TransMedics participates in a conference call with Cowen » 16:0204/1204/12/21
Healthcare Analyst Jennings holds a conference call with management on April 19 at 1 pm hosted by Cowen.
|Over a week ago|
Fly Intel: Pre-market Movers » 08:5704/0704/07/21
CAHC, TMDX, HYLN, HIMX, SMPL, MSM, RPM, FGEN, FIXX, UPST
Check out this morning's…
TransMedics label likely more limited than expected, says Canaccord » 08:3404/0704/07/21
Canaccord analyst William…
Canaccord analyst William Plovanic noted the FDA panel voted in favor of recommending approval for the TransMedics OCS Heart PMA after a contentious discussion of the data supporting the safety, efficacy, and ultimate risk/benefit of the device. As a result, the analyst believes the IFU label will be a bit more restrictive than anticipated. Plovanic maintains his Buy rating and $79 price target on TransMedics shares.
TransMedics announces FDA advisory committee vote in favor of OCS Heart System » 05:4104/0704/07/21
TransMedics announced that after the review of TransMedics' clinical evidence from the OCS Heart EXPAND trial, the associated Continued Access Protocol results, as well as the OCS Heart PROCEED II trial, the Circulatory Systems Device Advisory Panel convened by the FDA has issued a favorable vote in support of approval of the OCS Heart System to the FDA's Office of Health Technology 2. The panel voted 12 to 5, with one abstaining, that the benefits of the OCS Heart System outweigh its risks. The panel voted 10 to 6, with two abstaining, that there is reasonable assurance that the OCS Heart System is effective. The panel voted 9 to 7, with two abstaining, that there is reasonable assurance of the OCS Heart System's safety.
FDA Circulatory System Devices Panel holds a virtual meeting » 08:5004/0604/06/21
The Committee discusses,…
The Committee discusses, makes recommendations and votes on information regarding TransMedics' Premarket Approval Application for the TransMedics Organ Care System (OCS) Heart, a portable extracorporeal heart perfusion and monitoring system in a virtual meeting to be held on April 6 at 9 am. Webcast Link
TransMedics trading halted, FDA Advisory panel to review OCS Heart System » 07:0704/0604/06/21
TransMedics announced that Nasdaq has halted trading of the company's common stock. The U.S. FDA's Circulatory System Devices Panel of the Medical Devices Advisory Committee is meeting April 6 to review TransMedics' Organ Care System Heart System. The OCS Heart System is a portable organ perfusion and monitoring medical device intended to preserve a donated heart in a near-physiologic, beating and perfused state, while continually monitoring and optimizing heart function for eventual transplantation into the recipient. The Advisory Committee meeting is scheduled for 9:00 a.m. ET.
TransMedics Group trading halted, news pending 06:5504/0604/06/21
TransMedics price target raised to $49 from $44 at Cowen » 08:1503/2903/29/21
Cowen analyst Joshua…
Cowen analyst Joshua Jennings raised the firm's price target on TransMedics to $49 from $44 and keeps an Outperform rating on the shares. The analyst expects a positive panel partly thanks to Expand continued access program's greater role in the filing after the pandemic delays. He said he knows that Expand CAP enhances Expand's strong standalone findings.
|Over a month ago|
TransMedics price target raised to $79 from $46 at Canaccord » 08:1403/1503/15/21
Canaccord analyst William…
Canaccord analyst William Plovanic raised the firm's price target on TransMedics to $79 from $46 and keeps a Buy rating on the shares. The analyst believes they have the technology that will become the standard of care for organ transplant and in the process, facilitate a significant increase in the supply of implantable donated organs to address excess demand.
TransMedics price target raised to $38 from $16 at Morgan Stanley » 09:4003/0303/03/21
Morgan Stanley analyst…
Morgan Stanley analyst David Lewis raised the firm's price target on TransMedics to $38 from $16 and keeps an Equal Weight rating on the shares. The analyst believes the company "weathered 4Q well" and he's encouraged by OCS Lung's traction and management's 2021 guidance. Lewis sees the heart and liver FDA panels dictating the share performance this year. He expects mixed panel documents for heart but is optimistic that continued access protocol data will "alleviate any concerns."