare Conference, November 28-30th, in New York, NY, and the Evercore ISI 6th Annual HealthCONx Conference, November 28-30th, in Miami, Florida.

CymaBay Therapeutics to Present at Upcoming Investment Conferences

NEWARK, Calif., Nov. 01, 2023 (GLOBE NEWSWIRE) -- CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a biopharmaceutical company focused on innovative therapies for patients with liver and other chronic diseases, today announced that two-year safety and efficacy results of seladelpar for primary biliary cholangitis (PBC) have been published in Alimentary Pharmacology & Therapeutics:

CymaBay Announces Publication of Two-year Safety and Efficacy Results of Seladelpar in Patients with Primary Biliary Cholangitis

NEWARK, Calif., Oct. 31, 2023 (GLOBE NEWSWIRE) -- CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a biopharmaceutical company focused on innovative therapies for patients with liver and other chronic diseases, today announced that it will host a conference call and live audio webcast on Tuesday, November 7, 2023 at 4:30 p.m. Eastern Time to discuss financial results for the third quarter ended September 30, 2023 and to provide a business update.

CymaBay Therapeutics to Report Third Quarter of 2023 Financial Results on Tuesday, November 7, 2023

CymaBay Therapeutics Inc. (CBAY) made it through our "Recent Price Strength" screen and could be a great choice for investors looking to make a profit from stocks that are currently on the move.

CymaBay Therapeutics Inc. (CBAY) is on the Move, Here's Why the Trend Could be Sustainable

The leading drug candidate in the biotech's pipeline scored another win. Seladelpar's existing Breakthrough Therapy Designation was expanded by the FDA.

Why CymaBay Therapeutics Stock Rocketed Nearly 8% Higher Today

Cholestatic pruritus expert leads plenary discussion of correlated decreases in serum IL-31 levels and pruritus among patients with PBC treated with seladelpar

CymaBay Presents Results on the Potential of Seladelpar in Treatment of Patients with Primary Biliary Cholangitis at ACG 2023

NEWARK, Calif., Oct. 23, 2023 (GLOBE NEWSWIRE) -- CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a biopharmaceutical company focused on innovative therapies for patients with liver and other chronic diseases, today announced that the U.S. Food and Drug Administration (FDA) has revised the originally granted Breakthrough Therapy Designation for seladelpar to now reflect treatment of primary biliary cholangitis (PBC) including pruritus in adults without cirrhosis or with compensated cirrhosis (Child Pugh A). Seladelpar is the only potent, selective, orally active PPARδ agonist, or delpar, with phase 3 results demonstrating a statistically significant improvement in PBC-related cholestatic pruritus.

Seladelpar Granted Revised Breakthrough Therapy Designation for the Treatment of Primary Biliary Cholangitis Including Pruritus in Patients Without Cirrhosis or With Compensated Cirrhosis

Results from the RESPONSE registrational study to be highlighted in oral presentation on Monday, November 13th Fifth oral late-breaking presentation of seladelpar results at The Liver Meeting® NEWARK, Calif., Oct. 18, 2023 (GLOBE NEWSWIRE) -- CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a biopharmaceutical company focused on innovative therapies for patients with liver and other chronic diseases, today announced that a late-breaking presentation highlighting results from the RESPONSE Phase 3 study of seladelpar in patients with primary biliary cholangitis (PBC) will be presented at The Liver Meeting® of the American Association for the Study of Liver Diseases (AASLD), in Boston, MA (November 10th – 14th).

CymaBay's RESPONSE Phase 3 Data Evaluating Seladelpar for Primary Biliary Cholangitis to be Featured in an Oral Late-Breaking Presentation at The Liver Meeting® 2023

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CymaBay Therapeutics stock is continuing a slide that began last week. The pullback came on the heels of the biotech's dilution-causing stock and warrant offering.

Why CymaBay Therapeutics Stock Is Sinking This Week

AFFIRM is a unique event-driven, fixed-duration design intended to reduce the challenges for patient participation

CymaBay Initiates AFFIRM, a Phase 3b/4 Study Evaluating the Effect of Seladelpar on Clinical Outcomes in Patients with Cirrhosis due to Primary Biliary Cholangitis

NEWARK, Calif., Sept. 15, 2023 (GLOBE NEWSWIRE) -- CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a biopharmaceutical company focused on innovative therapies for patients with liver and other chronic diseases, today announced that members of its management team will participate in the Cantor Global Healthcare Conference, September 26-28th at the InterContinental Barclay Hotel in New York.

