ANDOVER, Mass., Dec. 19, 2019 -- TransMedics Group, Inc. (“TransMedics”) (Nasdaq: TMDX), a medical technology company that is transforming organ transplant therapy for patients.
TransMedics (TMDX) 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.
We often see insiders buying up shares in companies that perform well over the long term. Unfortunately, there are...
The Insider Monkey team has completed processing the quarterly 13F filings for the September quarter submitted by the hedge funds and other money managers included in our extensive database. Most hedge fund investors experienced strong gains on the back of a strong market performance, which certainly propelled them to adjust their equity holdings so as […]
All of the shares will be offered by TransMedics. TransMedics also expects to grant the underwriters a 30-day option to purchase additional shares of its common stock in an amount of up to 15 percent of the number of shares sold in the offering. J.P. Morgan and Morgan Stanley are acting as joint lead book-running managers for the proposed offering.
ANDOVER, Mass., Feb. 20, 2020 -- TransMedics Group, Inc. (“TransMedics”) (Nasdaq: TMDX), a medical technology company that is transforming organ transplant therapy for patients.
TransMedics (TMDX) successfully completes heart transplants from DCD donors, using its OCS technology.
The external fund manager backed by Berkshire Hathaway's Charlie Munger, Li Lu, makes no bones about it when he says...
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 on March 3) * Acceleron Pharma Inc (NASDAQ: XLRN) * BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) * Fate Therapeutics Inc (NASDAQ: FATE) (reacted to its fourth-quarter results) * Forty Seven Inc (NASDAQ: FTSV) * IGM Biosciences Inc (NASDAQ: IGMS) * Inovio Pharmaceuticals Inc (NASDAQ: INO)( announced an accelerated timeline for COVID-19 vaccine development) * Repro-Med Systems, Inc. (NASDAQ: KRMD) * SpringWorks Therapeutics Inc (NASDAQ: SWTX) * Zynex Inc. (NASDAQ: ZYXI)Down In The Dumps (Biotech Stocks Hitting 52-week lows on March 3) * ADDEX THERAPEUT/ADR (NASDAQ: ADXN) * Akorn, Inc. (NASDAQ: AKRX) * Aldeyra Therapeutics Inc (NASDAQ: ALDX) * ANI Pharmaceuticals Inc (NASDAQ: ANIP) * Evolus Inc (NASDAQ: EOLS) * EXACT Sciences Corporation (NASDAQ: EXAS) * HTG Molecular Diagnostics Inc (NASDAQ: HTGM) * Midatech Pharma PLC-ADR (NASDAQ: MTP)(began trading on a reverse split adjusted basis) * Mylan NV (NASDAQ: MYL) * Neuronetics Inc (NASDAQ: STIM)(announced its fourth-quarter results) * Passage Bio Inc (NASDAQ: PASG)(IPOed last week) * STRATA Skin Sciences Inc (NASDAQ: SSKN) * SurModics, Inc. (NASDAQ: SRDX) * Tetraphase Pharmaceuticals Inc (NASDAQ: TTPH) * TransMedics Group Inc (NASDAQ: TMDX)(reported its fourth-quarter results) * VIVUS, Inc. (NASDAQ: VVUS) * Xeris Pharmaceuticals Inc (NASDAQ: XERS)See Also: Attention Biotech Investors: Mark Your Calendar For These March PDUFA DatesStocks In Focus Takeda To Develop COVID-19 Treatments Takeda Pharmaceutical Co Ltd (NYSE: TAK) said it is initiating the development of an anti-SARS-CoV-2 polyclonal hyperimmune globulin to treat high-risk individuals with the viral infection. Hyperimmune globulins are plasma-derived therapies that had previously proven its efficacy in treating severe acute viral respiratory infections.The company added it is also studying its currently marketed and pipeline products to see whether they are effective treatments for infected patients.Separately, the company said it has completed its previously announced sale of portfolio of select products to STADA for $660 million.In pre-market trading Wednesday, Takeda shares were adding 3.94% to $18.20.Vir, Alnylam Expands Collaboration To Develop siRNA Therapies For COVID-19 Vir Biotechnology Inc (NASDAQ: VIR) and Alnylam Pharmaceuticals, Inc. (NASDAQ: ALNY) announced an expansion to their existing collaboration to include the development and commercialization of RNAi therapeutics against COVID-19. The agreement provides for Vir using Alnylam's recent advances in lung delivery of novel conjugates of siRNA along with its infectious disease expertise to develop one or some siRNAs to treat COVID-19 and other coronaviruses as well.In premarket trading Wednesday, Vir share were rallying 14.72% to $47 and Alnylam was edging up 0.41% to $111.88.Mallinckrodt Reports Positive Outcome Analysis of Acthar Gel In Immune-mediated Diseases Mallinckrodt PLC (NYSE: MNK) announced findings from a retrospective medical record analysis, which assessed practice patterns and outcomes of Acthar Gel in the treatment of immune-mediated diseases rheumatoid arthritis, systemic lupus erythematosus and dermatomyositis/polymyositis, which showed across all the three patient populations, symptoms improved with Acthar Gel.In premarket trading Wednesday, the shares were advancing 7.99% $3.38.Acadia's Rett Syndrome Investigational Drug Gets Rare Pediatric Designation ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD) and