ADMS Gets FDA Nod, ARQT Soars On Psoriasis Trial Data, DVAX Catches Eye, PRTA On Watch

Today’s Daily Dose brings you news about FDA approval of Adamas’ GOCOVRI for an expanded indication, positive results from Arcutis’ plaque psoriasis trial, Concert Pharma’s disappointing data from schizophrenia trial, and the progress in Clover’s phase I adjuvanted trial of COVID-19 S-Trimer vaccine candidates, to name a few.

Read on…

1. Adamas’ GOCOVRI Gets FDA Approval for Second Indication

Shares of Adamas Pharmaceuticals, Inc. (ADMS) touched a new high on Monday, following FDA approval for the company’s flagship product GOCOVRI as an adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease experiencing OFF episodes. This is the second indication for the drug.

GOCOVRI is already approved for the treatment of dyskinesia in patients with Parkinson’s disease receiving levodopa-based therapy, with or without concomitant dopaminergic medicines.

With the expanded indication, GOCOVRI is now the first and only medication approved to treat OFF and dyskinesia motor complications motor in Parkinson’s disease.

The product sales of GOCOVRI are estimated to be $19.8 million for fourth quarter 2020 and $71.2 million for full year 2020. GOCOVRI recorded sales of $16.3 million in the fourth quarter of 2019, and $54.6 million for 2019.

In other news, Adamas announced that it has resolved its ongoing litigation with Zydus Worldwide DMCC and Zydus Pharmaceuticals (USA) concerning Zydus’ Abbreviated New Drug Application seeking FDA approval to market a generic version of GOCOVRI. As part of the settlement, Adamas has granted grants Zydus license for generic version of GOCOVRI as of March 4, 2030.

According to Adamas, GOCOVRI has 15 U.S. patents that will expire from 2025 to 2034.

ADMS touched a high of $9.15 in intraday trading, before closing at $6.79, up 14.89%.

2. Arcutis Bio Rallies on Plaque Psoriasis Trial Data

Shares of Arcutis Biotherapeutics Inc. (ARQT) jumped more than 30% on Monday, following positive topline results from its two pivotal phase III studies of Roflumilast cream in plaque psoriasis.

In the two pivotal trials, dubbed DERMIS-1 and DERMIS-2, Roflumilast cream demonstrated statistically significant superiority over vehicle on the primary endpoint of Intertriginous IGA (I-IGA) Success. IGA Success is defined as an IGA score of clear or almost clear and at least a 2-grade improvement from baseline.

The company expects to submit New Drug Application for Roflumilast cream in the second half of 2021.

Taking advantage of the stock’s rally, the company has commenced an underwritten public offering of $150.0 million of shares of its common stock.

ARQT closed Monday’s trading at $35.58, up 30.38%.

3. New Formulation of Biogen’s PLEGRIDY Gets The Go-ahead

The FDA has approved a new intramuscular injection route of administration for Biogen Inc.’s (BIIB) PLEGRIDY for the treatment of relapsing forms of multiple sclerosis.

The new intramuscular administration offers people living with relapsing multiple sclerosis the well-characterized efficacy and safety of Plegridy with the potential for significantly reduced injection site reactions, according to the company.

Plegridy for treating relapsing forms of multiple sclerosis was first approved by the FDA in August 2014 in subcutaneous formulation. The European Commission authorized the intramuscular administration of Plegridy in December 2020.

PLEGRIDY registered sales of $93 million in the third quarter of 2020 compared to $110 million in the year-ago quarter.

The company is slated to report fourth quarter and full year 2020 financial results on February 3, 2021, before the financial markets open.

BIIB closed Monday’s trading at $278.46, down 1.47%.

4. Concert Plunges As Schizophrenia Study Fails

Shares of Concert Pharmaceuticals Inc. (CNCE) dropped over 28% on Monday as the company’s phase II trial of CTP-692 as an adjunctive treatment in patients with schizophrenia failed to meet the primary endpoint or other secondary endpoints.

The primary endpoint of the trial was the change in the Positive and Negative Syndrome Scale (PANSS) total score at 12 weeks compared to baseline. CTP-692 did not show a statistically significant improvement over placebo at any of the doses of 1, 2 or 4-gram.

CNCE closed Monday’s trading at $7.51, down 28.32%.

5. Dynavax Soars on Partner’s Covid-19 Vaccine Trial Results

Dynavax Technologies Corp. (DVAX) jumped nearly 63%, following its partner Clover Biopharmaceuticals’ positive data from a phase I trial of its protein-based COVID-19 S-Trimer vaccine candidates.

The phase I trial demonstrated that Clover’s protein-based COVID-19 S-Trimer vaccine candidates in combination with adjuvants from either GSK or Dynavax induces strong immune responses, including neutralizing antibodies and cell-mediated immunity, as well as favorable safety and tolerability profiles in 150 adult and elderly participants.

While Clover and GSK have decided to discontinue their tie-up to evaluate the S-Trimer COVID-19 vaccine candidate with GSK’s pandemic adjuvant system, the partnership between Clover and Dynavax will continue.

