Shares of generic drug makers have been pounded in recent years, pressured by lawsuits over the opioid crisis, falling prices for medicines, and other worries. Fadia argued that generic-drug pricing could rise in the short term due to scarcity created by supply-chain disruptions, and that in the long term, consumers might be willing to pay higher prices for a more secure supply. To that end, she argued, the Covid-19 crisis could result in generic drug makers bringing manufacturing back to the U.S. from India and China, where it is heavily concentrated.

Mallinckrodt (MNK) doesn't possess the right combination of the two key ingredients for a likely earnings beat in its upcoming report. Get prepared with the key expectations.

The company filed notice with the Securities and Exchange Commission that it had refinanced $495 million in debt due this year.

First quarter net sales of $665.8 million, with diluted loss per share of $0.60, with results impacted in part by competitive and payer pressures in certain products and a decline in demand due to COVID-19

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 April 14) * Bio-Rad Laboratories, Inc. (NYSE: BIO) * Acceleron Pharma Inc (NASDAQ: XLRN) * Dr.Reddy's Laboratories Ltd (NYSE: RDY) * Kala Pharmaceuticals Inc (NASDAQ: KALA) * Keros Therapeutics Inc (NASDAQ: KROS) (IPOed April 8) * Masimo Corporation (NASDAQ: MASI) * MEI Pharma Inc (NASDAQ: MEIP)(announced a licensing agreement with Japan's Kyowa Kirin for developing its ME-401, which is being evaluated for B-cell malignancies) * Neoleukin Therapeutics Inc (NASDAQ: NLTX) * Neubase Therapeutics Inc (NASDAQ: NBSE) * Regeneron Pharmaceuticals Inc (NASDAQ: REGN) * SUMMIT THERAPEU/S ADR (NASDAQ: SMMT)(announced appointment of controlling shareholder Robert Duggan as CEO)Down In The Dumps (Biotech Stocks Hitting 52-Week Lows April 14) * Cyclacel Pharmaceuticals Inc (NASDAQ: CYCC)(announced a 1-for-20 reverse stock split, effective close of trading Tuesday) * TherapeuticsMD Inc (NASDAQ: TXMD)See Also: Gilead Analysts Break Down Remdesivir Data Readout From Compassionate UseStocks In Focus Pfenex Says FDA Requests Additional Data For Establishing Bioequivalence Of Osteoporosis Drug To Forteo Pfenex Inc (NYSE: PFNX) said the FDA informed its commercialization partner Alvogen Malta Operations through a General Advice letter, additional comparative use human factors data, especially from Forteo experienced users, would be required before PF708 Therapeutic Equivalence could be determined.Forteo is Eli Lilly And Co's(NYSE: LLY) drug indicated to treat ostmenopausal women with osteoporosis at high risk for fracture."We intend to work closely with Alvogen and the FDA to expeditiously move toward a solution addressing the Agency's expressed views, so that we can submit additional data as soon as possible," said Eef Schimmelpennink, CEO of Pfenex.The company also said it will continue to support Alvogen with its commercial strategy planning in the U.S. while continuing to seek "A" therapeutic equivalence designation.Crinetics Announces 7.15M Common Stock Offering Crinetics Pharmaceuticals Inc (NASDAQ: CRNX) priced its underwritten public offering of 7.15 million shares at $14 per share. All the shares are being offered by the company. The company expects to raise gross proceeds of $100.1 million from the offering. The offering is expected to close on or about April 17.The company said it intends to use the net proceeds to fund the development of paltusotine and other R&D programs, and for working capital and general corporate purposes.Athersys Given Go Ahead To Initiate