Market Newsdesk

Englewood Cliffs, NJ, Jan. 06, 2021 (GLOBE NEWSWIRE) — Silo Pharma, Inc. (OTCQB: SILO) a developmental stage biopharmaceutical company focused on the use of psilocybin as a therapeutic, today announced that it has entered into an agreement to license technology covered by provisional patent applications filed by Silo Pharma with the United States Patent and Trademark Office in use for patients suffering with cancer. Silo Pharma’s patent applications relates to using a novel peptide with Psilocybin as a therapeutic.

Eric Weisblum, CEO of Silo Pharma, Inc, stated “We are excited about this opportunity as we continue to execute our plan to bring novel therapeutics to patients inflicted with neurological disorders and rare diseases, which we hope will bring about breakthroughs that can lead to improved care. This agreement is structured to provide $500,000 in an upfront cash payment as well as equity currently valued at $500,000 from a NASDAQ listed company. The Agreement also provides for Silo to collect royalties should the technology be commercialized.”

About Silo Pharma

Silo Pharma. Inc. is a developmental stage biopharmaceutical company focused on merging traditional therapeutics with psychedelic research for people suffering from indications such as depression, PTSD, Parkinson’s, and other rare neurological disorders. Silo’s mission is to identify assets to license and fund the research which we believe will be transformative to the well-being of patients and the health care industry.  For more information, visit www.silopharma.com

Safe Harbor and Forward-Looking Statements

This news release contains “forward-looking statements” within the meaning of the “safe-harbor” provisions of the Private Securities Litigation Reform Act of 1995. These statements are identified by the use of words “could”, “believe”, “anticipate”, “intend”, “estimate”, “expect”, “may”, “continue”, “predict”, “potential” and similar expressions that are intended to identify forward-looking statements. Such statements involve known and unknown risks, uncertainties and other factors that could cause the actual results of Silo Pharma, Inc. (“Silo” or “the Company”) to differ materially from the results expressed or implied by such statements, including changes to anticipated sources of revenues, future economic and competitive conditions, difficulties in developing the Company’s technology platforms, retaining and expanding the Company’s customer base, fluctuations in consumer spending on the Company’s products and other factors. Accordingly, although the Company believes that the expectations reflected in such forward-looking statements are reasonable, there can be no assurance that such expectations will prove to be correct. The Company disclaims any obligations to publicly update or release any revisions to the forward-looking information contained in this presentation, whether as a result of new information, future events or otherwise, after the date of this presentation or to reflect the occurrence of unanticipated events except as required by law.

Investor Relations Contact: 
Hayden IR 
Brett Maas 
646-536-7331 
Email: [email protected]

FOSTER CITY, Calif., Jan. 06, 2021 (GLOBE NEWSWIRE) — Vaxcyte, Inc., a next-generation vaccine company seeking to improve global health by developing superior and novel vaccines designed to prevent or treat some of the most common and deadly infectious diseases worldwide, today announced the publication of preclinical data for VAX-A1, the Company’s novel Group A Streptococcus (Group A Strep) conjugate vaccine candidate, in the journal Infectious Microbes & Diseases.

Group A Strep is one of the leading causes of bacterial infections worldwide, including strep throat and certain severe invasive infections such as sepsis, necrotizing fasciitis and toxic shock syndrome. Strep throat is particularly common in school-age children and a significant source of antibiotic prescriptions globally. The Group A Strep pathogen is also a leading cause of mortality in emerging countries by eliciting immune-mediated diseases such as rheumatic fever and rheumatic heart disease. The World Health Organization (WHO) has recognized the significant public health need caused by Group A Strep and has articulated a strategic goal to develop a safe and globally effective Group A Strep vaccine for prevention of acute infections, secondary immune-mediated sequelae and disease-associated mortality and to reduce reliance on antibiotics to help mitigate the growing concern of antibiotic resistance.