Clover plans to initiate a global phase II/III efficacy trial of its protein-based S-Trimer COVID-19 vaccine candidate adjuvanted with Dynavax’s CpG 1018 plus alum in the first half of 2021 with an interim analysis for vaccine efficacy potentially in the middle of 2021.

The Coalition for Epidemic Preparedness Innovations (CEPI) will continue to fund the development of Clover’s COVID-19 vaccine candidate, including the Phase 2/3 trial, through approval.

DVAX closed Monday’s trading at $10.27, up 62.76%.

6. Horizon Acquires Viela Bio

Horizon Therapeutics plc (HZNP) has agreed to acquire Viela Bio Inc. (VIE) for $53.00 per share in cash, which equates to an equity value of about $3.05 billion. The transaction is expected to close by the end of the first quarter of 2021.

The acquisition adds Viela’s UPLIZNA, the first and only FDA-approved monoclonal antibody for the treatment of neuromyelitis optica spectrum disorder, to Horizon’s commercial rare disease medicine portfolio. UPLIZNA is also being explored in phase III trials in myasthenia gravis and in phase II trial for kidney transplant desensitization.

Viela’s pipeline includes:

— VIB4920, which is under phase 2b trial in Sjögren’s syndrome and phase II trials for kidney transplant rejection and rheumatoid arthritis.
— VIB7734, which is under a phase I study for the treatment of COVID-19-related acute lung injury, and a phase II trial for systemic lupus erythematosus, expected to begin in the first half of 2021.
— VIB1116, a monoclonal antibody for autoimmune diseases, which is expected to move into a phase 1 first-in-human trial in mid-2021.

Horizon anticipates the transaction to reduce its adjusted EBITDA by approximately $140 million in 2021, nearly all of which is attributable to increased R&D investment.

HZNP closed Monday’s trading at $77.04, up 6.29%. VIE closed the day’s trading at $52.81, up 52.26%.

7. Matinas Down but Not Out

Shares of Matinas BioPharma Holdings Inc. (MTNB) slumped more than 34% on Monday, following disappointing results from its ENHANCE-IT study.

ENHANCE-IT is an open-label, randomized, 28-day crossover study assessing the pharmacodynamic effects of Matinas’ investigational drug Lypdiso against Amarin Corp.’s (AMRN) approved drug Vascepa.

Lypdiso, a phase 3-ready compound, is being developed for the treatment of cardiovascular and metabolic conditions.

In the ENHANCE-IT trial, plasma eicosapentaenoic acid (EPA) concentrations were statistically significantly higher with LYPDISO with a 46% relative percentage improvement in EPA blood level concentrations over Vascepa.

LYPDISO also demonstrated a 39% relative difference in response over Vascepa in triglyceride reduction. However, this relative improvement did not achieve statistical significance in the pharmacodynamic population.

Commenting on the trial results, Jerome Jabbour, Chief Executive Officer of Matinas, said, “Although we did not achieve statistical significance on the primary endpoint of triglycerides in the prespecified population, these data point to the potential for robust cardiovascular risk reduction with LYPDISO”.

The company has plans to initiate its Phase 3 program of Lypdiso in severe hypertriglyceridemia in the first half of 2021.

MTNB closed Monday’s trading at $0.96, down 34.25%.

8. Prothena Forges Ahead with AFFIRM-AL Trial

Prothena Corporation plc (PRTA) is all set to move its lead drug candidate Birtamimab into a phase III trial in patients with Mayo Stage IV AL amyloidosis, dubbed AFFIRM-AL.

AL amyloidosis is a rare, progressive and fatal disease characterized by a wide range of general symptoms that are common to other conditions such as fatigue, shortness of breath or edema. It is estimated that there are 60,000 to 120,000 patients worldwide living with Mayo Stage IV AL amyloidosis.

Birtamimab was previously evaluated in a phase III study of newly diagnosed, treatment naïve patients with AL amyloidosis and cardiac involvement, dubbed VITAL. Results from the analysis of patients categorized as Mayo Stage IV at baseline in the VITAL study revealed a significant survival benefit favoring Birtamimab in these patients, with 74% of Birtamimab-treated patients alive at 9 months versus 49% of patients in the control group.

The planned AFFIRM-AL study of Birtamimab is expected to be initiated in mid-2021.

PRTA closed Monday’s trading at $11.00, down 1.87%. In after-hours, the stock was up 43% at $15.73.

9. Some of the Top Gainers & Top Losers

BioCryst Pharmaceuticals Inc. (BCRX) closed Monday’s trading at $11.85, up 39.08%.

Retractable Technologies Inc. (RVP) closed at $21.50, up 33.62%.

Inovio Pharmaceuticals Inc. (INO) closed at $16.96, up 33.02%.

Quotient Limited (QTNT) closed at $5.04, down 16.83%.

ADiTx Therapeutics Inc. (ADTX) closed at $3.26, down 12.60%.

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