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  • MannKind and MidCap Amend Credit Facility
    GlobeNewswire

    MannKind and MidCap Amend Credit Facility

    * $10 million funded immediately * $25 million available upon TreT FDA approval * Interest-only period extended to September 2022WESTLAKE VILLAGE, Calif., Dec. 01, 2020 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD) today announced that it and MidCap Financial Trust, as agent, have entered into an amendment to the credit and security agreement dated August 6, 2019 (the “MidCap Credit Facility”).“We appreciate the unwavering financial support and partnership from MidCap as we progress our three most important business objectives – growing Afrezza to become the standard of care for mealtime insulin, working with our collaboration partner, United Therapeutics, to move Treprostinil Technosphere (TreT) toward an NDA submission with the FDA, and developing our pipeline,” said Michael Castagna, CEO of MannKind.The amendment to the MidCap Credit Facility provides that: (i) Tranche 2 of $10.0 million is made available to the Company and is scheduled to be funded on December 1, 2020, (ii) Tranche 3 of $25.0 million is available to the Company upon the satisfaction of certain conditions, including FDA approval of TreT, (iii) modifications to the financial covenant relating to trailing twelve month minimum Afrezza Net Revenue requirements, (iv) an additional covenant that requires the marketing of TreT if Tranche 3 is funded, (v) an extension of the interest-only period until September 1, 2022 (vi) the minimum cash covenant is increased to $30.0 million at all times, and (vii) amendments to the prepayment fees.About MannKind CorporationMannKind Corporation (Nasdaq: MNKD) focuses on the development and commercialization of inhaled therapeutic products for patients with endocrine and orphan lung diseases. MannKind is currently commercializing Afrezza® (insulin human) Inhalation Powder, its first FDA-approved product and the only inhaled ultra rapid-acting mealtime insulin in the United States, where it is available by prescription from pharmacies nationwide. MannKind is headquartered in Westlake Village, California, and has a state-of-the art manufacturing facility in Danbury, Connecticut. The Company also employs field sales and medical representatives across the U.S. For further information, visit www.mannkindcorp.com.About MidCap FinancialMidCap Financial is a middle market-focused, specialty finance firm that provides senior debt solutions to companies across all industries. MidCap Financial provides management or other services with respect to over $27 billion of commitments as of September, 2020 of which $3.9 billion are managed by MidCap Financial Services Capital Management LLC, a registered investment adviser. MidCap Financial provides a broad array of products intended to finance growth and manage working capital. MidCap Financial is managed by Apollo Capital Management, L.P., a subsidiary of Apollo Global Management, Inc., pursuant to an investment management agreement. Apollo Global Management, Inc. is one of the world's largest asset managers with approximately $414 billion of assets under management (as of June 30, 2020), providing market leading industry expertise, market reach, and financing synergies. Loans to CA residents issued under California Financing Law License No. 60DBO 45424, 60DBO 45427, 60DBO 45431, 60DBO 45435, 60DBO 45439, 60DBO 49531 or 603I389Forward-Looking Statements This press release contains forward-looking statements that involve risks and uncertainties. Words such as "believes," "anticipates," "plans," "expects," "intends," "will," "goal," "potential" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon MannKind's current expectations. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties detailed in MannKind's filings with the SEC. For a discussion of these and other factors, please refer to MannKind’s annual report on Form 10-K for the year ended December 31, 2019 as well as MannKind’s other filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and MannKind undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this press release.Company Contact: 818-661-5000 ir@mannkindcorp.com

