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Revolution Medicines Reports Third Quarter 2023 Financial Results and Update on Corporate Progress

Retrieved on:

Monday, November 6, 2023

REDWOOD CITY, Calif., Nov. 06, 2023 (GLOBE NEWSWIRE) -- Revolution Medicines, Inc. (Nasdaq: RVMD), a clinical-stage oncology company developing targeted therapies for RAS-addicted cancers, today announced its financial results for the quarter ended September 30, 2023, and provided an update on corporate progress.

Key Points:

The transaction is expected to close shortly following the stockholder vote, subject to satisfaction of customary closing conditions, including approval by both Revolution Medicines’ and EQRx’s stockholders.
If the transaction is completed, Revolution Medicines expects to issue approximately 55 million shares of its common stock in connection with the merger (excluding assumed warrants and earn-out shares).
Revenue: Total revenue was zero for the quarter ended September 30, 2023, compared to $3.4 million for the quarter ended September 30, 2022.
Revolution Medicines will host a webcast this afternoon, November 6, 2023, at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time).

Supernus Announces SPN-830 Apomorphine Infusion Device NDA Accepted for Review by FDA

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Thursday, November 2, 2023

FDA, NDA, PD, CNS, PDUFA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, OFF, Central nervous system, Pharmaceutical industry

ROCKVILLE, Md., Nov. 02, 2023 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced that the U.S. Food and Drug Administration (FDA) has acknowledged the resubmission of the new drug application (NDA) for its apomorphine infusion device (SPN-830) for the continuous treatment of motor fluctuations (OFF episodes) in Parkinson’s disease (PD).

Key Points:

ROCKVILLE, Md., Nov. 02, 2023 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced that the U.S. Food and Drug Administration (FDA) has acknowledged the resubmission of the new drug application (NDA) for its apomorphine infusion device (SPN-830) for the continuous treatment of motor fluctuations (OFF episodes) in Parkinson’s disease (PD).
The resubmission is now considered filed, with a user fee goal date (PDUFA date) of April 5, 2024.
“We are pleased with the FDA’s acceptance of our NDA resubmission for SPN-830 and look forward to continuing to work with them during their review,” said Jack Khattar, President and CEO of Supernus.
“SPN-830 is an important product candidate which, if approved by the FDA, represents a novel and less invasive treatment option for PD patients.”

Acorda Therapeutics Announces Biopas Laboratories Submission to Regulatory Agencies in Six Latin American Countries for Approval of INBRIJA®

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Monday, November 6, 2023

Health, Neurology, Research, Pharmaceutical, Science, Biotechnology, PD, Acorda Therapeutics, CNS, Marketing, OFF, Parkinson's disease, ACOR, Therapy, Patient, Pharmaceutical industry

Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced the submission of new regulatory filings for the approval of INBRIJA® (levodopa inhalation powder) in six countries in Latin America by its partner Biopas Laboratories (Biopas).

Key Points:

Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced the submission of new regulatory filings for the approval of INBRIJA® (levodopa inhalation powder) in six countries in Latin America by its partner Biopas Laboratories (Biopas).
Biopas has submitted for marketing approval of INBRIJA in Argentina, Colombia, Costa Rica, Ecuador, Panama and Peru.
It expects to submit additional regulatory filings for approval of INBRIJA in Chile in late 2023 and in Mexico and Brazil in 2024.
“We are delighted that Biopas has submitted filings for the approval of INBRIJA in six countries in Latin America, with up to five approvals expected in 2024.

Revolution Medicines Presents Promising Clinical Activity and Safety Data from Phase 1/1b Trial of RMC-6236

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Sunday, October 22, 2023

“Today’s presentation marks an important milestone in the clinical development of RMC-6236, an unprecedented, oral RASMULTI(ON) Inhibitor with an innovative mechanism of action.

Key Points:

“Today’s presentation marks an important milestone in the clinical development of RMC-6236, an unprecedented, oral RASMULTI(ON) Inhibitor with an innovative mechanism of action.
RMC-6236 demonstrated preliminary evidence of clinical activity and an acceptable safety profile that was generally well tolerated across the dose levels analyzed.
Clinical activity was evaluated in patients who had received the first dose of RMC-6236 at least eight weeks prior to the data extraction date (n=86).
A live webcast of the call will also be available on the Investors section of Revolution Medicines’ website at https://ir.revmed.com/events-and-presentations .