In the study, a novel protein and polysaccharide conjugate of the Group A Strep polysaccharide was constructed for inclusion in a universal subunit vaccine against infections by the pathogen. The study demonstrated that active immunization of mice with the vaccine protected against a Group A Strep challenge in systemic infection and localized skin infection models. Moreover, the antibodies induced by the vaccine bound to a wide array of genetically distinct circulating strains of Group A Strep, without evidence of cross-reactivity to human heart or brain tissue antigens.

The study referenced in the paper, “Site-Specific Conjugation of Cell Wall Polyrhamnose to Protein SpyAD Envisioning a Safe Universal Group A Streptococcal Vaccine,” was carried out in collaboration with researchers at the Division of Host-Microbe Systems and Therapeutics, Department of Pediatrics, University of California School of Medicine and the Skaggs School of Pharmacy and Pharmaceutical Sciences at UC San Diego. The paper can be accessed here.

“In these preclinical models, the vaccine showed broad and significant protection against systemic and soft tissue infection after challenge with no evidence of cross-reactivity with human tissue, which supports the path for further development,” said Jeff Fairman, Ph.D., Vice President, Research and Co-founder of Vaxcyte. “Furthermore, by using conserved antigens, we believe that the vaccine could address the full range of pathogenic serotypes of Group A Strep.”

Victor Nizet, M.D., a professor of pediatrics and pharmaceutical sciences at UC San Diego who led the preclinical vaccine testing, noted, “Successful immunization against Group A Strep to prevent strep throat, invasive infections and rheumatic heart disease would not only save lives, but also reduce the need for antibiotic prescriptions, which fuel the continual evolution of resistance to these important medications.”

Highlights of Findings from the Preclinical Study:

• The study examined the efficacy of a novel polysaccharide protein conjugate for a vaccine covering all serotypes of Group A Strep.
• The vaccine elicited antibodies that were protective in systemic and soft tissue mouse models of infection.
• Broad-based cross-reactivity with multiple M-protein serotypes of Group A Strep was observed in the serum of vaccinated animals.
• No cross-reactivity was detected with human heart or brain proteins.

About Group A Streptococcus

Streptococcus pyogenes (S. pyogenes or Group A Strep) is a preeminent human pathogen causing 700 million cases of disease annually, the majority of which are pharyngitis, commonly known as strep throat. Pharyngitis is highly prevalent in school-age children and a significant source of antibiotic prescriptions, contributing to the growing problem of antibiotic resistance globally. In the United States, an estimated 17.1% of outpatient antibiotic prescriptions dispensed to children aged 3 to 9 years are for treatment of suspected Group A Strep infections. Studies indicate that antibiotic resistance to Group A Strep has significantly increased in this past decade. For example, from 2010 to 2017, the percentage of Group A Strep infections that are resistant to erythromycin has nearly tripled from 8% to 23%, resulting in the elevation of the bacteria by the U.S. Centers for Disease Control (CDC) to the antibiotic resistant category of a “concerning threat.” Group A Strep also increases the risk of severe invasive infections, such as sepsis, necrotizing fasciitis and toxic shock syndrome, and is responsible for post-infectious, immune-mediated rheumatic heart disease (RHD), a leading cause of mortality in emerging countries. Some 30 million people are currently affected by RHD, with over 300,000 deaths in 2015 and 10.5 million disability-adjusted life years lost.

About VAX-A1

VAX-A1 is a conjugate vaccine candidate designed to confer broad protective immune responses against all subtypes of Group A Strep and be boostable to offer long-lasting protection from infection. A central component of the vaccine is polyrhamnose, a conserved polysaccharide in the bacterial cell wall, genetically engineered by UC San Diego technology to eliminate an immune epitope implicated in the autoimmune cross-reaction of rheumatic heart disease. Vaxcyte exclusively licensed the rights to this patented antigen and is developing the Group A Strep vaccine utilizing its proprietary conjugation technology. In the research program, the polyrhamnose was conjugated to conserved Group A Strep-specific immunogenic protein carrier using the Company’s site-specific conjugation technology. The resulting conjugate is designed to ensure optimal exposure of both the B-cell and T-cell epitopes on the protein carrier to confer robust, boostable and durable protective immune responses. The vaccine is a combination of this novel conjugate with three additional highly conserved virulence factors, designed to cover all Group A Strep strains.  