  • Sabrina Kay Appointed to MannKind Board of Directors
    GlobeNewswire

    Sabrina Kay Appointed to MannKind Board of Directors

    WESTLAKE VILLAGE, Calif., Nov. 30, 2020 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKD) today announced that Sabrina Kay Ed.D. has been appointed to its Board of Directors, effective December 1, 2020. Dr.  Kay will also serve as a member of the Audit Committee of the Board. A serial entrepreneur, tech educator, fashion designer, philanthropist, and public speaker, Dr. Kay brings to MannKind a wealth of experience in marketing, human capital development, finance and executive leadership. “We are excited to welcome Dr. Kay and her years of invaluable leadership to our Board of Directors,” said Kent Kresa, Chairman of the Board. “Her entrepreneurial vision will be a critical asset for MannKind as the company continues to evolve and the pipeline expands. Dr. Kay has a successful track record in launching and leading a variety of companies, and will add a fresh and diverse perspective as we continue to pursue our mission to give people control of their health and the freedom to live life.” Currently, Dr. Kay serves as Founder and CEO of Fremont Private Investments, where she has led the operations and exits of several companies including The Art Institute of Hollywood (sold to NASDAQ: EDMC), Premier Business Bank (sold to NASDAQ: FFWM), Fashion Umbrella, Fremont College, and Dale Carnegie of Los Angeles.In addition to her success in the business world, Dr. Kay is a philanthropist, having served on more than 30 charitable and civic boards. She is chairman of After-School All-Stars Los Angeles, and a board member of the Los Angeles Sports and Entertainment Commission, Petersen Automotive Museum, Portal Schools, the Leadership Council of International Medical Corps Leadership Council, and the Board of Leaders of USC Marshall School. Dr. Kay has also chaired and spoken at numerous tech, education, business, and leadership conferences, and taught entrepreneurship programs at various universities.Dr. Kay’s achievements have been recognized with numerous awards, including the Education Award from After-School All-Stars and the Humanitarian Award from International Medical Corps. She was named Woman of the Year by the California Legislature, Rising Asian Woman by the World Affairs Council, and was a finalist for Entrepreneur of the Year by Ernst & Young.Dr. Kay received her joint doctorate degree in Work-based Learning Leadership from the University of Pennsylvania. She holds an MBA from the University of Southern California and a Master of Science degree in education from the University of Pennsylvania.With the addition of Dr. Kay, there are nine members of the MannKind Board of Directors.About MannKind Corporation MannKind Corporation (NASDAQ: MNKD) focuses on the development and commercialization of inhaled therapeutic products for patients with diseases such as diabetes and orphan lung diseases. MannKind is currently commercializing Afrezza® (insulin human) Inhalation Powder, the Company’s first FDA-approved product and the only inhaled ultra rapid-acting mealtime insulin in the United States, where it is available by prescription from pharmacies nationwide. MannKind is headquartered in Westlake Village, California, and has a state-of-the art manufacturing facility in Danbury, Connecticut. The Company also employs field sales and medical representatives across the U.S. For further information, visit www.mannkindcorp.com.Forward-Looking Statements This press release contains forward-looking statements that involve risks and uncertainties. Words such as "believes," "anticipates," "plans," "expects," "intends," "will," "goal," "potential" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon MannKind's current expectations. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties detailed in MannKind's filings with the SEC. For a discussion of these and other factors, please refer to MannKind’s annual report on Form 10-K for the year ended December 31, 2019 as well as MannKind’s other filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and MannKind undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this press release.Company Contact: 818-661-5000 ir@mannkindcorp.com

  • The Daily Biotech Pulse: Amarin Surges On Vascepa Data, Mesoblast Rallies On Novartis Deal, Decision Day For Eiger
    Benzinga

    The Daily Biotech Pulse: Amarin Surges On Vascepa Data, Mesoblast Rallies On Novartis Deal, Decision Day For Eiger

