The following are the stocks scheduled for February, with regulatory catalysts.
1. Adamas Pharmaceuticals Inc. (ADMS)
The FDA decision on the expanded use of Adamas Pharma's lead drug GOCOVRI is expected on February 1, 2021.
GOCOVRI received its initial approval in August 2017 for the treatment of dyskinesia in patients with Parkinson's disease who receives levodopa-based therapy, with or without concomitant dopaminergic medications. Now, the company is seeking to modify the indication statement for GOCOVRI to include treatment for Parkinson's disease patients receiving levodopa and experiencing OFF episodes.
If approved, the revised indication would reflect the full spectrum of GOCOVRI's therapeutic benefit in Parkinson's disease motor complications and better support physicians to identify appropriate treatments for their patients.
The product sales of GOCOVRI are expected to be $19.8 million for fourth quarter 2020, an increase of 21%, and $71.2 million for full year 2020, a growth of 30%, compared to the respective periods during 2019.
2. Mallinckrodt plc (MNKKQ)
Mallinckrodt, which filed for bankruptcy protection last October, awaits the FDA decision on StrataGraft on February 2, 2021.
StrataGraft, an investigational regenerative skin tissue therapy, is proposed for the treatment of adult patients with deep partial-thickness thermal burns. StrataGraft is an engineered, bilayer tissue and is designed to mimic natural human skin with both inner dermis-like and outer epidermis-like layers.
The current standard of care for deep partial-thickness thermal burns is Autograft, which involves the surgical harvesting of healthy skin from an uninjured site on the patient and transplanting the skin graft to the injury, leaving the patient with more wounded areas requiring care.
3. G1 Therapeutics Inc. (GTHX)
The FDA decision on G1 Therapeutics' New Drug Application for Trilaciclib, which is under priority review, is expected to be announced on February 15, 2021.
Trilaciclib, which is designed to address the shortcomings of chemotherapy, is proposed for the treatment of small cell lung cancer.
If approved, Trilaciclib could rake in peak sales of $500 million in the indication of small cell lung cancer, according to Tony Butler, an analyst at ROTH Capital Partners.
The company is also exploring the potential of Trilaciclib in metastatic colorectal cancer and in triple-negative breast cancer.
GTHX closed Friday's trading at $20.81, down 2.76%.
4. TG Therapeutics Inc. (TGTX)
TG Therapeutics will know whether or not its Umbralisib as a monotherapy in the indication of marginal zone lymphoma will pass muster with the FDA on February 15, 2021.
Marginal zone lymphoma (MZL) is a group of slow growing NHL B-cell lymphomas, which account for approximately eight percent of all NHL cases (Source: Lymphoma Research Foundation). AbbVie's (ABBV) Imbruvica and Bristol-Myers Squibb/Celgene's Revlimid are the FDA-approved drugs for marginal zone lymphoma.
Umbralisib is also under FDA review in the indication of Follicular Lymphoma, with a decision expected on June 15, 2021.
GTHX closed Friday's trading at $49.42, up 4%.
5. Sarepta Therapeutics Inc. (SRPT)
Sarepta's Casimersen, proposed for the treatment of patients with Duchenne muscular dystrophy amenable to skipping exon 45, is under priority review, with a decision expected on February 25, 2021.
Duchenne muscular dystrophy (DMD) is a genetic disorder characterized by progressive muscle degeneration and weakness due to the alterations of a protein called dystrophin. The dystrophin has 79 exons.
There are already FDA-approved therapies for DMD caused by a mutation that would be amenable to skipping exon 51, which goes by the name Exondys 51, as well as for DMD caused by a mutation that would be impacted by skipping exon 53 under the name Vyondys 53.
If approved, Casimersen would be the third exon-skipping medicine for patients with Duchenne muscular dystrophy, and will be marketed under the brand name AMONDYS 45.
The global market size of Duchenne muscular dystrophy drugs is estimated to reach $4.11 billion by 2023, according to a new report by Grand View Research.
SRPT closed Friday's trading at $98.24, up 1.36%.
6. CorMedix Inc. (CRMD)
On February 28, 2021, the FDA is expected to announce its decision on CorMedix' Defencath, a synthetic broad-spectrum antimicrobial and antifungal.
The company is seeking approval of Defencath in the U.S. for use as a catheter lock solution in hemodialysis patients for the prevention of catheter related blood stream infections. Defencath is available in Europe and other territories under the brand name Neutrolin.
If approved, Defencath could achieve peak sales of roughly $370 million in the dialysis setting, according to JMP Securities analyst Jason Butler.
CRMD closed Friday's trading at $8.64, up 0.12%.
7. Athenex Inc. (ATNX)
Athenex' Oral Paclitaxel in combination with Encequidar, proposed for the treatment of metastatic breast cancer, is under Priority Review by the FDA, with a decision expected on February 28, 2021.
Paclitaxel is a chemotherapy drug administered intravenously. Oral Paclitaxel is a reformulated version and is co-administered with Encequidar that enables the oral absorption of a wide range of effective anticancer drugs.
In clinical trial, the combination of Oral Paclitaxel and Encequidar showed statistically significant improvement in overall response rate, along with a lower neuropathy, relative to IV Paclitaxel. But this combo was associated with higher rates of neutropenia, infection, and gastrointestinal side effects.
If approved, Oral Paclitaxel is expected to achieve blockbuster sales.
ATNX closed Friday's trading at $12.38, up 7.65%.
8. Regeneron Pharmaceuticals Inc. (REGN)
Regeneron Pharma will hear about the FDA's decision on two of its drugs, Evinacumab and Libtayo, during the month of February.
The decision on Evinacumab, proposed as an adjunct to other lipid-lowering therapies in patients with homozygous familial hypercholesterolemia (HoFH), is slated for February 11, 2021.
Libtayo awaits the FDA decision in the additional indication of treating patients with first-line locally advanced or metastatic non-small cell lung cancer (NSCLC) with "more than or equal to" 50% PD-L1 expression on February 28, 2021. This drug is already approved for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation.
REGN closed Friday's trading at $537.78, up 0.43%.
For comments and feedback contact: editorial@rttnews.com
Business News