Attention Biotech Investors: Mark Your Calendar For These November PDUFA Dates

The month of October could at best be termed as mixed from the perspective of drug approvals. Avenue Therapeutics Inc's ATXI pain drug and Zosano Pharma Corp's ZSAN migraine patch stumbled at the FDA altar.

The FDA announced a delay in deciding on Spectrum Pharmaceuticals, Inc.'s SPPI treatment candidate for chemotherapy-induced neutropenia, citing COVID-19 that impaired its ability to conduct inspections. Regeneron Pharmaceuticals Inc REGN succeeded in getting its antibody cocktail for Ebola past the finish line.

Two new molecular entities, including Gilead Sciences, Inc.'s GILD Veklury were approved during the month, taking the total NME approvals for the year to 42.

PDUFA dates are binary events that invariably serve as make-or-break catalysts for stocks. These dates are deadlines by which the FDA reviews a new drug application before announcing its decision concerning the approvability/non-approvability of the drug.

Here are the key PDUFA dates for November.

Supernus Awaits Nod For ADHD Drug

Company: Supernus Pharmaceuticals Inc SUPN
Type of Application: NDA
Candidate: SPN-812 (vilaxazine hydrochloride)
Indication: attention deficit hyperactivity disorder, or ADHD
Date: Nov. 8

SPN-812 is a once-daily, serotonin norepinephrine modulating agent. The company announced FDA acceptance of the NDA on Jan. 21, 2020.

About 6.1 million children and adolescents in the U.S. are diagnosed with ADHD, Supernus said: "SPN-812, if approved by the FDA, will be the first truly new therapy to treat ADHD in a decade."

Following a survey of 26 pediatric and adolescent psychiatrists with the goal of gauging receptivity to SPN-812, Piper Sandler said there were a sufficiently high number of respondents who are open to prescribing SPN-812 as an alternative to Strattera, the only other serotonin norepinephrine modulating agent available for ADHD as well as an alternative to stimulants.

The product, the firm said, can attain some modicum of commercial success.

Assuming FDA approval by the PDUFA action date, the company said it expects to begin shipments in December.

Sanofi Seeks Approval For Biologic to Treat Autoimmune Hemolytic Anemia

Company: Sanofi SA SNY
Type of Application: BLA
Candidate: Sutimlimab
Indication: hemolysis in adult patients with cold agglutinin disease
Date: Nov. 13

Cold agglutinin disease is a chronic autoimmune hemolytic anemia that causes the body's immune system to mistakenly attack healthy red blood cells and cause their rupture, thereby causing chronic anemia, profound fatigue, acute hemolytic crisis etc.

Sanofi noted in a release an estimated 5,000 people in the U.S. live with the disease.

Sutimlimab, an investigational monoclonal antibody, targets the underlying cause of hemolysis in CAD by selectively inhibiting complement C1s.

The FDA accepted the application on May 14, granting it priority review.

Will FDA Go With Adcom Verdict For Alkermes' Antipsychotic Drug

Company: Alkermes Plc ALKS
Type of Application: NDA
Candidate: ALKS 3831
Indication: schizophrenia and for the treatment of bipolar I disorder
Date: Nov. 15

Alkermes is seeking approval of fixed dosage strengths of ALKS 3831 composed of 10 mg of samidorphan co-formulated with 5 mg, 10 mg, 15 mg or 20 mg of olanzapine. It's an investigational, novel, once-daily, oral atypical antipsychotic drug candidate designed to provide the efficacy of olanzapine while mitigating olanzapine-associated weight gain.

The FDA accepted the NDA for ALKS 3831, an investigational, novel, once-daily, oral atypical antipsychotic drug, in late January.

The Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee, which met in early October to review the NDA, jointly voted that samidorphan meaningfully mitigates olanzapine-associated weight gain and that the safety profile of ALKS 3831 has been adequately characterized.

Can Second Time Be Charm For Adamis?

Company: Adamis Pharmaceuticals Corp ADMP
Type of Application: NDA
Candidate: Zimhi (naloxone HCI Injection, USP) 5mg/0.5ml
Indication: opioid overdose treatment
Date: Nov. 15

The original NDA was handed down a complete response letter in November 2019. Subsequently, the company resubmitted the application in May 2020.

Naloxone is an opioid antagonist and is generally considered the drug of choice for immediate administration for opioid overdose. It works by blocking or reversing the effects of the opioid, including extreme drowsiness, slowed breathing, or loss of consciousness.

Can Mylan's Copycat Version of Biogen's MS Drug Get The Nod?

Company: Mylan NV MYL
Type of Application: Abbreviated New Drug Application, or ANDA
Candidate: dimethyl fumarate
Indication: relapsing form of multiple sclerosis.
Date: Nov. 16

Mylan's dimethyl fumarate is a generic version of Biogen Inc's BIIB MS medication Tecfidera. The company said in a mid-July release it's one of the first companies to have filed a substantially complete ANDA containing a Paragraph IV certification for a dimethyl fumarate product and expects to be eligible for 180 days of marketing exclusivity in the U.S. upon approval.