In July 2019, Vaxcyte received a cost-reimbursement research award from Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator (CARB-X), a global non-profit partnership dedicated to supporting the development of antibiotics, vaccines, diagnostics and other products that address antibiotic-resistant bacteria. The CARB-X award provides funding of up to $2.7 million to support the development of an innovative vaccine to prevent infections caused by Group A Strep bacteria in developing countries and in the developed world. If the project meets certain milestones, Vaxcyte could be eligible to receive additional funding from CARB-X to support further development of the vaccine.

About Vaxcyte

Vaxcyte is a next-generation vaccine company seeking to improve global health by developing superior and novel vaccines designed to prevent or treat some of the most common and deadly infectious diseases worldwide. The Company’s cell-free protein synthesis platform, comprising the XpressCF^TM platform, exclusively licensed from Sutro Biopharma, Inc., together with Vaxcyte’s proprietary know-how, enables the design and production of protein carriers and antigens, the critical building blocks of vaccines, in ways that the Company believes conventional vaccine technologies currently cannot. Vaxcyte’s lead vaccine candidate, VAX-24, is a preclinical, 24-valent broad-spectrum pneumococcal conjugate vaccine (PCV) being developed for the prevention of invasive pneumococcal disease (IPD). Vaxcyte’s pipeline also includes VAX-XP, a PCV with an expanded breadth of coverage of at least 30 strains, including newly emerging strains responsible for IPD and antibiotic resistance; VAX-A1, a prophylactic vaccine candidate designed to prevent Group A Strep infections; and VAX-PG, a therapeutic vaccine candidate designed to slow or stop the progression of periodontal disease by targeting the keystone pathogen responsible for this chronic, oral inflammatory disease. For more information, visit www.vaxcyte.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements related to the process and timing of anticipated future development of Vaxcyte’s vaccine candidates, whether preclinical results support further development of its VAX-A1 and the potential success of the VAX-A1 program. The words “believe,” “could,” “expect,” “may,” “potential,” “should,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements are based on Vaxcyte’s current expectations and actual results and timing of events could differ materially from those anticipated in such forward-looking statements as a result of risks and uncertainties, including, without limitation, risks related to Vaxcyte’s product development programs, including development timelines, success and timing of chemistry, manufacturing and controls and related manufacturing activities, potential delays or inability to obtain and maintain required regulatory approvals for its vaccine candidates, and the risks and uncertainties inherent with preclinical and clinical development processes; the success, cost and timing of all development activities and clinical trials; and sufficiency of cash and other funding to support Vaxcyte’s development programs and other operating expenses. These and other risks are described more fully in Vaxcyte’s filings with the Securities and Exchange Commission (SEC), including its Quarterly Report on Form 10-Q filed with the SEC on November 12, 2020 or in other documents Vaxcyte subsequently files with or furnishes to the SEC. Vaxcyte undertakes no duty or obligation to update any forward-looking statements contained in this release as a result of new information, future events or changes in its expectations. Readers should not rely upon the information in this press release as current or accurate after its publication date.

The research reported in this news release is supported by the Cooperative Agreement Number IDSEP160030 from ASPR/BARDA and awards from Wellcome Trust, the UK Government’s Global AMR Innovation Fund (GAMRIF) and the German Federal Ministry of Education and Research, as administered by CARB-X. The content is solely the responsibility of the authors and does not necessarily represent the official views of the Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response, other funders or CARB-X. 

Investor Contact:

Andrew Guggenhime, President & Chief Financial Officer
Vaxcyte, Inc.
650-837-0111
[email protected]

BOSTON, Jan. 06, 2021 (GLOBE NEWSWIRE) — Brookline Bancorp, Inc. (NASDAQ: BRKL) announced today that it will report fourth quarter 2020 earnings at the close of business on Wednesday, January 27, 2021. Management will host a conference call/webcast to review this information at 1:30 PM Eastern Time on Thursday, January 28, 2021. Interested parties may listen to the call and view a copy of the Company’s Earnings Presentation by joining the call via https://services.choruscall.com/links/brkl210128.html. To listen to this call without access to the slides, interested parties may dial 877-504-4120 (United States) or 412-902-6650 (internationally) and ask for the Brookline Bancorp conference call. A recorded playback of the call will be available for one week following the call at 877-344-7529 (United States) or 412-317-0088 (internationally). The passcode for this playback is 10151088. The call will be available live or in a recorded version on the Company’s website at www.brooklinebancorp.com.