Revolution Medicines Presents Encouraging Clinical Data for RMC-6236 and RMC-6291 at 2023 Triple Meeting

Retrieved on:

Friday, October 13, 2023

REDWOOD CITY, Calif., Oct. 13, 2023 (GLOBE NEWSWIRE) -- Revolution Medicines, Inc. (Nasdaq: RVMD), a clinical-stage oncology company developing targeted therapies for RAS-addicted cancers, today announced encouraging preliminary clinical data for RMC-6236, its RASMULTI(ON) Inhibitor, and RMC-6291, its RASG12C(ON) Inhibitor, from the respective Phase 1/1b studies. These data were presented during the 2023 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics (“Triple Meeting”) in Boston, October 11-15, 2023.

Key Points:

These data were presented during the 2023 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics (“Triple Meeting”) in Boston, October 11-15, 2023.
“We are pleased to report encouraging clinical data for both RMC-6236 and RMC-6291, two pioneering RAS(ON) Inhibitors that are providing strong validation of our RAS(ON) Inhibitor platform broadly.
Revolution Medicines will host an investor webcast on Sunday, October 22, 2023 at 12:30 p.m. Eastern Time to discuss the data presented at both the Triple Meeting and the 2023 European Society for Medical Oncology Congress, in addition to other clinical updates.
A live webcast of the call will also be available on the Investors section of Revolution Medicines’ website at https://ir.revmed.com/events-and-presentations .

Supernus Resubmits NDA for SPN-830 Apomorphine Infusion Device

Retrieved on:

Monday, October 9, 2023

Symantec Endpoint Protection, COVID-19, Food, Central nervous system, Travel, Safety, FDA, OFF, NDA, CRL, New Drug Application, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, PD, Apomorphine, CNS, Patient, Pharmaceutical industry

Working closely with the U.S. Food and Drug Administration (FDA), Supernus believes it has addressed the FDA’s questions related to a Complete Response Letter (CRL) issued in October 2022 for the SPN-830 New Drug Application (NDA).

Key Points:

Working closely with the U.S. Food and Drug Administration (FDA), Supernus believes it has addressed the FDA’s questions related to a Complete Response Letter (CRL) issued in October 2022 for the SPN-830 New Drug Application (NDA).
The CRL required additional information and analysis related to the infusion device and drug product across several areas of the NDA.
Supernus will continue to work closely with the FDA as it reviews the SPN-830 NDA.
“SPN-830 represents a novel and less invasive therapy approach for PD patients who are seeking a convenient option in the form of a continuous subcutaneous infusion of apomorphine,” said Jack Khattar, President and CEO of Supernus.

InventHelp Inventor Develops Modified Jack for ATVs and UTVs (PHO-3054)

Retrieved on:

Wednesday, October 11, 2023

Torque, Multimedia, ATV, Safety, OFF, Herb Brooks National Hockey Center, Fatigue, UTV, Suite, Sale, Phoenix

My design would minimize delays and it would avoid soreness/fatigue related to using a manual jack."

Key Points:

My design would minimize delays and it would avoid soreness/fatigue related to using a manual jack."
It also reduces the fatigue associated with using a manual jack and it saves time and effort.
The invention features a safe and reliable design that is easy to use so it is ideal for the owners and users of ATVs and UTVs.
21-PHO-3054, InventHelp, 100 Beecham Drive, Suite 110, Pittsburgh, PA 15205-9801, or call (412) 288-1300 ext.

Premium Children's Bike Brand, woom, Now Available in 30 Retail Stores and Online in U.S. Market

Retrieved on:

Thursday, October 5, 2023

AIR, OFF, REI, Growth, IBD, Locator, Online shopping

AUSTIN, Texas, Oct. 5, 2023 /PRNewswire-PRWeb/ -- woom™, the Vienna-born premium children's bike manufacturer, today announced its initial entry into the U.S. retail marketplace through REI and select independent bike dealers (IBDs). Celebrating its 10th anniversary in direct-to-consumer business, woom's expansion allows more families to experience its high quality, lightweight children's bikes in-person.