Biogen's total IQVIA sales for Tecfidera in the U.S. for the 12 months ended April 30, were about $3.78 billion, Mylan said.

D-Day Around The Corner For Bristol-Myers Squibb's Lymphoma Cell Therapy

Company: Bristol-Myers Squibb Co BMY
Type of Application: BLA
Candidate: liso-cel
Indication: Lymphoma
Date: Nov. 16

Lisocabtagene maraleucel, or liso-cel, is a CD19-directed chimeric antigen receptor T cell therapy for the treatment of adults with relapsed or refractory large B-cell lymphoma after at least two prior therapies. It came into Bristol-Myers' stable through its Celgene acquisition.

Given the priority review accorded for the therapy, a decision was initially due mid-August. The FDA, however, extended the timeline by three months to review additional information submitted by the sponsor.

Can Eiger's Progeria Drug Pass The FDA Muster?

Company: Eiger Biopharmaceuticals Inc EIGR

Type of Application: NDA
Candidate: Lonfarnib
Indication: progeria and progeroid laminopathies
Date: Nov. 20

The FDA accepted the NDA for accelerated review on May 19. Lonfarnib, which goes by the trade name Zokinvy, has rare pediatric disease designation.

Zokinvy is an orally active inhibitor of farnesyltransferase, an enzyme involved in modification of proteins through a process called prenylation.

Both progeria and progeroid laminopathies are genetic conditions caused by mutation in genes, and manifests as accelerated aging.

Roche Seeks Label Expansions For Flu Medication

Company: Roche Holdings RHHBY
Type of Application: sNDA
Candidate: Xofluza
Indication: Influenza
Date: Nov. 23

Roche's Xofluza was originally approved for acute uncomplicated influenza in October 2018, and later in October 2019 its label was expanded to include people at high-risk of developing influenza-related complications.

The company now has two sBLAs pending before the FDA, one seeking approval for an additional formulation of Xofluza as granules for oral suspension for people one year of age and older with influenza, and another for post-exposure prophylaxis.

Liquidia Hopes For Relief With Hypertension Drug Approval

Company: Liquidia Technologies Inc LQDA
Type of Application: NDA
Candidate: LIQ861
Indication: pulmonary arterial hypertension
Date: Nov. 24

LIQ861 is an investigational, inhaled dry powder formulation of treprostinil designed using Liquidia's novel print technology and engineered with the goal of enhancing deep-lung delivery of treprostinil in PAH patients by means of a convenient, palm-sized dry powder inhaler.

Revance Seeks Clearance For Frown Lines Treatment

Company: Revance Therapeutics Inc RVNC
Type of Application: BLA
Candidate: Daxi
Indication: treatment of moderate to severe glabellar, or frown, lines
Date: Nov. 25

DAXI, or daxibotulinumtoxinA for injection, is a next-gen neuromodulator product.

Can Rhythm Win FDA Backing For Genetically-induced Obesity?

Company: Rhythm Pharmaceuticals Inc RYTM
Type of Application: NDA
Candidate: setmelanotide
Indication: obesity
Date: Nov. 27

Setmelanotide is an investigational, melanocortin-4 receptor agonist, for the treatment of pro-opiomelanocortin deficiency obesity and leptin receptor deficiency obesity, both of which are ultra-rare genetic disorders.

Keytruda Lined Up For Another Approval

Company: Merck & Co., Inc. MRK

Type of Application: sBLA
Candidate: Keytruda
Indication: triple-negative breast cancer
Date: Nov. 28

The sBLA seeks approval for Keytruda in combination with chemotherapy for the treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer, whose tumors express PD-L1. The application was based on the Phase 3 KEYNOTE-355 trial.

The FDA accepted the application on July 30 for priority review.

Y-mAbs Awaits Nod For In-licensed Antibody Treatment For Neuroblastoma

Company: Y-mAbs Therapeutics, Inc YMAB
Type of Application: BLA
Candidate: Naxitamab (trade name Danyelza)
Indication: relapsed/refractory high-risk neuroblastoma
Date: Nov. 30

Naxitamab is an investigational, humanized monoclonal antibody. Y-mAbs had licensed the drug from researchers at Memorial Sloan Kettering Cancer Center.

Adcom Calendar

FDA's Peripheral and Central Nervous System Drugs Advisory Committee will discuss Biogen Inc's BIIB BLA for its Alzheimer's treatment candidate aducanumab. The meeting is scheduled for Nov. 6. Biogen has a lot riding on the successful clearance of aducanumab, given the pressure the company is experiencing in its marketed products such as Spinraza.

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