Pliant Therapeutics: Positive Data From Lead Program In Scarred Lung Disorder

 

• Pliant Therapeutics Inc (NASDAQ: PLRX) has announced 12-week interim data from the 320 mg dose group of INTEGRIS-IPF Phase 2a clinical trial of bexotegrast (PLN-74809) in patients with idiopathic pulmonary fibrosis (IPF).

• The 320 mg group met its primary and secondary endpoints demonstrating that bexotegrast was well tolerated over a 12-week treatment period and displayed a favorable pharmacokinetic profile.

• Bexotegrast at 320 mg demonstrated a statistically significant mean increase in forced vital capacity from baseline at all time points, surpassing all lower dose cohorts.

• It also showed a strong treatment effect on FVC percent predicted (FVCpp), quality of life, and profibrotic biomarkers versus placebo at 12 weeks.

• The 320 mg group will continue until all patients have been treated for at least 24 weeks, with final data expected in the second quarter of 2023.

• Pliant plans to initiate a Phase 2b clinical trial of bexotegrast in mid-2023. Trial details will be shared closer to initiation.

• The company reported lower dose results from the Phase 2 trial, demonstrating that the 40 mg and 160 mg dose groups showed 38% and 66% reductions in FVC decline relative to placebo, respectively.

https://finance.yahoo.com/news/pliant-therapeutics-stock-surges-positive-111636103.html

Helius: Product launch drives strong prelims

 Q4 2022 revenue projected to range from $275,000 to $285,000 --

-- Full year 2022 revenue projected to range from $780,000 to $790,000 --
-- Unaudited year end cash balance of $14.5 million --

Helius Medical Technologies, Inc. (Nasdaq:HSDT) (“Helius” or the “Company”), a neurotech company focused on neurological wellness, today announced preliminary, unaudited results for the quarter and full year ended December 31, 2022, and provided a corporate update.

Business Highlights and Preliminary, Unaudited 2022 Financial Results

• Revenue for the fourth quarter of 2022 is anticipated to be in the range of $275,000 and $285,000, a sequential increase of approximately 40% over the third quarter of 2022, reflecting the U.S. commercial launch of PoNS® for multiple sclerosis (MS) during the second quarter and increased quarterly sales of PoNS in Canada

• Revenue for full year 2022 is anticipated to be in the range of $780,000 and $790,000, an increase of approximately 50% over full year 2021

• Expected 2022 year-end cash, cash equivalents and restricted cash balance of $14.5 million, compared to $16.7 million as of September 30, 2022, reflecting the Company’s ongoing efforts to closely manage cash burn

• Introduced UpScript Telehealth e-commerce site, making it easier for Americans with MS to access online health evaluations, fulfill PoNS Therapy prescriptions, and obtain PoNS through home delivery, with initial shipments occurring in January 2023

• Launched online module for physical therapists seeking to treat gait deficit in adults with MS, standardizing the process and reducing training time to bring faster relief to patients

https://finance.yahoo.com/news/helius-medical-technologies-inc-announces-120500672.html

Catalyst Pharmaceuticals Notified of Abbreviated New Drug Application Filing for FIRDAPSE

 Catalyst Pharmaceuticals, Inc. ("Catalyst") (NASDAQ: CPRX), a commercial-stage biopharmaceutical company focused on in-licensing, developing, and commercializing novel medicines for patients living with rare diseases, today announced that it has received a Paragraph IV Certification Notice Letter (the "Notice Letter") from Teva Pharmaceuticals, Inc. ("Teva") advising that Teva had submitted an Abbreviated New Drug Application ("ANDA") to the U.S. Food and Drug Administration ("FDA") seeking authorization from the FDA to manufacture, use or sell a generic version of FIRDAPSE® in the United States.

In the Notice Letter, Teva states that it intends to market a generic version of FIRDAPSE® before the expiration of Catalyst’s patents listed in the FDA Orange Book covering FIRDAPSE®: U.S. Patent Numbers 10,626,088 (expiring February 2037); 10,793,893 (expiring May 2034); 11,060,128 (expiring June 2032); 11,268,128 (expiring June 2032); 11,274,331 (expiring June 2032); and 11,274,332 (expiring June 2032). Teva’s Notice Letter states that its ANDA contains a Paragraph IV Certification alleging that these patents are not valid, not enforceable, and/or will not be infringed by the commercial manufacture, use or sale of the proposed product described in Teva’s ANDA submission.

Under the Federal Food, Drug, and Cosmetic Act, as amended by the Drug Price Competition and Patent Term Restoration Act of 1984, as amended, Catalyst has 45 days from receipt of the Notice Letter to commence a patent infringement lawsuit in a federal district court against Teva to trigger a stay precluding FDA from approving Teva’s ANDA until May 2026 or entry of judgment holding the patents invalid, unenforceable, or not infringed, whichever occurs first.

