Metoclopramide

Renexxion Ireland Ltd. and Dr. Falk Pharma GmbH Announce FDA Clearance of the Investigational New Drug Application for Naronapride to Treat Gastroparesis and Subsequent Expansion of the Ongoing Phase 2b MOVE-IT Study to the United States

Retrieved on: 
Wednesday, March 27, 2024
FACC, Obesity, Gastroparesis, Metoclopramide, Diabetes, Patient, Volunteering, MD, IND, Nausea, European, Investigational New Drug, Safety, Pharmacokinetics, Phase, Conditional sentence, Vomiting, FDA, Bloating, Pharmaceutical industry

Falk Pharma”), announce U.S Food and Drug Administration (FDA) clearance of the Investigational New Drug (IND) application for naronapride to treat patients with gastroparesis.

Key Points: 
  • Falk Pharma”), announce U.S Food and Drug Administration (FDA) clearance of the Investigational New Drug (IND) application for naronapride to treat patients with gastroparesis.
  • Renexxion and Dr. Falk Pharma will now expand patient enrollment for the ongoing global multi-center 320 patient placebo-controlled Phase 2b MOVE-IT study in gastroparesis to clinical sites in the United States (ClinicalTrials.gov ID: NCT05621811).
  • Furthermore, naronapride has already demonstrated dose-dependent accelerated gastric emptying in a GI transit study of healthy human volunteers.
  • We are aligned in our belief in the transformative power of naronapride to revolutionize treatment for gastroparesis patients and its ability to reshape the gastroparesis treatment landscape.”

Evoke Pharma Announces Senior Leadership Transition with Promotion of Matthew J. D’Onofrio to Chief Executive Officer

Retrieved on: 
Thursday, March 21, 2024
Metoclopramide, Patient, Gastroparesis, Pharmaceutical industry

Mr. D’Onofrio currently serves as President and Chief Operating Officer.

Key Points: 
  • 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 launching a highly unique and impactful therapy for patients suffering from diabetic gastroparesis.
  • In tandem with his new executive responsibilities, Mr. D’Onofrio will assume Mr. Gonyer’s board seat as of March 31, 2024.

Evoke Pharma Reports Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Thursday, March 14, 2024
Research, Certification, Quarter, Prevalence, Teva Pharmaceuticals, Gastrointestinal disease, Partnership, ACG, Metoclopramide, Patient, Pharmacy, Gastroparesis, Health care, Holocene, Prescription, Orange Book, Marketing, Gastroenterology, Woman, DDW, PBM, Hospital, Pharmaceutical industry

SOLANA BEACH, Calif., March 14, 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 announced its financial results for the fourth quarter and full year ended December 31, 2023, and recent corporate developments.

Key Points: 
  • Our commercial team’s dedicated efforts yielded a 107% increase in year-over-year revenue,” stated Dave Gonyer, R.Ph., CEO of Evoke Pharma.
  • Research and development expenses totaled approximately $23,000 for the fourth quarter of 2023 compared with $27,000 for the fourth quarter of 2022.
  • For the fourth quarter of 2023 selling, general and administrative (SG&A) expenses were approximately $3.5 million compared with $2.3 million for the fourth quarter of 2022.
  • Total operating expenses for the fourth quarter of 2023 were approximately $3.6 million compared with $2.3 million for the same period of 2022.

Evoke Pharma to Report Fourth Quarter and Full Year 2023 Results on March 14, 2024

Retrieved on: 
Thursday, March 7, 2024
Metoclopramide, Webcast

Management will host a conference call and webcast with accompanying slides on Thursday, March 14, 2024, at 4:30 p.m.

Key Points: 
  • Management will host a conference call and webcast with accompanying slides on Thursday, March 14, 2024, at 4:30 p.m.
  • The dial-in numbers for the conference call are (800) 267-6316 and (203) 518-9783 for international callers.
  • In addition, a telephonic replay of the call will be available until March 21, 2024.
  • The replay dial-in numbers are (888) 562-3381 for domestic callers and (402) 220-1189 for international callers.

Evoke Pharma Announces Closing of $7.5 Million Public Offering

Retrieved on: 
Wednesday, February 14, 2024
Attention, Suite, Telephone, Evoke, Fifth Avenue, Sale, Equity capital markets, Form, Series, Capital Group Companies, Form S-1, Security (finance), Metoclopramide, Prescription

"We are pleased to have closed this offering with these fundamental, healthcare-oriented institutional investors," stated Evoke Pharma Chief Executive Officer Dave Gonyer.

Key Points: 
  • "We are pleased to have closed this offering with these fundamental, healthcare-oriented institutional investors," stated Evoke Pharma Chief Executive Officer Dave Gonyer.
  • If the Series A Warrants are exercised in full, the Company would receive an additional $7.5 million in gross proceeds.
  • If the Series B Warrants are exercised in full, the Company would receive an additional $7.5 million in gross proceeds.
  • Evoke intends to use the net proceeds from the public offering for working capital and general corporate purposes.

Evoke Pharma Announces Pricing of Underwritten Public Offering of up to $30 Million

Retrieved on: 
Friday, February 9, 2024
Equity capital markets, Suite, Sale, Form, Metoclopramide, Security (finance), Attention, Fifth Avenue, Capital Group Companies, Evoke, Telephone, Series

The combined price per share of common stock, Series A Warrant, Series B Warrant and Series C Warrant is $0.68, totaling $7.5 million initial gross proceeds to the Company.