ABOUT BROOKLINE BANCORP, INC.

Brookline Bancorp, Inc., a bank holding company with approximately $9 billion in assets and branch locations in eastern Massachusetts and Rhode Island, is headquartered in Boston, Massachusetts and operates as the holding company for Brookline Bank and Bank Rhode Island. The Company provides commercial and retail banking services and cash management and investment services to customers throughout Central New England. More information about Brookline Bancorp, Inc. and its banks can be found at the following websites: www.brooklinebank.com, and www.bankri.com.

Brookline Bancorp, Inc.
Carl M. Carlson 617-425-5331
Chief Financial Officer

CHANDLER, Ariz., Jan. 06, 2021 (GLOBE NEWSWIRE) — In modern offline AC-DC power solutions, programmability and adaptive control offer the flexibility and intelligence needed by smart home devices to better interface with their power systems. In these systems, a secondary side microcontroller (MCU) is typically not capable of starting a system without the use of a separate bias power supply. A new reference design from Microchip Technology Inc. (Nasdaq: MCHP) solves this problem using the MCP1012 high voltage auxiliary AC-DC controller, demonstrating the ability to remove the independent bias power supply in many applications. The MCP1012 offline auxiliary device enables the system to transfer control of the power and duty cycle to a secondary MCU. The control between the system and the load can be more precise and purposefully coupled, through a design that can be simplified, reducing size and cost.

The reference design uses a patented isolation technique for isolated feedback. This patented isolation technique called Inde-Flux transformer technology is being licensed to Würth Elektronik eiSos. Inde-Flux technology is used in the Inde-Flux Transformer (Part Number 750318659), the first transformer made by Würth Elektronik eiSos using this IP and sold as part of Microchip’s 15W MCP1012 offline reference design. This transformer combines the signal power and signal communication into one device, eliminating the need for optical feedback or an independent signal transformer. The option is also available to use more traditional approaches with a planar pulse transformer on the reference design, as well as the ability of the design to work with more traditional optocouplers and signal transformers. The secondary-side control is then enabled through a combination of the transformer and Microchip’s newly released MCP1012 AC-DC controller along with the SAM D20 series 32-bit MCU.

The MPC1012 primary-side auxiliary controller provides for system start up, gating and protecting an offline flyback converter for the secondary MCU. The device enables a range of benefits such as direct measurement and active regulation of voltage and/or current, high loop bandwidth by direct loop closure and simplified communication for load-referenced systems.

The 15W MCP1012 offline reference design provides the principal working elements for a 15W offline power design with the necessary firmware to enable the elimination of the auxiliary power supply on the primary side. This can reduce the complexity of the system including eliminating the need for optocouplers in many applications such as appliances and smart speakers. This Inde-Flux transformer technology, in cooperation with Würth Elektronik eiSos, can be scaled to standard and custom transformer designs for different voltages and power levels as needed.

“The combination of our Inde-Flux technology in a Würth Elektronik eiSos transformer, our MCP1012 AC-DC controller and our SAM D20 series 32-bit MCU creates a unique solution to offline power management,” said Rich Simoncic, senior vice president of Microchip’s analog, power and interface business unit. “These devices enable a simpler, more reliable implementation of complex bi-directional communication between the primary and secondary elements used in many isolated applications utilizing offline power. Where this solution is used in systems with a secondary MCU, customers can realize up to 60% savings of the bias supply area and reduce the bias supply bill of materials costs by $3 or more.”

Development Tools

The 15W MCP1012 offline reference design includes a user guide and comes with schematics and bill of materials, design files, firmware, and a demonstration unit. Microchip also offers a fundamental 1W evaluation board, the DT100118, for the MCP1012 AC-DC controller.