Catalyst is currently assessing the Notice Letter and intends to vigorously enforce its intellectual property rights relating to FIRDAPSE®.

https://www.globenewswire.com/news-release/2023/01/23/2593179/0/en/Catalyst-Pharmaceuticals-Notified-of-Abbreviated-New-Drug-Application-Filing-for-FIRDAPSE.html

Rhythm: Quality of Life Improvements in Phase 3 Trial in Bardet-Biedl Syndrome

 Patients reported clinically meaningful improvements across multiple health-related quality of life measures following 52 weeks of treatment with setmelanotide -

- Analysis published in Orphanet Journal of Rare Diseases -

Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a commercial-stage biopharmaceutical company focused on transforming the lives of patients and their families living with hyperphagia and severe obesity caused by rare melanocortin-4 receptor (MC4R) pathway diseases, today announced that patients with Bardet-Biedl syndrome (BBS) and obesity who participated in the company’s global Phase 3 clinical trial of setmelanotide reported clinically meaningful improvements across multiple health-related quality of life (HRQOL) measures based on an analysis published in the Orphanet Journal of Rare Diseases.

https://finance.yahoo.com/news/rhythm-pharmaceuticals-announces-publication-analysis-130000148.html

HUTCHMED: License to Takeda to Develop and Commercialize Fruquintinib Outside China

 HUTCHMED to receive US$400 million upfront on deal closing and up to US$730 million in potential future milestone payments, totaling up to US$1.13 billion, plus royalties on net sales —

— Marketing authorization submissions in the U.S., Europe and Japan planned to complete in 2023 —

— Partnership approach aligned with HUTCHMED’s path to profitability and strategy to bring its innovative medicines to patients worldwide —

— HUTCHMED to host a conference call and webcast at 8:30 a.m. EST (1:30 p.m. GMT / 9:30 p.m. HKT) on Monday, January 23, 2023 —

Management of HUTCHMED will host a conference call and webcast for investors and analysts on Monday, January 23, 2023, at 8:30 a.m. New York time (1:30 p.m. London time, 9:30 p.m. Hong Kong Time). Details of the conference call dial-in and the webcast link will be provided on the company website at www.hutch-med.com/event/. A replay will also be available on the website shortly after the event.

https://finance.yahoo.com/news/hutchmed-announces-license-takeda-develop-080000014.html

MannKind’s Inhaled Clofazimine Will Advance to an Adaptive Phase 2/3 Study

 

• Direct delivery of clofazimine to the lungs may provide a treatment option for nontuberculous mycobacterial (NTM) lung disease that potentially overcomes systemic toxicity and lessens side effects

• Paper published on clofazimine inhalation suspension demonstrates promising tolerability and toxicokinetics for treating pulmonary NTM infection

MannKind Corporation (Nasdaq: MNKD), a company focused on the development and commercialization of inhaled therapeutic products and devices for patients with endocrine and orphan lung diseases, today announced clofazimine inhalation suspension (MNKD 101) will advance to an adaptive Phase 2/3 study. Additionally, a paper has been published in the American Society for Microbiology journal Antimicrobial Agents and Chemotherapy examining the potential for treatment of nontuberculous mycobacterial (NTM) infection through direct delivery of inhaled clofazimine to the lungs, overcoming the systemic toxicity witnessed in oral treatments.

Pulmonary NTM infection is recognized as a major global health concern due to its rising prevalence worldwide. It is a serious infection that is caused by bacteria common in the environment that can lead to a reduction in lung function, cough, fatigue, and quality of life. It is estimated that approximately 86,000-180,000 people in the U.S. alone are living with NTM lung disease, and it is on the rise growing 8% each year with women, the elderly, and those with underlying lung conditions at greatest risk. MNKD-101 has been designated by the FDA as both an orphan lung and a qualified infectious disease product (QIDP) for the treatment of pulmonary NTM infections.

https://finance.yahoo.com/news/mannkind-inhaled-clofazimine-advance-adaptive-110500590.html

ViewRay Enters into Cooperation Agreement with Hudson Executive Capital

 ViewRay, Inc. (NASDAQ: VRAY) today announced that it has reached an agreement with Hudson Executive Capital LP ("HEC") to appoint Sai Nanduri, Senior Investment Analyst and representative of HEC, as an observer of the ViewRay Board of Directors (the "Board"), effective as of January 20, 2023.

The Company has also agreed that the Board will appoint Mr. Nanduri to fill any vacancy on the Board arising during the term of the agreement.

In connection with this announcement, ViewRay has also entered into a cooperation agreement with HEC, which currently owns approximately 8.7% of the Company's outstanding common stock. Pursuant to its agreement with ViewRay, HEC has agreed to customary standstill and voting commitments, among other provisions.

The full agreement will be filed with the U.S. Securities and Exchange Commission on a Current Report on Form 8-K.

https://finance.yahoo.com/news/viewray-enters-cooperation-agreement-hudson-220500809.html