Midstage Study Of Stem Cell Therapy For Traumatic Injuries Athersys Inc (NASDAQ: ATHX) said the FDA has authorized an IND to initiate a Phase 2 study evaluating its MultiStem cell therapy for early treatment of traumatic injuries and the subsequent complications that result following severe trauma.Applied DNA Ships 5 Vaccine Constructs To Begin Animal Testing In Italy Applied DNA Sciences Inc (NASDAQ: APDN) said it has completed design, qualification, production and shipment of five COVID-19 vaccine candidates to Italy-based Takis Biotech to start preclinical testing immediately. The vaccine candidates, according to the company, were produced by its proprietary PCR-based Linear DNA manufacturing systems."Preliminary animal test results from the plasmid-based vaccine templates, from which Applied DNA's linear DNA-based vaccine constructs were manufactured at scale, were immunogenic and induced a strong production of antibodies across all five vaccine candidates," said Dr. Luigi Aurisicchio, CEO and CSO of Takis Biotech.In pre-market trading, shares were surging up 43.96% to $6.55.Merck Announces U.S. Launch Of Biosimilar For Roche's Popular Breast Cancer Drug Merck & Co., Inc. (NYSE: MRK) announced the U.S. launch of Ontruzant, a biosimilar of the reference biologic medicine Herceptin - Roche Holdings AG's (OTC: RHHBY) breast cancer drug.The company noted that the biosimilar will be available in both 150 mg single-dose vials, priced at WAC of $1,325, and 420mg multiple-dose vials, priced at $3,709. This represented a 15% discount to the current list price of Herceptin.Ontruzant is developed by Samsung Bioepis, with Merck assuming the responsibility of the commercialization of the biosimilar in the U.S.In pre-market trading, Merck shares were slipping 1.44% to $81.65.Mallinckrodt Announces Publication Of Positive Efficacy Data For Acthar Gel Mallinckrodt PLC (NYSE: MNK) announced the publication of findings from a Phase 4 study to assess the safety and efficacy of Acthar Gel in patients with persistently active rheumatoid arthritis, with Acthar Gel demonstrating the potential for effectiveness in achieving low disease activity as assessed by DAS28-ESR2 in patients with active RA despite current treatment with low-dose glucocorticoids and one or two DMARDs.The stock was gaining 1.53% to $3.99 in pre-market trading.Oragenics' Antibiotic Candidate Flunks Midstage Study In Treating Oral Mucositis Oragenics Inc (NYSE: OGEN) said early top-line results of the company's Phase 2 clinical trial of AG013 in oral mucositis in chemoradiation in head and neck cancer patients did not demonstrate statistical significance on the primary endpoint of severe oral mucositis duration when compared to placebo.The stock slumped 46.20% to 43 cents in premarket trading Wednesday.On The Radar Clinical Readouts Vir Biotechnology Inc (NASDAQ: VIR) will present at a Key Opinion leader call an update on its Phase 1/2 hepatitis B virus clinical trial with small interfering ribonucleic acid VIR-2218, Vir had licensed the investigational asset from Alnylam Pharmaceuticals, Inc. (NASDAQ: ALNY).See more from Benzinga * The Week Ahead In Biotech: Spotlight On Q1 Pre-Announcements As COVID-19 Continues To Disrupt Operations * The Daily Biotech Pulse: Milestone Pharma Flunks Late-Stage Study, CytomX Strikes Cancer Drug Collaboration, BARDA Grant For GenMark's COVID-19 Test * The Daily Biotech Pulse: Setback For DBV In Peanut Allergy Patch Review, Roche Starts Coronavirus Test Shipment, Regeneron Aims For 'Cocktail' COVID-19 Treatment(C) 2020 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

