Attention Biotech Investors: Mark Your Calendar For December PDUFA Dates

A majority of verdicts handed down by the FDA in November were positive. Three new molecular entities were approved during the month, taking the total number of NME approvals for the year-to-date period to 45. This is just one short of NME approvals received for the same period last year.

NME approvals are important as they are indicators of innovation in drug research. NMEs are drugs containing an active moiety that has never been approved or marketed in the U.S.

PDUFA date is a binary catalyst that can result in huge stock moves in either direction. It's the date by which the FDA is required to issue its verdict on the approvability/non-approvability of the drug following a review period that can span from six months to 10 months, depending on whether it is a standard review or priority review.

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Here are the key PDUFA dates scheduled for December.

Merck's Wonder Cancer Drug On Track For Another Label Expansion

  • Company: Merck & Co., Inc. MRK
  • Type of Application: supplemental biologic license application
  • Candidate: Keytruda
  • Indication:
  • Date: Dec. 4

Keytruda was evaluated in a two-part Phase 3 trial dubbed KEYNOTE-716 for the adjuvant treatment of patients with completely resected high-risk stage II melanoma. Interim analysis of data from the study released in early August showed statistically significant and clinically meaningful improvement in recurrent-free survival.

Dare Seeks Nod For Its Bacterial Vaginosis Treatment

  • Company: Daré Bioscience, Inc. DARE
  • Type of Application: new drug application
  • Candidate: Dare-BV1
  • Indication: bacterial vaginosis
  • Date: Dec. 7

Dare's NDA for Dare-BVI for the proposed indication of bacterial vaginosis was accepted for priority review on Aug. 9. DARE-BV1 is a unique hydrogel formulation of clindamycin phosphate 2% to treat bacterial vaginosis via a single application.

Can Calliditas' Kidney Inflammation Drug Find Favor With FDA?

  • Company: Calliditas Therapeutics AB (publ) CALT
  • Type of Application: NDA
  • Candidate: Nefecon
  • Indication: IgA nephropathy
  • Date: Dec. 15

Nefecon is a patented oral formulation of budesonide – for targeted release. The formulation is designed to deliver the drug to the Peyer's patch region of the lower small intestine, where the disease originates, as per the predominant pathogenesis models.

Nefecon is derived from the TARGIT technology, which allows for the substance to pass through the stomach and intestine without being absorbed, and to be released in a pulse-like fashion only when it reaches the lower small intestine.

IgA nephropathy, also known as Berger's disease, is a kidney disease that occurs when IgA deposits build up in the kidneys, causing inflammation that damages kidney tissues. IgA is an antibody made by the immune system to protect the body from foreign substances such as bacteria or viruses.

The original PDUFA of Sept. 15 was extended by three months to allow time for review of additional information submitted by the company on estimated glomerular filtration rate, upon FDA's request.

Can Second Time Be Charm For Eagle?

  • Company: Eagle Pharmaceuticals, Inc. EGRX
  • Type of Application: Abbreviated NDA
  • Candidate: Vasopressin
  • Indication: hypotension
  • Date (Generic Drug User Fee Act date): Dec. 15

Eagle is seeking approval for a generic version of Vasostrict, which is marketed by Endo International Plc's ENDP Par unit and had total U.S. sales of $786 million in 2020. The ANDA was accepted for priority review and the FDA rejected the application with a complete response letter in Feb. 2021.

Eagle's response to the CRL was submitted on June 15 and the FDA assigned a GDUFA date of Dec. 15. Contingent on FDA approval, the company expects a commercial launch prior to year-end.

Related Link: 3 Pharma Stocks Morgan Stanley Says Will Be Omicron Variant Beneficiaries

Intra-Cellular Looks Forward To Twp Label Expansion For Depression Drug

  • Company: Intra-Cellular Therapies, Inc. ITCI
  • Type of Application: supplemental NDAs
  • Candidate: Caplyta
  • Indication: bipolar depression
  • Date: Dec. 17

Caplyta, 42mg/day, is an oral, once daily atypical antipsychotic approved for the treatment of schizophrenia of adults. The treatment, which goes by the generic name lumateperone, is currently being evaluated for bipolar depression, depression and other neuropsychiatric and neurological disorders.

The FDA accepted the sNDA seeking approval for lumateperone for depressive episodes associated with bipolar I or II disorder as monotherapy and as adjunctive therapy with lithium or valproate in early May.

Argenx Knocks The FDA Door For Its Antibody Treatment For Autoimmune Disorder Causing Muscle Weakness

  • Company: argenx SE ARGX & Zai Lab Limited ZLAB
  • Type of Application: BLA
  • Candidate: Efgartigimod
  • Indication: generalized myasthenia gravis
  • Date: Dec. 17

Argenx' regulatory application for its lead drug Efgartigimod was accepted for a standard review in early March. It's an investigational antibody fragment designed to reduce disease-causing immunoglobulin G.