CymaBay Therapeutics to Present at the Cantor Global Healthcare Conference

NEWARK, Calif., Sept. 14, 2023 (GLOBE NEWSWIRE) -- CymaBay Therapeutics, Inc. (Nasdaq: CBAY), a clinical-stage biopharmaceutical company focused on developing innovative therapies for liver and other chronic diseases with high unmet medical need, today announced the closing of its previously announced underwritten public offering of common stock and pre-funded warrants. CymaBay sold 14,521,307 shares of common stock in the offering, including 1,970,227 shares pursuant to the full exercise of the underwriters' option to purchase additional shares, at a public offering price of $17.13 per share. In addition, CymaBay sold, in lieu of common stock to certain investors, pre-funded warrants to purchase 583,771 shares of common stock in the offering at a public offering price of $17.1299 per underlying share. The gross offering proceeds to CymaBay from this offering were approximately $258.7 million, before deducting the underwriting discount and other estimated offering expenses, and excluding the exercise of any pre-funded warrants. The pre-funded warrant has an exercise price of $0.0001 per share. All shares of common stock and pre-funded warrants were offered by CymaBay.

CymaBay Announces Closing of Upsized $258.7 Million Public Offering of Common Stock and Pre-Funded Warrants, Including Full Exercise of Underwriters' Option to Purchase Additional Shares

The biotech upsized its planned share issue. It's now seeking to raise gross proceeds of $225 million; previously, it was aiming for $150 million.

Why CymaBay Therapeutics Stock Triumphed Again on Tuesday

NEWARK, Calif., Sept. 11, 2023 (GLOBE NEWSWIRE) -- CymaBay Therapeutics, Inc. (Nasdaq: CBAY), a clinical-stage biopharmaceutical company focused on developing innovative therapies for liver and other chronic diseases with high unmet medical need, today announced the pricing of its previously announced underwritten public offering of common stock and pre-funded warrants. CymaBay is selling 12,551,080 shares of common stock and, in lieu of common stock to certain investors, pre-funded warrants to purchase 583,771 shares of common stock in the offering. The shares of common stock are being sold at a public offering price of $17.13 per share, and the pre-funded warrants are being sold at a public offering price of $17.1299 per underlying share. The gross offering proceeds to CymaBay from this offering are expected to be approximately $225 million, before deducting the underwriting discount and other estimated offering expenses, and excluding the exercise of any pre-funded warrants. The pre-funded warrant has an exercise price of $0.0001 per share. All shares of common stock and pre-funded warrants to be sold in the offering are being offered by CymaBay. CymaBay has granted the underwriters a 30-day option to purchase up to an additional 1,970,227 shares of its common stock at the public offering price per share less underwriting discounts and commissions. The offering is expected to close on September 14, 2023, subject to the satisfaction of customary closing conditions.

CymaBay Announces Pricing of Upsized $225 Million Public Offering of Common Stock and Pre-Funded Warrants

The biotech is going to the well for more capital. It is seeking to raise $150 million in a share-and-warrant flotation.

Why CymaBay Therapeutics Stock Popped Again Today

NEWARK, Calif., Sept. 11, 2023 (GLOBE NEWSWIRE) -- CymaBay Therapeutics, Inc. (Nasdaq: CBAY), a clinical-stage biopharmaceutical company focused on developing innovative therapies for liver and other chronic diseases with high unmet medical need, today announced that it has commenced an underwritten public offering of an aggregate of $150 million of its common stock and pre-funded warrants. All shares of common stock and pre-funded warrants to be sold in the offering will be offered by CymaBay. CymaBay intends to grant the underwriters a 30-day option to purchase up to an aggregate of an additional 15% of the shares of its common stock offered in the public offering, including shares of common stock underlying the pre-funded warrants. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. CymaBay anticipates using the net proceeds from the offering to fund ongoing development of seladelpar, including clinical trials targeting market expansion, and for working capital and general corporate purposes.

CymaBay Announces Proposed $150 Million Public Offering of Common Stock and Pre-Funded Warrants

Positive results achieved in phase 3 RESPONSE study, which used seladelpar for the treatment of patients with primary biliary cholangitis. Positive results of the phase 3 RESPONSE study leads to additional data at an upcoming medical meeting and possibly several regulatory submissions of seladelpar for primary biliary cholangitis. The global primary biliary cholangitis market is expected to reach $1.4 billion by 2032.

CymaBay: Positive Phase 3 Data And Competitive Advantage Established

CymaBay (CBAY) reports encouraging data from the phase III study of seladelpar in PBC patients. Stock up.

CymaBay (CBAY) Stock Up on Positive Results From PBC Study

CymaBay announced positive results on Thursday for its treatment for a rare liver disease. The company now plans to talk with regulators about filing for approvals.

Why CymaBay Therapeutics Stock Is Jumping Today

Shares of CBAY stock surged for a second day Friday as analysts compared CymaBay liver-disease treatment to rivals from Intercept and Genfit.

Why CymaBay, With 172% Growth This Year, Just Surged For A Second Day Running

Shares of CymaBay Therapeutics Inc. CBAY gained 23% premarket on Thursday after the company released positive results from a late-stage study of seladelpar, its investigational treatment for the rare chronic liver disease primary biliary cholangitis. About 62% of patients treated with seladelpar met the study's primary endpoint related to serum alkaline phosphatase and bilirubin, compared with 20% of those on placebo, CymaBay said in a release.

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