Pricing and Availability

The 15W MCP1012 offline reference design, part number EV37F82A, is available now for $225.00 each. The DT100118 1W reference design is available now for $115.00 each. The MCP1012-V/EKA is available now starting at $.40 each in 5,000-unit quantities.

For additional information, contact a Microchip sales representative, authorized worldwide distributor or visit Microchip’s website. To purchase products mentioned here visit our purchasing portal or contact a Microchip authorized distributor.

Resources

High-res images available through Flickr or editorial contact (feel free to publish):

• Application image: www.flickr.com/photos/microchiptechnology/50668703087/sizes/l/

About Microchip Technology

Microchip Technology Inc. is a leading provider of smart, connected and secure embedded control solutions. Its easy-to-use development tools and comprehensive product portfolio enable customers to create optimal designs which reduce risk while lowering total system cost and time to market. The company’s solutions serve more than 125,000 customers across the industrial, automotive, consumer, aerospace and defense, communications and computing markets. Headquartered in Chandler, Arizona, Microchip offers outstanding technical support along with dependable delivery and quality. For more information, visit the Microchip website at www.microchip.com.

Note: The Microchip name and logo and the Microchip logo are registered trademarks of Microchip Technology Incorporated in the U.S.A. and other countries. Inde-Flux is a trademark of Microchip Technology Inc. in the U.S.A. and other countries. All other trademarks mentioned herein are the property of their respective companies.

• Company to Expand R&D Focus for Pipeline Growth to include Earlier Stage Programs and Validated Technology Platforms

• Firdapse® 2020 Net Revenues Estimate of approximately $118 Million; about 16% Increase From 2019

• Ended 2020 with Estimated $140 Million in Cash and Investments

• Company Highlights Current Product Development Programs
  

CORAL GABLES, Fla., Jan. 06, 2021 (GLOBE NEWSWIRE) — Catalyst Pharmaceuticals, Inc. (Catalyst) (Nasdaq: CPRX), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating, chronic neuromuscular and neurological diseases, today announced an expansion in its strategic priorities related to portfolio planning and research and development. Catalyst also provided preliminary net revenues and cash on hand for fiscal-year 2020, as well as an update on product development activities and current litigation.

“Our board and management team are aligned in the opportunity to recalibrate our strategic priorities for 2021 and for the long-term. We believe that we have the ability to leverage our solid balance sheet and strong cash flow, along with our expertise, in developing and commercializing additional medicines to treat rare and ultra-rare diseases. With this in mind, we intend to move to expand our product portfolio beyond amifampridine, with a focus on validated technology platforms as well as earlier stage programs in other rare disease therapeutic categories,” said Patrick J. McEnany, Catalyst Pharmaceuticals’ Chairman and CEO.

Mr. McEnany continued: “Additionally, I am pleased to report our preliminary estimate indicates that 2020 Firdapse^® net revenues were approximately $118 million, an increase of $16 million from 2019. This reflects strong sales performance in an extremely difficult operating environment because of the COVID-19 pandemic. Lastly, we ended the year with approximately $140 million in cash and investments, which represents an increase of approximately $46 million compared to cash and investments at December 31, 2019, and we continue to have no funded debt.”

Strategic Plan for 2021 and Beyond

Catalyst’s Board of Directors recently approved an expansion in the company’s strategic focus to include acquiring or in-licensing innovative, validated technology platforms and earlier stage programs in other therapeutic categories outside of neuromuscular diseases. To accomplish these new priorities, Catalyst is prepared to invest more heavily in research and development, including acquiring earlier stage opportunities and validated innovative technology. Catalyst believes that this strategic expansion better positions the company to build out a broader more diversified portfolio of drug candidates that Catalyst expects will add greater value to the company over the near and long-term.

To spearhead this investment, Catalyst has commenced a national search for a key executive to manage this more progressive strategy. This will likely be an M.D. or Ph.D. with 15-20 years of relevant pharma experience and experience in innovated drug technology. This person will be responsible for portfolio planning and developing medicines from discovery through marketing authorizations, as well as strategic leadership across all R&D activities including, direct oversight of science and clinical research.

