| UNITED STATES | |
| SECURITIES AND EXCHANGE COMMISSION | |
| Washington, D.C. 20549 | |
| Notice of Effectiveness | |
| Effectiveness Date: | September 6, 2024 4:00 P.M. |
| Form: | S-3 | ||||||
| |||||||
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Submission status for EVOKE PHARMA INC's drug GIMOTI (SUPPL-1) with active ingredient METOCLOPRAMIDE HYDROCHLORIDE has changed to 'Approval' on 01/14/2021. Application Category: NDA, Application Number: 209388, Application Classification: Labeling
10-Q - Evoke Pharma Inc (0001403708) (Filer)
8-K - Evoke Pharma Inc (0001403708) (Filer)
8-K - Evoke Pharma Inc (0001403708) (Filer)
Expanded State Medicaid Access for GIMOTI Achieved highest ever monthly GIMOTI prescription fills in May 2024Promoted former VP of Finance, Mark Kowieski to Chief Financial OfficerSOLANA BEACH, Calif., June 17, 2024 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ:EVOK), a specialty pharmaceutical company focused primarily on treatments for gastrointestinal (GI) diseases with an emphasis on GIMOTI® (metoclopramide) nasal spray, announced updates regarding their business and commercial growth strategy. With a determined focus to ensure maximum market access for GIMOTI, Evoke continues to execute on its plan to expand net product sales throughout 2024. This update outlines the key areas of Evoke
Gainers OneMedNet (NASDAQ:ONMD) stock moved upwards by 15.6% to $1.7 during Thursday's after-market session. The company's market cap stands at $40.5 million. 23andMe Holding (NASDAQ:ME) shares increased by 11.85% to $0.57. The company's market cap stands at $275.2 million. As per the news, the Q4 earnings report came out today. Biora Therapeutics (NASDAQ:BIOR) stock moved upwards by 10.0% to $0.55. The market value of their outstanding shares is at $19.7 million. Cue Health (NASDAQ:HLTH) shares moved upwards by 9.54% to $0.1. The company's market cap stands at $16.4 million. Accelerate Diagnostics (NASDAQ:AXDX) shares increased by 9.01% to $1.39. The market value of their outstanding s
Evoke Pharma, Inc.(NASDAQ:EVOK), a specialty pharmaceutical company focused primarily on treatments for gastrointestinal (GI) diseases with an emphasis on GIMOTI® (metoclopramide) nasal spray, announced that its abstract demonstrating enhanced gastroparesis care in women using nasal metoclopramide will be presented at the 2024 Digestive Disease Week Conference (DDW 2024) taking place May 18-21, 2024 in Washington D.C.
GIMOTI third quarter net product sales of $2.7 million, highest quarterly revenue ever with a 70% increase year-over-year Strong cumulative prescriber growth, 45% year-over-year increase 52% year-over-year prescription fill increase; 39% increase since Q1 2024 Real-world data presented at ACG 2024 demonstrates that GIMOTI significantly enhanced outcomes for patients on GLP-1 therapy, marking it as a promising supportive care option compared to oral metoclopramide. SOLANA BEACH, Calif., Nov. 07, 2024 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ:EVOK), a specialty pharmaceutical company focused primarily on treatments for gastrointestinal (GI) diseases with an emphasis on GIMOTI® (met
GIMOTI second quarter net product sales grew 47% quarter-over-quarter and 126% year-over-year, indicating an annual run-rate in excess of $10 million Achieved record-high prescription fills during Q2 75% year-over-year prescription fill increase; 32% growth compared to Q1 2024 Two abstracts submitted and accepted by the American College of Gastroenterology (ACG) focusing on use of GIMOTI in patients on GLP-1 analogs SOLANA BEACH, Calif., Aug. 13, 2024 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ:EVOK), a specialty pharmaceutical company focused primarily on treatments for gastrointestinal (GI) diseases with an emphasis on GIMOTI® (metoclopramide) nasal spray, today an
SOLANA BEACH, Calif., March 07, 2024 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ:EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases with an emphasis on Gimoti® (metoclopramide) nasal spray, today announced that the Company is scheduled to release its fourth quarter and full year 2023 on Thursday, March 14, 2024, after the market closes. Management will host a conference call and webcast with accompanying slides on Thursday, March 14, 2024, at 4:30 p.m. ET to discuss the results. The dial-in numbers for the conference call are (800) 267-6316 and (203) 518-9783 for international callers. The conference ID number is EVOKQ423. The webcast de