Key Points:

woom™, the Vienna-born premium children's bike manufacturer, today announced its initial entry into the U.S. retail marketplace through REI and select independent bike dealers (IBDs).
AUSTIN, Texas, Oct. 5, 2023 /PRNewswire-PRWeb/ -- woom ™, the Vienna-born premium children's bike manufacturer, today announced its initial entry into the U.S. retail marketplace through REI and select independent bike dealers (IBDs).
Celebrating its 10th anniversary in direct-to-consumer business, woom's expansion allows more families to experience its high quality, lightweight children's bikes in-person.
woom products are now available in-store at 30 REI locations across the U.S., as well as in select IBDs and online at REI.com .

LA's Punk Rock Origins Explored in New Season for PBS SoCal/KCET Original Arts and Culture Series ARTBOUND Premiering October 4

Retrieved on:

Tuesday, August 29, 2023

LOS ANGELES, Aug. 29, 2023 /PRNewswire-PRWeb/ -- PBS SoCal and KCET, Southern California's flagship PBS stations, announced today the return of the original Emmy® award-winning arts and culture series ARTBOUND, as well as a host of options to join in-person for local screenings and for viewers (or interested parties) to host their own screening events. The fourteenth season of the one-hour documentary series kicks off with an examination of two Chinatown restaurants that became the implausible heart of L.A.'s burgeoning punk scene in the 1970s. The additional five episodes of ARTBOUND from the new season include a look at the murals of David Alfaro Siqueiros, the impact of publisher Angel City Press, the influence of Asian American theatre company East West Players, the birth of the LA Rebellion cinematic movement from UCLA's School of Theater, Film and Television as well as an exploration of the day to day life of artists-in-residence Céline Brunko, Christine Lee and Carol Zou. The new season of ARTBOUND will premiere with the documentary "Chinatown Punk Wars" on Wed., Oct. 4 at 9 p.m. PT on KCET and Fri., Oct. 6 at 8 p.m. on PBS SoCal. Following the broadcast, each episode will stream on the free PBS app. Members of PBS SoCal and KCET will get early access to stream all six episodes on PBS Passport starting Oct. 4.

Key Points:

The new season of ARTBOUND will premiere with the documentary "Chinatown Punk Wars" on Wed., Oct. 4 at 9 p.m. PT on KCET and Fri., Oct. 6 at 8 p.m. on PBS SoCal.
Members of PBS SoCal and KCET will get early access to stream all six episodes on PBS Passport starting Oct. 4.
Episodes from this season of ARTBOUND as well as other popular, locally-produced content from KCET and PBS SoCal will be available soon.
The full lineup and descriptions of the 14th season of ARTBOUND are listed below as are details for upcoming in-person screening events with LAist.

Diabetes treatment shows potential as an adjunct therapy for early Parkinson's disease

Retrieved on:

Sunday, August 27, 2023

PD, Disease, MDS, Type, Movement, Rush University, Neurology, Parkinson's disease, Patient, OFF, Pharmacology, International Congress on Tuberculosis, Pharmaceutical industry, Lixisenatide

COPENHAGEN, Denmark, Aug. 27, 2023 /PRNewswire-PRWeb/ -- Lixisenatide may have potential disease-modifying effects when used an adjunction to antiparkinsonian medications, according to a multicenter phase II clinical trial released today at the International Congress of Parkinson's Disease and Movement Disorders® in Copenhagen, Denmark.

Key Points:

"The study design is innovative, because it examines drug effects in both ON and OFF phases."
Lixisenatide, a glucagon-like peptide 1 receptor (GLP1-R) agonist, is commonly used to treat type II diabetes.
After one year of daily treatment, the lixisenatide subjects were less disabled, when assessed by the MDS-UPDRS, a standard examination score of PD impairment.
Larger international studies will definitively define this drug's place in our treatment portfolio, but disease-modifying therapies are a goal that would open the prospect of treating the underlying disease as well as ameliorating symptoms."