Year End 2020 Estimated Financial Results

Firdapse annual net revenues for 2020 are estimated at approximately $118 million, an increase of approximately 16% from 2019. Fiscal-year 2020 was a difficult period for patients and healthcare providers in many ways, including the ability to receive a definitive diagnosis of LEMS and providing access to therapies like Firdapse^®. Catalyst believes that as COVID-19 vaccines are administered over the next few quarters, Catalyst will see a more robust uptake in new patient starts and revenues.

Catalyst also estimates that it ended 2020 with approximately $140 million in cash and investments, compared to $94.5 million at the end of 2019, up $46 million, or approximately 48%.

Year-End 2020 Status of Product Development Programs

Firdapse LA (Long-Acting)

The development of the long-acting formulation of amifampridine phosphate remains on track. A large number of candidate formulations were prepared, and three of the most promising formulations were evaluated in a pharmacokinetic (PK) study completed during the fourth quarter of 2020. The results from this first PK study will be used to inform the design and refinement of future product formulations in 2021, and additional PK work is also expected to be conducted during 2021. Catalyst has also completed a number of advisory board meetings with both patients and doctors in order to establish the optimum target characteristics of Firdapse LA that are desired by the LEMS patient community and treating physicians. Periodic updates on this program will be provided as it proceeds.

HNPP

A proof-of-concept study evaluating Firdapse^® as a treatment for Hereditary Neuropathy with Liability to Pressure Palsies (HNPP) is scheduled to start in the first quarter of 2021. The scientific basis for considering this indication is that leakage of neuron potassium channels is observed in HNPP. Firdapse is a potassium channel blocker and may mitigate the pathological effects of the potassium channel leakage in HNPP patients.

HNPP is an autosomal-dominantly inherited peripheral nerve disease caused by a heterozygous deletion of PMP22 gene, leading to a reduction of PMP22 proteins by 35-50% of normal level, which results in disruption of the myelin sheaths of motor neuron axons. Patients with HNPP often present with focal sensory and motor deficits. The events may be triggered by mild mechanical compressions innocuous to healthy humans. In addition, HNPP patients are also afflicted by fatigue. Catalyst believes that HNPP affects about 6,000 patients in the Unites States.

It is hypothesized that functional demyelination in HNPP results in excessive outward current through internodal voltage-gated potassium channels. Application of a potassium channel blocker, like amifampridine, is expected to improve action potential propagation in HNPP, thereby alleviating sensory/motor deficits and fatigue in HNPP. This hypothesis is supported by results in a HNPP animal model with PMP22 heterozygous deletion (PMP22+/-).

MuSK-Myasthenia Gravis

Catalyst has concluded its detailed analysis of potential reasons why its MuSK-MG Phase 3 trial did not meet statistical significance on its endpoints. As reported previously, marked persistent clinical improvement was observed by patients and investigators during the initial dose-titration period of this trial and in the previous proof of concept trial. Catalyst also found that there was a large degree of symptom variability during the double-blind withdrawal period. Catalyst believes these sources of variability can be dealt with in a redesigned study that may better demonstrate the observed efficacy. Catalyst plans to present its hypotheses and a revised protocol to the FDA for discussion during the first half of 2021. However, there can be no assurance that FDA will accept the results of a single study of a different design as sufficient evidence for approval of the MuSK-MG indication. While Catalyst prepares for a meeting with the FDA, Catalyst will evaluate new clinical trial sites and discuss the new trial design with investigators. After the meeting with the FDA, Catalyst will determine whether or not to proceed with a new trial that incorporates the new trial design.

