Today’s Daily Dose brings you news about Adamas Pharma’s date with the FDA; Cyclerion’s near-term catalysts; the pipeline progress of Mereo; FDA approval of Merck’s combination antibiotic Recarbrio for a new indication; and the bidding war for Tetraphase.
1. Adamas To Face FDA On Feb.1, 2021
Adamas Pharmaceuticals Inc.’s (ADMS) supplemental New Drug Application for GOCOVRI as a treatment for OFF episodes in Parkinson’s disease patients receiving levodopa-based therapy has been accepted for review by the FDA – with a decision expected on February 1, 2021.
GOCOVRI is already approved for the treatment of levodopa-induced dyskinesia (LID) in patients with Parkinson’s disease.
The drug recorded annual product sales of $54.6 million in 2019, a 60% increase over 2018. In the first quarter of 2020, GOCOVRI product sales were $14.5 million, a 24% increase over the first quarter of 2019.
ADMS closed Thursday’s trading at $2.64, down 2.22%. In after-hours, the stock was up 18.18% at $3.12.
2. Cyclerion To Report Data From Sickle Cell Disease Trial Mid-Year
Cyclerion Therapeutics Inc. (CYCN) has a couple of catalysts to watch out for in the coming months.
The Company has three product candidates in clinical development – Olinciguat, Praliciguat, and IW-6463.
Olinciguat is under a phase II study in patients with sickle cell disease, dubbed STRONG SCD. Data readout from this study is expected in mid-2020.
Praliciguat, proposed for the treatment of diabetic nephropathy, demonstrated encouraging topline results from its phase II proof-of-concept study last October.
IW-6463, an oral, once-daily CNS-penetrant sGC stimulator for the treatment of serious neurodegenerative diseases, produced encouraging results in phase I healthy volunteer study in January of this year. A translational pharmacology study of the compound in approximately 24 elderly subjects is ongoing. Top-line clinical results are expected in mid-2020.
CYCN closed Thursday’s trading at $5.79, up 22.41%.
3. Mereo Completes Private Placement
Mereo BioPharma Group plc (MREO) has completed a $70 million (£56 million) private placement with a number of new and existing U.S based institutional and accredited investors.
The Company’s lead drug candidate is Setrusumab, a potential treatment for osteogenesis imperfecta, also known as brittle bone disease.
Although a phase IIb study, which evaluated Setrusumab in adults with Type I, III or IV osteogenesis imperfecta, dubbed ASTEROID, did not meet the primary endpoint of a change in Trabecular Volumetric Bone Mineral Density (Tr vBMD) of the radius (wrist) over baseline after 12 months of treatment, a trend of reduction in fractures was observed in the high dose cohort.
The Company is confident of Setrusumab’s potential and plans to advance Setrusumab to a pivotal trial. But prior to the initiation of the pivotal trial, the Company intends to complete a strategic partnership for Setrusumab.
Up next in the pipeline is Alvelestat, an oral neutrophil elastase inhibitor, being explored for the potential treatment of alpha-1 antitrypsin deficiency (AATD), which is under a phase II study. Mereo now expects to report top-line data from this study in the second half of 2021.
Another compound which the Company is planning to advance is Etigilimab (Anti-TIGIT) into a phase Ib study in advanced solid tumors in the fourth quarter of this year.
MREO closed Thursday’s trading at $3.05, up 55.61%.
4. FDA Approves Merck’s Recarbrio For New Indication
The FDA has approved Merck’s (MRK) combination antibiotic Recarbrio for the expanded indication in the treatment of adults with hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP).
Recarbrio is a combination of Imipenem, a penem antibacterial, Cilastatin, a renal dehydropeptidase inhibitor, and Relebactam, a betalactamase inhibitor.
The drug received initial approval in the U.S. in July 2019 for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, and complicated intra-abdominal infections (cIAI) caused by susceptible Gram-negative bacteria, in adults who have limited or no alternative treatment options.
Cowen & Co analysts expect the combo med to achieve sales of around $150 million in 2024.
MRK closed Thursday’s trading at $81.55, down 0.62%.
5. Tetraphase Finalizes Its Suitor
Tetraphase Pharmaceuticals Inc. (TTPH) has terminated its merger agreement with AcelRx (ACRX) and has agreed to be acquired by privately-held Melinta Therapeutics Inc.
As per the agreement, Melinta would acquire Tetraphase, through a tender offer, for an aggregate of $39.0 million in cash, plus an additional $16.0 million in cash potentially payable under contingent value rights to be issued in the proposed acquisition.
In March of this year, Tetraphase agreed to be acquired by AcelRx in an all-stock transaction, valued at approximately $14.4 million and one contingent value right (CVR), which was to entitle the holders to receive aggregate milestone-linked payments of up to $12.5 million.
But with Melinta making an unsolicited offer to acquire Tetraphase in May, AcelRx tabled a revised offer for Tetraphase, agreeing to pay $30 million in stock and cash plus an additional $14.5 million in CVRs, payable in cash.
Melinta had earlier agreed to acquire Tetraphase for $34.0 million in cash, plus an additional $16.0 million in cash payable under CVR. After AcleRx revised its offer in May, Melinta also boosted its earlier bid finalizing it to $39.0 million in cash, plus an additional $16.0 million in cash payable under CVR.
The Board of Directors of Tetraphase has unanimously recommended that stockholders tender their shares in the Melinta tender offer once it is commenced.
AcelRx will be paid a break-up fee of approximately $1.8 million, according to Tetraphase.
The acquisition is expected to close early in the third quarter of this year.
TTPH closed Thursday’s trading at $2.13, down 4.91%.
6. Stocks That Moved On No News
Personalis Inc. (PSNL) closed Thursday’s trading at $14.11, up 17.39%.
Replimune Group Inc. (REPL) closed Thursday’s trading at $23.51, up 16.44%.
IMARA Inc. (IMRA) closed Thursday’s trading at $52.24, up 16.37%.
Compugen Ltd. (CGEN) closed Thursday’s trading at $14.72, down 14.02%.
Turning Point Therapeutics Inc. (TPTX) closed Thursday’s trading at $62.19, down 11.40%.
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