    Here's a roundup of top developments in the biotech space over the last 24 hours:Scaling The Peaks (Biotech Stocks Hitting 52-week Highs Nov. 19) * Aligos Therapeutics Inc (NASDAQ: ALGS) * ALX Oncology Holdings Inc (NASDAQ: ALXO) * Atara Biotherapeutics Inc (NASDAQ: ATRA) * China Biologic Products Holdings Inc (NASDAQ: CBPO) (announced a go-private transaction) * Corcept Therapeutics Incorporated (NASDAQ: CORT) (announced a ruling upholding the validity of all claims of U.S. Patent No. 10,195,214) * Idera Pharmaceuticals Inc (NASDAQ: IDRA) * Infinity Pharmaceuticals Inc. (NASDAQ: INFI) * Pacira Biosciences Inc (NASDAQ: PCRX) * Prelude Therapeutics Inc (NASDAQ: PRL) * Replimune Group Inc (NASDAQ: REPL) * Rocket Pharmaceuticals Inc (NASDAQ: RCKT) * Spruce Biosciences Inc (NASDAQ: SPRB) * TRACON Pharmaceuticals Inc (NASDAQ: TCON) * Travere Therapeutics, Inc. (RTRX) * Trillium Therapeutics Inc (NASDAQ: TRIL) * Twist Bioscience Corp (NASDAQ: TWST) * Urovant Sciences Ltd (NASDAQ: UROV) * Veracyte Inc (NASDAQ: VCYT)Down In The Dumps (Biotech Stocks Hitting 52-week Lows Nov. 19) * Benitec Biopharma Inc (NASDAQ: BNTC) * Kiromic Biopharma Inc (NASDAQ: KRBP) * Polypid Ltd (NASDAQ: PYPD)Stocks In Focus Amarin's Late-Stage Vascepa Trial In China Meets Study Goals Amarin Corporation plc (NASDAQ: AMRN) announced positive, statistically significant top-line results from a Phase 3 clinical trial of its fish oil pill Vascepa conducted in China by its partner, Edding. The study, which investigated Vascepa as a treatment for patients with very high triglycerides, met its primary efficacy endpoint as defined in the clinical trial protocol and demonstrated a safety profile similar to placebo, the company said.The company said the findings are being prepared to support Edding's dossier for seeking regulatory approval of Vascepa in mainland China.Amarin shares were jumping 18.06% to $5.36 premarket Friday.Mesoblast Strikes Stem Cell Therapy Collaboration Agreement With Novartis Mesoblast limited (NASDAQ: MESO) announced an exclusive worldwide license and collaboration agreement with Novartis AG (NYSE: NVSP) for the development of its mesenchymal stromal cell product remestemcel-L, with an initial focus on the development of the treatment of acute respiratory distress syndrome, including that associated with COVID-19.The agreement provides for Novartis making a $50-million upfront payment, including $25 million in equity. Mesoblast may also receive a total of $505 million pending achievement of precommercialization milestones for ARDS indications. It could also receive additional payments post-commercialization of up to $750 million based on achieving certain sales milestones and tiered double-digit royalties on product sales.Separately, Mesoblast reported first-quarter revenue of $1.3 million, down from $17 million in the year-ago quarter, which included $15 million in upfront milestone payment received for the strategic partnership with Grunenthal GmbH.The net loss per share widened from 1.10 cents to 4.21 cents.The stock jumped 17.73% premarket to $13.88. Lilly's Drug Combo Issued Emergency Use Authorization For COVID-19 Eli Lilly And Co (NYSE: LLY) and Incyte Corporation (NASDAQ: INCY) said the FDA issued an emergency use authorization for the distribution and emergency use of baricitinib to be used in combination with Gilead Sciences, Inc.'s (NASDAQ: GILD) remdesivir in hospitalized adult and pediatric patients two years of age or older with suspected or laboratory confirmed COVID-19 who require supplemental oxygen, invasive mechanical ventilation or extracorporeal membrane oxygenation.Baricitinib, discovered by Incyte, has been licensed to Lilly.Separately, Lilly announced a R&D and exclusive license agreement to utilize Precision BioSciences Inc's (NASDAQ: DTIL) proprietary ARCUS genome editing platform for the R&D of potential in vivo therapies for genetic disorders, with an initial focus on Duchenne muscular dystrophy and two other undisclosed gene targets.Lilly shares were up 0.7% premarket at $144.41, while Gilead shares were down 1.62% at $59.65.Precision BioSciences shares were jumping 28.1% to $12.40 in premarket trading Friday.Pfizer, BioNTech To Submit EUA For Coronavirus Vaccine Friday Pfizer Inc. (NYSE: PFE) and BioNTech SE - ADR (NASDAQ: BNTX) confirmed that they would submit emergency use application for their coronavirus vaccine candidate to the FDA on Friday.In premarket trading Friday, Pfizer was adding 1.6% to $36.77 and BioNTech shares were rallying 6.99% to $101.57.Related Link: The Week Ahead In Biotech: The Vaccine Updates, Drug Presentations, And FDA Decisions That Will Move The MarketsBeiGene's In-Licensed Osteoporosis Drug Gets Label Expansion In China Beigene Ltd (NASDAQ: BGNE) said the China National Medical Products Administration has approved Xgeva for the prevention of skeletal-related events in patients with bone metastases from solid tumors and in patients with multiple myeloma.Developed by Amgen, Inc. (NASDAQ: AMGN) and licensed to BeiGene in China under a strategic collaboration commenced earlier this year, Xgeva is also approved and marketed in China for the treatment of