Neuren Pharma said the FDA has granted Rare Pediatric Disease designation to trofinetide for the treatment of Rett syndrome, a serious and rare neurological disorder.Upon approval of a product with the designation, the sponsor is eligible to receive a Priority Review Voucher, which can be used to obtain FDA approval of an NDA for another product in an expedited period of six months.Acadia shares were up 2.41% to $42.99 in after-hours trading.Morphosys' Licensing Agreement With Incyte For Lymphoma Drug Gets Antitrust Clearance Morphosys Ag (NASDAQ: MOR) and Incyte Corporation (NASDAQ: INCY) said their joint collaboration and license agreement for further development and global commercialization of Morphosys' investigational compound tafasitamab has received antitrust clearance and becomes effective Tuesday.The regulatory milestone triggers a $750 million upfront payment by Incyte to Morphosys, and also Incyte's equity investment of $150 million into MorphoSys within the defined timelines.The PDUFA date for the BLA for tafasitamab in combination with lenalidomide for the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma is Aug. 30.Ultragenyx CFO To Step Down Ultragenyx Pharmaceutical Inc (NASDAQ: RARE) said Shalini Sharp will step down as CFO and EVP, effective Sept. 2. The company said it will initiate a search for a successor.Exact Sciences Buys Two Cancer Diagnostics Companies Exact Sciences said it has completed its acquisition of Paradigm Diagnostics and Viomics, two privately held companies, which provide a differentiated late-stage therapy selection test and deep competencies in sequencing and biomarker discovery.View more earnings on TAKThe company expects the acquisition to extend its lab testing and research and development capabilities.J&J Makes Regulatory Submission For Approval of Multiple Sclerosis Drug In Europe Johnson & Johnson's (NYSE: JNJ) Janssen unit announced it submitted a Marketing Authorization Application to EMA, seeking approval for ponesimod for the treatment of adult patients with relapsing multiple sclerosis.Earnings DURECT Corporation (NASDAQ: DRRX) reported fourth-quarter net revenues of $10.69 million compared to $3.63 million last year. The net loss per share narrowed from 5 cents to 2 cents, in line with the consensus estimate.The stock jumped 12.21% to $1.93 in after-hours trading.Menlo Therapeutics Inc's (NASDAQ: MNLO), which has agreed to be bought by Foamix Pharmaceuticals Ltd (NASDAQ: FOMX), reported a wider loss of 89 cents per share compared to the year-ago loss of 76 cents per share and the consensus loss estimate of 83 cents per share.Updating on the pending merger, Menlo said it expects it to close March 9.The stock jumped 23.64% to $3.40 in after-hours trading.Voyager Therapeutics Inc (NASDAQ: VYGR) reported fourth quarter revenues of $32.67 million compared to $2.01 million a year ago. The net loss per share narrowed from 77 cents to 34 cents. Analysts had estimated a loss of 81 cents per share. The company said it expects its cash reserves as well as receivables to be sufficient to meet its projected operating expenses and capex into mid-2022.The stock gained 6.22% to $12.30 in after-hours trading.Vivus reported fourth-quarter total revenues of $17.25 million and a loss of 61 cents per share, narrower than the 68 cents per share loss expected by analysts.The stock rose 8.98% to $1.82 in after-hours trading.Offerings Zogenix, Inc. (NASDAQ: ZGNX) said it has priced its underwritten public offering of 8.52 million shares at $23.50 per share. The company expects to raise gross proceeds of $200.2 million from the offering. The offering is expected to close on or about March 6.The company said it expects to use the net proceeds for the potential commercialization of Fintepla for the treatment of Dravet syndrome, among other things.The stock fell 3.69% to $24 in after-hours trading.On The Radar Earnings * AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) (before the market open) * Recro Pharma Inc (NASDAQ: REPH) (before the market open) * PPD Inc (NASDAQ: PPD) (before the market open) * Axonics Modulation Technologies Inc (NASDAQ: AXNX) (after the close) * Orthopediatrics Corp (NASDAQ: KIDS) (after the close) * Opiant Pharmaceuticals Inc (NASDAQ: OPNT) (after the close)See more from Benzinga * The Daily Biotech Pulse: GenMark Diagnostics Ships COVID-19 Test Kits, Karyopharm To Offer Shares, And More * The Daily Biotech Pulse: Sangamo In Genome-Editing Therapy Deal With Biogen, FDA Nod For Biohaven, Passage Bio IPO(C) 2020 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
TransMedics Group, Inc. (“TransMedics”) (TMDX), a medical technology company that is transforming organ transplant therapy for patients with end-stage lung, heart and liver failure, today announced the completion of the first successful adult human heart transplants from DCD (donation after circulatory death) donors in the United States at Duke University Hospital and Massachusetts General Hospital.
