Coming off a stellar year, when a record 53 new molecular entities were approved, 2021 has a lot to live up to. NMEs are a measure of innovation among biopharma companies, as they refer to drugs containing an active ingredient that has never been approved previously.

Although the calendar for drug approval decisions, known as PDUFA dates, for January was fairly light, most verdicts issued in the month were positive. Among the drugs approved in the month were Merck & Co., Inc.'s (NYSE: MRK) heart failure drug, an expanded indication for Pfizer Inc.'s (NYSE: PFE) lymphoma drug and Aurinia Pharmaceuticals Inc's (NASDAQ: AUPH) kidney inflammation drug.

Here are the key FDA decisions due for February:

Adamas Seeks Label Expansion For Its Parkinson's Drug

Company: Adamas Pharmaceuticals Inc (NASDAQ: ADMS)
Type of Application: sNDA
Candidate: Gocovri
Indication: "Off episodes" in Parkinson's disease patients receiving levodopa-based therapy
Date: Feb. 1 (estimated date provided by the company)

The FDA accepted the application for label expansion on June 4.

Gocovri, extended-release capsules, has already been approved for dyskinesia in Parkinson's disease patients treated with levodopa-based therapy, with or without other dopaminergic medications.

In 2020, Gocovri sales came in at $71.2 million, up 30% year-over-year.

Clinical evidence supporting Gocovri's effect on off episodes was demonstrated in two large pivotal Phase 3 trials and is currently included in the GOCOVRI prescribing information.

Mallinckrodt Awaits Nod For Skin Tissue Therapy To Treat Burns

Company: Mallinckrodt PLC (OTC: MNKKQ)
Type of Application: BLA
Candidate: StrataGraft
Indication: deep partial-thickness thermal burns
Date: Feb. 2

StrataGraft, an investigational regenerative skin tissue therapy, is in development for the treatment of adult patients with deep partial-thickness thermal burns.

On Aug. 10, the FDA accepted the application for priority review, assigning a PDUFA goal date of Feb. 2.

Each year, approximately 40,000 patients in the U.S. require hospitalization for the treatment of severe burns, according to Mallinckrodt. Autograft, the current standard of care, involves 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.

StrataGraft skin tissue is engineered to mimic natural human skin with both inner dermis-like and outer epidermis-like layers.

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‘Go Or No-Go' For Regeneron's Adjuvant Therapy To Treat Inherited High Cholesterol Condition?

Company: Regeneron Pharmaceuticals Inc (NASDAQ: REGN)
Type of Application: BLA
Candidate: evinacumab
Indication: homozygous familial hypercholesterolemia, or HoFH
Date: Feb. 11

HoFH is an ultra-rare, inherited form of high cholesterol, affecting approximately 1,300 patients in the U.S. With the vast majority of these patients unable to reach target LDL-C levels with currently available therapies, the need for an effective therapy has become acute.

Evinacumab is an investigational fully-human monoclonal antibody that binds to and blocks the function of ANGPTL3.

Can TG Therapeutics Lymphoma Drug Cross The FDA Hurdle?

Company: TG Therapeutics Inc common stock (NASDAQ: TGTX)
Type of Application: NDA
Candidate: umbralisib
Indication: marginal zone lymphoma
Date: Feb. 15

Umbralisib, TG Therapeutics' investigational once-daily, oral, dual inhibitor of PI3K-delta and CK1-epsilon, is being evaluated as a treatment for patients with previously treated marginal zone lymphoma, who have received at least one prior anti-CD20 based regimen. It also is being evaluated for use in patients with follicular lymphoma who have received at least two prior systemic therapies.

G1's Trilaciclib Awaits Regulatory Clearance For Treating Chemotherapy-Induced Toxicities

Company: G1 Therapeutics Inc (NASDAQ: GTHX)
Type of Application: NDA
Candidate: trilaciclib
Indication: small cell lung cancer
Date: Feb. 15

Trilaciclib is an investigational therapy designed to improve outcomes for people with cancer treated with chemotherapy. G1 submitted the regulatory application in June based on myelopreservation data from three randomized, double-blind, placebo-controlled clinical trials in which trilaciclib was administered prior to chemotherapy in patients with small cell lung cancer.

The application was accepted by the FDA for priority review In August, with a PDUFA goal date of Feb. 15.

In clinical trials, trilaciclib significantly reduced chemotherapy-induced myelosuppression — damage to bone marrow stem cells. Myelosuppression often leads to anemia, neutropenia or thrombocytopenia.

Sarepta Seeks Nod For Third Exon-Skipping DMD Drug

Company: Sarepta Therapeutics Inc (NASDAQ: SRPT)
Type of Application: NDA
Candidate: casimersen
Indication: Duchenne muscular dystrophy
Date: Feb. 25

Casimersen, a phosphorodiamidate morpholino oligomer, is engineered to treat patients with Duchenne muscular dystrophy who have genetic mutations that are amenable to skipping exon 45 of the dystrophin gene.

The company submitted the NDA in June 2020, with the FDA accepting the application in late August, granting priority review.

If approved, casimersen would be the third exon-skipping medicine in its PMO RNA-based platform, offering treatment to the 8% of Duchenne patients who are amenable to exon-45 skipping.

The company has received conditional approval of Amondys 45 as the brand name for casimersen.

Second Approval For Regeneron's Checkpoint Inhibitor Libtayo In The Offing?

Company: Sanofi SA (NASDAQ: SNY) and Regeneron
Type of Application: sBLA
Candidate: Libtayo
Indication: lung cancer
Date: Feb. 28

Libtayo, jointly-developed by Sanofi and Regeneron, is a fully-human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T-cells. It has already been approved for treating cutaneous squamous cell carcinoma, a type of skin cancer, that has spread or cannot be cured by surgery or radiation.

The companies are now seeking approval for the drug as a treatment option for first-line locally advanced or metastatic non-small cell lung cancer with 50% or more PD-L1 expression.

CoreMedix Seeks Approval For Catheter-Related Blood Stream Infection Treatment

Company: CorMedix Inc. (NYSE: CRMD)
Type of Application: NDA
Candidate: defencath
Indication: catheter-related blood stream infections
Date: Feb. 28

Defencath is to be used as a catheter lock solution in hemodialysis patients for the prevention of catheter-related blood stream infections. The company said if approved, defencath will potentially be the first antibacterial and antifungal catheter lock solution in the U.S. to prevent catheter-related infections in hemodialysis patients.

Following FDA acceptance of the regulatory application for priority review, the PDUFA goal date was fixed at Feb. 28.

Can Athenex' Oral Chemotherapy Medication Pass FDA Muster?

Company: Athenex Inc (NASDAQ: ATNX)
Type of Application: NDA
Candidate: Oral Paclitaxel
Indication: breast cancer
Date: Feb. 28

The regulatory application for Oral Paclitaxel, comprising oral paclitaxel and encequidar, was accepted by the FDA for priority review in early September, as a treatment option for metastatic breast cancer.

Currently intravenous Paclitaxel is considered foundational chemotherapy in multiple tumor types.

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