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SC 13G/A - Evoke Pharma Inc (0001403708) (Subject)
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SC 13D/A - Evoke Pharma Inc (0001403708) (Subject)
SOLANA BEACH, Calif., Oct. 22, 2024 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ:EVOK), a specialty pharmaceutical company focused primarily on treatments for gastrointestinal (GI) diseases with an emphasis on Gimoti® (metoclopramide) nasal spray, announced the appointment of Ben Smeal to serve on the Company's Board of Directors effective October 18, 2024. This appointment fulfills a condition set as part of the company's most recent financing by Nantahala Capital Management. Mr. Smeal brings extensive experience in investment management and corporate governance. Before transitioning to full-time private investing, he held roles at Willett Advisors, the family office of Michael R. Bl
SOLANA BEACH, Calif., March 21, 2024 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ:EVOK), a specialty pharmaceutical company focused primarily on treatments for gastrointestinal (GI) diseases with an emphasis on GIMOTI® (metoclopramide) nasal spray, announced that Matthew J. D'Onofrio will be succeeding David A. Gonyer as Chief Executive Officer as of March 31, 2024 upon Mr. Gonyer's departure for personal reasons. Mr. D'Onofrio currently serves as President and Chief Operating Officer. "Working closely with Dave has been an absolute privilege," said Matt D'Onofrio, incoming Chief Executive Officer of Evoke Pharma. "His relentless leadership resulted in our company developing and launchi
SOLANA BEACH, Calif., May 14, 2021 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ:EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, today announced the appointment of Vickie Reed to the Company's board of directors. After serving for more than eight years on the Company's board, Ann Rhoads has announced her retirement. "We are excited to welcome Vickie to Evoke Pharma's board of directors. She possesses a wealth of leadership experience and financial knowledge in the biotechnology industry. We believe Vickie will support our current board of directors with her strategic focus and ambition to maximize corporate financial performance. Additi
GIMOTI third quarter net product sales of $2.7 million, highest quarterly revenue ever with a 70% increase year-over-year Strong cumulative prescriber growth, 45% year-over-year increase 52% year-over-year prescription fill increase; 39% increase since Q1 2024 Real-world data presented at ACG 2024 demonstrates that GIMOTI significantly enhanced outcomes for patients on GLP-1 therapy, marking it as a promising supportive care option compared to oral metoclopramide. SOLANA BEACH, Calif., Nov. 07, 2024 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ:EVOK), a specialty pharmaceutical company focused primarily on treatments for gastrointestinal (GI) diseases with an emphasis on GIMOTI® (met
Analysis of real-world data compared patients on GIMOTI (n=51) to Oral Metoclopramide (n=41), both taking GLP-1s, showing significant statistical improvement for GIMOTI over Oral Metoclopramide in All Cause Emergency Department Visits (-91%, p=0.001), All Cause Office Visits (-41%, p=0.027) and All Cause Hospital Outpatient Visits (-89%, p=0.032) within 6-month index period Data presented at American College of Gastroenterology (ACG) 2024; the submission garnered both the Presidential Poster Award as one of the top 5% of data accepted to the conference and selected as the Outstanding Research Award in the Stomach Category First study to show Gimoti's potential as supportive care for GLP-1
SOLANA BEACH, Calif., Oct. 23, 2024 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ:EVOK), a specialty pharmaceutical company focused primarily on treatments for gastrointestinal (GI) diseases with an emphasis on Gimoti® (metoclopramide) nasal spray, announced upcoming poster presentations at the American College of Gastroenterology (ACG) Annual Scientific Meeting in Philadelphia, held from October 25-29, 2024. Evoke will feature two poster presentations highlighting the use of Gimoti® (metoclopramide) nasal spray in patients. Notably, one of these abstracts, Poster P3339, has been honored with the prestigious ACG's Outstanding Research Award in the Stomach Category for the top abstract ac