adults and skeletally mature adolescents with giant cell tumor of the bone that is unresectable or where surgical resection is likely to result in severe morbidity.MannKind Gets Final Development Milestone Payment Of $12.5M For Hypertension Drug MannKind Corporation (NASDAQ: MNKD) said it has achieved the final development milestone under its licensing and collaboration agreement with United Therapeutics Corporation (NASDAQ: UTHR) for the development and commercialization of a dry powder formulation of treprostinil. The fourth milestone payment fetched MannKind $12.5 million.View more earnings on IBBTreprostinil Technosphere is an investigational product currently being evaluated in clinical trials for the treatment of pulmonary arterial hypertension."We are looking forward to working with United Therapeutics during the first part of 2021 to prepare an FDA submission for TreT," said MannKind CEO Michael Castagna.In after-hours trading, MannKind shares were up 2.54% to $2.83.AstraZeneca's Imfinzi Approved For Additional Dosage In Lung, Bladder Cancers AstraZeneca plc (NASDAQ: AZN) said its Imfinzi has been approved in the U.S. for an additional dosing option, a 1,500mg fixed dose every four weeks in the approved indications of unresectable Stage 3 non-small cell lung cancer after chemoradiation therapy and previously treated advanced bladder cancer.In premarket trading Friday, the shares were up 2.07% to $55.15.Aptevo Confirms Takeover Interest For $50/Share In Cash Aptevo Therapeutics Inc (NASDAQ: APVO) confirmed it has received an unsolicited non-binding indication of interest from Tang Capital Partners, LP expressing its interest in acquiring all of the outstanding shares of Aptevo that it does not already own for $50 per share in cash.While recommending that shareholders take no action at this juncture, the company said its board will carefully evaluate and consider this indication of interest in due course in the context of Aptevo's strategic plans, and its ongoing review of a broad range of opportunities to enhance stockholder value.After jumping 29.10% to $45.69 in regular trading on the speculation, the stock was down slightly premarket at $45.65.Affimed Reports Positive Phase 1 Results For Cancer Drug Combo Affimed NV (NASDAQ: AFMD) announced the publication in Blood of positive results for the Phase 1b study of AFM13, a CD30/CD16A innate cell engager, in combination with Merck & Co., Inc.'s (NYSE: MRK) Keytruda.The results demonstrate promising signs of efficacy including an objective response rate of 88% at the highest treatment dose, as well as a complete response of 46% in patients with relapsed/refractory Hodgkin lymphoma. As a monotherapy, Keytruda demonstrated an ORR of 69% and a CR of 22.4% in the KEYNOTE-087 trial.Affimed shares were up 1.66% to $4.90 in after-hours trading.Offerings Avrobio Inc (NASDAQ: AVRO) said it has priced its underwritten public offering of 5 million shares of its common stock at $15 per share for raising gross proceeds of $75 million. The offering is expected to close on or about Nov. 24, subject to customary closing conditions.The stock fell 7.13% to $15.77 in after-hours trading.On The Radar PDUFA Dates Eiger Biopharmaceuticals Inc (NASDAQ: EIGR) has a binary event with respect to its NDA for Lonfarnib in progeria and progeroid laminopathies.Clinical Readout/Presentations 2020 Society for Neuro-Oncology Meeting Presentations: Kazia Therapeutics Ltd (NASDAQ: KZIA): Phase 2 data for GDC-0084 in glioblastoma multiformeConnective Tissue Oncology Society Virtual Annual Meeting Presentations Karyopharm Therapeutics Inc (NASDAQ: KPTI): data from the Phase 3 portion of the SEAL study of Xpovio in advanced dedifferentiated liposarcomaCogent Biosciences Inc (NASDAQ: COGT): final clinical data from its Phase 1/2 study of PLX9486 in gastrointestinal stromal tumorsEarnings Burning Rock Biotech Ltd (NASDAQ: BNR) (before the market open)IPOs San Diego, California-based Maravai Lifsciences Holding, Inc. priced its upsized initial public offering of 60 million shares at $27 each, compared to the estimated price range of $24-$27.The shares of the company -- which provides critical products to enable the development of drug therapies, diagnostics, novel vaccines and support research on human diseases -- will be listed on the Nasdaq under the ticker symbol "MRVI."Sotera Health Company, a global provider of sterilization and lab testing and advisory services to the medical device and pharmaceutical industries, priced its 46.6-million share IPO at $23, the upper end of the estimated price range of $20-$23. The shares of the Broadview Heights, Ohio-based company will be listed on the Nasdaq under the ticker symbol "SHC."Related Link: Attention Biotech Investors: Mark Your Calendar For These November PDUFA Dates See more from Benzinga * Click here for options trades from Benzinga * The Daily Biotech Pulse: Aquestive's Positive FDA Meeting, Prevail Awarded Patent, Neuro-Oncology Conference Gets Underway * The Daily Biotech Pulse: Kazia Jumps On Data Readout, Clinical Hold On Cellectis' Blood Cancer Study Lifted(C) 2020 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.