Mallinckrodt (MNK) delivered earnings and revenue surprises of 16.31% and -2.15%, respectively, for the quarter ended March 2020. Do the numbers hold clues to what lies ahead for the stock?

Mallinckrodt plc (NYSE: MNK), a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the company's New Drug Application (NDA) for terlipressin, an investigational agent being evaluated for the treatment of hepatorenal syndrome type 1 (HRS-1). On March 17, 2020 the company announced the completion of its rolling submission of the NDA for terlipressin. The FDA assigned a Prescription Drug User Fee Act (PDUFA) target date of September 12, 2020.

Mallinckrodt plc (NYSE: MNK), a global biopharmaceutical company, today announced that its observational registry comparing the safety and effectiveness of INOmax® (nitric oxide) gas, for inhalation, in term and near-term neonates to that in preterm neonates with pulmonary hypertension (PH) was ended early due to achievement of the pre-specified primary outcome measure, non-inferiority (95 percent confidence interval: -0.0021, 0.1158, with a pre-defined margin of -0.1452). The decision was made following the second planned interim analysis at 75 percent enrollment. The company intends to share the results of this study in an appropriate scientific forum soon.

Mallinckrodt (MNK) declines on sales miss in the first quarter and a challenging outlook for the remainder of the year despite reporting an earnings beat.

Ladies and gentlemen, thank you for standing by, and welcome to the Q1 2020 Mallinckrodt earnings conference call. Joining me this morning are Mark Trudeau, CEO; Steven Romano, our chief scientific officer; and Bryan Reasons, our CFO.

Indiscriminate sell-offs can sometimes lead to opportunities the crowds have missed. Here are three stocks that fit the criteria.

Mallinckrodt plc (NYSE: MNK), a global biopharmaceutical company, announced today that it is supporting an investigator-initiated clinical study at Massachusetts General Hospital evaluating the potential benefits of inhaled nitric oxide as a treatment for pulmonary complications in patients infected with COVID-19. Mallinckrodt's support to Massachusetts General Hospital includes providing funding as well as INOmax® (nitric oxide) gas, for inhalation, to facilitate the study.

New York state brought civil charges on Tuesday accusing Mallinckrodt Plc of insurance fraud for misrepresenting the safety and efficacy of its opioid drugs, leading to medically unnecessary prescriptions. Governor Andrew Cuomo said the charges brought by New York's Department of Financial Services are the first against a major opioid manufacturer in the regulator's probe into entities that contributed to the nationwide opioid crisis. New York accused Mallinckrodt of overstating the benefits of long-term opioid treatment, downplaying the risks of addiction and abuse, and knowing its conduct would result in the payment of fraudulent insurance claims on unnecessary prescriptions.

Investors were disappointed by the company's Q1 results and the prospects of continued challenges from the COVID-19 pandemic.

Mallinckrodt plc (NYSE: MNK), a global biopharmaceutical company, announced today that it will report first quarter 2020 earnings results for the period ended March 27, 2020 on Tuesday, May 5, 2020.

Shares of Mallinckrodt (NYSE:MNK) were unchanged in pre-market trading after the company reported Q1 results.Quarterly Results Earnings per share decreased 15.46% over the past year to $1.64, which beat the estimate of $1.48.Revenue of $665,800,000 less by 15.79% year over year, which missed the estimate of $693,310,000.Looking Ahead Earnings guidance hasn't been issued by the company for now.Revenue guidance hasn't been issued by the company for now.Details Of The Call Date: May 05, 2020View more earnings on MNKWebcast URL: https://edge.media-server.com/mmc/p/u396hdtkPrice Action 52-week high: $17.4052-week low: $1.00Price action over last quarter: down 16.03%Company Description Mallinckrodt PLC develops, manufactures, markets and distributes specialty pharmaceutical products and therapies. Its areas of focus include autoimmune and rare diseases in specialty areas like neurology, rheumatology, nephrology, pulmonology and ophthalmology; immunotherapy and neonatal respiratory critical care therapies; analgesics and gastrointestinal products. The company operates its business in two reportable segments namely Specialty Brands that includes innovative specialty pharmaceutical brands; and Specialty Generics that includes niche specialty generic drugs and active pharmaceutical ingredients.See more from Benzinga * 16 Healthcare Stocks Moving In Monday's Pre-Market Session * 20 Healthcare Stocks Moving In Wednesday's Pre-Market Session(C) 2020 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

Q1 2020 Mallinckrodt Plc Earnings Call

Mallinckrodt plc (NYSE: MNK), a global biopharmaceutical company, today announced the publication of findings from its randomized, placebo-controlled, double-blind Phase 4 study to assess the safety and efficacy of Acthar® Gel (repository corticotropin injection, or RCI) in patients with persistently active rheumatoid arthritis (RA) despite treatment with stable background disease-modifying antirheumatic drugs (DMARDs) and low-dose glucocorticoids. Results of the study were recently published online in Rheumatology and Therapy, an open access peer-review journal. Preliminary findings from the study were presented at the European Congress of Rheumatology 2019 (EULAR) held in June.

Mallinckrodt (MNK) has an impressive earnings surprise history and currently possesses the right combination of the two key ingredients for a likely beat in its next quarterly report.

Mallinckrodt (MNK) begins rolling submission of BLA for StrataGraft regenerative skin tissue therapy to the FDA for addressing adult patients with deep partial-thickness thermal burns. Stock rises.