Key Points: 
  • The combined price per share of common stock, Series A Warrant, Series B Warrant and Series C Warrant is $0.68, totaling $7.5 million initial gross proceeds to the Company.
  • If the Series A Warrants are exercised in full, the Company would receive an additional $7.5 million in gross proceeds.
  • If the Series B Warrants are exercised in full, the Company would receive an additional $7.5 million in gross proceeds.
  • Evoke intends to use the net proceeds from the public offering for working capital and general corporate purposes.

Evoke Pharma Announces FDA Orange Book Listing of New GIMOTI Patent

Retrieved on: 
Monday, November 27, 2023
Orange Book, Food, Collection, FDA, The Orange Book, Metoclopramide, Patent, IP, Gastroparesis, Pharmaceutical industry

11,813,231 is now listed in the U.S. Food and Drug Administration (FDA) publication, “Approved Drug Products with Therapeutic Equivalence Evaluations”, commonly known as the “Orange Book”.

Key Points: 
  • 11,813,231 is now listed in the U.S. Food and Drug Administration (FDA) publication, “Approved Drug Products with Therapeutic Equivalence Evaluations”, commonly known as the “Orange Book”.
  • The patent titled “Nasal Formulations of Metoclopramide” covers a collection of nasal solutions of metoclopramide and its characteristics when formulated.
  • This new patent is now listed in the FDA’s Orange Book and carries a patent term to 2029.
  • The listing of the patent in the Orange Book adds additional patent protection for GIMOTI beyond the prior three listed patents.

United States Patent and Trademark Office (USPTO) Grants Another Formulation Patent Covering GIMOTI

Retrieved on: 
Tuesday, November 14, 2023
Vomiting, Absorption, Evoke, Disease, Gastroparesis, Tablet, Patient, FDA, Metoclopramide, Extrapyramidal system, Patent, Diabetes, Pharmaceutical industry

SOLANA BEACH, Calif., Nov. 14, 2023 (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 the United States Patent and Trademark Office (USPTO) issued U.S. Patent No.

Key Points: 
  • SOLANA BEACH, Calif., Nov. 14, 2023 (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 the United States Patent and Trademark Office (USPTO) issued U.S. Patent No.
  • 11,813,231 titled “Nasal Formulations of Metoclopramide”, pertaining to the Company’s commercially available and FDA-approved nasal formulation of metoclopramide, GIMOTI.
  • This new patent, issued on November 14, 2023, provides Evoke with additional intellectual property protections with claims to metoclopramide being delivered intranasally, amongst others.
  • GIMOTI is the only outpatient, non-oral drug labeled for the treatment of acute and recurrent diabetic gastroparesis.

Evoke Pharma Reports Third Quarter 2023 Financial Results

Retrieved on: 
Thursday, November 9, 2023
Gastroenterology, Pharmacy, ACG, PBM, Diabetes, Gastroparesis, Metoclopramide, Motility, Prescription, ASPN, Patient, Video game, Pharmaceutical industry

SOLANA BEACH, Calif., Nov. 09, 2023 (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 its financial results for the third quarter ended September 30, 2023, and recent corporate developments.

Key Points: 
  • 38% Revenue Increase Compared to Q2 2023; 88% Increase Year-Over-Year
    21% Increase Compared to Q2 2023; 95% Increase Year-Over-Year
    SOLANA BEACH, Calif., Nov. 09, 2023 (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 its financial results for the third quarter ended September 30, 2023, and recent corporate developments.
  • Prescription fills in Q3 2023 were also up 21% from Q2 2023,” commented David A. Gonyer, R.Ph., Chief Executive Officer of Evoke Pharma.
  • For the third quarter of 2023, net product sales were $1,562,860 compared to $832,100 during the third quarter of 2022.
  • For the third quarter of 2023, selling, general and administrative expenses were approximately $3.1 million compared to $2.6 million for the third quarter of 2022.

Evoke Pharma & EVERSANA Unveil Cost Savings Real-World Data Demonstrating Meaningfully Reduced Healthcare Costs for Patients Using GIMOTI Over Oral Metoclopramide Presented at the American College of Gastroenterology 2023

Retrieved on: 
Tuesday, October 31, 2023
IH, NMCP, Patient, Bloating, FDA, Abdominal pain, DGP, Research, American College, Martin PBM Mariner, Stomach, Metoclopramide, Vomiting, ACG, Ensuring Patient Access and Effective Drug Enforcement Act, News, Diabetes, Conditional sentence, American College of Gastroenterology, Texas Tech University, Nausea, Gastroparesis, ED, HO, UC San Diego Health, Comparison, Pharmacy, Annual general meeting, Cleveland Clinic, Hospital, IBM, Associate, DDW, LHT, Pharmaceutical industry, Medicine

The data describes the results of a comparative study that highlights cost-related healthcare resource utilization data (HCRU) in DGP patients taking GIMOTI (nasal metoclopramide) versus those on oral metoclopramide over a six-month period.

Key Points: 
  • The data describes the results of a comparative study that highlights cost-related healthcare resource utilization data (HCRU) in DGP patients taking GIMOTI (nasal metoclopramide) versus those on oral metoclopramide over a six-month period.
  • HCRU is the description and quantification of patients’ total usage of healthcare services such as emergency department (ED) visits, hospitalization or how often they visit a healthcare provider in the office.
  • The cost to the patients and the healthcare system is significant and the impact is considerable for all parties involved.
  • The data for GIMOTI continues to reinforce those providers can and should strive to improve outcomes for patients,” commented Chris Quesenberry, GIMOTI Chief Commercial Officer.