Myasthenia gravis is a rare and chronic autoimmune disease, often causing debilitating and potentially life-threatening muscle weakness. There are approximately 65,000 people in the U.S. and 20,000 people in Japan living with the disease

Can Amgen's Otezla Snag Another Approval?

  • Company: Amgen, Inc. AMGN
  • Type of Application: sNDA
  • Candidate: Otezla
  • Indication: plaque psoriasis
  • Date: Dec. 19

Amgen announced FDA acceptance of the application for review on May 5, and this time around, the company has applied for approval of the drug for the treatment of adults with mild-to-moderate plaque psoriasis who are candidates for phototherapy or systemic therapy.

Veru Hopes to Secure FDA Win With Maiden Regulatory Filing

  • Company: Veru, Inc. VERU
  • Type of Application: NDA under 505(b)(2) regulatory pathway
  • Candidate: Tadfin (Tadalafil and Finasteride combo)
  • Indication: benign prostatic hyperplasia
  • Date: Dec. 23

Tadfin, (tadalafil 5mg and finasteride 5mg) capsules, is an oral daily dosing combination formulation for the treatment of benign prostatic hyperplasia, also called as prostate gland enlargement.

Tadfin is Veru's first PDUFA filing and therefore the company received a waiver of the FDA NDA PDUFA filing fees, worth approximately $2.4 million in cost savings, as a first-time filer.

If approved, the company currently plans to launch Tadfin through third-party telemedicine sales channels, and out-licensing opportunities thus eliminating the need for and cost of a direct sales force.

Aquestive Hopes To Clear FDA Hurdle On Second Try

  • Company: Aquestive Therapeutics, Inc. AQST
  • Type of Application: NDA
  • Candidate: Libervant
  • Indication: seizure clusters
  • Date: Dec. 23

Libervant faltered once at the FDA altar, with the receipt of complete response letter for Aquestive's original regulatory filing in September 2020. The regulator had taken exception to certain weight groups showing a lower drug exposure level than desired.

On July 19, Aquestive announced the FDA accepted its resubmission, deeming it as a complete response.

Libervant, if approved by the FDA for U.S. market access, will enable a larger share of patients to receive more appropriate treatment by providing consistent therapeutic dosing in a non-invasive and innovative treatment form for epileptic seizures, the company said.

Bristol-Myers Squibb Seeks Approval For First Preventive Treatment For Acute Graft Versus Host Disease

  • Company: Bristol-Myers Squibb Company BMY
  • Type of Application: sBLA
  • Candidate: Orencia
  • Indication: acute graft versus host disease
  • Date: Dec. 23

Bristol-Myers Squibb is seeking approval for Orencia (abatacept) for the prevention of moderate to severe acute graft versus host disease in patients 6 years of age and older receiving unrelated donor hematopoietic stem cell transplantation.

If approved, Orencia would become the first therapy for the prevention of aGvHD, the company said.

Global Blood Targets Twin Approvals For Its Sickle Cell Disease Drug

  • Company: Global Blood Therapeutics, Inc. GBT
  • Type of Application: sNDA/NDA
  • Candidate: Oxbryta
  • Indication: sickle cell disease
  • Date: Dec. 25

The FDA has accepted for filing and review the company's sNDA, seeking accelerated approval for Oxbryta for the treatment of SCD in children ages 4 to 11 years and its NDA seeking approval for a new age-appropriate dispersible tablet dosage form of Oxbryta suitable for pediatric patients.

Oxbryta, which directly targets hemoglobin polymerization, the root cause of red blood cell sickling in SCD, is currently approved by the FDA in a tablet dosage form to treat SCD in patients age 12 years and older.

Coherus Awaits Nod For Its Humira Biosimilar

  • Company: Coherus BioSciences, Inc. CHRS
  • Type of Application: 351(k) BLA
  • Candidate: CHS-1420
  • Indication: Autoimmune disorders
  • Biosimilar Use Fee Date: December

CHS-1420 is Coherus' biosimilar for AbbVie, Inc.'sABBV best-selling drug Humira. Humira fetched over one-third revenues for AbbVie in the third quarter.

"If approved, Coherus plans to launch the adalimumab biosimilar in the U.S. on or after July 1, 2023, per the terms of an agreement with Humira manufacturer AbbVie," the company said in February, when it announced the acceptance of the BLA.

Adcom Meeting

FDA's Cardiovascular And Renal Drugs Advisory Committee is scheduled to meet on Dec. 8 to discuss Reata Pharmaceuticals, Inc.'s RETA NDA for bardoxolone methyl capsules for the proposed indication of slowing the progression of chronic kidney disease caused by Alport syndrome in patients 12 years of age and older.

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