Primary Effectiveness and Safety Endpoints Were Met. The OCS Liver Achieved Statistical Superiority of The Primary Effectiveness Endpoint by Demonstrating Significant Reduction of Early Allograft Dysfunction (EAD) Compared to Control. The trial achieved its primary clinical objectives by meeting both the primary and secondary effectiveness and safety endpoints.
ANDOVER, Mass., April 13, 2020 -- TransMedics Group, Inc. (“TransMedics”) (Nasdaq: TMDX), a medical technology company that is transforming organ transplant therapy for.
TransMedics Group, Inc. (“TransMedics”) (TMDX), a medical technology company that is transforming organ transplant therapy for patients with end-stage lung, heart and liver failure, today announced that the Company and FDA/CDRH have mutually agreed to postpone the originally scheduled April 16th FDA Advisory Committee meeting to review the OCS Heart System due to the national emergency status relating to the COVID-19 Cornavirus. TransMedics and the Office of Cardiovascular Devices at FDA have agreed to continuously monitor the situation and work to reschedule the panel meeting as soon as possible.
All of the shares are being offered by TransMedics. The gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by TransMedics, are expected to be $70.0 million. In addition, TransMedics has granted the underwriters a 30-day option to purchase up to an additional 750,000 shares of common stock at the public offering price, less underwriting discounts and commissions.
The TransMedics management team will host a corresponding conference call beginning at 4:30 p.m. ET / 1:30 p.m. PT. Investors interested in listening to the conference call may do so by dialing (866) 221-1172 for domestic callers or (270) 215-9603 for international callers, followed by Conference ID: 4939519. A live and archived webcast of the event will be available on the “Investors” section of the TransMedics website at www.transmedics.com.
ANDOVER, Mass., March 02, 2020 -- TransMedics Group, Inc. (“TransMedics”) (Nasdaq: TMDX), a medical technology company that is transforming organ transplant therapy for.
Ladies and gentlemen, thank you for standing by and welcome to the TransMedics Q1 2020 Earnings Conference Call. Earlier today, TransMedics released financial results for the quarter ended March 31, 2020. Before we begin, I would like to remind you that management will make statements during this call that include forward-looking statements within the meaning of federal securities laws, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
TransMedics Group, Inc. (“TransMedics”) (TMDX), a medical technology company that is transforming organ transplant therapy for patients with end-stage lung, heart and liver failure, today announced that it will release financial results for the fourth quarter and full year 2019 after market close on Monday, March 2, 2020. The TransMedics management team will host a corresponding conference call beginning at 4:30 p.m. ET / 1:30 p.m. PT. Investors interested in listening to the conference call may do so by dialing (866) 221-1172 for domestic callers or (270) 215-9603 for international callers, followed by Conference ID: 9496143.
Shares of TransMedics Group (NASDAQ: TMDX), a medical device company focused on organ transportation, fell about 16% as of 10:37 a.m. EDT on Wednesday after the company announced the pricing details of a common stock offering. TransMedics let investors know on Tuesday that it wanted to raise about $60 million through a secondary common-stock offering. TransMedics is selling 5 million shares for $14 each.
ANDOVER, Mass., May 06, 2020 -- TransMedics Group, Inc. (“TransMedics”) (Nasdaq: TMDX), a medical technology company that is transforming organ transplant therapy for patients.