SMA-001

Catalyst’s exploratory study, SMA-001 (A Randomized Placebo Controlled Crossover Study to Evaluate the Safety and Efficacy of Amifampridine Phosphate in Ambulatory Patients with Spinal Muscular Atrophy (SMA) Type 3, met the primary endpoint of a statistically significant difference for the Hammersmith Functional Motor Scale Expanded (HFSME). Clinically, however, the effect was modest. The secondary endpoints were not statistically significant, although several individual quality of life measures demonstrated a positive statistically significant change. Key opinion leaders with whom Catalyst has spoken believed that Firdapse^® needed to show a large clinically significant change if there was the possibility to affect disease progression through retrograde signaling from enhanced neuromuscular junction function. After considering all of these factors, Catalyst has concluded that the modest results exhibited in this study are unlikely to result in a sufficient modification of disease progression, and, particularly in light of the fact that there are now three approved disease modifying medications for SMA Type 3, Catalyst has decided not to pursue the SMA Type 3 indication further.

Kennedy’s disease

Previously, key opinion leaders had suggested that Firdapse may be effective in treating the symptoms of Kennedy’s disease (spinal and bulbar muscular atrophy). However, given the results of the SMA trial and the lack of a targeted mechanism of action for Firdapse in Kennedy’s disease, Catalyst has decided not to pursue this indication further.

Litigation Update

In Catalyst’s appeal of the U.S. District Court’s decision in its suit challenging the Food and Drug Administration’s interpretation of Firdapse’ s orphan drug exclusivity under the Orphan Drug Act, the briefs have been filed, and Catalyst is currently awaiting either a schedule for oral arguments or a decision from the 11^th Circuit Court of Appeals.  If oral arguments are scheduled, it is still anticipated that they will not occur for a few months.

Catalyst’s previously announced patent litigation against Jacobus Pharmaceuticals Inc. and PANTHERx, Jacobus’ sole specialty pharmacy provider for Ruzurgi^®, is proceeding as expected.  These types of cases, however, take a long time to develop through discovery and other pre-trial activities so no trial date is expected for the foreseeable future.

About Catalyst Pharmaceuticals

Catalyst Pharmaceuticals is a commercial-stage biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating, chronic neuromuscular and neurological diseases, including Lambert-Eaton myasthenic syndrome (LEMS), anti-MuSK antibody positive myasthenia gravis (MuSK-MG) and other neurological and neuromuscular disorders. Catalyst’s new drug application for Firdapse^® (amifampridine) 10 mg tablets for the treatment of adults with LEMS was approved in 2018 by the U.S. Food & Drug Administration (“FDA”), and Firdapse is now commercially available in the United States. Further, Canada’s national healthcare regulatory agency, Health Canada, recently approved the use of Firdapse^® (amifampridine) for the treatment of patients in Canada with LEMS.

Firdapse is currently being evaluated in clinical trials for the treatment of MuSK-MG and has received Orphan Drug Designation from the FDA for myasthenia gravis.

Forward-Looking Statements

This press release contains forward-looking statements. Forward-looking statements involve known and unknown risks and uncertainties, which may cause Catalyst’s actual results in future periods to differ materially from forecasted results. A number of factors, including (i) whether Catalyst can retain a key executive with the qualifications and experience that Catalyst seeks to lead Catalyst’s efforts to source and develop new products and/or technologies, (ii) whether Catalyst’ planned efforts to source and acquire or in-license innovated, validated technology platforms and earlier stage programs in new therapeutic categories will be successful, (iii) whether Catalyst will continue to be profitable and cash flow positive in future periods, (iv) whether Catalyst can successfully expand the number of LEMS patients being treated with Firdapse

^®

, (v) whether Catalyst’s plans for a long-acting amifampridine product, and its plans to further evaluate Firdapse

^®

for the treatment of MuSK-MG and HNPP, will be successful, (vi) whether Catalyst’s appeal of the District Court’s decision in its lawsuit against the FDA to overturn the approval of Ruzurgi

^®

will be successful, (vii) the scope of protection from competition provided by Catalyst’s recently granted patent, and (viii) those factors described in Catalyst’s Annual Report on Form 10-K for fiscal year 2019 and its other filings with the U.S. Securities and Exchange Commission (SEC), could adversely affect Catalyst. Copies of Catalyst’s filings with the SEC are available from the SEC, may be found on Catalyst’s website, or may be obtained upon request from Catalyst. Catalyst does not undertake any obligation to update the information contained herein, which speaks only as of this date.