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

Biotech stocks came under selling pressure in February, although the degree of weakness was not as worse as the broader market, thanks to strong upward moves by stocks that are levered to COVID-19 epidemic.

The FDA approved three new molecular entities, or NMEs, in February, taking the total number of NME approvals for the year-to-date period to six. Notable among the approvals for the month were Agile Therapeutics Inc's AGR contraceptive patch Twirla, Baudax Bio Inc's BXRX non-opioid pain medication Anjeso and Esperion Therapeutics Inc's ESPR cholesterol-lowering therapy Nexletol. Merck & Co., Inc. MRK faced a rejection, as the FDA shot down its application for Keytruda dose updation.

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 scheduled for March.

Bristol-Myers Squibb Seeks Label Expansion For IO Combo In Liver Cancer

• Company: Bristol-Myers Squibb Co BMY
• Type of Application: sBLA
• Candidate: Opdivo+Yervoy
• Indication: advanced hepatocellular carcinoma
• Date: March 10

The FDA accepted Bristol-Myers Squibb's sBLA in November, granting it Breakthrough Therapy Designation and Priority Review, for the treatment of patients with advanced hepatocellular carcinoma, previously treated with sorafenib.

The application was filed based on data from the Opdivo+Yervoy cohort of the Phase 1/2 CheckMate-040 study.

Eton's Epilepsy Drug Approval In Doubt After FDA Request For New Study

• Company: Eton Pharmaceuticals Inc ETON
• Type of Application: NDA
• Candidate: EM-105
• Indication: Epilepsy
• Date: March 17

EM-105 is an innovative formulation of lamotrigine being developed by Acuta Pharma as an adjunctive therapy for partial seizures, primary generalized tonic-clonic seizures, and generalized seizures of Lennox-Gastaut syndrome in patients two years of age and older. Eton has acquired U.S. marketing rights to it.

Lamotrigine is one of the widely used anti-epilepsy medications in the U.S., with annual sales exceeding $700 million.

Updating on the FDA review, Eton said in February the FDA requested Eton and Acuta to make changes to the Dosage and Administration section of the product's prescribing information to simplify the dosing information for intended users. In connection with this, the FDA sought a human factors validation study with the revised labeling to demonstrate that the intended users can prepare and administer the oral suspension safely and effectively.

See Also: GW Pharma's Epidiolex Label Expansion, EU Launch Key Growth Drivers In 2020

Bristol-Myers Squibb MS Drug Acquired Through Celgene Buy Awaits FDA Nod

• Company: Bristol-Myers Squibb
• Type of Application: NDA
• Candidate: Ozanimod
• Indication: Epilepsy
• Date: March 25

Celgene, which is now part of Bristol-Myers Squibb, announced FDA acceptance of its NDA for ozanimod in June, with the investigational asset being evaluated as a treatment option for patients with relapsing form of multiple sclerosis in the U.S.

Ozanimod has also been accepted for review in the EU, with a decision due in the first half of 2020.

Can IntelGenx's Migraine Drug Clear FDA Hurdle After 7-Year Wait?

• Company: IntelGenx Technologies Corp. IGXT
• Type of Application: NDA
• Candidate: Rizaport VersaFilm
• Indication: acute migraines
• Date: March 26

Intelgenx is knocking the FDA door for its migraine drug for the fourth time following three prior rejections. The company's initial regulatory application was filed in June 2013. Rizaport is an oral soluble film formulation of rizatriptan benzoate, the active drug in Maxalt.

Rockwell Medical Seeks Label Expansion For Anemia Drug

• Company: Rockwell Medical Inc RMTI
• Type of Application: sNDA
• Candidate: IV Triferic
• Indication: anemia in chronic kidney disease
• Date: March 28

Rockwell commercially launched Dialysate Triferic mixed with liquid bicarbonate last May to deliver iron to patients via the dialysate. The company is now seeking approval for intravenous formulation of the drug.

Label Expansion of AstraZeneca's Lung Cancer Drug

• Company: AstraZeneca plc AZN
• Type of Application: sBLA
• Candidate: Imfinzi
• Indication: previously untreated extensive-stage small cell lung cancer
• Date: First quarter (estimated to be March 29 based on the FDA acceptance of the application with Priority Review on Nov. 29)