Associated tags: Narcolepsy, SDX, ADHD, Safety, IH, Zebra, Attention deficit hyperactivity disorder, Patient, Idiopathic hypersomnia, API, Pharmaceutical industry, Serdexmethylphenidate, Therapy, Disease, Somnolence, Sleep, Drug, FDA, Brain, Doctor of Philosophy, Conference, Food, IND, Exercise, Research
Retrieved on:
Tuesday, November 7, 2023
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Acer Ended Q3 2023 with $83.4M in cash, cash equivalents, and investments, supporting our forecasted cash runway into 2026
Key Points:
- Ended Q3 2023 with $83.4M in cash, cash equivalents, and investments, supporting our forecasted cash runway into 2026
Conference call and live audio webcast scheduled for today,
CELEBRATION, Fla., Nov. 07, 2023 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company), a rare disease therapeutics company, today provided corporate updates and reported its financial results for the quarter ended September 30, 2023.
- Overview of Q3 2023 Financial Results:
Net revenue for Q3 2023 was $2.9 million compared to prior year Q3 net revenue of $2.9 million.
- As of September 30, 2023, these assets are included in secured corporate notes in the unaudited condensed consolidated balance sheet and totaled $42.0 million as of September 30, 2023.
- ET, to discuss its corporate and financial results for Q3 2023.
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IH CELEBRATION, Fla., Oct. 02, 2023 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company), a rare disease therapeutics company, announced interim data from the open-label dose titration phase of the Phase 2 clinical trial evaluating KP1077 in patients with idiopathic hypersomnia (IH). The data provide valuable information on the primary endpoint of the trial, which is the safety and tolerability of KP1077 in patients with IH, as well as insights related to the effective dose range and regimen. Topline data from the completed trial are expected in the first half of 2024 after all patients have completed the double-blind withdrawal phase. The combined open-label interim and upcoming topline data are expected to also provide information related to a number of secondary and exploratory endpoints, including excessive daytime sleepiness, sleep inertia, and brain fog.
Key Points:
- Data generated to date indicate SDX is well-tolerated across all doses and both dosing regimens studied, laying the groundwork for future Phase 3 trial
Topline data from completed trial expected in the first half 2024, with potential to initiate Phase 3 trial by the end of 2024
CELEBRATION, Fla., Oct. 02, 2023 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company), a rare disease therapeutics company, announced interim data from the open-label dose titration phase of the Phase 2 clinical trial evaluating KP1077 in patients with idiopathic hypersomnia (IH).
- Topline data from the completed trial are expected in the first half of 2024 after all patients have completed the double-blind withdrawal phase.
- “The open-label data yielded key insights for the design of the Phase 3 trial and potential unique benefits of KP1077 as a treatment for IH, if approved,” said Rene Braeckman, Ph.D., Senior Vice President of Clinical Development.
- The results from the completed Phase 2 trial are expected to inform the final design of the anticipated Phase 3 trial in IH, which is expected to be initiated by the end of 2024.
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Pharmacokinetics In addition, both doses of SDX were generally better tolerated compared to Ritalin and fewer subjects experienced cardiovascular adverse events after SDX compared to Ritalin.
Key Points:
- In addition, both doses of SDX were generally better tolerated compared to Ritalin and fewer subjects experienced cardiovascular adverse events after SDX compared to Ritalin.
- Lastly, vital signs after a single oral dose of 200 mg SDX (the highest dose tested) were comparable to Ritalin IR 80 mg and Ritalin LA 80 mg.
- The results demonstrate a robust safety profile for SDX, positioning it as a promising option for treating sleep disorders characterized by excessive daytime sleepiness.
- Details of Zevra’s poster presentation are as follows:
Sr. Vice President of Clinical Development, Zevra Therapeutics
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IH CELEBRATION, Fla., Aug. 14, 2023 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company), a rare disease therapeutics company, today provided corporate updates and reported its financial results for the quarter ended June 30, 2023.
Key Points:
- ET
CELEBRATION, Fla., Aug. 14, 2023 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company), a rare disease therapeutics company, today provided corporate updates and reported its financial results for the quarter ended June 30, 2023.
- AZSTARYS milestone revenues, ongoing royalties from AZSTARYS, and the French early access program for arimoclomol primarily drove Q2 2023 net revenue.
- General and administrative (G&A) expenses were $7.0 million for Q2 2023, compared to $3.6 million in Q2 2022.
- ET, to discuss its corporate and financial results for Q2 2023.
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Zebra CELEBRATION, Fla., June 03, 2023 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company, formerly Zevra.), a rare disease therapeutics company, today announced that an oral presentation featuring the Phase 2 clinical trial design evaluating KP1077 as a treatment for idiopathic hypersomnia (IH), a rare neurological sleep disorder, will be presented at the Hypersomnia Foundation’s 2023 Beyond Sleepy Conference being held June 2 - 4, 2023, in Indianapolis, IN, for people living with IH, narcolepsy and Kleine-Levin syndrome and their supporters. Zevra is a corporate sponsor of the Hypersomnia Foundation and the Beyond Sleep program.
Key Points:
- CELEBRATION, Fla., June 03, 2023 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company, formerly Zevra.
- Zevra is a corporate sponsor of the Hypersomnia Foundation and the Beyond Sleep program.
- SDX was recently granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of IH.
- Zevra has also opened an IND to study KP1077 for the treatment of narcolepsy.
