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Share Name | Share Symbol | Market | Type | Share ISIN | Share Description |
---|---|---|---|---|---|
Malin Corporation Plc | LSE:0Y71 | London | Ordinary Share | IE00BVGC3741 | MALIN CORPORATION ORD SHS |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 0.00 | - |
Industry Sector | Turnover | Profit | EPS - Basic | PE Ratio | Market Cap |
---|---|---|---|---|---|
Offices-holdng Companies,nec | 0 | 0 | 0.0000 | N/A | 102.95M |
TIDM0Y71
RNS Number : 8923Y
Malin Corporation PLC
14 May 2019
Malin Corporation plc
Poseida receives FDA orphan drug designation for lead candidate and FDA approval of fully outpatient dosing in Phase 2 clinical trial
Dublin-Ireland, 14 May 2019: Malin Corporation plc. (Euronext Growth Dublin:MLC) ("Malin"), a company investing in highly innovative life sciences companies, is pleased to note that Poseida Therapeutics Inc. ("Poseida"), one of Malin's Priority Assets, has announced the US Food and Drug Administration ("FDA") has granted orphan drug designation to P-BCMA-101 for the treatment of relapsed and/or refractory multiple myeloma.
Orphan drug designation is granted by the FDA Office of Orphan Products Development to drugs and biologics which are intended for the treatment, diagnosis or prevention of rare diseases/disorders. Under the Orphan Drug Act, the FDA may provide grant funding toward clinical trial costs, tax advantages, FDA user-fee benefits and seven years of market exclusivity in the US following marketing approval by the FDA.
"We are pleased with Poseida's continued positive progress in the development of P-BCMA-101," said Darragh Lyons, Chief Business and Financial Officer of Malin. "The receipt of orphan drug designation is an important regulatory milestone while the FDA approval of fully outpatient dosing in the Phase 2 clinical trial, due to commence in Q2 2019, is validation of the outstanding safety profile demonstrated by P-BCMA in the Phase 1 clinical trial."
P-BCMA-101 is an autologous CAR-T therapy developed using Poseida's piggyBac(R) platform technology. The programme is currently in an ongoing Phase 1 dose escalation clinical trial where it has displayed outstanding potency, with remarkably low rates of toxicity, and the FDA has approved fully outpatient dosing in the Phase 2 trial starting in the second quarter of 2019.
In April 2019, Poseida announced the closing of a Series C financing round, raising $142 million, led by a $75 million equity investment from Novartis Pharma AG. Having invested $4 million as part of this financing transaction, Malin retains approximately one-quarter of the issued share capital of Poseida.
A copy of Poseida's press release is available to view here:
https://poseida.com/poseida-therapeutics-receives-us-fda-orphan-drug-designation-for-p-bcma-101-for-the-treatment-of-multiple-myeloma/
ENDS
For further information please contact:
Malin
Jessica Bergin, Director of Investor Relations & External Reporting
Tel: +353 (0)1 901 5700
investorrelations@malinplc.com
Davy Corporate Finance (Euronext Growth Adviser)
Brian Garrahy / Daragh O'Reilly
Tel: +353 1 679 6363
Consilium Strategic Communications
Mary-Jane Elliott / Jessica Hodgson
Tel: +44 (0)20 3709 5700
malin@consilium-comms.com
Powerscourt (Irish media enquiries)
Jack Hickey
Tel: +353 83 448 8339
malin@powerscourt-group.com
About Malin Corporation plc
Malin (Euronext Growth Dublin:MLC) is a company investing in and supporting highly innovative life sciences companies developing exceptional science and technology to deliver transformative outcomes for patients and create significant value for shareholders. Its purpose is to create shareholder value through the application of long-term capital and strategic support to its investee companies to enable them to reach their value potential. Malin is headquartered and domiciled in Ireland and listed on the Euronext Growth Dublin. For more information visit www.malinplc.com
This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact rns@lseg.com or visit www.rns.com.
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May 14, 2019 02:01 ET (06:01 GMT)
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